Industry News

Erasca Announces First Patient Dosed in HERKULES-1 Phase 1b Trial Evaluating ERAS-007 and ERAS-601 MAPKlamp Combination in RAS/MAPK Pathway-Altered Solid Tumors

01/06/2023

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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Guardant Health and Susan G. Komen® Partner to Develop Clinical Studies to Identify Early-Stage Breast Cancer Patients Who May Benefit From Additional Monitoring or Therapy

01/05/2023

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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Anti-TIGIT Domvanalimab-Containing Study Arms Improve Progression-Free Survival Compared to Anti-PD1 Alone in Phase 2 Non-Small Cell Lung Cancer Study

01/05/2023

– 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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Exelixis Announces Initiation of the STELLAR-304 Phase 3 Pivotal Trial Evaluating Zanzalintinib in Patients with Advanced Non-Clear Cell Kidney Cancer

01/05/2023

– 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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Applied Molecular Transport Announces Top-line Phase 2 Results from LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe Ulcerative Colitis

01/04/2023

– 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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Akero-Therapeutics-Completes-Enrollment-of-Phase-2b-SYMMETRY-Study-and-Announces-Expected-2023-Milestones.htmlv

01/04/2023

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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Cerevel Therapeutics Announces Publication in The Lancet of Emraclidine Data from Phase 1b Clinical Trial in People Living with Schizophrenia

12/23/2022

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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Palisade Bio Provides Update on U.S. Phase 2 Study Evaluating LB1148 for Post-Surgical Abdominal Adhesions

12/23/2022

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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Equillium’s Partner Biocon Initiates Phase 2 Study of Itolizumab in Ulcerative Colitis

12/22/2022

Excerpt from the Press Release: LA JOLLA, Calif.–(BUSINESS WIRE)–Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that Biocon Limited, in collaboration with Equillium, has initiated a Phase 2 clinical study of itolizumab in patients with ulcerative colitis (UC). The Phase 2…

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Data Published in JCEM Demonstrate Strong Real-World Performance of Veracyte’s Afirma GSC in Thyroid Cancer Diagnosis

12/22/2022

Meta-analysis of 13 independent studies suggests genomic test performs even better in real-world clinical practice as compared to original clinical validation study Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT) today announced that findings demonstrating the strong real-world performance of the Afirma Genomic Sequencing Classifier (GSC) were published in The…

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