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Welcome back to Endpoints Weekly, thanks for starting your weekend with us. This week’s news was dominated by Robert F. Kennedy Jr.’s confirmation hearings to be HHS Secretary, as Kennedy faced two rounds of questions from multiple Senate committees. It’s looking like a vote will either pass or fail by the slimmest of margins, so keep tuning in to our coverage — and live blogs! — of President Donald Trump’s new administration. Elsewhere in biopharma, earnings season started to get rolling in earnest, with some of the biggest companies like Roche, Novartis, AbbVie and more reporting full-year results from 2024. We’re expecting another big round of earnings next week from the likes of Merck, Pfizer, Eli Lilly and GSK, followed by much of the biotech world in the ensuing weeks. We also had big news this week from Leerink, which is making a comeback after the Silicon Valley Bank fiasco, more developments on the Inflation Reduction Act with regard to President Trump’s HHS communications freeze as it continues to affect agencies, and some long-term MASH data from Akero. Grab a coffee and take a load off as we get into the week’s biggest stories. — Max Gelman 🏛️ Kennedy faced two hearings this week as the Senate took up his nomination for HHS Secretary. The first, which took place Wednesday, was held by the Finance Committee that will ultimately decide whether he can advance to a full Senate vote to be confirmed. While he faced a grilling, Kennedy emerged relatively unscathed. He faced a second panel, held by the Health, Education, Labor and Pensions, or HELP, committee, in a courtesy hearing that will help inform the Finance Committee’s decision. Thursday’s hearing was much more contentious as Kennedy repeatedly declined to refute his past comments that vaccines cause autism, failed to explain the differences between Medicare Parts A, B and C and defended race-based conspiracy theories about how different “antigen levels” in a person’s immune system depend on their skin color and should impact vaccine schedules. And in written answers to follow-up questions from senators submitted Friday, Kennedy continued to avoid directly giving an answer on the debunked claim that vaccines cause autism. Kennedy can’t lose more than three Republican votes . The GOP currently has a 53-47 majority in the Senate, and all Democrats are expected to oppose him despite some early flirtations by Sens. Bernie Sanders (I-VT) and John Fetterman (D-PA) as potential crossover votes. ( Watch how Thursday’s hearing ended. ) Other senators who are likely, but not confirmed, to vote no are Susan Collins (R-ME), Lisa Murkowski (R-AK) and Mitch McConnell (R-KY), a polio survivor who voted against Trump’s pick for Secretary of Defense, Pete Hegseth. Senator Bill Cassidy (R-LA) has emerged as the key vote to confirm Kennedy. Not typically one to break ranks with his fellow Republicans, Cassidy is a longtime physician who sits on both committees that interviewed Kennedy and is chair of the HELP committee. Cassidy opened his remarks Thursday by lamenting how some of the Hepatitis patients he used to work with who died could have been saved if they’d received vaccines as infants. By the end, he said he was still “struggling” with his vote and told Kennedy he’d be reaching out to him over the weekend. Kennedy appeared to shore up support from other undecided Republicans, however. Senators James Lankford (R-OK) and Thom Tillis (R-NC) had earlier expressed reservations about voting for Kennedy. Lankford, who has called himself the “most pro-life senator,” said he was concerned over Kennedy’s past comments on abortion, while Tillis seemed hesitant over his anti-vaccine activism. But both asked friendly questions during their allotted times, and Tillis said afterward he’s leaning toward voting yes. 💵Earnings season is upon us. Several drugmakers gave fourth-quarter updates this week, including Roche , which laid out its M&A strategy during a media call. CEO Thomas Schinecker highlighted the company’s recent Carmot and Poseida acquisitions as blueprints for future deals. And he said Roche would look to China as a source of “potential innovations that we could take over.” Sanofi also hinted at M&A ambitions during a media call on Thursday morning. “We have always been very active in the M&A space. We may be a bit more in the near future due to the fact that we have a strong balance sheet,” CFO François Roger said. CEO Paul Hudson said on a separate call that Sanofi would likely target preclinical and Phase 1 assets. But Roger added that the company “doesn’t feel any pressure to go crazy on M&A” and would be “very disciplined.” Takeda’s longtime CEO Christophe Weber announced his retirement in the company’s third-quarter earnings update this week. Julie Kim, current president of Takeda’s US business unit, will take over in June 2026 as the company’s first female CEO. Until then, Weber will continue to steer Takeda through a multiyear restructuring he announced last May. Teva also revealed a handful of pipeline cuts this week, including a Phase 3 treatment for a form of epilepsy. AbbVie touted the success of Skyrizi and Rinvoq, raising its combined 2027 sales outlook for the two drugs by $4 billion. CEO Rob Michael said the strategy is expected to “drive a rapid return to growth for the company beyond Humira,” which faced its first biosimilar competition in 2023. And Teva told Endpoints News it expects sales growth to continue for Austedo, even after it becomes subject to prices negotiated under the Inflation Reduction Act. 📂Leerink Partners is on a hiring spree to build out its M&A practice. The investment bank has landed several veteran Wall Street dealmakers, and told Endpoints’ Andrew Dunn that it’s at a “distinct pivot point” in M&A. Leerink reemerged following the 2023 collapse of Silicon Valley Bank, which had acquired Leerink in 2019. Founder and CEO Jeff Leerink bought the firm back through bankruptcy proceedings. Now Leerink says it’s “at the strongest point in our history.” 💊The company’s stock price nearly doubled on new data looking at its efruxifermin program in the severe form of MASH, showing a 24% benefit on fibrosis reduction over placebo in a crucial mid-stage trial. Elizabeth Cairns notes there’s nuance to these data, however, as they come from the higher 50 mg dose in the so-called completer analysis. In the intention-to-treat analysis, the benefit over placebo shrank to 17%. That analysis counted the 47 patients who were dosed with efruxifermin but who had missing week 96 data as treatment failures. The drug could still get approved as there are still no treatments on the market for severe MASH, and this week’s data were nominally statistically significant. CMS announced that it will consider “opportunities to bring greater transparency” to the Medicare drug price negotiation process under the Inflation Reduction Act. It’s the first time the Trump administration has commented on how it plans to run the second cycle of negotiations, which begin in about a month. The administration said it is “committed to incorporating lessons learned to date from the program,” but also intends to give stakeholders the chance to “provide specific ideas to improve the negotiation program.” 🗓️Meanwhile, one February FDA advisory committee meeting has been canceled and another has been delayed as the presidential transition continues. A Feb. 24 meeting to discuss a label expansion for Novartis’ Fabhalta was canceled , while a Feb. 5 meeting on opioids was postponed. The cause for the meeting changes remains unclear. DON’T MISS:

Novartis said Friday that last year was one of its “strongest” financial performances in its history following a multiyear reorg as a pure-play pharma company, bolstered by steady growth of its top three medicines and a skyrocketing cholesterol franchise. CEO Vas Narasimhan said on a media call that the company exceeded its full-year guidance for both sales and operating income. The Swiss drugmaker’s 2024 sales grew 12% to $45.4 billion, according to an earnings release . The update was not a complete surprise, because the company upped its sales guidance through 2028 in November. Novartis’ cholesterol drug Leqvio saw the most growth in 2024, with sales soaring 112% to $754 million. But its top three best sellers were heart failure medicine Entresto ($7.8 billion), psoriasis treatment Cosentyx ($6.1 billion) and multiple sclerosis drug Kesimpta ($3.2 billion). In 2023, the company completed a long-term restructuring process that saw it integrate its pharmaceuticals and oncology business units into a so-called innovative medicines unit, and zero in on four core therapeutic areas: cardiovascular, renal and metabolic (CRM), as well as oncology, immunology and neuroscience. “When you look at [this change] from a value creation standpoint, in January 2018 the market capitalization of Novartis was $196 billion, and you can see today that [it] stands at over $200 billion,” Narasimhan said on the second media call. “The strategy of focusing the company has unlocked value and actually enabled Novartis to be much stronger for the long run.” Last year, the drugmaker slashed the size of its development and commercial functions with an eye to a leaner structure that would allow it to focus on “the biggest opportunities” in its pipeline. It’s targeting 15 new launches or label expansions over the next few years, starting with a potential indication for its immunoglobulin A nephropathy drug Fabhalta. The factor B inhibitor was due for an FDA adcomm meeting next month to discuss its risk-benefit profile in C3 glomerulopathy, but the agency called the meeting off earlier this week. “Our understanding is that the FDA no longer deemed it necessary to hold an advisory committee meeting,” Narasimhan told reporters. “We think it’s based on the overall data package we’ve been able to generate and the additional follow-on data that we’ve provided.” Narasimhan also stressed that Novartis remains a leader in the radiopharmaceutical space, with close to $2 billion in yearly sales from radioligand products, a global manufacturing footprint and more than 15 assets in the clinic using lutetium or actinium isotopes. The company made several investments in the approach last year, including a $1 billion bet on Mariana Oncology. Novartis plans to carry on with this kind of dealmaking , Narasimhan said. “But I think it’s really important to note that right now, lutetium is the isotope that has the most data and is the only approved isotope,” he continued, adding that newer isotopes such as actinium and lead have yet to demonstrate the necessary risk-benefit profile for approval and broad use. Also on the call, the company’s chief medical officer Shreeram Aradhye said it had discontinued development of a Phase 2 candidate for Sjögren’s syndrome. Novartis dropped work on anti-CD40 antibody iscalimab because its risk-benefit profile to date was not competitive, Aradhye said. But the company is still advancing another antibody program for Sjögren’s called ianalumab. In 2022, the drugmaker gave up on advancing iscalimab for liver transplant patients for similar reasons. Editor’s note: This story has been updated to add more comments from the company’s calls.