Crinetics Doses First Patient in CALM-CAH Phase 3 Trial for CAH Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 11 2025
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Should l Buy CRNX?
Source: Globenewswire
- Trial Initiation: Crinetics Pharmaceuticals has successfully dosed the first patient in the CALM-CAH Phase 3 trial, marking a critical advancement in the clinical development of atumelnant for classic congenital adrenal hyperplasia (CAH), demonstrating the company's commitment to addressing unmet patient needs.
- Innovative Therapy Potential: Atumelnant, as the first small molecule ACTH receptor antagonist, aims to provide a more effective management solution for CAH by reducing adrenal androgen levels and improving glucocorticoid use, which could significantly enhance patients' quality of life.
- FDA Orphan Drug Designation: Crinetics recently received Orphan Drug Designation from the FDA for atumelnant, further enhancing the drug's market competitiveness and paving the way for future regulatory approvals.
- Clinical Data Support: In Phase 2 studies, atumelnant demonstrated significant reductions in key biomarkers, proving its effectiveness in controlling CAH-related disease activity, thereby laying a solid foundation for the success of the Phase 3 trial.
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Analyst Views on CRNX
Wall Street analysts forecast CRNX stock price to rise
11 Analyst Rating
11 Buy
0 Hold
0 Sell
Strong Buy
Current: 44.080
Low
67.00
Averages
89.40
High
105.00
Current: 44.080
Low
67.00
Averages
89.40
High
105.00
About CRNX
Crinetics Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of therapeutics for rare endocrine diseases and endocrine-related tumors. Its lead development candidate, PALSONIFY (paltusotine), is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist that is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors. Its second product candidate is Atumelnant, which is in clinical development for congenital adrenal hyperplasia (CAH) and patients with either Cushing's disease or Ectopic ACTH Syndrome (EAS). Its drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts, including other programs addressing a variety of endocrine conditions such as hyperparathyroidism, polycystic kidney disease, Graves' disease, thyroid eye disease, diabetes and obesity.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Successful Dose Adjustment: Among patients treated with an 80 mg dose, 88% were able to reduce glucocorticoid doses to physiological replacement levels after 12 weeks, enhancing patient quality of life while potentially reducing long-term side effect risks.
- Good Safety Profile: Atumelnant showed no serious adverse events during the study, with no participants discontinuing treatment due to adverse events, indicating strong tolerability and enhancing its marketability.
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- New Drug Development: Atumelnant, an oral medication, aims to treat CAH by blocking the MC2R receptor on the adrenal gland, thereby reducing excess cortisol and androgen production, further enhancing Crinetics' innovative capabilities in the endocrine disease sector.
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- Offering Size: Crinetics Pharmaceuticals announced the pricing of 7.62 million shares at $45.95 each, expected to raise approximately $350 million, enhancing the company's financial capacity for future growth initiatives.
- Use of Proceeds: The proceeds will fund commercial activities related to PALSONIFY™, research and development of new product candidates, and other general corporate purposes, ensuring ongoing innovation in endocrine disease treatment.
- Underwriter Lineup: The offering is managed by Leerink Partners, J.P. Morgan, Evercore ISI, Piper Sandler, and Cantor, reflecting strong market confidence and support for Crinetics.
- Market Outlook: With its lead product PALSONIFY™ approved by the FDA, Crinetics is positioned to drive growth in the endocrine tumor treatment market, further solidifying its industry standing.
See More
Crinetics Pharmaceuticals Reports Significant Results in CAH Study with Atumelnant
- Rapid Efficacy Demonstrated: In the fourth cohort study, atumelnant resulted in a rapid average reduction of 67% in androstenedione levels among eight patients, indicating significant efficacy in treating congenital adrenal hyperplasia (CAH), which could transform patient treatment protocols.
- Successful Dose Adjustment: Among patients treated with an 80 mg dose, 88% were able to reduce glucocorticoid doses to physiological replacement levels after 12 weeks, enhancing patient quality of life while potentially reducing long-term side effect risks.
- Good Safety Profile: Atumelnant showed no serious adverse events during the study, with no participants discontinuing treatment due to adverse events, indicating strong tolerability and enhancing its marketability.
- Broad Market Potential: Crinetics recognized over $5 million in revenue from Palsonify in Q4 2025, demonstrating strong market acceptance and demand for its products, further solidifying the company's position in the endocrine disease treatment sector.
See More
Crinetics Pharmaceuticals Updates on Atumelnant Phase 2 Trial Results and PALSONIFY Commercialization
- Clinical Trial Progress: Crinetics Pharmaceuticals announced positive topline results from the Phase 2 trial of Atumelnant for Congenital Adrenal Hyperplasia in January 2025, demonstrating up to an 80% mean reduction in androstenedione levels across three dose cohorts, significantly improving patient health and indicating strong market potential for the drug.
- New Drug Development: Atumelnant, an oral medication, aims to treat CAH by blocking the MC2R receptor on the adrenal gland, thereby reducing excess cortisol and androgen production, further enhancing Crinetics' innovative capabilities in the endocrine disease sector.
- Subsequent Trial Initiation: Following the positive Phase 2 results, Crinetics has initiated the Phase 3 CALM-CAH trial to evaluate Atumelnant's ability to normalize adrenal androgen levels while reducing glucocorticoid levels, showcasing the company's ongoing progress in drug development.
- Market Response: Crinetics' stock rose 0.39% to $46.73 in Friday's trading, reflecting investor optimism regarding the company's drug development advancements and bolstering market confidence in its future growth potential.
See More
Crinetics Pharmaceuticals to Update PALSONIFY™ Commercialization and Phase 2 Trial Results on January 5, 2026
- Conference Call Announcement: Crinetics Pharmaceuticals will host a conference call on January 5, 2026, at 8:30 a.m. ET to update on PALSONIFY™ (paltusotine) commercialization and disclose topline results from the fourth cohort of the Phase 2 trial, aiming to bolster investor confidence in the company's product pipeline.
- Product Highlight: PALSONIFY™ is the first once-daily oral treatment approved by the U.S. FDA for adults with acromegaly who have had an inadequate response to surgery, which is expected to enhance the company's market share in the endocrine disease treatment sector.
- Clinical Development Progress: The ongoing Phase 2 trial of atumelnant for congenital adrenal hyperplasia will provide critical data that could lay the groundwork for future product line expansion, further solidifying Crinetics' leadership in the treatment of endocrine tumors.
- Investor Engagement: The conference will include a live Q&A session aimed at strengthening communication with investors and enhancing transparency, thereby boosting market confidence in Crinetics' long-term growth potential.
See More
Inaugural Week of CRNX Options Trading for February 2026
Put Contract Overview: The $46.00 put contract for CRNX has a bid of $3.40, allowing investors to potentially buy shares at a cost basis of $42.60, which is attractive compared to the current price of $47.17. There is a 58% chance the contract may expire worthless, offering a potential 7.39% return on cash commitment.
Call Contract Overview: The $48.00 call contract has a bid of $2.80, and if shares are purchased at $47.17 and the call is sold, it could yield a total return of 7.70% if the stock is called away by February 2026. There is a 48% chance this contract may also expire worthless, providing a 5.94% additional return.
Volatility Insights: The implied volatility for the put contract is 76%, while for the call contract it is 71%. The actual trailing twelve-month volatility is calculated at 59%, indicating a significant difference between implied and actual market conditions.
YieldBoost Concept: The article discusses the concept of YieldBoost, highlighting potential returns from both put and call contracts, and emphasizes the importance of tracking these options over time for better investment decisions.
See More
