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.
The common wisdom that August tends to be a quiet month did not apply this past week. The Endpoints team found nuggets in biopharma earnings, chased down company layoffs and closures, had conversations with power players — all while covering the steady stream of financing, deal, data readout, drug approval and other news in detail. Grab a coffee and dig in.
Latest on MDMA rejection
The FDA rejected Lykos’ MDMA-assisted treatment for patients with post-traumatic stress disorder, a major setback for the company that had hoped to translate more than two decades of research into the first approved psychedelic medicine. The FDA requested that Lykos run an additional Phase 3 study, the company announced late Friday.
Takeaways from market meltdown
Biotech and pharma weren’t spared on the global market crash at the beginning of the week. Why did indices fall so much, and what were industry insiders saying? We had six questions (and some answers) about what happened and what it means for the industry once the dust settles.
Big drugmakers pull back
Charles River, one of the drug industry’s biggest service providers, shared a chilling message in its quarterly earnings report: Expect early pipelines to shrink and research work to decrease as big pharma companies cut costs. “This is an unusual activity for our pharma clients,” its CEO said.
Genentech CEO on AI, IRA and more
Six months into her tenure as Genentech’s new CEO, Ashley Magargee sat down for a Q&A with Max Bayer. They talked about how AI will affect the company’s workforce, what it’s like interacting with US lawmakers as a former Capitol Hill staffer, leading Genentech’s business, and what areas the company is — or isn’t — currently focusing on.
Recursion’s merger with Exscientia
Recursion and Exscientia, two longtime bellwethers of AI bio, agreed to merge in an all-stock deal valued at an estimated $688 million. The merger is one of the biggest M&A deals for the nascent but fast-evolving AI biotech space. The companies’ leaders said they will benefit from combining their pipelines and platforms while also producing savings of about $100 million per year.
Novo vs. Lilly
Back-to-back earnings reports from the two leaders in the weight loss treatment space turned out to offer stark contrasts as shortages are starting to ease. Novo Nordisk’s quarterly revenue missed analysts’ estimates, despite scaling supply and ramping up prescriptions, while Eli Lilly resoundingly beat expectations and raised its revenue forecast for the full year. As for future competitors, Lilly execs said to “take some caution” on other companies’ early-stage obesity data.
SPOTLIGHT
TPG reveals $580M life sciences fund, which has already backed multiple biotechs
Q2 EARNINGS
- On top of the earnings miss, Novo Nordisk revealed it is running into a speed bump with Wegovy’s label expansion efforts in heart disease. It has pulled its FDA submission in heart failure with obesity and will refile at the start of 2025. Due to portfolio prioritizations, it also chopped two Phase 1 programs.
- Lilly’s anti-tau pill for Alzheimer’s fails in Phase 2 study
- Bayer details 3,200 job cuts so far, spotlights ‘momentum’ in pharma pipeline
- Updated: Madrigal finally reveals first wave of sales for MASH drug Rezdiffra
- Updated: Amgen’s Horizon buyout powers growth, with MariTide plans intact
- BioMarin scales back launch for hemophilia gene therapy, pitches path to profitability
- Bicycle Therapeutics focuses pipeline and streamlines leadership team
- Sarepta faces lower revenue for Duchenne gene therapy ahead of expected sales jump with expanded treatment label
- Gilead shells out $320M to J&J to buy out rare liver disease drug royalties
- Inspection delays hold back BeiGene’s Tevimbra progress once again
- Weak China demand weighs on Illumina’s sales
STARTUPS
- Two biotechs have shuttered amid shifting financial and R&D landscapes, Kyle LaHucik reported this week. Florida-based gene therapy startup Lacerta Therapeutics sold its assets to an undisclosed buyer, while Aerium Therapeutics ceased operations and ended its mission of developing antibodies against Covid and epidemic threats after the emergence of variants.
- Exclusive: TCG, DCVC and Lux back new autoimmune biotech from Kallyope co-founder
- Exclusive: MIT spinout launches with focus on improving DNA payloads for gene insertion
- A new Apple Tree Partners biotech launches with $55M to make ‘pan-variant’ antivirals
DEALS
- Merck inked a pair of sizable deals in opposite directions this week. In the first, it is teaming up with Daiichi Sankyo to jointly develop a T cell engager from its Harpoon acquisition, grabbing $170 million in the process. With the other, it’s paying $700 million upfront for a clinical-stage CD3xCD19 bispecific antibody from Shanghai-based Curon.
- A decades-old, relatively unknown private biotech focused on iron deficiency is buying G1 Therapeutics, a commercial-stage oncology company nestled in North Carolina, in cash at a total equity value of about $405 million.
- Bristol Myers returns TIGIT bispecific to Agenus, frees itself from $1B+ milestones
- Genentech partners with cash-strapped Sangamo on epigenetic Alzheimer’s therapy
- BioNTech says no to Phase 3 with Genmab’s bispecific antibody
- Third Rock and Arie Belldegrun’s firm come together for CD20/CD3 bispecific out of China
- Pfizer got a $1.2B payout for its stake in Cerevel
- Eisai picks SEED Therapeutics for molecular glue deal worth as much as $1.5B
- Mallinckrodt sells photopheresis platform Therakos for $925M
PEOPLE
- Roughly two months after Bristol Myers Squibb disclosed hundreds of job cuts at its New Jersey corporate headquarters, it’s further shrinking the headcount there as part of a previously announced restructuring.
- Exclusive: Biotech investor Sofinnova hires former Biogen medical chief
- Precigen lays off staff, pauses multiple CAR-T programs and all preclinical work and aims for $30M offering
- Infectious disease biotech undergoes makeover after lung disease trial underwhelms
- Entero Therapeutics turns the lights off as creditors come calling
- Bill Haney’s Dragonfly nabs former Cerevel CFO; Cellectis’ new CMO
FINANCING
- Arie Belldegrun and team unveil $600M life sciences credit firm amid struggling biotech market
- IDRx raises $120M for targeted GIST drug following leadership change
- MBX Biosciences rakes in $63.5M for peptide therapies
- Japanese government grants Shinobi $59M for cell therapy development
FDA+
- As drug companies embrace artificial intelligence as a part of their R&D operations, regulators at the FDA are working to decide how and when they will play a role in overseeing the technology. Andrew Dunn reports from a gathering of industry executives, regulatory experts and academics where they shared viewpoints on using AI in drug development.
- FDA reprimands Bristol Myers over misleading efficacy claims on Krazati website
- Genentech, Gilead push FDA to modernize research inspections
- Updated: FDA approves Servier’s brain cancer drug, setting up $1B payout for Agios
- FDA approves Novartis’ complement inhibitor Fabhalta for rare kidney disease
- FDA lifts hold on 4DMT’s Fabry gene therapy
- FDA approves Citius Pharma’s non-Hodgkin lymphoma drug Lymphir
- Amneal Pharma’s extended-release Parkison’s treatment clinches FDA approval
- Purdue’s emergency opioid overdose treatment is approved by the FDA
- Hello, neffy: FDA approves first nasal spray for severe allergic reactions
- Alfasigma’s PBC treatment Ocaliva to face an FDA adcomm in September
LAW
- Novo Nordisk is turning up the heat on compounding pharmacies making versions of its GLP-1 blockbuster. Late last week, it filed 11 new lawsuits against med spas, weight loss clinics and telehealth companies advertising compounded versions of its semaglutide products for diabetes and weight loss.
- UPenn sues BioNTech, says it owes ‘significant’ Covid-related royalties
- Ohio federal judge dismisses IRA suit brought by US Chamber of Commerce
- GSK wins second Zantac cancer case to go to trial
HEALTH TECH
- Hims takes steps to lock up drug supply for its booming weight loss business
- 23andMe trades drug discovery for GLP-1 weight loss prescriptions
- CVS ousts Aetna president as it tries to fix its health insurance business
- Oscar Health’s guidance gets a boost from ex-Medicaid members
- Health insurers are covering fewer telehealth companies, Talkspace says
R&D
- CAR-T therapy clinical trials in autoimmune diseases are under the microscope after Cabaletta Bio’s candidate was linked with a high-grade neurotoxicity event in one lupus patient.
- TIGIT drugs take another hit as Merck stops Phase 3 lung cancer trial for futility
- FDA wants new trial of Actinium’s radioactive iodine drug, company to seek partner
- Exelixis’ Cabometyx misses survival endpoint, but will still file in prostate cancer
- Nuvation pauses BET inhibitor plans after checking out interim Phase 1 data
- Ultimovacs’ cancer vaccine flunks again — this time in head and neck cancer
- Avidity CEO says it’s ‘full steam ahead’ in DMD as stock rallies on Phase 1/2 win
- Aldeyra to resubmit dry eye disease drug this year following positive Phase 3 data
- Intellia’s gene editing therapy succeeds in Phase 2 genetic swelling condition study
- Apellis and Sobi land another late-stage win for rare kidney disease drug
- Sanofi’s Sarclisa scores in Phase 3 transplant-eligible multiple myeloma test
- Eliot Forster’s pain biotech unveils Phase 2 data in degenerative joint disease
MANUFACTURING
- WuXi Biologics appears to be making some progress in Europe in recent days, after securing a new biotech partner and EMA certifications for its manufacturing sites in China.
- Pfizer invests $98M in Australian manufacturing to help develop new antimicrobial treatments
- Novavax plots to reduce European footprint to become a ‘leaner’ company
PHARMA
- Amgen announces plans for new site in India to strengthen AI, data and life sciences
- UK’s NHS, Vertex strike pact, accelerating Casgevy rollout in beta thalassemia
- Bayer plans label expansion for Kerendia after Phase 3 win in heart failure
- CDC chief says new RSV guidance was meant to be ‘clear’ and ‘actionable’