Today we talk about an advance in an experimental mRNA vaccine for HIV, dive deep on Vinay Prasad’s sudden FDA departure, and more.

The need-to-know this morning

• Alnylam Pharma raised its revenue outlook as its heart drug sees quick uptake.
• Biogen, Argenx, Sanofi, and Bristol Myers Squibb reported second-quarter earnings. 
• AbbVie and Apellis Pharma reported earnings, too. 

Inside the undoing of Vinay Prasad at the FDA

Vinay Prasad’s short-lived but polarizing run as head of the FDA’s biologics division ended just 84 days in, after his aggressive push to tighten oversight on gene therapies and Covid-19 vaccines drew heat from all sides — Trump allies, RFK Jr. loyalists, Democrats, and Duchenne patient advocates.

His decision-making on Sarepta Therapeutics’ gene therapy— which he viewed as backed by staff and rooted in safety concerns — fueled political pressure that only mounted after far-right influencer Laura Loomer launched a campaign highlighting his progressive leanings and past anti-Trump comments. A powerful and extremely online regulator ran out of friends when it mattered most.

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Joel Sussman, a former head of the Protein Data Bank, remembers when he found his first intrinsically disordered protein, though it wasn’t called that at the time. He showed it to a collaborator. “‘Oh, Joel, you’re not a very good biochemist. Obviously, it has a structure and you’re confused,’” he recalled her saying.

Most proteins fold into shapes with distinct elements: the ordered spiral of an alpha-helix, like a piece of cavatappi pasta; or beta sheets, like a slice of a lasagna — squiggly lines of pasta amino acids held parallel to each other with cheesy and saucy hydrogen bonds. A central tenet of structural biology is that a protein’s structure dictates its function. But around the same time that the world was preparing for Y2K, structural biologists finally began admitting that — just as Sussman and other scientists had seen — not all proteins have a permanent shape. A surprisingly large amount of important proteins (in fact, over half of all proteins in eukaryotes, it’s estimated) have strands of wiggly “spaghetti” in them. 

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Hello! Today, we talk about a cool experimental enzyme therapy, observe more patent maneuvers over Eylea, and see an ‘underdog’ startup get a huge seed round to target a common kidney disease.

The need-to-know this morning

• Soleno Therapeutics pre-announced $31-33 million in Vykat XR sales for the second quarter — beating consensus expectations by a wide margin. The drug was approved in late March to treat Prader-Willi syndrome, a rare genetic disease that causes an insatiable desire to eat. Soleno is also raising $200 million in a follow-on stock sale.
• AbbVie is paying $700 million upfront to acquire licensing rights to a “trispecific antibody” treatment for cancer developed by Ichnos Global Innovation. The drug, called ISB 2001, targets CD38 and BCMA protein receptors on tumor cells and the CD3 receptor on T cells. A Phase 1 study in multiple myeloma is underway.

Brawl over Eylea gets biosimilar industry’s attention

A high-stakes legal fight between Regeneron and Amgen over the blockbuster eye drug Eylea is putting the U.S. patent system under a microscope — and is being closely watched by biosimilar makers.

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AbbVie said Monday that it would pay up to $2.1 billion to acquire Capstan Therapeutics, a startup developing CAR-T therapies for autoimmune conditions, fibrosis, and cancer. 

AbbVie will pay up to $2.1 billion in cash when the deal closes, according to a press release. The companies did not give further details about the financial terms or a timeline for completing the acquisition. 

Capstan launched in 2022 and has raised around $340 million from OrbiMed, Vida Ventures, RA Capital, Polaris Partners, and the venture teams at Pfizer, Bayer, Eli Lilly and Company, and Bristol Myers Squibb. It was last valued at around $500 million, according to Pitchbook. 

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The meeting was with a startup created by Flatiron Health veterans Josh Haimson and Ben Birnbaum. The duo had built the first team at Flatiron focused on machine learning, and, a few years after pharmaceutical giant Roche snapped up the company for $1.9 billion, they launched their own company.

Their new venture, Inductive Bio, has created an artificial intelligence tool that biotechs can use to design and model different versions of a small-molecule drug, sussing out what variation might cause drug toxicity or be metabolized too quickly. 

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The hulking factories are tucked away off the roads around the village of Ringaskiddy — operated by the likes of Pfizer, Johnson & Johnson, and BioMarin, whose plant featured signs last week touting a new facility “coming Q1 2027.”

The nearby town of Carrigtwohill crows that it’s grown “+400% over the past 20 years,” a surge driven by sites run by AbbVie and Gilead. 

And down in Kinsale, an Eli Lilly campus rises up out of the Irish countryside, a hub that recently underwent an $800 million expansion to meet the surging demand for the company’s obesity and diabetes drugs. Placards along the edge of the property celebrate Lilly’s sponsorship of the upcoming Kinsale 10-mile road race. 

“It’s absolutely everything to this area,” Jack White, a member of the County Cork council, told STAT, referring to the presence of pharma manufacturing here. 

President Trump is less fond of the industry’s operations in Ireland. As he seeks to impose tariffs on goods worldwide, part of a bid to bring companies back to the U.S. and generate jobs, he has specifically called out pharma manufacturing in this country and pledged to announce new levies on drugmakers. In his view, the U.S. trade imbalance with Ireland — one largely driven by pharmaceutical exports — is a particular injustice. As a result, the industry is now caught in his crosshairs, anxiously awaiting details from the administration.

“All of a sudden Ireland has our pharmaceutical companies, this beautiful island of five million people has got the entire U.S. pharmaceutical industry in its grasp,” Trump said in a March meeting with Irish Prime Minister Micheál Martin marking St. Patrick’s Day. “I’d like to see the United States not have been so stupid for so many years, not just with Ireland, with everybody.”

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Good morning. Let’s get straight into the news today.

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So, too, is the vast, unexplored drug-hunting territory of chemical space, waiting to be illuminated by data’s light.

Every AI model trained for biology only can see what’s illuminated by the data points it is trained on. AlphaFold succeeded in predicting protein structures because the 200,000 or so known protein structures in the Protein Data Bank covered enough of the limited ways amino acids can combine that the model was able to understand what almost the entire protein structure space looked like. But ask the PDB for only the structures where proteins are hugging other proteins or — even rarer — interacting with drug-like molecules, and there’s nowhere near enough illumination for AI biology models to understand what the topography of those plains look like, much less make useful predictions for drug discovery.

Life sciences data company Apheris on Thursday announced an effort to boost the capabilities of protein AI models by uniting several pharmaceutical companies’ proprietary data. Apheris’ consortium of pharma companies is partnering with OpenFold3 — Columbia professor Mohammed AlQuraishi’s open-source dupe of AlphaFold3 — to train the model on AbbVie and Johnson & Johnson’s vast stores of structural data. The collaboration will focus on structures relevant to drug discovery, such as small molecule-protein and antibody-antigen interactions. 

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Good morning. The MAHA movement is influencing not only the federal government, but also state legislatures across the U.S. We discuss all that and the key biotech news today.

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When it comes to delivering shareholder value through M&A, Ron Renaud is a biotech investor’s best friend. Over the last 10 years, all three of the companies he has helmed were sold to Big Pharma for a combined $16 billion. 

With that track record — and the financial windfall it brings — no one would have begrudged Renaud, 55, had he desired to spend more time with his Cape Cod fishing buddies. But he can’t quit biotech. Weeks after overseeing the close of Cerevel Therapeutics’s $8.7 billion acquisition by AbbVie, Renaud is back as CEO of Kailera Therapeutics, a newly formed company with a pipeline of weight loss drug candidates.

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