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SpringWorks Therapeutics Announces Positive Topline Results from the Phase 2b ReNeu Trial of Mirdametinib in NF1-PN

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星期四, 十一月 16, 2023
NDA, Medicine, Vomiting, Disease, Safety, Food, Therapy, Rash, MEK, European Commission, Aes, First grade, Civil service commission, Patient, Solar cycle 24, FDA, New Drug Application, ORR, Diarrhea, Nausea, Cancer, Pain, Orphan drug, NF1, MRI, Quality of life, Fast Track, Sympathetic nervous system, Nursing, Pharmaceutical industry

The ReNeu trial enrolled 114 patients in two cohorts (pediatric and adult) across 50 sites in the U.S.

Key Points: 
  • The ReNeu trial enrolled 114 patients in two cohorts (pediatric and adult) across 50 sites in the U.S.
  • Mirdametinib was generally well tolerated in the ReNeu trial, with the majority of adverse events (AEs) being Grade 1 or Grade 2.
  • “We are extremely pleased that the results of our ReNeu trial demonstrate a compelling clinical profile across measures of both safety and efficacy.
  • SpringWorks plans to submit a New Drug Application (NDA) for mirdametinib to the FDA in the first half of 2024.

SpringWorks Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

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星期四, 十一月 2, 2023
Bispecific monoclonal antibody, Cycle, Patient, NRAS, FDA, Molecular Cancer Research, Research, Research and development, New Drug Application, IND, American Association for Cancer Research, CD3, PDUFA, Multiple myeloma, Amgen, TEAD, Biotechnology, Regeneron Pharmaceuticals, MAPK, Prescription Drug User Fee Act, Plantar fibromatosis, G&A, European Medicines Agency, Panitumumab, R, RAF, Solar cycle 10, MEK, Growth, Common, Annual general meeting, EMA, Solar cycle 2, NDA, Cancer, Therapy, Solar cycle 24, BCMA, Administration, BeiGene, EGFR, Pharmaceutical industry, Medical imaging

STAMFORD, Conn., Nov. 02, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported third quarter financial results for the period ended September 30, 2023 and provided an update on recent business highlights.

Key Points: 
  • – PDUFA target action date for nirogacestat NDA in adults with desmoid tumors remains set for November 27, 2023 –
    STAMFORD, Conn., Nov. 02, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported third quarter financial results for the period ended September 30, 2023 and provided an update on recent business highlights.
  • SpringWorks expects to file a Marketing Authorisation Application for nirogacestat with the European Medicines Agency (EMA) in the first half of 2024.
  • SpringWorks plans to file an IND for SW-682, the Company's TEAD inhibitor development candidate, in the fourth quarter of 2023.
  • Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $79.4 million, or $1.27 per share, for the third quarter of 2023.