What is FDA's responsibility to Cassava's patients?

The SEC last week concluded that Cassava Sciences misled investors about its experimental Alzheimer's drug. Now the FDA needs to act, my colleague Adam Feuerstein writes in his latest column.

Cassava included falsified data in its investigators' brochure — a summary document of data that is meant to inform physician investigators participating in clinical trials, Adam reports. That means it's possible that patients and their families consented to participate in the Phase 3 studies under false pretenses.

The first of the company's Phase 3 studies is already nearing completion, but the second Phase 3 study remains open and will continue well into 2025.

biotech

The biggest biotech events to watch this quarter

As is quarterly tradition, Adam has compiled a list of the major stock-moving events to watch in the fourth quarter. Here are some highlights:

Amgen's Phase 2 readout of its monthly obesity drug MariTide, a monoclonal antibody linked to two peptides that activates receptors of the GLP-1 hormone while blocking receptors of the GIP hormone
Novo Nordisk's Phase 3 readout of its next-gen weight loss treatment CagriSema, a combination of the GLP-1 drug semaglutide (the active ingredient in Ozempic and Wegovy) and cagrilintide, a treatment that activates amylin and calcitonin receptors
AbbVie's Phase 2 readout of schizophrenia drug emraclidine that it got through its Cerevel acquisition. Observers will be looking to see how it compares with Bristol Myers Squibb's Cobenfy, which recently became the first schizophrenia drug that targets muscarinic receptors in the brain to secure U.S. approval.

Read on for the other big events to watch.

financing

Immunology biotech raises $115 million

Triveni Bio, a biotech focused on immunology and inflammation, said today that it raised $115 million in a Series B round led by Goldman Sachs Alternatives. It's the latest big financing round in the disease area.

Triveni's lead candidate, TRIV-509, is a monoclonal antibody that inhibits proteins called kallikreins 5 and 7 (KLK 5/7). It's being developed to treat atopic dermatitis, and the biotech plans to submit an IND application for it in the first quarter of next year.

obesity

Lilly appears to follow Novo with prevention plans

Eli Lilly is considering testing its obesity drugs in people who aren't overweight or obese but are at risk of weight gain, CEO David Ricks said in an interview with the Financial Times. From the article, it seems this is still early thinking and Ricks did not provide concrete details, but Lilly looks to be moving toward a similar line of thinking as competitor Novo Nordisk.

My colleagues and I reported last year that Novo is looking beyond its blockbuster treatments Ozempic and Wegovy and aiming to eliminate obesity altogether. Among other steps, it's launching a "transformational prevention unit" tasked with identifying factors that can predict who's at risk of becoming obese and developing interventions to halt such outcomes. Novo's CSO has also told me that the company is thinking of making a "vaccine-like" obesity compound.

These are, of course, moonshot ideas that would take years to begin to materialize into actual products, but experts worry that companies are moving in the wrong direction to address rising obesity rates.

The concerns about cost, equity, and societal values that already surround the current obesity treatments are heightened even more when thinking about developing drugs for prevention (and not just treatment) in a healthier population.

Read more about these concerns in our story last year.

pharma

Lilly invests $4.5 billion in a new research hub

From my colleague Matt Herper: Traditionally, companies have started work on figuring out how to manufacture their drugs at scale long after they began research on the basic molecules. That's because traditional drugs are pretty easy to make. But for lots of newer medicines, from gene therapies to GLP-1s, manufacturing can be the bottleneck that prevents a new drug from achieving blockbuster status.

This morning, Eli Lilly announced that it will invest $4.5 billion to create the Lilly Medicine Foundry, which the drug giant says will be the first-ever facility to combine research and manufacturing in a single location. The foundry will be based in Lebanon, Ind.

"In addition to supplying high-quality medicine for our clinical studies, this new complex will further strengthen our process development and scale up our manufacturing capabilities to speed delivery of next-generation medicines to patients around the world," said David Rick, Lilly's CEO.

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