Alkermes' Sleeping Disorder Studies' Data Look Excellent, Analyst Says

On Tuesday, Alkermes plc ALKS revealed topline results from the narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) cohorts of a phase 1b, proof-of-concept study evaluating ALKS 2680 for narcolepsy. 

ALKS 2680 data demonstrated clinically meaningful and statistically significant improvements from baseline in mean sleep latency on the Maintenance of Wakefulness Test (MWT) compared to placebo at all doses tested. 

ALKS 2680 was generally well tolerated in both patient populations at all doses tested.

In Narcolepsy Type 2 (NT2), treatment with ALKS 2680 resulted in statistically significant and clinically meaningful improvements in sleep latency, with a mean change from baseline versus placebo of 12 minutes at the 5 mg dose, 19 minutes at the 12 mg dose, and 21 minutes at the 25 mg dose.

Placebo treatment in this cohort resulted in no change in mean sleep latency. 

The company plans to initiate a phase 2 study in patients with NT2 in the second half of 2024.

In the eight patients with Idiopathic Hypersomnia (IH), treatment with ALKS 2680 resulted in statistically significant and clinically meaningful improvements in sleep latency in these patients with IH, with a mean change from baseline versus placebo of 8 minutes at the 5 mg dose, 11 minutes at the 12 mg dose, and 18 minutes at the 25 mg dose. 

Placebo treatment in this cohort reduced mean sleep latency by two minutes. 

At the 12 mg and 25 mg doses, the observed mean MWT scores over eight hours post-dose were within the reported normal range for healthy individuals.

Jefferies writes that Alkermes’ ALKS-2680 data looks excellent. The analyst increased the price target from $42 to $50.

Jefferies increased the probability of success for ALKS-2680 to 50%, with peak sales of $1 billion, up from $700 million.

Price Action: ALKS shares are up 3.43% at $26.82 on the last check Tuesday.

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