Biotech Currents

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Phase II data could drive SpringWorks' Ogsiveo (nirogacestat) to approval in second indication | $SWTX

Phase II data could drive SpringWorks' Ogsiveo (nirogacestat) to approval in second indication | $SWTX

Bill Langbein
Aug 19, 2024
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Biotech Currents
Biotech Currents
Phase II data could drive SpringWorks' Ogsiveo (nirogacestat) to approval in second indication | $SWTX
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A simple and minimalistic illustration of human ovaries, similar to a previous design. The image features two small oval shapes representing the ovaries, connected by a curved line for the fallopian tubes. The ovaries should be in a soft pink color, and the fallopian tubes in a light pastel shade, such as light blue. The background is plain white, and the lines are thin and black, keeping the image visually clear and easy to understand. The overall design is straightforward, with no intricate details or textures.

SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) became a commercial biotech in November 2023 after the FDA approved nirogacestat, now branded as Ogsiveo, as a monotherapy to treat adults with desmoid tumors. While most of the investor spotlight on SpringWorks centers on the anticipated approval of mirdametinib to treat a mostly benign disease, the company plans to release Ogsiveo data from a phase II trial in ovarian granulosa cell tumors (OvGCTs) before year’s end.

Approval in the OvGCT indication would advance Ogsiveo into treatment of tumors that can lead to more serious cancer. Moreover, it would solidify the projected peak revenue for Ogsiveo. After the approval in desmoid tumors, one analyst projected peak revenue of $615 million. That projection, however, was increased to $810 million after SpringWorks set annualized pricing of Ogsiveo to $348,000. Before approval, the projected annual price was $200,000. A second analyst pegged $544 million in peak revenue in 2032 and forecast $79 million in 2024 sales. Significantly, Ogsiveo recorded $61.2 in net product revenue in the first six months of 2024, signaling strong adoption by clinicians.

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Key catalysts

  • Initial data from phase II trial of Ogsiveo (nirogacestat) to treat ovarian granulosa cell tumors

Key catalyst dates

  • 2H 2024

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