FoundationOne®CDx

Search documents
Karyopharm Announces Strategic Financing Transactions to Support Growth; Extends Cash Runway Into Second Quarter of 2026, Beyond Expected Top-Line Readout of Phase 3 SENTRY Trial in Myelofibrosis
Prnewswire· 2025-10-08 11:00
– Transactions Provide Karyopharm with $100 Million of Financial Flexibility and Additional Capital – – Preliminary Total Revenue and U.S. XPOVIO (selinexor) Net Product Revenue for the Third Quarter of 2025 Expected to be in the Range of $42 to $44 Million and Approximately $32 Million, Respectively – – Top-Line Data from the Phase 3 SENTRY Trial in Myelofibrosis on Track for March 2026 – , /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering n ...
PMV Pharmaceuticals Reports Full Year 2024 Financial Results and Corporate Highlights
Newsfilter· 2025-03-03 13:00
Core Viewpoint - PMV Pharmaceuticals, Inc. reported strong progress in its clinical trials and financial results for the year ended December 31, 2024, highlighting the advancement of its lead drug candidate, rezatapopt, in treating cancers with TP53 mutations [1][4]. Clinical Development - The pivotal Phase 2 portion of the PYNNACLE trial is advancing well, with enrollment on track and more than 90% of sites activated across multiple regions [3][5]. - An interim analysis of the Phase 2 monotherapy data is expected in mid-2025, with a New Drug Application submission anticipated by the end of 2026 [3][5]. - Enrollment has begun in a Phase 1b study at MD Anderson Cancer Center, evaluating rezatapopt in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome with a TP53 Y220C mutation [2][6]. Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $183.3 million, providing a cash runway expected to last until the end of 2026 [5][12]. - The net loss for the year ended December 31, 2024, was $58.7 million, a decrease from a net loss of $69.0 million in 2023 [12][17]. - Research and development expenses increased to $58.5 million in 2024 from $55.9 million in 2023, primarily due to clinical expenses related to rezatapopt [12][17]. Research Highlights - The Phase 1 data of rezatapopt in advanced ovarian cancer showed a confirmed partial response in 7 out of 15 patients, with a median duration of response of seven months [6]. - In advanced breast cancer, 3 out of 8 patients achieved a confirmed partial response, indicating a favorable safety profile [6]. - A paper detailing the discovery of rezatapopt was published, emphasizing its role as a first-in-class small-molecule reactivator of the p53 Y220C mutant [6][9].