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Welcome back to another edition of Endpoints Weekly. Two of the year’s major oncology conferences are coming up soon: AACR starting April 17, and ASCO at the end of May. We’re also hosting our New York City event with our parent company the Financial Times on May 14, so be sure to register for that here . Jumping into the headlines, this week saw another spate of biopharma M&A with deals from Gilead and Neurocrine. Our reporters also took a look at some of Eli Lilly and Merck’s recent acquisitions as dealmaking surges across the industry. Elsewhere, the FDA’s latest budget is winning plaudits from the biotech industry, Takeda ended a partnership amid its restructuring process, and Sanofi reported mixed results for a bispecific antibody. Also on Friday, the FDA again rejected a treatment from Replimune for advanced melanoma, saying the company didn’t resolve the issues from the previous rejection. Have a great weekend!  — Max Gelman 🤝 Biopharma continued its recent run of acquisitions this week . Gilead will buy out the private German startup Tubulis and its ADC platform for $3.15 billion upfront, a total that could grow with another $1.85 billion in milestones on the table. It’s Gilead’s third acquisition of the year following takeouts of Arcellx and Ouro Medicines. Endpoints’ Lei Lei Wu took a close look at how CEO Dan O’Day’s dealmaking is aiming to push Gilead beyond HIV — roughly half the company’s revenue comes from the HIV drug Biktarvy. Neurocrine also jumped into the fray, acquiring rare disease biotech Soleno Therapeutics for $2.9 billion. Soleno’s sole drug, Vykat XR, was approved last year for a condition called Prader-Willi syndrome, in which patients experience ravenous hunger starting around age 8 and often go to extreme lengths to satiate themselves. Analysts questioned the deal value for Neurocrine, however, after a string of pipeline setbacks. Kyle LaHucik has more here . Other recent deals also made it back into the spotlight. Max Bayer examined Eli Lilly’s recent deal for Centessa Pharmaceuticals and its pipeline of orexin receptor 2 agonists, noting the drug class’ significant potential in sleep disorders . Wall Street is wondering if Lilly has struck another gold mine following its GLP-1 success. We also got an SEC document detailing negotiations for Merck’s buyout of Terns Pharmaceuticals and how it lowered its bid after taking a look at additional clinical data. Read more about that story here . And for a bird’s-eye view of the recent M&A surge, be sure to watch our episode of Post-Hoc Live this week where Drew Armstrong and Kyle LaHucik chat with Emily Field, head of US biopharmaceuticals equity research at Barclays. 💰 The latest FDA budget proposal outlines policy changes to speed up trials, cut costs for companies that do experimental work in the US, and expedite regulatory reviews, Max Bayer reported this week. One of the reforms is a new clinical trial pathway that reflects the quicker processes some other countries have. The agency specifically expects the pathway to help “smaller biotechnology firms,” saying that the US’ existing IND process has fueled growth in China and Australia. The budget asked for a 3.3% increase to the FDA’s budget in the new fiscal year, exceeding $7 billion in total proposed agency funds, thanks to an increase in proposed user fee revenue. But it’s still just a proposal. How much money the agency has will ultimately be determined by Congress. The biotech sector praised the reforms . Jake Becraft, CEO of Strand Therapeutics and a recent representative of the biotech sector in DC, wrote on social media that it will “bring a wave of domestic innovation.” You can read more here. ❌ Takeda’s ongoing restructuring hit another Denali program this week. Takeda returned the full rights to a Denali drug called DNL593 ahead of a Phase 1/2 readout later this year, as an eight-year-old partnership came to an end between the two companies. The decision was “not related” to any of the program’s efficacy or safety data, Denali said. Designed to treat one of the most common genetic causes of frontotemporal dementia, DNL593 is the third and final program to be scrapped from the original 2018 deal. Takeda and Denali previously ended work on two experimental Alzheimer’s programs in 2022 and 2025 that targeted tau and TREM2, respectively. For Takeda, the move comes in the midst of an imminent CEO transition and yearslong attempt to turn the company around. Outgoing CEO Christophe Weber laid out plans in 2024 to simplify Takeda’s structure, leading to layoffs, pipeline cuts and the closure of a San Diego research center. ⚾Sanofi went 2-for-3 for its experimental nanobody lunsekimig this week. The drug passed two Phase 2 trials in asthma and an inflammatory sinus condition, but flunked a third study in atopic dermatitis. The latter Phase 2b trial called VELVET didn’t meet its primary endpoint of change from baseline in Eczema Area and Severity Index (EASI) score. But Sanofi touted improvements in key secondary endpoints measuring skin clearance. Lunsekimig was designed to improve upon Sanofi and Regeneron’s blockbuster Dupixent and AstraZeneca’s Tezspire. For the two indications where lunsekimig posted positive results, Jefferies analysts said the experimental drug could reach $3 billion in global peak sales. Sanofi said it was “generally well tolerated” across all three trials, with common side effects including nasopharyngitis and upper respiratory tract infection. More detailed results will be presented at future medical meetings — but you can click here for Ayisha Sharma’s early analysis. ⏰ The company, called Life Biosciences, is developing a one-time treatment that is intended to rewind the clock on dying cells. It’s testing a hypothesis that aging is caused by a loss of epigenetic information, and its therapy is based on three proteins that should help reset the epigenetic code to a younger state, but stop short of a complete wipe. The idea is part of a related suite of techniques that broadly fall under the umbrella of cellular rejuvenation. Earlier this year, Life became the first company to get the FDA’s green light to begin a clinical trial of a partial epigenetic reprogramming therapy. The Series D round will be used to support a Phase 1 trial of a gene therapy in two forms of vision loss and fund preclinical studies using a similar therapy to rejuvenate cells in other parts of the body. Ryan Cross has the full story here.