Crinetics Surges 21% on FDA Nod for Acromegaly Drug
Regulator approves Palsonify, the first once-daily oral treatment for the rare hormone disorder, prompting multiple analyst upgrades.
Crinetics Pharmaceuticals (CRNX) saw its shares jump more than 21% after the company announced it had received U.S. Food and Drug Administration (FDA) approval for Palsonify (paltusotine), its novel treatment for acromegaly. The drug is the first once-daily oral medication approved for the rare and debilitating hormone disorder, offering a significant alternative to the standard-of-care monthly injections.
The regulatory green light sparked a significant rally and intense investor interest, with the stock gaining over 36% in the week of the announcement on trading volume 2.7 times its daily average. In response to the approval, , with Stifel boosting its target to $75 from $58. Leerink Partners and Morgan Stanley followed suit, lifting their targets to $88 and $77, respectively, citing the drug's strong commercial potential.
Palsonify's approval was based on data from two successful Phase 3 trials, which demonstrated the drug was well-tolerated and effective in maintaining stable hormone levels in patients switching from injections. According to the , patients experienced rapid and durable biochemical control, along with a reduction in common symptoms like headaches, fatigue, and joint pain.
Crinetics has priced Palsonify at an annual cost of $290,000, a figure that exceeded analyst expectations. The company plans a U.S. launch by early October, with a European rollout anticipated in 2026. Stifel analysts project the drug could achieve peak sales of $2.5 billion. The approval also ignited conversation among retail investors, where message volume on platforms like Stocktwits surged over 400% as traders cheered the arrival of a .