Industry News
— On-track to initiate Phase 2b trial in 1Q 2023; Topline data expected in 1Q 2024 — — Received remaining $25 million investment under previously announced private placement financing — Excerpt from the Press Release: ARLINGTON, Mass., Dec. 27, 2022 (GLOBE NEWSWIRE) — Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development…
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–Company Expects to Initiate a Phase 1/2 Study for ALN-KHK in Early 2023, with Initial Results Expected in Late 2023 – Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi (RNA interference) therapeutics company, announced today that the Company has submitted a Clinical Trial Authorization (CTA) application to Health…
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Promising preliminary monotherapy data for ERK1/2 inhibitor ERAS-007 and SHP2 inhibitor ERAS-601 in advanced solid tumors, which had favorable safety, tolerability, and efficacy profiles that support combination development BRAF Class 2 and 3 alterations have no approved targeted therapies and represent up to 25% of all BRAF-driven tumors Excerpt from the Press Release: SAN DIEGO,…
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Excerpt from the Press Release: PALO ALTO, Calif. & DALLAS–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and Susan G. Komen®, the world’s leading breast cancer organization, announced today that they have entered into a partnership to bring the patient perspective to the development of clinical studies that help identify early-stage breast…
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– 35-45% Reduction in Risk of Progression or Death and a Doubling of mPFS Were Observed in the Domvanalimab-Containing Study Arms, Compared to Zimberelimab Monotherapy in First-Line, PD-L1-High NSCLC – – With Median Follow-Up of Approximately 12 Months, Both Domvanalimab-Containing Study Arms Also Improved ORR and Six-Month Landmark PFS Compared to Zimberelimab Monotherapy – –…
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– STELLAR-304 is the second phase 3 pivotal trial evaluating zanzalintinib, a next-generation tyrosine kinase inhibitor in development for multiple advanced tumor types – Excerpt from the Press Release: ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-304, a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in…
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– Similar clinical remission rates observed in patients receiving AMT-101 monotherapy compared to placebo at week 12 – AMT-101 was well-tolerated – Planned Phase 1b trial for the company’s second clinical asset, AMT-126, in UC patients – Exploring strategic partnership options to advance AMT-101 into Phase 3 in patients with chronic pouchitis – Strong cash…
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Results of the main study in patients with compensated cirrhosis due to NASH (F4) expected in fourth quarter of 2023 Results of the cohort D expansion to evaluate EFX in combination with GLP-1 therapy in patients with pre-cirrhotic NASH expected in second quarter of 2023 Following designation of EFX as a Breakthrough Therapy, a meeting…
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Emraclidine is being developed as a potential once-daily treatment for schizophrenia without the need for titration Data show clinically meaningful and statistically significant improvement with emraclidine in PANSS total score at six weeks and was overall well-tolerated compared with placebo Results demonstrate selective targeting of the M4 muscarinic receptor subtype as a potential novel treatment…
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Topline data readout from study expected in first half of 2023 Excerpt from the Press Release: Carlsbad, CA, Dec. 16, 2022 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, is providing an update on its U.S. Phase 2 study evaluating LB1148 for reduction…
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