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Welcome back to Endpoints Weekly. Endpoints News broke the news this week on the deaths of three patients who received Novartis’ experimental CAR-T therapy. Novartis has paused immunology and neuroscience studies for the drug, and Bristol Myers Squibb also put a similar therapy on hold to review safety issues. There’s still a lot we don’t know, and I spoke with industry experts to unpack what the uncertainty means for the broader field. Our team also covered Eli Lilly’s 13th acquisition this year, the Trump administration’s latest drug pricing deals, Teva’s success in celiac disease and more. One programming note: Our team will be off Monday for Labor Day. We’ll be
back in your inbox on Tuesday! |
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Nicole DeFeudis |
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Senior Reporter, Endpoints News |
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CAR-T deaths prompt halt by Novartis |
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Three patients died after receiving Novartis’ experimental CD19-directed CAR-T treatment rapcabtagene autoleucel, the company told Endpoints News. Novartis is temporarily pausing several immunology and neuroscience studies and conducting a “comprehensive review.” The three patients experienced complications due to immune effector
cell-associated hemophagocytic syndrome — a condition in which the immune system becomes overactive.
A similar therapy from Bristol Myers Squibb was also put on hold to review safety issues, the company separately told Endpoints. The company voluntarily paused enrollment in autoimmune trials for zolacabtagene autoleucel, another CD19 CAR-T, due to “transient and reversible inflammatory events during routine study surveillance.” The company declined to share more details.
There’s still much we don’t know. There’s been speculation that the toxicities could be related to rapid manufacturing platforms used by Novartis and Bristol Myers. But more information will be necessary to determine the actual cause and what it means for the field.
For now, the events are a reminder that CAR-Ts aren’t without risk. The deaths have also ignited a debate over what odds are acceptable when treating diseases that may not be fatal. Industry experts weighed in on the issue in my story here. |
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Eli Lilly’s 13th acquisition of 2026 |
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💰Lilly will pay up to $2.875 billion for Merida Biosciences and its asset in the increasingly popular subfields of thyroid eye disease and Graves’ disease. Merida’s MER511 is in a Phase 1 that began in December 2025 and is expected to wrap up in July 2028.
The Merida deal is the latest in Lilly’s M&A spree. The company has not gone one month of 2026 without making an acquisition. In total, it has announced deals worth about $32 billion so far this year. In a July 8 note to investors, Stifel’s Tim Opler said Lilly's deal spending alone had accounted for “over half of all M&A capacity executed by the top 12 pharmaceutical companies combined."
Endpoints’ Kyle LaHucik took a look at where that money is going. At least 50 different venture investors have benefited from Eli Lilly’s dealmaking this year, sending early investment dollars back into the startup ecosystem, Kyle wrote. There’s hardly any overlap among the venture capital firms and large institutional investors backing the acquired drug developers, according to an Endpoints review of the deals. Lilly appears to be casting a wide net in its search for external assets and platforms, turning the tens of billions of dollars in revenue from its obesity portfolio into a wide range of bets across sleep disorders, cancer, genetic medicines and infectious diseases. You can check out Kyle’s analysis here. |
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Trump announces new drug pricing deals |
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🤝President Donald Trump announced voluntary drug pricing deals with nine new drug manufacturers on Monday. The latest batch of deals includes Alcon, Teva, Sun Pharma, BridgeBio, Kyowa Kirin, BeOne Medicines, UCB, CSL and Astellas. But Endpoints’ Max Bayer wrote that comments from Trump and other top health officials, plus disclosures that followed the event, stood out more than the deals themselves.
Following the White House announcement, a tenth company unveiled itself in a discreet SEC filing. Delaware-based Incyte said it also agreed to supplemental Medicaid rebates in order to be exempted from future drug pricing plans, though it wasn’t clear why the company wasn’t at the White House event. Similar-sized companies like Bayer, Takeda, Vertex and argenx weren’t included in the latest announcement, and they don’t appear to have struck deals (yet).
The administration is working to make more MFN deals, White House senior deputy press secretary Kush Desai said in a social media post Tuesday. He also said it’s working to strike more trade agreements with European countries that include them paying more for drugs.
During the event, Heidi Overton made her first public comments since the president tapped her to lead the FDA after Marty Makary. Trump said he would like the Senate to vote on Overton’s nomination before the November midterms. Max recapped his biggest takeaways from the event here. |
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China deaths reignite debate over CRISPR delivery |
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The deaths of two children who received CRISPR therapies in China have rattled scientists who work on similar genetic medicines in the US, adding new fuel to a yearslong debate about the gene therapy field’s most-used delivery method, Ryan Cross wrote this week. At the heart of the safety concerns are engineered viruses called adeno-associated viruses, or AAVs, that were used to shuttle the gene editing treatments into the
body.
More than 20 people around the world have died after receiving AAV-based treatments, many of which were given at doses that some scientists now view as dangerously high. Due to the limited information about the incidents in China, it’s difficult to draw conclusions about AAV. But the tragedies are reigniting bigger questions about the kinds of experiments that drugmakers are conducting with these technologies. Read more from Ryan here.
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Teva’s success in celiac disease |
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🍞A single injection of Teva’s experimental antibody significantly reduced intestinal damage among people with celiac disease who then ate gluten daily, the company said on Wednesday. The topline results came from a Phase 2a challenge study, in which both patients in a placebo arm and those given treatment consumed 3 grams of gluten daily — roughly equivalent to a slice of bread — for six weeks. Andrew Dunn has the details here. |
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