FDA alignment on Phase 3 ozuriftamab vedotin (Oz-V) trial design, including dosing regimen and endpoints to support potential accelerated approval Company continues preparations for enabling initiation of the Phase 3 study with the goal of advancing the study with a strategic partner early next year Company maintains previous guidance for completion of a strategic partnership with one of our advanced clinical assets this year Sept. 08, 2025 -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-st

Dura Medical, together with pending acquisitions of Neurospa TMS and Cohen & Associates, to provide contiguous coverage at more than 8 locations along Florida’s West Coast, with planned coverage throughout the Florida Peninsula Dura delivers a full range of precision psychiatry services for severe depression and PTSD, including Ketamine Therapy and Transcranial Magnetic Stimulation (TMS), to Veterans and civilian patients Stephen Durand, CRNA, a US Army Veteran and founder of Dura will serve as

Sept. 08, 2025 -- CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that it has made a $5 million strategic minority equity investment in Talphera, Inc. (Nasdaq: TLPH), acquiring 9,090,909 shares at an at-market price of $0.55 per share as part of Talphera’s concurrently announced private placement financing. Talphera expects to use the proceeds of th

Data obtained from ongoing third-party funded, investigator-sponsored trials have been submitted in effort to address the December 2024 complete response letter Company seeks alignment on reasonable path forward for Zynquista NDA resubmission FDA feedback from Type D meeting expected by end of September Sept. 08, 2025 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the Company has submitted additional clinical data to the U.S. Food and Drug Administration (FDA) from ongoin

Spain site opens with two R/R AML subjects enrolled; One treated On track to recruit 45 subjects in 4Q25 for initial data unblinding Sept. 08, 2025 -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, today announced that it has enrolled the first two subjects, and treated one, in the European Union (EU) in its pivotal Phase 2B/3, multi-cente

EGRIFTA WR™ offers convenience of weekly reconstitution and reduced daily injection volume, compared to EGRIFTA SV® Specialty pharmacies are now ordering EGRIFTA WR™ to fill prescriptions Sept. 05, 2025 -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced the availability of EGRIFTA WR™ (tesamorelin) for injection for the reduction of excess abdominal fat in adult patients with HIV and lipodystr

Sept. 05, 2025 -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that an abstract titled “Study of THIO Sequenced with Cemiplimab in 3rd Line Immune Checkpoint Inhibitor-resistant aNSCLC: Improvement in PFS” was selected for poster presentation at the 2025 IASLC World Conference on Lung Cancer (WCLC) taking place September 6–9, 2025, in Barcelona, Spain.

Sept. 07, 2025 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that company’s product, recombinant humanized anti-IL-17A monoclonal antibody (code: JS005) has achieved positive results in a multi-center, randomized, double-blind, parallel, placebo-controlled pivotal registrational Phase 3 clinical study (study n

~Pivotal Launch-HTN trial of novel aldosterone synthase inhibitor lorundrostat enrolled a diverse range of participants with uncontrolled or resistant hypertension~ ~Subgroups - including Black or African American adults, older adults, women, and participants with comorbid obesity – face heightened risk of poor cardiovascular outcomes and represent high unmet need~ ~Lorundrostat demonstrated significant and clinically meaningful blood pressure reductions across all participant subgroups, with a

First dual-acting anti-inflammatory and anti-fibrotic candidate in development for FSCD, a condition with no approved therapies Patient dosing expected to commence in H2 2025; Topline data anticipated in Q1 2026 Continued progress toward Phase 2 IND submissions in Q1 2026 Sept. 05, 2025 -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio,” or the “Company”), a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases