SpringWorks Therapeutics Trading Volume Surges 93.85% to 2.72 Billion, Ranks 302nd in Daily Trading

On May 23, 2025, SpringWorks Therapeutics (SWTX) saw a significant surge in trading volume, reaching 2.72 billion, marking a 93.85% increase from the previous day. This surge positioned the company at the 302nd spot in the day's trading rankings. The stock price of SpringWorks Therapeutics rose by 0.45%, marking the second consecutive day of gains, with a total increase of 0.58% over the past two days.

SpringWorks Therapeutics, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a conditional marketing authorization for mirdametinib, a MEK inhibitor, for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above. The European Commission (EC) will review the CHMP opinion and is expected to make a final decision regarding the approval in the third quarter of 2025. If approved, mirdametinib will be available in 1 and 2 mg capsules and in a 1 mg dispersible tablet, which dissolves easily in water.

Saqib Islam, Chief Executive Officer of SpringWorks, expressed optimism about the positive opinion from the CHMP, stating that it brings the company one step closer to delivering mirdametinib to both children and adults with NF1-PN in Europe. He emphasized the need for new therapeutic advances for these patients and the company's commitment to bringing mirdametinib to appropriate patients in Europe as quickly as possible upon approval.

NF1 is a genetic disorder that affects approximately 3 in 10,000 people in the EU, or an estimated 135,000 people. Patients with NF1 have a 30 to 50% lifetime risk of developing plexiform neurofibromas, which are tumors that grow in an infiltrative pattern along the peripheral nerve sheath and can cause severe disfigurement, pain, and functional impairment. Surgical removal of these tumors can be challenging due to their infiltrative growth pattern, and up to approximately 85% of plexiform neurofibromas are considered not amenable to complete resection.

The CHMP opinion was based on the Marketing Authorization Application (MAA) for mirdametinib, which was validated by the EMA in August 2024. The MAA centered on the primary results from the Phase 2b ReNeu trial, which enrolled 114 patients with NF1-PN age 2 years or older. The study met the primary endpoint of confirmed objective response rate (ORR), demonstrating an ORR of 41% in adults and 52% in children. Both adults and children also experienced early and sustained significant improvements from baseline in pain and quality of life as assessed across multiple patient-reported outcome tools.

Mirdametinib demonstrated a manageable safety and tolerability profile. The most common adverse events reported in adults receiving mirdametinib were rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue. The most common adverse events occurring in children were rash, diarrhea, musculoskeletal pain, abdominal pain, vomiting, headache, paronychia, left ventricular dysfunction, and nausea.