Aankondiging • Jun 02

Crinetics Pharmaceuticals Presents Six Abstracts Featuring Palsonify And Atumelnant At Endocrine Society Annual Meeting ENDO 2026

Crinetics Pharmaceuticals, Inc. 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. 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).” 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. 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. 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. 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.

Aankondiging • Jun 05

+ 1 more update

Crinetics Pharmaceuticals, Inc. Presents New Data At ENDO 2024 That Increases Body of Evidence Positioning Once-Daily, Oral Paltusotine as Potential First-Choice Treatment Option for Acromegaly

Crinetics Pharmaceuticals, Inc. presented findings from its clinical development program evaluating oral, once-daily investigational paltusotine in acromegaly. Data presented included results of the Phase 3 PATHFNDR-2 trial, a new analysis of patient reported outcome (PRO) data from the Phase 3 PATHFNDR-1 trial, and interim long-term efficacy and safety results at 42 months from the open-label ACROBAT Advance extension study. The data were presented at the Endocrine Society’s Annual Meeting (ENDO2024), with findings from PATHFNDR-1 published as a manuscript in The Journal of Clinical Endocrinology & Metabolism. Efficacy and Safety of Once-daily Oral Paltusotine in Medically Untreated Patients with Acromegaly: Results from the Phase 3, Randomized, Placebo-controlled PATHFNDR-2 Study (Abstract #MON-694): PATHFNDR-2 was a randomized, double-blind, placebo-controlled trial with a 24-week treatment period, followed by an optional open-label extension study evaluating paltusotine in 111 participants with active acromegaly (IGF-1 > 1.1 ULN) who were not pharmacologically treated. Results demonstrated: The study met statistical significance (p<0.0001) on the primary endpoint, based on the proportion of participants taking paltusotine (56%) who achieved an insulin-like growth factor 1 (IGF-1) level = 1.0 times the upper limit of normal (xULN) compared to those taking placebo (5%); This represents the second Phase 3 trial showing a significant difference in symptoms favoring paltusotine; Response to paltusotine was rapid, with the majority of the effect in IGF-1 reductions observed between weeks two and four, and sustained throughout treatment; Among those treated with paltusotine, a reduction in IGF-1 levels occurred in 92.6% of patients (n=50/54) by the end of treatment; Paltusotine was generally well-tolerated and no serious adverse events were reported in participants treated with paltusotine. The frequency of participants with at least one treatment emergent adverse event (TEAE) was comparable in the paltusotine treatment arm and placebo arm; and The most commonly reported TEAEs in paltusotine-treated participants included: diarrhea, headache, arthralgia and abdominal pain. The frequency of adverse events considered related to acromegaly was notably lower in paltusotine treated participants compared to placebo treated participants. Use of the Acromegaly Symptom Diary (ASD) in a Phase 3, Placebo-Controlled Study of Once-Daily, Oral Paltusotine in Patients with Acromegaly Switched from Injected Octreotide or Lanreotide (Abstract #MON-156): PATHFNDR-1 was a randomized, double-blind, placebo-controlled trial with a 36-week treatment period, followed by an optional open-label extension study evaluating paltusotine in participants with acromegaly switching from standard-of-care injected depot somatostatin receptor ligands (SRL). The study enrolled participants with acromegaly who were biochemically controlled on octreotide or lanreotide depot monotherapy. The study met the primary endpoint and all three secondary endpoints, as previously announced. Findings clearly demonstrated that once-daily, oral paltusotine maintained biochemical and symptom control in patients with acromegaly switched from SRL. Paltusotine was well tolerated with no severe or serious TEAEs. In a new analysis of PATHFNDR-1 data presented at ENDO2024, Acromegaly Symptom Diary (ASD) scores for patients at screening (and on injected SRL, the current standard of care) were compared to scores while on paltusotine (n=25). The ASD is a novel PRO tool developed in accordance with U.S. Food and Drug Administration (FDA) guidance to assess disease-related symptom burden. Paltusotine was associated with statistically significant reductions in the frequency of breakthrough acromegaly symptom exacerbations for total ASD scores, most bothersome symptom, headache, joint pain, sweating, fatigue, numbness/tingling, sleep difficulty and memory difficulty. Numerical differences favoring paltusotine were seen for the remaining symptoms of leg weakness and swelling. Long-Term Safety and Efficacy of Once-Daily Oral Paltusotine in the Treatment of Patients with Acromegaly: Update from ACROBAT Study (Abstract #MON-695): ACROBAT Advance is an ongoing, six-year, single-arm, open-label extension study of paltusotine in the treatment of patients with acromegaly. This analysis includes interim results as the first enrolled patients approach four years of treatment. Enrolled patients had completed either the ACROBAT Edge or Evolve Phase 2 parent studies. Results demonstrated: Once-daily oral paltusotine treatment was well-tolerated, with stable biochemical and symptom control, comparable to that observed with prior injected SRL; Parent study baseline median IGF-I levels were 1.15× ULN (0.84, 1.46; n=43). In ACROBAT Advance, median IGF-1 levels were 1.14× ULN (0.89, 1.29; n=40), 1.06× ULN (0.87, 1.24; n=35), and 1.08× ULN (0.87, 1.57; n=10) at months 12, 24, and 42, respectively; Important clinical outcomes including acromegaly symptoms, blood pressure, HbA1c, and residual pituitary tumor size were stable over the period of observation; Paltusotine continues to be well-tolerated. The most common adverse events (AEs) (reported at least during the study) were arthralgia (37.2%), headache (30.2%), and fatigue (23.3%). One serious drug-related AE (cholelithiasis) was reported. Of the eight patients who discontinued the study, two were due to AEs (mild or moderate); and Preparation of regulatory filings for paltusotine based on PATHFNDR-1 and PATHFNDR-2 data are currently underway, with a New Drug Application submission to the FDA planned in the second half of 2024.

Totaal aandeelhoudersrendement	-4.8%
Toekomstig dividendrendement	0%
Dividendgroei	n/a
Volgende betaaldatum dividend	n/a
Ex-dividenddatum	n/a
Dividend per aandeel	n/a
Uitbetalingsratio	n/a

Segment	Dividendrendement
Bedrijf (CRNX)	n/a
Markt onderkant 25% (US)	1.4%
Markt Top 25% (US)	4.2%
Gemiddelde industrie (Pharmaceuticals)	1.9%
Analist prognose (CRNX) (tot 3 jaar)	0%

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/09/03 14:43
Aandelenkoers aan het einde van de dag	2026/08/31 00:00
Inkomsten	2026/06/30
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
Brian Skorney	Baird
Joshua Schimmer	Cantor Fitzgerald & Co.
David Lebowitz	Citigroup Inc

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Recent updates

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