The CMV vaccine had been the company’s lead program prior to the Covid-19 pandemic. Leadership had repeatedly said it could bring in between $2 billion and $5 billion in peak annual sales. Analysts polled by Visible Alpha forecast peak sales of $1.6 billion for the product.

“It’s obviously disappointing,” said Stephen Hoge, Moderna’s president, in an interview.

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Morning. Today, we note that psychedelics are suddenly a hot topic for larger pharmaceutical companies, dissect Patrick Soon-Shiong’s claims on his lung cancer drug, and more.

Pharma is quickly warming to psychedelics

AbbVie’s $1.2 billion move to buy Gilgamesh’s psychedelic candidate is the first time a traditional drugmaker has snapped up an investigational psychedelic — a milestone that analysts say could trigger a wave of follow-on deals, STAT’s Olivia Goldhill writes.

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AbbVie’s purchase of Gilgamesh Pharmaceuticals’ psychedelic compound bretisilocin for up to $1.2 billion last month marked the first time a traditional pharma company has bought an investigational psychedelic drug. The deal suggests pharma is getting more comfortable with psychedelic drugs, despite the Food and Drug Administration’s rejection of MDMA last year. 

Following the success of Janssen’s depression treatment Spravato, which had $780 million in sales in the first three quarters of 2024 and is currently the only legal psychedelic psychiatric treatment, other pharma companies are increasingly eyeing the space for potential future deals, according to biotech executives and consultants. “It’s clearly validation for our sector,” said Kabir Nath, chief executive of Compass Pathways, which is developing psilocybin to treat depression.

Psychedelics present both a risk and an opportunity, especially for companies with an interest in psychiatry. Currently there are a handful of biotechs with psychedelic compounds in Phase 2 or later trials and, similarly, a handful of larger pharmaceutical companies that are circling the field. “There’s a huge amount of interest coming in suddenly from pharma,” said Josh Hardman, founder of the media and consulting firm Psychedelic Alpha. “We’ve seen a huge uptick in the last six months of larger pharma companies joining the mailing list, taking out paid subscriptions.”

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The pharma giant will acquire the treatment, called bretisilocin, for up to $1.2 billion, including an upfront payment and development milestones. Meanwhile, Gilgamesh will spin off a new company called Gilgamesh Pharma Inc. for its staff and other drug programs.

The move builds on AbbVie’s growing focus on neuroscience. The company had already signed a collaboration agreement with Gilgamesh. Last year, it also acquired Cerevel Therapeutics for $9 billion, but following the closing of the deal, the key schizophrenia drug at the center of the acquisition failed to show benefits in key trials.

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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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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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Health and Human Services Secretary Robert F. Kennedy Jr. recently revealed on a health influencer podcast that he received unproven stem cells at a clinic in Antigua for his throat condition, spasmodic dysphonia. He also suggested that he wants to give the public much broader access to such unproven therapies, which would be extremely risky.

This revelation confirms what I had suspected for months about Kennedy. It also raises new concerns about a possible upcoming wave of reckless cell therapy deregulation from this administration.

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The report found that 96% of the Part D plans and 88% of the Medicare Advantage drug plans agreed to cover at least one of the 10 available copycat drugs on their 2025 formularies. And some did not cover the brand-name version. This was a big jump in coverage from 2024, when only 64% of the Part D plans and 52% of the Medicare Advantage drug plans covered at least one biosimilar version of Humira.

Overall, 99% of enrollees in Part D Plans and 90% in Medicare Advantage drug plans had access to at least one Humira biosimilar in 2025. However, some plans are still restricting access to the biosimilars this year, which precludes usage. Specifically, 10% of Medicare Advantage drug plans and 1% of Part D plans cover only the brand-name medication.

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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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