News & Updates

Ultragenyx Announces Successful End-of-Phase 2 Meeting with FDA for GTX-102 Angelman Syndrome Program

07/24/2024

Alignment with FDA on Phase 3 study primary endpoint of Bayley-4 cognition and key secondary endpoint of Multi-Domain Responder Index (MDRI) Phase 3 study on track to initiate by the end of this year Excerpt from the Press Release: NOVATO, Calif., July 17, 2024 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced the…

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GRAIL Announces First Participant Enrolled in REACH Study Evaluating Clinical Impact of Galleri® Multi-Cancer Early Detection (MCED) Test in the Medicare Population

07/23/2024

Community Health Network Has Begun Enrollment of the Prospective, Multi-Center Study to Assess the Real-World Clinical Impact of Galleri® in Addition to Currently Recommended Cancer Screenings Study Enrollment Includes Focus on Diverse and Underrepresented Populations Costs of Galleri and Related Items and Services for Study Participants Will be Covered by Medicare Excerpt from the Press Release:…

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Clinical Data from Open-Label Extension LILAC-1™ and LILAC-2™ Studies Evaluating Long-Term Safety and Efficacy of DAYBUE™ (trofinetide) in Patients with Rett Syndrome Published in Med

07/22/2024

— Continued Improvements in RSBQ and CGI-I scores seen with long-term DAYBUE treatment in Phase 3 LAVENDER™ and LILAC studies — DAYBUE safety profile was consistent with findings from the LAVENDER trial Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the journal Med published results from two open-label…

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Rgenta Therapeutics Announces FDA Clearance of IND Application for RGT-61159, an Oral Small Molecule RNA Modulator Designed to Halt Disease-Driver MYB Production in Adenoid Cystic Carcinoma (ACC) and Colorectal Cancer (CRC)

07/19/2024

First-in-human Phase 1a/1b clinical trial will evaluate orally available, RGT-61159 designed to selectively target MYB RNA and inhibit oncogenic MYB protein production Preclinical data supporting the clinical trial were recently presented at the American Society of Clinical Oncology Annual Meeting (ASCO 2024) Excerpt from the Press Release: WOBURN, Mass., July 10, 2024 /PRNewswire/ — Rgenta…

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Biophytis Obtains IND Approval from the FDA to Start its Phase 2 OBA Study in Obesity

07/18/2024

Excerpt from the Press Release: PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / July 11, 2024 / Biophytis SA (Euronext Growth Paris:ALBPS), (“Biophytis” or the “Company”), a clinical-stage biotechnology company specialized in the development of therapeutics for age-related diseases, today announced that it has received Investigational New Drug (IND) approval from the Food and Drug…

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Landmark Clinical Study Demonstrates Superiority of 3-Level Circumferential Cervical Fusion Over Anterior Cervical Fusion Alone

07/17/2024

FDA clears CORUS™ PCSS for multilevel circumferential cervical fusion procedures based on results from the prospective, multicenter, randomized, controlled FUSE Study Excerpt from the Press Release: PLEASANTON, Calif., July 11, 2024 /PRNewswire/ — Providence Medical Technology announces FDA Clearance of its CORUS™ Posterior Cervical Stabilization System (PCSS) for the treatment of up to 3-level cervical…

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Revolution Medicines Announces Publication Demonstrating Robust Anti-Tumor Activity of RAS(ON) Inhibitors in Preclinical Models of Refractory KRAS-Mutated Non-Small Cell Lung Cancer

07/16/2024

Original research published in Cancer Discovery reveals a RAS(ON) multi-selective inhibitor exhibited robust anti-tumor activity alone or in combination with a RAS(ON) G12C-selective inhibitor in preclinical models of difficult-to-treat KRAS-mutated non-small cell lung cancer (NSCLC) Results also highlight that, in contrast to mutant-selective RAS inhibition, broad-spectrum, reversible RAS-GTP inhibition with a RAS(ON) multi-selective inhibitor alone…

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Verastem Oncology Announces First Patient Dosed with GFH375/VS-7375, a KRAS G12D (ON/OFF) Inhibitor, in a Phase 1/2 Trial in China as Part of Collaboration with GenFleet Therapeutics

07/15/2024

GenFleet’s IND in China was cleared in June 2024; this is the first discovery program from the collaboration Verastem announced in 2023 to advance into human clinical trials Verastem plans to initiate development studies outside of China after evaluating initial dose escalation data from the Phase 1 study in China Excerpt from the Press Release:…

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Allogene Therapeutics Activates Three Community Cancer Centers as First Sites for the Pivotal Phase 2 ALPHA3 Trial Evaluating Cemacabtagene Ansegedleucel (cema-cel) as First Line (1L) Consolidation Treatment for Patients with Large B-Cell Lymphoma (LBCL)

07/11/2024

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., July 01, 2024 (GLOBE NEWSWIRE) — Allogene Therapeutics Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that Rocky Mountain Cancer Centers (RMCC), part of the US Oncology Network and Sarah…

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Eirion Therapeutics Announces Initiation of First-in-Human Clinical Trial Evaluating Topical ET-02 for the Treatment of Androgenic Alopecia

07/10/2024

Excerpt from the Press Release: WOBURN, Mass., July 1, 2024 /PRNewswire/ — Eirion Therapeutics Inc. announced today that the first participant has been enrolled in a Phase 1 clinical trial to evaluate the safety of the patented topical pharmaceutical ET-02 for the treatment of androgenic alopecia (age-related hair loss). This double-blind, placebo-controlled study is designed…

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