SpringWorks' Investigational Cancer Treatment Is Standard Care, Analyst Unfazed By FDA Update
Portfolio Pulse from Vandana Singh
SpringWorks Therapeutics Inc (NASDAQ:SWTX) received a Form 483 letter from the FDA in March due to a failure in the analysis of an exploratory endpoint in the Phase 3 DeFi trial. However, the company corrected the analysis and the FDA has completed all required inspections. Analysts from HC Wainwright continue to view nirogacestat as the standard-of-care regimen for treating desmoid tumors and expect it to receive FDA approval. They reiterated a Buy rating for SWTX with a price target of $66.
August 24, 2023 | 6:35 pm
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SpringWorks Therapeutics received a Form 483 letter from the FDA, but corrected the issue and completed all required inspections. Analysts from HC Wainwright maintain a Buy rating for the stock and expect nirogacestat to receive FDA approval.
The news is directly related to SpringWorks Therapeutics and its drug nirogacestat. Despite the FDA's Form 483 letter, the company corrected the issue and the FDA has completed all required inspections. This, along with the analysts' continued support and expectation of FDA approval for nirogacestat, is likely to have a positive impact on the company's stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100