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FDA raises questions about Lilly’s Alzheimer’s drug ahead of Monday adcomm
The FDA laid out its concerns around Eli Lilly’s experimental Alzheimer’s therapy donanemab ahead of an advisory committee meeting scheduled for Monday. While the outlook was generally positive, regulators said they disagree with Lilly’s decision to emphasize its own assessment of cognition and function over a standard measurement, raised questions about the proper time to stop treating patients, noted a lower efficacy in patients with more advanced disease, and probed an apparent higher rate of deaths in those who received the drug compared to a placebo infusion.
RayzeBio’s early warnings
Last year, RayzeBio advised investors that it could have trouble securing actinium isotope from a Russian supplier that it relies on for some of its clinical trials. The development, first reported by Endpoints News on Sunday, has thrown a potential wrench into Phase 3 development for its lead radiopharma drug, RYZ101. Bristol Myers acquired RayzeBio for $4.1 billion in December.
FDA adcomm votes against MDMA therapy
The agency’s Psychopharmacologic Drugs Advisory Committee voted 10-1 against approving Lykos’ MDMA-assisted therapy, citing concerns over study protocol, safety and potential abuse. Functionally, FDA reviewers said, the study was not blinded due to the “profound alterations in mood, sensation, suggestibility, and cognition” associated with MDMA.
Walmart’s healthcare clinics led to $230M in losses
Walmart’s push into primary care clinics led to $230 million in losses last year, Shelby Livingston reported. Current and former Walmart employees told Endpoints News that the business struggled to attract enough patients. While its goal was to open 1,000 clinics by this year, it had only opened 51.
Summit prepares to spar with Merck
News of Summit Therapeutics’ success over Keytruda in a China-only trial sent the company’s shares soaring last week. Our Kyle LaHucik spoke with Summit CEO Bob Duggan and the CMO for Merck Research Laboratories, Eliav Barr, on the sidelines of ASCO about the upcoming David and Goliath moment.
Structure elbows its way into oral GLP-1 space
The biotech’s oral GLP-1 drug, GSBR-1290, hit all endpoints in a pair of mid-stage studies evaluating weight loss and safety. Analysts said the data looked comparable to Eli Lilly’s orforglipron, which is in Phase 3 trials. Structure’s stock rose 55% on the news.
SPOTLIGHT/ASCO
- At ASCO: big readouts, revenue questions, and the ups and downs of ADCs
- Daiichi Sankyo, AstraZeneca say Enhertu works better than chemo in certain breast cancer patients
- AstraZeneca, J&J share new data in bids to expand reach of lung cancer drugs
- Sanofi touts Phase 3 Sarclisa data in multiple myeloma as it plays catch-up with J&J’s Darzalex
- Caribou says partial HLA matching will improve durability of response to cell therapy
CELL/GENE TX
- Intellia will shoot for a Phase 3 study and 2026 FDA submission for its CRISPR therapy called NTLA-2002 after a single infusion almost entirely eliminated swelling attacks in 10 people with hereditary angioedema.
DEALS
- Illumina will spin out Grail into its own company later this month, after announcing in December it would unwind its $8 billion buyout that saw a litany of antitrust challenges.
- J&J’s dealmaker: Plenty of ‘firepower,’ but mostly focused on tuck-in M&A
- Ipsen returns to Marengo Therapeutics for new trispecific deal
- Cytokinetics CEO addresses acquisition rumors, says buyer walked away, SEC filing shows
- Eli Lilly licenses preclinical antisense program designed to treat ALS, dementia
- Merck KGaA continues AI drug discovery deal spree with Biolojic Design
R&D
- Agios Pharmaceuticals announced its oral candidate for the blood disorder thalassemia reduced patients’ need for transfusions in a Phase 3 trial. The readout comes as Agios plans a marketing application that will include both patients who depend on transfusions and those who don’t.
- Biomea’s early-stage diabetes drug put on full clinical hold, stock crashes
- Aligos, Arbutus and others tout early hepatitis efficacy data at #EASL24
- Lilly details mid-stage win for tirzepatide in MASH with fibrosis data
- BridgeBio spotlights 12 and 18-month data for potential achondroplasia drug in children
- Amgen’s Uplizna succeeds in Phase 3 trial for rare autoimmune disease
- Annexon proclaims Phase 3 win for complement inhibitor in Guillain-Barré Syndrome
- Bristol Myers’ Opdivo-Yervoy beats Lenvima and Nexavar in Phase 3 early liver cancer trial
- After Phase 3 win, Arrowhead’s RNAi chases Ionis to market entry in rare genetic disorder
- Viking expands on Phase 2b data for NASH drug, touting histological endpoints
- Vir’s early Phase 2 hepatitis D data show reduction, removal of virus with combo and monotherapy
PEOPLE
- BioNTech co-founder Özlem Türeci discussed the company’s strategy after a “major pipeline reshaping” last year, and talked about the hype around “hip” ADCs.
- Former Sanofi R&D leader Frank Nestle to lead Deerfield’s growing drug discovery arm
- Google’s parent company Alphabet poaches Eli Lilly CFO; More changes at Exscientia
- Amarin names new CEO as Patrick Holt departs
PHARMA
- It’s been years since Martin Shkreli bought the rights to the HIV drug Daraprim and sharply increased the price. Despite generic competition, the price has still not fallen to pre-Shkreli figures.
- Lilly exec says developing new therapies for lupus is ‘in scope’
- Novo Holdings’ head of Asia on investing in ‘China for China,’ and staying out of biotech (for now)
- Senate Finance Chair presses HHS to crack down on cybersecurity in wake of UnitedHealth attack
FINANCING
- Envisagenics, a company based on the science of RNA splicing, secured a $25 million Series B this week. Its founders worked on the academic science that led to Spinraza.
- Rapport Therapeutics sets out for $122M Nasdaq debut as IPO backlog seeks fresh air
- Radiopharmaceutical company Telix aims for $202M IPO
- Australian life sciences VC Brandon Capital raises $180M for sixth fund
FDA+
- The “Operation Warp Speed” for rare diseases is up and running. Read about what the first five companies selected to receive funds are working on.
- Senate fails to pass bill codifying access to contraception
- FDA greenlights Geron’s imetelstat to treat anemia in certain cancer patients
- Fauci pushes back on pandemic criticisms before divided House panel
- House lawmakers float transparency reforms for 340B program at hearing
- FDA explains why it rejected Vanda’s insomnia application as company faces takeover bid
HEALTH TECH
- How FarmboxRx uses food deliveries to encourage patients to get preventive care
- Virtual physical therapy programs can be just as good as in-person care, report says
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