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FDA authorizes Novavax Covid booster
The FDA on Friday authorized the emergency use of Novavax’s updated Covid vaccine, just over a week after clearing mRNA boosters from Pfizer and Moderna. Unlike Moderna and Pfizer’s shots which target the variant KP.2, Novavax’s vaccine targets a “parent strain” known as JN.1.
Recursion nears key data readouts
Recursion’s AI platform will be put to the test as the company prepares to read out results from 10 trials in 18 months, Andrew Dunn and Max Gelman reported this week. The first Phase 2 readout, coming next month, is for a drug that predates Recursion — a decades-old compound called tempol that’s being tested in patients with a brain condition called cerebral cavernous malformation. “It feels like we’re at that moment, people launching things,” CEO Chris Gibson told Endpoints News.
What’s next for CD47?
The CD47 pathway, once one of immuno-oncology’s great hopes, has been plagued by safety risks and disappointing readouts. Some big pharma companies have terminated or narrowed their efforts, while other drugmakers still believe in harnessing the immune system’s “don’t eat me” signal — and some try to move CD47 beyond cancer. Endpoints’ Max Gelman dives into the challenges and what’s ahead.
Pfizer partners with Flagship startup
Pfizer is joining up with Flagship Pioneering startup Quotient Therapeutics to identify genetic mutations that appear throughout life and make individual cells more susceptible or resistant to disease. They’ll use the learnings as a starting point for new cardiovascular and renal disease treatments. The research is part of a broader collaboration between Flagship and Pfizer announced last year.
Alnylam presents Phase 3 ATTR data
Alnylam’s siRNA drug vutrisiran will face tough competition in transthyretin amyloid cardiomyopathy, with Pfizer’s Vindaquel currently dominating the market and BridgeBio’s acoramidis following close behind. Ayisha Sharma unpacks new data from the European Society of Cardiology annual meeting in London. Stay tuned for more of her conference coverage.
SPOTLIGHT
Once-promising cancer drugs appear to protect mice from Alzheimer’s
Neurocrine’s schizophrenia data are good enough for Phase 3 — but maybe not enough to beat Karuna
PHARMA
- Both BioMarin and Repare Therapeutics announced layoffs this week. BioMarin said its decision to scale back its gene therapy ambitions would result in 225 staff cuts by the end of 2024, while Repare said it’s reducing its headcount by 25%, with most layoffs concentrated in the company’s preclinical team.
- Eli Lilly announced it will sell single-dose vials of its popular weight loss drug Zepbound at a price 50% lower than the list price of all other incretin medicines for obesity. Lilly said the decision is intended to increase access to Zepbound and expand the supply for patients with obesity.
- Widening GLP-1 coverage could cost Medicare almost $150B annually, study finds
- Major Galapagos investor says it will push board on company’s ‘performance’ and ‘strategic opportunities’
- Regeneron wins EU approval for lymphoma bispecific following FDA rejection
R&D
- Novo Nordisk offered a detailed look on Friday at semaglutide’s effect on lowering the risk of heart failure and cardiovascular death in type 2 diabetes patients with chronic kidney disease. The company also read out post-hoc cardiovascular data from a handful of trials.
- Merck said it’s discontinuing two Phase 3 trials of Keytruda — KEYNOTE-867 and KEYNOTE-630 — after independent data monitoring committees determined they weren’t going to succeed.
- Swiss biotech’s inhibitor of cancer driver shows promise in rare bleeding disorder
- NuCana stops Phase 2 as chemotherapy derivative ‘unlikely’ to meet primary endpoint
- UK government partners with pharma on new £400M life science infusion
- Updated: Oculis closes Phase 3 eye drop trial due to ‘administrative error’ from third party
- Novartis seeks to expand Leqvio into heart disease prevention
- Invivyd says new Phase 3 data on Covid antibody support prophylactic use
- California Institute for Immunology and Immunotherapy gets $120M gift for vaccine, microbiome research
FDA+
- The House is planning to vote on the closely-watched Biosecure Act at the start of next month, the latest progression in efforts to rein in the influence of key China-based drug manufacturers.
- FDA approves Emergent vaccine for mpox as company plans to donate 50,000 doses
- FDA hints at what Chevron’s elimination means in new SCOTUS filing
- Ipsen sells priority review voucher for highest price since 2016
- Biopharma companies, BARDA call for more clarity on FDA’s new platform tech proposal
- FDA’s drug evaluation wing launches new AI oversight panel
- Federal agency opposes J&J’s new 340B discount model, promises to take ‘actions as warranted’
- Illumina wins FDA approval for test to identify treatable cancers
- House Oversight chair tells PBM CEOs to correct testimonies from July hearing
STARTUPS
- Novartis has agreed to pay $20 million upfront to collaborate with North Carolina’s Lindy Biosciences on technology that could be used to turn its infused drugs into injections that can be administered at home.
- RA Capital and Forbion set up new autoimmune biotech with bispecific from Korean startup
- Exclusive: Noetik raises $40M Series A to advance AI ambitions in cancer — with an unlikely lead investor
- Former Regenxbio leaders take rare disease gene therapies to startup with $15M
- Elektrofi, a startup that helps drugmakers formulate biologics for easier delivery, is raising a $112M Series C
- Peptide biotech MBX submits IPO plans, making a trio of post-Labor Day Nasdaq hopefuls
- Duality Biologics, an ADC partner of BeiGene and BioNTech, files for Hong Kong IPO
DEALS
- Bayer is partnering with NextRNA Therapeutics on two cancer programs in a deal that could give NextRNA up to $547 million plus an undisclosed upfront payment.
- Novartis to sell molecular imaging business to Siemens Healthineers
- Mubadala, CBC Group ink $680M deal for UCB’s neurology and allergy portfolio in China
MANUFACTURING
- Ahead of its anticipated acquisition by Novo Holdings, Catalent said its quarterly revenue grew to $1.3 billion, up 23% compared to the year prior. Catalent said little about Novo’s $16.5 billion acquisition deal, reaffirming that the deal should close by the end of the year despite additional inquiries from the FTC.
- Sanofi pauses supply of two flu vaccines in China over ‘unexpected circumstances’
- AstraZeneca pours $135M into boosting biologics capacity in Sweden
- FDA warns EyePoint over eye implant manufacturing woes
HEALTH TECH
- Pfizer launched a new website, called PfizerForAll, that connects patients to clinicians who can prescribe its migraine drugs, such as Nurtec, and respiratory and Covid-19 products, including its antiviral pill Paxlovid.
- Another major PBM will cut AbbVie’s Humira from its largest commercial formularies
- How an upstart pharmacy benefit manager has been winning over companies like TikTok and Zoom
LAW
- Delaware high court to review expert testimony in Zantac suits, in win for drugmakers
- Regeneron sues Sandoz to halt biosimilar to its blockbuster eye drug
- Pennsylvania judge sides with drugmakers on first steps for growing GLP-1 lawsuits
- Ipsen files another Onivyde lawsuit two weeks after receiving new patent