Aankondiging • Nov 13

Crinetics Pharmaceuticals, Inc. to Showcase Pipeline Advancements with Neuroendocrine Tumor Candidates at the North American Neuroendocrine Tumor Society Annual Meeting

Crinetics Pharmaceuticals, Inc. announced two abstracts from its transformative, in-house discovery and development programs will be presented at the upcoming North American Neuroendocrine Tumor Society Multidisciplinary NET Medical Symposium (NANETS 2024), taking place November 21-23, 2024, in Chicago. CRN09682, is a first-in-class, somatostatin receptor 2 (SST2) targeted, nonpeptide drug conjugate (NDC). Built upon the well-validated concept of antibody-drug conjugates, Crinetics’ NDCs use a highly optimized small molecule G protein coupled receptor (GPCR) ligand, instead of an antibody, to deliver a potent anti-cancer agent to tumor cells with high selectivity and efficiency. CRN09682 was designed to provide enhanced tumor penetration, selectively bind to SST2 expressing tumor cells, induce internalization, and intracellularly release a potent anti-tumor agent, while minimizing systemic exposure and associated toxicities. In addition, CRN09682 is manufactured by traditional chemical synthesis methods, avoiding the complex and heterogeneous manufacturing methods required for antibody drug conjugates. Preclinical data to be presented at NANETS 2024 demonstrate the potent and selective anti-tumor activity of CRN09682, potentially providing a novel alternative for the treatment of NETs and other SST2-expressing tumors. Another abstract will be featured as both an oral and poster presentation, which includes follow-up from an open-label Phase 2 carcinoid syndrome study of investigational candidate paltusotine, a once-daily, oral, nonpeptide, selective SST2 agonist being developed for the treatment of acromegaly and carcinoid syndrome. The NANETS presentation includes findings from all 36 trial participants, with new analyses that show paltusotine reduced the frequency and severity of carcinoid syndrome symptoms and was well tolerated, justifying further clinical development. Data for paltusotine and CRN09682, along with additional information on NDCs, will also be featured in a Crinetics-sponsored symposium titled “Paltusotine and CRN09682: Novel Nonpeptide Approaches to Treating Carcinoid Syndrome and Neuroendocrine Tumors” at the conference on November 21, from 12:15-1:15 p.m. CT. Featured speakers include Scott Struthers and Dr. Aman Chauhan, leader of Neuroendocrine Oncology and Co-Leader Radiopharmaceutical Drug Development at Sylvester Comprehensive Cancer Center, University of Miami Health System. CRN09682 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. Crinetics’ lead development candidate, paltusotine, is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist that has completed Phase 3 clinical development for acromegaly and is in Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. It was designed by Crinetics with the goal of providing a once-daily, oral option for reliable and consistent control of acromegaly and carcinoid syndrome. In Phase 3 studies, once-daily, oral paltusotine 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. Results from the Phase 2 study in carcinoid syndrome provide supporting data and rationale for paltusotine to initiate a Phase 3 trial for another important indication related to the treatment of carcinoid syndrome in patients with neuroendocrine tumors.

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	-10.9%
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)	4.3%
Gemiddelde industrie (Pharmaceuticals)	2.1%
Analist prognose (CRNX) (tot 3 jaar)	0%

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/05/22 03:07
Aandelenkoers aan het einde van de dag	2026/05/22 00:00
Inkomsten	2026/03/31
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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Recente updates van dividend en inkoop

Recent updates

Consensus revenue estimates increase by 11%

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Founder exercised options to buy US$2.1m worth of stock.

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New minor risk - Share price stability

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Price target increased by 9.8% to US$76.87

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Chief Medical & Development Officer notifies of intention to sell stock

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Second quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind

Price target decreased by 9.0% to US$68.60

Crinetics Pharmaceuticals, Inc. to Present New Long-Term Data Demonstrating Durable Control of Once-Daily, Oral Palsonify™? (Paltusotine) in Acromegaly At Endocrine Society

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Consensus revenue estimates fall by 23%

First quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind

Insufficient new directors

Crinetics Pharmaceuticals, Inc., Annual General Meeting, Jun 11, 2025

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Consensus revenue estimates fall by 20%

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New major risk - Shareholder dilution

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Consensus revenue estimates fall by 20%

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Chief Operating Officer notifies of intention to sell stock

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