Mendra, Inc. (“Mendra”), a biopharmaceutical company built to advance promising therapies for rare disease medicines, utilizing artificial intelligence (AI), today announced its launch in conjunction with the closing of an $82 million oversubscribed Series A financing. The round was co-led by OrbiMed, 8VC, and 5AM Ventures with participation from Lux Capital and Wing VC. Mendra aims to modernize the development and commercialization of rare disease therapies to more efficiently reach patients o

January 21, 2026 Athos Therapeutics, Inc. ("Athos"), an AI software and clinical stage biotechnology company pioneering the development of precision small molecule therapeutics for patients with immune-mediated diseases, announced today that it has been granted US FDA authorization to commence an international Phase 2 clinical trial of ATH-063 in patients with moderately to severely active, biologic-refractory ulcerative colitis. In addition to the main efficacy and safety assessment goals of

January 21, 2026 -- Rosemont Pharmaceuticals Announces License Agreement with Fidelity Biopharma to Market ONTRALFY™ (tizanidine oral solution) for Treatment of Spasticity in Adults. Product will be available nationwide in February Rosemont Pharmaceuticals has announced a license agreement with Fidelity BioPharma Company to market ONTRALFY™ (tizanidine oral solution 2 mg/5 mL) in the United States. Product will be available nationwide in February. ONTRALFY is the first FDA approved oral solut

NeuraLight, the leader in developing precision brain function measures, and Teitur Trophics ApS, a pioneering biotech company developing first-in-class therapeutics for neurodegenerative diseases, today announced that they have entered into a collaboration granting Teitur Trophics access to NeuraLight’s brain function biomarker platform for use in its upcoming clinical trial of TT-P34 in Parkinson’s disease. NeuraLight’s platform provides precise, actionable measures of brain function. The plat

-Initiation of phase 1 portion of the trial planned in 2H 2026 -Phase 2 portion of the trial will initiate development of the elraglusib tablet in specific indications, including refractory melanoma and additional target solid tumor and hematologic cancers -Program builds on early clinical evidence of monotherapy activity observed in immune checkpoint inhibitor (CPI)-refractory metastatic melanoma in a previously completed trial Jan. 21, 2026 -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Act

Infinitopes said Wednesday it closed the second tranche of its seed financing round, raising an additional $15.4 million to bring total proceeds to $35.1 million, as the UK-based biotech prepares to launch a first-in-human study of its lead asset ITOP1 — an 'off-the-shelf' precision cancer vaccine targeting oesophageal cancer recurrence. The latest investment was co-led by Octopus Ventures and new backer Amplify Bio, with participation from new investor Macmillan Cancer Support and existing sup

– No objections raised by FDA to advancement of pilavapadin into Phase 3 development utilizing two-arm registrational studies of 10 mg daily dose compared to placebo – Jan. 21, 2026 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the successful completion of the End-of-Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) for pilavapadin in diabetic peripheral neuropathic pain (DPNP). During the meeting, the FDA raised no objections to the advancement of pilav

Jan. 20, 2026 -- Spur Therapeutics today announced that it will share updated clinical data from its Phase 1/2 GALILEO-1 and GALILEO-2 trials of avigbagene parvec (FLT201), its Phase 3 gene therapy candidate for Type 1 Gaucher disease, in platform and poster presentations at the 22nd Annual WORLDSymposiumTM being held February 2-6, 2026 in San Diego. Details of the platform presentation are below: Title: Two-year follow up of FLT201 AAV gene therapy in adults with Type 1 Gaucher Disease: Resul

- PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus sunitinib combination demonstrating mPFS of 16.5 months and ORR of 46% in patients who had received prior treatment with imatinib - Cogent is expected to initiate the RTOR process immediately; completion of the PEAK NDA submission expected in April 2026 Jan. 20, 2026 -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing

Jan. 20, 2026 -- Olatec Therapeutics, Inc. ("Olatec"), a clinical stage biotechnology company leading the development of specific NLRP3 inhibitors, presented preclinical data at The Michael J. Fox Foundation (MJFF) Parkinson's Disease Research Exchange forum. The studies were supported by funding from MJFF for Parkinson's Research and conducted by Dr. Nadia Stefanova of the Medical University of Innsbruck. The results presented by Dr. Stefanova demonstrated that chronic oral treatment with dapa