FDA Approves SpringWorks Therapeutics' Lead Therapy As First For Subtype Of Soft Tissue Sarcomas
Portfolio Pulse from Vandana Singh
The FDA has approved SpringWorks Therapeutics Inc's Ogsiveo for adult patients with progressing desmoid tumors, marking it as the first drug for this condition. The approval is based on the Phase 3 DeFi trial results, which showed a 71% reduction in the risk of disease progression and a 41% objective response rate compared to placebo. Ogsiveo will be available in the U.S. soon and a European application is expected in the first half of 2024. Analysts project U.S. sales of $3 million in 2023, $79 million in 2024, and peak sales of $544 million in 2032. SpringWorks' shares rose 9.24% in premarket trading.
November 28, 2023 | 11:43 am
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POSITIVE IMPACT
SpringWorks Therapeutics' Ogsiveo has been approved by the FDA for treating desmoid tumors, with positive trial results and significant sales projections. The stock rose 9.24% in premarket trading.
The FDA approval of Ogsiveo is a significant milestone for SpringWorks Therapeutics, as it is the first drug approved for desmoid tumors. The positive trial results and the projected sales figures suggest a strong market potential for the drug, which is reflected in the premarket stock price increase. The confidence in the analysis is high due to the clear correlation between the FDA approval and the stock's positive reaction.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100