Maxim Shares Two Cents on AEterna Zentaris Inc. (USA) (AEZS) Following Positive Lead from EMA Pediatric Committee
Maxim analyst Jason Kolbert is optimistic on AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) on the heels of the biotech firm indicating that the Pediatric Committee of EMA will allow AEZS to file a Marketing Authorization Application (MAA) before overseeing the pediatric investigation plan (PIP) for Macrilen in adult growth hormone deficiency (AGHD). This is a solid step forward, although the firm must still get a green light from the EMA to file the MAA.
From the analyst’s eyes, this is a strong move forward for the firm to advance its MAA filing. As such, Kolbert reiterates a Buy rating on AEZS with a price target of $10, which represents a 217% increase from where the shares last closed.
Kolbert notes, “PIP is a dose escalating safety and PK/PD study followed by a diagnostic efficacy and safety study in pediatric patients. Normally, conducting of PIP is required for filing the MAA. What this means is: 1) the EMA Pediatric Committee has approved the company’s PIP as sufficient; 2) the company could potentially file for approval in Europe earlier than anticipated with PIP deferred; and 3) while completion of PIP is ultimately required, it is not required for initial approval of Macrilen for AGHD in Europe because of this waiver.”
“Due to the acceptance and deferring of PIP, Aeterna could potentially file the MAA sooner, though the company has not yet provided a specific timeline. In the U.S., Aeterna has a meeting with the FDA at the end of March, at which point we will know if the data from Phase 3 is sufficient for filing the NDA,” Kolbert surmises.
As usual, we recommend taking analyst notes with a grain of salt. According to TipRanks, Jason Kolbert is ranked #4,434 out of 4,513 analysts. Kolbert has a 32% success rate and faces a loss of 13.1% in his yearly returns. When suggesting AEZS, Kolbert forfeits 46.5% in average profits on the stock.
TipRanks analytics show AEZS as a Buy. Based on 2 analysts polled by TipRanks, both analysts rate a Buy on AEterna stock. The 12-month average price target stands at $7.75, marking a 146% upside from where the stock is currently trading.