Crinetics Pharmaceuticals (CRNX) Company Report

Crinetics Pharmaceuticals has dosed the first patient in the CALM-CAH Phase 3 trial evaluating atumelnant for the treatment of classic congenital adrenal hyperplasia (CAH).
Atumelnant is an investigational, once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist and is the first-and-only small molecule ACTH receptor antagonist in late-stage clinical development.
The CALM-CAH study aims to evaluate atumelnant's ability to normalize adrenal androgen levels and reduce glucocorticoid levels.
Crinetics recently received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) for atumelnant in CAH.

Dec 11, 2025, 9:05 PM

Press Release

Crinetics Pharmaceuticals Reports Q3 2025 Results and Provides Palsanafy Launch Update

CRNX

Earnings

Product Launch

Guidance Update

Crinetics Pharmaceuticals reported $0.1 million in Q3 2025 revenue from a licensing agreement, with no Palsanafy revenue recognized in the quarter due to its late-quarter approval, but expects recognition in Q4 2025.
The launch of Palsanafy for acromegaly is progressing well, with initial prescriptions primarily from switch patients (95%) and positive early feedback from payers, including some approvals for up to 12-month supplies. Detailed launch metrics, including revenue, new patient starts, and unique prescribers, will be provided in Q1 2026.
Research and development expenses increased to $90.5 million in Q3 2025, reflecting continued investment in clinical programs, while the company ended the quarter with a strong cash position of $1.1 billion, sufficient to fund operations into 2029.
Pipeline updates include the activation of first sites for the CAH trial with patient randomization expected before year-end, though timelines for the TSH candidate for Graves' disease and the SST-3 agonist program for ADPKD have been delayed due to preclinical findings.

Nov 6, 2025, 9:30 PM

Transcript

Crinetics Pharmaceuticals Reports Q3 2025 Financial Results and PALSONIFY Launch Update

CRNX

Earnings

Product Launch

Guidance Update

Crinetics Pharmaceuticals reported a net loss of $130.1 million on $0.1 million in revenues for the third quarter ended September 30, 2025.
The company successfully launched PALSONIFY™ (paltusotine) in the U.S. on September 25, 2025, for acromegaly, noting encouraging early feedback and approximately 50% of filled prescriptions reimbursed.
As of September 30, 2025, Crinetics maintained a strong financial position with $1.1 billion in cash, cash equivalents, and investments, which is expected to fund operations into 2029.
The company reiterated its 2025 cash burn guidance of $340 million to $370 million and anticipates multiple clinical trial initiations in Q4 2025 and H1 2026 for its pipeline candidates.

Nov 6, 2025, 9:20 PM

8-K

Crinetics Pharmaceuticals Reports Q3 2025 Financial Results and PALSONIFY™ Launch

CRNX

Earnings

Product Launch

Guidance Update

Crinetics Pharmaceuticals reported $0.1 million in revenues and a net loss of $130.1 million for the third quarter ended September 30, 2025.
The company successfully launched PALSONIFY™ (paltusotine) in the U.S. following its FDA approval on September 25, 2025, for acromegaly.
As of September 30, 2025, Crinetics held $1.1 billion in cash, cash equivalents, and investments, projecting a cash runway into 2029.
The company reiterated its 2025 cash burn guidance of $340-370 million and expects to randomize the first patients in multiple Phase 3 trials for paltusotine and atumelnant in Q4 2025.

Nov 6, 2025, 9:05 PM

Press Release

Crinetics Pharmaceuticals announces FDA approval and launch of PALSONIFI for acromegaly

CRNX

Product Launch

New Projects/Investments

Crinetics Pharmaceuticals announced that PALSONIFI has been approved by the FDA for the treatment of adults living with acromegaly.
The broad label reflects extensive clinical data, allowing PALSONIFI to be a first-line treatment for adult patients who have had an inadequate response to surgery or for whom surgery is not an option, and notably includes data showing improvement in symptoms.
The addressable market in the U.S. for acromegaly patients is approximately 11,500, with an estimated 1,500 newly diagnosed patients each year.
The annual wholesale acquisition cost (WAC) for PALSONIFI is set at approximately $290,000, which is comparable to other approved acromegaly products.
To ensure broad patient access, Crinetics has implemented programs such as a Quick Start program for 48-hour delivery of the prescription and co-pay assistance, with expectations for formulary placement within six to nine months after launch.

Sep 25, 2025, 10:00 PM

Transcript

Crinetics Pharmaceuticals Announces FDA Approval and Launch of Telsomify for Acromegaly

CRNX

Product Launch

New Projects/Investments

Crinetics Pharmaceuticals announced the FDA approval of Telsomify for the treatment of adults living with acromegaly.
Telsomify is approved as a first-line treatment for adult patients who have had an inadequate response to surgery or for whom surgery is not an option, with a broad label reflecting its safety, efficacy, and impact on symptom management.
The annual Wholesale Acquisition Cost (WAC) price for Telsomify is set at approximately $290,000.
Crinetics expects to achieve broad access for Telsomify, with most payers covering the drug based on prior authorization to label, and anticipates placement on most formularies within six to nine months after launch.
The company estimates approximately 11,500 addressable acromegaly patients in the U.S., with an additional 1,500 newly diagnosed patients each year.

Sep 25, 2025, 10:00 PM

Transcript

Crinetics Pharmaceuticals Announces FDA Approval of Telsomify

CRNX

Product Launch

Crinetics Pharmaceuticals announced the FDA approval of Telsomify for the first-line treatment of acromegaly in adult patients who have had an inadequate response to surgery or for whom surgery is not an option.
Telsomify is a once-daily oral SST2 selective agonist with a broad label that uniquely includes data demonstrating improvement in seven key acromegaly symptoms.
The U.S. addressable market for acromegaly is approximately 11,500 patients, with 1,500 new diagnoses annually. The annual WAC price is set at approximately $290,000, utilizing a flat pricing structure.
The launch strategy focuses on activating patients, driving adoption among 5,400 targeted healthcare professionals, and ensuring broad access through programs like QuickStart, co-pay assistance, and patient assistance.

Sep 25, 2025, 10:00 PM

Transcript

Crinetics Pharmaceuticals Receives FDA Approval for PALSONIFY

CRNX

Product Launch

New Projects/Investments

PALSONIFY (paltusotine) tablets received initial U.S. Approval in 2025 from the FDA.
It is indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.
The recommended initial dosage is 40 mg once daily, which can be titrated to 60 mg once daily after 2 to 4 weeks based on IGF-1 levels.
Clinical data from Phase 3 studies demonstrated that PALSONIFY achieved rapid, reliable, and consistent biochemical control, with 83% of switch patients and 56% of naive patients maintaining or achieving IGF-1 ≤ 1.0xULN.

Sep 25, 2025, 10:00 PM

Presentation

Crinetics Pharmaceuticals Announces FDA Approval and Launch of Palsonify

CRNX

Product Launch

Crinetics Pharmaceuticals' drug, Palsonify, has received FDA approval for the treatment of adults with acromegaly and is now available in the U.S..
Palsonify is an oral therapeutic option with a broad label, approved for first-line treatment of acromegaly in adult patients who have had an inadequate response to surgery or for whom surgery is not an option.
The label is uniquely differentiated by including data on symptom control, addressing a key unmet need for patients.
The annual Wholesale Acquisition Cost (WAC) price for Palsonify is set at approximately $290,000, which is within the price range of other approved acromegaly products.
Crinetics has implemented the Crinetics Care program, including a QuickStart program for 48-hour delivery of the drug and financial assistance programs, to ensure broad patient access and support.

Sep 25, 2025, 10:00 PM

Transcript

Crinetics Pharmaceuticals Announces FDA Approval of PALSONIFY for Acromegaly

CRNX

Product Launch

New Projects/Investments

Crinetics Pharmaceuticals, Inc. announced the FDA approval of PALSONIFY (paltusotine) for the treatment of adults with acromegaly.
PALSONIFY is notable as the first once-daily, oral therapy approved by the FDA for this condition.
The approval was based on positive data from the PATHFNDR-1 and PATHFNDR-2 Phase 3 pivotal trials.
The company expects PALSONIFY to be available in the U.S. in early October.
A Marketing Authorization Application for paltusotine is currently under review in the European Union, with a Committee for Medicinal Products and Human Use (CHMP) opinion anticipated in the first half of 2026.

Sep 25, 2025, 9:36 PM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for Crinetics Pharmaceuticals.

Q3 2025

Nov 6, 2025

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Q2 2025

Aug 7, 2025

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Q1 2025

May 8, 2025

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Crinetics Pharmaceuticals (CRNX)

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Leland Gershell

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