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Biotech Receives First Approval; Drug Now Available

Source: Robert Burns


November 29, 2023 ( Newswire) Recently, SpringWorks Therapeutics Inc. announced FDA approval of OGSIVEO (nirogacestat) for treating progressing desmoid tumors (DT) in adult patients based on Phase 3 DeFi trial results, noted H.C. Wainwright & Co. analysts Robert Burns and Dr. Raghuram Selvaraju.

Recently, SpringWorks Therapeutics Inc. (SWTX:NASDAQ) announced FDA approval of OGSIVEO (nirogacestat) for treating progressing desmoid tumors (DT) in adult patients based on Phase 3 DeFi trial results.

H.C. Wainwright analyst Robert Burns and Dr. Raghuram Selvaraju noted OGSIVEO showed clinically meaningful improvements on key efficacy endpoints, including progression-free survival, response rate, symptom severity, and quality of life versus placebo.

First FDA-Approved Option for Devastating Disease

With no therapies previously approved for DT, a rare fibroblastic proliferative disorder, analysts view OGSIVEO as establishing a new standard of care.

The robust efficacy and safety data enable it to disrupt the existing paradigm of watchful waiting.

Compelling Data Across All Key Metrics

The Phase 3 data showed OGSIVEO achieved a 71% reduction in risk of disease progression or death versus placebo. It also posted a significantly higher response rate of 41% versus 8% for placebo.

Further, OGSIVEO delivered statistically significant improvements in patient-reported pain, symptom severity, and quality of life.

Commercial Launch Underway; Peak Sales Forecast Raised

With the launch now starting, H.C. Wainwright has raised its model price target for SpringWorks to US$64 based on higher penetration and pricing assumptions for the newly approved treatment. The firm sees further upside from the broader pipeline, including mirdametinib. Multiple upcoming catalysts over the next 18 months provide opportunities to realize value.

Given the strong efficacy and safety profile demonstrated, analysts view OGSIVEO as well-positioned for rapid adoption. With commercial efforts ramping up and additional pivotal readouts approaching, SpringWorks appears favorably positioned heading into 2023.

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