ALETH / LIFESCI-BRIEF / 2026-03-13 / BIONTECH’S FOUNDERS LEAVE TO START AGAINThe Aleth Briefs link to the sources behind the stories and show how the week unfolded.
The week in five lines:
BioNTech’s founders Sahin and Türeci will leave to start a new mRNA company.
Vinay Prasad, the FDA’s biologics chief, will leave in April, his second exit in a year.
Hims & Hers will sell branded Wegovy after Novo Nordisk dropped its lawsuit.
Servier agreed to buy Day One for $2.5bn in cash, a 68% premium.
Stryker said a cyberattack disrupted its ordering, manufacturing and shipping.
Browse by day:
Weekend catch-up: Servier-Day One · Lonza · Incyte · AZ panel · Sotyktu · Prasad
Monday: Roche · BMS · Ipsen · GSK · Novo-Hims · Regeneron · Xenon · biosimilars
Tuesday: BioNTech · Evotec · leucovorin · CRC screening
Wednesday: UCB · Lilly China · Stryker
Thursday: Ultragenyx · Lilly vs compounders · Insulet
Weekend catch-up
Servier agreed to buy Day One Biopharmaceuticals for about $2.5bn in cash.
Servier will pay $21.50 a share through a tender offer, a 68% premium to Day One’s closing price on 5 March. The French group says the deal makes it a leader in paediatric low-grade glioma. It expects to close in Q2 2026.
Servier and Day One Biopharmaceuticals announce acquisition · Servier
Lonza agreed to sell its capsules and health ingredients business to Lone Star Funds for an enterprise value of CHF 2.3bn ($3bn).
Lonza takes CHF 1.7bn ($2.2bn) upfront, keeps a 40% stake and will return CHF 500m through a buyback. It calls the sale the last step in becoming a pure-play CDMO. Closing is expected in H2 2026.
Lonza to divest Capsules & Health Ingredients · Lonza
The FDA rejected Incyte’s Zynyz (retifanlimab) in metastatic non-small cell lung cancer over inspection findings at Novo Nordisk’s Catalent plant.
The complete response letter was issued on 27 February and disclosed in a filing dated 6 March. It named the fill-finish site’s compliance as the only approvability issue and raised no concerns about efficacy or safety.
Incyte Form 8-K on the Zynyz complete response letter · Incyte
The FDA’s Oncologic Drugs Advisory Committee will meet on 30 April to review AstraZeneca’s camizestrant and a new use for Truqap (capivasertib).
Camizestrant would join a CDK4/6 inhibitor when an ESR1 mutation emerges in first-line treatment of HR-positive, HER2-negative breast cancer. Truqap would be paired with abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer.
Oncologic Drugs Advisory Committee: notice of meeting · Federal Register
April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee · FDA
The FDA approved Bristol Myers Squibb’s Sotyktu (deucravacitinib) for adults with active psoriatic arthritis.
Sotyktu is the first TYK2 inhibitor approved in the disease, on the phase 3 POETYK PsA-1 and PsA-2 trials. It was first approved in plaque psoriasis in 2022.
FDA approves Sotyktu for active psoriatic arthritis · Bristol Myers Squibb
Vinay Prasad will leave the FDA at the end of April.
An agency spokesperson confirmed to Fierce Biotech that Prasad, director of the Center for Biologics Evaluation and Research, is departing. Commissioner Marty Makary wrote on X that Prasad will return to UCSF after a one-year sabbatical and that a successor will be named before he goes.
Prasad was briefly ousted last summer after a dispute over Sarepta’s Duchenne gene therapy Elevidys (delandistrogene moxeparvovec). He has since drawn criticism over the FDA’s handling of rare disease programmes, notably uniQure’s Huntington’s disease gene therapy.
CBER Director Vinay Prasad to depart FDA · Fierce Biotech
FDA vaccine chief Dr. Vinay Prasad to leave agency next month · ABC News
Monday 9 March
Roche’s giredestrant missed its primary endpoint in first-line breast cancer.
In the phase 3 persevERA study, adding giredestrant to Ibrance did not significantly improve progression-free survival against Femara plus Ibrance in ER-positive, HER2-negative advanced breast cancer. The study is the first of two in the first-line setting. The FDA has already accepted an application based on evERA in advanced disease, and Roche will submit lidERA data in early-stage disease in the coming weeks.
Roche provides update on phase III persevERA study in breast cancer · Roche
Bristol Myers Squibb’s mezigdomide improved progression-free survival in relapsed or refractory multiple myeloma in the phase 3 SUCCESSOR-2 trial.
At an interim analysis, the oral drug given with Kyprolis (carfilzomib) and dexamethasone beat the two drugs alone. It is the second positive phase 3 for BMS’s cereblon E3 ligase modulator (CELMoD) programme. The data will go to regulators and a future medical meeting.
Positive phase 3 SUCCESSOR-2 results for oral mezigdomide · Bristol Myers Squibb
Ipsen withdrew Tazverik (tazemetostat) from all its markets after secondary blood cancers emerged in a confirmatory trial.
The independent data monitoring committee of the phase 1b/3 SYMPHONY-1 study in follicular lymphoma said the risks may outweigh the benefits. The withdrawal also covers epithelioid sarcoma, where Tazverik held a US accelerated approval from 2020. Ipsen is ending all tazemetostat trials and expanded access programmes.
Ipsen withdraws Tazverik in follicular lymphoma and epithelioid sarcoma · Ipsen
GSK licensed worldwide rights to linerixibat, its experimental pill for itch in primary biliary cholangitis, to Alfasigma for $300m upfront.
GSK gets $100m more on US approval, expected before the deal closes against an FDA target date of 24 March. It also stands to receive $20m on EU and UK approval, up to $270m in sales milestones and tiered double-digit royalties.
GSK and Alfasigma announce agreement on worldwide rights for linerixibat · GSK
Hims will sell branded Ozempic and Wegovy after Novo Nordisk dropped its lawsuit.
Ozempic and Wegovy (both semaglutide) injections and Wegovy pills reach the Hims & Hers platform later this month. Hims will stop advertising compounded GLP-1 drugs and will offer them only where a provider judges one clinically necessary. Novo is dismissing its patent infringement lawsuit against Hims & Hers.
Hims & Hers announces strategic shift for US weight loss business · Hims & Hers
Novo Nordisk expands semaglutide access through Hims & Hers · Novo Nordisk
Regeneron’s Chinese partner Hansoh reported up to 19% mean weight loss at 48 weeks with olatorepatide in a phase 3 obesity trial.
The once-weekly dual GLP-1/GIP agonist met both co-primary endpoints in 604 adults, and up to 97% lost at least 5% of their weight. Regeneron holds rights outside mainland China, Hong Kong and Macau and plans to start a global registrational programme later this year.
Olatorepatide demonstrates positive phase 3 results in Chinese patients · Regeneron
Xenon’s azetukalner cut focal seizure frequency by 53.2% at its higher dose in the phase 3 X-Tole2 epilepsy trial.
The figure is for 25 mg daily at 12 weeks. The 15 mg dose gave a 34.5% reduction and placebo about 10%. Xenon plans to file with the FDA in Q3 2026. Discontinuations because of side effects were 14.5% at 25 mg, 4.8% at 15 mg and 3.2% on placebo.
Xenon release on the phase 3 X-Tole2 results · Xenon Pharmaceuticals
The FDA proposed cutting clinical pharmacokinetic testing for biosimilars where it is scientifically justified.
The agency says the draft guidance could save developers up to 50% of their pharmacokinetic study costs, about $20m. It follows an October draft proposing to reduce certain comparative efficacy studies.
FDA takes further steps to streamline biosimilar development · FDA
Tuesday 10 March
BioNTech’s co-founders will leave by the end of 2026 to run a new mRNA company.
Ugur Sahin and Özlem Türeci will set up an independent company for next-generation mRNA work. BioNTech plans to contribute related rights and mRNA technologies in exchange for a minority stake and other consideration such as milestones and royalties. It expects binding agreements by the end of H1 2026.
BioNTech’s supervisory board has started a search for successors. The company will concentrate on its late-stage immunomodulator, antibody-drug conjugate and mRNA candidates, and expects to run 15 phase 3 oncology trials by year-end.
BioNTech and co-founders plan a co-founder-led new mRNA company · BioNTech
Evotec will cut up to 800 positions and shrink to 10 sites over two years under a programme it calls Horizon.
The German drug discovery services company already went from 19 sites to 14 in 2024 and 2025. It expects about €75m of run-rate savings by the end of 2027.
Evotec announces ‘Horizon’, next inflection in its strategic transformation · Evotec
The FDA approved Wellcovorin (leucovorin) for cerebral folate deficiency in patients with a FOLR1 variant, on published literature alone.
Commissioner Makary said the approval may help some patients who have developmental delays with autistic features. GSK holds the drug’s application.
FDA approves first treatment for cerebral folate transport deficiency · FDA
The US Centers for Medicare & Medicaid Services proposed new coverage rules for non-invasive colorectal cancer screening tests, including blood tests.
Medicare would cover an FDA-authorised test indicated for colorectal cancer screening every three years for average-risk people aged 45 to 85 without symptoms. The test would need either ≥90% sensitivity and ≥87% specificity, or ≥79% sensitivity and ≥90% specificity, against colonoscopy.
Screening for colorectal cancer: biomarker tests, proposed decision memo · CMS
Wednesday 11 March
UCB’s Bimzelx (bimekizumab) was superior to AbbVie’s Skyrizi (risankizumab) on ACR50 at week 16 in the head-to-head BE BOLD trial in psoriatic arthritis.
It is the first licensed biologic to show superiority over an IL-23 inhibitor in the disease, and the fourth head-to-head win for Bimzelx across psoriatic disease.
Bimzelx superior to Skyrizi in head-to-head study in psoriatic arthritis · UCB
Eli Lilly pledged $3bn over 10 years for manufacturing in China, partly to build supply of its experimental GLP-1 pill orforglipron.
The plan includes $200m for Beijing contract manufacturer Pharmaron. Lilly has now put nearly $6bn into China.
Lilly commits $3B to China manufacturing expansions · Fierce Pharma
Stryker said a cyberattack caused a global disruption to its Microsoft environment.
It found no sign of ransomware or malware and believes the incident is contained. A day later it said order processing, manufacturing and shipping were still disrupted, but it did not believe patient-related services or connected products were affected. Check Point Research said Iran-linked group Handala claimed the attack.
Stryker Form 8-K on the cybersecurity incident · Stryker
Stryker Form 8-K update on the cybersecurity incident · Stryker
Stryker investigating cyberattack that caused widespread outage · MedTech Dive
Thursday 12 March
Ultragenyx’s gene therapy DTX301 cut ammonia levels by 18% against placebo at 36 weeks, meeting one of two co-primary endpoints in a phase 3 trial.
The 37-patient study is in ornithine transcarbamylase deficiency. The second endpoint, the share of patients able to cut back or stop standard disease management, is assessed at 64 weeks, with data due in H1 2027.
Ultragenyx release on the phase 3 DTX301 results · Ultragenyx
Eli Lilly warned that compounded tirzepatide made with vitamin B12 contains significant levels of an impurity, and asked the FDA for a recall.
Compounding pharmacies were allowed to make copies of tirzepatide while it was in short supply, from 2022 to 2024. Since the FDA declared the shortage over, they have kept selling copies by adding vitamins or other ingredients and calling them “personalised”. Lilly said nothing is known about the impurity’s effects in humans. Its recall request covers all compounded tirzepatide with personalised additives.
Eli Lilly open letter on compounded tirzepatide · Eli Lilly
Insulet began a voluntary correction of specific US lots of Omnipod 5 Pods that may leak insulin inside the Pod.
It has received 18 reports of serious adverse events linked to high blood glucose, including hospitalisation and diabetic ketoacidosis, and no deaths. The affected Pods make up about 1.5% of annual global Omnipod 5 Pod production.
Insulet initiates voluntary correction for certain Omnipod 5 Pods in the U.S. · Insulet
ALETH · OPEN ACCESS RESEARCH