Peptide News Digest

Novo's €1.165B Nanexa Long-Acting Injectable Deal, Roche Enicepatide Phase 2, Avacta Peptide-Drug Conjugate

Novo licenses Nanexa's PharmaShell for monthly or quarterly peptide shots, Roche reports enicepatide Phase 2 data, and Avacta details a pancreatic cancer PDC.

4 stories · Covering industry, clinical-trials, regulatory

Editor's Note

The largest peptide deal of the past day was about how often patients inject, not what they inject. Novo Nordisk licensed Nanexa's PharmaShell particle-coating technology for up to five peptide programs in obesity, diabetes, and cardiometabolic disease, with monthly and quarterly dosing as the targets, and Nanexa's shares more than doubled in Stockholm on Friday. Roche's September 22 enicepatide results, not covered here earlier, add another once-weekly GLP-1/GIP agonist to the late-stage field: 15.5% weight loss at 48 weeks on the top dose in people with type 2 diabetes, though Roche's announcement gave no placebo figures. Outside metabolism, Avacta described the Phase 1 FOCUS-01 trial of AVA6103, a peptide-drug conjugate designed to release the chemotherapy drug exatecan inside tumors, and Health Canada approved Rhythm's setmelanotide for acquired hypothalamic obesity. Two of the four items are four days old; few new peptide stories from September 25 and 26 could be verified, so this digest is short.

Industry

Novo Licenses Nanexa's PharmaShell Coating Technology for Up to Five Long-Acting Peptide Programs in a Deal Worth Up to €1.165 Billion

Swedish drug-delivery company Nanexa announced on the evening of Thursday, September 24, 2026 a global exclusive license and collaboration agreement giving Novo Nordisk rights to use its PharmaShell platform in up to five development programs for peptide-based drugs in obesity, type 2 diabetes, and other cardiometabolic diseases. PharmaShell uses atomic layer deposition to apply an ultra-thin inorganic coating to individual drug particles to control their release, and the companies are targeting monthly and quarterly injection schedules. Nanexa can receive up to €1.165 billion, of which €615 million is an upfront payment plus development and regulatory milestones and the rest is sales milestones, along with low single-digit royalties; Novo will lead development and commercialization. Reuters reported that Nanexa's shares were up about 122% in Stockholm early on Friday, September 25.

#novo-nordisk #nanexa #drug-delivery #licensing-deal #obesity
Clinical Trials

Roche's Once-Weekly GLP-1/GIP Agonist Enicepatide Lowers HbA1c 2.65 Points and Weight 15.5% at 48 Weeks in Phase 2 Type 2 Diabetes Trial

Roche announced on Tuesday, September 22, 2026 that enicepatide (CT-388), an investigational once-weekly GLP-1/GIP receptor agonist, met both primary endpoints in the randomized, placebo-controlled Phase 2 CT-388-104 trial in 447 adults with type 2 diabetes and overweight or obesity. At the highest titrated dose of 24 mg, HbA1c fell 2.65 percentage points from a baseline of 8.1%, mean weight loss was 15.5% at 48 weeks with no plateau, and 90% of patients on that dose reached an HbA1c of 6.5% or lower. Discontinuation due to adverse events was 2.0% across enicepatide arms versus 0.0% on placebo, and side effects were mostly mild-to-moderate gastrointestinal. Roche's announcement did not give placebo results for weight or HbA1c; the company plans a Phase 3 glycemic-control program and cardiovascular outcomes trials in the first half of 2027, alongside the ongoing ENITH-1 and ENITH-2 weight-management trials.

#roche #enicepatide #gip #glp-1 #type-2-diabetes
Clinical Trials

Avacta Details Phase 1 FOCUS-01 Trial of AVA6103, a FAP-Targeted Peptide-Drug Conjugate Carrying Exatecan, at AACR Pancreatic Cancer Conference

Avacta Group announced on Friday, September 25, 2026 that it would present the design of its Phase 1a FOCUS-01 trial and new preclinical data for AVA6103 (FAP-Exd) on September 26 at the AACR Conference on Pancreatic Cancer in San Diego. AVA6103 is a peptide-drug conjugate built on Avacta's pre|CISION platform, which is designed to be cleaved inside the tumor by fibroblast activation protein (FAP) so that the chemotherapy payload exatecan is released there, limiting exposure elsewhere in the body. The company said AVA6103 was well tolerated through the first three dose levels, up to a payload dose about 50% above the maximum tolerated dose of conventional exatecan, and that enrollment continues at dose level 4, including an every-two-weeks arm for pancreatic cancer. In mice implanted with human tumor tissue, Avacta reported durable complete and partial responses lasting weeks after dosing stopped; it released no efficacy data from patients.

#avacta #peptide-drug-conjugate #pancreatic-cancer #exatecan
Regulatory

Health Canada Approves Rhythm's IMCIVREE (Setmelanotide) for Acquired Hypothalamic Obesity in Patients 4 and Older

Rhythm Pharmaceuticals announced on Tuesday, September 22, 2026 that Health Canada approved IMCIVREE (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for weight management in adults and children 4 years and older with acquired hypothalamic obesity, a rare condition that develops after injury to the hypothalamus. Rhythm called it the first targeted therapy approved in Canada for the condition. The approval rests on the Phase 3 TRANSCEND trial in 142 patients, which met its primary endpoint; Rhythm's Canadian announcement gives the placebo-adjusted reduction in body mass index as 18.8%, while its March 19, 2026 U.S. approval announcement reported 18.4% at 52 weeks. IMCIVREE was first approved in Canada in 2023 for obesity due to Bardet-Biedl syndrome or POMC, PCSK1, or LEPR deficiency, and the acquired hypothalamic obesity indication is already authorized in the U.S., the European Union, and the UK.

#rhythm-pharmaceuticals #setmelanotide #imcivree #hypothalamic-obesity #health-canada #mc4r