SpringWorks stock on track for record gain after FDA approves first treatment for rare type of aggressive tumors

By Eleanor Laise

New drug treats tumors that can invade surrounding organs, cause mobility issues

SpringWorks Therapeutics Inc. shares (SWTX) were on track for a record percentage gain on Tuesday after the company got the first U.S. regulatory approval for a drug targeting a rare type of non-cancerous but aggressive tumors.

The stock was up more than 25% Tuesday morning, following the U.S. Food and Drug Administration's late Monday approval of Ogsiveo for the treatment of desmoid tumors, which can invade surrounding organs and cause severe pain and mobility issues. The regulatory action marks the first approved treatment option for patients with the tumors, beyond surgery and radiation, Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in a statement.

In a clinical trial, Ogsiveo produced clinically meaningful and statistically significant improvement in progression-free survival, compared with a placebo, the FDA said. Common side effects included diarrhea, ovarian toxicity, rash, and nausea, the agency said.

Patients with desmoid tumors have been "waiting for an effective treatment that not only shrinks their tumors but also significantly improves pain, which is the most debilitating symptom reported" by people with the condition, SpringWorks CEO Saqib Islam said in a statement. "We are pleased with the broad label, which includes all progressing adult patients and specifically references improvement in pain," Islam said.

The approved product label is also "a clear win scenario," J.P. Morgan analysts wrote in a research note Monday, because it includes no black-box warning for ovarian dysfunction. The labeling "should remove a persistent overhang on the program," the analysts wrote.

Ogsiveo has "blockbuster potential globally," the analysts said. SpringWorks is also researching the drug as a potential treatment for a certain type of ovarian tumor and for multiple myeloma.

SpringWorks was spun out from Pfizer Inc. (PFE) in 2017 to develop drugs for rare diseases.

SpringWorks shares have gained about 1% in the year to date, while the S&P 500 SPX has gained 18.5%.

-Eleanor Laise

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11-28-23 1106ET

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