The drug will now be released through a restricted distribution program and is expected to be available through Zogenix’s specialized pharmacy partner by the end of July.
“The FDA approval of Fintepla is an important milestone,” said Stephen Farr, CEO of Zogenix. “We started this global development program almost six years ago after researchers in Belgium recognized the potential of fenfluramine, a drug with a pharmacology different from all other anticonvulsant agents, in treating intractable seizures in Dravet syndrome.”
Dravet syndrome is a rare childhood-onset epilepsy marked by frequent and severe seizures resistant to treatment, as well as significant developmental and motor deficits, and an increased risk of sudden unexpected death.
“There remains a great unmet need for the many Dravet syndrome patients who continue to experience frequent severe attacks even while taking one or more of the currently available anticonvulsant medications,” said Joseph Sullivan, Fintepla principal investigator for Dravet syndrome.
FDA approval was based on data from two placebo-controlled phase 3 clinical trials and safety data from one extension trial. When added to existing treatments, the drug significantly reduced the frequency of monthly seizures compared to placebo in patients whose seizures were not adequately controlled with antiepileptic medications. Furthermore, most patients responded to treatment in three to four weeks and the effects remained consistent.
Following the news, LifeSi Capital analyst David Sherman reiterated his buy rating on Zogenix, writing: “We see this as a major uprising of the cloud in action, and we believe that in the future, the company can start. to collect on their debt for several of the other promising opportunities they are pursuing and the recent progress they have made. “
Sherman added that he is waiting for more details on today’s call before updating his current $ 45 price target.
Similarly, Mizuho Securities’ Difei Yang also reiterated its bullish outlook on the action, saying, “We note that this is a broader patient designation than the Phase 3 trial, which consisted of subjects 2-18 years old.” The analyst notes that the labeling includes a warning box stating that Fintepla is associated with valvular heart disease (HDV) and pulmonary arterial hypertension (PAH), but says this is also “as expected.”
Yang already had a 100% probability of success on the indication, and therefore reaffirmed his buy rating and $ 64 target price. This suggests that stocks may more than double current levels.
Overall, Street has a Strong Buy bullish consensus on Zogenix, with an average analyst price of $ 51 (81% upside potential). Shares are currently down 46% so far this year. (See ZGNX stock analysis at TipRanks).
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