Peptide News Digest

Zealand Glepaglutide CHMP for SBS, Keytruda+Padcev EU Perioperative MIBC, Sandoz-mAbxience Emicizumab Biosimilar Deal

Zealand's glepaglutide wins EU CHMP backing for short bowel syndrome, Keytruda+Padcev gets a perioperative MIBC nod, and Sandoz signs an emicizumab deal.

6 stories · Covering regulatory, industry

Editor's Note

Friday's European regulatory news included a CHMP recommendation for Zealand Pharma's Zeydovio (glepaglutide), a twice-weekly GLP-2 analog for short bowel syndrome, which Zealand called the first major advance in the condition in Europe in more than a decade; a European Commission decision is expected in about 67 days. The CHMP also backed Merck's Keytruda plus Padcev before and after surgery for resectable muscle-invasive bladder cancer, based on KEYNOTE-B15 results showing a 47% reduction in the risk of an event-free survival event and a 35% reduction in the risk of death versus chemotherapy. Sandoz and Fresenius-owned mAbxience agreed to develop and sell an emicizumab biosimilar for hemophilia A, a reference market the companies estimate at about $5.7 billion. Xenon filed its azetukalner NDA for focal seizures but paused new enrollment in its depression studies after neuropsychiatric adverse events, and analysts raised Ultragenyx price targets after Thursday's FAYUVI approval, with Cantor Fitzgerald and Canaccord Genuity both at $39.

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: glepaglutide was described as under FDA review with an early-2027 decision date, but Zealand says its U.S. EASE-5 trial is ongoing; the FDA approval of Keytruda plus Padcev was dated September 2026, but Merck cites July 2026; the $5.7 billion emicizumab figure is the companies' estimate of the global reference market, not Hemlibra's 2025 sales; azetukalner's NDA rests on the Phase 2b X-TOLE and Phase 3 X-TOLE2 studies, not X-TOLE 2 and X-TOLE 3; and Cantor's roughly $400 million estimate refers to selling two priority review vouchers, not peak sales. Removed claims include a $325 million peak-sales estimate attributed to Cantor, a William Blair rating presented as a reaction to the approval (William Blair downgraded the stock on September 3), royalty terms owed to Abeona Therapeutics, a placebo response rate for glepaglutide, a Xenon share-price decline and analyst views, patent dates for emicizumab, and COVID-19 variant, regulatory, and revenue details absent from the Health Canada announcement.

Regulatory

Zealand Pharma's Zeydovio (Glepaglutide), a Long-Acting GLP-2 Analog, Receives Positive CHMP Opinion for Short Bowel Syndrome

Zealand Pharma announced on Friday, September 18, 2026 that the EMA's CHMP recommended approval of Zeydovio (glepaglutide) for short bowel syndrome. Zeydovio is a long-acting GLP-2 analog given twice weekly by subcutaneous injection from a ready-to-use, single-dose autoinjector. In the Phase 3 EASE-1 trial of 106 patients dependent on parenteral support, two thirds of patients on glepaglutide had at least a 20% reduction in weekly parenteral support volume at 24 weeks and one in seven weaned off it entirely; twice-weekly glepaglutide cut weekly parenteral support by 5.13 liters versus 2.85 liters on placebo. Zealand called the opinion the first major advance in short bowel syndrome treatment in Europe in more than a decade and expects a European Commission decision in about 67 days. In the U.S., the EASE-5 trial is ongoing, and glepaglutide has FDA orphan drug designation.

#zealand-pharma #zeal #zeydovio #glepaglutide #glp-2-receptor-agonist #long-acting-peptide #short-bowel-syndrome #sbs #chmp-positive-opinion #european-marketing-authorization #ease-1-phase-3 #1-in-7-weaned-off
Regulatory

Merck and Astellas Receive Positive CHMP Opinion for Keytruda Plus Padcev Before and After Surgery in Resectable Muscle-Invasive Bladder Cancer

Merck announced on Friday, September 18, 2026 that the CHMP recommended approval of Keytruda (pembrolizumab) with Padcev (enfortumab vedotin) as neoadjuvant treatment, continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer; the recommendation also covers subcutaneous Keytruda. In the Phase 3 KEYNOTE-B15 (EV-304) trial, the regimen reduced the risk of an event-free survival event by 47% and the risk of death by 35% versus gemcitabine and cisplatin chemotherapy plus surgery, and the pathologic complete response rate was 55.8% versus 32.5%. Merck said it would be the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for muscle-invasive bladder cancer regardless of cisplatin eligibility in the EU. A European Commission decision is expected by the fourth quarter of 2026, and the FDA approved the combination for this use in July 2026. Merck's partners on the regimen are Astellas and Pfizer.

#merck #msd #mrk #astellas #keytruda #pembrolizumab #padcev #enfortumab-vedotin-ejfv #nectin-4-adc #anti-pd-1-mab #chmp-positive-opinion #perioperative-mibc #resectable-muscle-invasive-bladder-cancer #keynote-b15-ev-304-phase-3 #event-free-survival-primary #ec-decision-q4-2026 #non-peptide
Industry

Sandoz and mAbxience Sign Global Agreement to Develop and Sell an Emicizumab Biosimilar for Hemophilia A

mAbxience, majority-owned by Fresenius with partial ownership by Insud Pharma, and Sandoz announced on Friday, September 18, 2026 a licensing, development, manufacturing, and commercialization agreement for a biosimilar candidate of emicizumab for hemophilia A. mAbxience will develop and manufacture the product at its GMP-approved facilities in Spain and Argentina, and Sandoz will hold exclusive global commercialization rights outside Argentina, Uruguay, and Paraguay. The companies estimate the global reference market at about $5.7 billion. Financial terms were not disclosed.

#sandoz #sdz #mabxience #fresenius #fsnuy #emicizumab-biosimilar #hemophilia-a #bispecific-factor-ixa-factor-x-mab #5-7-billion-reference-market #spain-argentina-manufacturing #non-peptide
Regulatory

Xenon Submits Azetukalner NDA for Focal Seizures and Pauses New Enrollment in Its Depression Studies After Neuropsychiatric Adverse Events

Xenon Pharmaceuticals announced on Thursday, September 17, 2026 that it submitted a New Drug Application to the FDA for azetukalner, a Kv7 potassium channel opener, in focal seizures, supported by the Phase 2b X-TOLE and Phase 3 X-TOLE2 studies. The company also paused enrollment of new patients in its major depressive disorder and bipolar depression studies after an analysis of neuropsychiatric adverse events; the pause was put in place with its Data Safety Monitoring Board, is expected to be temporary, and does not affect enrolled participants. Xenon said the events were consistent with azetukalner's known safety and tolerability profile. X-NOVA2, its depression study, had enrolled about 80% of its initial 450-patient target, and topline data are now expected in the first quarter of 2027.

#xenon-pharmaceuticals #xene #azetukalner #kv7-potassium-channel-opener #focal-seizure-nda-submitted #x-tole2 #voluntary-mdd-enrollment-pause #x-nova-psychiatry-program #neuropsychiatric-adverse-events #non-peptide
Industry

Analysts Raise Ultragenyx Price Targets After FAYUVI Approval: Cantor Fitzgerald and Canaccord to $39, Citi to $32, Morgan Stanley to $20

Several analysts raised their Ultragenyx price targets on Friday, September 18, 2026, a day after the FDA's standard full approval of FAYUVI for the neurologic manifestations of Sanfilippo syndrome type A (MPS IIIA) in children. Cantor Fitzgerald moved to $39 from $33 with an Overweight rating, raised its probability of success to 100% from 90%, and valued the MPS IIIA opportunity at about $12 to $13 per share; Canaccord Genuity moved to $39 from $37 (Buy), Morgan Stanley to $20 from $18 (Equal Weight), and Citi to $32. Cantor also estimated that the priority review voucher Ultragenyx received with the approval, together with another voucher the company already holds, could bring in about $400 million if sold. Ultragenyx expects FAYUVI to be available to ship to qualified treatment centers within 30 to 60 days.

#ultragenyx #rare #fayuvi #rebisufligene-etisparvovec-hopf #cantor-fitzgerald-39-target #canaccord-genuity-39-target #citi-32-target #morgan-stanley-20-equal-weight #30-60-day-launch #priority-review-voucher #non-peptide
Regulatory

Health Canada Authorizes Pfizer and BioNTech's XFG-Adapted Comirnaty COVID-19 Vaccine for People 6 Months and Older

Pfizer Canada and BioNTech announced on Thursday, September 17, 2026 that Health Canada authorized the XFG variant-adapted Comirnaty vaccine for active immunization against COVID-19 in people aged 6 months and older. The authorization was based on the cumulative clinical, non-clinical, and real-world data the companies had already submitted. The companies said the vaccine will be available through various distribution channels in the coming days and weeks, and Pfizer Canada said it has enough inventory to meet its contractual commitments.

#biontech #bntx #pfizer #pfe #comirnaty #xfg-adapted-covid-19-vaccine #mrna-vaccine #health-canada-authorization #ages-6-months-and-older #non-peptide

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