BGE-102 was well-tolerated in SAD and initial MAD cohorts, with a pharmacokinetic profile supporting once-daily oral dosing Strong target engagement: BGE-102 achieved 90-98% suppression of IL-1β, a cytokine directly downstream of NLRP3, at Day 14 High brain penetration: BGE-102 doses of 60 mg and higher exceeded target IC90 levels in cerebrospinal fluid (CSF) at Day 14 Company is expanding the Phase 1 trial to include MAD cohorts in participants with obesity and elevated hsCRP, with data anticip

Dec. 04, 2025 -- Merakris Therapeutics, a clinical-stage biopharmaceutical company focused on advancing innovative biologic drug therapies for chronic wounds, announced that it has successfully completed a Type C meeting with the U.S. Food and Drug Administration (FDA). This results in meaningful regulatory alignment for clinical efficacy expectations, potency assay validation strategy, and manufacturing scale-up plans for its lead clinical asset, MTX-001, which is currently being developed f

TARA-002 demonstrates 72% complete response rate at any time in BCG-Naïve patients TARA-002 demonstrates a 69% complete response rate at the 6-month landmark and a 50% complete response rate at the 12-month landmark in BCG-Naïve patients Favorable safety and tolerability profile observed with no Grade 3 or greater treatment-related adverse events reported Company obtained written feedback from FDA on registrational path forward for TARA-002 in BCG-Naïve patients Company remains on track to repor

Phase 3 trial assessed the efficacy and safety of Elevar’s rivoceranib in combination with camrelizumab as a first-line therapy for uHCC The combination continued to show clinically meaningful survival improvement versus sorafenib, a standard first-line treatment for uHCC Elevar plans to resubmit its new drug application for camrelizumab/rivoceranib combination therapy in January 2026 Dec. 03, 2025 -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrate

Dec. 03, 2025 -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the first patient has been dosed in the Phase 1/2 study evaluating CRN09682 in patients with metastatic or locally advanced somatostatin receptor type 2 (SST2)-positive neuroendocrine tumors and other SST2-expressing solid tumors. CRN09682 is the lead candidate from Crinetics’ proprietary nonpeptide drug conjugate (NDC) platform, which leverages the company’s expertise in GPCR drug discovery and small molecule desig

FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026. NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of ketamine. Current worldwide generic ketamine market is estimated at $750

PolarityBio thanks the clinical trial sites and, most importantly, the participants, for making this milestone in DFU biologic therapy development possible Final trial results anticipated in the first quarter of 2026 Dec. 02, 2025 -- PolarityBio©, a clinical-stage biotechnology company focused on addressing unmet needs in wound healing through innovation in autologous regenerative skin multicellular therapy, today announced the successful completion of the COVER DFUS II trial, a Pivotal Phas

sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025 First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA Primary and key secondary endpoints met with high statistical significance (p <0.0001) Favorable recurrence outcomes at one-year follow-up BCC is the most common skin cancer in the US with more than 3 million cases diagnosed annually1 Dec. 02, 2025 -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofron

Dec. 01, 2025 -- Propanc Biopharma, Inc. (Nasdaq: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company developing novel treatments for recurrent and metastatic cancer, today announced that it has submitted a request for a foreign filing license from Spain for two provisional patents detailing new methods to treat resistant cancer and fibrosis. The patents will be filed with IP Australia under Propanc Pty Ltd, the Company’s wholly owned operating subsidiary based in Melbourne, Austral

Dec. 01, 2025 -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces the acceptance of an abstract for poster spotlight (with oral) presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), being held on December 9-12, 2025, in San Antonio, TX. TitleRhenium (186Re) obisbemeda (rhenium nanoliposome, 186RNL) for t