Agios Pharmaceuticals Inc (NASDAQ:AGIO) announced that its collaboration partner Celgene Corporation (NASDAQ:CELG) intends to file for an NDA for its AML-treating drug AG-221 on the heels of Phase 1/2 data. Canaccord analyst John Newman sees this as an “unexpected, but positive” development, and therefore, reiterates a Buy rating on shares of AGIO with a $90 price target.
Agios shares reacted to the news rising 21% to $45.13 on heavy volume, making it among the top winners today.
Newman believes, “Even if FDA does not grant approval for AG-221 without further data, we believe minimal time would be lost versus waiting to file on Phase 3 data. Importantly, FDA has generally required overall survival data from a controlled study in AML for approval, but CELG and AGIO are seeking approval for a very narrow indication.”
“The Phase 3 IDHENTIFY study for AG-221 in relapsed/refractory AML is ongoing and might be used to support FDA approval, in our view, given the primary endpoint is overall survival. Importantly, given that overall survival is approximately 3-4 months in relapsed/ refractory AML, survival data from IDHENTIFY might become available during the review cycle for AG-221 based on Phase 1/2 data. However, overall survival data may not be needed, given that CELG and AGIO are seeking approval for a very narrow subset of AML patients. As such, FDA might be less stringent regarding overall survival data for AG-221,” the analyst added.
As usual, we recommend taking analyst notes with a grain of salt. According to TipRanks, analyst John Newman is ranked #4,039 out of 4,147 analysts. Newman has a 33% success rate and faces a loss of 13.5% in his yearly returns. When recommending AGIO, Newman loses 13.9% in average profits on the stock.
TipRanks analytics exhibit AGIO as a Buy. 50% of analysts polled in the last 3 months rate a Buy on AGIO, while 50% maintain a Hold. The 12-month average price target stands at $64.60, marking a nearly 38% upside from where the shares last closed.