Springworks Therapeutics, Inc. Stock Price, News & Analysis

SpringWorks Therapeutics (SWTX) has initiated a Phase 2 trial for nirogacestat, a gamma secretase inhibitor, targeting recurrent ovarian granulosa cell tumors. As these tumors constitute about 5% of ovarian cancers with no FDA-approved treatments, the trial addresses a significant unmet medical need. The study will enroll 40 patients to evaluate nirogacestat's safety, efficacy, and pharmacokinetics. With a primary endpoint of objective response rate, the trial represents a promising step towards potential regulatory approval for this patient population.

SpringWorks Therapeutics (SWTX) announced positive results from their Phase 3 DeFi trial of nirogacestat, a treatment for progressing desmoid tumors. The trial met its primary endpoint with a 71% reduction in disease progression risk and demonstrated a confirmed objective response rate of 41% for nirogacestat versus 8% for placebo. The company plans to submit a New Drug Application to the FDA in the second half of 2022, utilizing the Real-Time Oncology Review program. Additionally, a manageable safety profile was observed, although some participants experienced treatment-emergent adverse events.

SpringWorks Therapeutics Announces Financing Agreement

SpringWorks Therapeutics, Inc. (NASDAQ: SWTX) has entered a securities purchase agreement to issue approximately 8.63 million shares at $26.01 each, raising about $225 million before expenses. The deal, set to close on September 9, 2022, includes participation from major institutional investors and aims to bolster the company’s cash reserves to over $600 million. This funding will support the anticipated U.S. launch of nirogacestat and ongoing research programs, with projections for operational funding through 2026.

SpringWorks Therapeutics has announced a significant collaboration with GSK, involving a $75 million equity investment and up to $550 million in milestone payments for the development of nirogacestat. This investigational oral gamma secretase inhibitor will be supplied for GSK's Blenrep global development program, where SpringWorks retains full commercialization rights. This partnership aims to explore nirogacestat's potential in enhancing BCMA-targeted therapies for multiple myeloma, expanding the treatment options available for patients.

SpringWorks Therapeutics (Nasdaq: SWTX) announced the presentation of data from the Phase 3 DeFi trial assessing nirogacestat for adults with progressing desmoid tumors at the ESMO Congress 2022. The late-breaking oral presentation will occur on September 10, 2022, emphasizing the trial's significance. The company plans to submit a New Drug Application (NDA) by year-end under the FDA’s Real-Time Oncology Review program. This investigational drug has received Orphan Drug Designation and both Fast Track and Breakthrough Therapy Designations.

SpringWorks Therapeutics (SWTX) announced strong progress in its clinical trials, particularly with nirogacestat for desmoid tumors, achieving its primary endpoint in the Phase 3 DeFi trial, demonstrating a 71% risk reduction in disease progression. The company also reported preliminary positive data from the Phase 1/2 study of nirogacestat in combination with low-dose belantamab mafodotin for multiple myeloma. Financially, Q2 2022 saw a net loss of $69.1 million, up from $47.0 million in Q2 2021, with a cash position of $334.5 million. NDA submission for nirogacestat is expected in H2 2022.

SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) will participate in a fireside chat at the 2022 Wedbush PacGrow Healthcare Conference on August 10th at 10:55 a.m. ET. The event can be accessed via a live webcast on the company’s website, with a replay available afterward. SpringWorks focuses on developing life-changing medicines for severe rare diseases and cancer, boasting a targeted oncology pipeline that includes late-stage clinical trials for rare tumors and genetically defined cancers. For more details, visit SpringWorks’ website.

SpringWorks Therapeutics (Nasdaq: SWTX) has announced the appointment of Carlos Albán to its Board of Directors. Albán, the former Vice Chairman and Chief Commercial Officer at AbbVie, brings over 30 years of experience in global commercial strategy. His leadership is expected to be crucial as SpringWorks transitions to a commercial-stage company. Under Albán's tenure at AbbVie, sales surged from $18 billion in 2013 to over $45 billion in 2020. SpringWorks focuses on developing treatments for severe rare diseases and cancer.

SpringWorks Therapeutics (Nasdaq: SWTX) announced a virtual R&D Day on June 10, 2022, showcasing advancements in their oncology pipeline. Key highlights include the upcoming NDA filing for Nirogacestat in Desmoid Tumors expected in late 2022 and a new Phase 2 study for ovarian granulosa cell tumors. Ongoing collaborations with BCMA therapies and significant focus on Mirdametinib for rare tumors were also discussed. The company aims to provide approved therapies for desmoid tumors by 2023 and anticipates two approvals by 2025.