Progenics’ NDA for Azedra has been accepted with a Priority Review.
Atara got a clearance from FDA for Phase 3 studies with tabelecleucel.
Avadel provided corporate and financial update for 2018.
Analysis of top Seeking Alpha coverage: Progenics
Progenics announced that the FDA has accepted for review its New Drug Application (NDA) for Azedra. The FDA also granted a Priority Review. The agency has set April 30 PDUFA date. The news sent PGNX shares up more than 21% in pre-market trading on Friday. The shares though failed to hold on to their gains and finished the day around 2% higher.
It has been a disappointing year for PGNX, with shares down 31.3% for the year even as the NBI closed the year 21.05% higher. PGNX has struggled amid some debate over the date from the phase 2b trial for Azedra.
Azedra became part of PGNX’s pipeline after the company acquired Molecular Insights a few year ago. Molecular Insights had already begun a phase 2b trial with the drug under a Special Protocol Assessment (SPA) from the FDA. However, the company discontinued the trial after it ran out of money. PGNX picked up the drug and continued the phase 2b trial. The main debate is over the efficacy data reported by Molecular Insights for its part of the trial and by PGNX for the second part of the trial.
The phase 2b data reported by Progenics has been poorer on the efficacy front when compared to what Molecular Insights reported. We addressed the issue in a recent article.
As we noted, the fact that Azedra’s trial was conducted under an SPA means that PGNX only has to meet the efficacy threshold pre-specified by the agency. As we discussed in detail in our recent article, Azedra has met the requirements under the SPA. Given this, we do not see any reason for the debate.
As we noted, the bear case from one of the Seeking Alpha author has some logic. The author discusses the discrepancy between the two data sets but the approval will be based on the phase 2b trial meeting FDA requirements under the SPA. Also considering that this is a rare disease, we do not expect the agency to do any nitpicking with regards to the trial data. Remember that the agency has softened its stance as well with regards to drug approvals, with approvals in 2017 seeing a sharp increase from last year.
Your Daily Pharma Scoop: Progenics Azerda Update, Atara Gets FDA Clearance For Phase 3 Trial, Avadel Provides Update