On track to initiate TRX319 Phase 1/2a dose-escalation trial in early 2026 TRX319 is an allogeneic CAR-Tr1 Treg cell therapy designed to pair targeted B-cell control with active anti-inflammatory signaling and pathogenic T-cell modulation in a CNS-penetrant package $50 million in venture financing extends cash runway into 2027, allowing Tr1X to advance the TRX319 Phase 1/2a study and the ongoing TRX103 Phase 1/2a trial for patients with refractory Crohn’s disease Oct. 14, 2025 -- Tr1X, a clini

Dec. 03, 2025 -- BioNexus Gene Lab Corp. (NASDAQ: BGLC) ("BGLC" or the "Company"), a biotechnology company advancing precision diagnostics and gene-based technologies, today announced the formal completion of its strategic transaction with Fidelion Diagnostics Pte. Ltd. ("Fidelion") and Tongshu Biotechnology. With the closing of the agreements, BGLC has become a strategic shareholder in Fidelion Diagnostics and secured exclusive commercial rights for the VitaGuard™ Tumor-Naïve Minimal Residual

TARA-002 demonstrates 72% complete response rate at any time in BCG-Naïve patients TARA-002 demonstrates a 69% complete response rate at the 6-month landmark and a 50% complete response rate at the 12-month landmark in BCG-Naïve patients Favorable safety and tolerability profile observed with no Grade 3 or greater treatment-related adverse events reported Company obtained written feedback from FDA on registrational path forward for TARA-002 in BCG-Naïve patients Company remains on track to repor

Dec. 02, 2025 -- Citizen Health today announced a new strategic partnership with UCB, a global biopharmaceutical leader in neurological and autoimmune research and development. The multi-year collaboration launches with a focus on epilepsy and five rare disease indications. By combining Citizen Health’s advanced AI-driven patient insights and advocacy networks with UCB’s expertise in drug development, the partnership aims to help deliver faster, more patient-centered solutions. Citizen Health

Phase 3 trial assessed the efficacy and safety of Elevar’s rivoceranib in combination with camrelizumab as a first-line therapy for uHCC The combination continued to show clinically meaningful survival improvement versus sorafenib, a standard first-line treatment for uHCC Elevar plans to resubmit its new drug application for camrelizumab/rivoceranib combination therapy in January 2026 Dec. 03, 2025 -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrate

Dec. 03, 2025 -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has received a formal pre-New Drug Application (“NDA”) meeting minutes from the U.S. Food and Drug Administration (“FDA”) supporting the NDA submission of D-PLEX100, the Company’s lead product candidate for the prevention of surgical site infections in abdominal colorectal surgeries. The FDA agreed that the Company’s existing cli

Dec. 03, 2025 -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the first patient has been dosed in the Phase 1/2 study evaluating CRN09682 in patients with metastatic or locally advanced somatostatin receptor type 2 (SST2)-positive neuroendocrine tumors and other SST2-expressing solid tumors. CRN09682 is the lead candidate from Crinetics’ proprietary nonpeptide drug conjugate (NDC) platform, which leverages the company’s expertise in GPCR drug discovery and small molecule desig

Extends cash runway through at least the first half of 2028 Led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners and Squadron Capital Management Dec. 02, 2025 -- Pasithea Therapeutics Corp. (“Pasithea” or the “Company”) (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for the treatment of neurofibrom

FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026. NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of ketamine. Current worldwide generic ketamine market is estimated at $750

PolarityBio thanks the clinical trial sites and, most importantly, the participants, for making this milestone in DFU biologic therapy development possible Final trial results anticipated in the first quarter of 2026 Dec. 02, 2025 -- PolarityBio©, a clinical-stage biotechnology company focused on addressing unmet needs in wound healing through innovation in autologous regenerative skin multicellular therapy, today announced the successful completion of the COVER DFUS II trial, a Pivotal Phas