Industry News

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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Adamis Pharmaceuticals Provides Update on Clinical Study Assessing Tempol for the Treatment of COVID-19

08/03/2022

Interim DSMB review expected in late September Excerpt from the Press Release: SAN DIEGO, July 29, 2022 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today provided an update on the Company’s ongoing U.S. Phase 2/3 clinical trial to evaluate the safety and efficacy of Tempol as a treatment for COVID-19. The next Data Safety Monitoring Board…

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National Cancer Institute Prostate Cancer Screening Study Indicates QTscan® Has Equal or Better Sensitivity Than MRI

08/03/2022

Excerpt from the Press Release: NOVATO, Calif., July 28, 2022 /PRNewswire/ — QT Imaging, Inc., a medical device company focused on the development and clinical adoption of novel products for body imaging, today announced results of a National Cancer Institute study comparing the QTscan with 7-Tesla MRI for prostate cancer screening. In an initial series of 10 patients,…

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Ionis announces enrollment completion of Phase 3 Lp(a) HORIZON cardiovascular outcomes study of pelacarsen

08/02/2022

Pelacarsen is a potentially first-in-class treatment specifically targeting elevated lipoprotein(a) (Lp(a)), an independent, inherited and causal risk factor for cardiovascular disease There are currently no approved pharmacological therapies to effectively lower Lp(a), which cannot be effectively addressed by diet and other lifestyle changes Topline results expected 2025 Excerpt from the Press Release: CARLSBAD, Calif., July 20, 2022 /PRNewswire/ — Ionis Pharmaceuticals,…

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Belite Bio Submits Investigational New Drug (IND) Application to FDA for Approval to Proceed with LBS-008 Phase 3 Clinical Trial for the Treatment of Stargardt Disease

08/02/2022

LBS-008 (a/k/a Tinlarebant) is the Company’s orally administered tablet for the treatment of Stargardt disease (STGD1) There are currently no approved treatments for STGD1 Approximately 30,000 patients in the U.S. suffer from STGD1 A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing The Phase 3,…

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