Peptide News Digest

Novo + Orbis $1.4B Oral Macrocycle Deal, Novo Capital Markets Day Preview, Roche Lunsumio CELESTIMO Phase 3 Hit

Novo signs an Orbis oral macrocycle deal worth up to $1.4B, Roche's Lunsumio hits in Phase 3 CELESTIMO, and Halozyme upsizes convertible notes to $1.3B.

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

Editor's Note

Novo signed a discovery deal worth up to $1.4 billion with Orbis Medicines, a Copenhagen and Lausanne company that designs oral macrocycle drugs; the targets are undisclosed cardiometabolic proteins, and Orbis's chief executive said its macrocycles have reached up to 18% oral bioavailability in preclinical studies. The deal came days before Novo's September 21 Capital Markets Day in London. Roche's Lunsumio plus lenalidomide met its progression-free survival endpoint in CELESTIMO, the confirmatory Phase 3 trial in relapsed or refractory follicular lymphoma. Halozyme priced an upsized $1.3 billion convertible note offering and will use part of the proceeds to buy back 2027 and 2028 notes. Bristol Myers Squibb ended the degrader-antibody conjugate it bought from Orum Therapeutics after a Phase 1 review, forgoing up to $80 million in milestones, and Nuvation Bio's IBTROZI label now reports a 49.7-month median duration of response in TKI-naive ROS1-positive lung cancer. Healthline covered an nference study that found about 5.5% and 2.2% weight loss at one year on sustained low doses of tirzepatide and semaglutide.

Correction (September 23, 2026): This digest was revised to remove claims that could not be traced to a primary source and to replace general source links with specific ones. Corrected facts: Orbis Medicines' Series A was led by NEA, not by Novo Holdings and Forbion; and the low-dose GLP-1 item had given Wegovy's STEP 1 weight loss as 13.7%, a figure that belongs to semaglutide in the SURMOUNT-5 trial. Removed claims include Morgan Stanley, Barclays and HSBC ratings and a 2031 semaglutide exclusivity date attributed to a preview that did not contain them, a statement that the Orbis deal was the company's first big pharma partnership, a claimed $1 billion U.S. market for second-line follicular lymphoma, partner product names for Halozyme's ENHANZE technology, and a claim that Bristol Myers Squibb had dropped three in-licensed programs this year.

Industry

Novo Signs Deal Worth Up to $1.4 Billion With Orbis Medicines to Discover Oral Macrocycle Drugs for Cardiometabolic Diseases

Orbis Medicines, based in Copenhagen and Lausanne, announced on Thursday, September 17, 2026 a multi-target discovery and license agreement with Novo to design oral macrocycle drugs for undisclosed cardiometabolic targets. Orbis can receive up to $1.4 billion in upfront and development and commercial milestone payments plus tiered royalties, and Novo will make a strategic investment of undisclosed size. The work uses Orbis's nGen platform, which combines generative AI, high-throughput synthesis, and a multi-parameter optimization engine trained on the company's experimental macrocycle data. Orbis chief executive Morten Graugaard said its synthetic macrocycles have reached up to 18% oral bioavailability in preclinical studies. Orbis launched in January 2025 with a €90 million (about $93 million) Series A led by NEA, with Lilly Ventures, Forbion, and Novo Holdings among its investors.

#novo-nordisk #novo #nvo #orbis-medicines #1-4-billion-deal #oral-macrocyclic-peptides #ngen-ai-platform #cardiometabolic-diseases #18-percent-oral-bioavailability #macrocycle-drug-discovery #danish-biotech #peptide
Industry

Novo Heads Into Its September 21 Capital Markets Day in London With Shares Near the Low End of Their 52-Week Range

Novo will hold its Capital Markets Day in London on Monday, September 21, 2026, with CEO Mike Doustdar presenting the corporate strategy. A TIKR preview published September 10 noted that the U.S.-listed shares closed at $44.56 on September 9, nearer their 12-month low of $35.12 than their high of $64.16. The preview put total Wegovy pill prescriptions past five million, with the latest million added in four weeks, and the pill's share of the U.S. oral obesity market at about 90%. It also pointed to a U.S. obesity decision on CagriSema at the end of 2026 and to semaglutide losing exclusivity in markets such as Canada and Brazil in the second half of 2026. The event follows Novo's announcement that it will drop 'Nordisk' from its name in day-to-day use.

#novo-nordisk #novo #nvo #capital-markets-day-london-september-21 #mike-doustdar-ceo #wegovy-pill-5-million-prescriptions #cagrisema-late-2026-decision #glp-1
Clinical Trials

Roche's Lunsumio Plus Lenalidomide Meets Progression-Free Survival Endpoint in Phase 3 CELESTIMO Trial in Relapsed or Refractory Follicular Lymphoma

Roche announced on Thursday, September 17, 2026 that the Phase 3 CELESTIMO trial met its primary endpoint: Lunsumio (mosunetuzumab) plus lenalidomide produced a statistically significant improvement in progression-free survival versus rituximab plus lenalidomide in people with relapsed or refractory follicular lymphoma who had received at least one prior line of treatment. Overall survival data were immature at the interim analysis, and safety was consistent with the known profiles of both drugs, with no new signals. CELESTIMO is the confirmatory study required to convert the accelerated approval and conditional authorization of Lunsumio monotherapy for third-line or later follicular lymphoma into full approval. Roche will submit the data to health authorities and present them at an upcoming medical meeting.

#roche #rog #rhhby #lunsumio #mosunetuzumab #cd20xcd3-bispecific-antibody #t-cell-engager #lenalidomide #celestimo-phase-3 #relapsed-refractory-follicular-lymphoma #pfs-primary-endpoint-met #non-peptide
Industry

Halozyme Prices Upsized $1.3 Billion of 1.50% Convertible Notes Due 2033, Using Part of the Proceeds to Repurchase 2027 and 2028 Notes

Halozyme priced $1.3 billion of 1.50% convertible senior notes due 2033 on Thursday, September 17, 2026, up from the $1.05 billion originally announced. Interest is payable semi-annually, and the initial conversion rate of 7.1509 shares per $1,000 of principal equals about $139.84 per share. Halozyme plans to spend about $162.5 million on capped call transactions, about $217.0 million to repurchase $151.7 million of its 2027 notes, and about $435.5 million to repurchase $220.0 million of its 2028 notes, with the rest for general corporate purposes including potential acquisitions. Closing was expected on September 22, 2026. Halozyme's ENHANZE drug delivery technology is used in ten commercialized products and is licensed to companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol Myers Squibb, and argenx.

#halozyme-therapeutics #halo #1-3-billion-convertible-notes #upsized-offering #1-50-percent-coupon #notes-due-2033 #enhanze-platform #rhuph20-recombinant-hyaluronidase #subcutaneous-conversion #652-million-refinancing #roche-partner #jnj-partner #bristol-myers-squibb-partner #argenx-partner #recombinant-enzyme
Regulatory

FDA Approves Updated IBTROZI (Taletrectinib) Label Reporting a 49.7-Month Median Duration of Response in TKI-Naive ROS1-Positive Lung Cancer

Nuvation Bio announced on Thursday, September 17, 2026 that the FDA approved a supplemental New Drug Application updating the IBTROZI (taletrectinib) label for locally advanced or metastatic ROS1-positive non-small cell lung cancer. The label now reports a median duration of response of 49.7 months in TKI-naive patients in the Phase 2 TRUST-I study, based on a median follow-up of 51 months and an August 2025 data cutoff that added 14 months of data from TRUST-I and TRUST-II. Nuvation said the approval came four months ahead of the PDUFA date and brought no changes to the label's safety sections. IBTROZI, which Nuvation describes as a CNS-active next-generation ROS1 inhibitor, was first approved on June 11, 2025; Innovent Biologics markets it in China as DOVBLERON.

#nuvation-bio #nuvb #ibtrozi #taletrectinib #ros1-tyrosine-kinase-inhibitor #ros1-positive-nsclc #trust-i-51-month-follow-up #49-7-month-median-dor #innovent-biologics #non-peptide
Industry

Bristol Myers Squibb Ends ORM-6151 Degrader-Antibody Conjugate Program From Orum After Phase 1 Review, Forgoing Up to $80 Million in Milestones

Bristol Myers Squibb has told Orum Therapeutics it is ending development of BMS-986497 (ORM-6151), a degrader-antibody conjugate that pairs a CD33-targeting antibody with a GSPT1 degrader, after reviewing Phase 1 data in acute myeloid leukemia and high-risk myelodysplastic syndrome, Korea Biomedical Review reported on September 18, 2026. BMS bought the program from Orum in October 2023 for $100 million upfront in a deal worth up to $180 million; Orum keeps the upfront payment but is no longer eligible for up to $80 million in remaining milestones. Orum said it was notified unexpectedly and is assessing the situation. It will concentrate on ORM-1153, a CD123-targeting degrader-antibody conjugate for the same indications, for which the FDA has cleared an investigational new drug application.

#bristol-myers-squibb #bmy #orum-therapeutics #orm-6151 #bms-986497 #cd33-degrader-antibody-conjugate #gspt1-protein-degrader #dac-modality #acute-myeloid-leukemia #high-risk-mds #phase-1-termination #80-million-milestones-extinguished #orm-1153-next-generation #non-peptide
Research

Healthline Reports nference Study of Sustained Low-Dose GLP-1 Use: About 5.5% Weight Loss at 12 Months on Low-Dose Tirzepatide and 2.2% on Low-Dose Semaglutide

Healthline reported on Friday, September 18, 2026 on a study by nference researchers, including Venky Soundararajan, published August 31 in Biology Methods & Protocols. The study followed 1,016 people who stayed on 2.5 mg tirzepatide for at least six months and 814 who took at least three 0.25 mg semaglutide doses over at least six months; at 12 months, weight loss averaged about 5.5% and 2.2%, respectively. At 24 months, people on sustained low-dose semaglutide had lower rates of constipation (23.3% vs 36.3%), nausea (39.7% vs 50.1%), and low blood pressure (1.7% vs 5.4%) than people on higher doses. Mir Ali, MD, of MemorialCare told Healthline that most patients will need some dose escalation to keep losing weight, and the article noted that dosing outside approved schedules is not FDA- or manufacturer-approved.

#microdosing-glp-1 #sustained-low-dose #real-world-evidence #tirzepatide-low-dose #semaglutide-low-dose #5-5-percent-tirzepatide #2-2-percent-semaglutide #12-month-outcomes #reduced-gi-side-effects #off-label-dosing-pattern #glp-1 #wegovy #zepbound

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