Comprehensive meeting with FDA conducted in Q3 in conjunction with Breakthrough Therapy Designation Key aspects of a potential NDA application discussed and aligned with the Agency Praxis plans to perform an interim analysis of the EMBOLD cohort 2 pivotal trial in Q4 2025, which if positive should serve as the basis of an NDA in early 2026 Nov. 04, 2025 -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the developme

Nov. 03, 2025 -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, after receiving the official minutes from the FDA Type A meeting conducted in September 2025. ONS-5010 is an investigational ophthalmic formulation of bevacizumab which, if appr

Nov. 03, 2025 -- March Biosciences (March Bio), an emerging clinical stage biotechnology company committed to combating challenging cancers and other diseases, today announced that interim clinical data from its ongoing Phase 2 trial of MB-105 will be presented during an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition, being held December 6-9, 2025, in Orlando, Florida. March Bio is developing MB-105, a first-in-class autologous CD5-targeted CAR-T

FDA lifts clinical hold following review of Company’s Complete Response submission. Company expects to restart U.S. enrollment in late 2025 or early 2026 across 20 clinical sites. Early data suggests that LTI-03 may not only slow fibrosis but also promote lung healing. Nov. 03, 2025 -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indicatio

Ongoing Phase 1 APOLLO study investigating MT-601 in patients with relapsed B cell lymphomas showed encouraging preliminary efficacy data MT-601 demonstrated robust safety profile with no dose limiting toxicities (DLTs) or immune-effector cell associated neurotoxicity syndrome (ICANS) in the dose escalation cohort Nov. 03, 2025 -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatm

MHRA response is based on the Phase 3 DRAGON interim analysis results Topline final data expected in Q4 2025 Nov. 02, 2025 -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to accept a Conditional Marketing Authorization application for Ti

Phase 2 clinical trial underway with first patient dosed in October to support a clear path to Phase 3 based on previous alignment with FDA Patients randomized to either 10 or 20 mg/kg of muzastotug, in combination with KEYTRUDA with up to 30 patients per arm Company anticipates trial completion in early 2027, and potential updates in 2026 Additional updates from the ongoing Phase 1b/2 trial with muzastotug, previously reported at ASCO 2025, are anticipated in the coming months Oct. 31, 2025 -

-- Posters will review product characterization and manufacturing data on T-knife’s lead program, TK-6302, a supercharged PRAME T cell receptor therapy that is advancing towards the clinic, with the filing of a Clinical Trial Application planned in Q4 2025 -- PRAME is a validated target and is expressed in cancers of the skin, uterus, ovaries, lungs, breasts, esophagus, kidneys, cervix, and head & neck Oct. 30, 2025 -- T-knife Therapeutics, Inc., a biopharmaceutical company developing T cell r

Oct. 30, 2025 -- Forward Therapeutics, Inc (“Forward”), a biotechnology company developing oral small molecule therapies for inflammation-driven diseases, today announced that the first participants have been dosed in its Phase 1 healthy volunteer trial evaluating FT2109, the company’s second TNF signaling inhibitor in development for chronic inflammatory diseases. FT2109 is a next-generation oral small molecule designed to inhibit TNFR1 signaling by binding to soluble TNF (sTNF), a primary dr

Oct. 28, 2025 -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that negative symptom data for brilaroxazine from the Phase 3 RECOVER double-blind trial in patients with acute exacerbation of schizophrenia, and from the long-term open-label extension trial in