News & Updates

Erasca Doses First Patient in SEACRAFT-1 Phase 1b Trial Evaluating Naporafenib Plus Trametinib in Patients with RAS Q61X Solid Tumors


Anti-tumor activity in patients with NRAS Q61X melanoma and KRAS Q61X NSCLC supports tissue agnostic development in RAS Q61X solid tumors Initial Phase 1b combination data from SEACRAFT-1 expected in Q2-Q4 2024 Dosing of first patient in pivotal SEACRAFT-2 trial in NRAS-mutant melanoma expected in H1 2024 Excerpt from the Press Release: SAN DIEGO, Aug.…

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Denali Therapeutics Announces New Interim Data from Phase 1/2 Study of DNL310 (ETV:IDS) in MPS II (Hunter Syndrome) at SSIEM 2023


Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Aug. 30, 2023 (GLOBE NEWSWIRE) — Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases and lysosomal storage diseases, today announced new interim data from the ongoing open-label,…

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Foghorn Therapeutics Announces First Patient Dosed in Phase 1 Combination Study of FHD-286 for Relapsed and/or Refractory AML


Excerpt from the Press Release: CAMBRIDGE, Mass., Aug. 31, 2023 (GLOBE NEWSWIRE) — Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious disease by correcting abnormal gene expression, today announced the first patient has been dosed in the Phase 1 study of FHD-286 in combination with decitabine…

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Astria Therapeutics Announces Publication of STAR-0215 Preclinical Data in the Journal of Pharmacology and Experimental Therapeutics


Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and immunological diseases, today announced that preclinical data supporting STAR-0215’s profile as a potential long-acting therapy for hereditary angioedema (HAE) dosed once every three…

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Your eClinical Technology Should Adapt To Your Protocol


You should not have to compromise your study design simply because your eClinical Technology does not support your unique study requirements. At TrialStat we do things differently. We believe that you should not have to compromise and to make that a reality, we specialize in Custom Validated Development. Whether it’s a small change in workflow,…

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Exelixis Announces Positive Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors


– CABINET trial will be unblinded and stopped early due to a dramatic improvement in efficacy per a unanimous recommendation by The Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board – – Based on positive results, findings will be discussed with the U.S. Food and Drug Administration – Excerpt from the…

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AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment


Excerpt from the Press Release: SAN FRANCISCO, Aug. 25, 2023 /PRNewswire/ — AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotech company committed to advancing antiviral therapies and vaccines, with a primary focus on achieving a functional cure for chronic hepatitis B (CHB) infection, today announced the U.S. Food and Drug…

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XyloCor Therapeutics Presents Phase 2 Data Highlighting Safety and Efficacy of XC001 at the European Society of Cardiology (ESC) Congress 2023


– Positive Phase 2 EXACT Trial results at 6-months underscore significant potential of investigational therapy in refractory angina – Six-month data have since been sustained out to 12-months supporting durability of XC001 safety and efficacy profile – XC001 targets unmet medical need among patients with refractory angina who have a debilitating quality-of-life burden and no…

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Nura Bio Initiates Phase I Clinical Trial for its Oral, Brain-Penetrant SARM1 Inhibitor, NB-4746


– NB-4746 is being developed as a neuroprotective therapy for neurological diseases – Milestone marks Nura Bio’s transition to a clinical-stage company Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Nura Bio, Inc. (Nura Bio), a biopharmaceutical company developing neuroprotective, small molecule therapies for the treatment of debilitating neurological diseases, today announced the initiation…

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Bioxytran Announces FDA Clearance of its IND Application for ProLectin-M in Clinical Trials


Excerpt from the Press Release: BOSTON, MASSACHUSETTS, Aug. 24, 2023 (GLOBE NEWSWIRE) — BIOXYTRAN, INC. (BIXT), (the “Company”), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA), to…

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