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It’s been quite a week with some big scoops from the Endpoints team, on top of what is shaping up to be an interesting earnings season. See you next week as we track the biggest themes emerging from media and investor calls.
Bristol Myers eyes major cuts
About five months into his tenure as Bristol Myers Squibb CEO, Chris Boerner unveiled plans for $1.5 billion in cost-cutting measures, including changes to the pipeline and a workforce reduction of 2,200 by the end of the year. “About 12” programs are getting swept out of the pipeline, and the company is also closing a cell therapy manufacturing site in California, Max Gelman reports.
That $1B AI startup
A star-studded mix of venture capitalists and scientists, backed by more than a billion dollars, launched an ambitious biotech that aims to reinvent drug R&D using artificial intelligence, Andrew Dunn and Ryan Cross report. They chatted with ARCH Venture Partners’ Bob Nelsen about his bet on the startup, Xaira Therapeutics, and interviewed its CEO, former Stanford president Marc Tessier-Lavigne.
Pharma reacts to China bill
Multiple pharma companies addressed questions about the potential impact of US targeting Chinese companies during their quarterly updates. Novartis said it will change its contract research relationships “over time” to align with new rules, Sanofi is counting on a grandfather clause, while Roche remained unruffled by the bill as it looks to grow roots in the region. On the service provider side, Thermo Fisher said it will be a “long-term beneficiary” as biopharma customers localize their supply chains.
AstraZeneca CEO’s pay isn’t just about him
Pascal Soriot has been pushing for US-sized CEO pay for more than a decade. The AstraZeneca CEO’s grinding campaign for the big money — set against the backdrop of a massive and durable turnaround — has paid off handsomely. And in winning bigger pay, he is helping to reset the financial scales by which board members use peers’ pay to establish compensation for all the pharma chiefs, John Carroll writes. For his part, Soriot says the pay rise is “really about” his future successor.
SPOTLIGHT
The next generation of AI biotechs is here. Can they deliver on the hype?
Xaira Therapeutics became an instant new leader in the AI biotech field. And this group is hoping they can do what an earlier crop of equally-hyped companies that launched a decade ago couldn’t.
Drug and biotech companies on China bill as scrutiny of WuXi continues
Almost 20 biopharma and life sciences companies have registered to lobby on a bill that could ban US companies from working with Chinese life sciences contractors, according to federal records.
Regeneron’s $500M fund spotlights corporate venture’s influential role in biotech
Few new corporate venture capital have launched in recent years. Regeneron’s move into the space last week emphasizes how integral these funds are to nascent science and startups and insiders say they are more willing to take on risky science than traditional VC firms. Kyle LaHucik takes a look at their longstanding role.
WHAT WE’RE WATCHING NEXT WEEK
More earnings are on the way, and the FDA is set to make approval decisions on a cancer drug from Amgen and a rare disease drug from X4 Pharmaceuticals.
Q1 EARNINGS
- Despite recently executed cuts in oncology, Sanofi is keeping an early pipeline of projects in the area, highlighted in its quarterly update. CEO Paul Hudson underscored that the company is “doing the right thing” with its shift to immunology, with a Phase 3 win for its BTK inhibitor to show for it.
- Biogen recorded higher-than-expected revenue for the lead rare disease drug from its $7 billion acquisition of Reata Pharmaceuticals, but the rollout of its second-generation Alzheimer’s drug Leqembi is still a work in progress. In an earnings call, execs offered updates on resetting Biogen’s business, including a $103 million priority review voucher and a focus on new licensing deals.
- Novartis’ simplified strategy takes shape as the company seeks former Bristol Myers CEO as chair
- AstraZeneca on emerging markets, GLP-1 plans and why it’s selective about vaccines
- Roche doubles down on high-impact projects after slashing 20% of its pipeline
- Another quarter, another Keytruda win for Merck
- AbbVie beats first-quarter expectations, but Humira guidance leaves analysts confused
- BioMarin’s Roctavian struggles continue. Is a divestment in the future?
- Gilead leans on CymaBay liver drug, Trodelvy readouts and long-active PrEP yet to come this year
- Sage focuses on successful launch of postpartum depression drug
- Astellas cuts a bispecific in cancer and a mitochondria-focused asset from Mitobridge deal
PEOPLE
- Pfizer is letting go of an undisclosed number of employees and ending research operations at its site in Boulder, CO. The site came to Pfizer through its $11.4 billion acquisition of Array BioPharma in 2019.
- Flagship’s gene editing startup Tessera cuts jobs as it shifts resources to clinic
- Weeks after closing Bristol Myers deal, Karuna’s ex-CEO heads to Blackstone-backed Anthos
- Exclusive: Gene editing startup Seamless hires ex-Homology leader, doubles seed round
- AI drug discovery startup BenevolentAI cuts 30% of staff, closes US office
- Cancer testing company Freenome to lay off 100 employees
- Following lower-than-expected profits, Evotec plans to cut costs, completes CEO search
- UCB makes major management changes; Bristol Myers’ ADC partner tops list of new CEOs
DEALS
- Incyte hopped on the tuck-in M&A train, shelling out $750 million to buy San Diego biotech Escient Pharmaceuticals and its pipeline of early-stage oral small molecules.
- Regeneron is expanding its genetic medicine efforts and will work with California startup Mammoth Biosciences in a $100 million deal to pair Mammoth’s tiny CRISPR editors with Regeneron’s delivery approach.
- One bidder and a $5 hike: How Vertex inked $4.9B Alpine deal
- Eisai, BioArctic to develop new drug for Alzheimer’s that can cross blood-brain barrier
- Boehringer Ingelheim inks chronic liver disease research pact with Ochre Bio
- To bring bold promises to fruition, Moderna collaborates with OpenAI on ChatGPT tech
- Cidara buys back flu rights, sells antifungal and inks $240M PIPE
CELL/GENE TX
- Pfizer won FDA approval for its gene therapy for the rare genetic bleeding disorder hemophilia B. The one-time treatment, which will be marketed as Beqvez, is the second gene therapy approved for the disease after CSL’s Hemgenix. It will have the same list price of $3.5 million.
- Bristol Myers, Cellares sign global CAR-T deal as biopharma companies look to diversify manufacturing partners
- Astellas’ Friedreich’s ataxia gene therapy cleared for clinical study after earlier version stumbled
R&D
- Biosplice searches for a path forward after osteoarthritis drug fails late-stage study
- CureVac to cut costs, starts GSK-partnered bird flu vaccine trial
- Neurocrine’s depression drug passes Phase 2 trial
FDA+
- The FDA granted accelerated approval to Day One Biopharmaceuticals’ pediatric brain tumor treatment, more than five years after the biotech was founded with a goal to bring targeted therapies to children, a population that the drug industry has largely treated as an afterthought.
- FDA’s biologics chief Peter Marks previews accelerated approval guidance
- Novartis brings Lutathera to adolescents with rare cancer in first for radioligand class
- FDA approves ImmunityBio’s bladder cancer therapy combo
- FDA hands CRL to Abeona’s rare skin disease cell therapy
- FDA greenlights label update to Gilead’s Biktarvy to include more data in pregnant people
- CHMP recommends eight new drug approvals, six label expansions
- Researchers seek FDA transparency on use of surrogate endpoints outside of oncology
- FDA revises guidance on biosimilar promotional labels and advertising
- In rare move, Colombia issues compulsory license for HIV medicine in effort to expand access
FINANCING
- John Hood has secured a $132.5 million Series C for Endeavor BioMedicines after hiring four C-suite leaders, licensing an antibody-drug conjugate and revealing Phase 2a data for its investigational idiopathic pulmonary fibrosis medicine in recent months.
- Irish biotech collects $75M in Series B to start Phase 3 rare joint tumor trial
- Rubedo pulls in $40M Series A to advance atopic dermatitis candidate targeting aging cells
- Dutch biotech attracts J&J support for cancer pipeline in $21M Series A
PHARMA
- Sen. Bernie Sanders (I-VT) is once again putting pressure on drugmakers. In addition to launching a probe into what he says are “outrageously high” list prices for Novo Nordisk’s weight loss and diabetes blockbusters Wegovy and Ozempic, he also called on global pharmaceutical leaders to get behind proposals laid out in a World Health Organization-led global pandemic preparedness agreement that’s nearing completion.
- GSK accuses Pfizer and BioNTech of mRNA patent infringement
- Esteve to acquire Perrigo’s rare disease pharma business for up to $295M
HEALTH TECH
- UnitedHealth Group’s Optum is shutting down its virtual care business. Endpoints was the first to report the closing of the unit, known as Optum Virtual Care, which was a major part of Optum’s push into telehealth services in 2021.
- Walgreens will build out specialty pharmacy business, leaning into drug and therapy services
- Cigna’s Evernorth just made a move to boost Humira biosimilar use
- Headspace will add more mental-health services to its consumer business, going against trend
MARKETING
- Pharma companies are scaling back the use of terms like “ESG” and “diversity, equity and inclusion,” much like companies in other industries. Experts say the change is more of a shift in language than a change in strategy as companies pay close attention to the politicized backlash.
- Marketing payments to cancer doctors lead to more prescriptions but not better outcomes, NBER paper finds
- Neurocrine launches CAH rare disease education campaign ahead of FDA submission
- Ipsen matches rare disease and TikTok influencers to create connections
- Inizio Evoke Comms taps Stephanie DeViteri in return to agency as president
MANUFACTURING
- Vertex licenses TreeFrog’s tech to upscale cell therapy manufacturing for diabetes candidates
- Merck KGaA to expand German headquarters with €300M+ research center
- Lilly nabs injectable medicines facility from Nexus Pharma
- Samsung Bio’s bet on Plant 4 continues to pay off with first-quarter earnings growth
DON’T MISS