H.C. Wainwright Downgrades Aeterna To Neutral Following CRL From FDA
In a research note published today, H.C. Wainwright analyst Swayampakula Ramakanth downgraded shares of Aeterna Zentaris (NASDAQ:AEZS) to a Neutral rating, following the company’s announcement that it has received a complete response letter (CRL) for its New Drug Application for Macrilen from the US Food and Drug Administration (FDA) this morning. No price target was provided.
Ramakanth wrote, “We expect management to provide additional details regarding the next steps for Macrilen on Friday, November 7. If management decides to pursue development of the drug, we anticipate at least a delay of three years, given the requirement for a new confirmatory clinical trial and a thorough QT prolongation study. If successful, the drug could be launched in 2018.”
The analyst continued, “We initially anticipated Macrilen launch in 1Q15. Accordingly, we were expecting Macrilen revenues to grow from $5 million in 2015 to $69 million in 2025. With the CRL, and our new assumption that Macrilen could enter the market in 2018, we now project risk-adjusted sales to grow from $500,000 in 2018 to $19.6 million in 2025.”
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Swayampakula Ramakanth has a total average return of -16.1% and a 40% success rate. Ramakanth has an 8.8% average return when recommending AEZS, and is ranked #3208 out of 3380 analysts.