SpringWorks Therapeutics portfolio features Ogsiveo for desmoid tumors and Gomekli for NF1‑plexiform neurofibromas. In fact, Ogsiveo's revenues alone reached $172 million in 2024, supported by orphan drug designations in the US and EU. Similarly, Gomekli is the first FDA-approved MEK inhibitor for NF1‑plexiform neurofibromas, which targets both adults and children.
SWTX reports mixed fourth-quarter 2024 results. Its newly approved desmoid tumor drug, Ogsiveo, witnesses a strong launch.
– Achieved $61.5 million and $172.0 million in fourth quarter and full year 2024 OGSIVEO ® (nirogacestat) U.S. net product revenues, respectively –
LOUISVILLE, Ky., Feb. 17, 2025 (GLOBE NEWSWIRE) -- Onco360®, the nation's leading independent specialty pharmacy, has been selected as a national pharmacy partner by SpringWorks Therapeutics, Inc. for GOMEKLI (mirdametinib). The Food & Drug Administration approved GOMEKLI for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.1
– GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data from Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in robust ORR, deep and durable reductions in tumor volume, and a manageable safety profile – – SpringWorks granted rare pediatric disease priority review voucher by the FDA – Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/8eb8effc-49a5-4b24-911f-d3e6dfa9c8a9 https://www.globenewswire.com/NewsRoom/AttachmentNg/f1041678-3f79-43b7-a101-2390fb8cb86b https://www.globenewswire.com/NewsRoom/AttachmentNg/7d8cb318-e5f8-4944-8736-24cb19a5dec9 https://www.globenewswire.com/NewsRoom/AttachmentNg/072d748b-3237-48ad-8d83-1c6c23dda65f STAMFORD, Conn., Feb. 11, 2025 (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 GOMEKLI™ (mirdametinib), SpringWorks' MEK inhibitor, for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.1 With the approval, SpringWorks was granted a rare pediatric disease priority review voucher (PRV) by the FDA.
– GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data from Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in robust ORR, deep and durable reductions in tumor volume, and a manageable safety profile – – SpringWorks granted rare pediatric disease priority review voucher by the FDA – Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/8eb8effc-49a5-4b24-911f-d3e6dfa9c8a9 https://www.globenewswire.com/NewsRoom/AttachmentNg/f1041678-3f79-43b7-a101-2390fb8cb86b https://www.globenewswire.com/NewsRoom/AttachmentNg/7d8cb318-e5f8-4944-8736-24cb19a5dec9 https://www.globenewswire.com/NewsRoom/AttachmentNg/072d748b-3237-48ad-8d83-1c6c23dda65f STAMFORD, Conn., Feb. 11, 2025 (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 GOMEKLI™ (mirdametinib), SpringWorks' MEK inhibitor, for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.1 With the approval, SpringWorks was granted a rare pediatric disease priority review voucher (PRV) by the FDA.
SpringWorks reports preliminary fourth-quarter and full-year 2024 product revenues. It also provides updates across the commercial portfolio and other pipelines.
SpringWorks has shown strong revenue growth with OGSIVEO, achieving a 23% increase from Q2 of 2024 to Q3 of 2024, and potential EMA approval if it could boost sales further. Mirdametinib, a MEK inhibitor for NF1-PN, has a PDUFA date of February 28th of 2025, and could unlock significant shareholder value if approved. Results from phase 1b study using brimarafenib to treat patients with MAPK mutant solid tumors are expected to be released in the 2nd half of 2025.
SpringWorks Therapeutics (SWTX) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.
SpringWorks Therapeutics shows promising growth with their first approved drug and an imminent second approval for mirdametinib in NF1 treatment. SWTX's financials reveal strong cash reserves and growing sales, though they remain unprofitable, with a net loss of $53.5 million in Q3 2024. Strengths include sustained sales growth and potential back-to-back drug approvals, but risks involve market competition and aggressive goal setting.