The stock price of SpringWorks Therapeutics, Inc. (NASDAQ: SWTX) is rising on the US stock charts today, indicating that investors are feeling more optimistic about the recent regulatory developments. Following a steady close in the last trading session, SWTX shares increased by 7.35% to $43.94 during the pre-market session. The company’s medication approval procedure has made substantial progress, which is the main driver of this stock price spike.
The FDA accepts the new drug application (NDA)
The U.S. Food and Drug Administration’s (FDA) has approved of SpringWorks’ NDA, for mirdametinib for the treatment of adults and children with plexiform neurofibromas, commonly known as NF1-PN associated with neurofibromatosis type 1.
For now, there are no effective treatment options available for this rare and debilitating condition. The NDA has been granted Priority Review, with an action deadline of February 28, 2025 under the Prescription Drug User Fee Act, or PDUFA. The FDA’s notification that it would not be conducting an advisory committee meeting to consider this application serves as additional evidence of the submission’s validity.
European Medicines Agency (EMA) Validates SWTX’s Application
In addition to the events in the US, SpringWorks announced that the EMA has validated the Marketing Authorization Application (MAA) for mirdametinib. This validation is crucial in order to make mirdametinib the first medication licensed for adult patients and the best available treatment for children with NF1-PN.
Mirdametinib had already been designated as an Orphan Drug by the FDA and the European Commission, highlighting the treatment’s potential to meet unmet medical requirements in this patient group.
Positive Clinical Trial Outcomes
Present at the 2024 Annual Meeting of the American Society of Clinical Oncology, the study results demonstrated the safety and efficacy of mirdametinib, including its profound and persistent responses, manageable safety profile, improvements in pain and quality of life, and significant objective response rates across both adult and pediatric groups.
Data from the pivotal Phase 2b ReNeu study, which assessed mirdametinib in individuals with NF1-associated PN aged two years and older, are included in the NDA and MAA filings. These results bolster mirdametinib’s promise as a ground-breaking treatment for NF1-PN.
