Company Description
Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX) is a global pharmaceutical company focused on the discovery, development, and commercialization of novel therapies for endocrine diseases and endocrine-related tumors. According to company disclosures, Crinetics’ research is rooted in patient needs and centers on targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties.
The company’s lead product is PALSONIFY™ (paltusotine), described as the first once-daily, oral treatment approved by the U.S. Food and Drug Administration (FDA) for adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY is a selectively targeted somatostatin receptor type 2 (SST2) nonpeptide agonist. In addition to its approved acromegaly indication, paltusotine is in clinical development for carcinoid syndrome associated with neuroendocrine tumors, including evaluation in the pivotal Phase 3 CAREFNDR trial.
Beyond PALSONIFY, Crinetics reports a deep pipeline of more than ten disclosed programs aimed at a variety of endocrine and endocrine-related conditions. A key late-stage investigational candidate is atumelnant, a once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist that acts selectively at the melanocortin type 2 receptor (MC2R) on the adrenal gland. Atumelnant is in late-stage or Phase 3 clinical development for classic congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing’s syndrome, with clinical data showing reductions in CAH-related biomarkers such as androstenedione and 17-hydroxyprogesterone in Phase 2 studies.
Crinetics is also advancing CRN09682, an investigational, first-in-class, non-radioactive, nonpeptide drug conjugate (NDC) designed for the treatment of neuroendocrine tumors (NETs) and other SST2-expressing solid tumors. CRN09682 links a somatostatin receptor 2 agonist to the cytotoxic drug monomethyl auristatin E (MMAE) via a spacer and cleavable linker. The ligand component is designed to bind SST2 on tumor cells, internalize, and release MMAE within the cell after enzymatic cleavage, with the goal of concentrating cytotoxic activity in tumors while limiting systemic exposure. CRN09682 is being evaluated in the Phase 1/2 BRAVESST2 trial in patients with metastatic or locally advanced SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors.
In addition to these advanced programs, Crinetics describes multiple discovery and preclinical efforts that extend its GPCR-focused approach. These include:
- CRN12755, a thyroid-stimulating hormone receptor (TSHR) antagonist program for Graves’ disease, including Graves’ hyperthyroidism and Graves’ orbitopathy (thyroid eye disease).
- CRN10329, a selective SST3 nonpeptide agonist for autosomal dominant polycystic kidney disease (ADPKD).
- Additional discovery programs addressing conditions such as neuroendocrine tumors, Graves’ disease, polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications.
Crinetics’ regulatory and clinical milestones highlight its transition from a clinical-stage company toward commercial operations. The company has reported that the FDA approved PALSONIFY for first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option, and that it has initiated and advanced pivotal trials such as the CALM-CAH Phase 3 study for atumelnant in classic CAH and the CAREFNDR Phase 3 trial for paltusotine in carcinoid syndrome. The company has also disclosed Orphan Drug Designation from the FDA for atumelnant in the treatment of classic CAH.
Crinetics’ pipeline and clinical programs are frequently featured in its research and development events, scientific conference presentations, and SEC filings. For example, the company has highlighted eight abstracts from its clinical development programs at the Endocrine Society’s ENDO meeting and has provided detailed R&D Day updates on early-stage assets such as CRN12755, CRN10329, and CRN09682, including preclinical data on biomarker changes, receptor expression, and anti-tumor activity in animal models.
From a corporate perspective, Crinetics trades on the Nasdaq Global Select Market under the ticker symbol CRNX. The company uses equity-based compensation, including stock options and restricted stock units granted under its 2021 Employment Inducement Incentive Award Plan, as a tool to recruit and retain non-executive employees, as disclosed in multiple inducement grant announcements made in accordance with Nasdaq Listing Rule 5635(c)(4). The company also accesses the capital markets through underwritten public offerings of common stock, with proceeds intended to support commercialization of PALSONIFY, research and development of product candidates, and other general corporate purposes.
Crinetics’ SEC filings provide additional context on its operations and governance. Current reports on Form 8-K have addressed topics such as FDA approval of PALSONIFY, financial results for specified reporting periods, research and development updates, and executive transitions. For instance, the company has reported a transition of its Chief Medical and Development Officer role and subsequent advisory engagement, illustrating how it manages leadership changes while maintaining continuity in regulatory and development strategy.
Overall, Crinetics Pharmaceuticals presents itself as a specialized pharmaceutical company within the biotechnology and life sciences ecosystem, with a focus on small-molecule GPCR-targeted therapies for complex endocrine and endocrine-related conditions. Its combination of an FDA-approved oral therapy for acromegaly, late-stage candidates for CAH and carcinoid syndrome, and a growing portfolio of discovery and preclinical programs positions the company as an active participant in the development of targeted treatments for rare and serious endocrine disorders.