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Saturday, 2 May 2026 |
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Welcome back to Endpoints Weekly! The last week of April brought a downpour of news as several pharma companies reported their first-quarter earnings. Max Gelman took a close look at a make-or-break moment for Bristol Myers Squibb, and Lei Lei Wu and I had updates on Amgen’s ongoing saga over its rare disease drug Tavneos. Meanwhile, Andrew Dunn reported from one of the world’s largest AI research gatherings, I attended Supreme Court arguments in a patent case that’s being
closely watched by the generics industry, and John Carroll put out his annual review of pharma’s biggest research spenders. We’ll be back next week with earnings updates from several more companies, including Pfizer and Novo Nordisk. Have a great weekend! — Nicole DeFeudis |
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Nicole DeFeudis |
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Editor, Endpoints News |
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Bristol Myers’ pivotal year |
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❓Bristol Myers Squibb is facing a bit of an identity crisis. As it approaches two looming patent cliffs for the blood thinner Eliquis and the immunotherapy Opdivo, BMS will have to figure out where its next big source of growth will come from. The company has a slate of pipeline readouts coming this year that has drawn excitement from Wall Street.
But analysts say BMS is struggling to clearly chart a path beyond these multibillion-dollar franchises. “I don’t know what you really say right now, if you say, like, ‘What is Bristol Myers?’” William Blair’s Matt Phipps told Endpoints. Max Gelman took a look at the dilemma ahead of BMS’ earnings this week in what’s expected to be the company’s most pivotal year since it acquired Celgene for $74 billion in 2019.
Here are some other highlights from earnings this week:
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FDA claims ‘manipulation’ of Tavneos data |
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🔍The FDA escalated its push this week to withdraw a rare disease drug now owned by Amgen, accusing ChemoCentryx’s study personnel of manipulating the results of a pivotal clinical trial used to approve the drug. ChemoCentryx won approval for Tavneos in 2021 to treat an autoimmune disease called ANCA-associated vasculitis, and Amgen swooped in the following year with a $4 billion
acquisition.
The FDA asked Amgen to withdraw the drug voluntarily at the beginning of this year, but Amgen said it had no plans to do so. CDER reiterated its effort in a proposal to withdraw the drug this week, citing new
information that it says suggests Tavneos “has not been shown to be effective for its approved use,” and that its marketing application held “untrue statements of material fact.” Regulators also said they were “increasingly concerned” about the drug’s safety, bringing up cases of drug-induced liver injury.
Amgen said in its first-quarter earnings report that it intends to engage with the FDA, but reiterated that it continues to believe Tavneos “demonstrates effectiveness and a favorable benefit-risk profile.” The company also filed a
supplement that would add more information to the warning label about post-market cases of vanishing bile duct syndrome, a serious liver complication. |
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Should AI be swinging bigger? |
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🖥️Biopharma companies may be thinking too small when it comes to implementing AI, senior correspondent Andrew Dunn reports from Rio de Janeiro. At one of the world’s largest AI research gatherings, the International Conference on Learning Representations, Andrew chatted with Roche vet Kyunghyun Cho, who said the industry is looking at things the wrong way.
Pharma is looking at AI as a way to shave a few months off the drug development process. Instead, he sees potential for it to upend the labyrinthine system leading to medications that somewhat help a percentage of patients but work perfectly for relatively few. “We’ve got to lower the barrier between the pharmaceutical and the care providers, because the incentives are not aligned despite the fact that the technology is actually getting better,” Cho said. Read more from Andrew here. |
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Intellia’s in vivo CRISPR data |
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🧬An experimental treatment that uses CRISPR to edit genes directly inside the body succeeded in a Phase 3 trial this week in a first for the technology. It puts the treatment on track for a potential FDA approval in the first half of next year. The one-time infusion reduced swelling attacks in people with hereditary angioedema by 87% compared to placebo, Intellia announced.
It’s one of the biggest milestones yet for CRISPR, a nearly 14-year-old technology that has promised to bring cures to thousands of diseases. But as in vivo gene editing gets closer to becoming a bona fide drug, skepticism about how big a role the technology will have in medicine and this disease has grown. Read more from Ryan Cross and Lei Lei Wu here. |
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The Endpoints R&D 15 |
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💵Endpoints founding editor John Carroll reviewed the top 15 biggest pharma research spenders. John wrote that these companies “play with big stakes for even larger pots,” as pipeline-in-a-product assets “remain the holy grail of R&D” and the field continues to shift toward drugs that address big populations. It’s no surprise that Merck is at the top of the list, as it looks to navigate Keytruda’s upcoming patent cliff. You can see the full list here. |
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Worldwide made. Thanks for reading.
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