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.
Whether you will be in San Diego for BIO, we hope you will join us for our panels on some of the most important topics facing the industry right now, from China tensions to fixing gene therapy’s business model to the stop-start market recovery.
Pfizer’s $1.5B cuts
Months after beginning a $4 billion savings strategy, Pfizer is planning on a new $1.5 billion round of cost cuts, as well as what are likely to be more reductions in the future. The cuts include shrinking the company’s manufacturing base.
Biogen’s $1.15B buyout
Biogen struck a $1.15 billion upfront acquisition of Human Immunology Biosciences, or HI-Bio, further expanding beyond its neuroscience roots and dipping more into immunology. Days later, HI-Bio revealed Phase 2 data that helped seal the deal.
AstraZeneca’s $80B ambition
Pascal Soriot has unveiled the “new era of growth” he’s envisioning for AstraZeneca, featuring an ambitious $80 billion revenue target by 2030 — which would make it one of the fastest-growing pharma companies by the end of the decade. Central to the long-term growth plan will be drugs made on new technologies that will be “very difficult to copy,” and AstraZeneca is also doubling down on its China stronghold. Ayisha Sharma reports from the company’s investor day in Cambridge, UK.
RNA startups unite
Orna Therapeutics will acquire ReNAgade Therapeutics in an all-equity transaction, combining two buzzy, well-funded biotech startups in a bid to create a powerhouse at the bleeding edge of genetic medicines. The combined company will focus on RNA therapies that can reprogram blood and immune cells directly inside the body, Ryan Cross reports.
SPOTLIGHT
Exclusive: Members of Congress buy and sell stocks that would gain from bill banning China biotech companies
At least seven members of Congress since 2023 have bought and sold stocks of life science companies that would gain from legislation to ban several key Chinese biotech suppliers and contractors, Zach Brennan reports.
FINANCING
- AstraZeneca is stepping further into the obesity field with an option for a fledgling Versant startup that seeks to preserve muscle mass, a common concern for the GLP-1 medicines currently on the market. The startup, SixPeaks Bio, came out of stealth with $30 million in Series A funding.
- Exclusive: SR One raises $200M+ for third fund, still with GSK support
- Startup launches with ‘RNA sensor’ technology from Stanford and MIT to better control mRNA therapies
- AltruBio secures $225M for an updated version of its ulcerative colitis drug
- ADC biotech Pheon raises $120M to test three assets in the clinic
- With a fresh $100M, Monte Rosa CEO details plans to move several molecular glues into the clinic
- Progentos emerges with $65M for multiple sclerosis trials with IP from Frequency
- Grey Wolf reels in $50M to expand into autoimmune diseases
- UK biotech raises £35M to develop solid tumor drugs based on machine learning
DEALS
- After announcing an up to $575 million deal with Royalty Pharma and a $500 million public offering, Cytokinetics CEO Robert Blum blamed investor frustration over the deal on a “hijacked” narrative that the company would be better off selling itself than continuing on its own. Max Gelman reports.
- Eli Lilly is again dipping into the buzzy area of radiopharmaceuticals, this time by way of private biotech Aktis Oncology. The pharma giant will dish out $60 million upfront and make an undisclosed equity investment in the Boston biotech.
- AstraZeneca taps more China-derived tech with $19M cancer deal for Nona antibodies
- Sanofi, OpenAI, Formation Bio announce AI drug development partnership
- Boehringer Ingelheim, OSE Immunotherapeutics expand partnership beyond cancer
#ASCO24
- Abstracts for the American Society of Clinical Oncology are out. Among the most closely-watched news, Johnson & Johnson presented the first results on an experimental prostate cancer drug that uses a rare radioactive particle called actinium-225. It led to three patients seeing their tumors shrink substantially, but four patient deaths, spurring plans for capped dosing.
- Pfizer shares the ADC data that convinced it to start a Phase 3 lung cancer trial
- After $4B Takeda deal, Nimbus lays out ‘grand’ hopes for its next-gen immunotherapy drug
- Merck, Kelun trumpet Phase 3 breast cancer data for anti-TROP2 ADC
- #ASCO24: A roundup of the latest data from Merus, MorphoSys and others
- Nuvation Bio shares pivotal China data for cancer drug from AnHeart buyout
STARTUPS
- Takeda enters hot molecular glue space in up to $1.2B pact with Degron
- UK biotech revives former Kyowa Kirin cancer drug for Epstein-Barr-driven diseases
PEOPLE
- Updated: Lobbying group BIO restructures staff in shakeup under new CEO
- AI biotech Exscientia to trim nearly a quarter of workforce, following pipeline cut and CEO firing
- Idorsia’s Jean-Paul Clozel retires as CEO, plots next steps; CRISPR Therapeutics nabs CMO from Sanofi
R&D
- Novo Nordisk’s semaglutide cut the risk of major cardiovascular events and death from multiple causes in a Phase 3 study involving patients with type 2 diabetes and chronic kidney disease, building the company’s case for expanding the drug in a broad range of indications.
- Dyne Therapeutics sharpens case for two muscle disease therapies with updated data
- GSK says long-acting asthma treatment clears two Phase 3 studies
- AstraZeneca, Amgen tout Phase 2a Tezspire data in COPD ahead of Dupixent decision
- Verastem’s stock takes a hit after sharing updated filing plans in ovarian cancer
- Otsuka terminates Alzheimer’s agitation drug after failed Phase 3
- Gilead’s rare liver disease drug improves symptoms in another Phase 3 study ahead of FDA decision
- Zealand touts safety of new ‘double-G’ drug despite modest weight loss in small trial
- Daiichi Sankyo to open two new research sites in Cambridge and Munich this year
- Crinetics’ stock jumps following promising Ph2 data in four patients with rare genetic disorder
- Oral drug shows promise in diabetic macular edema as biotech touts anti-VEGF injection alternative
LAW
- Merck KGaA’s subsidiary MilliporeSigma evaded charges from the US Department of Justice after exposing an alleged eight-year scheme by a former employee and his accomplice to illegally ship biochemicals, such as cocaine and methamphetamine, to China.
- Talc claimants file class action suit accusing J&J of fraud over bankruptcy moves
- Jury says AstraZeneca should pay Pfizer $107M+ over Tagrisso infringement
- Federal appeals court sides with drugmakers on 340B limitations
- European Commission finalizes joint clinical assessment rules for member countries
MANUFACTURING
- Merck KGaA announced it is acquiring Mirus Bio, a startup that develops transfection reagents for viral cell and gene therapies, for $600 million. With the new acquisition, Merck KGaA said it will be able to provide solutions “for almost every step of viral vector development and manufacturing.”
- Lilly budgets additional $5.3B for tirzepatide API factory in Indiana
- AstraZeneca earmarks $1.5B for end-to-end ADC factory in Singapore
- AGC Biologics, BioConnection forge partnership to be an alternative to WuXi
- Evotec ends gene therapy business, shuts down facility in Austria
PHARMA
- As Novo Nordisk hauls in huge sales from its popular GLP-1 products, the company is thinking about a future beyond obesity and diabetes. During a press call, Novo executives laid out ambitions in a handful of conditions — and made clear they have the resources to grow.
- Sen. Wyden questions Pfizer over tax rate as part of ongoing investigation
- Senators strike bipartisan tone on more pharma patent reforms
FDA+
- After the FDA raised concerns about increased rates of hypoglycemia following treatment with Novo Nordisk’s experimental once-weekly basal insulin, an advisory committee voted not to recommend the injection in type 1 diabetes patients, saying the risks outweigh the benefits.
- Peter Marks, the FDA’s biologics center director, and Janet Woodcock, former FDA deputy commissioner who retired earlier this year, discussed the need for regulatory flexibility for rare disease therapies and underscored the need to bolster gene therapy manufacturing.
- FDA withdraws Helsinn’s accelerated approval for cancer drug after company’s request
- FDA approves first two interchangeable biosimilars to Regeneron’s blockbuster Eylea
- NIH drafts policy on ensuring access to new drugs funded by taxpayers
- House committee presses FDA center directors on domestic manufacturing, LDTs
- FDA denies Ipsen’s citizen petition for blockbuster drug Somatuline
- Public Citizen sues FDA over citizen petition on SSRI sexual side effects labeling
- FDA lifts partial clinical hold on Larimar’s Friedreich’s ataxia treatment
- Bristol Myers’ subcutaneous version of Opdivo gets earlier PDUFA date
- PTC’s muscular dystrophy drug Translarna to get another review in the EU
HEALTH TECH
- Digital health company Hims & Hers has started prescribing a cheaper, compounded version of semaglutide, the active ingredient in Novo Nordisk’s popular GLP-1 weight loss drug, a move that experts say could land the company in pharma companies’ crosshairs. As Shelby Livingston reports, the company has long-term plans for those custom weight loss shots even after supply shortages resolve.
- Exclusive: Senior primary care startup Gather Health has raised $16M in a new round
- Atropos Health raises $33M to arm doctors and pharma companies with evidence
- Health plan startup Centivo acquires primary care operator Eden Health
- Twin Health expands into treating obesity with digital twins
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