SpringWorks Therapeutics, Inc. acquires, develops, and commercializes medicines for underserved patient populations suffering from rare diseases and cancer. Its lead product candidate is nirogacestat, an oral small molecule gamma secretase inhibitor that is in Phase 3 clinical trials for the treatment of desmoid tumors. The company is also developing mirdametinib, an oral small molecule MEK inhibitor that is in Phase 2b clinical trials for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas; Nirogacestat + belantamab mafodotin -blmf, which is in Phase Ib clinical trial for the treatment of relapsed or refractory multiple myeloma (RRMM); and Nirogacestat + ALLO-715 that is in Phase 1 clinical trial for the treatment of RRMM. In addition, it is developing Nirogacestat + teclistamab, which is in clinical stage that targets BCMA and CD3; Nirogacestat + elranatamab; Nirogacestat + PBCAR269A, which is in Phase 1/2a clinical trial for allogeneic BCMA CAR T cell therapy; Mirdametinib that is in Phase 1/2a clinical trial for the treatment of NF1-PN; Mirdametinib + lifirafenib, a combination therapy that is in Phase 1b/2 clinical trial in patients with advanced or refractory solid tumors; and BGB-3245, an oral selective small molecule inhibitor of monomeric and dimeric forms of activating BRAF mutations, which is in Phase I clinical trial. The company has collaborations with BeiGene, Ltd., GlaxoSmithKline LLC, and Allogene to develop combination approaches with nirogacestat and mirdametinib; and license agreements with Pfizer Inc. for nirogacestat and mirdametinib. It also has a license agreement with Katholieke Universiteit Leuven and the Flanders Institute for Biotechnology; and clinical trial collaboration agreement with Seagen Inc. SpringWorks Therapeutics, Inc. was founded in 2017 and is headquartered in Stamford, Connecticut.
IPO Year: 2019
Exchange: NASDAQ
Website: springworkstx.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
2/5/2024 | $75.00 | Buy | Guggenheim |
12/1/2022 | $45.00 | Buy | BofA Securities |
9/8/2021 | $97.00 → $105.00 | Overweight | JP Morgan |
8/5/2021 | $136.00 → $137.00 | Buy | HC Wainwright & Co. |
– PDUFA target action date of February 28, 2025 – – EU Marketing Authorization Application also validated by European Medicines Agency – STAMFORD, Conn., Aug. 28, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for mirdametinib, an investigational MEK inhibitor, for the treatment of adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). The NDA was granted Priority Review and has been given a Prescription Drug Us
– Achieved $40.2 million in OGSIVEO® (nirogacestat) net product revenue in the second quarter – – Completed submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Presented Phase 2b ReNeu trial results and additional analyses from Phase 3 DeFi trial at the 2024 ASCO Annual Meeting – – Initiated Phase 1a trial of SW-682 in patients with Hippo mutant solid tumors – STAMFORD, Conn., Aug. 07, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today reported financial results for the second quarter of 2024 and provided an update
STAMFORD, Conn., July 29, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced the appointment of Martin Mackay, Ph.D. to the Company's Board of Directors. Dr. Mackay is a highly accomplished research and development (R&D) executive with more than 30 years of pharmaceutical and biotech R&D experience, including leadership roles at Pfizer, AstraZeneca and Alexion. "Martin is a proven industry leader whose experience in developing and delivering novel treatments to patients in need is exceptional," said Saqib Islam, Chief Executive Officer of SpringWorks. "His expertise
STAMFORD, Conn., July 23, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that it will host a live conference call and webcast at 8:30 a.m. ET on Wednesday, August 7, 2024 to report its second quarter financial results and discuss recent business updates. To join the live webcast and view the corresponding slides, please click here. To participate in the live conference call by phone, please click here to pre-register. Registered participants will then be provided with a dial-in number and conference code to access the call. A replay of the webcast will be availa
STAMFORD, Conn., July 01, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib, an investigational MEK inhibitor, for the treatment of pediatric and adult patients with neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN). "We are pleased to be one step closer towards our goal of bringing mirdametinib to patients with NF1-PN in the U.S. and believe that our ReNeu data support the potential for mirdametinib to be
STAMFORD, Conn., June 05, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference, taking place in Miami, Florida on Tuesday, June 11, 2024 at 2:00 p.m. ET. To access the live webcast, please visit the Events & Presentations page within the Investors & Media section of the company's website at https://ir.springworkstx.com. A replay of the webcast will be available on SpringWorks' website for a limited time following the conference. About SpringWorks Therapeu
– Results from pivotal Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN to be presented in an oral presentation – – Additional data and analyses from Phase 3 DeFi trial of OGSIVEO® (nirogacestat) highlighting consistent safety and efficacy across subgroups of adults with desmoid tumors also being presented in oral and poster sessions – STAMFORD, Conn., May 23, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that four abstracts from the company's portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting b
STAMFORD, Conn., May 08, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will participate in a fireside chat at the BofA Securities 2024 Health Care Conference, taking place in Las Vegas, Nevada on Tuesday, May 14, 2024 at 3:40 p.m. PT / 6:40 p.m. ET. To access the live webcast, please visit the Events & Presentations page within the Investors & Media section of the company's website at https://ir.springworkstx.com. A replay of the webcast will be available on SpringWorks' website for a limited time following the conference. About SpringWorks The
– Achieved $21.0 million in OGSIVEO® (nirogacestat) net product revenue in the first quarter – – Received validation from the EMA for MAA of nirogacestat for the treatment of adults with desmoid tumors – – Initiated rolling submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Phase 2b ReNeu trial results accepted for oral presentation at the 2024 ASCO Annual Meeting – STAMFORD, Conn., May 02, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today reported first quarter financial results for the period ended March 31, 2024 and
– Results from Phase 2b ReNeu trial of mirdametinib in NF1-PN accepted for oral presentation – – Additional data from the Phase 3 DeFi trial of OGSIVEO® (nirogacestat) in adults with desmoid tumors also accepted for presentations at ASCO – STAMFORD, Conn., April 24, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that data from the Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) will be presented in an oral presentation at
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8-K - SpringWorks Therapeutics, Inc. (0001773427) (Filer)
In the second half of 2024, SpringWorks also plans to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for mirdametinib for the treatment of children and adults with NF1-PN.
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HC Wainwright & Co. analyst Robert Burns reiterates SpringWorks Therapeutics (NASDAQ:SWTX) with a Buy and maintains $74 price target.
HC Wainwright & Co. analyst Robert Burns reiterates SpringWorks Therapeutics (NASDAQ:SWTX) with a Buy and maintains $74 price target.
HC Wainwright & Co. analyst Robert Burns reiterates SpringWorks Therapeutics (NASDAQ:SWTX) with a Buy and maintains $74 price target.
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STAMFORD, Conn., July 29, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced the appointment of Martin Mackay, Ph.D. to the Company's Board of Directors. Dr. Mackay is a highly accomplished research and development (R&D) executive with more than 30 years of pharmaceutical and biotech R&D experience, including leadership roles at Pfizer, AstraZeneca and Alexion. "Martin is a proven industry leader whose experience in developing and delivering novel treatments to patients in need is exceptional," said Saqib Islam, Chief Executive Officer of SpringWorks. "His expertise
STAMFORD, Conn., Sept. 11, 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 announced the appointment of Tai-An Lin, Ph.D., as its Chief Scientific Officer. Dr. Lin brings more than 25 years of biotechnology and global pharmaceutical experience in advancing drug discovery programs from target identification through early clinical trials across the therapeutic areas of oncology, immuno-oncology, and immunology. "Tai-An is a talented scientist with a strong track record of advancing innovative oncology programs from discovery
STAMFORD, Conn., July 15, 2022 (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 announced the appointment of Carlos Albán to the Company's Board of Directors. Mr. Albán, who served as Vice Chairman and Chief Commercial Officer at AbbVie, Inc. ("AbbVie") until his retirement last year, brings over 30 years of experience in global commercial strategy and operations. "Carlos' success in building and leading global commercial organizations will be valuable as SpringWorks continues its planned transition into a commercial-stage compa
NEW YORK, Nov. 11, 2021 /PRNewswire/ -- Gilgamesh Pharmaceuticals, a mental health focused biotechnology company developing novel psychedelic-related medicines for the treatment of neuropsychiatric conditions, today announced the addition of several key additions to its leadership team and board of directors. The additions will enable Gilgamesh to rapidly advance its pipeline toward clinical trials beginning in late 2022 and further expand its IP portfolio. Key hires include: Chief Medical Officer Gerard Marek, MD/Ph.D. is a renowned expert on serotonin system biology. Gerard is a former asst. professor at Yale University and was the Chief Scientific Officer of Psychiatric Disorders Discove
STAMFORD, Conn., May 10, 2021 (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, announced today that Mike Burgess, M.B.Ch.B., Ph.D. has been appointed Head of Research and Development (R&D). Dr. Burgess is a physician-scientist with clinical experience in pediatrics and pediatric oncology and over 20 years of pharmaceutical industry R&D leadership experience across several therapeutic areas, including oncology. Dr. Burgess will lead the R&D organization as the company continues to advance its diversified targeted oncology pipeline and t
For Immediate Release: November 27, 2023 Today, the U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas. Desmoid tumors are non-cancerous but can be locally aggressive. The tumor
Submission status for SPRINGWORKS THERAPEUTICS INC's drug OGSIVEO (ORIG-1) with active ingredient NIROGACESTAT has changed to 'Approval' on 11/27/2023. Application Category: NDA, Application Number: 217677, Application Classification: Type 1 - New Molecular Entity
Guggenheim initiated coverage of SpringWorks Therapeutics with a rating of Buy and set a new price target of $75.00
BofA Securities initiated coverage of SpringWorks Therapeutics with a rating of Buy and set a new price target of $45.00
JP Morgan reiterated coverage of SpringWorks Therapeutics with a rating of Overweight and set a new price target of $105.00 from $97.00 previously
HC Wainwright & Co. reiterated coverage of SpringWorks Therapeutics with a rating of Buy and set a new price target of $137.00 from $136.00 previously
Goldman Sachs resumed coverage of SpringWorks Therapeutics with a rating of Buy and set a new price target of $112.00
HC Wainwright reiterated coverage of SpringWorks Therapeutics with a rating of Buy and set a new price target of $124.00 from $101.00 previously
Barclays reiterated coverage of SpringWorks Therapeutics with a rating of Overweight and set a new price target of $105.00 from $92.00 previously
HC Wainwright & Co. reiterated coverage of SpringWorks Therapeutics with a rating of Buy and set a new price target of $124.00 from $101.00 previously
Barclays reiterated coverage of SpringWorks Therapeutics with a rating of Overweight and set a new price target of $92 from $83 previously
– Achieved $40.2 million in OGSIVEO® (nirogacestat) net product revenue in the second quarter – – Completed submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Presented Phase 2b ReNeu trial results and additional analyses from Phase 3 DeFi trial at the 2024 ASCO Annual Meeting – – Initiated Phase 1a trial of SW-682 in patients with Hippo mutant solid tumors – STAMFORD, Conn., Aug. 07, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today reported financial results for the second quarter of 2024 and provided an update
STAMFORD, Conn., July 23, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that it will host a live conference call and webcast at 8:30 a.m. ET on Wednesday, August 7, 2024 to report its second quarter financial results and discuss recent business updates. To join the live webcast and view the corresponding slides, please click here. To participate in the live conference call by phone, please click here to pre-register. Registered participants will then be provided with a dial-in number and conference code to access the call. A replay of the webcast will be availa
– Achieved $21.0 million in OGSIVEO® (nirogacestat) net product revenue in the first quarter – – Received validation from the EMA for MAA of nirogacestat for the treatment of adults with desmoid tumors – – Initiated rolling submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Phase 2b ReNeu trial results accepted for oral presentation at the 2024 ASCO Annual Meeting – STAMFORD, Conn., May 02, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today reported first quarter financial results for the period ended March 31, 2024 and
STAMFORD, Conn., April 18, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that it will host a live conference call and webcast at 8:30 a.m. E.T. on Thursday, May 2, 2024 to report its first quarter financial results and discuss recent business updates. To join the live webcast and view the corresponding slides, please click here. To access the live call by phone, please pre-register for the call by clicking here. Once registration is complete, participants will be provided with a dial-in number and conference code to access the call. A replay of the webcast will
– Approval based on positive data from Phase 3 DeFi trial, in which OGSIVEO significantly improved progression-free survival and objective response rate, with rapid and sustained improvements in pain, physical functioning and overall quality of life – – SpringWorks to host conference call tomorrow at 8:00 a.m. ET – A Media Snippet accompanying this announcement is available by clicking on this link. STAMFORD, Conn., Nov. 27, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has approved OGSIVEO™ (nirogacestat), a
– Confirmed objective response rate of 52% in pediatric patients and 41% in adult patients, as assessed by Blinded Independent Central Review – – Mirdametinib treatment resulted in deep and durable responses and significant improvements in key secondary patient-reported outcome measures – – Mirdametinib was generally well tolerated with low rates of Grade 3+ adverse events – – Additional data expected to be presented at medical conference and NDA submission to the U.S. FDA planned in the first half of 2024 – – Company to host conference call today at 8:30 a.m. Eastern Time – STAMFORD, Conn., Nov. 16, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a clinical-st
STAMFORD, Conn., Aug. 19, 2022 (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 announced that data from the Phase 3 DeFi trial of nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors, will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress 2022. The abstract is expected to be published online via the ESMO website on September 8, 2022 (12:05 a.m. CEST; 6:05 p.m. ET on September 7). "We are very pleased that t
-- NDA filing for Nirogacestat in Desmoid Tumors, Which Will Be Reviewed Under the FDA's Real-Time Oncology Review (RTOR) Program, Expected in Second Half of 2022 -- -- New Phase 2 Study Announced to Evaluate Nirogacestat in Patients with Ovarian Granulosa Cell Tumors -- -- Eight Clinical Collaborations Evaluating Nirogacestat as a Cornerstone of BCMA Combination Therapy Ongoing; Nirogacestat in Combination with Low Dose of GSK's BLENREP Being Evaluated in Phase 2 Trial and Advanced into Additional Sub-Studies with Standard of Care Agents -- -- Mirdametinib Being Evaluated in Monotherapy and Combination Studies in Rare Oncology Indications and Biomarker-Defined Solid Tumors -- -- BGB-324
-- Results Showed Statistically Significant Improvement in Progression-Free Survival (PFS) Compared to Placebo (Hazard Ratio (HR) = 0.29; P < 0.001) -- -- Statistical Significance Was Also Achieved on All Key Secondary Endpoints, Including Objective Response Rate (ORR) and Patient-Reported Outcomes (PROs) -- -- Nirogacestat Was Generally Well Tolerated with a Manageable Safety Profile -- -- Additional Data Expected to be Presented at Medical Conference in the Second Half of 2022 -- -- NDA Submission to the U.S. FDA Planned for Second Half of 2022 -- -- Company to Host Conference Call at 8:30 a.m. Eastern Time -- STAMFORD, Conn., May 24, 2022 (GLOBE NEWSWIRE) -- SpringWorks Therapeuti