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Alkermes Reports Positive Phase I Data for ADHD Drug ALKS 7290
Alkermes announced positive top-line data from a phase I proof-of-concept study of its investigational orexin 2 receptor agonist ALKS 7290 in adults with attention-deficit hyperactivity disorder. At day 14, median AISRS total scores fell by 14 points from baseline at the 20-mg dose and 19 points at the 50-mg dose, with improvements also seen on the CGI-S and across the AISRS inattentive and hyperactivity/impulsivity subscales. The treatment was generally well tolerated across all doses, with no serious adverse effects reported, and Alkermes said ALKS 7290 is the first orexin 2 receptor agonist to show clinically meaningful improvements in ADHD symptoms in adults. Enrollment is ongoing in a phase II study of ALKS 7290 in adults with ADHD, with data expected in 2027. Alkermes is also developing alixorexton for narcolepsy type 1 and type 2 in phase III Brilliance studies and for idiopathic hypersomnia in the phase II Vibrance-3 study, with top-line data expected by the end of 2026; the FDA granted alixorexton orphan drug designation for idiopathic hypersomnia in June 2026.
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J&J's Caplyta Hits Primary Endpoint in Bipolar I Mania Phase III Study
Johnson & Johnson announced positive top-line data from a pivotal phase III study evaluating Caplyta (lumateperone) for treating manic episodes, with or without mixed features, in adults with bipolar I disorder. In Study 451, the first of two pivotal phase III studies of Caplyta in bipolar I mania, patients treated with once-daily Caplyta (42 mg) achieved a 4.8-point greater reduction in Young Mania Rating Scale total score versus placebo at week three, with significant improvement seen as early as day three, the study's primary endpoint. The proportion of patients achieving at least a 50% reduction in YMRS total score was more than twice as high with Caplyta as with placebo, at 45.8% versus 20.9%, respectively, and the safety and tolerability profile was similar to Caplyta's established profile. Management noted that the second pivotal phase III study, Study 452, has been completed, with data analysis underway. Caplyta, an atypical antipsychotic added to J&J's neuroscience portfolio through the 2025 acquisition of Intra-Cellular Therapies, generated sales of $631 million in the first half of 2026 and is not presently approved for the treatment of manic episodes associated with bipolar I disorder; J&J believes it has the potential to deliver peak sales of $5 billion.
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AbbVie Q2 Revenue Rises 10.2% to $16.99 Billion, Beating Estimates
AbbVie reported second-quarter revenues of $16.99 billion, up 10.2% year on year and 1.2% above analysts' consensus expectations, though the quarter was mixed with only a narrow beat of EPS estimates and a slight miss of full-year EPS guidance estimates. The results came as the 11 therapeutics stocks tracked by the report collectively beat consensus revenue estimates by 8% in Q2, with share prices up 24.8% on average since the latest earnings results. Biogen posted the group's best quarter, with revenues of $2.74 billion, up 3.4% year on year and 12.1% above expectations, while Myriad Genetics delivered the weakest performance, reporting revenues of $190.7 million, down 10.5% year on year and 8.2% below expectations, alongside full-year revenue guidance that missed and a significant EPS miss. Gilead Sciences reported revenues of $7.80 billion, up 10.2% year on year and 6.2% above expectations, and Moderna reported revenues of $145 million, up 2.1% year on year and 35.8% above expectations, the biggest analyst estimate beat of the group. AbbVie's stock is up 2.9% since reporting and currently trades at $264.79.