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.
What a busy week for news. From ESMO and the Federal Reserve, to the FTC and 23andMe, we’ve got a weekly roundup chock-full of excellent stories. And be sure to sign up for our Endpoints 11 event on Sept. 26 in Boston, celebrating the most promising private biotechs the industry has to offer. — Max Gelman
John Carroll on fighting a rare cancer
Our founding editor John Carroll was diagnosed with a rare form of cancer a few months ago called Merkel cell carcinoma. After posting semi-regular updates on social media about his search for treatment, John wrote about his diagnosis and the frustrating road he had to take to finally get the right doctors and drugs. If you haven’t already, please take a few minutes out of your weekend to read his article. We’re all rooting for John — Endpoints News wouldn’t be what it is without him.
#ESMO24’s biggest surprise
This year’s ESMO conference featured the usual presentations of oncology data, but what stood out the most was a retrospective study showing how mRNA-based Covid-19 vaccines significantly improved lung and skin cancer patients’ survival when given a few months after immunotherapy. Researchers still haven’t pinpointed why this happened, but the results could have big implications for Moderna and BioNTech’s personalized cancer vaccine programs. Check out below for more of our dispatches from Barcelona.
Clashing cultures at Lykos
Lykos’ quest for a psychedelics drug approval was thwarted earlier this summer, leading to a significant workforce reduction and CEO Amy Emerson eventually stepping down. Max Bayer, who has been reporting on the Lykos story for weeks at Endpoints, took an in-depth look at the company’s journey dating all the way back to 1986 and how long-simmering tensions and the founder’s personal ambitions collided with growing pains as it tried to secure that approval.
The Fed cuts interest rates
The Federal Reserve made its long-awaited interest rate cuts this week, lowering the benchmark rate by a half of a percentage point to 4.75% to 5%. While the cut is likely to pressure investors into getting their cash off the sidelines, industry insiders told Endpoints that they hoped Wednesday’s cut would be the start of a trend. Predicting how the recovery will shake out over the coming months, however, will be difficult.
23andMe board resigns, and potential buyer emerges
All seven of 23andMe’s independent board directors resigned this week over their differing views with CEO Anne Wojcicki and her attempts to take the health tech startup private. The company went public by merging with Richard Branson’s SPAC in 2021, but it hasn’t been able to persuade investors it can tackle genetic testing and drug development simultaneously. The resignations came the same day 23andMe presented data from two clinical programs at ESMO. And, late Friday, a small genetic testing startup said it was interested in acquiring 23andMe.
SPOTLIGHT
- FTC to sue major PBMs over insulin rebates, claiming they inflated patient cost
- Exclusive: Flagship-backed Valo Health loses interim CEO ahead of key Phase 2 readout
- Why did Eli Lilly ask a patient on a compounded GLP-1 drug for their medical information?
#ESMO24
- Reporters Kyle LaHucik and Lei Lei Wu shared some thoughts on the vibes at this year’s ESMO conference, reflecting on immunotherapy’s increasing difficulty, no studies that prompted a standing ovation, and Novartis’ Apple Vision Pro headsets. Read more here.
- Merck’s Eliav Barr on subcutaneous Keytruda, Summit and deal-shopping
- Pfizer tees up Phase 3 test in weight management — but in an unexpected area
- Bristol Myers touts LAG-3 strategy in lung cancer, but data caveats dampen excitement
- BioNTech rolls out Phase 2 lung cancer data as VEGF bispecifics take center stage
R&D
- Insilico has been attempting to blaze a path in AI drug development for years, and the company read out its first Phase 2a data saying a fibrosis program had a dose-dependent response in a small trial. But it left out other key efficacy details, and the CEO declined to comment on whether the results were statistically significant.
- Edgewise’s stock surges as heart drug passes early safety test
- Aligos’ trial for oral MASH treatment succeeds, but placebo group shows odd trend
- Novo says its CB1 drug helped shed weight, but efficacy and safety questions remain
- Sanofi’s BTK inhibitor again slows MS progression, but liver enzymes continue to be tricky
- Immatics loses Bristol Myers’ support on Phase 1 bispecific T cell engager
PHARMA
- In one of ESMO’s under-the-radar presentations, a GDF-15-directed monoclonal antibody from Pfizer called ponsegromab helped cancer patients gain weight in a Phase 2 trial. Important questions remain, however, before Pfizer can run a pivotal Phase 3 study.
- Novartis’ Kisqali snags FDA approval to reduce recurrence in patients with early forms of breast cancer
- The drug lobby’s lawsuit against the IRA finds a sign of life after appeals court ruling
- Novo axes Phase 2 of Forma-acquired drug in myelodysplastic syndromes
- Sanofi’s Sarclisa gets approved as a first-line option for some patients newly diagnosed with multiple myeloma
- FDA approves Zevra’s rare disease drug after resubmission
- FDA approves AstraZeneca’s asthma medication Fasenra to treat rare autoimmune condition
FINANCING
- A spinout from George Church’s lab at Harvard raised $75 million this week in its formal debut. GC Therapeutics is attempting to write the recipe book for turning a stem cell into nearly any natural human cell.
- Emmet Stephenson gives $150M to City of Hope for pancreatic cancer, creating million-dollar research prize
- Nura Bio raises $68M for clinical tests of SARM1 inhibitor to potentially slow or prevent nerve degeneration
- Biotech VC firm outlines plans for $100M fund
FDA+
- FDA cancels Applied Therapeutics adcomm, shares skyrocket 65%
- FDA tells oncology companies how to run multi-regional cancer trials with a US approval in mind
- FDA rejects Vanda’s treatment for digestion condition, company rebukes agency’s actions
- FDA inspectors discover trucks carrying torn-up records leaving Indian generics factory
- Conducting trials via routine clinical practice: FDA explains how in new draft guidance
MANUFACTURING
- CDMO Serán sets out to build first commercial facility, with a $200M investment led by Bain Capital
- Roche outlines commercial manufacturing strategy for GLP-1/GIP assets
- Senators tell FDA that ‘greater action is needed’ to use manufacturing tech in US supply chains
HEALTH TECH
- Cigna sues FTC, calling for withdrawal of ‘biased, erroneous’ PBM report
- Exclusive: Former Amazon Pharmacy execs back Mevo, a startup bringing online prescribing to Brazil
- Sheryl Sandberg-backed Cercle raises $6M seed round with future plans to sell its services to pharma
DON’T MISS