Alkermes Plc (ALKS) News & EventsALKSAlkermes Plc

Bitcoin Price Surge Boosts Related Stocks

Stock futures are mixed in early Monday trading as oil prices have declined, with Wall Street looking to recover from last week.In pre-market trading, S&P 500 futures gained 0.04%, Nasdaq 100 futures climbed 0.33% and Dow futures fell 0.38%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Crypto-linked stocks up after the price of bitcoin hit its highest level since January, with Coinbaseand Circleup 5% apieceand Strategyup 7%Accentureup 5% after announcing a partnership with Anthropic to evaluate and red-team models, conduct alignment assessments, and test model safeguardsParamount Skydanceup 6% following reports that the company has discussed a $1.5B investment in California to clear a lawsuit blocking its $81B Warner Bros.merger, with Warner Bros. up 7%Critical Metalsup 27% after President Donald Trump said the he reached an agreement with Denmark over Greenland that would give the U.S. "permanent control over security" of the Arctic island. Greenland Energygained 155%, while Greenland Minesrose 160%Alkermesup 7% after announcing positive Phase 1b results for ALKS 7290 in adults With attention-deficit hyperactivity disorderSecuritizeup 9% after Cantor Fitzgerald initiated coverage with an Overweight ratingLOWER -Novo Nordiskdown 4% after the company guided to launching over five "multi-blockbusters" by 2030 and delivering over DKK 150B of pipeline sales in 2035HP Inc.down 5% after the company declined to provide financial guidance for FY27 and notes it is assuming industry-wide PC unit volumes down mid-single digits vs. FY26

Alkermes Rises 8% to $46.99 After Phase I Adult ADHD Data

Alkermes jumps 8% to $46.99 after Phase I adult ADHD data

Alkermes ALKS 7290 Phase 1 Study Shows Significant Improvements

Alkermes announced topline results from a phase 1 proof-of-concept study evaluating ALKS 7290, the company's novel, investigational orexin 2 receptor agonist in development for the treatment of attention-deficit hyperactivity disorder. The study evaluated the safety and tolerability and pharmacokinetics and pharmacodynamics of ALKS 7290 in healthy volunteers and in adults with ADHD. In the phase 1 study, ALKS 7290 was generally well tolerated at all doses tested in healthy volunteers and adults with ADHD. In adult participants with ADHD, ALKS 7290 demonstrated dose-dependent, clinically meaningful improvements on exploratory endpoints evaluating change from baseline on established clinical scales, the Adult ADHD Investigator Symptom Rating Scale and Clinical Global Impression-Severity Scale, at day 14 of treatment. These findings represent the first clinical evidence of the effects of an orexin receptor agonist in the treatment of ADHD and further support the dose range selected for the ongoing phase 2 study evaluating the efficacy and safety of ALKS 7290 in adults with ADHD. The phase 1b study enrolled 50 adults with ADHD in a double-blind, placebo-controlled, parallel-group trial with two cohorts. Following a two-week washout of existing ADHD medications, participants were randomized within each cohort to receive ALKS 7290 or placebo for 14 days of inpatient treatment. In addition to safety, tolerability and PK and PD effects, the study evaluated change from baseline across a range of exploratory endpoints to begin to characterize the effects of ALKS 7290 on symptoms of ADHD. The study was not designed or powered to detect statistically significant differences between treatment groups. Topline results from the study include: AISRS 1: ALKS 7290 demonstrated clinically meaningful improvements from baseline in ADHD symptoms as measured by the AISRS, a 54-point, clinician-administered, validated measure of ADHD symptom severity. At baseline, participants had a median AISRS total score of approximately 39, consistent with substantial ADHD symptom burden. Clinically meaningful improvements were observed as early as day 6, the first post-baseline AISRS assessment. At day 14, treatment with ALKS 7290 demonstrated median reductions from baseline in AISRS total scores of 14.0 points for the 20 mg dose and 19.0 points for the 50 mg dose. Clinically meaningful improvements were observed across AISRS Inattentive and Hyperactivity/Impulsivity subscales. CGI-S 3: ALKS 7290 demonstrated clinically meaningful2 improvements from baseline in overall ADHD disease severity as measured on the CGI-S scale. At baseline, participants had median CGI-S scores of 4.0 and 5.0 in the 20 mg and 50 mg dose groups, respectively. Clinically meaningful improvements were observed as early as day 6, the first post-baseline CGI-S assessment. At day 14, treatment with ALKS 7290 demonstrated median reductions from baseline in CGI-S scores of 1.0 for the 20 mg dose and 2.0 for the 50 mg dose, representing a shift in disease severity from markedly or moderately ill to mildly ill. The phase 1b study included multiple EEG-based biomarkers and performance-based cognitive tests designed to measure dose-related central activity and domains underlying ADHD symptoms. Findings from these assessments support our dosing decisions for phase 2 and showed treatment effects of ALKS 7290 across important cognitive domains, including processing speed, information processing, working memory and attention. ALKS 7290 was generally well tolerated across all doses tested in participants with ADHD. No serious treatment-emergent adverse events (TEAEs) were reported. Most TEAEs were mild in severity. The most common TEAEs4 were insomnia, pollakiuria, dizziness, change in sustained attention, micturition urgency, and constipation. There were no clinically significant findings observed in hepatic or renal parameters, vital signs or ECGs. Two participants in the placebo group discontinued the study; there were no discontinuations among participants receiving ALKS 7290. In healthy volunteers (n=88), single- and multiple-ascending doses of ALKS 7290 were evaluated for up to 10 days. ALKS 7290 was generally well tolerated across all doses tested and the maximum tolerated dose was not reached. ALKS 7290 was observed to be centrally active and to have a PK and PD profile that supports oral dosing with a wide therapeutic index. A phase 2 study evaluating the safety and efficacy of once-daily and split doses of ALKS 7290 compared to placebo in adults with ADHD is currently enrolling. Following a two-week washout period of existing ADHD medications, participants will be randomized to receive one of three dosing regimens of ALKS 7290 or placebo. The study will evaluate the primary endpoint of change from baseline in AISRS total score at week four compared to placebo. The study is expected to enroll approximately 312 participants with ADHD. The first participant was dosed in September 2026.