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SpringWorks Therapeutics SWTX announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending conditional marketing authorization for its MEK inhibitor, mirdametinib, for a rare genetic disorder.
The CHMP has recommended granting a conditional marketing authorization to mirdametinib for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric and adult patients with neurofibromatosis type 1 (NF1) aged two years and above.
The European Commission will now review the CHMP’s opinion and a decision from the regulatory body is expected in the third quarter of 2025. The EMA validated the marketing authorization application (MAA) for mirdametinib last August.
If approved, mirdametinib would become the first and only therapy to receive marketing authorization for treating adults and children with NF1-PN in the European Union.
The FDA approved mirdametinib under the brand name Gomekli for treating adult and pediatric patients aged two years and older with NF1-PN in February 2025. Gomekli generated sales worth $4.9 million in the United States during the first quarter of 2025.
Year to date, shares of SpringWorks have risen 28.6% against the industry’s decline of 5.5%.
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SWTX Set to be Acquired by Merck KGaA
In April 2025, Merck KGaA, Darmstadt, Germany, announced that it had agreed to acquire SpringWorks for $47 per share in cash, representing a total equity value of approximately $3.9 billion.
The transaction is expected to be closed in the second half of 2025, subject to customary closing conditions.
The acquisition of SpringWorks will add its oral gamma-secretase inhibitor, Ogsiveo (nirogacestat), to Merck KGaA’s portfolio.
Ogsiveo was approved in the United States for treating adult patients with desmoid tumors in November 2023. Ogsiveo is the first and only FDA-approved treatment indicated specifically for desmoid tumors.
Ogsiveo generated sales worth $172 million in 2024. In the first quarter of 2025, the drug recorded sales of $44.1 million in the United States.
Several label expansion studies on Ogsiveo, targeting different cancer indications, are currently ongoing.
Notably, the EMA validated the MAA for Ogsiveo for the treatment of adult patients with desmoid tumors in February 2024. The CHMP’s opinion related to the MAA for Ogsiveo is expected later in the second quarter of 2025.
The impending acquisition by Merck KGaA will help SpringWorks to reach global markets and build on the resources, helping more patients with such rare tumors.