Paltusotine

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended 12 medicines for approval at its February 2026 meeting, including a first-in-class combined mRNA vaccine targeting both seasonal influenza and COVID-19. At the forefront, the CHMP recommended granting a marketing authorization for mCombriax, a combined influenza and COVID-19 mRNA vaccine developed by Moderna. Designed for adults aged 50 and older, mCombriax combines two messenger RNA constructs into a single formulation intended to simplify annual respiratory virus immunisation. The recommendation now goes to the European Commission for final approval. According to World Health Organization data, Europe has recorded more than 281 million COVID-19 cases since the pandemic began, while seasonal influenza alone causes up to 50 million symptomatic cases annually in the European Economic Area (EEA). In oncology, the CHMP recommended a conditional marketing authorisation for Ojemda (tovorafenib) for patients aged six months and older with pediatric low-grade glioma, a non-cancerous brain tumor. The once-weekly oral targeted therapy – developed by Day One Biopharmaceuticals, with ex-US rights licensed to Ipsen SA – aims to expand treatment options beyond surgery and conventional chemotherapy, which can have modest benefit and significant toxicity in young patients. The committee also adopted a positive opinion for Onerji, a levodopa/carbidopa product developed by Tanabe Pharma GmbH, for adults with advanced Parkinson’s disease. In endocrinology, Recordati Rare Diseases-partnered paltusotine, marketed as Palsonify by Crinetics Pharmaceuticals, received a positive opinion for acromegaly, a rare disorder of excess growth hormone. Immunology saw a positive opinion for Rhapsido (remibrutinib) from Novartis for chronic spontaneous urticaria, a long-term itchy rash. For rare inherited immune dysfunction, the CHMP adopted an opinion under exceptional circumstances for Xolremdi (mavorixafor) from X4 Pharmaceuticals, intended for patients aged 12 and older with WHIM syndrome, an ultra-rare condition marked by recurrent infections and increased malignancy risk. The committee also endorsed six biosimilar medicines. Among them was Poherdy, a pertuzumab biosimilar developed by Shanghai Henlius Biotech and partnered with Organon for global ex-China commercialization. If approved, Poherdy would be the first pertuzumab biosimilar endorsed by the CHMP, broadening competition to Roche’s reference product Perjeta in the EU. Poherdy was approved by the US FDA in November 2025. Additional biosimilars recommended include insulin lispro Bysumlog and insulin aspart Dazparda (both from Gan & Lee Pharmaceuticals, and marketed by Sandoz); etanercept Fubelv (by Biosimilar Collaborations Ireland); tocilizumab Tuyory (developed by Gedeon Richter in collaboration with Mochida Pharmaceutical); and teriparatide Zandoriah (by Cinnagen Co. Unipessoal Lda). Final marketing authorizations are subject to European Commission decisions, typically issued within two to three months following CHMP positive opinions.

PALSONIFY™ (Paltusotine) Net Product Revenue of $5.4 Million for Fourth-Quarter 2025, with >200 Enrollment Forms at the End of December Operationally Seamless Phase 2/3 Study of Atumelnant for the Treatment of ACTH-Dependent Cushing's Syndrome to Initiate in the First Half of 2026 Multiple Clinical Trials Initiated for Early- and Late-Stage Candidates Management Hosting Conference Call at 4:30 p.m. ET Today SAN DIEGO, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, today reported financial results for the fourth quarter and full year ended December 31, 2025. “2025 was a breakout year for Crinetics, as the approval and launch of Palsonify demonstrated our ability to bring an innovative therapy from concept to the patients who need it most,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “With strong launch dynamics, we are now focused on building a business capable of scaling that success. We have the commercial infrastructure, the pipeline depth and the capital to build a premier, multi-product company that will define the future of endocrinology.” Full Year 2025 and Recent Highlights: Secured FDA approval on September 25, 2025 for PALSONIFY as the first and only once-daily oral somatostatin receptor ligand for the treatment of acromegaly. The subsequent U.S. commercial launch in Q4 2025 demonstrated strong early execution, generating $5.4 million in net product revenue and over 200 enrollment forms at the end of December 2025. In addition, over 125 unique HCPs prescribed PALSONIFY in Q4 2025. Today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of PALSONIFY (paltusotine) for the medical treatment of adult patients with acromegaly. The positive opinion is now referred to the European Commission (EC) for an approval decision. PALSONIFY was previously granted Orphan Designation by the EMA in February of 2025. Reported positive data from the Phase 2 open-label study of atumelnant in patients with congenital adrenal hyperplasia (CAH), with 88% of participants in Cohort 4 reducing glucocorticoid doses to physiologic replacement levels by week 12, while maintaining androstenedione (A4) reductions similar to those observed in earlier cohorts. Across all cohorts of the Phase 2 open-label study, atumelnant administration has resulted in rapid, substantial and sustained statistically significant reduction in A4 levels. Atumelnant has been well-tolerated and treatment with atumelnant has been associated with significant clinical improvements. These results reinforce the strong clinical rationale for the ongoing pivotal Phase 3 development program and highlight atumelnant's potential as a best-in-class oral ACTH antagonist. Initiated three pivotal trials including the CAREFNDR Phase 3 trial evaluating paltusotine for carcinoid syndrome, the CALM-CAH Phase 3 trial evaluating atumelnant in adults with congenital adrenal hyperplasia (CAH), and the BALANCE-CAH Phase 2/3 trial addressing the critical unmet need in pediatric CAH patients. Finalized protocol for the pivotal seamless Phase 2/3 EQUILIBRIUM study of atumelnant in patients with ACTH-dependent Cushing’s Syndrome with the first patient expected to enroll in the first half of 2026. Brought the first candidate from our proprietary nonpeptide drug conjugate (NDC) platform, CRN09682, into clinical development with the initiation of the BRAVESST2 Phase 1/2 trial. The study is evaluating CRN09682 in patients with SST2-expressing neuroendocrine tumors (NETs) and other solid tumors, validating the company's intent to extend its endocrine expertise into GPCR-targeted oncology indications. Fourth Quarter and Full Year 2025 Financial Results: Revenue was $6.2 million and $7.7 million for the quarter and year ended December 31, 2025, compared to $0.0 million and $1.0 million for the same periods in 2024. Revenue for the quarter and year ended December 31, 2025 includes $5.4 million in net product revenue from the U.S. commercial launch of PALSONIFY. Cost of product revenue was $1.1 million for the quarter and year ended December 31, 2025, primarily related to costs in expanding our commercial manufacturing capacity. Research and development expenses were $85.1 million and $332.1 million for the quarter and year ended December 31, 2025, compared to $66.6 million and $240.2 million for the same periods in 2024, and compared to $90.5 million in the quarter ended September 30, 2025. The increase compared to the prior year period reflects our continued commitment and investments in paltusotine, atumelnant, and other research and development programs. The sequential decline compared to the prior quarter was primarily due to pre-approval and launch costs, as well as startup costs associated with our ongoing Phase 3 trials, which were recognized in the third quarter but not the fourth quarter. Selling, general and administrative expenses were $53.7 million and $191.3 million for the quarter and year ended December 31, 2025, compared to $28.2 million and $99.7 million for the same periods in 2024, and compared to $52.3 million in the quarter ended September 30, 2025. The increase compared to the prior year period is related to our commercial organization build-out and investment in our overall infrastructure as a commercialized company. The stability compared to the prior quarter reflects the company’s strategic decision to put in place key investments for commercialization, including field force, commercial team and corporate functions, prior to approval of PALSONIFY. Net loss was $122.8 million and $465.3 million for the quarter and year ended December 31, 2025, compared to net loss of $80.6 million and $298.4 million for the same periods in 2024. Crinetics used $326.2 million of net total cash, cash equivalents, and investment securities in 2025, which was below our guidance range of $340 million to $370 million. Cash, cash equivalents, and investment securities totaled $1.0 billion as of December 31, 2025, compared to $1.4 billion as of December 31, 2024. On January 8, 2026, Crinetics completed an underwritten public offering of 8,763,000 shares of its common stock at a price to the public of $45.95 per share, which included 1,143,000 shares of common stock issued pursuant to the underwriters' option to purchase additional shares. Net proceeds from the offering were approximately $380.0 million, after underwriting discounts and commissions and other offering costs. Immediately after the completion of this public offering, Crinetics had approximately $1.4 billion in cash, cash equivalents, and investment securities. Guidance and Outlook: Crinetics expects 2026 operating expenses presented in accordance with U.S. generally accepted accounting principles (“GAAP”) to be between $600 million to $650 million and non-GAAP operating expenses – which exclude cost of product revenue, stock-based compensation, depreciation and amortization – to be between $480 million to $520 million. Crinetics is unable to reconcile forward-looking non-GAAP operating expenses to the most directly comparable GAAP measure without unreasonable effort because the items that are being excluded are difficult to predict or a range of results could lead to disclosure that would be imprecise or potentially misleading. Material changes to any one of the exclusions could have a significant effect on our forward-looking estimates and GAAP results. Such items include cost of product revenue, stock-based compensation, depreciation and amortization. See "Use of Non-GAAP Financial Measures". Conference Call and Webcast Details Management will hold a live conference call and webcast today, Thursday, February 26 at 4:30 p.m. ET. To participate, please dial 1-833-470-1428 (domestic) or 1-646-844-6383 (international) and refer to Access Code 027322. To access the webcast, the direct link ( here ) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of . 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 development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, and CRN09682, a nonpeptide drug conjugate candidate that is being developed to treat SST2 expressing neuroendocrine tumors and other SST2 expressing solid tumors. 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 Company’s ability to effectively commercialize PALSONIFY, the expected timing of initiation of a Phase 2/3 program of atumelnant for ACTH-dependent Cushing’s syndrome; the plans and timelines for the clinical development of our drug candidates, including the therapeutic potential and clinical benefits or safety pro the expected timing of additional research pipeline updates or the expected timing of the advancement of those programs; the expected timing of receipt of a final decision from the EC; and expected 2026 GAAP and non-GAAP operating expenses. 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; 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 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; 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. Use of Non-GAAP Financial Measures Crinetics has presented certain unaudited non-GAAP operating expenses and forward-looking non-GAAP operating expenses. Non-GAAP operating expenses exclude cost of product revenue, stock-based compensation, depreciation and amortization. Crinetics excludes cost of product revenue, stock-based compensation, depreciation and amortization because management believes the exclusion of these items is helpful to investors to evaluate Crinetics ’ recurring operational performance. Crinetics management uses this non-GAAP financial measure to monitor and evaluate its operating results and trends on an ongoing basis, and internally for operating, budgeting and financial planning purposes. The non-GAAP financial measure should be considered in addition to results prepared in accordance with GAAP but should not be considered a substitute for or superior to GAAP results. Crinetics is unable to reconcile forward-looking non-GAAP operating expenses to the most directly comparable GAAP measure without unreasonable effort because the items that are being excluded are difficult to predict or a range of results could lead to disclosure that would be imprecise or potentially misleading. Material changes to any one of the exclusions could have a significant effect on our forward-looking estimates and GAAP results. Such items include cost of product revenue, stock-based compensation, depreciation and amortization. CRINETICS PHARMACEUTICALS, INC. Consolidated Statements of Operations and Comprehensive Loss (In thousands, except per share data) (Unaudited) Quarter ended December 31, Year ended December 31, 2025 2024 2025 2024 Revenue: Product revenue, net $ 5,420 $ — $ 5,420 $ — Collaboration and license revenue 741 — 2,276 1,039 Total revenue, net 6,161 — 7,696 1,039 Operating expenses: Cost of product revenue 1,076 — 1,076 — Research and development 85,053 66,566 332,058 240,156 Selling, general and administrative 53,698 28,179 191,331 99,737 Total operating expenses 139,827 94,745 524,465 339,893 Loss from operations (133,666 ) (94,745 ) (516,769 ) (338,854 ) Total other income, net 11,031 14,150 51,632 40,916 Loss before income taxes (122,635 ) (80,595 ) (465,137 ) (297,938 ) Income tax expense 180 — 180 — Loss before equity method investment (122,815 ) (80,595 ) (465,317 ) (297,938 ) Loss on equity method investment — — — (470 ) Net loss $ (122,815 ) $ (80,595 ) $ (465,317 ) $ (298,408 ) Net loss per share — basic and diluted $ (1.29 ) $ (0.88 ) $ (4.95 ) $ (3.69 ) Weighted average shares — basic and diluted 95,096 91,494 94,057 80,783 CRINETICS PHARMACEUTICALS, INC. Consolidated Balance Sheets (In thousands, except per share data) (Unaudited) December 31, 2025 December 31, 2024 ASSETS CURRENT ASSETS Cash and cash equivalents $ 101,536 $ 264,545 Restricted cash — 500 Investment securities, amortized cost of $924,317 at December 31, 2025 and $1,088,561 at December 31, 2024 926,353 1,089,524 Trade accounts receivable, net 592 — Inventory 2,022 — Prepaid expenses and other current assets 17,839 20,819 Total current assets 1,048,342 1,375,388 Property and equipment, net 14,296 12,068 Operating lease right-of-use assets 40,492 43,507 Restricted cash, net of current portion 800 800 Prepaid expenses and other assets, net of current portion 22,327 2,829 TOTAL ASSETS $ 1,126,257 $ 1,434,592 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES Accounts payable and accrued expenses $ 41,770 $ 21,469 Accrued compensation and related expenses 35,578 28,887 Deferred revenue 1,235 2,176 Operating lease liabilities 6,489 7,152 Total current liabilities 85,072 59,684 Operating lease liabilities, non-current 42,052 44,570 Deferred revenue, non-current 3,810 4,704 Other non-current liabilities 3,240 829 TOTAL LIABILITIES 134,174 109,787 Commitments and contingencies STOCKHOLDERS’ EQUITY Preferred stock, $0.001 par; 10,000 shares authorized, no shares issued or outstanding at December 31, 2025 or 2024 — — Common stock and paid-in capital, $0.001 par; 200,000 shares authorized, 95,575 shares issued and outstanding at December 31, 2025; 92,926 shares issued and outstanding at December 31, 2024 2,407,757 2,275,952 Accumulated other comprehensive income 1,865 963 Accumulated deficit (1,417,427 ) (952,110 ) Stock held in trust (112 ) — TOTAL STOCKHOLDERS’ EQUITY 992,083 1,324,805 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 1,126,257 $ 1,434,592 CRINETICS PHARMACEUTICALS, INC. Reconciliation of GAAP Operating Expenses to Non-GAAP Operating Expenses (Unaudited) Year ended December 31, (In thousands) 2025 2024 GAAP operating expenses $ 524,465 $ 339,893 Adjustments: Cost of product revenue (1,076 ) — Stock-based compensation (91,024 ) (69,386 ) Depreciation and amortization (3,890 ) (2,785 ) Non-GAAP operating expenses $ 428,475 $ 267,722 Investors: Gayathri Diwakar Head of Investor Relations gdiwakar@crinetics.com (858) 345-6340 Media: Natalie Badillo Head of Corporate Communications nbadillo@crinetics.com (858) 345-6075