Cidara Therapeutics, Inc.

Welcome back to Endpoints Weekly. It’s going to be a chilly weekend here in Boston, with low temperatures dipping into the 30s — the perfect weather for a warm cup of tea while recapping another busy week in biopharma. If you haven’t already, be sure to read the Endpoints team’s exclusive on how Pfizer closed its deal with Metsera. We also have a feature from Max Gelman on how competition is stacking up in the PD-(L)1xVEGF space, details on Richard Pazdur’s appointment to CDER, some positive results for Roche’s BTK inhibitor, and the story behind a new VC firm hunting for the next big advances in obesity treatment. We’ll be back on Monday. Until then, stay warm! — Nicole DeFeudis 💇‍♂️Pfizer completed its up to $10 billion acquisition of the obesity biotech Metsera this week, ending a high-stakes bidding war between Pfizer and Novo Nordisk. Last week, we reported that Metsera had accepted Pfizer’s offer after the FTC warned the biotech that Novo’s bid was risky under US antitrust law. But you can see exactly how the final deal unfolded in this exclusive by Endpoints’ Elizabeth Cairns, Kyle LaHucik and Drew Armstrong — including how Metsera’s co-founder Paul Berns was in the middle of a haircut when he was alerted that Novo was submitting its surprise offer. The deal gives Pfizer a fresh chance in obesity after the company dropped its obesity pill danuglipron in April. Novo fought hard for Metsera, as it looks to maintain a leading stake in the obesity market. But even though Pfizer won the battle, all eyes will be on how the experimental drugs it acquired perform in trials. Stay tuned. 🏎️ Drugmakers in the PD-(L)1xVEGF space are revving their engines, Endpoints’ Max Gelman reported this week. While much of the focus has been on Summit Therapeutics and its lead drug ivonescimab, two other rival teams have recently detailed their clinical development plans. Check out Max’s in-depth look at the competition here. One of the challengers is Pfizer and 3SBio, which inked a licensing deal for a PD-1xVEGF bispecific called SSGJ-707, or PF’4404, earlier this year. Pfizer said on Monday that among other trials, it has plans for a Phase 3 study in first-line metastatic colorectal cancer and a Phase 3 non-small cell lung cancer study evaluating both squamous and non-squamous tumors. Bristol Myers Squibb and BioNTech are also in the running. They teamed up this year to advance a PD-L1xVEGF program that BioNTech got in its Biotheus acquisition. Bristol Myers outlined plans for five mid- and late-stage studies during an earnings call last month, and BioNTech said this week that it’s also looking at studies in pancreatic cancer, ovarian cancer and glioblastoma. Both companies intend to look at combinations within their respective pipelines, Max reported. Despite all the momentum, the race could take a while to play out as Summit plans to launch more studies and we wait for key data from Pfizer and BMS. Longtime cancer chief Richard Pazdur was appointed to lead the Center for Drug Evaluation and Research, just over a week after former director George Tidmarsh’s sudden resignation. Pazdur has 26 years of experience at the agency and is the founding director of the FDA’s Oncology Center of Excellence. During his time at the FDA, he has been focused on speeding up the development of new cancer therapies. Pazdur vs. Prasad: Current CBER Director Vinay Prasad previously criticized Pazdur in social media posts before Prasad joined the FDA. Endpoints’ Zachary Brennan analyzed the complex dynamic and the events that led to Pazdur’s appointment here. 💵Two former executives of Lilly’s diabetes unit have launched a venture capital firm called 501 Ventures, and they’re looking for the next approaches to obesity treatment. The firm will fund science for next-generation metabolic health medicines. Its founders, Enrique Conterno and Meg Powell, wouldn’t disclose the amount of capital they’re working with so far. But Powell said they’ll court pharma companies to help support the fund. Kyle LaHucik reported the details from this year’s ObesityWeek conference in Atlanta. Read more here . Roche reported positive results from two separate Phase 3 trials that tested fenebrutinib  in relapsing multiple sclerosis and primary progressive multiple sclerosis. Roche hasn’t shared the detailed results, but CMO Levi Garraway described the wins as “unprecedented.” Roche said it will wait for data from a second Phase 3 RMS trial before finalizing regulatory filing plans.

Merck will acquire Cidara Therapeutics in a nearly $9.2 billion deal , the companies said on Friday, gaining access to an experimental drug for flu prevention . Merck is looking to diversify its revenue beyond Keytruda as its patents for the blockbuster drug begin to expire later this decade. The drugmaker will pay $221.50 per share in cash for Cidara, a premium of 108.9% from its last closing price. Shares of Cidara, which has a market capitalization of $3.3 billion, doubled in value to $216.05 in premarket trading. Merck, through a subsidiary, will acquire all of Cidara's outstanding shares. The transaction has an equity value of $6.96 billion, according to a Reuters calculation. Since 2021, Merck has nearly tripled its late-stage pipeline, combining in-house development with deals such as the $11.5  billion purchase of Acceleron in 2021, which netted the pulmonary arterial hypertension drug Winrevair. In July, Merck signed its $10 billion buyout of UK-based Verona Pharma gaining Ohtuvayre, a newly approved drug for chronic obstructive pulmonary disease, commonly known as "smoker's lung". Cidara is developing its long-acting antiviral drug CD388, which has the potential to be a single-dose, universal prevention against all flu strains. "We are confident that CD388 has the potential to be another important driver of growth through the next decade," said Merck CEO Robert Davis. It belongs to a class known as drug-Fc conjugates that links a drug to a human antibody fragment and is being studied in late-stage trial in adults and adolescents who are at higher risk of developing complications from influenza. A single dose of the antiviral gave up to 76% protection from symptomatic influenza over 24 weeks compared to placebo, in mid-stage trial studying the drug in healthy unvaccinated adults aged 18 to 64. The deal is expected to close in the first quarter of 2026. (Reporting by Sriparna Roy in Bengaluru; Editing by Arun Koyyur)

Merck said Friday it is buying Cidara Therapeutics in a deal worth $9.2 billion, centered around the biotech’s late-stage preventive antiviral biologic for seasonal influenza. The large pharma will pay $221.50 per share in cash, and the deal is expected to close in the first quarter of next year. The deal value represents a threefold boost over Cidara’s market cap of $3.3 billion when trading closed Thursday. Johnson & Johnson was previously working with Cidara on the antiviral, named CD388, in a deal that featured $27 million upfront. In 2024, Cidara took back the rights to the candidate. Observers have been keeping a close eye on how Merck would bolster its pipeline in the face of the upcoming patent cliff for Keytruda. Merck CEO Rob Davis told analysts during its third-quarter earnings call in October that it is reviewing how it can bolster its portfolio “ with urgency .” And it appears Merck may have a penchant for respiratory assets. Earlier this year, Merck bought Verona Pharma for its pulmonary disease therapies in a deal worth $10 billion. On Thursday, before the Cidara deal was announced, the Financial Times reported that a bidding war ensued for the biotech. This is a stark contrast to Merck’s move on Verona, where the large drugmaker was its only bidder . It is, however, reminiscent of the recently concluded contest between Novo Nordisk and Pfizer for the obesity biotech Metsera. Also on Friday, another bidding war started for the sleep biotech Avadel Pharmaceuticals between Alkermes and Lundbeck. Cidara, when reporting its earnings earlier this month, said its Phase 3 trial of CD388 is forecast to meet its 6,000-participant target by December. The study is recruiting healthy adults aged 65 years and over, as well as participants aged 12 years or older who are immunocompromised or at high risk of comorbidities. Interim data analysis is expected in Q1 next year. Last month, Cidara got an award from the US Biomedical Advanced Research and Development Authority (BARDA) worth up to $339 million to move the production of CD388 to the US and for further clinical research. CD388 features an Fc fragment of a human antibody that is conjugated with a small molecule inhibitor of viral neuraminidase. The biotech’s other assets are yet to enter the clinic. CBO421, which is in an IND-enabling stage, is designed to target CD75 for solid tumors. There are also two preclinical cancer assets, targeting CD73/PD-1 and CCR5, respectively.