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Jazz (JAZZ) Starts Study on Epidiolex for a Fourth Indication

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Jazz Pharmaceuticals (JAZZ - Free Report) initiated a new pivotal phase III study to evaluate its cannabidiol drug, Epidiolex/Epidyolex, for a new indication in epilepsy.

This pivotal late-stage study will evaluate the safety and efficacy of Epidiolex versus placebo to treat seizures associated with epilepsy with Myoclonic-Atonic Seizures (EMAS) in individuals aged 1 to 18 years, i.e., children and adolescents.

Currently, Epidiolex is approved by the FDA for treating seizures associated with two rare and severe forms of epilepsy, namely Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS), in patients aged one year and older. The drug is also approved by the FDA to treat seizures associated with tuberous sclerosis complex (TSC) in the same age group. The drug is yet to be approved for EMAS.

The phase III study will be divided into two parts — Part A and Part B. The first part will evaluate Epidiolex as an adjunctive treatment for participants with EMAS over a 14-week treatment period. Those participants who have completed part A of the study will be given the option to enroll in part B of the study, an open-label extension study that will continue over a 54-week period.

Shares of Jazz have gained 22.9% in the year so far against the industry’s 17.8% fall.

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EMAS (also called Doose Syndrome) is a rare form of epilepsy that begins in early childhood. Per management, EMAS accounts for around 2% of epilepsies commencing from childhood.

The initiation of this late-stage study is based on preliminary data from Jazz’s clinical development program, which support the use of Epidiolex in seizures associated with EMAS.

Epidiolex was acquired by Jazz following its acquisition of GW Pharmaceuticals last year. The company is making significant progress related to the launch of Epidyolex in Europe and other ex-U.S. markets. Management expects that Epidiolex has the potential to be a blockbuster drug in epilepsy indication. Sales of the drug have been rising consistently since its acquisition. Jazz recorded $175.3 million from Epidiolex sales in second-quarter 2022, a 12% year-over-year increase (on a proforma basis).

 

Zacks Rank & Stocks to Consider

Jazz currently carries a Zacks Rank #2 (Buy).

Some better-ranked stocks in the overall healthcare sector include Assertio (ASRT - Free Report) , Morphic (MORF - Free Report) and Sesen Bio (SESN - Free Report) . While Morphic and Sesen Bio sport a Zacks Rank #1 (Strong Buy) at present, Assertio carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for Sesen Bio’s 2022 bottom line have narrowed from a loss of 44 cents to 43 cents in the past 30 days. Loss estimates for 2023 have narrowed from 35 cents to 1 cent during the same period. Share prices of Sesen Bio have fallen 14.7% in the year-to-date period.

Earnings of Sesen Bio beat estimates in each of the last four quarters, the average surprise being 89.49%. In the last reported quarter, Sesen Bio delivered an earnings surprise of 61.54%.

In the past 30 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.75. Loss estimates for 2023 have narrowed from $3.96 to $3.77 during the same period. Shares of Morphic have lost 36.1% in the year-to-date period.

Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.

In the past 30 days, estimates for Assertio’s 2022 earnings per share have risen from 40 cents to 49 cents. Earnings estimates for 2023 have risen from 29 cents to 30 cents during the same period. Shares of Assertio have surged 63.8% in the year-to-date period.

Earnings of Assertio beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 126.39%, on average. In the last reported quarter, ASRT delivered an earnings surprise of 100.00%.

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