Biotechnology

Alcyone Therapeutics Announces Continued Enrollment Approval from FDA of the PIERRE Pivotal IDE Clinical Study of the ThecaFlex DRx™ System for Administration of nusinersen

08/08/2024

Excerpt from the Press Release: LOWELL, Mass., July 31, 2024 /PRNewswire/ — Alcyone Therapeutics Inc. (Alcyone), a clinical-stage biotechnology company pioneering next-generation precision genetic therapies and precision delivery solutions of therapies for complex neurological conditions, announced today that the U.S. Food and Drug Administration (FDA) has provided approval to continue enrollment of the PIERRE study (https://clinicaltrials.gov/ct2/show/NCT05866419) to…

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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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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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Allogene Therapeutics Initiates Pivotal Phase 2 Trial Investigating Cemacabtagene Ansegedleucel (cema-cel), an Allogeneic CAR T Product, as Part of First Line Treatment for Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse

06/27/2024

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif. and BOULDER, Colo., June 20, 2024 (GLOBE NEWSWIRE) — Allogene Therapeutics Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products, and Foresight Diagnostics (Foresight), a leader in ultra-sensitive liquid biopsy-based minimal residual disease (MRD) detection, today announced the…

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HotSpot Therapeutics Presents Preclinical Data for Potential First-in-Class MALT1 Scaffolding Inhibitor at the 4th AACR International Meeting: Advances in Malignant Lymphoma

06/26/2024

Presentation highlights preclinical profile for HST-1021, a highly differentiated potent, selective, and potential first-in-class MALT1 scaffolding inhibitor Excerpt from the Press Release: BOSTON, June 20, 2024 /PRNewswire/ — HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting regulatory sites on proteins referred to as “natural hotspots,”…

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Ocugen Announces Data and Safety Monitoring Board Approves Enrollment in High Dose Cohort 3 in GARDian Study for Stargardt Disease

06/24/2024

• Established Medium Dose as Safe and Tolerable Dose in Current OCU410ST Clinical Trial• DSMB Determination to Proceed with High Dose Cohort Dosing Excerpt from the Press Release: MALVERN, Pa., June 21, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and…

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Nutcracker Therapeutics Demonstrates Enhanced Activity of B Cell Lymphoma Candidate NTX-472 at the 2024 ASCO Annual Meeting

06/07/2024

Excerpt from the Press Release: EMERYVILLE, Calif.–(BUSINESS WIRE)–Nutcracker Therapeutics, Inc., a biotechnology company dedicated to developing transformative RNA therapies through its proprietary technology platform, recently presented a poster on NTX-472, its new preclinical drug candidate for B cell lymphoma, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Monoclonal antibody immunotherapies…

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Edgewood Oncology Announces First Patients Dosed in Phase 2a Study of BTX-A51 in Genetically-Defined Breast Cancer

06/04/2024

Excerpt from the Press Release: BROOKLINE, Mass.–(BUSINESS WIRE)–Edgewood Oncology, a clinical-stage biotechnology company focused on delivering BTX-A51 to patients with hematologic malignancies and genetically-defined solid tumors, today announced that the first two patients with metastatic breast cancer were treated with BTX-A51, a multi-specific kinase inhibitor of casein kinase 1 alpha (CK1α) and cyclin-dependent kinases 7…

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Pliant Therapeutics Presents Data from its Bexotegrast Program at the American Thoracic Society International Conference

06/03/2024

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., May 21, 2024 (GLOBE NEWSWIRE) — Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today announced that the Company presented clinical data and preclinical data of bexotegrast (PLN-74809) this…

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