Crinetics Pharmaceuticals Poised for Growth with PDUFA Approval Looming and Multiple Late-Stage Programs Underway

Crinetics Pharmaceuticals is a promising buy with a Buy rating from Leerink Partners analyst Joseph Schwartz. The company is set for a PDUFA action date for Palsonify, a treatment for acromegaly, and is preparing for its first commercial launch. Crinetics is also actively engaging with payers and has multiple late-stage programs in progress. The anticipated launch in Europe in 2026, pending approval, supports a positive outlook. The price target remains at $80.00.

Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on endocrine diseases and tumors, reported its second-quarter 2025 financial results and provided a business update on August 7, 2025. The company continues to make significant progress towards its goal of becoming a fully-integrated, commercial-stage entity and delivering transformative therapies to patients [1].

Financial Highlights

- Revenue: The company reported revenues of $1.0 million for the quarter ended June 30, 2025, compared to $0.4 million for the same period in 2024. Revenues were derived from the paltusotine licensing and supply agreements with Sanwa Kagaku Kenkyusho Co., Ltd. [1].
- Research and Development Expenses: R&D expenses were $80.3 million for the three months ended June 30, 2025, compared to $58.3 million for the same period in 2024. The increases were primarily attributable to an increase in personnel costs and clinical and manufacturing activities costs [1].
- Selling, General, and Administrative Expenses: Selling, general, and administrative expenses were $49.8 million for the three months ended June 30, 2025, compared to $24.8 million for the same period in 2024. The increases were primarily driven by an increase in personnel costs and outside services costs [1].
- Net Loss: The net loss for the three months ended June 30, 2025, was $115.6 million, compared to a net loss of $74.1 million for the same period in 2024. Cash, cash equivalents, and investments totaled $1.2 billion as of June 30, 2025, compared to $1.4 billion as of December 31, 2024 [1].
- Cash Runway: Crinetics expects its cash, cash equivalents, and investments to be sufficient to fund its current operating plan into 2029 [1].

Clinical and Commercial Milestones

- Palsonify (Paltusotine): The review process for paltusotine's New Drug Application (NDA) for acromegaly remains on track with consistent and productive engagement with the FDA. The FDA PDUFA target action date for paltusotine NDA is September 25, 2025. The company expects to initiate the CAREFNDR Phase 3 trial in carcinoid syndrome and the CALM-CAH Phase 3 study in adults with CAH in the second half of 2025 [1].
- Atumelnant: The company expects to initiate the Phase 2/3 study of atumelnant in ACTH-dependent Cushing's syndrome in the first half of 2026. The Phase 2/3 BALANCE-CAH pediatric study is also expected to begin in the second half of 2025 [1].
- CRN09682: The company plans to initiate a Phase 1/2 dose escalation study for CRN09682, the first candidate from the nonpeptide drug conjugate (NDC) platform, in the second half of 2025 [1].

Analyst Rating

Leerink Partners analyst Joseph Schwartz has given Crinetics Pharmaceuticals a Buy rating, with a price target of $80.00. The analyst cited the company's strong financial position, upcoming milestones, and active engagement with payers as reasons for the positive outlook [2].

Conclusion

Crinetics Pharmaceuticals is well-positioned with a strong financial foundation and a robust pipeline of late-stage programs. The company's upcoming milestones, including the expected launch of Palsonify in Europe in 2026 and the initiation of various Phase 3 trials, support a positive outlook for investors. With a Buy rating and a price target of $80.00, Crinetics Pharmaceuticals presents an attractive opportunity for investors seeking exposure to innovative therapeutic solutions in endocrine diseases and tumors.

References

[1] https://crinetics.com/crinetics-pharmaceuticals-reports-second-quarter-2025-financial-results-and-provides-business-update/
[2] https://www.leerink.com/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/analysts/anal