SAGE - Sage hits eight-month low as FDA decision on depression therapy nears

2023-07-26 13:36:56 ET

Sage Therapeutics ( NASDAQ: SAGE ) lost more than 14% Wednesday to reach the lowest level since November amid investor concerns over its depression therapy, zuranolone, as the FDA is set to decide on its marketing application by early August.

In March, the company said that the regulator would not conduct an advisory committee meeting to discuss its marketing application for the treatment, which is under the FDA’s priority review with a PDUFA date of Aug. 5.

Despite the upcoming decision, Biogen ( NASDAQ: BIIB ), its partner for the treatment, was noticeably silent on its prospects when the company reported its Q2 2023 results on Tuesday, analysts from RBC Capital Markets and Mizuho noted.

RBC’s Brian Abrahams argued that Biogen’s ( BIIB ) lack of enthusiasm for zuranolone during the earnings call "has spooked investors and raised concerns there may be a late review issue."

However, the analyst retains the Outperform rating and $71 per share target on Sage ( SAGE ), indicating bullish remarks on the drug’s approval and initial launch.

After Biogen’s ( BIIB ) earnings, Mizuho analyst Uy Ear also cited investor worries over a potential rejection of the company’s marketing application for zuranolone, particularly in relation to major depressive disorder (MDD).

Ear pointed to "the absence of a standalone slide, the lack of discussion and prepared remarks, and lack of meaningful comments to sell-side questions as cause for concerns."

"While management’s limited commentary may raise concerns, management indicated they are tight-lipped to not disturb the review process or to say anything that could impact the FDA review" Ear wrote, with a Neutral rating and a $45 price target on the stock.

More on Sage

• Sage upgraded to outperform at RBC on greater confidence in zuranolone approval
• Sage, Biogen complete rolling filing with FDA for depression therapy zuranolone
• Sage Therapeutics: Zuranolone August Approval Likely, Opportunity Uncertain

For further details see: