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.
In a few weeks, I’ll be flying out to San Diego for the annual BIO conference, where Endpoints News will host a parallel event to explore some of the most important issues driving the biopharma industry. Check out the full agenda here.
Mega startup watch
A pair of hefty startups have entered the room to tackle some of the hottest areas in biotech. Blackstone unveiled its $300 million bet on Uniquity Bio, which will test a former Merck monoclonal antibody for atopic dermatitis in asthma and COPD. Meanwhile, Bain, Atlas and RTW are forming a company dubbed Hercules around obesity drugs licensed from China’s Hengrui with $400 million in capital.
Tracking Wegovy’s long-term effects
A new analysis of Novo Nordisk’s vast SELECT study showed Wegovy helped people with obesity keep their weight off over four years. It also suggested that the heart protection offered by Wegovy goes beyond the cardiovascular improvements that come from weight loss — also researchers said that they can’t yet pinpoint what is driving the heart benefits. Katherine Lewin and Lei Lei Wu look at some of the hypotheses.
Biogen’s ALS flop
Facing a challenging launch for the Alzheimer’s drug Leqembi, Biogen CEO Chris Viehbacher said he would welcome competition from other companies, including Eli Lilly, which is aiming for an approval of its therapy later this year. Speaking at Thursday’s Financial Times–Endpoints News US Pharma and Biotech Summit, he also commented on Biogen and Ionis’ move to drop an experimental treatment for amyotrophic lateral sclerosis after a disappointing early trial and risk-taking.
AI-made antibodies draw pharma interest
Nabla Bio, a small startup founded by scientists from geneticist George Church’s lab at Harvard Medical School, has formed drug discovery collaborations with AstraZeneca, Bristol Myers Squibb and Takeda. It also raised $26 million in Series A financing, Ryan Cross reports.
SPOTLIGHT
The Endpoints Slack interview: Siddhartha Mukherjee on the doctor-writer worldview, AI, and the future of cancer
Andrew Dunn sat down virtually with Siddhartha Mukherjee, biotech’s Renaissance man, to talk about AI, his slew of ambitious biotech startups, and how he got into writing epic, Pulitzer-winning tomes on medicine and science.
Q&A: FTC’s top healthcare enforcer on pharma M&A, company growth and PBMs
The Federal Trade Commission has loomed large over M&A in the biopharma industry in the last two years. At the FT-Endpoints summit, Drew Armstrong spoke with FTC Deputy Director of the Bureau of Competition Rahul Rao about the regulator’s antitrust approach in biopharma, how it views the PBM industry, and more.
BeiGene looks at new partnerships, with a full cancer pipeline and growing footprint
Less than a year after the end of a PD-1 deal with Novartis, BeiGene is looking at new partnerships that could bring in new assets it could develop or commercialize, or out-license some of its substantial cancer pipeline, CEO John Oyler said in an interview with Drew Armstrong.
DEALS
- Takeda is snagging the exclusive option to license AC Immune’s anti-amyloid Alzheimer’s vaccine for $100 million upfront. The vaccine is in Phase 1b/2 testing; if Takeda decides to pick it up, the Japanese pharma dish out up to another $2.1 billion in option fees and milestones.
- Sanofi buys ex-US rights to Fulcrum’s Phase 3 rare neuromuscular drug
- J&J makes small I&I acquisition to enter competitive IL-13, TSLP arena
- AbbVie goes deeper into neuroscience with collaboration worth as much as $2B
- Roche was in ‘advanced’ talks to out-license its Angelman syndrome drug, but potential partner withdrew
PHARMA
- More details have started to emerge on how exactly Bayer is executing its broader company restructuring. The German conglomerate disclosed that 1,500 full-time employees had been laid off across pharmaceuticals, crop science and consumer health at the end of the first quarter.
- As Eisai and Biogen head to the FDA with the subcutaneous version of their Alzheimer’s treatment Leqembi, the Japanese drugmaker is projecting Leqembi sales to grow 13-fold to around $360 million in fiscal year 2024, with an “aggressive investment” planned.
- House committee advances bipartisan bill targeting Chinese biotech suppliers
- Eli Lilly settles with medical spa over its marketing of compounded tirzepatide
- Moderna scores European victory over Pfizer and BioNTech in mRNA patent battle
- GSK plans to sell off remaining stake in consumer spinout Haleon
- As adcomm looms, ICER raises questions over Lykos’ MDMA studies
- Size of 340B market triples since 2018 and may double again, report says
R&D
- Roche offered a glimpse at promising early efficacy data from Phase 1 study of the GLP-1/GIP agonist it obtained through the $2.7 billion acquisition of Carmot Therapeutics. Given the highly competitive market, analysts were careful to note that questions remain even if the weight loss numbers appear encouraging.
- Novo Nordisk’s investigational hemophilia A treatment met both primary endpoints in an open-label Phase 3a study, meaning patients had fewer bleeding episodes. The topline announcement spurred hopes that Novo could have a therapy to compete with Roche’s blockbuster Hemlibra.
- Cytokinetics lifts curtain on Phase 3 aficamten data, commercial launch prep underway
- Merck winds down Phase 3 TIGIT/PD-1 combo study due to safety-related dropouts
- Lilly touts topline late-phase data for once-weekly insulin in race to enter US market
- AstraZeneca’s successor to Covid blockbuster Evusheld succeeds in Phase 3 trial
- Pfizer, Arvinas’ breast cancer drug combo keeps momentum after Phase 1b update
- Cardurion touts Phase 2 data for PDE9 inhibitor in heart failure, plans for two more trials
- Pliant touts additional Phase 2a data for oral IPF drug that’s already in a pivotal study
- Bayer details data from two Phase 3 trial wins for menopause symptom drug
- Shionogi misses primary endpoint in Phase 3 for Covid-19 antiviral
FINANCING
- Rapport Therapeutics, which emerged out of Johnson & Johnson’s neuroscience unit last year, submitted its pitch for a Nasdaq listing on Friday. It would be the third neuroscience drug developer to go public this year.
- Sanofi, Pfizer and AstraZeneca separately pledged to increase their footprint in France, with investments adding up to almost €2 billion. GSK, AbbVie and Novartis are also allocating money to expand their respective manufacturing and R&D capabilities in the country.
- Carolyn Bertozzi-founded Lycia Therapeutics raises $106M to enter the clinic
- ‘Attack JAK’: Ajax secures $95M to test new JAK2 inhibitor after industry’s string of myelofibrosis deals
- Australian radiopharma Telix launches bid for Nasdaq listing
- Updated: Sands Capital raises $555M for third life sciences fund
- NewVale unveils $167M fund to back pharma service providers and ‘old ideas that are working’
- Exclusive: Gastroparesis biotech CinDome secures $40M for path to pivotal trial
PEOPLE
- Significant pipeline overhauls prompted personnel changes at two separate cancer-focused biotechs in California. Erasca is laying off 18% of its staff as it drops several early-stage cancer assets, picks up new ones from China and raises $160 million to help push its lead candidate to the finish line. At Bolt Biotherapeutics, the CEO will step down while the company slashes its headcount in half and cuts its lead program.
- BioMarin to lay off 170 staffers after pipeline reorg
- WuXi AppTec trims ‘small percentage’ of workers at US site as market shifts
- Jim Burns reunites with Genzyme colleague at Ensoma; Lilly exec to retire after 27 years
HEALTH TECH
- More pharma companies are considering taking a tip from Eli Lilly and offering their drugs directly to patients. After Pfizer submitted a trademark application that suggests it could be launching a direct-to-patient program, a Novartis executive shared some thoughts with the FT-Endpoints summit audience (while Novo Nordisk played coy).
- LG spins off a new business that bets big on health software
- Amazon veteran Missy Krasner shares why now is the time for young health startups to go shopping
- GoodRx gets back in Kroger’s good graces, will work directly with grocer
FDA+
- Korean biotech HLB and its China-based partner Jiangsu Hengrui Pharmaceuticals said that the FDA rejected their drug combination for the most common form of liver cancer, pairing the small molecule tyrosine kinase inhibitor rivoceranib and the anti-PD-1 camrelizumab.
- The FDA granted accelerated approval to Amgen’s bispecific T cell engager tarlatamab in small cell lung cancer, an aggressive disease that makes up roughly 10% to 15% of lung cancer cases. It’s the first bispecific T cell engager to be approved for a major solid tumor, according to Amgen.
- Study identifies groups of people who mistrust the FDA
- FDA offers more clarity on safety testing for cell therapies
- Bristol Myers’ CAR-T therapy Breyanzi adds follicular lymphoma to list of approvals
- Destruction of documents, insufficient data lead FDA to reject hep B vaccine update
- WHO greenlights Takeda’s dengue vaccine as company plans to ‘re-engage’ with FDA
- EMA’s safety committee recommends suspending preterm birth drugs
- Ascendis’ hypoparathyroidism drug saddled with three-month delay at FDA
- House panel advances bills targeting rare disease, priority review vouchers
MANUFACTURING
- Galapagos is teaming up with the US’s largest blood supply group to try to establish a nationwide network of decentralized CAR-T manufacturing. By doing so, it could potentially shave several days or weeks from current methods, the company said.
- Merck KGaA stays positive on CDMO arm’s future despite first-quarter slump
- WuXi Biologics pauses Massachusetts build; Novo Holdings nabs majority stake in pharma tools firm
DON’T MISS