Welcome to our dedicated page for Alkermes Plc news (Ticker: ALKS), a resource for investors and traders seeking the latest updates and insights on Alkermes Plc stock.
Alkermes plc (ALKS) develops and commercializes medications for central nervous system disorders, making its news flow particularly relevant for investors tracking the biopharmaceutical sector. The company's focus on schizophrenia, depression, addiction, and multiple sclerosis means that clinical trial results, regulatory decisions, and product launch announcements carry significant weight for the stock.
This news feed captures the types of developments that move biopharmaceutical companies: clinical trial topline results revealing whether investigational drugs meet their efficacy endpoints, FDA decisions that determine whether products reach the market, and quarterly earnings reports that detail product revenue trends and pipeline advancement. For Alkermes specifically, investors watch for updates on its commercial products' prescription trends, progress of pipeline programs through clinical development phases, and announcements regarding its proprietary drug delivery technology partnerships.
Biopharmaceutical company news requires understanding the distinction between various clinical trial phases, the significance of primary versus secondary endpoints, and the regulatory pathway differences between new molecular entities and reformulations. Partnership announcements for Alkermes' drug delivery platforms can signal future royalty revenue streams, while manufacturing or supply updates may impact product availability and revenue recognition.
Track this news feed to follow how Alkermes' pipeline programs advance through development, how its commercial products perform in competitive CNS markets, and how the company navigates the complex regulatory landscape for psychiatric and neurological medications. The coverage includes investor presentations, conference participation, and material events that provide insight into the company's strategic direction and operational execution.
Alkermes (Nasdaq: ALKS) announced that the U.S. FDA granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1 (NT1) on January 6, 2026.
The designation is based on phase 1 and phase 2 data, including positive results from Vibrance-1 (n=92), where alixorexton met the primary endpoint with statistically significant, dose-dependent improvements on the Maintenance of Wakefulness Test (MWT) and was generally well tolerated. Alkermes plans to initiate a global phase 3 program in Q1 2026.
Alkermes (Nasdaq: ALKS) said CEO Richard Pops will deliver a corporate overview at the 44th Annual J.P. Morgan Healthcare Conference on Jan. 13, 2026 at 10:30 a.m. PST (1:30 p.m. EST / 6:30 p.m. GMT).
The presentation will be available live via webcast under the Investors tab at www.alkermes.com and will be archived for 14 days.
Alkermes is a mid-cap biopharmaceutical company focused on neuroscience, with marketed products for alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a clinical pipeline including programs in narcolepsy and idiopathic hypersomnia.
Alkermes (Nasdaq: ALKS) said management will participate in two investor conferences in early December 2025: the 8th Annual Evercore Healthcare Conference on Dec. 3, 2025 at 2:10 p.m. ET and the Piper Sandler 37th Annual Healthcare Conference on Dec. 4, 2025 at 12:00 p.m. ET.
The company said live webcasts will be available under the Investors tab at www.alkermes.com and that the webcasts will be archived for 14 days. Alkermes is described as a mid-cap biopharmaceutical company focused on neuroscience, with marketed products for alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder and a clinical/preclinical pipeline including narcolepsy and idiopathic hypersomnia. Headquarters: Ireland; R&D office: Massachusetts; manufacturing: Ohio.
Alkermes (Nasdaq: ALKS) agreed to increase its recommended offer to acquire Avadel (Nasdaq: AVDL) to up to $22.50 per share — consisting of $21.00 cash plus one non-transferable contingent value right (CVR) payable up to $1.50 if final FDA approval for LUMRYZ for idiopathic hypersomnia in adults is achieved by the end of 2028.
The Increased Offer values Avadel at up to approximately $2.37 billion. The Amended Agreement was approved by both boards and the transaction remains expected to close in Q1 2026, subject to customary conditions and an extended End Date. J.P. Morgan provided fully committed financing for Alkermes.
Alkermes (Nasdaq: ALKS) responded on November 14, 2025 to Avadel's announcement about a possible Lundbeck offer for Avadel. Alkermes said its board is considering options with advisors and reiterated contractual protections in the existing Transaction Agreement.
Key contractual points: Avadel cannot terminate the agreement to accept a Company Superior Proposal unless its board, in good faith, determines doing so meets fiduciary duties and Avadel gives Alkermes at least five (5) Business Days written notice and engages in good‑faith discussions about amendments. Avadel also cannot change its board recommendation or sign with Lundbeck until those steps occur. Alkermes said a further announcement will follow as appropriate and will post this release on its website by 12:00 p.m. ET on November 17, 2025.
Alkermes (Nasdaq: ALKS) announced positive topline results from the Vibrance-2 phase 2 study of once-daily alixorexton in patients with narcolepsy type 2 on Nov. 12, 2025. In a randomized, double-blind trial (n=93) alixorexton met dual primary endpoints at week eight: clinically meaningful improvements in wakefulness (MWT) and excessive daytime sleepiness (ESS) versus placebo.
By pre-specified analysis, the 14 mg and 18 mg doses achieved statistical significance on MWT, and the 18 mg dose achieved statistical significance on ESS. Alixorexton was generally well tolerated; most TEAEs were mild-to-moderate and no serious TEAEs were reported. Alkermes plans to start a global phase 3 program in Q1 2026.
Alkermes (Nasdaq: ALKS) said management will participate in two investor conferences in November 2025: the Stifel 2025 Healthcare Conference on Nov. 13, 2025 at 2:40 p.m. ET and the Jefferies Global Healthcare Conference in London on Nov. 19, 2025 at 11:30 a.m. ET.
Both events will be webcast live and the webcasts will be available under the Investors tab at www.alkermes.com and archived for 14 days.
Alkermes (Nasdaq: ALKS) filed an Opening Position Disclosure (Form 8.1(a)&(b)) under Irish Takeover Panel rules on 5 November 2025 with a position date of 3 November 2025. The form names Avadel Pharmaceuticals plc as the related offeror/offeree and states Alkermes as the offeror. The disclosure reports no indemnities, option arrangements, or derivative agreements and no supplemental Form 8 attached. It lists J.P. Morgan staff holdings totalling 13,553 ordinary shares (0.0139%) in Avadel, split between two entities (53 and 13,500 shares).
Alkermes (Nasdaq: ALKS) reported Q3 2025 total revenues of $394.2 million and GAAP net income of $82.8 million (diluted EPS $0.49) for the quarter ended Sept. 30, 2025. Total proprietary net sales were $317.4 million, led by VIVITROL $121.1M, ARISTADA i $98.1M and LYBALVI $98.2M (LYBALVI +32% revenue, +25% prescriptions vs Q3 2024).
The company recorded cash and investments of $1.14 billion and raised its 2025 outlook: total revenues to $1.43–$1.49B, GAAP net income to $230–$250M, EBITDA to $270–$290M and adjusted EBITDA to $365–$385M. R&D expense for the quarter was $81.7M.
Alkermes (Nasdaq: ALKS) agreed to acquire Avadel (Nasdaq: AVDL) for $18.50 per share in cash plus a non-transferable CVR of $1.50 per share contingent on FDA approval for idiopathic hypersomnia, valuing the deal at up to $20.00 per share and ≈$2.1 billion. The boards approved the transaction, which is expected to close in Q1 2026 subject to regulatory and shareholder approvals.
The acquisition adds FDA-approved LUMRYZ (once-at-bedtime sodium oxybate) with expected 2025 net revenues of $265–$275 million, ~3,100 patients on therapy as of June 30, 2025, and a U.S. oxybate-eligible population >50,000. Alkermes expects the deal to be immediately accretive and will finance with cash on hand plus new debt, with J.P. Morgan providing committed financing.
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