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Quick Update on BioPharma News
- Jana Chisholm
- Dec 28, 2025
- 5 min read
Last week we had Eyes On more M&A counter offers + the success of M&A as Kura Oncology's Komzifti gets approved in the US (partner Kyowa Kirin). What caught you eye in BioPharma News lately?
More M&A Drama with Avadel
Updated to share the final details (fromFierce Pharma). Alkermes and Avadel agreed on a new offer of up to $22.50 per Avadel share. The upgraded bid features $21 per Avadel share in plus a CVR of up to $1.50 per share based on the potential FDA approval of Avadel’s narcolepsy drug Lumryz in idiopathic hypersomnia by the end of 2028. The increased bid values Avadel at $2.37 billion, contingent upon the Lumryz milestone paying out.
A surprising counteroffer put another planned biopharma acquisition in jeopardy just as Pfizer and Novo Nordisk’s brief Metsera bidding war was coming to an end. Lundbeck, which disclosed last week that it has submitted an offer valuing the target firm at $23 per share, interfering with Alkermes’ planned acquisition of its Irish bipharmaceutical rival, Avandel Pharmaceuticals.
In addition to a contingent value right (CRV) that could result in two additional $1-per-share payments linked to future sales milestones for Avandel’s narcolepsy medication Lumryz and its recently acquired sleep aid valiloxybate, Lundbeck’s proposal included $21 per ordinary Avandel share at the time of the acquisition’s close. The bid for Dublin-based Avandel follows the announcement last month by fellow Irish pharmaceutical company Alkermes that it intended to buy its neighbour for up to $20 per share, or $2.1 billion in total. Analysts estimate that Avandel is worth about $2.25 billion based on Lundbeck’s offer.
The business stated that after considering Lundbeck’s proposal, Avadel’s board of directors has decided in good faith that the offer will probably be regarded as better under its present contract with Alkermes. Avandel’s board is now authorised to give information to and engage with the bidder because Lundbeck’s offer appears more attractive, but it is still unable to end its current contract with Alkermes or make any new agreements with Lundbeck. In response to the Lundbeck bid, Alkermes stated that its board is currently reviewing its alternatives with advisors.
Alkermes reaffirmed that Avandel cannot end the prior acquisition contract unless certain conditions are met. Notably, before Avadel could accept a different offer, it would have to return to the negotiation table with Alkermes. Alkermes’ offer for Avadel, which was initially made public on October 22, was $18.50 per Avadel share, with a possible CVR of $1.50 per share if the FDA approves Lumryz, which is now approved for narcolepsy, for idiopathic hypersomnia by the end of 2028. Alkermes had stated at the time that it anticipated closing the purchase in the first quarter of 2026 and that the addition of Avadel would result in an instant increase in revenue.
In the meantime, Lundbeck is moving on with its so-called Focused Innovator strategy, which calls for the company to transition its operations in Europe and abroad to a partnership model. By the following month, the new model should be completely operational. The Danish pharmaceutical company is essentially trying to concentrate its commercial engine around more expensive, cutting-edge medicinal items, with a focus on its medications Vyepti and Rexulti.
The recent bidding war between Lundbeck and Alkermes follows a similar dispute with the obesity biotech Metsera. In the end, Metsera accepted Pfizer’s offer because the biotech’s board thought Novo’s offer included unacceptably significant legal and regulatory risks.
Pfizer agreed to pay up to $20.65 per share via a CRV in addition to $65.60 per share up front for Metsera under the terms of the final agreement. This represents an overall deal value of almost $10 billion, which is significantly higher than the up to $7.3 billion deal Pfizer had originally suggested.
For more details:
Kyowa Kirin’s large investment in Kura Oncology quickly paid off, when the FDA approved a Komzifti to treat a subset of patients with acute myeloid leukaemia.
Kura’s menin inhibitor ziftomenib was approved by the FDA last week as a novel treatment for adults with refractory or relapsed acute myeloid leukaemia (AML) who have a susceptible nucleophosmin 1 (NPM1) mutation. According to the FDA, patients must not be a good fit for any alternative treatments in order to be eligible for the medication, which will be sold under the brand name Komzifti.
Although there have historically been few specific therapy choices for the approximately one-third of AML patients with NPM1 mutations, Syndax Pharmaceuticals made history last month when the FDA approved its medication Revuforj as the first menin inhibitor in the indication. Syndax’s medication was first authorised in November of last year to treat lysine methyltransferase 2A (KMT2A), a hereditary form of leukaemia. Since both medications belong to the same class, there will probably be direct competition between them for the indication. According to Kura and Kyowa Kirin, NPM1 mutations are among the most prevalent founder mutations in AML. According to the partners, about 20% of patients with NPM1-m AML do not respond to frontline therapy, and of those who do, about 70% will recur within three years.
After analysing data from the partner’s key KOMET-100 trial, where 21.4% of patients on Komzifti achieved complete remission (CR) or CR with patial haematologic recovery (CRh), the FDA gave its approval, according to Kura and Kyowa Kirin. According to the partners, the median length of remission for individuals who attained CR or CRh was five months. Additionally, Kura and Kyowa Kirin noted that 88% of patients who achieved either CR or CRh did so within six months of beginning therapy with Komzifti. Komzifti will have a boxed warning for differentiation syndrome, a potentially serious reaction to some leukaemia therapies. However, these risks can be mitigated if patients and physicians are more careful about the medications they take with Komzifti. Additionally, the medication carries risks related to embryo-fetal damage and QTc interval prolongation. Similar cautions and warnings are found on Syndax’s Revuforj label, which includes boxed warnings about the risks of Torsades de Pointes, QTc prolongation, and differentiation syndrome.
Analysts stated that the overall safety profile of Kura and Kyowa’s medication appears to be slightly better than that of Revuforj, noting that a differentiation syndrome boxed warning for the menin inhibitor class is not particularly surprising.
Just under a year ago, Kyowa Kirin joined forces with Kura and Ziftomenib, investing $330 million up front in November of last year and offering up to $1.1 billion in possible milestones to divide the asset’s development and commercialisation. As part of the agreement, Kyowa Kirin will handle R&D and marketing responsibilities outside of the United States, while Kura will handle development, manufacturing, and regulatory and commercial strategy for Komzifti in the United States.
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