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.
As earnings pour in, analysts are pressing pharma companies for commentary on their plans in obesity drug development, IRA price negotiations and more. Be sure to check out our other coverage, too.
Mapping GLP-1 game plans
Several drugmakers developing the next wave of obesity treatments took to earnings calls to stir up excitement for their pipelines. Roche, on the back of recent readouts, suggested it will consider more M&A as it speeds up programs from Carmot Therapeutics; AstraZeneca detailed a “very ambitious” strategy for its early-stage programs; while Viking Therapeutics announced it will be forgoing a Phase 2b study and jumping right into Phase 3.
J&J vets regroup at biologics startup
After more than a decade steering Johnson & Johnson’s oncology drug R&D, Peter Lebowitz is ready for his next challenge: shepherding the “third arc” of biologics development. The startup, aptly named Third Arc Bio, raised a $165 million Series A that will be used to move three experimental multispecific antibodies into the clinic.
Adcomm weighs in on overtreatment
The FDA asked a panel of experts to weigh in after outlining concerns of overtreatment in AstraZeneca’s clinical trial of its immune checkpoint drug Imfinzi before and after lung cancer surgery. While the advisors unanimously agreed that pharma companies should design more nuanced trials in the future, they also gave AstraZeneca a pass.
The dual-track dynamic
In a tough market, many boards of private drug developers are electing to simultaneously seek an IPO and a buyout at a time when M&A is heating up and there’s been a slight uptick in public debuts. Kyle LaHucik takes a close look at the “dual-track” processes involved in some recent deals.
SPOTLIGHT
HI-Bio dishes on motivations for Biogen buyout, citing desire to move fast
WuXi AppTec more than tripled lobbying spend as Biosecure Act advanced in Congress
What’s changed about rare disease medicine
Q2 EARNINGS
- A year into Roche’s comprehensive portfolio review, the Swiss pharma said it has now taken out 25% of new drug candidates from its pipeline. Among the programs dropped in the second quarter are two trials involving its TIGIT drug tiragolumab, in light of a recent Phase 3 failure.
- Sanofi disclosed it is shelving a mid-stage treatment for a form of dwarfism and three other early-stage studies as part of its quarterly update. The French drugmaker also reiterated blockbuster ambitions for its RSV antibody — despite a rocky rollout — while Dupixent brought in record sales.
- Among pharma CEOs, the IRA now and the IRA later get very different reactions
- AbbVie beats expectations with smaller Humira slide — and big gains for next autoimmune blockbusters
- AbbVie expects $8.7B Cerevel buy to close ‘as early as next week,’ new CEO says
- Updated: With cost-cutting underway, Bristol Myers raises guidance, touts Phase 3 win and scraps another
- Updated: AstraZeneca says there’s ‘very limited’ impact on Farxiga after US drug pricing negotiations
- Argenx to retest Vyvgart in autoimmune platelet disease after failure last year
PEOPLE
- Mirati Therapeutics’ longtime leader Charles “Chuck” Baum has taken a new job as CEO of Terremoto Biosciences, a Bay Area biotech that’s developing drugs that can bind permanently to challenging targets for cancer and other diseases. “I’d like to do it again,” Baum told Endpoints’ Lei Lei Wu about leading another company looking to crack the “undruggable.”
- Layoffs at Rapt Therapeutics after winding down mid-stage trials of lead drug
- Bob Langer, Flagship’s Stephen Berenson to depart Moderna’s board as Carlyle co-founder joins
- Sino Biopharm’s invoX to restructure, likely cutting about 60 roles
- Cue Biopharma prioritizes autoimmune pipeline, axes a quarter of staff to save cash
R&D
- Ionis revealed new six-month data from its Angelman syndrome program, presenting Phase 1/2a results from a pooled group of patients taking three different doses of ION582 and saying it’s preparing for a Phase 3 study.
- Sage’s essential tremor drug fails in another blow to pipeline, Biogen partnership
- Bristol Myers restarts radiopharmaceutical Phase 3 trial, but delays readout by one year
- Chinese biotech boasts competitive Phase 2b weight loss data for GLP-1 drug
- Pfizer touts Phase 3 gene therapy data in hemophilia A, but now it needs to prove it can win the market
- Updated: Merck, without sharing details, says RSV antibody successfully protected infants
- Calliditas claims mid-stage win for rare liver disease drug
- GSK says Dovato was as effective as Biktarvy in head-to-head HIV trial — but patients gained less weight
- Cellectar to seek approval for radioactive iodine-based therapy in rare blood cancer
FINANCING
- Brenig Therapeutics closed a $65 million Series A, getting backing from big-name investors such as New Enterprise Associates and OrbiMed. The neurology startup spawned out of an incubation collaboration that uses AI and machine learning to identify new drug targets.
- Exclusive: RA Capital invests $35M in UK cancer biotech CellCentric
- Flagship launches AI-powered biologics biotech with $50M backing
- With new mission in psychiatry, Autobahn raises $100M to help back Phase 2 work
- Chinese biotech developing semaglutide biosimilar files for Hong Kong IPO
DEALS
- Novartis will pay Dren Bio $150 million upfront — including $25 million in equity — as part of a new research pact for select bispecific myeloid engagers to treat cancer. It marks Dren’s second pharma collaboration after teaming up with Pfizer.
- AstraZeneca signs preclinical EGFR drug deal with antibody biotech
- Ipsen pays Day One $111M upfront for ex-US rights to pediatric brain tumor drug
- BioNTech signs 3D printing deal to develop oral RNA drugs
LAW
- Andrew Left and his short-selling fund Citron Research have been accused of fraud by the SEC In biopharma, Left and Citron rose to fame because of their targeting of Valeant Pharmaceuticals.
- Pfizer and BioNTech say GSK’s Covid patent suit is ‘groundless’
- Republican-led states can’t intervene in case on abortion pill restrictions, appeals court says
- SEC staff recommends enforcement action against Allarity over potential federal securities laws violations
- AbbVie files lawsuit in Missouri federal court over 340B contract pharmacies
- Ipsen loses legal appeal over whether blockbuster cancer treatment is a drug or biologic
FDA+
- The European Medicines Agency on Friday held its ground against anti-amyloid treatments, saying it will not recommend Eisai and Biogen’s Alzheimer’s drug Leqembi for approval. The decision is due to only a slight advantage of Leqembi over placebo on a clinical dementia rating scale, and the potential for serious side effects.
- Compounded weight loss drugs have resulted in misdosing, hospitalizations, FDA warns
- EU panel follows FDA’s lead on Wegovy, recommending use to prevent cardiac events
- FDA finalizes guidance on using EHR data to support drug submissions
- Rare pediatric PRV reauthorization faces uncertain fate as summer recess approaches
- FDA approves Sun Pharma’s JAK inhibitor Leqselvi for hair loss in adults
- BioMarin snags expanded Brineura label, now approved for all kids regardless of symptoms
PHARMA
- North Carolina’s Medicaid program to cover weight loss drugs beginning in August
- Bluebird bio handed negative opinion from federal oversight agency for fertility support program
- PBM executives dodge grilling in House committee hearing
- Updated: Samsung wins FDA approval for second Soliris biosimilar
- Activist investor calls for board shakeup at Assertio, threatens proxy contest
- US bankrolls a third of global Pandemic Fund. Can it get congressional support?
MANUFACTURING
- Pfizer lifts curtain on $740M+ extension at API manufacturing site in Singapore
- Agilent Technologies to acquire CDMO Biovectra for $925M
- BeiGene plots to further build its manufacturing muscle outside of China
- Indian manufacturer Brassica hit with warning letter after employees faked data results
HEALTH TECH