– 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

Immunomic Therapeutics, Inc. (“ITI”), a privately held clinical-stage biotechnology company pioneering nucleic acid-based immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has cleared ITI’s Investigational New Drug (IND) application for ITI-5000. This clearance allows ITI to initiate the first-in-human clinical trial evaluating ITI-5000, a UNITE®-based self-amplifying RNA vaccine, as monotherapy and in combination with pembrolizumab (Keytruda®), in patients with Sta

The European Commission approved Bayer's higher-dose version of Eylea (aflibercept) for the treatment of patients with visual impairment due to macular oedema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion. The clearance, announced Friday, marks the third indication for the 8-mg formulation of the VEGF inhibitor. The EU approval "expands the range of retinal indications for Eylea 8 mg – now encompassing wet age-related macular degeneration, diabe

Based on the topline results from the EPCORE® DLBCL-1 trial, AbbVie along with partner Genmab will engage global regulatory authorities to discuss next steps Jan. 16, 2026 -- AbbVie (NYSE: ABBV) today announced topline results from the Phase 3 EPCORE® DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, compared to investigator's choice of chemoimmunotherapy in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL)

The Preston Robert Tisch Brain Tumor Center grants first IRB approval for APTN-101’s Phase I clinical trial, enabling patient recruitment to begin APTN-101, the Company’s Brain Bispecific T cell Engager (BRiTE), yields precise and potent anti-tumor activity by redirecting T cells to bind and destroy cancer cells in the brain Dose-response efficacy and favorable safety profile observed by Duke University scientists in preclinical studies Jan. 20, 2026 -- Adaptin Bio, Inc. (“Adaptin” or the “Com

Jan. 20, 2026 -- Tanabe Pharma America, Inc., the wholly owned subsidiary of Tanabe Pharma Corporation, today announced positive topline efficacy and safety results from the global Phase 3 clinical trial, also known as the INSPIRE study, of investigational dersimelagon (MT-7117), a selective melanocortin-1 receptor (MC1R) agonist, being developed for the oral treatment of adult and adolescent patients with erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). EPP and XLP are ra

Jan. 16, 2026 -- Curonix LLC, a leading medical technology company dedicated to relieving chronic pain, today announced the commercial availability of the Freedom® PNS System for the treatment of chronic craniofacial pain. Freedom PNS is now the first and only PNS System in the United States available for this indication and supported by data from an FDA-approved Investigational Device Exemption (IDE) clinical study, allowing a greater patient population to benefit from PNS therapy. Craniofaci