Peptide News Digest

#Crinetics

8 stories

Crinetics Pharmaceuticals is an SST2-pathway-focused company building a peptide-and-non-peptide pipeline against neuroendocrine and endocrine targets that historically have relied on injectable somatostatin analogs.

The lead asset Palsonify (paltusotine) is the first once-daily oral SST2 nonpeptide agonist for acromegaly — the European Commission approved it on April 27, 2026 across the 27 EU member states plus Iceland, Liechtenstein, and Norway, with first launches planned in Germany and Austria. The May 7 Q1 print disclosed Palsonify net product revenue of $10.3M in its first full commercial quarter (nearly doubling from $5.4M in Q4 2025), with 263 unique prescribers (up from 125 at year-end), 232 new patient enrollment forms in the quarter, and approximately 70% reimbursement with payer coverage above 60%. R&D rose 17.6% to $100.1M to fund Phase 3 paltusotine in carcinoid syndrome plus atumelnant Phase 3 programs in congenital adrenal hyperplasia and Cushing's syndrome. CRN09682, a first-in-class SSTR2 non-peptide drug conjugate coupling a small-molecule SST2 agonist with monomethyl auristatin E via a cleavable linker, is in the Phase 1/2 BRAVESST2 trial in metastatic neuroendocrine tumors and other SST2-expressing solid tumors — directly competing with peptide radioconjugates including Lutathera and Perspective Therapeutics' alpha-PRRT.

Crinetics is presenting six abstracts at ENDO 2026 in Chicago (June 13-16, 2026), including an oral on up to two years of Palsonify PATHFNDR-1/PATHFNDR-2 open-label-extension data (June 14, 1:45-3:15 PM CT, Room W183BC), long-term Palsonify + cabergoline combination data from the ACROBAT Advance trial, atumelnant Phase 2 data in congenital adrenal hyperplasia, and interim findings on ACTH-dependent Cushing's syndrome.

Stories here cover trial readouts, regulatory milestones, and the broader SST2 competitive landscape. See [[palsonify]], [[crn09682]], and [[sstr2]].

Clinical Trials · View digest

Crinetics Presents Full Phase 2 Atumelnant Results in Congenital Adrenal Hyperplasia and Interim ACTH-Dependent Cushing's Data at ENDO 2026

Crinetics Pharmaceuticals (Nasdaq: CRNX) presented on June 14 full results from its 12-week Phase 2 trial of atumelnant (CRN04894) in adults with classic congenital adrenal hyperplasia (CAH), the company's investigational once-daily oral ACTH receptor antagonist. The data showed rapid, substantial, and sustained statistically significant reductions in CAH disease biomarkers including androstenedione and 17-hydroxyprogesterone, with patients able to reduce glucocorticoid doses while maintaining androgen control. A separate Phase 1b/2a interim analysis in ACTH-dependent Cushing's syndrome showed that atumelnant rapidly lowered early-morning cortisol and normalized urinary free cortisol even at lower doses. Both programs are advancing toward Phase 3.

Clinical Trials · View digest

Crinetics Presents 2-Year Palsonify (Paltusotine) Open-Label Extension Data at ENDO 2026, Confirms Durable Acromegaly Control

Crinetics Pharmaceuticals (Nasdaq: CRNX) presented data on June 14 from up to two years of efficacy and pooled safety follow-up in the PATHFNDR-1 and PATHFNDR-2 open-label extensions of Palsonify, the once-daily oral SST2 nonpeptide agonist for acromegaly. Palsonify maintained lowered IGF-1 levels, stable symptoms, and stable or reduced pituitary tumor volumes through 48 weeks across 167 patients. Pooled safety data identified no new safety signals; common adverse events were diarrhea, arthralgia, headache, and UTI. A separate ACROBAT Advance analysis showed safety and efficacy with up to four years of Palsonify + oral cabergoline combination therapy in patients whose IGF-1 had not normalized on Palsonify alone. With Camurus's rival monthly octreotide depot Oclaiz pushed to a 2027 US launch after the June 10 second CRL, Palsonify now stands alone as the next-generation acromegaly therapy in the US market.

Clinical Trials · View digest

Crinetics Palsonify (Paltusotine) Up to 2-Year PATHFNDR-1 and PATHFNDR-2 Open-Label Extension Data at ENDO 2026 on June 14

Crinetics Pharmaceuticals (Nasdaq: CRNX) will present an oral abstract Sunday June 14 (1:45-3:15 PM CT, Room W183BC) covering up to two years of efficacy and pooled safety data from the Palsonify (once-daily oral paltusotine) PATHFNDR-1 and PATHFNDR-2 open-label extensions in acromegaly, plus long-term combination data with cabergoline from the ACROBAT Advance trial. The presentation lands four days after Camurus's second Complete Response Letter on Oclaiz (CAM2029), the rival monthly subcutaneous octreotide depot, leaves the US acromegaly market with only one approved next-generation entrant (Palsonify, approved September 2025) through at least H1 2027. Crinetics will also present six total abstracts at ENDO including Phase 2 atumelnant data in congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome.

Clinical Trials · View digest

Crinetics Atumelnant Phase 2/3 Cushing's Syndrome Q2 2026 Initiation + Ohio University Growth Hormone Receptor Antagonist License

Crinetics also disclosed in the May 7 Q1 update that the company is on track to initiate a seamless Phase 2/3 trial of atumelnant in ACTH-dependent Cushing's syndrome in Q2 2026. The trial will assess efficacy in a broad population including Cushing's disease and ectopic ACTH syndrome. Atumelnant is also in Phase 3 for congenital adrenal hyperplasia. Separately, Crinetics announced an exclusive license agreement with Ohio University to develop an early-preclinical growth hormone receptor antagonist (GHRA) for acromegaly — a mechanism complementary to paltusotine's SST2 agonism that would compete in the same indication once both reach market.

Industry · View digest

Crinetics Q1 2026 (May 7): Palsonify $10.3M Net Product Revenue (~2× Q4), 263 Unique Prescribers, $1.3B Cash; R&D Up 17.6% to $100.1M for Phase 3 Carcinoid + Atumelnant Programs

Crinetics Pharmaceuticals reported Q1 2026 results May 7 — total revenue $10.7M (vs $8.5M consensus, +25.7% beat), Palsonify (paltusotine) net product revenue $10.3M in its first full commercial quarter (up from $5.4M in Q4 2025), 263 unique prescribers (up from 125 at year-end), 232 new patient enrollment forms in the quarter, and approximately 70% of patients reimbursed with payer coverage above 60% (target above 75% by Q3). Cash, equivalents, and investments closed at $1.3B. R&D rose 17.6% to $100.1M to fund Phase 3 paltusotine in carcinoid syndrome plus atumelnant Phase 3 programs in congenital adrenal hyperplasia and Cushing's syndrome. Shares rose 4.3% in after-hours trading.

Industry · View digest

Crinetics Q1 2026 Set for May 7 After-Market Close: Palsonify EU Launch Detail + CRN09682 SSTR2 NDC BRAVESST2 Update Expected

Crinetics Pharmaceuticals reports Q1 2026 financial results after market close May 7, with a 4:30 p.m. ET conference call. Investors will be looking for first commercial color on Palsonify (paltusotine), the once-daily oral SST2 nonpeptide agonist that won European Commission approval April 27 for adult acromegaly across the 27 EU member states plus three EEA countries (Iceland, Liechtenstein, Norway). First launches are planned for Germany and Austria. Q1 commentary on CRN09682 — the first-in-class SSTR2 non-peptide drug conjugate currently in Phase 1/2 BRAVESST2 in metastatic neuroendocrine tumors — is also expected, with the program designed as a direct challenge to peptide-based PRRT including Lutathera and Perspective Therapeutics' alpha-PRRT.

Regulatory · View digest

Crinetics Wins European Commission Approval for Palsonify (Paltusotine), the First Once-Daily Oral SST2 Agonist for Acromegaly

Crinetics Pharmaceuticals announced April 27 that the European Commission approved Palsonify (paltusotine), a selectively-targeted somatostatin receptor type 2 nonpeptide agonist, as the first once-daily oral therapy for acromegaly in adults across all 27 EU member states plus three EEA countries. The approval rests on two pivotal Phase 3 trials in medical-naïve and previously treated patients, with diarrhea, abdominal pain, and nausea reported as the most common adverse reactions and no serious adverse events in the randomized portion. First launches are planned for Germany and Austria, marking Crinetics' first regulatory approval outside the U.S. and a competitive challenge to injectable somatostatin analogs.

Clinical Trials · View digest

Crinetics CRN09682 First-in-Class SSTR2 Non-Peptide Drug Conjugate Reported — Direct Challenge to Peptide-Based PRRT

BioWorld reported April 24 on Crinetics Pharmaceuticals' CRN09682, a first-in-class non-peptide drug conjugate (NDC) coupling a small-molecule somatostatin receptor 2 (SST2) agonist to monomethyl auristatin E (MMAE) via a cleavable linker. The compound is in Phase 1/2 BRAVESST2 trial in metastatic neuroendocrine tumors and other SST2-expressing solid tumors — directly competing with peptide-radioconjugate therapies like Novartis' Lutathera and Perspective Therapeutics' alpha-PRRT. The non-peptide approach trades off receptor-binding peptide selectivity for small-molecule manufacturing simplicity.