考察健康受试者在空腹条件下单次口服1片由河北一品生物医药有限公司提供的磷酸二氨基吡啶片（受试制剂，规格：10mg）与单次口服1片由SERB S.A.持证的磷酸二氨基吡啶片（参比制剂，商品名：FIRDAPSE®，规格：10mg）的药动学特征，评价两制剂间的生物等效性和安全性，为该受试制剂注册申请提供依据。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral administration of one tablet of diaminopyridine phosphate tablets (test preparation, specification: 10 mg) provided by Hebei Yipin Biotechnology Co., Ltd. and a single oral administration of one tablet of diaminopyridine phosphate tablets (reference preparation, trade name: FIRDAPSE®, specification: 10 mg) certified by SERB S.A. in healthy subjects under fasting conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

Start Date06 May 2025

Sponsor / Collaborator

Hebei Yipin Biopharmaceutical Co., Ltd.

NCT05769478

/ CompletedPhase 1IIT

A Proof of Concept Study of the Effect of Amifampridine (Firdapse®) on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA (Botox®, BTX-A)

if amifampridine can improve neuromuscular transmission in muscles previously injected with OnabotulinumtoxinA (BTX-A)

Start Date15 Sep 2023

Sponsor / Collaborator

Wake Forest School of Medicine

NCT05919407

/ RecruitingPhase 3IIT

IMproving Symptomatic Treatment With Pyridostigmine and Amifampridine: a Randomized Double-blinded, Placebo Controlled Crossover Trial in Patients With Myasthenia Gravis (IMPACT-MG)

A randomized, double-blind, placebo controlled, crossover intervention study evaluating the effect of pyridostigmine (part 1) and amifampridine (part 2) in Myasthenia Gravis (MG).

Start Date22 Mar 2023

Sponsor / Collaborator

Leids Universitair Medisch Centrum

[+1]

100 Clinical Results associated with Amifampridine phosphate

100 Translational Medicine associated with Amifampridine phosphate

100 Patents (Medical) associated with Amifampridine phosphate

910

Literatures (Medical) associated with Amifampridine phosphate

28 Apr 2026·NEUROLOGY

Efficacy and Safety of Amifampridine in Myasthenia Gravis

Article

Author: Verschuuren, Jan J.G.M. ; Badrising, Umesh A. ; Bakker, Wisse R. ; Tannemaat, Martijn R. ; Ruiter, Annabel M. ; Straathof, Chiara S.M. ; van Gelder, Teun ; Moes, Dirk Jan A.R. ; Campman, Yvonne J.M. ; Remijn-Nelissen, Linda

BACKGROUND AND OBJECTIVES:

Amifampridine, a short-acting potassium-channel blocker, is the first-line treatment for Lambert-Eaton myasthenic syndrome. Its benefit as add-on to pyridostigmine in acetylcholine receptor (AChR)-positive myasthenia gravis (MG) has been proposed, but no randomized controlled trials have been conducted. We aimed to evaluate the efficacy and safety of amifampridine in AChR-MG with insufficient symptom control on pyridostigmine.

METHODS:

A randomized, double-blind, placebo-controlled crossover trial was conducted at Leiden University Medical Center, a tertiary center for the treatment of MG in the Netherlands, as part 2 of the IMPACT-MG trial. Eligible patients had either completed part 1 (pyridostigmine vs placebo) or failed the initial 2-day pyridostigmine washout, and had an Myasthenia Gravis Impairment Index (MGII) score >10. Participants were randomized (1:1:1) to 1 of 3 treatment sequences. Each treatment period lasted 5 days, with a 2-day washout between treatments, during which participants received either 30 mg or 60 mg of amifampridine modified release, or placebo. The primary outcome was the difference in MGII score between the 2 amifampridine dosages and placebo. Pharmacokinetics, safety, and tolerability were assessed throughout the trial.

RESULTS:

Between March 2023 and April 2024, 20 patients were enrolled (median age 60 years, 55% female). For the MGII score, the estimated mean differences were -1.0 (95% CI -4.1 to 2.0, p = 0.681) for amifampridine 30 mg vs placebo and -1.7 (95% CI -4.7 to 1.4, p = 0.379) for amifampridine 60 mg vs placebo. No statistically significant association was observed between pharmacokinetic parameters and the MGII. No serious adverse events were reported. Adverse events were more common with amifampridine 30 mg (12 patients [60%]) and 60 mg (15 patients [75%]), compared with placebo (6 patients [30%]), with paresthesia, fatigue, numbness, dizziness, and sleep disturbances most frequently reported. Three patients discontinued amifampridine early due to adverse events.

DISCUSSION:

The addition of amifampridine to pyridostigmine was not superior to treatment with pyridostigmine alone and was associated with a higher incidence of adverse events.

TRIAL REGISTRATION INFORMATION:

The trial was registered at EudraCT (2021-004110-20, registration date: July 12, 2022) and ClinicalTrials.gov (NCT05919407, registration date: June 16, 2023). First patient enrolled: March 23, 2023.

CLASSIFICATION OF EVIDENCE:

This study provides Class I evidence that in patients with AChRAb+ MG, the addition of amifampridine to pyridostigmine was not superior to treatment with pyridostigmine alone and was associated with a higher incidence of adverse events.

01 Jan 2026·FUEL

Co(salen)-based hyper-crosslinked porous ionic polymer as heterogeneous synergistic catalyst for the cycloaddition of CO2 with epoxides

Author: Ji, Hongbing ; Qiu, Yongjian ; Wang, Zhitong ; Lei, Lin ; Chen, Haowen ; Chen, Yaju ; Zhou, Xiaoxue ; Wang, Yating

The incorporation of various active sites with task-specific functions within porous organic polymer is crucial for carbon dioxide (CO₂) capture and catalysis.A bifunctional hyper-crosslinked porous ionic polymer [Co(salen)-HPiP)] bearing Co(salen) complexes and pyridinium ionic liquids was synthesized via a simple and low-cost synthetic method.Co(salen)-HPiP had an improved sp. surface area, good CO₂ adsorption capacity, high CO₂/N₂ adsorption selectivity, high d. of nucleophilic/electrophilic sites (bromide/cobalt ions), and robust physiochem. stability.Co(salen)-HPiP was then employed as a synergistic heterogeneous catalyst for the solvent-additive-free synthesis of cyclic carbonates from CO₂ and epoxides.Thanks to its unique porous structure, high CO₂ affinity and easily accessible dual active sites, Co(salen)-HPiP demonstrated outstanding catalytic performance under mild conditions.To our delight, Co(salen)-HPiP also exhibited good substrate expansibility and robust reusability with retention of catalytic performance.Notably, the intrinsic CO₂/N₂ selective adsorption rendered this catalytic protocol still highly effective for the cycloaddition of the simulated flue gas (15% CO₂ in 85% N₂, volume/volume).This work offers a sustainable strategy for developing multifunctional heterogeneous PiP-based catalysts and presents a promising platform for the chem. fixation of real-world CO₂.

15 Dec 2025·INTERNAL MEDICINE

Long-term Efficacy and Safety of Amifampridine Phosphate (Firdapse<sup>®</sup>) in Japanese Patients with Lambert-Eaton Myasthenic Syndrome (LMS-005 Study)

Article

Author: Yabe, Ichiro ; Tsujino, Akira ; Motomura, Masakatsu ; Igarashi, Yuko ; Fujita, Nobuya ; Hatanaka, Yuki ; Mori-Yoshimura, Madoka ; Utsugisawa, Kimiaki

Objective To evaluate the efficacy and safety of amifampridine (3,4-diaminopyridine) phosphate in Japanese adults with Lambert-Eaton myasthenic syndrome (LEMS). Methods The LMS-005 study was an uncontrolled, single-blind (patient blinded), multicenter, one-year phase 3 clinical study. The administration of amifampridine phosphate was started at 15 mg/day, and the dose was increased every 3 to 4 days to determine the optimal dose for each patient. After 7 days of treatment with the optimal dose, efficacy was assessed by evaluating quantitative myasthenia gravis (QMG), subject global impression (SGI), and Clinical Global Impression-Improvement scale (CGI-I) scores. Patients Adult patients with LEMS were analyzed for safety [n=12, mean age±standard deviation (SD) of 61.1±14.6 years old] and efficacy (n=10, mean age±SD of 60.7±15.9 years old). Results In the efficacy population, the mean±SD [median (interquartile range)] QMG score was 13.2±3.1 [13.5 (11.0, 15.0)] at baseline and 8.0±2.7 [8.0 (6.0, 9.0)] at the end of the treatment period, with a mean±SD [median (interquartile range)] change of -5.2±2.8 [-5.5 (-7.0, -3.0)]. All patients showed a decrease in the QMG score from baseline and experienced improvement in their LEMS symptoms. The SGI/CGI-I scores also improved. Efficacy was maintained until the end of the study. Five patients in the safety population experienced adverse drug reactions, the most common of which was dysesthesia (n=2). Conclusion This study revealed the long-term efficacy and tolerability of amifampridine phosphate in Japanese adults with LEMS.

211

News (Medical) associated with Amifampridine phosphate

13 Aug 2026

·www.biospace.com

Zenas BioPharma Reports Second Quarter 2026 Financial Results and Provides Corporate Update

- Obexelimab BLA submission for the treatment of IgG4-RD accepted by FDA; PDUFA target action date of May 27, 2027 - - New study data confirm bioequivalence of obexelimab single-dose prefilled autoinjector pen compared to prefilled syringes - - Obexelimab global Phase 2 SunStone SLE trial topline results expected in Q4 2026 - - ZB021 (oral IL-17AA/AF inhibitor) dosing ongoing in Phase 1 trial; initial clinical data expected by year-end - - Four Orelabrutinib abstracts accepted for poster presentation at MSToronto 2026 - - Expanded Board of Directors with the appointment of Christy Oliger, who brings more than 30 years of global biopharmaceutical commercial and operating experience - - CFO to transition to Strategic Advisor to the Board Chair at the end of September - - Cash, cash equivalents and investments of $673.9 million as of June 30, 2026 - WALTHAM, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company advancing therapies for patients living with autoimmune and inflammatory diseases, today reported financial results for the quarter ended June 30, 2026, and provided recent corporate updates. "2026 continues to be a transformative year for Zenas, highlighted by FDA acceptance of the obexelimab BLA for the treatment of IgG4-RD, with a PDUFA date of May 27, 2027. Our expanding team is actively preparing for the potential commercialization of our first product," said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. "The strength of the Phase 3 INDIGO data for obexelimab in IgG4-RD was underscored by its selection as an oral presentation at EULAR and simultaneous publication in the New England Journal of Medicine . Beyond IgG4-RD, we are on track to report Phase 2 topline data for obexelimab in SLE and initial Phase 1 data for ZB021 by year-end. We continue to execute across our portfolio and make meaningful progress toward our vision of becoming a fully integrated, global development and commercial-stage biopharmaceutical company that brings impactful treatments to patients living with autoimmune and chronic inflammatory diseases." Corporate highlights Obexelimab, a CD19 and FcγRIIb inhibitor of B cell function In August, the U.S. Food and Drug Administration (FDA) accepted the Company’s Biologics License Application (BLA) for obexelimab for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD): The BLA has a Prescription Drug User Fee Act (PDUFA) target action date of May 27, 2027. Zenas expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second half of 2026. Positive results from the Phase 3 INDIGO registrational trial of obexelimab for the treatment of IgG4-RD presented at EULAR and published in NEJM in June 2026: Additional data from the INDIGO trial presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, and published online by the New England Journal of Medicine . Obexelimab met the primary endpoint, demonstrating a highly statistically significant and clinically meaningful 56% (HR 0.44; 95% CI 0.277–0.711; p=0.0005) reduction in the risk of IgG4-RD flare compared to placebo during the 52-week randomized placebo-controlled period. A majority of patients treated with obexelimab (73.2%) remained flare-free through Week 52, compared to fewer than half (45.4%) of placebo-treated patients. Obexelimab met and demonstrated highly statistically significant activity compared to placebo on all four key secondary endpoints and significantly lowered the total amount of glucocorticoid use and reduced glucocorticoid-related toxicities. Obexelimab was well tolerated, treatment-emergent adverse events (TEAEs) were similar between obexelimab and placebo-treated patients, and the incidence of Grade ≥3 TEAEs and infections were lower with obexelimab compared to placebo. More information on the Phase 3 INDIGO trial (NCT05662241) is available at clinicaltrials.gov. In August, our partner Bristol Myers Squibb announced they submitted a marketing authorization application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for obexelimab for the treatment of IgG4-RD: The application is based on the results of the global Phase 3 INDIGO trial. BMS hold exclusive rights to develop, manufacture and commercialize obexelimab in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia. Bioequivalence established for obexelimab delivered via prefilled syringe versus prefilled pen: New clinical study data confirm bioequivalence between obexelimab delivered via prefilled syringe and single-dose prefilled pen. The single-dose prefilled pen has the potential to offer a more convenient delivery option for patients. Zenas intends to submit a supplemental application to obexelimab's IgG4-RD BLA, if approved, and to include the single-dose prefilled pen and bioequivalence data in a European MAA submission in the second half of 2026. Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) topline results expected in 4Q 2026: Zenas anticipates reporting topline overall and biomarker population results in the fourth quarter of 2026. More information on the Phase 2 SunStone trial (NCT06559163) is available at clinicaltrials.gov. ZB021, a novel oral, IL-17AA/AF inhibitor that blocks IL-17 AA homodimer and IL-17AF heterodimer signaling Dosing ongoing in Phase 1 trial of ZB021 in healthy volunteers: Dosing is ongoing in the single ascending dose (SAD) and now, the multiple ascending dose (MAD) parts of the Phase 1 trial designed to evaluate the safety, tolerability, and pharmacokinetic pro ZB021 in healthy volunteers. The trial is being conducted in partnership with InnoCare Pharma in China. These data are expected by year-end 2026. Upon completion and evaluation of the SAD and MAD study, Zenas plans to initiate a proof-of-concept (POC) trial in North America to evaluate clinical activity and safety in psoriasis patients with results anticipated in 2027. Orelabrutinib, a highly selective CNS-penetrant Bruton’s Tyrosine Kinase (BTK) inhibitor Orelabrutinib Phase 3 PriMroSe Primary Progressive Multiple Sclerosis (PPMS) trial ongoing: PriMroSe, a Phase 3, global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of orelabrutinib in patients with PPMS is ongoing. More information on the Phase 3 PriMroSe trial (NCT07067463) is available at clinicaltrials.gov. Orelabrutinib Phase 3 Monarch non-active Secondary Progressive Multiple Sclerosis (naSPMS) trial ongoing: Monarch, a Phase 3, global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of orelabrutinib in patients with naSPMS is ongoing. More information on the Phase 3 Monarch trial (NCT07299019) is available at clinicaltrials.gov. Four abstracts accepted for MSToronto 2026 including 24-week data and pharmacokinetic analysis from the orelabrutinib Phase 2 relapsing remitting multiple sclerosis trial along with study designs for the Phase 3 Monarch and PriMroSe trials: Efficacy and Safety of Orelabrutinib in Relapsing-Remitting Multiple Sclerosis: 24-Week Results from a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study. Pharmacokinetics of Orelabrutinib in a Phase 2 Study in Relapsing Remitting Multiple Sclerosis. Orelabrutinib in Non-Active Secondary Progressive Multiple Sclerosis: Design of the Monarch Phase 3 Randomized Controlled Trial. Orelabrutinib in Primary Progressive Multiple Sclerosis: Design of the PriMroSe Phase 3 Randomized Controlled Trial. Zenas to host industry-supported symposium at MSToronto 2026: Symposium entitled “BTK Inhibition in MS: An Emerging Therapeutic Approach to Disability Progression” to be chaired and moderated by Amit Bar-Or, MD, FRCP, FAAN, FANA Chief of the Multiple Sclerosis Division, Department of Neurology, Perelman School of Medicine at the University of Pennsylvania. Early development programs ZB022, an oral, brain-penetrant, TYK2-JH2 inhibitor IND enabling studies ongoing: Subject to the results of IND enabling studies, Zenas expects to initiate a Phase 1 clinical study in 2027. ZB014, a half-life extended, anti-CD19 and FcγRIIb monoclonal antibody (mAb) IND enabling studies ongoing : Developed using half-life extension technology for mAbs, and based on preclinical study results, ZB014 has the potential to provide the clinical activity and safety pro with obexelimab while offering a once-monthly dosing schedule. Zenas expects to advance the program into Phase 1 clinical development in 2027. Board of Directors Appointment In August 2026, Zenas appointed Christy Oliger to its Board of Directors. Ms. Oliger brings more than 30 years of commercial and operating experience across global biopharmaceutical organizations, including as Senior Vice President and Business Unit Head, Oncology at Genentech, where she led a portfolio of 15 products representing more than $13 billion in U.S. revenue, and as Senior Vice President and Business Unit Head, Neurology, Rare Disease and Infectious Disease, where she led the teams behind launches in multiple sclerosis, hemophilia and spinal muscular atrophy. She currently serves on the boards of directors of Bicara Therapeutics, Vera Therapeutics, Karyopharm Therapeutics and Replimune Inc., and previously served as a director of Nuvalent Inc., Sierra Oncology, Reata Pharmaceuticals, RayzeBio and LAVA Therapeutics. She began her career in life sciences at Schering-Plough and holds a B.A. in economics from the University of California, Santa Barbara. "We are pleased to welcome Christy to our Board of Directors as Zenas advances toward becoming a commercial-stage company," said Lonnie Moulder, Chief Executive Officer of Zenas BioPharma. "Christy has spent her career building the organizations and capabilities that bring important new medicines to patients and leading the business units behind multiple successful launches. She has since served as a director of numerous public late-stage clinical- and commercial-stage biotechnology companies. Her experience complements our board as we work to deliver potentially transformative therapies to patients with autoimmune and chronic inflammatory diseases." Leadership Transition The Company announced that Jennifer Fox will transition from her current role as Chief Financial Officer and Chief Business Officer to serve in a new role as Strategic Advisor to the Board Chair effective September 30th. Joe Farmer, President and COO, will serve as Principal Financial Officer and Principal Accounting Officer until the appointment of a Chief Financial Officer. “I would like to thank Jennifer Fox, who has played an instrumental role in the development and execution of our growth strategy over the past several years, as we successfully executed several substantial capital raising transactions and significantly expanded our R&D pipeline. I look forward to her future contributions and working with her as a strategic advisor,” said Lonnie Moulder, Chief Executive Officer of Zenas BioPharma. Second quarter 2026 financial results As of June 30, 2026, the Company’s cash, cash equivalents and investments were $673.9 million including $43.2 million aggregate net proceeds in April 2026 from the underwriters’ exercise in full of their over-allotment option for the convertible notes and option to purchase additional shares of common stock from the March 2026 concurrent public offerings. The Company expects that its cash, cash equivalents and investments, as of June 30, 2026, together with the net proceeds of $48.7 million received to date in the third quarter of 2026 from sales under its ATM facility, and assuming receipt of the potential $75 million milestone from Royalty Pharma and $75 million drawn from the debt facility with Pharmakon associated with achieving FDA marketing approval of obexelimab for IgG4-RD, its cash, cash equivalents and investments will fund its operating expenses and capital expenditure requirements at least through the second quarter of 2029. Revenue was $1.0 million for the quarter ended June 30, 2026, related to the achievement of a development milestone pursuant to the Company’s agreement with Tenacia Biotechnology (Hong Kong) Co., Limited associated with ZB005, which were originally licensed from Dianthus Therapeutics. The Company did not recognize revenue for the quarter ended June 30, 2025. Research and development (R&D) expenses were $62.9 million for the quarter ended June 30, 2026, compared to $43.0 million for the quarter ended June 30, 2025. The increase of $19.9 million in R&D expenses was primarily due to an increase in costs related to clinical trial and regulatory costs and an increase in personnel costs including stock-based compensation expense primarily due to an increase in headcount. General and administrative (G&A) expenses were $15.7 million for the quarter ended June 30, 2026, compared to $12.1 million for the quarter ended June 30, 2025. The increase of $3.6 million in G&A expenses was primarily due to an increase in personnel costs, including stock-based compensation expense primarily due to an increase in headcount associated with pre-commercialization activities and other expenses primarily attributable to company growth and continued operations as a public company. Acquired in-process research and development (AIPR&D) expenses were $30.0 million for the quarter ended June 30, 2026, which related to the achievement of a milestone under the Xencor Agreement for the completion of the FDA marketing authorization submission, and for the achievement of one of the near-term regulatory milestones under the InnoCare Agreement. The Company did not recognize AIPR&D expense for the quarter ended June 30, 2025. Other income (expense), net was $3.7 million of expense for the quarter ended June 30, 2026, compared to $3.0 million of income for the quarter ended June 30, 2025. The change of $6.6 million is primarily related to an increase in interest expense related to our royalty obligation, senior secured term loan and convertible senior notes, partially offset by interest income related to higher cash, cash equivalents and investments balances. Net loss was $111.5 million for the quarter ended June 30, 2026, compared to a net loss of $52.2 million for the quarter ended June 30, 2025. About Obexelimab Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique inhibitory mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of the B cell lineage in chronic autoimmune disease. Obexelimab has been evaluated in eight clinical trials in a total of 383 subjects, including INDIGO. Obexelimab was well tolerated and demonstrated clinical activity across these clinical trials. Zenas expects to report topline results from a Phase 2 trial for obexelimab in systemic lupus erythematosus in the fourth quarter of 2026. About ZB021 ZB021 is a novel potentially best-in-class oral small molecule IL-17AA/AF inhibitor being developed by Zenas BioPharma in partnership with InnoCare Pharma. ZB021 is designed to selectively block the signal transduction pathways of both the IL-17AA homodimer and IL-17AF heterodimer, inhibiting downstream pro-inflammatory cytokine and chemokine release. Preclinical studies have demonstrated potent anti-inflammatory activity, a favorable safety profile, and excellent Absorption, Distribution, Metabolism, and Excretion (ADME) properties. The IL-17 pathway has demonstrated broad utility across many rheumatic and dermatologic indications. Currently, no oral IL-17 inhibitors have been approved or are in late-stage development globally. ZB021's oral, small molecule pro offer meaningful advantages over currently approved biologic IL-17 therapies in terms of convenience, compliance, and accessibility. Zenas licensed the exclusive rights from InnoCare Pharma to develop, manufacture, and commercialize ZB021 in all fields of use worldwide, excluding greater China and Southeast Asia. About Orelabrutinib Orelabrutinib is a late-stage, potentially best-in-class, highly selective central nervous system (CNS)-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells in both the periphery and the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in multiple sclerosis (MS). In MS, Zenas is advancing PriMroSe, a Phase 3 trial in Primary Progressive MS (PPMS), and Monarch, a Phase 3 trial in non-active Secondary Progressive MS (naSPMS). Orelabrutinib is approved for B cell malignancies in mainland China and Singapore, marketed by our partner InnoCare. About Zenas BioPharma Zenas is a clinical-stage global biopharmaceutical company focused on the development and commercialization of therapies for autoimmune diseases and inflammatory conditions. Zenas combines our experienced leadership team with a disciplined global product candidate acquisition approach to identify, acquire and develop product candidates with the potential to deliver clinically meaningful benefits to patients. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind CD19 and FcγRIIb to inhibit the activity of B cells implicated in many autoimmune diseases without depleting them. Zenas believes that the unique mechanism of action of obexelimab and its self-administered, subcutaneous injection regimen may enable sustained control across multiple chronic autoimmune diseases. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells not only in the periphery but also within the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in MS. Zenas’ earlier stage programs include ZB021, a novel, potentially best-in-class, oral, IL-17AA/AF inhibitor, ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor, and ZB014, a preclinical, half-life extended anti-CD19 and FcγRIIb monoclonal antibody. For more information about Zenas BioPharma, please visit and follow us on LinkedIn . Zenas BioPharma Forward-Looking Statements This press release contains “forward-looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward looking statements include, but are not limited to, statements regarding the Company’s product candidates, including the timing, progress and results of preclinical studies and clinical trials, including the timing of reporting the topline results from the SunStone trial and the ZB021 SAD and MAD study; the timing of regulatory submissions, including timing of our submission of a MAA to the EMA for obexelimab in IgG4-RD; subject to ZB021 SAD and MAD study results, the initiation of a POC trial of ZB021; the potential for ZB021 to provide meaningful advantages over currently approved biologics; subject to IND studies and clearance, the initiation of Phase 1 clinical studies of ZB014 and ZB022; the potential for ZB014 to provide the clinical activity and safety pro with obexelimab while offering a once-monthly dosing schedule; our ability to draw down on the Pharmakon debt facility; receipt of additional funding under our Royalty Pharma and Pharmakon agreements contingent upon FDA approval of obexelimab; the potential approval and commercialization of obexelimab; our readiness for commercialization; and the Company’s cash guidance. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction; the risk that the data from our clinical trials is not sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a biologics license application or other comparable submission or to obtain regulatory approval for our product candidates for which we seek approval in the U.S. or elsewhere, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; significant political, trade, and regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for obexelimab drug substance and drug product, WuXi Biologics (Hong Kong) Limited, and our partner, InnoCare, both of which are located in China; the risk that the Company’s indebtedness resulting from the Company’s loan agreement with Pharmakon Advisors LP, and the guarantors party to such agreement, or future indebtedness could adversely affect the Company’s financial condition or restrict the Company’s future operations; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as well as other information we the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain, speak only as of the date of this press release and may prove incorrect. These statements are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward-looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. The Zenas BioPharma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies. All rights reserved. Contacts: Investors: Argot Partners Zenas@argotpartners.com Media: Kristin Ainsworth SVP, U.S. Commercial Strategy & Corporate Affairs 612.839.6748 Zenas BioPharma, Inc. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands except share and per share amounts) Three Months Ended June 30, 2026 2025 Revenue: License and collaboration revenue $ 1,000 $ — Total revenue 1,000 — Operating expenses: Research and development 62,913 43,027 General and administrative 15,746 12,136 Acquired in-process research and development 30,000 — Total operating expenses 108,659 55,163 Loss from operations (107,659 ) (55,163 ) Other income (expense), net (3,683 ) 2,960 Income tax provision 114 20 Net loss $ (111,456 ) $ (52,223 ) Net loss per share - basic and diluted $ (1.77 ) $ (1.25 ) Weighted-average common stock outstanding - basic and diluted 63,112,314 41,865,400 Zenas BioPharma, Inc. SELECTED CONSOLIDATED BALANCE SHEET DATA (Unaudited) (in thousands) June 30, December 31, 2026 2025 Cash, cash equivalents and investments $ 673,889 $ 360,464 Total assets 701,690 383,640 Royalty obligation 91,737 78,636 Senior secured term loan, net 74,060 — Convertible senior notes, net 222,956 — Total liabilities 454,593 141,496 Working capital 587,976 288,522 Accumulated deficit (957,571 ) (765,128 ) Total stockholders’ equity 247,097 242,144

05 Aug 2026

·www.biospace.com

Xencor Reports Second Quarter 2026 Financial Results

-- XmAb819 ccRCC expansion cohorts to be presented in an oral session at ESMO 2026; multiple Phase 1 sub-studies in earlier lines of therapy and additional indications now open for enrollment or planned -- -- XmAb942 enrollment in XENITH-UC remains on track with primary endpoint of the 12-week induction period expected in 2H27 -- -- XmAb412 (TL1A x IL23p19) first-in-human healthy participant study open for enrollment -- PASADENA, Calif.--(BUSINESS WIRE)--Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, today reported financial results for the second quarter ended June 30, 2026. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “We are excited to present XmAb819 results at ESMO this fall and for other fast-approaching key milestones across our wholly owned clinical pipeline,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “Enrollment remains on track for updates later this year for XmAb942 in the XENITH-UC study and for our two B-cell depleting bispecifics, plamotamab and XmAb657, in their respective Phase 1 studies. And we recently started the Phase 1 study of XmAb412, our first XenLock™ bispecific antibody, and plan to have healthy participant data in the first half of 2027. Xencor’s focus on clinical execution and data delivery is setting us up for an accelerating tempo of anticipated readouts in 2027 and beyond.” “Consistent with our focus on efficient clinical decision-making, we have prioritized the ongoing combination study of XmAb541 and XmAb808, which provides tumor-targeted co-stimulation through CD28 agonism, after observing moderate anti-tumor activity from early monotherapy data of XmAb541. CLDN6 remains a challenging tumor target, and we hope to expand upon an emerging therapeutic window through the orthogonal targeting provided by XmAb808.” Wholly Owned Pipeline Overview XmAb819 (ENPP3 x CD3), a potential first-in-class, tumor-targeted, T-cell engaging XmAb® 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma and other tumors with high ENPP3 expression, including colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma Clear cell renal cell carcinoma (ccRCC) : On track to initiate a registration enabling study of XmAb819 as a monotherapy in advanced ccRCC during 2027. Phase 1 results for patients with advanced ccRCC were accepted for a proffered paper oral presentation at the European Society For Medical Oncology (ESMO) Congress 2026, to be held October 23-27 in Madrid, Spain. The presentation during ESMO will focus on dose levels in intravenous expansion cohorts under evaluation as recommended Phase 3 doses (RP3D). Dose escalation of subcutaneous administration in advanced ccRCC is ongoing with evaluation for further development expected prior to a registration enabling study. A sub-study for patients with intermediate- or poor-risk advanced ccRCC who have progressed after nivolumab in combination with ipilimumab as a first-line treatment (IO doublet therapy) is planned to open for enrollment in the third quarter of 2026. A sub-study evaluating the combination of XmAb819 and anti-PD1 therapy in patients with advanced ccRCC is currently being planned. Additional tumors with high ENPP3 expression A sub-study for patients with ENPP3+ advanced colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma began enrollment in the second quarter of 2026. XmAb541 (CLDN6 x CD3) in combination with XmAb808 (B7-H3 x CD28), in Phase 1 clinical development for T-cell engagement of Claudin-6 expressing tumors, including high-grade serous ovarian cancer XmAb541 development in the ongoing Phase 1 dose-escalation study in combination with XmAb808 has been prioritized. XmAb541 monotherapy expansion cohorts at the putative RP3D (60 mg dosed every 3 weeks) in high-grade serous ovarian carcinoma (TPS≥50) and germ cell tumors are expected to complete enrollment by year end, with the data supporting combination development with XmAb808. The Phase 1 dose-escalation study of XmAb541 and XmAb808 is ongoing and expected to reach the combination’s target dose range in 2027. Prioritization of the combination is anticipated to reduce projected overall XmAb541 program expense for 2027 and 2028. XmAb541 Clinical Data Emerging data from XmAb541 monotherapy indicate clinical activity to date at the putative RP3D in heavily-pretreated patients, with an approximate 14% overall response rate (ORR) in patients with ovarian cancer and an approximate 28% ORR in patients with germ cell tumors, which supports further evaluation in combination with XmAb808 to provide tumor-targeted CD28 agonism and additional T-cell stimulation. Potential additional anti-tumor activity was observed at doses above 60 mg, but reversible hearing impairment limited XmAb541 drug exposure due to the frequency of dose interruptions and dose reductions. Hearing impairment is potentially on target for CLDN6, which is expressed on cochlear hair cells. Cytokine release syndrome (CRS) has been low grade and no cases of Grade ≥3 CRS were reported at any dose level. At the putative RP3D, Grade 1 CRS was reported in approximately 14% of patients, and Grade 2 CRS was reported in approximately 17%. No other clinically significant safety signals were observed, and the pro supportive of future outpatient administration. Based on monotherapy data, in July 2026 the U.S. FDA granted Fast Track designation to XmAb541 for the treatment of patients with germ cell tumors who have relapsed following two or more lines of platinum therapy or were refractory to prior platinum therapy. At the American Association for Cancer Research Annual Meeting in April 2026, Xencor presented data demonstrating the co-expression of CLDN6 and B7-H3 on high-grade serous ovarian carcinoma cells. Preclinical testing demonstrated that XmAb808 promoted durable T-cell-directed killing of cancer cells with XmAb541, enhanced XmAb541-induced killing by exhausted T cells, and enhanced anti-tumor activity of XmAb541. CLDN6 and B7-H3 have low expression overlap on normal tissues, potentially localizing T-cell co-stimulation to tumor cells. XmAb942 (Xtend™ anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease Xencor is conducting the XENITH-UC Study, a global Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderately to severely active UC, whose disease has progressed after at least one conventional or advanced therapy. Enrollment expectations continue to support a XENITH-UC blinded interim analysis around year-end 2026 and reaching the primary endpoint of the 12-week induction period in 2H27. The primary endpoint of XENITH-UC is the percentage of patients achieving clinical remission defined by the modified Mayo score at week 12. XmAb412 (TL1A x IL23p19), a potential best-in-class, extended half-life bispecific antibody for dual targeting of inflammatory pathways in autoimmune and inflammatory disease, in Phase 1 development and enrolling healthy participants XmAb412 robustly suppresses both TL1A and IL-23 inflammatory pathways and is predicted to have a human half-life between 60 and 70 days. XmAb412 supports high-concentration, low viscosity and citrate-free formulation suitable for subcutaneous dosing. XmAb412 is Xencor’s first novel bispecific antibody developed using the XenLock™ platform. Xencor initiated a first-in-human study of XmAb412 in the third quarter of 2026 and plans to present initial data from the study in 1H27. Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in Phase 1 development for patients with rheumatoid arthritis (RA), who have progressed through prior standard-of-care treatment Xencor plans to provide an update on progress achieved in the Phase 1b study of plamotamab in RA in 2H26. XmAb657 (CD19 x CD3), a clinical-stage, potent, extended half-life B-cell depleting bispecific T-cell engager in Phase 1 dose escalation, enrolling healthy participants and patients with idiopathic inflammatory myopathies, systemic scleroderma and Sjögren’s disease Xencor plans to provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26. Recent Partnership Developments Alexion: In July 2026, Xencor announced that it will receive $105 million from Alexion pursuant to a settlement agreement that resolves the previously disclosed dispute regarding U.S. royalties from sales of Ultomiris®. Under the settlement agreement, Alexion is obligated to pay Xencor in two equal installments. The first $52.5 million payment is anticipated in August 2026, the second $52.5 million payment within 14 days following the one-year anniversary of the date of the settlement agreement, and Alexion will have no further obligation to pay royalties on U.S. sales of Ultomiris. Xencor expects to continue receiving royalties on ex-U.S. sales of Ultomiris under the existing terms of its license agreement with Alexion. Ultomiris is a drug being developed and commercialized by Alexion and is its registered trademark. Zenas BioPharma: In May 2026, Zenas submitted a biologics license application (BLA) to the U.S. FDA for obexelimab in IgG4-related disease, and Xencor received a $10 million regulatory milestone payment in June 2026 in connection with this BLA submission. Obexelimab targets CD19 with its variable domain and uses an XmAb Immune Inhibitor Fc Domain. In November 2021, Xencor licensed obexelimab to Zenas, and under the license agreement, Xencor is eligible to receive up to $450 million in future milestone payments and tiered royalties on net sales that range from mid-single-digit to mid-teen percentages, dependent on geography. Financial Guidance: Based on current operating plans, Xencor expects to end 2026 with between $420 million and $440 million in cash, cash equivalents and marketable debt securities, and to have sufficient cash resources to fund research and development programs and operations through 2028. Financial Results for the Second Quarter Ended June 30, 2026 Cash, cash equivalents and marketable debt securities totaled $486.4 million as of June 30, 2026, compared to $610.8 million as of December 31, 2025. Revenue for the second quarter ended June 30, 2026 was $51.2 million, compared to $43.6 million for the same period in 2025. Revenue earned in the second quarter of 2026 was primarily milestone revenue from Zenas BioPharma and royalty revenue from Alexion and Incyte. As the Settlement Agreement with Alexion resolved the uncertainty surrounding the variable consideration associated with U.S. Ultomiris royalties, the Company recognized $27.6 million of royalty revenue during the second quarter ended June 30, 2026, representing royalty attributable to U.S. Ultomiris sales during the dispute period through June 30, 2026. The remaining $77.4 million of settlement consideration relates to royalty rights for periods subsequent to June 30, 2026 and will be recognized in the third quarter of 2026. Research and development (R&D) expenses for the second quarter ended June 30, 2026 were $71.9 million, compared to $61.7 million for the same period in 2025. Increased R&D spending for the second quarter of 2026 compared to 2025 is primarily due to increased spending on pipeline programs, partially offset by lower stock-based compensation expense. General and administrative (G&A) expenses for the second quarter ended June 30, 2026 were $16.4 million, compared to $15.1 million for the same period in 2025. G&A spending for the second quarter of 2026 compared to 2025 remained relatively consistent. Other income, net, for the second quarter ended June 30, 2026 was $15.1 million, compared to $2.1 million for the same period in 2025. Increased other income, net, for the second quarter of 2026, compared to 2025, is primarily due to unrealized gains on an equity security. Net loss attributable to Xencor for the second quarter ended June 30, 2026 was $21.7 million, or $(0.29) on a fully diluted per share basis, compared to net loss of $30.8 million, or $(0.41) on a fully diluted per share basis, for the same period in 2025. About Xencor Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of patients with cancer and autoimmune diseases. More than 20 candidates engineered with Xencor's XmAb ® technology are in clinical development, and multiple XmAb medicines are marketed by partners. Xencor’s XmAb engineering technology enables small changes to a protein’s structure that result in new mechanisms of therapeutic action. For more information, please visit . Forward-Looking Statements Certain statements contained in this press release may constitute forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “indicates,” “supports,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding our expectations regarding regulatory and partnership milestone achievements, clinical pipeline advancements, planned receipt and presentations of clinical data, including the expected timing thereof, and planned and ongoing clinical trials, including the expected timing thereof, projected financial resources and financial guidance, including estimated cash, cash equivalents and marketable debt securities at year end and cash runway for research and development programs and operations, expectations for and estimates of future royalty revenues, the quotations from Xencor's president and chief executive officer, and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics, the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments, the risk of loss of key members of management, the risk that the fair value of our marketable equity securities will decline and the risks, uncertainties and other factors described under the heading “Risk Factors” in Xencor's Annual Report on Form 10-K for the year ended December 31, 2025 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Xencor undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. Xencor, Inc. Selected Consolidated Balance Sheet Data (in thousands) June 30, December 31, 2026 2025 (unaudited) Cash, cash equivalents and marketable debt securities $ 486,350 $ 610,833 Other current assets 145,398 164,590 Other long-term assets 93,212 100,072 Total assets $ 724,960 $ 875,495 Liabilities related to the sales of future royalties $ 104,895 $ 119,749 Other current liabilities 54,507 52,640 Non-current lease and other liabilities 62,330 67,519 Total liabilities 221,732 239,908 Total stockholders' equity 503,228 635,587 Total liabilities and stockholders’ equity $ 724,960 $ 875,495 Xencor, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share amounts) Three Months Ended J une 30, Six Months Ended June 30, 2026 2025 2026 2025 (Unaudited) Revenue Collaborations, milestones, and royalties $ 51,221 $ 43,608 $ 55,737 $ 76,340 Operating expenses: Research and development 71,905 61,665 136,574 120,243 General and administrative 16,384 15,115 34,093 32,452 Total operating expenses 88,289 76,780 170,667 152,695 Operating loss (37,068 ) (33,172 ) (114,930 ) (76,355 ) Total other income (expense) 15,149 2,097 (35,625 ) (2,985 ) Loss before income tax expense (benefit) and noncontrolling interest (21,919 ) (31,075 ) (150,555 ) (79,340 ) Income tax (benefit) expense (190 ) (250 ) 90 117 Net loss including noncontrolling interest (21,729 ) (30,825 ) (150,645 ) (79,457 ) Net loss attributable to noncontrolling interest — — — (214 ) Net loss attributable to Xencor, Inc. $ (21,729 ) $ (30,825 ) $ (150,645 ) $ (79,243 ) Net loss per share attributable to Xencor, Inc. (basic and diluted) $ (0.29 ) $ (0.41 ) $ (1.99 ) $ (1.07 ) Weighted-average shares used in calculating net loss per share (basic and diluted) 75,859 74,279 75,555 73,975 Other comprehensive income (loss), net of tax: Net unrealized (loss) gain on marketable debt securities (899 ) (97 ) (2,448 ) 921 Comprehensive loss (22,628 ) (30,922 ) (153,093 ) (78,536 ) Less: comprehensive loss attributable to the noncontrolling interest — — — (214 ) Comprehensive loss attributable to Xencor, Inc. $ (22,628 ) $ (30,922 ) $ (153,093 ) $ (78,322 ) Contacts For Investors: Charles Liles cliles@xencor.com (626) 737-8118 For Media: Cassidy McClain Inizio Evoke cassidy.mcclain@inizioevoke.com (619) 694-6291

Phase 1License out/inPhase 2Financial StatementFast Track

19 Jul 2026

·www.biospace.com

Zenas BioPharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - July 17, 2026

WALTHAM, Mass., July 17, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced that on July 15, 2026 (the “Grant Date”), the Compensation Committee of the Company’s Board of Directors granted non-qualified stock options to purchase an aggregate of 35,750 shares of the Company’s common stock (“Stock Options”) and an aggregate of 79,050 restricted stock units of the Company’s common stock (“RSUs”) to newly hired employees of the Company as an inducement material to such employees’ entry into employment with the Company, in accordance with Nasdaq Listing Rule 5635(c)(4) (the “Inducement Grant”). The Stock Options have a ten-year term and an exercise price per share of $29.41, which is equal to the closing price of Zenas’ common stock on the Grant Date. The Stock Options will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of each of the employees’ first day of employment with the Company, and thereafter the remainder of the option will vest in 36 equal monthly installments. The RSUs will vest in four (4) equal installments over a four-year period, with vesting as to twenty-five percent (25%) of the RSUs subject to the award on each of July 15, 2027, July 15, 2028, July 15, 2029 and July 15, 2030. Inducement Grants are subject to the employees’ continued service with Zenas through the applicable vesting dates. The Inducement Grants were granted pursuant to, and are subject to, the terms and conditions of the Company’s 2026 Inducement Plan and the applicable award agreement. About Zenas BioPharma, Inc. Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells not only in the periphery but also within the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in MS. Zenas’ earlier stage programs include ZB021, a novel, potentially best-in-class, oral, IL-17AA/AF inhibitor, ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor, and ZB014, a preclinical, half-life extended anti-CD19 and FcγRIIb monoclonal antibody. For more information about Zenas BioPharma, please visit and follow us on LinkedIn . ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The Zenas BioPharma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies. All rights reserved. Investor and Media Contact: Argot Partners Zenas@argotpartners.com

100 Deals associated with Amifampridine phosphate

External Link

KEGG	Wiki	ATC	Drug Bank
D10689	Amifampridine phosphate	N07XX05	DB11640

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Lambert-Eaton Myasthenic Syndrome	European Union	SERB SA	23 Dec 2009
Lambert-Eaton Myasthenic Syndrome	Iceland	SERB SA	23 Dec 2009
Lambert-Eaton Myasthenic Syndrome	Liechtenstein	SERB SA	23 Dec 2009
Lambert-Eaton Myasthenic Syndrome	Norway	SERB SA	23 Dec 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myasthenia Gravis	Phase 3	United States	Catalyst Pharmaceuticals, Inc.	18 Apr 2018
Myasthenic Syndromes, Congenital	Phase 3	United States	Catalyst Pharmaceuticals, Inc.	01 Jan 2016
Juvenile Spinal Muscular Atrophy	Phase 2	Italy	Catalyst Pharmaceuticals, Inc.	21 Jan 2019
Muscle Weakness	Phase 2	Italy	Catalyst Pharmaceuticals, Inc.	02 Oct 2015
Botulism	Preclinical	United States	Wake Forest Institute for Regenerative Medicine	15 Nov 2022
Bulbo-Spinal Atrophy, X-Linked	Preclinical	United States	Catalyst Pharmaceuticals, Inc.	-
Multiple Sclerosis	Discovery	United States	BioMarin Pharmaceutical, Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05919407 (IMPACT-MG, Pubmed \| Neurology)	Phase 2	Myasthenia Gravis acetylcholine receptor (AChR) positive	20	Amifampridine 30 mg	xwiovkagzx(cqakhxvprs) = gkfvwgxkrl itzwdbznen (attrjjapyi ) View more	Negative	28 Apr 2026
				Amifampridine 60 mg	xwiovkagzx(cqakhxvprs) = sbvgxnwzxj itzwdbznen (attrjjapyi ) View more
NCT03579966 (CTgov)	Phase 3	Myasthenia Gravis	63	amifampridine (Treatment Emergent Adverse Events)	possgvyrmd = mhrmythucv fdfpimdhlm (wrefqhqpov, nrxhsraihr - cbadfgxciv)	-	07 May 2024
				amifampridine (Serious Adverse Event)	welhgxrckz(uinxulhfxa) = yccgqytkbe zdebmsilpk (kvujyoibhw, gnwssiefoj - psyglcuwnq) View more
NCT03819660 (SMA3, CTgov)	Phase 2	Juvenile Spinal Muscular Atrophy	13	Amifampridine Phosphate 10 MG Oral Tablet	jdcycezspf = oqdiodbcuf bqnrhrgqit (ypictajyvh, lbrbrxkcrh - stffltizou) View more	-	30 Nov 2023
NCT03304054 (CTgov)	Phase 3	Myasthenia Gravis	93	Amifampridine Phosphate (Amifampridine Phosphate - MuSK)	xtaiwitqqb(iabbmtapms) = fjcfeqfdtd xnhkwpselp (jkmegdalss, 2.915) View more	-	13 Aug 2021
				Placebo+amifampridine phosphate (Placebo - MuSK)	xtaiwitqqb(iabbmtapms) = chlgnnawlt xnhkwpselp (jkmegdalss, 2.103) View more
NCT03781479 (SMA-001, CTgov)	Phase 2	Juvenile Spinal Muscular Atrophy	13	Amifampridine Phosphate (Amifampridine Phosphate)	tnyqyygeyx(gjxsjdwgvv) = umymsgwbvr ucooclvasq (rjtvyhzwib, 0.326)	-	01 Jun 2021
				placebo+amifampridine (Placebo)	tnyqyygeyx(gjxsjdwgvv) = osuqudtqyc ucooclvasq (rjtvyhzwib, 0.326) View more
NCT02090725 (3-4DAP, CTgov)	Phase 2	Lambert-Eaton Myasthenic Syndrome \| Muscle Weakness	4	3-4 Diaminopyridine	zkxqqqahpk = wpzdeeseeo wzyvgwopkw (ajpqevvtot, lezhgtloyw - gwidcuobxl) View more	-	21 May 2019
NCT02970162 (Pubmed) Manual	Phase 3	Lambert-Eaton Myasthenic Syndrome	26	Amifampridine	xpdlerhgts(iteksjuwuh) = Other measures of efficacy, including Clinical Global Impression-Improvement, 3TUG, and QMG limb domain score also improved. ynhbeshjdd (aiqoxqgczd ) View more	Positive	01 Mar 2019
				Placebo
NCT02970162 (CTgov)	Phase 3	Lambert-Eaton Myasthenic Syndrome	26	Amifampridine Phosphate (Amifampridine Phosphate)	qgyzpzoshm(sscyslbmlb) = dpfzwgssvq kwdewwrqur (tfxtbejpzb, 4.20) View more	-	24 Dec 2018
				Placebo Oral Tablet (Placebo (for Amifampridine Phosphate))	qgyzpzoshm(sscyslbmlb) = sucurohuss kwdewwrqur (tfxtbejpzb, 5.43) View more
NCT01377922 (CTgov)	Phase 3	Lambert-Eaton Myasthenic Syndrome	38	Placebo (Placebo)	heliffyjyj(lkvxuxiepg) = qwqqffggsh gkkhccksjr (eevpboyrrf, 3.99) View more	-	04 Jan 2018
				Amifampridine Phosphate (Amifampridine Phosphate)	heliffyjyj(lkvxuxiepg) = gagaxayooq gkkhccksjr (eevpboyrrf, 3.22) View more
NCT01511978 (DAPPER, CTgov)	Phase 2	Lambert-Eaton Myasthenic Syndrome	32	3,4-Diaminopyridine (3,4-DAP) (Continuous 3,4-Diaminopyridine (3,4-DAP))	upllpglgjb = njwxhrvwdb lquvmlmzfp (myapifwffk, qvcxikvyjt - yxashaygrr) View more	-	11 Jul 2017
				Placebo (3,4-DAP Taper to Placebo)	upllpglgjb = eaglgsdlsx lquvmlmzfp (myapifwffk, sanewxrldq - qaikrvuglg) View more

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