Industry News

Noema Pharma Announces Recruitment of First Patient in Orpheus Phase 2b Study of PDE10A Inhibitor gemlapodect in Adults with Childhood Onset Fluency Disorder

08/09/2022

Study evaluating the safety and efficacy of gemlapodect (NOE-105) in adults with Childhood Onset Fluency Disorder (also known as stuttering) Top-line data expected in Q4 2023 Excerpt from the Press Release: BASEL, Switzerland and BOSTON, Aug. 04, 2022 (GLOBE NEWSWIRE) — Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today…

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Astria Therapeutics Announces Initiation of Phase 1a Trial of STAR-0215, a Monoclonal Antibody Inhibitor of Plasma Kallikrein for Treatment of Hereditary Angioedema

08/09/2022

— Preliminary Results from the Phase 1a Trial Anticipated by Year-End — Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for hereditary angioedema and focused on life-changing therapies for rare and niche allergic and immunological diseases, today announced initiation of a Phase 1a clinical trial of STAR-0215 in…

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UPDATE — Rain Therapeutics Announces Completion of Enrollment in Phase 3 MANTRA Trial for Milademetan in Liposarcoma

08/09/2022

– Phase 3 MANTRA trial completed enrollment five months ahead of previous guidance – – MANTRA topline data anticipated in 1H 2023 – – Management to host 2Q 2022 Earnings Call today at 5:00 PM Eastern Time – Excerpt from the Press Release: NEWARK, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) — Rain Therapeutics Inc. (NasdaqGS:…

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Cyclerion Therapeutics Announces Positive Topline Clinical Data for CY6463 in Patients with Cognitive Impairment Associated with Schizophrenia (CIAS)

08/08/2022

Study data demonstrate positive effects of CY6463 on cognition and inflammation after two weeks of dosing in patients with stable schizophrenia on standard of care Oral, once-daily CY6463 was well tolerated, with no reports of serious adverse events (SAEs) or treatment discontinuation due to adverse events (AEs) Data demonstrate the translation of sGC multi-dimensional pharmacology…

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Cortexyme Successfully Completes Phase 1 Single and Multiple Ascending Dose Clinical Trial of COR588

08/08/2022

Once daily dose of COR588 over 10-day period well-tolerated with no serious adverse events observed Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company focused on advancing therapeutics for rare and degenerative diseases, today reported the successful completion of its Phase 1 single ascending dose and multiple…

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IDEAYA Announces IDE397 Clinical Program Update and ctDNA Molecular Responses Demonstrating Tumor Pharmacodynamic Modulation

08/08/2022

Initiated monotherapy expansion cohorts with enrollment open for NSCLC and esophagogastric tumors with MTAP deletion Initiated combination dose escalation cohorts with enrollment open for combinations with taxanes and separately, with potential first-in-class combinations, including pemetrexed Entered into Clinical Trial Collaboration and Supply Agreement with Amgen to clinically evaluate IDE397 in combination with AMG 193, Amgen’s…

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Certara Announces Collaboration with Leading Cancer Center to Advance CAR T-cell Therapies

08/04/2022

Certara and Memorial Sloan Kettering Cancer Center to develop biosimulation platform for CAR T-cell therapies Excerpt from the Press Release: PRINCETON, N.J., July 28, 2022 (GLOBE NEWSWIRE) — Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced a 2-year collaboration with Memorial Sloan Kettering Cancer Center (MSK) to develop new biosimulation software. Certara…

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Bristol Myers Squibb Provides Update on CheckMate -914 Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) as Adjuvant Treatment of Localized Renal Cell Carcinoma

08/04/2022

Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that Part A of the Phase 3 CheckMate -914 trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as an adjuvant treatment for patients with localized renal cell carcinoma (RCC) who have undergone full or partial removal of the kidney and who are at moderate or high risk…

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Enanta Pharmaceuticals Announces Positive Data from a Phase 1 Clinical Study of EDP-235, its Oral 3CL Protease Inhibitor Designed for the Treatment of COVID-19

08/04/2022

– 200mg and 400mg Once-Daily Doses Achieved Strong Exposure Multiples Over EC90 and Were Generally Safe and Well-Tolerated – Plan to Initiate Phase 2 Study in 4Q 2022 Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating novel, small molecule drugs for viral infections and liver…

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Acer Therapeutics and Relief Therapeutics Announce ACER-001 IND Submission for the Treatment of Maple Syrup Urine Disease

08/03/2022

Phase 2a trial initiation planned for the first half of 2023 subject to IND clearance and available capital Excerpt from the Press Release: NEWTON, Mass. and GENEVA, Switzerland, July 28, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today…

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