欧洲制药行业周报

EUROPE | Pharmaceuticals Weekly Wrap Key Research Published: We provide a short summary of key updates and additional tidbits acrossour European Pharma, Biopharma, and Biotech coverage. the establishment of a long-duration •Bayer:SCOTUS Caps Future RoundupRisk&Key Takes From Ag CycleExpert Call Genmab's 1st-line Epkinly study still awaits its interim analysis, supporting our catalystoptimism:Genmab's partner confirms that the interim for Epkinly’s Phase 3 1st-line DLBCLhas not yet passed, and hence a readout this year would be an interim, supporting our priorillustrative analysis and providing us with increased optimism that a compelling result is still Galderma:Relfydess: It's Not About"If", It's about "When" Medincell:Profitability Delayed, but Pfizer's sigvotatug vedotin misses in second-line lung cancer:Pfizer's Phase 3 SigVie-002(Be6A Lung-01) of sigvotatug vedotin, an IB6-directed antibody-drug conjugate (ADC), missedits primary overall survival endpoint versus docetaxel chemotherapy in patients with previouslytreated non-squamous non-small cell lung cancer (NSCLC), with the second-line subsetshowing only a directional trend and no clear IB6 expression-response link. This is the first newADC to read out pivotal data after Pfizer's $43bn Seagen acquisition, and the miss adds to astring of pipeline cuts. Pfizer is now pivoting the asset into earlier-line combinations, with Be6A at BuyLundbeck:Internal Succession asHead of R&D Retires Exelixis CRC subgroup miss in colorectal cancer:Exelixis' Phase 3 Stellar-303 final analysismissed overall survival in the non-liver-metastases subgroup of previously treated non-MSI-high metastatic colorectal cancer (mCRC), with zanzalintinib plus Roche's Tecentriq delivering15.9 months versus 12.7 months on regorafenib but a HR=0.83 that fell short of significance(p=0.1185). The intention-to-treat population had previously hit, so an FDA approval ahead of New indications for camlipixant in Phase II:Phase 2b BALANCE study of camlipixant inirritable bowel syndrome with diarrhoea (IBS-D) and mixed type (IBS-M) has moved to 'activelyrecruiting' on CT.gov, with 420 participants planned across 110 sites and primary completionexpected in March 2027. The adaptive, 2 part design allows dose optimisation through re- Kymera STAT6 acceleration:Kymera Therapeutics has significantly accelerated developmentof KT-621, completing enrolment for the Phase 2b BROADEN-2 trial in atopic dermatitis around6 months ahead of schedule, bringing the top-line readout to YE26E (from mid-2027). Withencouraging Phase 1b efficacy (63% mean EASI reduction at day 29, comparing favourablyto c.55% seen with Dupixent in earlier studies), this suggests KT-621 could emerge as a Michael Leuchten * | Equity Analyst+44 (0) 20 7029 8346 | mleuchten@jefferies.comBenjamin Jackson * | Equity Analyst+44 (0)20 7548 5146 | bjackson@jefferies.comShan Hama * | Equity Analyst+44 (0)20 7548 4084 | shama@jefferies.com Alyna Shamsi * | Equity Analyst+44 (0)20 7548 4239 | ashamsi@jefferies.com New Head of R&D at Sanofi: Sanofi announced the appointment of Paulo Fontoura as GlobalHead of R&D, with Houman Ashrafian set to pursue another external opportunity. Following theR&D setbacks, questions on whether Houman will stay have been frequent, with some investorshaving argued it could be a step in the right direction. The question at Q2 will be how many of the New zenagamtide Phase 3 registered:Novo Nordisk has registered a new Phase 3 trial evaluatingzenagamtide for weight management versus semaglutide, with study initiation planned for 22 Sep2026 and primary completion expected by Oct 2028. The 650-patient trial across 46 sites willdirectly compare efficacy and safety against Novo's own standard of care semagltuide, focussingon safety and efficacy. At ADA 2026, zenagamtide demonstrated up to 14.6% weight loss at 36weeks in Phase 2 type 2 diabetes alongside an HbA1c reduction of up to 1.71 points. Novo is Orion Orphan Drug Designation for ODM-212:Orion secured Orphan Drug Designation (ODD) fromthe European Commission for ODM-212, its first-in-class oral pan-TEAD inhibitor, for the treatmentof rare solid tumours. Orion was granted ODD by FDA in April. The company views ODM-212 as akey growth driver and potential first independent US commercial asset. It is currently in the Phase Merck anti-TL1A met primary endpoint:Phase III ATLAS-UC induction-only study of anti-TL1Atusilokibart met primary endpoint in patients with moderately to severely active ulcerative colitis.Recall, tusilokibart is from Merck's $10.8bn acquisition of Prometheus Biosciences in 2023. Data isto be presented at an upcoming congress, along with data from ongoing induction & maintenance Corxel US pII data for CX11:Corxel reported positive US Phase 2 data for CX11, an oral smallmolecule GLP-1 receptor agonist licensed from Vincentage for ex-China rights, delivering up to11.5% weight loss at 36 weeks with no sign of a plateau in the trajectory. To