Leerink analysts Paul Matteis and Seamus Fernandez have enhanced conviction in the commercial potential for ACADIA's (ACAD) pimavanserin and Neurocrine's (NBIX) VMAT2 after speaking to four specialists and two payors regarding the clinical potential and reimbursement considerations for a set of emerging central nervous system assets. Payors view the central nervous system as a highly complex therapeutic area, and are thus unlikely likely to aggressively manage access to new drugs when there are no on-label alternatives, the analysts tell investors in a research note. Physicians see a place for those two drugs, as well as Alkermes' ALKS3831 and Intra-Cellular's (ITCI) ITI-007, in their respective indications, Matteis and Fernandez contend. They point out that while physicians were mostly positive on ALKS383, there were some "polarizing views" on the importance of a metabolic side-effect benefit to the drug's value proposition.

Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024.

Reports Q1 revenue $350.4M, consensus $360.26M. "The first quarter of 2024 marks our first full quarter as a profitable, pure-play neuroscience company. During the quarter, we continued to advance our strategic priorities across the business, highlighted by solid underlying prescription growth for LYBALVI and advancement of ALKS 2680, our novel, investigational, oral orexin 2 receptor agonist in development as a once-daily treatment for narcolepsy," said Richard Pops, Chief Executive Officer of Alkermes. "For ALKS 2680, we recently initiated our Vibrance-1 phase 2 study in narcolepsy type 1 and announced positive topline phase 1b results in narcolepsy type 2. With these new data now in hand, we plan to initiate a phase 2 study in narcolepsy type 2 in the second half of 2024. In an area where there remains significant unmet patient need, orexin 2 biology represents an important new potential approach to treating disorders characterized by excessive daytime sleepiness. ALKS 2680 is the first candidate from our orexin portfolio to advance in the clinic and we plan to share details regarding our other orexin development programs later this year."

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Neurocrine Biosciences announced the FDA has approved INGREZZA SPRINKLE, or valbenazine, capsules, a new oral granules formulation of INGREZZA, or valbenazine, capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease. INGREZZA SPRINKLE provides an alternative administration option for those who experience dysphagia or have difficulty swallowing. Like the original formulation of INGREZZA capsules, INGREZZA SPRINKLE offers simple dosing that's always one capsule, once daily with no complex titration. INGREZZA is the only selective vesicular monoamine transporter 2 inhibitor that offers three effective dosages that can be adjusted by the healthcare provider based on patient response and tolerability. INGREZZA SPRINKLE offers the same dosage strengths, and the contents of the capsules can be easily sprinkled on soft food for oral administration.