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We’re back with our take on this year’s up-and-coming biotechs. Our reporters spent months reviewing hundreds of nominations and talking to investors and biotech veterans about what makes a great biotech startup.
Meet the 2024 Endpoints 11
This year’s Endpoints 11 class is making big bets and pursuing interesting new science. Want to learn more about three young AI companies flush with cash, a big neuroscience bet, or an intriguing approach to in vivo CAR-T? Check out our full list here.
BMS wins approval for schizophrenia drug
Some of our Endpoints 11 winners celebrated as their old company, Karuna Therapeutics, scored a win on Thursday for its schizophrenia drug. The FDA approved the first new schizophrenia drug in decades, Bristol Myers Squibb and Karuna’s Cobenfy. The pharma giant acquired the drug in its $14 billion takeover of Karuna last year. Cobenfy works differently than other schizophrenia drugs on the market and has a price tag of $1,850 for a 30-day supply, or $22,500 annually. BMS is projecting “multibillion-dollar” peak sales.
J&J winds down cardiovascular and metabolic unit
Johnson & Johnson is shutting down its pharma division’s cardiovascular and metabolic unit, marking at least the second large restructuring for the pharma group following the closure of its infectious disease and vaccine unit last year. The change primarily impacts the sales, marketing and medical affairs teams, who have been notified, a person familiar with the matter told Endpoints News’ Max Bayer.
Pfizer pulls sickle cell treatment from the market
Pfizer decided on Wednesday to pull its sickle cell drug Oxbryta from all markets worldwide, after data showed an “imbalance” of fatalities and complications common to the disease. The decision is likely to diminish the value of Pfizer’s $5.4 billion purchase of Global Blood Therapeutics in 2022. Regulators followed up with their own alerts, including the FDA which advised health care professionals to stop prescribing the treatment.
Bluebird bio cuts costs again
Amid a broader downturn in cell and gene therapy companies, bluebird bio once again cut costs and laid off staff. The company said 25% of its workforce will not return and expenses — including R&D costs — will be trimmed by 20%. Once a $10 billion company, bluebird’s market cap fell below $100 million this week.
SPOTLIGHT
- Q&A: Bristol Myers’ tech chief on the promises and perils of AI bio
- You bet your life: After I was diagnosed with a rare cancer, I discovered how a small band of physician-scientists triggered a revolution
R&D
- Datopotamab deruxtecan, AstraZeneca and Daiichi Sankyo’s much-hyped successor to the blockbuster Enhertu, failed a Phase 3 breast cancer study this week. The treatment, a TROP2-directed antibody-drug conjugate, did not improve overall survival figures compared to standard of care.
- Biogen and UCB said a lupus program succeeded in a Phase 3 study and are planning a second to confirm the benefit. But details about the data were scant.
- Wave rides new Phase 2 DMD data as it sets sights on accelerated approval
- Biogen walks away from Sage’s essential tremor drug after mid-stage flop, pill’s future in question
- Amgen reports dual Phase 3 wins in atopic dermatitis and myasthenia gravis
- Clive Meanwell’s new obesity biotech, Metsera, unveils early GLP-1 data with an eye on Phase 3 next year
PHARMA
- Sen. Bernie Sanders announced during a Senate hearing on Tuesday that three major pharmacy benefit managers have promised not to punish Novo Nordisk if the company lowers the list prices of its popular weight loss and diabetes medications. But Novo CEO Lars Fruergaard Jørgensen appeared skeptical.
- Sanofi hires Mike Quigley as next chief scientist, internal memo says
- US government renews threats over J&J’s proposed 340B rebate model
- 2seventy bio, Bristol Myers stop late-stage Abecma study in multiple myeloma due to recruitment challenges
- Cassava and its former execs settle SEC charges for ‘misleading’ Alzheimer’s drug data
MANUFACTURING
- Novo Nordisk has told government and global nonprofits that it plans to significantly downsize its manufacturing of some of its insulin pens, according to one of the groups, and will transition a portion of its global supply to insulin vials and syringes that are easier to make but less convenient for patients.
- Emergent says it has $400M in orders related to mpox outbreak
- Travere halts Phase 3 inherited disease trial due to manufacturing scale-up issue
- Telix buys radiopharmacy network for $230M up front to expand US capacity
- CSL Seqirus inks fifth contract with BARDA, making the partnership now worth $1.14B
FINANCING
- Flagship Pioneering is committing $50 million to its new startup, Mirai Bio. The company is working to create nanoparticles that deliver genetic medicines “to any tissue and cell type.”
- ARCH, biotech’s star slugger, snags another $3B for 13th fund
- UK vaccine startup Vicebio snags $100M to take on GSK, Pfizer and Moderna
FDA+
- The US House of Representatives unanimously passed a bill on Monday to extend the rare pediatric voucher program into 2029. Without an extension, the program will lapse at the end of September.
- Updated: FDA adcomm votes to limit Opdivo, Keytruda use in stomach, esophageal cancers based on key biomarker
- FDA approves Dupixent in COPD, opening ‘next chapter’ for Sanofi and Regeneron’s bestseller
- FDA OKs IntraBio’s drug less than a week after rare disease’s first-ever approval
- AstraZeneca’s lung cancer blockbuster Tagrisso wins label expansion in early-stage EGFR patients
DEALS
- Is Sanofi making a move into obesity? French pharma invests $27M into Ventyx
- Flagship’s AI biotech Generate lands $65M upfront in Novartis deal, as first clinical readouts near
HEALTH TECH