First Ever Breakthrough Designation for a Drug Being Developed for PWS Designation is Based on Data from the Phase 3 Program for DCCR Planned Submission of a New Drug Application (NDA) for DCCR Remains on Track for Mid-2024 REDWOOD CITY, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare...Read more
Ziftomenib is the first investigational treatment to be granted Breakthrough Therapy Designation for NPM1-mutant AML Registration-directed trial of ziftomenib in NPM1-mutant AML on track to complete enrollment by mid-2024 SAN DIEGO, April 22, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment...Read more
Breakthrough Therapy Designation (“BTD”) provides an expedited review pathway, as well as increased access to U.S. Food and Drug Administration (“FDA”) guidance on trial design, with the potential to significantly reduce drug development timelines First known BTD granted by the FDA for an adjunctive psychedelic based therapy for the treatment of Major Depressive Disorder (“MDD”) Robust, sustained and statistically...Read more
A single oral administration of MM120 100 µg met its key secondary endpoint and maintained a clinically and statistically significant HAM-A reductions compared to placebo at 12 weeks with a 65% clinical response rate and 48% clinical remission rate MindMed plans to hold an End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA) in the first half of 2024 and initiate its Phase 3 clinical program in the second half of...Read more
CAMBRIDGE, Mass., Feb. 27, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-520 for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC)...Read more
Latozinemab is the most advanced progranulin-elevating candidate in development for FTD-GRN and has now become the first investigational medicine to receive a Breakthrough Therapy Designation for the treatment of FTD-GRN SOUTH SAN FRANCISCO, Calif., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC) and GSK plc (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough...Read more
Designation is based on Phase 1/2 safety and efficacy data in patients with Human Epidermal Growth Factor Receptor 2 (“HER2”)-expressing advanced endometrial cancer with encouraging early signs of anti-tumor activity Breakthrough Therapy designation will allow for an expedited development and regulatory review of BNT323/DB-1303 Endometrial or uterine cancer is the second most common gynecologic cancer globally with over 400,000 cases...Read more
Company Today Also Provided Updates on R&D Portfolio and Strategy at Investor Event Crinecerfont New Drug Application Submission Planned in 2024 NBI-'770, an Oral NMDA NR2B Negative Allosteric Modulator, Entering Phase 2 for the Treatment of Major Depressive Disorder Advancing Largest Portfolio of Muscarinic Compounds in Clinical Development Top-Line Phase 2 Data Readouts for Five Programs Anticipated in 2024...Read more
U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation (BTD) for epcoritamab-bysp for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy European Medicines Agency (EMA) validates regulatory application for epcoritamab for the same indication The regulatory actions are supported by data from the phase 1/2 EPCORE™ NHL-1 trial COPENHAGEN, Denmark /...Read more
Updates are supported by data from the Phase 1/2 EPCORE™ NHL-1 clinical trial NORTH CHICAGO, Ill., Nov. 27, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular lymphoma (FL). The FDA has...Read more
FDA granted Breakthrough Therapy Designation for felzartamab in PMN upon positive clinical data from M-PLACE, a Phase 2 study led by I-Mab partner HI-Bio I-Mab has full development and commercialization rights of felzartamab in Greater China for all indications, with Phase 3 multiple myeloma data expected in 2024, followed by a planned BLA submission ROCKVILLE, Md. and SHANGHAI, Nov. 2, 2023 /PRNewswire/ -- I-Mab (Nasdaq: IMAB) (the...Read more
Designation is based on results from the progressive pulmonary fibrosis cohort of the Phase 2 study assessing the safety and efficacy of BMS-986278 treatment versus placebo PRINCETON, N.J. / Oct 24, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for BMS-986278, a potential first-in-class, oral, lysophosphatidic acid...Read more
NEWARK, Calif., Oct. 23, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) has revised the originally granted Breakthrough Therapy Designation for seladelpar to now reflect treatment of primary biliary cholangitis (PBC) including pruritus in...Read more
Supported by positive data in F2/F3 and F4 NASH patients from the ENLIVEN Phase 2b trial of pegozafermin Discussions with regulatory agencies regarding the NASH Phase 3 program planned for the fourth quarter of 2023 SAN FRANCISCO, Sept. 21, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver...Read more
Designation based on clinical evidence indicating INO-3107 may demonstrate substantial improvement over existing therapies First Breakthrough Therapy designation for an INOVIO DNA medicine candidate PLYMOUTH MEETING, Pa., Sept. 7, 2023 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer,...Read more
LEXINGTON, Mass., July 20, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the Company’s Candida auris (C. auris) direct-from-blood molecular diagnostic test. This marks the third T2 Biosystems’ product to receive FDA...Read more
Zeno granted BTD for the treatment of NRG1+ non-small cell lung cancer UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 05, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 29, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment of patients with advanced unresectable...Read more
First FDA Breakthrough Therapy Designation granted for AdenoVerse immunotherapy platform; designation prioritizes PRGN-2012 as a potential treatment for RRP Designation based on positive Phase 1 clinical data that showed 50% of patients were "surgery-free" (Complete Response) after PRGN-2012 treatment with a minimum follow up of 12 months post-treatment GERMANTOWN, Md. , June 20, 2023 /PRNewswire/ -- Precigen, Inc....Read more
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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