BGE-102 was well-tolerated in SAD and initial MAD cohorts, with a pharmacokinetic profile supporting once-daily oral dosing Strong target engagement: BGE-102 achieved 90-98% suppression of IL-1β, a cytokine directly downstream of NLRP3, at Day 14 High brain penetration: BGE-102 doses of 60 mg and higher exceeded target IC90 levels in cerebrospinal fluid (CSF) at Day 14 Company is expanding the Phase 1 trial to include MAD cohorts in participants with obesity and elevated hsCRP, with data anticip

Dec. 04, 2025 -- Denali Therapeutics Inc. (Nasdaq: DNLI) and Royalty Pharma plc (Nasdaq: RPRX) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa. Tividenofusp alfa is Denali’s lead investigational TransportVehicle™-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome). A Biologics License Application (BLA) for accelerated approval of tividenofusp alfa is under review by

Dec. 04, 2025 -- Merakris Therapeutics, a clinical-stage biopharmaceutical company focused on advancing innovative biologic drug therapies for chronic wounds, announced that it has successfully completed a Type C meeting with the U.S. Food and Drug Administration (FDA). This results in meaningful regulatory alignment for clinical efficacy expectations, potency assay validation strategy, and manufacturing scale-up plans for its lead clinical asset, MTX-001, which is currently being developed f

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