Oral presentation features open label extension PALSONIFY™ (paltusotine) data, reinforcing its best-in-class potential in acromegaly following recent U.S. and E.U. approvals

Two oral presentations of novel, investigational ACTH receptor antagonist atumelnant include full Phase 2 study results in congenital adrenal hyperplasia and data from additional patients in the Phase 1b/2a ACTH-dependent Cushing's syndrome study

SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today announced that data from six abstracts, including oral presentations featuring PALSONIFY™ (paltusotine) and investigational candidate atumelnant, will be presented at the Endocrine Society's Annual Meeting, ENDO 2026, June 13-16, 2026, in Chicago, IL.

"At ENDO 2026, new data will be presented which increase the depth of clinical evidence supporting the long-term safety and efficacy of Palsonify for the treatment of acromegaly," said Dr. Alan Krasner, M.D., Chief Endocrinologist, Crinetics. "In addition, updated data will be presented characterizing the potential of atumelnant to set an uncompromising bar for treating diseases of ACTH excess. I have often been frustrated by the lack of optimized treatments for these and many other difficult to manage endocrine conditions. At Crinetics, we are continuously working with many outstanding external investigator colleagues to redefine the possibilities."

Three abstracts will report data related to PALSONIFY in acromegaly, including an oral presentation featuring long-term (up to two years) efficacy and pooled safety data from the PATHFNDR-1 and PATHFNDR-2 open-label extension (OLE) studies. Additionally, one poster presentation evaluates real-world biochemical control in acromegaly using U.S. claims and laboratory data to identify areas of unmet need for patients and to inform optimization of acromegaly management. Another poster presentation assesses long-term safety and efficacy of PALSONIFY in combination with cabergoline from the ACROBAT Advance trial.

Three abstracts from Crinetics' atumelnant clinical development program will also be presented, including oral presentations of full Phase 2 data in congenital adrenal hyperplasia (CAH) and new interim results from a Phase 1b/2a study in ACTH-dependent Cushing's syndrome. An additional rapid-fire presentation highlights dose selection data for the Phase 3 trial in CAH.

Crinetics will also present a product theater June 15 from 12:30-1:30 CST, titled "Advancing Acromegaly Management: Bridging Clinical Evidence and the Patient Journey with PALSONIFY™ (paltusotine). Presenters include Dr. Anthony Heaney and a patient living with acromegaly.

Presentation details are shown below.

PALSONIFY™ (paltusotine) Presentations

Title (oral presentation): Efficacy and Safety of Once-Daily Oral Paltusotine in Patients with Acromegaly: Up to 2 years in the PATHFNDR-1 and PATHFNDR-2 Open-Label Extension Studies

Authors: Gadelha, M.R. "et. al."

Date/Time: June 14, 1:45 PM – 3:15 PM CT

Location: Room W183BC

Title (poster presentation): Long-Term Safety and Efficacy of Once-Daily Oral Paltusotine in Combination With Cabergoline for the Treatment of Patients With Acromegaly

Authors: Gadelha. M.R. "et. al."

Date/Time: June 14; 12:00 PM – 1:30 pm CT

Location: ENDO Expo Hall, McCormick Place West

Title (poster presentation): Real-World Biochemical Control in Acromegaly: Insights from US Claims and Laboratory Data

Authors: Wang, S "et. al."

Date/Time: June 15; 12:00 PM – 1:30 pm CT

Location: ENDO Expo Hall, McCormick Place West

Atumelnant Presentations

Title (oral presentation): Once Daily Atumelnant (CRN04894) Enables Lowering of Glucocorticoid Doses With Sustained Androgen Reduction in Adults With Congenital Adrenal Hyperplasia

Authors: Srirangalingam, U., "et. al."

Date/Time: June 14, 1:45 PM – 3:15 PM CT

Location: Room W184ABC

Title (oral presentation): ‘Block And Replace' Atumelnant (CRN04894) And Physiologic Hydrocortisone Replacement Rapidly Controls Hypercortisolism In ACTH-dependent Cushing Syndrome

Authors: Elenius, H., "et al"

Date/Time: June 14, 3:30 PM – 4:15 PM CT

Location: Room W187

Title (rapid-fire and poster presentations): Model-Informed Atumelnant Dose Selection for a Phase 3 Study in Adult Patients With Classic Congenital Adrenal Hyperplasia

Authors: Curd, L., "et. al."

Dates/Times: Rapid Fire: June 14, 1:45 PM - 3:15 PM CT

Poster: June 15, 12:00 PM – 1:30 PM CT

Locations: Rapid Fire: Room W184ABC

Poster: ENDO Expo Hall, McCormick Place West

About PALSONIFY™ (Paltusotine)

PALSONIFY, a selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide agonist, is the first and only once-daily, oral therapy approved for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. In Phase 3 studies, once-daily, oral PALSONIFY maintained IGF-1 levels and symptom control in patients with acromegaly who were switched from monthly injectable medications (PATHFNDR-1) and rapidly decreased IGF-1 levels and symptom burden in medically untreated acromegaly patients (PATHFNDR-2). IGF-1 is the primary biomarker endocrinologists use to manage acromegaly patients. Paltusotine is also in Phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors (CAREFNDR). Results from a Phase 2 study in carcinoid syndrome demonstrated rapid and sustained reductions in flushing episodes and bowel movement frequency, which are the most common symptoms of carcinoid syndrome.

PALSONIFY is approved in the U.S. for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. It is also approved for use in the EU for the medical treatment of adult patients with acromegaly.

About Atumelnant

Atumelnant, Crinetics' second investigational compound, is the first once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist that acts selectively at the melanocortin type 2 receptor (MC2R) on the adrenal gland. Diseases associated with excess ACTH can have significant impact on physical and mental health. Atumelnant has exhibited strong binding affinity for MC2R in preclinical models and has demonstrated suppression of adrenally derived glucocorticoids and androgens that are under the control of ACTH. Data from a 12-week Phase 2 study demonstrated compelling treatment benefits of atumelnant, evidenced by the rapid, substantial and sustained statistically significant reductions in key CAH disease related biomarkers, including androstenedione and 17-hydroxyprogesterone, in a diverse population. Atumelnant is in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with the Phase 3 CALM-CAH trial and a Phase 1/2b trial in ADCS currently enrolling patients.

About Crinetics Pharmaceuticals

Crinetics Pharmaceuticals is a global pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumors through science rooted in patient needs. Crinetics is focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties.

Crinetics' first commercial product, PALSONIFY™ (paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA and EMA for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics' deep pipeline of 10+ disclosed programs includes late-stage investigational candidate atumelnant, which is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, and CRN09682, a nonpeptide drug conjugate candidate that is being developed to treat somatostatin receptor 2 (SST2) expressing neuroendocrine tumors and other SST2 expressing solid tumors. Additional discovery programs are focused on a variety of endocrine targets such as thyroid stimulating hormone (TSH), parathyroid hormone (PTH), somatostatin receptor 3 (SST3), growth hormone (GH), glucagon-like peptide-1 (GLP-1), and glucose-dependent insulinotropic polypeptide (GIP), as well as GPCR-targeted oncology indications.

PALSONIFY™ (paltusotine) INDICATION:

PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS:

Cholelithiasis and Its Complications: Cholelithiasis, including related complications such as acute cholecystitis and pancreatitis, have been reported. Monitor patients periodically. Discontinue PALSONIFY if complications of cholelithiasis occur and treat appropriately.
Hyperglycemia and Hypoglycemia: Hyperglycemia, diabetes mellitus, or hypoglycemia, may occur. Monitor blood glucose levels when PALSONIFY treatment is initiated or when dosage is altered. Adjust antidiabetic treatment accordingly.
Cardiovascular Abnormalities: Cardiac conduction abnormalities and other ECG changes such as PR interval prolongation, bradycardia, sinus arrest, and atrioventricular block may occur in patients with acromegaly and were reported in PALSONIFY clinical trials. Dosage adjustments of concomitant drugs that have bradycardic effects may be necessary.
Thyroid Function Abnormalities: Somatostatin analogs may suppress the secretion of thyroid-stimulating hormone, which may result in hypothyroidism. Periodic assessment of thyroid function is recommended.
Steatorrhea and Malabsorption of Dietary Fats: Somatostatin analog treatment may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new or worsening symptoms are reported with PALSONIFY, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.
Vitamin B12 Deficiency: Vitamin B12 deficiency may occur. Monitor vitamin B12 levels, if clinically indicated.

ADVERSE REACTIONS:

Most common adverse reactions (>5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis.

DRUG INTERACTIONS:

Strong or Moderate CYP3A4 Inducers: may decrease PALSONIFY exposure. May require an increased dosage of PALSONIFY.
Proton Pump Inhibitors: may decrease PALSONIFY exposure. May require an increased dosage of PALSONIFY. Avoid concomitant use of proton pump inhibitors in patients who are already on PALSONIFY 60 mg.
Cyclosporine: may decrease cyclosporine exposure. May require cyclosporine dosage adjustment when used with PALSONIFY; follow therapeutic monitoring recommendations.

Please report adverse events to Crinetics Pharmaceuticals at 1-833-CRN-INFO (1-833-276-4636) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information including Patient Information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the plans and timelines for the clinical development of atumelnant and paltusotine for the treatment of carcinoid syndrome; or the potential for our development candidates to transition to clinical development. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential," "upcoming" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; geopolitical events may disrupt Crinetics' business and that of the third parties on which it depends, including delaying or otherwise disrupting clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects, complications and/or drug interactions or inadequate efficacy of the Company's product candidates that may limit their development, regulatory approval and/or commercialization; the Company's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments or political changes, including policies related to pricing and pharmaceutical drug reimbursement, in the United States and foreign countries; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics' drug candidates may not advance in development or be approved for marketing; Crinetics may use its capital resources sooner than expected or our cash burn rate may accelerate; any future impacts to our business resulting from geopolitical developments outside our control; and the other risks and uncertainties described in the Company's periodic filings with the Securities and Exchange Commission (SEC). The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading "Risk Factors" in Crinetics' periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Media:

Natalie Badillo

Head of Corporate Communications

nbadillo@crinetics.com

(858) 345-6075

Investors:

Gyathri Diwakar

Head of Investor Relations

gdiwakar@crinetics.com

(858) 345-6340

Crinetics' Paradigm-Shifting Portfolio and Pipeline on Display at ENDO 2026 with Six Presentations