AusperBio on Thursday said it successfully concluded a $120-million series C financing to advance its portfolio of investigational oligonucleotide therapeutics for chronic hepatitis B (CHB). The latest round was led by an unnamed strategic investor, with new participation from RA Capital Management, alongside existing backers HanKang Capital, Sherpa Capital, InnoPinnacle Fund, Qiming Venture Partners, YuanBio Venture Capital and CDH Investments. Proceeds from the latest round will support the

MZ‑1866 Phase 1/2 UNITE Study is now more than 50% enrolled Aug. 25, 2026 -- Mahzi Therapeutics Inc., a clinical-stage biotechnology company developing precision therapies for neurogenetic disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to MZ-1866, Mahzi's investigational gene therapy for the treatment of Pitt Hopkins syndrome. The designation was granted by the FDA's Office of Orphan Products Development and Off

Aug. 21, 2026 -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Opamtistomig (LBL-024), the Company's proprietary PD-L1/4-1BB bispecific antibody, as a monotherapy for the treatment of previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). Opamtistomig is the first PD-L1/4-1

GSK is looking to expand its COPD biologics franchise beyond IL-5 blockade, kicking off two Phase III studies of its long-acting anti-TSLP antibody felcorekibart (GSK5784283/AIO-001). Sanofi and Regeneron's IL-4/IL-13 inhibitor Dupixent (dupilumab) and GSK's IL-5 inhibitor Nucala (mepolizumab) are currently the only approved biologics for the condition. Earlier this year, CEO Luke Miels singled out felcorekibart as one of the pipeline programmes that could help GSK raise its game (see – Spotli

If at first you don’t succeed in gene therapy, then try, try again. That's the lesson Ultragenyx likely took home this week as it pocketed its first FDA nod in the class just over a year after a separate program stalled on manufacturing grounds. Late Wednesday, the FDA gave an accelerated go-ahead to pariglasgene brecaparvovec-opnr, Ultragenyx’s AAV gene therapy for the rare genetic disorder glycogen storage disease type Ia (GSDIa), which will now head to market with the brand name Genglycos.

Pumitamig plus B7H3-targeting elfetabart drozuntecan delivers the first data in lung cancer for any PD-(L)1xVEGF bispecific immunomodulator combined with an antibody-drug conjugate, underscoring BioNTech’s leadership in novel-novel combination treatment strategies Updated overall survival data for gotistobart from the PRESERVE-003 Phase 3 clinical trial will add to the growing body of evidence for this chemotherapy-free treatment approach in the second- and later-line treatment of advanced squam

Aug. 21, 2026 -- Dizal (SSE: 688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today that the latest clinical data on its novel epidermal growth factor receptor (EGFR) inhibitor ZEGFROVY® (sunvozertinib) in non-small cell lung cancer (NSCLC) will be presented at the 2026 World Conference on Lung Cancer (WCLC) from September 12 to 15 in Seoul, Republic of Korea. ZEGFROVY is approved in China and the U.S.

Designation offers pathway to expedite regulatory review, pending positive data, and reinforces safusidenib's potential to address significant medical needs for patients with IDH1-mutant glioma Pivotal Phase 3 SIGMA study enrollment underway Aug. 20, 2026 -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for safus

IntraGel secures up to $7 million equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer UroGen gains access to IntraGel's biodegradable sustained-release gel platform with broad potential across solid tumors, as well as an exclusive option to acquire worldwide rights to TumoCure Aug. 20, 2026 -- IntraGel Therapeutics, developer of next generation long-acting injectables, today announced an equity investment agreement

FDA raises no objection to the Company's planned Phase 1 program design, dose-escalation approach, or CMC and nonclinical packages; IND submission remains on track for the fourth quarter of 2026 August 20, 2026 / Protagenic Therapeutics, Inc. (OTCQB:PTIX), a clinical-stage biopharmaceutical company developing novel peptide-based treatments for stress-related neuropsychiatric disorders, today announced that it has received written responses from the U.S. Food and Drug Administration (FDA) to its