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By PharmaCompass
2025-11-20
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In this week’s Phispers, Merck struck a US$ 9.2 billion deal to acquire Cidara Therapeutics to strengthen its infectious-disease portfolio. Johnson & Johnson announced the acquisition of Halda Therapeutics for US$ 3.05 billion in cash. And Eli Lilly signed a US$ 2.6 billion licensing pact with South Korea’s ABL Bio to develop multiple bispecific antibodies. Separately, a bidding contest emerged in sleep medicine, with Lundbeck topping Alkermes’ earlier offer for Avadel.
More drugmakers committed investments in the US. Novartis is building a manufacturing hub in North Carolina; CSL is committing US$ 1.5 billion to expand its plasma-therapy operations and; Regeneron unveiled plans for a US$ 2 billion production facility in New York.
In approvals, the US Food and Drug Administration (FDA) cleared Kura Oncology-Kyowa Kirin’s Komzifti for adults with relapsed or refractory acute myeloid leukemia (AML). It also approved Arrowhead’s Redemplo for a rare metabolic disorder and granted accelerated approval to Bayer’s Hyrnuo for treating people with non-squamous non-small cell lung cancer (NSCLC). Meanwhile, the agency expanded the use of AbbVie and Genmab’s Epkinly for earlier treatment of follicular lymphoma. It also added a boxed warning to Sarepta’s Elevidys after the deaths of two non-ambulatory children with Duchenne muscular dystrophy (DMD).
In clinical trials, Bristol Myers Squibb halted a late-stage study in acute coronary syndrome after an interim readout suggested its therapy was unlikely to meet the main goal.
Merck expands infectious disease portfolio with US$ 9.2 bn Cidara buy
Merck has agreed to acquire Cidara Therapeutics in a deal valued at US$ 9.2 billion, strengthening its infectious disease portfolio ahead of expected revenue pressure from the loss of exclusivity for its blockbuster Keytruda (pembrolizumab). The transaction gives Merck access to Cidara’s experimental antiviral for influenza, which is designed to provide season-long protection with a single dose. The deal is subject to shareholder and regulatory review.
J&J to acquire Halda for US$ 3.05 bn: Johnson & Johnson is buying Halda Therapeutics for US$ 3.05 billion in cash, adding a set of early-stage cancer programs to its fast-growing oncology business. Halda’s lead candidate is being tested in prostate cancer, and the company also has experimental treatments for breast, lung, and other solid tumors.
Lilly signs up to US$ 2.6 bn bispecific antibody deal with South Korea’s ABL Bio
Eli Lilly has signed a licensing and research agreement with South Korea’s ABL Bio, paying US$ 40 million upfront and up to US$ 2.56 billion in milestones to access the company’s Grabody platform for developing multiple bispecific antibodies. The partners did not disclose the number of programs or disease areas they will pursue. Alongside the licensing deal, Lilly also made a KRW 22 billion (US$ 15 million) equity investment in ABL. The agreement follows a series of recent pipeline-building moves by Lilly.
Lundbeck outbids Alkermes with US$ 2.42 bn offer for sleep med-biotech Avadel
After the Pfizer-Novo Nordisk bidding war for Metsera, a new contest has emerged. This time for the sleep-medicine biotech Avadel Pharmaceuticals. Denmark’s Lundbeck has made an unsolicited offer worth up to US$ 2.42 billion, edging past Alkermes’ earlier bid of US$ 2.1 billion. Alkermes had previously agreed to acquire Avadel for US$ 20 per share, with closing expected in early 2026. Avadel now says Lundbeck’s proposal is “superior” and will begin discussions, though the Alkermes agreement technically remains in effect. Following Lundbeck's move, Alkermes also raised its offer to approximately US$ 2.37 billion.
FDA clears Kura-Kyowa Kirin’s med for relapsed leukemia with specific mutation
FDA has approved Komzifti (ziftomenib), a once-daily pill from Kura Oncology and Japan’s Kyowa Kirin, for adults with acute myeloid leukemia (AML) that has relapsed or stopped responding to treatment and has an NPM1 mutation, a change seen in about one-third of AML cases. Komzifti’s label includes a boxed warning for a serious treatment reaction, along with additional safety cautions.
Approves Bayer’s lung cancer pill: FDA has granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) for treating people with non-squamous NSCLC that has come back or spread after earlier treatment and is found to have a specific HER2 mutation.
FDA approves Arrowhead’s shot for rare genetic fat-metabolism disorder
FDA has approved Redemplo (plozasiran sodium), Arrowhead Pharmaceuticals’ first marketed drug, for adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder that causes extremely high levels of fat in the bloodstream. This disorder can cause abdominal pain and, in severe cases, can also lead to acute pancreatitis. The drug needs to be injected once every three months.
Okays Epkinly for follicular lymphoma: FDA has expanded AbbVie and Genmab’s Epkinly (epcoritamab), allowing the drug to be used earlier in treating relapsed or refractory follicular lymphoma. Epkinly can now be given in the second line alongside lenalidomide and rituximab.
Adds boxed warning to Sarepta’s gene therapy: FDA has added its strongest safety warning to Sarepta Therapeutics’ gene therapy Elevidys (Delandistrogene moxeparvovec), following the deaths of two non-ambulatory children with DMD due to acute liver failure. It has restricted the therapy’s use to ambulatory DMD patients aged four and older, removing its earlier approval for non-ambulatory DMD patients.
Novartis to build manufacturing hub in NC; Regeneron to invest US$ 2bn in NY
Following the recent US–Switzerland trade agreement to cut tariffs from 39 percent to 15 percent, Novartis has announced a new round of US investment. The move is part of a wider pledge by Swiss companies to invest US$ 200 billion in the US by 2028. Novartis will set up a flagship manufacturing hub in North Carolina, with plans for two new facilities in Durham for biologics production and sterile packaging, plus a new Morrisville site for solid dosage manufacturing.
Regeneron’s new NY site: Regeneron is investing US$ 2 billion in a new facility in New York. The site, a former Quad Graphics magazine-printing plant, will be rebuilt for pharmaceutical production. The project is expected to create at least 1,000 full-time jobs.
CSL to invest US$ 1.5 bn in US: Australian biotech CSL will invest about US$ 1.5 billion to expand its plasma-therapy manufacturing in the US over the next five years. The plan aims to strengthen its domestic production capabilities, support the US supply chain, and create “hundreds of high-quality American jobs,” the company said.
BMS halts late-stage heart study: Bristol Myers Squibb and Johnson & Johnson have stopped a phase 3 acute coronary syndrome study after an interim analysis showed the experimental therapy was unlikely to meet its main goal. The company said no new safety issues were found.
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