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

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. 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

~ All patients in the first cohort achieved between 27- to 208-fold increases in α-Gal A activity relative to mean normal level ~ ~ All patients in first cohort discontinued enzyme replacement therapy ~ ~ Preliminary data show AMT-191 has a manageable safety profile at the highest dose ~ ~ Updated clinical results expected in the first half of 2026 ~ Sept. 05, 2025 -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical

Migaldendranib (MGB) is a new class of targeted nanomedicine for the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) with a novel mechanism of action that normalizes VEGF expression. End of study, 40-week results demonstrated that MGB, delivered via subcutaneous (subQ) administration, is safe and well-tolerated with no MGB treatment-related ocular or systemic serious adverse events. This Phase 2 clinical study showed improvements in efficacy outc

-New Preprint: PridCor Therapeutics LLC has released a pre-print detailing a case series of 15 patients with Long COVID (LC) who were given a continuous regimen of 120-days of valacyclovir and celecoxib with a pulsed 15-day treatment of Paxlovid (combination antiviral treatment, or CAR), and these patients were compared to 12 patients with Long COVID who received the 120-day valacyclovir and celecoxib protocol only. This CAR appeared superior to the valacyclovir and celecoxib combination in impr