September 1, 2026

Novartis Remibrutinib REMODEL RMS Wins, GSK mRNA Flu Phase 3, Alumis Lupus Miss, RedHill-Ferring Rebyota Deal

Novartis remibrutinib meets Phase 3 endpoints in relapsing MS, GSK mRNA flu advances to Phase 3, Alumis TYK2 lupus miss, RedHill nabs Rebyota rights.

10 stories · Covering clinical-trials, industry, regulatory

Editor's Note

Tuesday brought a heavy mix of Phase 3 wins, a stinging Phase 2b miss, and a follow-through on ESC Congress from Munich. Novartis's remibrutinib (an oral BTK inhibitor) hit both primary endpoints in the twin REMODEL-1 and REMODEL-2 Phase 3 trials in relapsing multiple sclerosis, reducing annualized relapse rate versus teriflunomide with a clean liver-safety profile across a 4,500-plus-patient program. GSK announced advancement of its bivalent HA-plus-NA-targeted mRNA flu vaccine to Phase 3 after positive Phase 2 data, positioning the program against Moderna's mNEXSPIKE and the wider mRNA respiratory-vaccine class. Alumis's envudeucitinib (an oral allosteric TYK2 inhibitor) missed on all primary and secondary endpoints in the 408-patient LUMUS Phase 2b in systemic lupus erythematosus, cratering the stock roughly 55% despite subgroup activity in high-interferon-signature patients; the company will file the psoriasis NDA on schedule in Q4 2026. RedHill Biopharma acquired global and U.S. commercialization rights to Ferring's Rebyota (fecal microbiota, live-jslm) and Clenpiq for $12 million upfront plus tiered royalties and milestones, extending the microbiome-therapy commercial category. On the peptide-adjacent calendar, Corbus's CANYON-1 topline for CRB-913 (a peripherally-restricted CB1 inverse agonist for obesity) remains on track for September; Roche Pharma Day September 28 will update on the top-three obesity portfolio (petrelintide, enicepatide, HM17321).

Clinical Trials

Novartis Remibrutinib Meets Both Primary Endpoints in Twin REMODEL-1 and REMODEL-2 Phase 3 Trials for Relapsing Multiple Sclerosis; Clean Liver-Safety Profile Across 4,500+ Patient Program

Novartis (NYSE: NVS) announced Tuesday September 1, 2026 that the twin REMODEL-1 and REMODEL-2 Phase 3 trials of remibrutinib (an oral, selective, high-efficacy Bruton's tyrosine kinase inhibitor) met both primary endpoints in relapsing multiple sclerosis, with remibrutinib demonstrating statistically significant superiority versus teriflunomide (Aubagio) in reducing annualized relapse rate (ARR) and inflammatory brain MRI lesions. Key secondary endpoints related to disability progression trended in favor of remibrutinib, with nominal significance in 6-month confirmed disability progression (6mCDP) in a preplanned pooled analysis. Safety was clean: no liver-safety signal and no cases meeting Hy's Law criteria across a broader remibrutinib development program that has now enrolled more than 4,500 participants across neurologic and immune-mediated indications. Full REMODEL-1/-2 data will be presented at MSToronto2026 (ECTRIMS-ACTRIMS joint meeting, October 21-23, Toronto). Regulatory submissions will follow. The readout positions remibrutinib as a potential oral option in a category currently anchored by injectable anti-CD20 therapies (Ocrevus, Kesimpta, Briumvi) plus Sanofi's Aubagio and the sphingosine-1-phosphate receptor modulators.

#novartis #nvs #remibrutinib #remodel-1 #remodel-2 #btk-inhibitor #relapsing-multiple-sclerosis #teriflunomide #aubagio #hy-s-law-clean #mstoronto2026 #ectrims-actrims #non-peptide

Industry

GSK Advances mRNA Seasonal Influenza Vaccine to Phase 3 Trial Targeting Both Hemagglutinin and Neuraminidase Antigens After Positive Phase 2 OPTIONS XIII Data

GSK (NYSE: GSK) announced Tuesday September 1, 2026 that its mRNA seasonal influenza vaccine candidate will advance to Phase 3 development in September 2026 following positive Phase 2 immunogenicity data presented at the OPTIONS XIII Conference for the Control of Influenza. The vaccine candidate demonstrated higher immune responses against all influenza strains tested compared to licensed standard-dose and high-dose inactivated flu vaccines in both younger and older adults, and was generally well tolerated. Differentiation: GSK's vaccine is the first mRNA flu candidate to advance to Phase 3 designed to target both hemagglutinin (HA) and neuraminidase (NA), the two primary influenza surface antigens; licensed flu vaccines primarily target HA. Growing evidence suggests dual HA-plus-NA targeting could improve protection, illness severity, and transmission reduction. The FDA granted Fast Track designation in July 2026. The advancement sets up direct Phase 3 competition with Moderna's mNEXSPIKE (approved May 2025) and Pfizer's mRNA flu program, extending the mRNA respiratory-vaccine class beyond COVID-19.

#gsk #mrna-flu-vaccine #hemagglutinin-neuraminidase #phase-3-advance #options-xiii #fda-fast-track #seasonal-influenza #mnexspike-competitor #moderna-comparator #mrna-respiratory-vaccine-class

Clinical Trials

Alumis Envudeucitinib Phase 2b LUMUS Trial Fails Primary and Secondary Endpoints in Systemic Lupus Erythematosus; Shares Fall Approximately 55%

Alumis (NASDAQ: ALMS) announced Tuesday September 1, 2026 that the Phase 2b LUMUS trial of envudeucitinib (an oral allosteric TYK2 inhibitor designed to correct immune dysregulation across IL-23, IL-17, and Type I interferon pathways) failed to meet the primary endpoint of British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at Week 48 in patients with systemic lupus erythematosus (n=408). All secondary objectives also missed. Strong responses were observed in the pre-specified high-interferon-gene-signature subgroup (which characterizes a majority of moderate-to-severe SLE patients), but IFNGS-high patients were under-represented in the overall trial population which reduced the treatment effect. Alumis (ALMS) shares fell approximately 55% and erased more than $1.6 billion of market capitalization. The company will meet with regulators to discuss a Phase 3 SLE path targeting the IFNGS-high subgroup and remains on track to submit the envudeucitinib NDA for moderate-to-severe plaque psoriasis in Q4 2026 following the Phase 3 ONWARD program win.

#alumis #alms #envudeucitinib #tyk2-inhibitor #lumus-trial #systemic-lupus-erythematosus #bicla-endpoint #ifngs-high-subgroup #shares-down-55-percent #1-6-billion-market-cap-loss #onward-psoriasis-nda #non-peptide

Industry

RedHill Biopharma Acquires Global and U.S. Commercialization Rights to Ferring's Rebyota (Fecal Microbiota) and Clenpiq for $12 Million Upfront Plus Royalties

RedHill Biopharma (NASDAQ: RDHL) announced Tuesday September 1, 2026 an exclusive global commercialization license for Rebyota (fecal microbiota, live-jslm) and an exclusive U.S. commercialization license for Clenpiq (sodium picosulfate, magnesium oxide, and citric acid oral solution for colonoscopy bowel preparation) from Ferring Pharmaceuticals, for an upfront payment of $12 million plus tiered royalties on net sales and potential milestones. Rebyota is the first-in-class FDA-approved microbiota-based therapy for the prevention of recurrent Clostridioides difficile infection in adults 18+ following antibiotic treatment (approved November 2022), generating approximately $16.9 million in 2025 U.S. net sales. The two products collectively generated approximately $37.5 million in 2025 U.S. net sales. Ferring retains Rebyota manufacturing and continues supply under the agreement. Not a peptide, but the transaction matters for the peptide-microbiome intersection: RedHill's expanded GI franchise now anchors the microbiome-therapy category alongside Vedanta's VE303, Seres Therapeutics' VOWST/SER-109, and the emerging peptide-antimicrobial and postbiotic categories.

#redhill-biopharma #rdhl #ferring-pharmaceuticals #rebyota #clenpiq #fecal-microbiota #c-difficile #12-million-upfront #microbiome-therapy #vowst-comparator #gi-franchise #non-peptide

Clinical Trials

Corbus CANYON-1 Phase 1b Topline for CRB-913 Peripherally Restricted CB1 Inverse Agonist for Obesity Remains On Track for September 2026

Corbus Pharmaceuticals (NASDAQ: CRBP) confirmed Tuesday September 1, 2026 that the CANYON-1 Phase 1b topline data readout for CRB-913 (a once-daily orally-administered highly peripherally-restricted CB1 inverse agonist for obesity) remains on track for September 2026, following completion of the last patient last visit announced August 4. The CANYON-1 study is a 16-week double-blind placebo-controlled dose-ranging trial in 240 obese non-diabetic U.S. adults testing once-daily oral doses of 20 mg, 40 mg, and 60 mg versus placebo with dose titration and 4-week safety follow-up. CRB-913 is engineered to remain peripheral (approximately 15-fold lower brain penetration than the CB1 inverse agonist monlunabant in preclinical models) to preserve efficacy while limiting the psychiatric side effects that led to the withdrawal of Sanofi's Acomplia (rimonabant) in 2008. The mechanism is designed to complement or serve as an alternative to GLP-1 receptor agonists, and the CANYON-1 tolerability profile will determine whether Corbus advances CRB-913 into Phase 2 later in 2026.

#corbus-pharmaceuticals #crbp #crb-913 #canyon-1 #peripherally-restricted-cb1-inverse-agonist #obesity #phase-1b #240-participants #monlunabant-comparator #rimonabant-history #topline-september-2026 #non-peptide

Industry

Samsung-PolyPeptide Cooling-Off Period Begins September 1, 2026; Formal Tender Offer Runs September 15 to October 12

The Samsung Biologics tender offer for PolyPeptide Group AG (announced July 20 at CHF 44.31 per share, CHF 1.46 billion / $1.8 billion) entered its 10 SIX Swiss Exchange trading-day cooling-off period Tuesday September 1, 2026 following the Monday August 31 publication of the formal tender offer prospectus by Samsung's Swiss subsidiary Samsung Peptide AG. The main offer period commences Tuesday September 15 and runs through October 12, 2026 at 4 p.m. Swiss time. Closing conditions include a 66⅔% minimum acceptance threshold plus customary regulatory approvals. Draupnir Holding B.V. (approximately 55.65% of PolyPeptide shares outstanding) has already committed to tender all of its shares. Transaction close is targeted for end of 2026, after which Samsung intends to squeeze out remaining minorities and delist PolyPeptide from SIX, integrating the Malmö, Limhamn, Strasbourg, Braine-l'Alleud, and Torrance sites into Samsung's Incheon multi-modality footprint alongside the existing monoclonal antibody and antibody-drug conjugate operations.

#samsung-biologics #samsung-peptide-ag #polypeptide-group #cooling-off-period #september-1-2026 #main-offer-september-15-october-12 #66-2-3-percent-threshold #draupnir-holding-55-65-percent #end-of-2026-close #peptide-cdmo-consolidation

Industry

Roche Pharma Day September 28 Preview: Top-Three Obesity Portfolio Update (Petrelintide, Enicepatide, HM17321) Ahead of EASD 2026 September 28-October 2 Rome

Roche (SIX: ROG) is scheduled to hold its investor Pharma Day Monday September 28, 2026, providing updates across the R&D portfolio including three obesity assets that collectively position the company as the credible third-place global obesity competitor behind Eli Lilly and Novo Nordisk. Petrelintide (amylin analog, partnered with Zealand Pharma under the March 2025 up-to-$5.3 billion collaboration, Phase 3 monotherapy initiation planned late 2026 following ZUPREME-1's 10.7% weight loss at 42 weeks). Enicepatide (CT-388, dual GLP-1/GIP receptor agonist acquired from Carmot Therapeutics in 2023, 54% obesity resolution at 24 mg in Phase 2). HM17321 (urocortin-2 / CRFR2 receptor agonist peptide licensed from Hanmi Pharm on August 24, 2026 with $190 million upfront plus up to $2.3 billion in milestones plus tiered royalties). The Roche Pharma Day coincides with the EASD 2026 Annual Meeting Rome September 28 through October 2, where AstraZeneca will present AZD6234 Phase 2 data, Zealand Pharma will present petrelintide data, and Novo Nordisk will present amycretin and CagriSema updates.

#roche #rog #pharma-day-september-28 #petrelintide #enicepatide #ct-388 #hm17321 #urocortin-2-crfr2 #zealand-pharma #hanmi-genentech #top-three-obesity-portfolio #easd-2026-rome #amylin-analog #amycretin #cagrisema

Industry

Amylyx Pre-Launch Update: Avexitide Commercial Buildout Continues With Q1 2027 NDA Submission Target and Priority Review Voucher Backing

Amylyx Pharmaceuticals (NASDAQ: AMLX) provided pre-launch commercial-readiness detail Tuesday September 1, 2026 as the company continues to advance toward NDA submission for avexitide (exendin-9-39, a GLP-1 receptor antagonist peptide) in post-bariatric hypoglycemia (PBH) following the August 18 Phase 3 LUCIDITY primary-endpoint hit (55% reduction in composite Level 2/3 hypoglycemic events, p=0.000003). Target NDA submission end of 2026; commercial launch preparation continues on schedule; and the company will use the upsized $500.2 million August 21 public offering to fund launch operations plus AMX0318 (long-acting follow-on peptide) IND-enabling studies. The Priority Review Voucher regime granted Arrowhead $215 million for plozasiran continues to shape the commercial economics of first-in-class peptide approvals in rare metabolic indications, and Amylyx is expected to be eligible if avexitide receives Breakthrough Therapy designation.

#amylyx #amlx #avexitide #exendin-9-39 #glp-1-receptor-antagonist #post-bariatric-hypoglycemia #lucidity-phase-3 #500-million-offering #amx0318 #nda-end-2026 #priority-review-voucher #peptide-therapeutic

Regulatory

TrumpRx GLP-1 Pricing Rollout: $245 Zepbound and Wegovy Medicare Coverage Plus TrumpRx Direct-to-Consumer Portal Launch on Schedule for January 2026

The Trump administration's landmark November 6, 2025 GLP-1 drug pricing agreement with Eli Lilly and Novo Nordisk continues implementation through September 2026 with the TrumpRx.gov direct-to-consumer platform on schedule for January 2026 launch. Terms confirmed as of September 1, 2026: starting doses of Wegovy and Zepbound available at $350/month on TrumpRx (trending down to $245/month over a two-year period); Medicare prices set at $245/month for Ozempic, Wegovy, Mounjaro, and Zepbound, with Medicare beneficiaries paying $50/month copays; upcoming oral obesity pills (Lilly Foundayo, Novo Wegovy pill) priced at $149/month for Medicare, Medicaid, and TrumpRx patients. The Most-Favored-Nation pricing framework requires both companies to guarantee MFN prices on all new medications and repatriate increased foreign revenue on existing products. The agreement extends Medicare coverage to Wegovy and Zepbound for obesity plus related comorbidities for the first time, ending the Medicare Part D exclusion that has constrained the class since launch.

#trumprx #mfn-pricing #eli-lilly #novo-nordisk #wegovy #zepbound #ozempic #mounjaro #245-per-month-medicare #149-per-month-oral-pills #50-copay #medicare-part-d-coverage #january-2026-launch

Industry

Chinese Biotech GLP-1 Ecnoglutide Post-Lancet Publication Follow-Through: Xianweida's cAMP-Biased Agonist Continues Global-Launch Positioning

Following the August 22 Lancet Diabetes & Endocrinology publication of the full EECOH-2 Phase 3 trial results for Xianweida's ecnoglutide (XW003, a first-in-class cAMP-biased GLP-1 receptor agonist that preferentially activates the cAMP signaling pathway over β-arrestin recruitment), Chinese biotech peptide activity continued through end of August into September. Ecnoglutide received its Chinese NMPA approval for type 2 diabetes January 30, 2026, followed by the March 6, 2026 approval for weight management in adults with overweight or obesity; the Lancet publication supplies the peer-reviewed data package supporting global regulatory submissions. Ecnoglutide is licensed to Pfizer under the up-to-$495 million partnership announced in 2024 for ex-China commercialization. The biased-agonism concept (selective signaling pathway activation to separate efficacy from tolerability) is now being pursued by CSPC (SYH2069 GLP-1/GIP dual-biased agonist) and other Chinese biotech peptide developers.

#xianweida #ecnoglutide #xw003 #camp-biased-glp-1 #lancet-diabetes-endocrinology #eecoh-2 #pfizer-495-million #china-nmpa #biased-agonism #cspc-syh2069 #ex-china-commercialization