Merck's EZMEKLY Receives Conditional Marketing Authorization in Europe for Neurofibromatosis Treatment.

Merck & Co. has received conditional marketing authorization from the European Commission for EZMEKLY to treat symptomatic, inoperable plexiform neurofibromas in pediatric and adult patients with neurofibromatosis type 1. The approval is based on data from the ongoing Phase 2b ReNeu trial, which showed an objective response rate of 41% in adults and 52% in children. EZMEKLY demonstrated an encouraging efficacy and safety profile in both groups. Merck's stock is trading at $80.61, down 1.12% on the NYSE.

Merck KGaA (MKKGY) has achieved a significant milestone with the European Commission's approval of its innovative drug, EZMEKLY (mirdametinib). This medication is set to bring relief for patients aged two and over suffering from symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1 (NF1). The approval represents a strategic advancement for Merck, reinforcing its collaboration with SpringWorks Therapeutics in the fight against rare tumors.

The approval is based on data from the ongoing Phase 2b ReNeu trial, which showed an objective response rate of 41% in adults and 52% in children. EZMEKLY demonstrated an encouraging efficacy and safety profile in both groups. The drug is available in 1 and 2 mg capsules and in a 1 mg dispersible tablet, which dissolves easily in water, making it accessible to patients who may have difficulty swallowing pills.

The stock's average target price suggests significant upside potential from its current level. One analyst has provided a one-year price target for Merck KGaA (MKKGY), placing the average target price at $42.20, indicating an impressive upside potential of 60.69% from the current stock price of $26.26 [1]. Additionally, the firm's average brokerage recommendation is solidly positioned at 1.0, which corresponds to a "Buy" rating. Further value estimation by GuruFocus sheds light on the stock's potential, with the estimated GF Value for Merck KGaA (MKKGY) standing at $38.06 for the next year, pointing to a projected upside of 44.93% from its present price of $26.261 [1].

Merck's stock is currently trading at $80.61, down 1.12% on the NYSE as of July 2, 2025. The approval of EZMEKLY marks a significant step forward for the company, expanding its portfolio in the treatment of rare tumors and potentially increasing its market share in the pharmaceutical sector.

References:
[1] https://www.gurufocus.com/news/2988320/european-approval-for-mercks-mkkgy-ezmekly-in-rare-tumor-treatment
[2] https://ir.springworkstx.com/news-releases/news-release-details/european-commission-grants-conditional-approval-ezmeklyr