Crinetics Stock Soars 13% on Promising Adrenal Disorder Drug Data
Phase 2 results for atumelnant show significant hormone reduction and allow nearly 90% of patients to cut steroid dosage, a key goal in treating congenital adrenal hyperplasia.
Shares of Crinetics Pharmaceuticals (NASDAQ: CRNX) surged to a near 52-week high on Monday after the company announced positive results from a mid-stage trial of its experimental drug for a rare genetic disorder.
The San Diego-based biotech company saw its stock climb more than 13% to trade at $52.89 after reporting that its drug, atumelnant, achieved key goals in a Phase 2 study for congenital adrenal hyperplasia (CAH). The data showed the once-daily oral pill could significantly reduce harmful hormone levels and, crucially, allow patients to lower their intake of burdensome steroids.
CAH is a rare genetic condition affecting the adrenal glands' ability to produce essential hormones, leading to an overproduction of androgens (male sex hormones). For decades, the standard treatment has been high-dose glucocorticoids, or steroids, to manage the condition. While effective, this lifelong treatment carries a heavy burden of side effects, including bone loss, metabolic syndrome, and cardiovascular complications. As a result, a primary objective for new therapies is to enable patients to reduce their steroid dose to more physiologic levels.
Crinetics reported that its trial data hit this crucial endpoint. According to the company's official announcement, 88% of trial participants on atumelnant were able to successfully reduce their glucocorticoid dosage. Furthermore, patients treated with the drug showed a 67% mean reduction in androstenedione, a key marker of the disease's severity.
The results position atumelnant as a potentially formidable player in a newly competitive market. For years, no new treatments emerged for CAH, but in December 2024, Neurocrine Biosciences won FDA approval for Crinecerfont, the first novel treatment for the disorder in decades. Crinetics' atumelnant, which has a different mechanism of action as a melanocortin type 2 receptor (MC2R) antagonist, now appears to be a strong contender targeting the same patient population.
"We are excited to announce additional positive atumelnant clinical data which reinforces its potential to become an uncompromising, highly differentiated treatment for people struggling with CAH," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics, in a statement. He added that the results mark a major step forward for the company's goal to "redefine the standard of care for people struggling with endocrine and endocrine-related diseases."
The company, which focuses on developing therapies for rare endocrine diseases, has a market capitalization that has swelled to approximately $4.4 billion on the back of its pipeline progress. The FDA has already granted atumelnant Orphan Drug Designation, a status intended to encourage the development of drugs for rare conditions.
Wall Street has responded positively to Crinetics' strategy. The company holds a strong consensus buy rating from analysts, with 14 analysts recommending a 'Buy' or 'Strong Buy' and only two assigning a 'Hold' rating. The average analyst price target sits at $80.21, suggesting significant potential upside from its current trading level.
Investors will now be closely watching the drug’s progression into late-stage trials. Crinetics has already initiated a pivotal Phase 3 study in adults, known as CALM-CAH, and plans to begin a pediatric trial. While the Phase 2 results have significantly de-risked the program, atumelnant's ultimate success and path to market will depend on replicating these positive findings in the larger, more rigorous Phase 3 setting. If successful, atumelnant could capture a significant portion of a market projected to reach nearly $1 billion by the early 2030s, offering a new ray of hope for CAH patients.