Peptide News Digest

Crinetics Q1 Palsonify $10.3M, Zealand Q1 + $700M Roche Milestone, AstraZeneca Eleglipron Phase 2b, Entrada DMD Phase 1/2 Topline, Foley Legal Memo, Bicycle BT8009 ASCO Slot

Crinetics Q1 Palsonify $10.3M, Zealand Q1 + $700M petrelintide milestone, AstraZeneca eleglipron Phase 2b wins, Entrada DMD positive topline, Foley legal memo.

10 stories · Covering industry, clinical-trials, regulatory, research

Editor's Note

May 7 was the second wave of Q1 prints in the peptide space and the day Entrada Therapeutics turned in the first peptide-conjugate Duchenne muscular dystrophy clinical readout of 2026. Crinetics Pharmaceuticals reported Palsonify (paltusotine) at $10.3M in net product revenue — the molecule's first full quarter of commercialization, nearly doubling from $5.4M in Q4 2025 — alongside 263 unique prescribers and $1.3B in cash. Zealand Pharma's same-day print landed even better: revenue beat consensus more than 2×, the company recognized $700M as Roche-collaboration revenue tied to petrelintide's advancement to Phase 3, and the board authorized a DKK 1.3B share buyback. AstraZeneca's late-April Q1 print confirmed eleglipron Phase 2b primary-endpoint wins in both VISTA (obesity) and SOLSTICE (T2D vs semaglutide), with full data scheduled for ADA 2026 in June. Entrada's ENTR-601-44 Phase 1/2 ELEVATE-44-201 readout showed a 2.36% mean dystrophin increase from 4.00% baseline, statistically significant Time-to-Rise velocity improvement, and clean safety at the 6 mg/kg dose — the first DMD readout for the company's Endosomal Escape Vehicle (EEV) peptide-PMO conjugate platform. Foley & Lardner's May 2026 legal memo translated the FDA's April peptide reclassification for compounders ahead of the July 23–24 PCAC, and Pharmacy Times ran a Ferry Ossendorp Q&A on antigen-targeted peptide cancer vaccines. Bicycle Therapeutics confirmed the BT8009 / zelenectide pevedotin Duravelo-2 oral abstract for ASCO 2026 (June 1). Camurus's Oclaiz octreotide ER PDUFA on June 10, NPR's May 6 explainer of the Medicare GLP-1 Bridge, and the ECO 2026 + TIDES USA Boston convergence next week round out the calendar.

Industry

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.

#crinetics #q1-2026 #palsonify #paltusotine #atumelnant #acromegaly
Industry

Zealand Pharma Q1 2026 (May 7): Revenue 4× Year-Ago + 2× Consensus on $700M Roche Petrelintide Milestone, DKK 1.3B Buyback, Stock +8.4%

Zealand Pharma reported Q1 2026 revenue of DKK 34M against DKK 8M a year earlier and the DKK 17M analyst consensus — a more-than-2× beat on the recognition of Roche's $700M (DKK 4.5B) milestone payment tied to petrelintide's advancement into Phase 3. The board authorized a share buyback of up to DKK 1.3B. Net operating expenses came in at DKK 573M (below the DKK 679M consensus), and the company reaffirmed petrelintide Phase 3 obesity initiation in H2 2026. Petrelintide is the long-acting amylin analog that posted ~10.7% mean weight loss with placebo-like tolerability in ZUPREME-1; the Roche partnership combines it with the GLP-1/GIP enicepatide (CT-388) in a fixed-dose Phase 2 starting mid-2026. Shares rose 8.4% to DKK 344.

#zealand-pharma #q1-2026 #petrelintide #roche #buyback #amylin
Clinical Trials

AstraZeneca Eleglipron Phase 2b VISTA + SOLSTICE Met Primary Endpoints; Comprehensive Phase 3 Obesity Program Confirmed at Q1 Print, Full Data Slot at ADA 2026 in June

AstraZeneca's eleglipron (formerly elecoglipron / AZD5004 / ECC5004), the oral small-molecule GLP-1 agonist licensed from Eccogene in 2023, met primary endpoints in two Phase 2b trials with results detailed at the company's April 29 Q1 print: VISTA (NCT06579092, 310 obesity patients, 26-week weight loss) and SOLSTICE (NCT06579105, 406 type-2 diabetes patients, 26-week HbA1c change vs semaglutide and placebo). AstraZeneca held back exact weight-loss numbers, framing the molecule as 'very competitive,' with full data scheduled for the American Diabetes Association meeting in June. The company committed to a comprehensive Phase 3 program targeting both weight-loss efficacy and outcome benefits, with monotherapy and fixed-dose combination programs anchored against the SYH2082 dual-agonist and LiquidGel monthly-dosing platform from the $18.5B CSPC Pharmaceuticals collaboration.

#astrazeneca #eleglipron #elecoglipron #vista #solstice #ada-2026 #oral-glp-1
Clinical Trials

Entrada Therapeutics ENTR-601-44 Phase 1/2 ELEVATE-44-201 Topline (May 7): 2.36% Mean Dystrophin Increase, Statistically Significant Time-to-Rise Velocity, Clean Safety at 6 mg/kg in Duchenne Muscular Dystrophy

Entrada Therapeutics announced May 7 positive topline results from Cohort 1 of the Phase 1/2 ELEVATE-44-201 study of ENTR-601-44, the first-in-class Endosomal Escape Vehicle (EEV) peptide-PMO conjugate for exon-44-amenable Duchenne muscular dystrophy. At 6 mg/kg, treated participants showed mean dystrophin increase of 2.36% from a 4.00% baseline, exon-skipping increase of 2.31% from a 2.66% baseline, and a statistically significant improvement in Time-to-Rise (TTR) velocity. No serious adverse events or treatment-driven discontinuations; the most common AE was headache. All eight Cohort 1 participants transitioned to the open-label portion. Cohort 2 (12 mg/kg) is now dosing, with year-end 2026 readouts planned for Cohort 1 OLE and Cohort 2 MAD; Cohort 3 (up to 18 mg/kg) follows.

#entrada-therapeutics #entr-601-44 #elevate-44-201 #duchenne-muscular-dystrophy #eev #peptide-conjugate #exon-skipping
Regulatory

Foley & Lardner Legal Memo (May 2026): How Compounders Should Read FDA's Peptide Restrictions Lifting Ahead of July 23–24 PCAC

Foley & Lardner published a May 2026 client memo translating the FDA's April 22 Category 2 removal of 12 peptides for the compounding-pharmacy audience. Key framing: the removal does not, by itself, place these substances on the 503A bulks list, and the peptides will exist in a regulatory gray zone until the PCAC meets July 23–24 to consider seven of them (BPC-157, KPV, TB-500, MOTs-C, Emideltide, Semax, Epitalon) and the FDA takes final action — which under standard rulemaking timelines could run more than a year past the meeting. The piece joins the Orrick May 2026 503B GLP-1 memo, the FDA Law Blog Pep(tide) Rally analysis (April 23), Holt Law's California Sherman-Law alert, and the Frier Levitt April peptide update as the legal cluster compounders are reading ahead of the meeting.

#foley-lardner #compounding #pcac #category-2 #peptide-policy #503a
Research

Pharmacy Times Q&A (May 5): Ferry Ossendorp on Peptide Cancer Vaccines — Antigen-Targeted T-Cell Activation Against Aggressive Tumors

Pharmacy Times ran a Ferry Ossendorp Q&A on May 5 walking through the mechanistic case for peptide-based cancer vaccines: T cells recognize small peptides presented on the surface of tumor cells, and synthetic peptides matched to tumor antigens can be used to vaccinate the immune system to recognize and target those tumors. Ossendorp's own work showed that knowledge of a tumor's antigen profile combined with peptide vaccination can protect against very aggressive tumors in animal models. The piece sits inside a 2026 peptide-vaccine pipeline with 31 active personalized cancer-vaccine trials registered (more than dendritic-cell or RNA-vaccine platforms), the BioVaxys MVP-S survivin program heading to ASCO 2026, the Greenwich GP2/GLSI-100 FLAMINGO-01 readout, and the BriaCell Bria-IMT Phase 3.

#peptide-vaccine #pharmacy-times #ossendorp #cancer-immunotherapy #neoantigen #t-cell
Clinical Trials

Bicycle Therapeutics Duravelo-2 Oral Abstract Confirmed for ASCO 2026 June 1 (8:30 a.m. CT): Zelenectide Pevedotin (BT8009) + Pembrolizumab Interim Analysis in 1L Locally Advanced/Metastatic Urothelial Cancer

Bicycle Therapeutics confirmed the Duravelo-2 oral abstract presentation slot at the ASCO 2026 Annual Meeting on Monday, June 1, 8:30–8:36 a.m. CT. The abstract reports interim analysis results from Duravelo-2, a Phase 2/3 trial of zelenectide pevedotin (BT8009) plus pembrolizumab as first-line treatment for previously untreated locally advanced or metastatic urothelial carcinoma. Zelenectide pevedotin is Bicycle's Nectin-4-targeting bicyclic peptide-drug conjugate, a separate program from the EphA2-targeting nuzefatide pevedotin (BT5528) covered earlier on this site. The Q1 2026 print (April 30) reaffirmed $559.5M cash and runway to 2030 supporting the Phase 3 expansion of the platform.

#bicycle-therapeutics #zelenectide-pevedotin #bt8009 #duravelo-2 #asco-2026 #urothelial-cancer #nectin-4
Regulatory

Camurus Oclaiz (CAM2029, Octreotide Subcutaneous Depot) FDA PDUFA Set for June 10 — Next Peptide Depot Decision in Acromegaly After Crinetics Palsonify EU Win

Camurus's Oclaiz (CAM2029) — a once-monthly subcutaneous octreotide FluidCrystal depot delivered via prefilled autoinjector — has an FDA Prescription Drug User Fee Act target action date of June 10, 2026, following an October 2024 Complete Response Letter tied to a third-party manufacturer's cGMP inspection. CAM2029's ACROINNOVA Phase 3 program documented approximately five-fold higher bioavailability versus the currently approved long-acting intramuscular octreotide formulation. The June PDUFA sets up a back-to-back acromegaly decision pair with Crinetics' Palsonify (paltusotine), already approved in the EU on April 27 and reported $10.3M in Q1 US net product revenue (covered above). Both target the same patient population through different routes — once-daily oral nonpeptide vs once-monthly subcutaneous peptide depot.

#camurus #oclaiz #cam2029 #octreotide #acromegaly #fluidcrystal #pdufa
Regulatory

NPR May 6: Medicare GLP-1 Bridge Beneficiary Explainer Translates the July 1 $50/Month Copay Mechanics for Part D Enrollees

NPR ran a consumer-facing explainer May 6 of the Medicare GLP-1 Bridge demonstration that begins July 1, 2026 and runs through December 31, 2027. Eligible Medicare Part D beneficiaries can access Wegovy, Foundayo, and the Zepbound KwikPen formulation for a $50/month copay through the Bridge after meeting prior-authorization criteria. The piece consolidates a regulatory thread that has been jagged in mainstream coverage — the BALANCE pilot's collapse in late April when CVS pulled out, the Trump-administration extension of the Bridge to 2027, and the May 2026 confirmation that state Medicaid agencies can opt in. NPR's translation arrives in the same window as Novo's May 6 Q1 print and the Hims & Hers May 11 print, both of which are partly leveraged on Bridge eligibility expanding the addressable patient base.

#npr #medicare-bridge #cms-balance #part-d #wegovy #foundayo #zepbound
Industry

ECO 2026 Istanbul (May 12–15) and TIDES USA Boston (May 11–14) Open Next Week — Convergence Week for the Obesity-Pharmacology and Peptide-Manufacturing Calendars

Two of the year's biggest peptide-related meetings open within 24 hours of each other next week. The European Congress on Obesity 2026 runs May 12–15 in Istanbul, with Novo Nordisk presenting 52 abstracts spanning Wegovy 7.2 mg full STEP UP data, CagriSema higher-dose Phase 3 plans, Wegovy pill efficacy and tolerability, and women's-obesity / perimenopause / migraine subgroups; the 21-expert global panel will also formally propose the 10-year prospective GLP-1 cancer-prevention trial. TIDES USA 2026 runs May 11–14 in Boston with six concurrent scientific tracks across oligonucleotides, peptides, and mRNA — featuring Bachem, PolyPeptide, CordenPharma, Gilead, and Novo Nordisk on the CMC strategy and GMP capacity panels. Hims & Hers prints Q1 May 11 the same evening.

#eco-2026 #tides-usa-2026 #istanbul #boston #obesity #peptide-cdmo #convergence-week