SpringWorks Therapeutics

Merck has opened a €150 million, 3,000-square-meter cleanroom facility in Blarney, Cork, to manufacture advanced filtration products for vaccines, monoclonal antibodies, and cell and gene therapies.

The European Commission has granted conditional approval for Ezmekly (mirdametinib), the first therapy approved for both adults and children with neurofibromatosis type 1-associated plexiform neurofibromas.

Pharmaceutical M&A activity is experiencing a significant rebound with major deals including Novartis's $1.7 billion acquisition of Regulus Therapeutics and Merck KGaA's $3.9 billion purchase of SpringWorks Therapeutics.

CG Oncology's cretostimogene grenadenorepvec demonstrated a 75.5% complete response rate in high-risk BCG-unresponsive non-muscle invasive bladder cancer patients, with 34% maintaining complete response at 24 months.

German pharmaceutical giant Merck KGaA has agreed to acquire Connecticut-based SpringWorks Therapeutics for $3.9 billion, paying $47 per share in cash, representing a 26% premium over SpringWorks' unaffected 20-day average price.

SpringWorks Therapeutics expects the European Medicines Agency's CHMP to issue an opinion on nirogacestat for adult desmoid tumors in Q2 2025, potentially expanding access beyond its current FDA approval.

• SpringWorks Therapeutics' drug Ogsiveo is under review by the European Medicines Agency's CHMP, with analysts anticipating a positive opinion to be announced Friday. • Evercore ISI maintains an "Outperform" rating with a $65 price target on SpringWorks, describing it as an "emerging multi-product story" with increasing strategic value. • Geographic expansion into Europe would significantly enhance SpringWorks' market position and appeal to European pharmaceutical companies, according to analyst Cory Kasimov.

Long-term treatment with nirogacestat (Ogsiveo) demonstrated improved objective response rates reaching 45.7% at 4 years compared to 34.3% at 1 year in patients with desmoid tumors, according to updated DeFi trial data.

• SpringWorks Therapeutics recently secured FDA approval for Gomekli (mirdametinib), a drug once abandoned by Pfizer, providing the first treatment option for adults with neurofibromatosis type 1. • The Children's Tumor Foundation played a crucial role in rescuing the drug from Pfizer's intellectual property vault, demonstrating how patient advocacy groups can bridge the gap between academia and industry for rare disease treatments. • Experts estimate that approximately 30 more potential treatments for neurofibromatosis alone may be sitting idle in pharmaceutical companies' portfolios, highlighting a significant opportunity to replicate this model across rare diseases.

Merck KGaA confirms advanced acquisition discussions with SpringWorks Therapeutics, though critical conditions remain unmet and no binding agreement has been reached.