AEterna Zentaris Inc. (USA) (AEZS) Macrilen Is Back, Cheers Maxim

AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) shares are rising almost 8% today on the heels of indicating it intends to file a new drug application (NDA) for Macrilen (macimorelin), designed to treat adults’ growth hormone deficiency (AGHD), by the third quarter of this year. The news follows AEZS’s meeting with the FDA yesterday, where the agency found the data to bolster “the proposed conclusions.”

What does this mean from the perspective of Maxim analyst Jason Kolbert? “Macrilen is back,” the analyst asserts, reiterating a Buy rating on shares of AEZS with a price target of $11, which represents a just under 253% increase from where the stock is currently trading.

Kolbert notes, “The Agency stated that the clinical studies performed with respect to Macrilen do address the prior deficiencies mentioned in the November 2014 complete response letter. This conclusion paves the way for the re-submission of an NDA for Macrilen.”

“Following a comprehensive review of Phase 3 data obtained from the confirmatory Phase 3 clinical trial of Macrilen for the evaluation of growth hormone deficiency in adults (AGHD), using the insulin tolerance test (ITT) as a comparator, it concluded that Macrilen did in fact demonstrate utility and safety,” elaborates the analyst who concludes, “The Macrilen test, in our view, is a safer and more reliable option. As such, we believe regulators will be open to discuss a path forward.”

As usual, we recommend taking analyst notes with a grain of salt. According to TipRanks, Jason Kolbert is ranked #4,489 out of 4,555 analysts. Kolbert has a 33% success rate and loses 10.7% in his annual returns. When recommending AEZS, Kolbert forfeits 42.4% in average profits on the stock.

TipRanks analytics show AEZS as a Buy. Out of 2 analysts polled by TipRanks in the last 3 months, both are bullish on Aeterna stock. With a return potential of 170%, the stock’s consensus target price stands at $8.25.

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