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What an action-packed weekend! To stay on top of cancer research, be sure to check out our ASCO coverage and the wrap-up event on Tuesday. Meanwhile, another team will be in San Diego next week to cover the BIO conference. For those of you who will be at Endpoints’ parallel event, see you there!
Merck’s $3B return to eye disease
Merck is launching a return to the lucrative eye disease market in an acquisition for EyeBio that could be worth $3 billion, including $1.3 billion upfront. EyeBio, a Series A-stage biotech, is seeking to begin a pivotal study of its lead tri-specific antibody. The move comes a decade after Merck departed the ophthalmology drug market.
J&J’s $1.25B tuck-in
Johnson & Johnson is spending $1.25 billion in cash to buy Yellow Jersey Therapeutics, marking its second acquisition in the burgeoning inflammation & immunology field in as many weeks. Yellow Jersey, a wholly owned subsidiary of Swiss biotech Numab Therapeutics, has a bispecific antibody that is ready for Phase 2 testing in atopic dermatitis.
Keytruda challenger steals the show
Hours before America’s biggest cancer conference started in Chicago, a dataset that’s not being presented there made a splash. Summit Therapeutics touted a rare triumph over Keytruda in lung cancer from a Phase 3 study. The fact that the study was conducted only in China by Summit’s partner Akeso did not stop the news from adding over $5 billion to Summit’s market cap.
#ASCO24 first look
We’re heading into the thick of ASCO this weekend, but some researchers pulled back the curtain on clinical data earlier than that. Gilead presented more data from a failed Trodelvy study in lung cancer, Novartis demonstrated that its newer CML treatment is better than older therapies, Immunocore unveiled early-stage data of its skin cancer treatment that led it to start Phase 3 trial, and Merus is touting Phase 2 data as it plots a pivotal. Here’s what else our reporters on the ground — Lei Lei Wu and Kyle LaHucik — are paying attention to.
Moderna’s RSV vaccine approval
After a short delay, Moderna secured a long-awaited but expected approval for its RSV vaccine, giving the biotech its first FDA approval for a non-Covid-19 product and kickstarting what’s now a three-way race with GSK and Pfizer in the RSV market.
SPOTLIGHT
After 14 years calling partnering shots at Genentech/Roche, James Sabry is headed back into the biotech fray
James Sabry, the longtime doyen of biotech dealmakers from his global perch at Roche/Genentech, is making a return to the US.
Merck CEO says Keytruda is ‘not a repeatable model’
Can there be another Keytruda? Merck CEO Rob Davis, whose company makes the $25 billion-a-year cancer medicine, says it’s a “once-in-a-lifetime drug” that his team isn’t necessarily looking for.
‘Invisible hand’ of inherited genetics can drive cancer risk, new study suggests
A new study shows that for breast cancers, small and previously overlooked genetic variations present at birth shape the aggressiveness of a disease that often emerges decades later, with implications for diagnostics, treatment selection and cancer vaccine design.
CELL/GENE TX
- The FDA released a long-awaited draft guidance explaining how companies can win designations for platform technologies, a regulatory step that could speed up cell or gene therapy approvals based around common technologies.
- Flush with cash, Novo Nordisk Foundation now plans to reinvest some GLP-1 profits into regenerative medicines
- New York startup raises $33M for fertility treatment based on George Church’s stem cell research
- Second engineered B cell therapy enters the clinic, promising to do in hemophilia B what gene therapies can’t
- Ultragenyx touts Phase 3 win for gene therapy in rare glycogen storage disorder
- Adaptimmune taps Galapagos to decentralize manufacturing of solid tumor T cell therapy
- Bristol Myers’ CAR-T therapy Breyanzi adds new approval in mantle cell lymphoma
- Ori Biotech, Cytiva separately unveil tech to accelerate cell therapy production
DEALS
- Japan’s Asahi Kasei is offering to buy Calliditas Therapeutics for more than $1 billion in a bid to enter a burgeoning autoimmune disease space.
- BioNTech doubles down on ADC partner MediLink in new $1.8B biobucks pact
- Gilead forms pact with Cartography to map new targets for cancer drugs
- Bristol Myers pays $80M to license another Prothena neuroscience candidate
- Company developing video games for ADHD announces sale
R&D
- AstraZeneca unveiled the early efficacy profile of its oral PCSK9 inhibitor in patients with high levels of “bad” cholesterol. While Merck is ahead in the race, AstraZeneca touted its pharmacokinetic edge.
- Biohaven’s autoimmune drug disappoints investors in study of healthy volunteers
- Insmed stock skyrockets on Phase 3 lung disease data
- Immunovant postpones trial readouts for its late-stage FcRn drug as it prioritizes another
- Gilead’s blockbuster ADC Trodelvy fails bladder cancer confirmatory study
- Novartis ends development of KRAS drug, citing ‘increasing options available’
- Duchenne muscular dystrophy drug flunks Phase 3 confirmatory trial
- J&J’s major depressive disorder drug hits endpoints in Phase 3 trial
- Ionis outlines Phase 3 data for rare disease drug, preps for another potential launch
- Arcturus teases data from small trial of inhalable cystic fibrosis mRNA therapy, stock rockets
- Novartis to seek approvals in two rare kidney diseases after positive Phase 3 trials
- NewAmsterdam says former Amgen cardio drug reduces heart disease risk factor
- Arrowhead plots next steps for RNAi therapies after mid-stage win in mixed hyperlipidemia
- BridgeBio touts additional ATTR-CM drug data in new analyses of Phase 3 trial
PEOPLE
- Takeda to lay off 640 workers in Massachusetts as part of multiyear overhaul
- Joe Panetta to step down as Biocom California CEO
- Ikena Oncology weighs ‘strategic options’ as it drops cancer asset, trims headcount to save cash
- Neurocrine CEO Kevin Gorman to retire after 32-year run; Bluebird picks up fifth CFO in three years
PHARMA
- As GLP-1 prescriptions reach an all-time high, Novo Nordisk ramped up its legal campaign against medical spas, pharmacies and clinics marketing compounded versions of its popular weight loss and diabetes drugs.
- Drugmakers to Maryland affordability board: Capping list prices may not help patients
- Novartis sues Maryland over state law banning limits on discounts to 340B contract pharmacies
- BioNTech to increase mRNA vaccine footprint in Africa with $145M investment
- Doctors who endorse drugs on social media are often compensated, JAMA study finds
FINANCING
- Former Novartis CEO Joe Jimenez and research leader Mark Fishman are fundraising again for their life sciences firm Aditum Bio, which in-licenses translational-stage drugs and sets up individual companies around them, Kyle LaHucik reports.
- Canadian biotech VC Amplitude raises $192M second fund
- CinRx raises $73M to create more biotechs, further support obesity drug development
FDA+
- NIH officials used personal emails, tweaked words to skirt FOIA searches during pandemic, lawmakers find
- NIH-funded trials often miss diversity targets, small study shows
- FDA to begin restructuring its inspection office in October
- FDA delays Dupixent in COPD decision by three months while EMA gives thumbs-up
- FDA questions data on MDMA-based therapy in PTSD ahead of advisory committee
- Amgen nabs FDA approval for first Soliris interchangeable biosimilar
- Lilly’s Retevmo lands new accelerated approval for pediatric cancers
- FDA approves Tris Pharma’s non-stimulant pediatric ADHD liquid medication
- Lab group sues FDA over final rule regulating laboratory-developed tests
- CHMP recommends 14 new approvals, seven label expansions
HEALTH TECH
- Dollar General has shut down its mobile healthcare clinic partnership, the latest in a string of retail health exits, Ngai Yeung reports.
- Insurance upstart Clover Health launches new business selling its tech, borrowing from Oscar playbook
- Exclusive: Plenful nabs $17M to automate pharmacy operations
DONT MISS