Shares of Crinetics Pharmaceuticals (NASDAQ: CRNX) were up more than 67% as of 12:30 p.m. ET on Monday after the company posted positive phase 3 trial results for one of its therapies. The healthcare stock is up more than 28% for the year.
Crinetics focuses on finding and commercializing treatments for rare endocrine diseases and endocrine-related tumors. On Sunday, the company reported positive top-line data for its therapy to treat acromegaly, a disease caused by excess growth hormone from a pituitary tumor.
The biotech company said that its therapy, once-daily tablet paltusotine, met all of its primary and secondary endpoints in the trial compared to a placebo to treat acromegaly. The plus for Crinetics is that the current standard of care requires a monthly injection, so a once-daily oral therapy would be preferred by many patients.
The company said that it plans to seek regulatory approval from the Food and Drug Administration (FDA) as soon as the study on the therapy is completed early next year.
The stock’s surge represents a big swing forward for Crinetics. Shares had been reeling after the FDA declined to allow the phase 2 trial of CRN04777 to treat infants and children with congenital hyperinsulinism (excess secretion of insulin) late in 2022. The key will be quickly bringing paltusotine to market so that the company could have its first commercial product.
In the second quarter, Crinetics reported that it had $264.5 million in cash after a net loss of $51 million in the quarter. That doesn’t leave a lot of money to market paltusotine, so it wouldn’t be surprising if the company holds a stock sale in the near future.
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Jim Halley has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
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