Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.
This short week has been an interesting one with the Independence Day in the US marked by the UK general election. Don’t overlook the big updates from the biopharma world, of which there were quite a few.
Eli Lilly’s Alzheimer’s OK
After decades of trying to develop a treatment for Alzheimer’s disease, Eli Lilly has finally won FDA approval for its drug donanemab. An approval was originally expected late last year, but it was delayed twice, including after regulators called for an 11th-hour meeting to discuss the drug’s safety and efficacy. An independent advisory committee ultimately voted unanimously that the drug’s benefits outweigh its risks. The drug will be marketed as Kisunla.
GSK picks its mRNA bets
GSK will take full control of the mRNA vaccines for flu and Covid-19 that it has been developing with CureVac as it restructures its three-year alliance. The biotech will receive $429 million upfront and regain rights to the other, preclinical programs under the deal. As CureVac moves away from late-stage development, it’s also taking steps to “rightsize” and correct a “pandemic infrastructure” — laying off 30% of its workforce.
Megaround tally
In biotech’s uneven recovery, 50 private startups have raised financing rounds of $100 million or more so far in 2024. If that pace continues, it could top the heydays of 2020 and 2021.
Biosecure’s shadow
Geopolitical tensions and threats of decoupling have led to a steep decline in American companies’ confidence in working with Chinese partners and caused some to take precautions, although few have taken steps to end relationships, according to a new survey from LEK Consulting.
DEALS
- Eisai is taking back an antibody-drug conjugate Bristol Myers Squibb originally paid $650 million to team up on in 2021. The candidate, a combination of a folate receptor (FRα) antibody and the chemotherapy Halaven, did not make the cut in Bristol Myers portfolio prioritization efforts.
- Lilly inks radiopharma deal with Radionetics, with rights to buy the biotech
- Seeking ‘financial flexibility,’ Esperion sells European royalty on cholesterol-lowering drugs
FINANCING
- Flagship Pioneering, the sprawling life sciences investor and startup incubator, appears to be seeking $500 million more than originally planned for its eighth fund, Kyle LaHucik reported.
- Artiva refiles for IPO three years after original plans in a vastly different environment
- Circle Pharma raises $54M as part of Series D while macrocycles heat up
PEOPLE
- Takeda plans to let go another 220 staffers in Massachusetts, where it was the largest biopharma in 2023 with 6,290 workers. The workforce reduction follows another layoff disclosure last month amid a broad restructuring initiative.
- Aerovate plans to lay off nearly all employees after trial failure
- Apollomics plans to lay off staff, narrow focus for lung cancer trial
R&D
- Boehringer Ingelheim is beginning an early-stage trial for a triple agonist candidate for obesity that it’s developing with Danish biotech Gubra. The drug, dubbed BI 3034701, will be tested in a 124-patient Phase 1 trial with two parts.
- Roche’s TIGIT drug tiragolumab flunks another Phase 3 lung cancer test
- Following a pivotal trial fail and layoffs, Ovid finds itself in a familiar spot
- Dianthus teases preclinical data for autoimmune drug as it starts clinical trials
- Four key weight loss readouts to watch at #EASD24
CELL/GENE TX
- Transatlantic biotech Beacon Therapeutics raised $170 million to potentially bring a rare ophthalmology gene therapy to market in a competition with Johnson & Johnson.
- Cartesian clears an autoimmune CAR-T trial, starts another Phase 2 and raises $130M
- J&J and Legend say Carvykti improved survival in earlier-line multiple myeloma
PHARMA
- Last week, experts on the CDC’s panel that sets vaccine recommendations created new guidance for who should get RSV shots. The goals of the Advisory Committee on Immunization Practices (ACIP) were to create clearer advice for older Americans and to make access easier. But in doing so, there are concerns that it may have, paradoxically, left fewer people eligible.
- Checkpoint Therapeutics refiles PD-L1 drug cosibelimab after FDA rejection
- Moderna wins $176M BARDA award to finance bird flu work
- Emergent, HHS disclose $250M updated contract that includes anthrax and smallpox vaccines
- UK trade group slams Novo, Novartis, Pfizer and Otsuka for code breaches
- Dupixent wins EU label expansion in COPD ahead of delayed FDA decision
- ‘Optimizing R&D structure is also on the horizon, without exception,’ new Sumitomo Pharma CEO says
LAW
- The Federal Trade Commission has turned up the pressure in its patent probe, officially launching a civil investigation into a group of Teva’s drug patents that the agency claims are improperly listed in an FDA database.
- London court upholds Moderna patent in vaccine dispute with Pfizer, but invalidates another
- Cassava says two senior employees included in federal probes
- Federal judge tosses Boehringer Ingelheim’s IRA lawsuit, deciding Medicare negotiations are voluntary
- Mississippi judge rejects efforts by Novartis, PhRMA to block 340B state law
MANUFACTURING
- Samsung Biologics signed a manufacturing contract worth 1.46 trillion won ($1.06 billion) with an unnamed “large” US pharmaceutical company, a notable win that marks at least the fourth major contract the manufacturer has signed this year.
- UniQure sells Massachusetts manufacturing site to Genezen as it continues to downsize
- FDA says cancer drug cisplatin is no longer in shortage