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Crinetics Announces Strong PALSONIFY Launch Execution and Positive Results for Concurrent Androstenedione Lowering and Glucocorticoid Dose Reduction in Phase 2 Trial of Atumelnant for Congenital Adrenal Hyperplasia

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Strong PALSONIFY U.S. Launch Execution Resulted in Unaudited and Preliminary Net Product Revenue of ...

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Crinetics Pharmaceuticals reported over $5 million in PALSONIFY revenue for Q4 2025 and received more than 200 enrollment forms post-FDA approval. Positive results from the Phase 2 trial of Atumelnant demonstrate significant efficacy without serious side effects, enhancing its prospects in the market. Management is expected to provide more insights during today's investor conference call.

Trading Thesis

With solid early revenue and strong clinical results, CRNX could see positive momentum.

Market-Moving

  • Revenue of over $5 million for PALSONIFY boosts investor confidence.
  • Positive clinical trial results from Atumelnant could elevate market interest.
  • Near-term developments may catalyze stock price increases for CRNX.
  • Investor call today could trigger significant trading activity.
  • Successful payer engagement enhances market perspectives on PALSONIFY.

Key Facts

  • PALSONIFY was FDA approved on September 25, 2025.
  • Atumelnant shows a 67% reduction in Androstenedione levels.
  • 88% of participants reduced glucocorticoid doses to physiological levels.
  • Crinetics received over 200 enrollment forms by December 2025.
  • No serious adverse events recorded during Atumelnant trials.

Companies Mentioned

  • Crinetics Pharmaceuticals (CRNX): Leaders in endocrine disease therapeutics, recently gaining traction in acromegaly treatment.

Corporate Developments

The developments from Crinetics fall under pharmaceutical product launches and clinical trial results, positioning the company favorably within the niche market of endocrine disorders.

FAQ

Why Bullish?

Successful product revenue and positive clinical trial results typically boost stock performance, as observed in similar biotech firms after favorable drug outcomes.

How important is it?

The article provides substantial insights about product performance and trial results, directly impacting investor sentiment and stock viability.

Why Short Term?

Immediate revenue and investor sentiment can influence stock performance within the next few quarters.

Related Companies

Crinetics Pharmaceuticals Reports Strong PALSONIFY Launch and Positive Atumelnant Trial Results

San Diego, Jan. 5, 2026 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) has announced impressive early results from the launch of its product PALSONIFY, revealing an unaudited preliminary net product revenue exceeding $5 million for the fourth quarter of 2025. The company has additionally disclosed positive topline outcomes from the fourth cohort of its ongoing Phase 2 trial, focusing on its investigational drug atumelnant, aimed at treating congenital adrenal hyperplasia (CAH).

PALSONIFY Launch Success

Since gaining FDA approval on September 25, 2025, PALSONIFY has shown significant traction in the market. Crinetics has recorded over 200 enrollment forms within the first three months post-launch and a broad base of more than 125 unique prescribers.

Key highlights from PALSONIFY’s launch include:

  • Unaudited preliminary net product revenue of >$5 million in Q4 2025.
  • Over 200 enrollment forms submitted by healthcare providers.
  • Approximately 50% of newly filled prescriptions reimbursed without Quickstart bridge supplies.
  • 12-month duration for most prior authorizations.

“We are encouraged by these results, which reflect the strong execution of our team in launching PALSONIFY,” stated Scott Struthers, Ph.D., Founder and CEO of Crinetics Pharmaceuticals. “Our engagement with patients, prescribers, and payers has been very positive, indicating that PALSONIFY is meeting an unmet medical need.”

Positive Results from Atumelnant Phase 2 Trial

Crinetics also announced favorable results from the fourth cohort of its Phase 2 TouCAHn trial of atumelnant, a once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist. The trial involved 10 patients with classic CAH on stable glucocorticoid doses, with results demonstrating:

  • A mean 67% reduction in serum androstenedione (A4) levels after 12 weeks, with a final mean A4 of 866 ng/dL.
  • 88% of participants successfully reducing their glucocorticoid doses to physiologic replacement levels.
  • No serious adverse events or hepatic transaminase elevations reported.

This highlights atumelnant's potential as a differentiated treatment option for individuals managing CAH.

Interim Update on Open-Label Extension

In an interim update from the open-label extension of the Phase 2 trial, early data from seven patients continues to show reductions in serum A4 and glucocorticoid doses similar to those observed in the primary cohort. There have been no serious treatment-related adverse events reported within the expanded patient group.

Atumelnant's safety profile further solidifies its promise, as it has now been evaluated in >200 participants across various trials, consistently demonstrating a favorable benefit-risk profile.

Investor Conference Call

Crinetics will host an investor conference call today at 8:30 AM ET to discuss the topline results from the atumelnant study. Interested parties can join the call by dialing 1-833-470-1428 (domestic) or 1-646-844-6383 (international) and using Access Code 640078. A live webcast of the call will also be available on the Crinetics website.

About Atumelnant

Atumelnant is a first-in-class, once-daily oral ACTH receptor antagonist that targets the melanocortin type 2 receptor on the adrenal gland. Currently in Phase 3 development, atumelnant aims to transform treatment for patients with congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome. It has demonstrated significant reductions in key CAH biomarkers, positioning it as a potential new standard in care.

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