Announcements

LAPIX Therapeutics Doses First Patient-In Phase 1b Clinical Trial of LPX-TI641 for Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA)

01/30/2025

Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 23, 2025 (GLOBE NEWSWIRE) — LAPIX Therapeutics, Inc. (“LAPIX”), a clinical-stage biopharmaceutical company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases based on agonism of TIM (T cell/transmembrane, immunoglobulin, and mucin receptor), today announced the dosing of first subject with its investigational…

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Aro Biotherapeutics Doses First Patient in Phase 1b Trial of ABX1100 in Late-Onset Pompe Disease (LOPD)

01/29/2025

Trial aims to establish safety and provide proof of concept for GYS1 inhibition as promising new treatment strategy in patients with late-onset Pompe disease Dosing milestone extends momentum of ABX1100 development program, with data from normal healthy volunteers to be presented at WORLDSymposium™ in February Excerpt from the Press Release: PHILADELPHIA–(BUSINESS WIRE)–Aro Biotherapeutics, a clinical-stage…

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CG Pharmaceuticals: Progress of U.S. Phase 1b/2 Metastatic Pancreatic Cancer Clinical Trial at the ASCO Gastrointestinal Symposium

01/28/2025

Excerpt from the Press Release: ORINDA, Calif., Jan. 23, 2025 /PRNewswire/ — CG Pharmaceuticals (CG Pharma), a clinical biopharmaceutical company located in the San Francisco Bay Area, was established as an independent entity in 2024 after licensing ivaltinostat from CG Invites. The company has since been conducting various research projects on ivaltinostat in the U.S. including…

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ENVISION Trial Results Published in the February Issue of The Journal of Urology Highlight UGN-102 Achievement of 82.3% Duration of Response at 12 Months Paving the Way for the Potential First FDA-Approved Treatment for LG-IR-NMIBC in June 2025

01/27/2025

ENVISION Reports 79.6% Complete Response Rate at 3 Months, 82.3% Duration of Response at 12 Months, and Consistent Safety Profile Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the 3-month complete response…

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Palisade Bio Completes All Five SAD Cohorts and Advances to MAD Cohorts of Phase 1a/b Study of PALI-2108 for Treatment of Ulcerative Colitis

01/23/2025

Company on track to report topline data in first half of 2025 Positive preliminary data from all five single ascending dose (SAD) cohorts ranging from 15mg to 450mg support safety and tolerability of PALI-2108 Continued progress toward Phase 1b/2a of PALI-2108 trial for the treatment of UC Excerpt from the Press Release: Carlsbad, CA, Jan. 16,…

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Zai Lab Announces Acceptance of New Drug Application for KarXT for the Treatment of Schizophrenia

01/22/2025

SHANGHAI & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults. Excerpt from the Press Release: “There are more than 8 million patients living with schizophrenia in China who face…

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Naveris Announces Expansion of the NavDx® Test in Anal Cancer Molecular Residual Disease Surveillance

01/20/2025

The NavDx test demonstrates high performance in detecting recurrent disease, providing an enhanced and widely accessible surveillance tool for HPV+ anal squamous cell carcinoma patients Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, today announced the expanded commercial availability of the NavDx test for Molecular…

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Mersana Therapeutics Announces Positive Initial Clinical Data from Phase 1 Clinical Trial of Emiltatug Ledadotin (XMT-1660); Initiation of Expansion in Triple Negative Breast Cancer

01/17/2025

– Emiltatug ledadotin observed to be generally well tolerated with differentiated safety and tolerability profile– Promising clinical activity observed in patients with triple-negative breast cancer (TNBC) previously treated with topoisomerase-1 inhibitor (topo-1) ADCs; confirmed responses observed across all enrolled tumor types– First expansion cohort initiated in patients with TNBC previously treated with at least one…

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Tyra Biosciences Receives IND Clearance from FDA to Proceed with Phase 2 Study of TYRA-300 in Non-Muscle Invasive Bladder Cancer (SURF302)

01/16/2025

-TYRA appoints urologic oncologist, Erik Goluboff, M.D., as SVP, Clinical Development to lead NMIBC- Excerpt from the Press Release: CARLSBAD, Calif., Jan. 10, 2025 /PRNewswire/ — Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today that…

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Totus Medicines Announces Successful Completion of a Phase 1 Dose-Escalation Study and Initiation of an Expansion Trial Evaluating TOS-358, a Covalent PI3Ka Selective Therapy for the Treatment of Select Solid Tumors and Appoints Zelanna Goldberg as Chief Medical Officer

01/15/2025

Successfully completed a Phase 1 dose-escalation study demonstrating pan-mutant clinical activity, 95% target engagement and no grade 3 or 4 toxicities at doses as low as 5 mg BID Initiating an expansion trial in breast, endometrial, urothelial and head and neck cancers at 5 & 8 mg BID Appoints Zelanna Goldberg, M.D., M.A.S. as Chief…

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