Retail Chatter Surges As Crinetics Wins FDA Nod For First Oral Acromegaly Drug — Traders Expect Big Price Move

The company plans to launch in the U.S. in early October, with a European launch expected in 2026.

Retail chatter around Crinetics Pharmaceuticals picked up on Thursday after the U.S. Food and Drug Administration approved its lead therapy Palsonify (paltusotine) for adults with acromegaly.

Crinetics’ stock closed Thursday up 2.02% at $35.89 and added another 0.8% in after-hours trading.

The once-daily oral treatment is the first of its kind to be cleared in the U.S. for patients who do not respond to surgery or are unable to undergo surgery. The FDA decision was supported by two pivotal Phase 3 trials, PATHFNDR-1 and PATHFNDR-2, in which Palsonify was well-tolerated, provided rapid and durable biochemical control, and reduced symptom burden. Patients reported improvements in headaches, fatigue, joint pain and swelling.

Crinetics released long-term data in July from the same studies, showing that patients who switched from monthly injections to Palsonify were able to maintain steady hormone levels for nearly two years. 

Symptom flares fell significantly, from more than 30% of days on injectable therapies to just 6.2% on stable Palsonify dosing. 

CEO Scott Struthers called the FDA approval a “new era” for patients and the company, marking the first product launch from its pipeline of small-molecule drugs. The company said Palsonify will be available in the U.S. in early October, supported by a patient services program called CrinetiCARE.

Paltusotine is also being evaluated for the treatment of carcinoid syndrome in the pivotal Phase 3 CAREFNDR trial, with global enrollment expected throughout 2025.

On Stocktwits, retail sentiment for Crinetics was ‘extremely bullish’ amid a 410% surge in 24-hour message volume, placing it among the top three trending equities on the platform. 

Users expressed relief after a discussion clarified that while Crinetics sources some ingredients from Europe and previously India, its final tablets are manufactured in the United States, reducing tariff concerns.

Another user remarked that the overwhelmingly positive news, combined with a temporary trading halt, suggested a significant price increase for Crinetics stock could be expected.

Crinetics Pharmaceuticals’ stock has declined 29.8% so far in 2025.

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