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This week brought some high-profile shakeups, including the resignation of Lykos CEO Amy Emerson following an FDA rejection last month, Laurie Glimcher’s announced departure from the Dana-Farber Cancer Institute, and more details on BioMarin’s reorganization and business strategy after recruiting prominent dealmaker James Sabry. We’ve got more information in today’s report.
Lykos CEO steps down…
Amy Emerson resigned as CEO of Lykos Therapeutics, following the FDA’s rejection last month of its MDMA-assisted therapy for PTSD. Emerson sat down with Endpoints News’ Max Bayer last month to discuss the rejection and “changes at all levels of the organization,” though she and the company did not disclose any C-suite changes.
…and so does Laurie Glimcher
Glimcher will relinquish her duties as head of the Dana-Farber Cancer Institute at the end of the month and will be replaced by Benjamin Ebert, chair of the institute’s Department of Medical Oncology. Glimcher has for years been rumored as a potential pick to lead the NIH, and she even emerged as a wild-card pick for President Joe Biden’s FDA commissioner. But her future, as of now, remains unclear.
BioMarin restructures
BioMarin detailed its progress this week on a “cost transformation program” that’s expected to continue into next year and save $500 million in operating expenses. Executives also laid out a new corporate strategy that relies on three key business units: skeletal conditions, enzyme therapies and the hemophilia A gene therapy Roctavian. After recruiting well-known dealmaker dealmaker James Sabry, the company said it’s on the hunt for new opportunities.
Recursion’s mixed data
In its first of many expected clinical trial readouts over the next 18 months, Recursion reported data for a rare neurological disorder that can cause strokes, seizures and partial paralysis. But the results were decidedly mixed, particularly as investors and analysts had viewed the data as a potential “moment of truth.”
Eli Lilly’s $1 billion bet
Lilly is teaming up with the “dark genome” biotech called HAYA Therapeutics, putting down a 10-figure wager on a company that’s only raised a seed round. The upfront and equity investments remained undisclosed. Lilly’s deal follows a tie-up between Bayer and NextRNA last week on the “dark genome” focused on treating cancer.
SPOTLIGHT
Duke spinout launches in hopes of prevailing with brain cancer bispecific where Amgen, Roche did not
Three Dyne executives leave as company reports new Duchenne drug data
Astellas CEO talks future beyond Xtandi as Japanese drugmaker puts roots in Boston
R&D
- On Thursday, Eli Lilly dropped more data for its once-weekly insulin candidate in adults with type 2 diabetes. Lilly and Novo Nordisk are racing to get a once-weekly insulin to many markets, but Novo hit a roadblock last month when the FDA turned down its weekly insulin candidate.
- IN8bio pauses glioblastoma program, halves workforce as it prioritizes leukemia asset
- Arrowhead spotlights key pancreatitis figures from Phase 3 lipid disease study to differentiate itself from Ionis
- Vaxcyte surges on Phase 1/2 data for 31-valent pneumococcal vaccine
- GSK’s Nucala cuts exacerbations in Phase 3 COPD trial, but numbers remain under wraps
- Athira’s small molecule drug for Alzheimer’s fails in mid-stage study
- Moderna’s mpox vaccine outperforms approved version in preclinical study
- ProKidney axes one Phase 3 study, aims for ‘expedited approval pathway’ using another
- Praxis’ epilepsy drug reduces seizures by 46% in pediatric patients in Phase 2 study
- Researchers seek answers as they spell out Phase 3 failure of Bayer’s next-gen anticoagulant
PHARMA
- Amid the brouhaha over Alnylam’s disappointing and perhaps confusing HELIOS-B data presentation last week, competitor BridgeBio is — at least publicly — attempting to stay above the fray and stick to its commercialization plans.
- Federal judge rejects pharma industry’s request to halt Maryland’s 340B law
- J&J increases talc settlement by $1.1B after negotiating with plaintiffs, lawyers say
- Court orders J&J to pay $1B following buyout of surgical robotics company
- Court’s ruling on Illumina-Grail deal could signal a limit to European antitrust powers
- Higher dose of Spinraza helped spinal muscular atrophy patients, Biogen says
- Sanofi’s BTK inhibitor goes 1-for-3 in key MS trials, slows disability progression
- Roche unveils more mid-stage data for BTK inhibitor in relapsing multiple sclerosis
- Pfizer and Valneva say second Lyme booster led to ‘strong’ responses, target 2026 FDA submission
- Bayer’s Kerendia cuts heart death, failure and hospitalization by 16% in Phase 3 trial
STARTUPS
- ZipBio has raised $4 million in seed funding to explore a new use for existing AI systems, it told Endpoints exclusively. The idea involves compressing large proteins to better package them in gene therapies or deliver them to hard-to-reach places like the back of the eye.
- Non-viral delivery startup Vesigen Therapeutics trims staff as it evaluates ‘strategic options’
- Exclusive: Lilly-backed OrsoBio raises $67M for slate of obesity drugs as combinations take root
- Bicara, Zenas outline plans for $180M IPOs amid restored optimism for biotech debuts
- Little-known startup, backed by Foresite and Samsara, swings $60M China I&I deal
FDA+
- The FDA has raised concerns about potential “inappropriate use” of Iterum’s oral candidate for uncomplicated urinary tract infections ahead of a Monday advisory committee meeting. The agency is asking the committee to discuss the benefits and risks of sulopenem and considerations to ensure appropriate use. Stay tuned.
- The General Court of the European Union temporarily suspended the European Commission’s decision to revoke the conditional marketing authorization for Ocaliva. The drug will be available “until further notice,” Advanz Pharma said Thursday.
- CBER chief forecasts better global regulatory convergence around cell and gene therapies
- FDA grants full approval to Travere’s Filspari for IgAN
- Milestone’s arrhythmia drug on track for China filing with new Phase 3 data
FINANCING
- Arsenal Biosciences secured a $325 million Series C this week, while also reprioritizing its pipeline. The company’s lead program, AB-1015, will no longer advance past a Phase 1 trial in ovarian cancer. More news is expected before the year ends.
- Transplant biotech eGenesis snags $191M after first use of gene-edited pig kidney
- BioAge files for IPO, riding momentum for weight loss drugs
MANUFACTURING
- Novartis will invest $200 million in its radioligand manufacturing efforts, planning to open a new site in Carlsbad, CA, and beef up its capabilities in Indianapolis. The new California site will be the company’s third radioligand manufacturing site in the US.
- Novo Nordisk continues to grapple with patchy GLP-1 drug supply in Europe
HEALTH TECH
- Evernorth, the health services arm of Cigna, is planning to make a Stelara biosimilar available for $0 out-of-pocket for select patients
- PatientPartner raises $7M to help pharma companies match patients with mentors
- MDLive veterans nab $7.5M Series A for virtual specialty care startup
DON’T MISS