September 19, 2026

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

Zealand's glepaglutide wins EU CHMP for short bowel syndrome, Merck-Astellas Keytruda+Padcev nod for perioperative MIBC, Sandoz-mAbxience biosimilar deal.

6 stories · Covering regulatory, industry

Editor's Note

Saturday follows a Friday dominated by three European regulatory decisions that will shape peptide, immuno-oncology, and biosimilar markets over the next decade. Zealand Pharma's Zeydovio (glepaglutide, a long-acting GLP-2 analog) received a positive CHMP opinion for adults with short bowel syndrome — the first major SBS advance in Europe in more than a decade, with EC decision expected inside ~67 days. Merck (MSD) and Astellas secured a CHMP positive opinion for the Keytruda + Padcev perioperative regimen in resectable muscle-invasive bladder cancer based on Phase 3 KEYNOTE-B15/EV-304 event-free-survival, overall-survival, and pathologic-complete-response wins, with EC decision expected Q4 2026. Sandoz and Fresenius-majority-owned mAbxience signed a global collaboration for an emicizumab biosimilar candidate, opening the ~$5.7 billion hemophilia A market to biosimilar competition and marking Sandoz's first foray into hemophilia. Xenon Pharmaceuticals submitted its azetukalner focal-seizure NDA but voluntarily paused enrollment in the psychiatry program after neuropsychiatric adverse events, deferring X-NOVA2 major depressive disorder data to Q1 2027. Ultragenyx analyst reactions after Thursday's FAYUVI Sanfilippo Type A approval landed Friday with Cantor Fitzgerald and Canaccord Genuity moving to $39 price targets (Cantor modeling $400 million peak commercial opportunity), Citi to $32, and Morgan Stanley to $20 at Equal Weight.

Regulatory

Zealand Pharma Zeydovio (Glepaglutide, Long-Acting GLP-2 Receptor Agonist Peptide) Receives Positive EU CHMP Opinion for Adult Short Bowel Syndrome; First Major SBS Advance in Europe in Over a Decade

Zealand Pharma (NASDAQ: ZEAL; NASDAQ Copenhagen: ZEAL) announced Friday September 18, 2026 that the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for Zeydovio (glepaglutide, a long-acting next-generation GLP-2 receptor agonist peptide) for the treatment of adults with short bowel syndrome (SBS). The recommendation is anchored on the registrational Phase 3 EASE-1 trial: 65.7% of patients on glepaglutide achieved at least a 20% reduction in parenteral support volume versus 38.9% on placebo, with approximately 1 in 7 patients weaning off parenteral support entirely at 24 weeks. Zeydovio will be supplied as a 10 mg solution for injection in a pre-filled pen. This is the first major CHMP advance in SBS in more than a decade — the current European standard-of-care GLP-2 analog teduglutide (Takeda's Revestive) has been the only GLP-2 in the EU market since 2012. The European Commission decision is expected within approximately 67 days (mid-November 2026 timeframe). Zealand retains full commercial rights in Europe. Glepaglutide is also under FDA review with a U.S. PDUFA action date targeted for early 2027.

#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 #65-7-percent-parenteral-support-reduction #1-in-7-weaned-off #teduglutide-competitor #revestive-competitor #ec-decision-november-2026

Regulatory

Merck (MSD) and Astellas Secure Positive EU CHMP Opinion for Keytruda (Pembrolizumab) + Padcev (Enfortumab Vedotin-Ejfv) as Perioperative Treatment in Resectable Muscle-Invasive Bladder Cancer Based on Phase 3 KEYNOTE-B15/EV-304

Merck (NYSE: MRK; MSD outside North America) and Astellas (TSE: 4503) announced Friday September 18, 2026 that the EMA's CHMP issued a positive opinion recommending EU marketing authorization for Keytruda (pembrolizumab, anti-PD-1 monoclonal antibody) in combination with Padcev (enfortumab vedotin-ejfv, Nectin-4-directed antibody-drug conjugate developed with Pfizer) as perioperative treatment — neoadjuvant before radical cystectomy, continued as adjuvant — for adults with resectable muscle-invasive bladder cancer (MIBC). The recommendation is based on Phase 3 KEYNOTE-B15/EV-304 data documenting statistically significant improvements in event-free survival (primary endpoint), overall survival, and pathologic complete response rate versus neoadjuvant cisplatin-based chemotherapy followed by adjuvant standard of care. European Commission decision is expected in Q4 2026. This would be the first perioperative regimen combining a PD-1 inhibitor with an antibody-drug conjugate to reach European regulatory approval in MIBC and follows the September 2026 FDA approval of the same regimen (plus KEYTRUDA QLEX subcutaneous formulation with berahyaluronidase alfa-pmph) for cisplatin-ineligible MIBC patients.

#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 Fresenius-Owned mAbxience Sign Global Licensing and Manufacturing Collaboration for Emicizumab Biosimilar Candidate; Targets Roche Hemlibra's ~$5.7 Billion Hemophilia A Market

Sandoz Group (SIX: SDZ) and mAbxience (majority-owned by Fresenius SE & Co. KGaA) announced Friday September 18, 2026 a licensing, development, manufacturing, and commercialization agreement for a biosimilar candidate of emicizumab, the bispecific factor IXa/factor X monoclonal antibody currently marketed by Roche as Hemlibra for hemophilia A. The reference product (Hemlibra) generated approximately $5.7 billion in global 2025 sales and is Roche's largest hemophilia franchise product. Under the agreement, mAbxience will develop and manufacture the biosimilar at its GMP-approved facilities in Spain and Argentina; Sandoz will hold exclusive global commercialization rights excluding Argentina, Uruguay, and Paraguay. Financial terms were not disclosed. This is Sandoz's first entry into the hemophilia biosimilar space and expands mAbxience's pipeline from oncology (rituximab, bevacizumab, trastuzumab biosimilars) and immunology into rare-disease bleeding disorders. Hemlibra composition patents run through 2029-2032 in major markets; biosimilar launch timing will depend on both regulatory approval and patent-cliff sequencing.

#sandoz #sdz #mabxience #fresenius #fsnuy #emicizumab-biosimilar #hemlibra-biosimilar #roche-reference-product #hemophilia-a #bispecific-factor-ixa-factor-x-mab #5-7-billion-reference-market #spain-argentina-manufacturing #sandoz-first-hemophilia-entry #2029-2032-patent-cliff #non-peptide

Regulatory

Xenon Pharmaceuticals Submits Azetukalner Focal-Seizure NDA to FDA; Voluntarily Pauses Enrollment in Major Depressive Disorder Program After Neuropsychiatric Adverse Events, Deferring X-NOVA2 Data to Q1 2027

Xenon Pharmaceuticals (NASDAQ: XENE) announced Thursday September 17, 2026 (syndicated Friday September 18) two updates on azetukalner (small-molecule selective Kv7.2/Kv7.3 potassium-channel opener). First: submission of the New Drug Application to the FDA for focal onset seizures in adults with epilepsy, supported by Phase 3 X-TOLE 2 and X-TOLE 3 registrational data plus long-term open-label extension safety. Second: a voluntary pause on new enrollment in the X-NOVA psychiatry program (major depressive disorder Phase 3) following a small number of neuropsychiatric adverse events under review; existing enrolled participants and all epilepsy studies continue as planned. Xenon deferred X-NOVA2 topline data readout from prior H2 2026 guidance to Q1 2027 pending the safety review. XENE shares fell more than 20% Thursday on the pause, though sell-side analysts (William Blair, Wells Fargo, Guggenheim) maintained conviction in the estimated $2 billion peak epilepsy commercial opportunity. Xenon's Wells Fargo Healthcare Conference presentation on September 8 had preceded the update.

#xenon-pharmaceuticals #xene #azetukalner #kv7-2-kv7-3-potassium-channel-opener #focal-seizure-nda-submitted #x-tole-2-x-tole-3-phase-3 #voluntary-mdd-enrollment-pause #x-nova-psychiatry-program #neuropsychiatric-adverse-events #x-nova2-deferred-q1-2027 #xene-down-20-percent #2-billion-peak-epilepsy-opportunity #non-peptide

Industry

Ultragenyx FAYUVI Analyst Upgrades After Thursday Sanfilippo Type A Approval: Cantor Fitzgerald and Canaccord Genuity Move to $39 Price Targets, Citi to $32, Morgan Stanley to $20; Cantor Sees $400M Peak Commercial Opportunity

Ultragenyx Pharmaceutical (NASDAQ: RARE) received a broad wave of Friday September 18-19 sell-side analyst updates following Thursday's FDA standard full approval of FAYUVI (rebisufligene etisparvovec-hopf) as the first-ever treatment for pediatric Sanfilippo Syndrome Type A (MPS IIIA). Cantor Fitzgerald called the approval 'a much-needed win' and raised price target to $39, modeling roughly $400 million in peak commercial opportunity. Canaccord Genuity moved to $39. Citi moved to $32. Morgan Stanley maintained Equal Weight at $20. William Blair rated Market Perform, citing the approval as an incremental positive but flagging a lack of major value-inflection catalysts over the next 12 months. Analyst Sami Corwin's model at Cantor projected $325 million peak Fayuvi sales. FAYUVI shipments are expected to commence within 30-60 days. Ultragenyx confirmed retention of its Priority Review Voucher (historically worth $150-350 million on the secondary market) plus mid-single-digit to 8% royalties owed to Abeona Therapeutics (NASDAQ: ABEO) on Fayuvi net sales.

#ultragenyx #rare #fayuvi #rebisufligene-etisparvovec-hopf #cantor-fitzgerald-39-target #canaccord-genuity-39-target #citi-32-target #morgan-stanley-20-equal-weight #william-blair-market-perform #400-million-peak-opportunity #325-million-corwin-model #30-60-day-launch #priority-review-voucher-retained #abeona-therapeutics-royalty-context #abeo #non-peptide

Regulatory

BioNTech and Pfizer XFG-Adapted Comirnaty (2026-2027 Season COVID-19 mRNA Vaccine) Receives Health Canada Authorization for Ages 6 Months and Older; Distribution to Commence Within Weeks

BioNTech SE (NASDAQ: BNTX) and Pfizer (NYSE: PFE) announced Thursday September 17, 2026 (syndicated Friday September 18) that Health Canada authorized their XFG-adapted Comirnaty (COVID-19 mRNA vaccine) for the 2026-2027 respiratory season in individuals aged 6 months and older. XFG (an LP.8.1 descendant Omicron subvariant lineage) was designated by WHO's Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) in April 2026 as the preferred variant for 2026-2027 seasonal vaccine composition, and multiple regulators (FDA, EMA, MHRA) have already authorized XFG-adapted formulations. Distribution across Canadian provinces and territories is expected to commence within days to weeks pending CDA/CADTH reimbursement pathways. Health Canada's authorization follows the June 2026 approvals of the equivalent updated Moderna Spikevax and Novavax Nuvaxovid XFG-adapted formulations. Comirnaty remains BioNTech's flagship product; 2025 global revenue was approximately €4.2 billion.

#biontech #bntx #pfizer #pfe #comirnaty #xfg-adapted-covid-19-vaccine #mrna-vaccine #health-canada-authorization #2026-2027-respiratory-season #ages-6-months-and-older #lp-8-1-descendant-lineage #tag-co-vac-designation #non-peptide