Atumelnant

Preliminary analysis of one-year progression-free survival data from Phase 2 study of novel SST2 agonist paltusotine under investigation for carcinoid syndrome demonstrated potential anti-tumor effectsSAN DIEGO, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced three abstracts from its clinical development programs will be presented at the upcoming North American Neuroendocrine Tumor Society Annual Meeting (NANETS 2025), taking place October 23-25, 2025, in Austin, Texas. “At the 2025 NANETS annual meeting, we are excited to showcase the continued progress of multiple development programs focused on the treatment of neuroendocrine tumors (NETs),” said Dana Pizzuti, M.D., Chief Medical and Development Officer at Crinetics. “For the first time, we will present progression-free survival data from our Phase 2 study of paltusotine for the treatment of carcinoid syndrome associated with NETs. Details of recently-initiated clinical trials for both paltusotine and our nonpeptide drug candidate (NDC) CRN09682 program will also be presented, demonstrating our deep commitment and continued momentum in the NETs space.” A preliminary analysis of Phase 2 data from the open-label trial of paltusotine in the treatment of patients with carcinoid syndrome due to NETs will be featured in a poster presentation, showing an overall investigator-assessed progression free survival rate of 74% following one year of treatment. Paltusotine is approved as PALSONIFY™ in the U.S. as a once-daily oral 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 currently being investigated for new indications, including for the treatment of carcinoid syndrome; it is not currently approved in the U.S. or any other countries for the treatment of carcinoid syndrome. Two additional poster presentations will feature study details from the randomized, Phase 3 trial of paltusotine in carcinoid syndrome due to NETs and the first-in-human study of NDC candidate CRN09682 in patients with somatostatin receptor 2-expressing tumors. Details on the abstracts to be presented at NANETS are shown below: Title:Investigator-Assessed Disease Progression in a Phase 2 Study of Paltusotine in Patients with Neuroendocrine Tumors and Carcinoid SyndromeDate/Time:October 23, 2025; 5:15 pm – 6:30 pm Title:CAREFNDR: Phase 3, Randomized, Placebo-Controlled Study of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine TumorsDate/Time:October 23, 2025; 5:15 pm – 6:30 pm Title:First-in-Human Study of a Novel Nonpeptide Drug Conjugate (CRN09682) in Patients With Somatostatin Receptor 2-Expressing TumorsDate/Time:October 23, 2025; 5:15 pm – 6:30 pm About Paltusotine Paltusotine, a selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide, is 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™ (paltusotine) is currently approved in the U.S. for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. ABOUT CRN09682CRN09682 is an investigational, potentially first-in-class, non-radioactive, nonpeptide drug conjugate (NDC) linking a somatostatin receptor 2 (SST2) agonist with the cytotoxic drug monomethyl auristatin E (MMAE) via a spacer and a cleavable linker for the treatment of neuroendocrine tumors (NETs) and potentially for use in other solid tumors that express SST2. The SST2 ligand on the NDC molecule binds to SST2 on the tumor cell surface and is internalized in the cell whereby enzymes cleave the MMAE and release it within the cell. MMAE is known to cause microtubule disruption leading to cell arrest and death. The NDC approach is intended to enhance tumor penetration, selectively bind to specific GPCR expressing tumor cells, induce internalization, and intracellularly release a potent anti-tumor agent, while minimizing systemic exposure and associated toxicities. Additionally, NDCs are manufactured by traditional chemical synthesis methods, avoiding the limitations of fermentation, bioconjugation, and heterogeneous manufacturing methods required by most ADCs. NETs are generally incurable when metastatic, regardless of tumor grade. Overall survival rates vary significantly by stage, grade, age at diagnosis, primary site, and time period of diagnosis. 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’ lead product, PALSONIFY™ (paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA 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 late-stage development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome. Additional discovery programs address a variety of endocrine conditions such as neuroendocrine tumors, Graves’ disease (including Graves’ hyperthyroidism and Graves’ orbitopathy, or thyroid eye disease), polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications. 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 approval of additional product candidates in our pipeline; the plans and timelines for the clinical development of paltusotine for the treatment of carcinoid syndrome, including the therapeutic potential and clinical benefits or safety profiles thereof and the timeline for global enrollment for CAREFNDR; or the therapeutic potential, clinical benefits or safety profiles for atumelnant or our development candidates, including their potential 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, data that we report may change following completion or a more comprehensive review of the data related to the clinical studies, and the FDA and other regulatory authorities may not agree with our interpretation of such results; 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 its 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; the success of Crinetics’ clinical studies and nonclinical studies; regulatory developments or political changes, including policies related to pricing and pharmaceutical drug reimbursement, in the United States and foreign countries; clinical studies and preclinical studies may not proceed at the time or in the manner expected, or at all; 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, 2024. 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.  Contact:   Media:   Natalie Badillo   Head of Corporate Communications   nbadillo@crinetics.com   (858) 345-6075      Investors:   Gayathri Diwakar   Head of Investor Relations   gdiwakar@crinetics.com   (858) 345-6340  

Crinetics Pharmaceuticals on Thursday said the FDA greenlit its nonpeptide somatostatin receptor type 2 (SST2) agonist Palsonify (paltusotine), making a first-line once-daily oral option available for adults with acromegaly who are refractory to or unsuitable for surgery. The product, which could offer patients freedom from frequent injections of current therapies, is expected to hit the shelves early next month — with a $290,000 yearly treatment price.Palsonify’s clearance “marks a new era for those living with acromegaly,” said Scott Struthers, chief executive of Crinetics, adding that the “approval is the first to come from our deep pipeline of first-in-class, small molecule drugs.” The FDA decision was supported by two Phase III pivotal trials, PATHFNDR-1 and PATHFNDR-2, which enrolled previously treated and treatment-naïve adults with acromegaly, respectively. In both studies, A significantly higher proportion of participants receiving Palsonify maintained IGF-1 levels ≤1 times the upper limit of normal compared with those on placebo, alongside significant reductions in acromegaly-associated symptoms. Moreover, 91% of PATHFNDR-1 and 97% of PATHFNDR-2 participants enrolled in open-label extension studies, highlighting durable IGF-1 control and sustained symptom improvements.Analysts’ predictions materialiseAnalysts at HC Wainwright last month said they were pretty confident of an approval for Palsonify, with a label enabling broad use across treatment-naïve patients, those switching from injectables, and those who discontinued therapy. They anticipate “treatment-naïve patients to drive the first wave of adoption post launch, with the other two groups to pick up momentum over time.”The optimism was echoed by Citizens JMP analysts, assigning a 90% probability of approval.. Considering patients with acromegaly visit endocrinologists infrequently, they expect a modest early launch, modelling revenues of $2 million this year and $45 million in 2026.While injectables, including somatostatin analogues and growth hormone receptor antagonists, make up the bulk of the acromegaly treatments, the FDA in 2020 approved Chiesi’s oral somatostatin analogue Mycapssa (octreotide) for long-term maintenance in injectable somatostatin responders. However, Palsonify is the first oral therapy okayed for front-line use in this condition.The drug remains under review in the EU, with a decision expected in the first half of next year. At the same time, Crinetics is partnering with Sanwa Kagaku Kenkyuso to develop and commercialise the therapy in Japan. Crinetics is also investigating the SST2 agonist in a Phase III study for carcinoid syndrome. With cash reserves of $1.2 billion providing a runway into 2029, the company’s pipeline also boasts  ACTH antagonist atumelnant being studied in congenital adrenal hyperplasia and Cushing’s syndrome, and a non-peptide drug conjugate CRN09682 for neuroendocrine tumours among others..