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

Initial funding of $25 million from the first of four tranches Facility strengthens Kyverna’s financial flexibility, further supporting advancement of its late-stage indications in generalized myasthenia gravis (gMG) and stiff person syndrome (SPS), while also accelerating pre-launch activities Topline data readout of registrational Phase 2 SPS trial now expected in early 2026; narrowed from previous guidance of first half 2026 Nov. 03, 2025 -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX) (“Kyver

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

Oct. 31, 2025 -- IntoCell Inc. (KOSDAQ: 287840), a biotechnology company developing next-generation payload and linker technologies for antibody–drug conjugates (ADCs), and Xcellon Biologics, a U.S.-based contract development and manufacturing organization (CDMO) specializing in ADCs and complex biologics, today announced a strategic collaboration to advance ADC development and manufacturing. Through this collaboration, IntoCell’s proprietary OHPAS drug-linker platform, which includes Duocarmy

Three abstracts accepted for presentation, including one rapid oral abstract session Presentations to highlight ongoing clinical and translational research across PDS Biotechnology’s immunotherapy platforms Oct. 30, 2025 -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that the National Cancer Institute (NCI) will present new clinical dat

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

Oct. 31, 2025 -- Alps Group Inc (the “Company” or “Alps Group”), the parent company of Alps Life Sciences Inc. (“Alps Holdco”), a fully integrated biotechnology research and healthcare platform specializing in predictive, preventive, and precision medicine, and Globalink Investment Inc., a Delaware corporation and a special purpose acquisition company (“Globalink”), today jointly announced the successful completion (“Closing”) of their previously announced business combination (“Business Combin

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 -