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AVDL-News
AVDL-Events
Monopar Therapeutics Appoints Susan Rodriguez as Chief Commercial and Strategy Officer
Monopar Therapeutics (MNPR) announced the appointment of Susan Rodriguez as Chief Commercial and Strategy Officer, effective immediately. In this newly created executive role, Ms. Rodriguez will lead the Company's commercial strategy and infrastructure build-out as Monopar prepares for the planned submission of a New Drug Application to the U.S. Food and Drug Administration in the first half of 2026 for ALXN1840, its late-stage investigational therapy for Wilson disease. She most recently served as COO of Avadel Pharmaceuticals (AVDL).
Avadel Pharmaceuticals and Alkermes Reach Acquisition Agreement
Avadel Pharmaceuticals (AVDL) announced that the Irish High Court has sanctioned, without modification, the scheme of arrangement between Avadel and its shareholders under Chapter 1 of Part 9 of the Irish Companies Act 2014 pursuant to which Alkermes (ALKS) will acquire the entire issued and to be issued ordinary share capital of Avadel. Completion of the proposed transaction remains subject to the delivery to the Registrar of Companies of a copy of the Court Order sanctioning the Scheme. Assuming that a copy of the Court Order is processed and made available to Avadel by no later than February 11, the Court Order is expected to be delivered to the Registrar of Companies on February 12 and, accordingly, the Scheme is expected to take effect on February 12. Accordingly, February 11 is expected to be the last date on which trading of Avadel Shares on Nasdaq will occur. It is expected that Avadel will request Nasdaq halt trading of the Avadel Shares effective as of 8.00 p.m. on February 11.
Avadel Pharmaceuticals Shareholders Approve Acquisition Scheme
Avadel Pharmaceuticals (AVDL) announced that, in relation to the previously announced offer for the company by Alkermes (ALKS), pursuant to which Alkermes will acquire the entire issued and to be issued ordinary share capital of the company, the resolutions required to approve the scheme of arrangement under Chapter 1 of Part 9 of the Irish Companies Act 2014 were passed by the requisite majorities at the scheme meeting of shareholders and the related extraordinary general meeting of shareholders held earlier.
Avadel Pharmaceuticals Completes Patient Enrollment in REVITALYZ Trial
Avadel Pharmaceuticals announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM extended-release oral suspension as a potential treatment for idiopathic hypersomnia. The primary objective of REVITALYZ is to demonstrate reduction in daytime sleepiness as measured by the primary endpoint, change in total score on the Epworth Sleepiness Scale at Week 14. Secondary endpoints will evaluate the effect of LUMRYZ on additional efficacy parameters including patient and clinician impression of change, idiopathic hypersomnia severity, and a measure of the functional outcomes of sleep.
Alkermes Raises Acquisition Bid for Avadel Pharmaceuticals to $22.50 per Share
Alkermes (ALKS) and Avadel Pharmaceuticals (AVDL) announced that the companies have reached agreement on the terms of an increased recommended offer under which Alkermes will acquire Avadel for total transaction consideration of up to $22.50 per share, consisting of $21.00 in cash and one non-transferable contingent value right entitling holders to a potential additional cash payment of $1.50 per share, contingent upon final FDA Lumryz approval for the treatment of idiopathic hypersomnia in adults by the end of 2028. In connection with the increased offer, Alkermes and Avadel have entered into an amendment, dated November 18 to the definitive transaction agreement between the parties previously entered into and announced on October 22. The increased offer values Avadel at up to approximately $2.37B, assuming the milestone payment is made. The transaction, as revised by the increased offer and the amendment, has been approved by the boards of directors of Alkermes and Avadel and, subject to the satisfaction of the conditions, it continues to be expected to close in the first quarter of 2026. On November 14, Avadel announced that it had received an unsolicited proposal from H. Lundbeck A/S to acquire Avadel and that the Lundbeck Proposal was reasonably expected to constitute a company superior proposal. On November 17, Avadel further announced that the board of directors of Avadel had determined in good faith, after consultation with its financial and legal advisors, that the Lundbeck Proposal constituted a "Company Superior Proposal" for the purposes of the transaction agreement. Following this determination, Alkermes submitted the terms of its proposed Increased offer to Avadel on November 18. After assessing both the Lundbeck Proposal and Alkermes' increased offer and revised terms with its outside legal counsel and financial advisors, the board of directors of Avadel has determined that the Lundbeck Proposal no longer constitutes a "Company Superior Proposal" for the purposes of the transaction agreement. In making this determination, the board of directors of Avadel determined that while the upfront cash consideration of $21.00 per share in Alkermes' increased offer is identical to the cash consideration proposed in the Lundbeck Proposal, the terms of the CVR in Alkermes' increased offer are superior to the terms of the CVR included in the Lundbeck Proposal, which was determined to be unlikely to be achieved.
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