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Welcome back to Endpoints Weekly, our roundup of the top headlines in biopharma. Earnings season continued this week, with more comments from pharma executives on the potential impact of tariffs, new details around Pfizer and Moderna’s cost-efficiency efforts, and more. Read below for a recap of the top news out of this week’s earnings calls. We’ve also got a summary of data out of the American Association for Cancer Research’s annual meeting, where Lei Lei Wu reported from Chicago. And Endpoints News’ Andrew Dunn welcomed Arc Institute co-founder Patrick Hsu to our special Slack channel to discuss all things AI. Stay tuned next week as more companies, including BioNTech, Novo Nordisk, Takeda and more, report their earnings.  — Nicole DeFeudis 💲 More pharma companies reported their Q1 earnings this week, including AstraZeneca, Novartis, Pfizer, GSK, Eli Lilly, Moderna and Amgen. Tariffs were a central theme during earnings calls, as drugmakers provided some detail on the potential impact to their business. “Our goal, as I mentioned, is to have 100% of our products produced in the US for the US,” Novartis CEO Vas Narasimhan said during a first-quarter earnings call with the media Tuesday. AstraZeneca CEO Pascal Soriot said the company “can actually move the manufacturing of products that are made in Europe, move it to the US for supply to the US. And we can also potentially do the other way around.” Here’s what else our reporters tracked: The privately-held biotech Stealth BioTherapeutics said its rare disease drug was delayed this week. A person familiar with the situation said the company hadn’t been asked to run more trials or provide more data, that the FDA hadn’t identified any safety concerns, and that the agency hadn’t raised manufacturing issues, Endpoints’ Max Gelman reported. The apparent delay comes amid upheaval at health agencies, though several companies have said in earnings calls and interviews in recent weeks that they aren’t seeing an impact on their interactions with the FDA so far. The agency made decisions on time for two other drugs this week: Johnson & Johnson’s rare disease drug Imaavy and Satsuma Pharmaceuticals’ migraine drug Atzumi. The agency also hit PDUFA dates for other big-name medicines in recent weeks, like Dupixent, Amvuttra, Uplizna and Eylea. Stealth’s drug had an original decision deadline in January, but the company said the FDA requested more time to review supplemental material. Max examines lingering questions around the situation here . AACR recap: Data from GSK, Merck and more 🔬Scientists descended on Chicago this week for the American Association for Cancer Research’s annual meeting. Some in attendance, including cancer scientists, former NIH leaders and patient advocates, spoke about how cuts to science funding could impact cancer research. “It is a time to be clear-eyed about what is happening and to decide what role each of us is willing to play,” Yale oncologist Patricia LoRusso said during a panel. Read more here . Elsewhere, GSK presented data showing that its PD-1 inhibitor Jemperli induced a 100% complete response rate in 49 patients with a specific type of rectal cancer after six months. Even though the results were excellent, Endpoints’ Elizabeth Cairns reported that they are unlikely to have major commercial implications. Jemperli is already approved in this cancer type, known as mismatch repair deficient (MMRd) solid tumors, though only after the patient has progressed on prior treatment and has no further options. The new data could move the product into the neoadjuvant setting for dMMR cancers, but it’s still a tiny patient population. Only around 3% of solid tumors carry the dMMR biomarker. Merck also impressed with Keytruda data in head and neck cancer, showing that adding Keytruda before and after surgery cut the risk of disease recurrence or death by 27%. Patients in the study remained disease-free for more than four years at the median. 🌎 The US’ drug infrastructure has historically been robust, making it an attractive country in which to run clinical trials. But some companies say uncertainty is driving them to look elsewhere for their studies. Jared Whitlock examined this phenomenon in a story this week . Of note, companies find FDA Commissioner Marty Makary’s comments on rare disease approval pathways and animal testing largely promising. “Since we are in the ultra-rare disease space, Makary’s words on creating paths for rare [diseases] creates hope, and we are looking forward to learning more about his plans,” Mahzi Therapeutics CEO Yael Weiss said. While overseas trials have limitations, agencies in Europe, Canada, Australia and the UK have worked in recent years to harmonize guidelines with the FDA. 🎤 Endpoints’ Andrew Dunn welcomed Patrick Hsu to the newsroom’s Slack channel earlier this month to share his thoughts from the frontlines of the AI bio space. Hsu co-founded the Arc Institute in 2021, a Palo Alto, CA-based nonprofit research organization that has spearheaded some leading AI biology research. “I think AI will become a universal copilot that we use for everything,” he said during the interview. Read more here . DON’T MISS:

Alnylam CEO Yvonne Greenstreet, M.D., characterizes Amvuttra's entrance in the suddenly competitive ATTR-CM market as a "category growth story." With attention focused on their recently approved drugs for transthyretin amyloid cardiomyopathy (ATTR-CM), there was a serendipitous timeliness to Alnylam and BridgeBio presenting their quarterly updates on consecutive days.While BridgeBio blew away analyst projections on Wednesday, reporting sales of $37 million for Attruby in its first full quarter on the market, Alnylam countered with positive news as well for Amvuttra on Thursday.Since Amvuttra earned its FDA label expansion to treat patients with ATTR-CM so late in the first quarter on March 20, there were no significant sales to report for the indication. But the company is pointing to encouraging signs in its uptake.“Our first priority out of the gate was the access setup and we’re pleased to say it’s progressing exactly to plan, enabling the second half growth story that we have portrayed,” Tolga Tanguler, Alnylam’s chief commercial officer, said during a conference call.Tanguler explained that 80% of TTR volume in the U.S. flows through 170 health systems, and that the company had gained formulary placements of Amvutta within four weeks of the label expansion at more than half of the systems. He added that a “majority” have initiated Amvuttra treatment for ATTR-CM patients.Tanguler also reported early feedback from patients and doctors indicates “excitement for a new mechanism of action in ATTR-CM.”“What we’re hearing from prescribers is that the Amvuttra’s disruptive value proposition resonates and is enabling this early encouraging launch momentum,” Tangular said.Alnylam and BridgeBio are challenging powerhouse Pfizer, which has dominated the market with its booming Vyndaqel franchise. In 2024, the Pfizer treatments achieved sales of $5.4 billion, which was up from $3.3 billion in 2023.Alnylam CEO Yvonne Greenstreet, M.D., said there is plenty of room for new options for ATTR-CM patients.“We really are in a category growth story,” Greenstreet said. “What we’re seeing is continued evidence of a large, growing, and frankly, unsatisfied market and I think we’re very excited to be able to participate.” Alnylam points to its experience with treating patients with polyneuropathy caused by hereditary transthyretin amyloidosis (hATTR-PN). The company earned approvals for Onpattro (2018) and Amvuttra (2022) to treat the condition.“We are finding that in categories where the majority of patients remain untreated, more treatment options mean more voices helping to raise disease awareness ultimately accelerating category growth and increasing the number of patients on therapy,” Tanguler said. “We believe about 80% of the addressable patient population remains untreated. This bodes well for the opportunity ahead in ATTR-CM.” In the first quarter, sales for Amvuttra and Onpattro came in at $310 million and $49 million, which were up a combined 37% year over year and 4% sequentially. The combined $359 million TTR franchise sales were in line with the analysts' forecast of $355 million.In 2024, sales of the two treatments were at $1.22 billion. With the new indication for Amvuttra, the company is sticking to its previously announced guidance for the pair to generate between $1.6 billion and $1.725 billion in 2025.For the company overall, revenue was up in the quarter 20% to $594 million. Alnylam is guiding to overall sales of between $2.05 billion and $2.25 billion, which would be a 31% increase year over year at midpoint.