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.
It’s earnings season! Our reporters will be closely following announcements next week from Pfizer, Novartis, Eli Lilly, GSK, AbbVie, Merck and more. Stay tuned for the latest. — Nicole DeFeudis
Latest salvo in Pfizer activist fight
In a 74-page presentation, activist investor Starboard Value said this week the company’s board needs to “hold management accountable” after not being able to capitalize on what it described as one of the best pipelines in biopharma. Though Starboard did not call for changes to the board or Pfizer’s management team, it’s not unusual for activists to make such declarations to test the waters for a company’s response.
John Carroll’s Q3 biotech roundup
Endpoints’ founding editor takes a look at some of 2024’s biggest industry trends as they stand at the end of the third quarter. Among the highlights: AI appears to be driving higher M&A figures, licensing deals are down, venture totals are up and IPOs have been a mixed bag. Check out John’s full analysis here.
Intellia unveils CRISPR results in hereditary angioedema
Intellia Therapeutics said this week that its experimental gene editing therapy reduced patients’ mean rate of monthly swelling attacks caused by hereditary angioedema by about 80%. Danny Cohn, a doctor who led the Phase 2 study, said he was “overwhelmed by the clinical response.” Ryan Cross has the details here.
Former Karuna crew nab $225M for Seaport
Just six months after launching with $100 million, Boston’s latest neuropsychiatry startup Seaport Therapeutics closed a $225 million Series C this week. The company spun out of publicly traded PureTech and is developing prodrugs of molecules that have already been tested or approved. Seaport is starting in depression, with a Phase 2b study expected for a prodrug version of allopregnanolone.
Roche says Novo-Catalent deal shouldn’t close
Roche is taking a stance on Novo Holdings’ planned acquisition of Catalent. CEO Thomas Schinecker said on Wednesday that antitrust regulators shouldn’t clear the deal, citing concerns that it could limit competition from a broader industry perspective. Why would the company try to block the deal? Drew Armstrong unpacks the news here.
Roche, Genentech walk away from UCB anti-tau deal
The companies will no longer partner on a program called bepranemab. Roche and Genentech had ponied up $120 million upfront and promised up to $2 billion in milestones to team up back in 2020. It’s not the first Alzheimer’s deal Roche and Genentech have broken off this year: In January, the two ended a partnership with AC Immune after lackluster readouts. UCB regained global rights to the program.
SPOTLIGHT
Editas pivots away from ex vivo sickle cell therapy in favor of in vivo approach
‘It’s not right.’ Califf slams pharma over weight loss drug prices
R&D
- Novo Nordisk’s oral semaglutide lowered the risk of some cardiac events in a late-phase study in type 2 diabetes and related metabolic conditions. The company plans to file for a label expansion for non-injectable forms of its GLP-1.
- Intellia wasn’t the only company this week with gene editing news. Precision Biosciences received clearance from regulators in the Eastern European country of Moldova to begin a human trial of a gene editor for chronic hepatitis B, marking the first such test in the world.
- Ahead of Novo’s CagriSema readout, Lilly returns to a promising new class of obesity drugs
- Vertex shares full pivotal non-opioid pain data, showing better safety than placebo
- Alto Neuroscience’s mid-stage trial misses primary endpoint in depression
FDA+
- Sangamo Therapeutics says it will not need to run an additional confirmatory trial in order to nab accelerated approval for its Fabry disease gene therapy. Execs said in an interview the FDA has not asked for anything outside of the data Sangamo already submitted.
- GSK offers glimpse at RSV vaccine in at-risk younger adults before ACIP meeting
- CDC advisors decline to recommend RSV shots to younger at-risk adults, affirming prior guidance
- Novo Nordisk asks FDA to prohibit semaglutide compounding, following Eli Lilly
- Lawyers predict Biosecure passage in lame duck session, but Senate may decide key details
PHARMA
- In addition to Pfizer, Starboard Value has also taken an activist stake in the J&J consumer product spinout Kenvue. Starboard’s move comes a little over a year after Kenvue became a standalone company.
- Hungary’s Olivér Várhelyi readies to be EU health commissioner, pledging major pharma support
- Icon’s quarterly earnings hit by biotech and pharma pullback
- UK’s price watchdog says Lilly’s Alzheimer’s drug is too costly for broad uptake
- Amgen preps to launch Eylea biosimilar years early after Regeneron loses appeal
FINANCING
- Fable Therapeutics has raised $53.5 million. The startup combines two of this year’s buzziest biotech trends: artificial intelligence and obesity drugs.
- Septerna bags $288M upsized IPO for GPCR drugs
- AvenCell gets $112M to build switchable CAR-T therapies for ‘the last frontier’ of blood cancers
- Be Bio raises $82M to fund work on B cell therapy in hemophilia B
- Life sciences investor Dimension seeks to raise $500M second fund
DEALS
- Merck acquired a startup spun out of Yale called Modifi Bio for $30 million upfront. The startup is taking a “chameleon-like” approach to developing brain cancer drugs, in a similar approach to precision chemotherapy.
- Eye drop maker to merge with a retinal gene therapy startup from Spark co-founder
MANUFACTURING
- GSK said it is making its largest manufacturing investment in the US yet, allocating $800 million to upgrade its vaccine production site in Pennsylvania.
- FDA hits Camurus with CRL for acromegaly therapy over manufacturing issues
HEALTH TECH
- MGM Resorts plans to stop covering GLP-1 weight loss shots for its employees next year, after it faced constraints in what it could do to manage soaring costs without losing crucial drug discounts, a top benefits director said.
- Experts debate the way AI can transform mental healthcare
- Former Amazon leader is betting the future of healthcare will blend in-person and online care