Alkermes plc (NASDAQ:ALKS) is one of the stocks Jim Cramer recently looked at. When a caller asked Cramer about the stock, he said: Okay… by this point, something should have happened, much better there than it has. I do not recommend the stock. I think it’s a hold, maybe a weak one. Photo by Joshua Mayo on Unsplash Alkermes plc (NASDAQ:ALKS) is a biopharmaceutical company that develops and sells medicines to treat schizophrenia, bipolar I disorder, and addiction to alcohol or opioids. On January 6, t ...

Core Insights - Alkermes (ALKS) has received Breakthrough Therapy Designation from the FDA for alixorexton, an oral orexin 2 receptor agonist, aimed at treating narcolepsy type 1 (NT1) [1][7] - The Breakthrough Therapy designation is designed to expedite the development and review of therapies for serious diseases with unmet medical needs [1] Company Developments - Alixorexton's Breakthrough Therapy designation is based on positive data from the phase I and phase II Vibrance-1 study, which showed significant improvements in wakefulness compared to placebo [3] - The Vibrance-1 study met its primary endpoint, demonstrating dose-dependent improvements in wakefulness as measured by the Maintenance of Wakefulness Test [3][4] - Treatment with alixorexton also significantly reduced excessive daytime sleepiness at week six, as measured by the Epworth Sleepiness Scale [4] - Alkermes plans to initiate a global phase III program for alixorexton in Q1 2026 [7][10] Market Context - Over the past year, Alkermes' shares have increased by 1.3%, while the industry has seen a rise of 14.2% [2] - Alixorexton is also being studied for narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), with positive data from the phase II Vibrance-2 study for NT2 announced in November 2025 [8][10] - The Vibrance-2 study showed statistically significant improvements in wakefulness and reductions in excessive daytime sleepiness for NT2 patients [8]

Alkermes plc (NASDAQ:ALKS) is one of the most promising mid-cap healthcare stocks under $50. At the close of play on December 19, the consensus ratings remain bullish for Alkermes plc (NASDAQ:ALKS). The stock has been covered by 15 analysts, of which 11 assigned it Buy ratings and the remaining 4 were Holds. As per analyst estimates, the forecasted median 1-year price target for the stock is $46.17 a share, resulting in 62.3% upside potential at the prevailing prices. Likoper/Shutterstock.com On Decemb ...

Core Viewpoint - Alkermes plc acknowledges the announcement by Avadel Pharmaceuticals plc regarding a potential acquisition offer from H. Lundbeck A/S for all issued and to be issued ordinary shares of Avadel [1][2]. Group 1: Transaction Agreement Details - The Transaction Agreement stipulates that Avadel cannot terminate the agreement to pursue a superior proposal unless the board determines that doing so is consistent with its fiduciary duties and that the Lundbeck offer qualifies as a superior proposal [3]. - Avadel must notify Alkermes in writing at least five business days prior to taking any action related to the Lundbeck offer and must engage in good faith discussions with Alkermes regarding any amendments to the Transaction Agreement [3]. Group 2: Future Announcements - Alkermes will make further announcements as appropriate regarding the situation and any developments related to the potential acquisition [4].

Summary of Alkermes Conference Call Company Overview - **Company**: Alkermes (NasdaqGS:ALKS) - **Event**: 2025 Conference on November 13, 2025 Key Industry Insights - **Focus Area**: Development of drugs for narcolepsy, specifically targeting narcolepsy type 1 (NT1) and type 2 (NT2) with the Rexin compound [2][8] - **Market Dynamics**: The company is addressing major unmet medical needs in the narcolepsy patient population, which has been historically under-researched [8][9] Core Findings from Recent Data Release - **Study Design**: The recent data release focused on NT2 patients, providing new insights into a previously under-studied population [9] - **Efficacy Signal**: The drug demonstrated a clear efficacy signal, particularly in the Maintenance of Wakefulness Test (MWT) at hour two and hour four, despite variability in patient responses [12][14] - **Tolerability**: Higher doses were well tolerated by NT2 patients, contradicting previous assumptions that higher doses would lead to increased adverse effects [10][17] - **Adverse Events**: Commonly reported adverse events included polyuria, urinary urgency, insomnia, and visual disturbances, but these did not significantly impact overall tolerability [17] Statistical Analysis and Drug Development - **Statistical Significance**: The study employed a phase three statistical plan in a phase two study, which complicated the interpretation of some lower doses [54][56] - **Dose Response**: There was a clear dose response observed in individual patient levels, although averaging across responders and non-responders obscured this [15][17] - **Future Studies**: Plans for phase three studies are underway, with a focus on both NT1 and NT2 populations, utilizing MWT and Epworth Sleepiness Scale (ESS) as primary endpoints [87][88] Competitive Landscape - **Market Position**: Alkermes is positioned as a pioneer in the NT2 space, with no direct competitors currently offering similar treatments [43][44] - **Comparison with Existing Treatments**: Current treatments like Provigil and Xyrem have not focused on pure NT2 cohorts, making Alkermes' data unique [46][50] Commercial Strategy and Financial Health - **Revenue Growth**: The company reported continuous growth driven by demand, with a billion-plus dollar top line generating significant profitability [94] - **Acquisition Strategy**: The acquisition of Avadel is being funded through cash generated from strong business performance, avoiding stock dilution [94] Regulatory Environment - **FDA Engagement**: Alkermes is preparing for a type B meeting with the FDA to discuss phase three study designs and endpoints, with expectations to initiate the program in early Q1 [87][88] - **PDUFA 8 Reauthorization**: The company is optimistic about the reauthorization of user fees that fund drug reviews, which is crucial for the drug development process [97][98] Future Directions - **Research Expansion**: Alkermes is exploring additional indications beyond narcolepsy and hypersomnolence, with plans to advance new rexins into clinical trials by 2026 [90] - **Focus on Cognition and Fatigue**: The company aims to incorporate measures of cognition and fatigue into future studies, addressing patient-reported outcomes that are critical for treatment satisfaction [88][89] This summary encapsulates the key points discussed during the conference call, highlighting Alkermes' strategic focus, recent findings, and future plans in the context of the narcolepsy treatment landscape.

Core Insights - Alkermes plc announced positive topline results from the Vibrance-2 phase 2 study for alixorexton in narcolepsy type 2, showing significant improvements in excessive daytime sleepiness and sleep latency compared to placebo [1][2][4] Group 1: Study Results - Alixorexton met dual primary endpoints, showing statistically significant improvements on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week eight [2] - The 14 mg and 18 mg doses of alixorexton achieved statistical significance in mean sleep latency improvements compared to placebo [3] - The 18 mg dose also showed statistically significant improvements in excessive daytime sleepiness on the ESS at week eight [4] Group 2: Safety and Tolerability - Alixorexton was generally well tolerated across all doses during the eight-week treatment period, with most treatment-emergent adverse events (TEAEs) being mild to moderate [4] Group 3: Future Plans - Results from Vibrance-2 and the previous Vibrance-1 study support the initiation of a global phase 3 program for alixorexton in patients with narcolepsy type 1 and type 2, planned to start in Q1 2026 [5] - Detailed results, including exploratory patient-reported outcomes related to cognition and fatigue, will be presented at a future scientific meeting [5] Group 4: Ongoing Studies - The Vibrance-3 phase 2 study evaluating alixorexton in adults with idiopathic hypersomnia is currently enrolling [6]

Alkermes (NasdaqGS:ALKS) Update / Briefing November 12, 2025 08:30 AM ET Speaker2Greetings and welcome to the Alkermes conference call. My name is Rob, and I'll be your operator for today's call. All participants will be placed on mute to prevent background noise. If you should require operator assistance during the call, please press star zero on your telephone keypad. Please note that this conference is being recorded. I'll now turn the call over to Sandra Coombs, Senior Vice President of Investor Relatio ...

Core Insights - Alkermes plc reported earnings from continuing operations of 49 cents per share for Q3 2025, exceeding the Zacks Consensus Estimate of 42 cents and down from 56 cents per share in the same quarter last year [1][8] - Total revenues for the third quarter reached $394.2 million, a 4% increase year-over-year, significantly surpassing the Zacks Consensus Estimate of $355.7 million [1][8] Revenue Breakdown - Alkermes' proprietary products, including Vivitrol, Aristada, and Lybalvi, generated total sales of $317.4 million, reflecting a 16% year-over-year growth, driven by strong demand [3][4] - Vivitrol sales increased by 7% year-over-year to $121.1 million, exceeding the Zacks Consensus Estimate of $112.1 million [5] - Aristada sales rose 16% year-over-year to $98.1 million, surpassing the Zacks Consensus Estimate of $87 million [6] - Lybalvi achieved sales of $98.2 million, a 32% increase year-over-year, also beating the Zacks Consensus Estimate of $87.1 million [7] Financial Guidance - Alkermes raised its 2025 revenue guidance to a range of $1.43 billion to $1.49 billion, up from the previous range of $1.34 billion to $1.43 billion [13] - The company expects Vivitrol net sales to be between $460 million and $470 million, Aristada sales between $360 million and $370 million, and Lybalvi sales between $340 million and $350 million for the full year [14] Strategic Developments - Alkermes announced a definitive agreement to acquire Avadel Pharmaceuticals for up to $20.00 per share, totaling approximately $2.1 billion, expected to close in Q1 2026 [15] - The acquisition will enhance Alkermes' portfolio with Avadel's Lumryz, a product for treating narcolepsy, projected to generate $265 million to $275 million in net revenues in 2025 [16] - The integration of Avadel is anticipated to create cost synergies and improve operational efficiency, aligning with Alkermes' ongoing development of alixorexton for narcolepsy [17]

Core Insights - Alkermes plc (ALKS) has entered into a definitive agreement to acquire Avadel Pharmaceuticals (AVDL) for up to $20.00 per share in cash, totaling approximately $2.1 billion [1][7] - The acquisition is expected to close in the first quarter of 2026, pending customary closing conditions [1] - The deal represents a 38% premium to Avadel's average trading price over the past three months and a 12% premium to its closing price on October 21, 2025 [2] Acquisition Details - Alkermes will pay $18.50 per share in cash at closing, with Avadel shareholders also receiving a contingent value right (CVR) worth up to an additional $1.50 per share, contingent on FDA approval of Lumryz by the end of 2028 [4] - The acquisition will be funded through Alkermes' existing cash reserves and new debt issuance, with cash and cash equivalents of $1.05 billion as of June 30, 2025 [5] Product and Market Impact - Avadel's Lumryz is the first and only once-at-bedtime oxybate approved for treating narcolepsy, with sales of $120.6 million in the first half of 2025, reflecting a 76% year-over-year increase [8] - Lumryz's projected net revenues for 2025 are estimated to be between $265 million and $275 million, indicating strong growth potential [8] - The acquisition allows Alkermes to enter the high-growth sleep medicine market and complements its existing pipeline, particularly its orexin program [9][7] Strategic Fit - The integration of Avadel's operations is expected to generate cost synergies and enhance operational efficiency as Alkermes prepares for the potential launch of its lead orexin program, alixorexton [12] - Alkermes is also developing alixorexton for narcolepsy and idiopathic hypersomnia, with ongoing clinical trials expected to yield data in 2025 and 2026 [10][11]

Core Insights - Alkermes has agreed to acquire Avadel Pharmaceuticals for up to $20 per share, valuing Avadel at $2.1 billion, which will expedite Alkermes' entry into the sleep medicine sector [1][2] - The acquisition is expected to be immediately accretive and represents a strategic opportunity to enhance Alkermes' operational infrastructure and rare disease capabilities [2][4] - The transaction has received approval from the boards of both companies and is set to conclude in the first quarter of 2026 [1] Company Strategy - Alkermes CEO Richard Pops emphasized that this acquisition is a pivotal step in the company's strategic evolution, allowing for accelerated entry into the sleep medicine market [3] - The acquisition will enhance Alkermes' revenue growth profile and is expected to reinforce long-term value for shareholders [4] - The combined organization will leverage its financial capabilities to develop Alkermes' orexin-2 receptor agonists portfolio, which includes ALKS 4510 and ALKS 7290, currently in Phase I trials [4] Product Details - Avadel's FDA-approved therapy, Lumryz (sodium oxybate), is used to treat cataplexy or excessive daytime sleepiness in narcolepsy patients aged seven and older [2] - The acquisition will allow Alkermes to build on Avadel's innovative portfolio and commercial capabilities, providing a strong foundation for growth in the sleep medicine therapeutic area [4]