Sage Therapeutics, Inc. SAGE is focused on developing life-changing brain health medicines.

In July, Sage Therapeutics and partner Biogen BIIB announced top-line data from the phase II KINETIC 2 study, which evaluated its investigational neurology candidate, SAGE-324 as a potential treatment for essential tremor (ET). The study failed to demonstrate a statistically significant dose-response relationship on the primary endpoint in participants with ET.

Following the disappointing data, SAGE and BIIB decided to stop further development of SAGE-324 for the ET indication.

Last month, Biogen terminated its rights related to SAGE-324. The termination will be effective from Feb. 17, 2025.

Following the termination of the deal by BIIB, Sage Therapeutics will obtain full ownership and rights of SAGE-324. The company plans to study SAGE-324 for other indications, if any.

Shares of Sage Therapeutics have plunged 39.3% in the past three months against the industry’s growth of 7.9%.

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The disappointing data on SAGE-324 and the subsequent termination of the deal by BIIB could have been the reasons for the stock’s decline during the said time.

Pipeline Setbacks a Concern for SAGE

Sage Therapeutics has had its share of pipeline setbacks that has remained a constant niggle for the company in recent quarters.

In April 2024, SAGE reported that the phase II PRECEDENT study on dalzanemdor in Parkinson’s disease (PD) failed to achieve its primary endpoint. Based on this outcome, management decided not to pursue the development of the candidate in PD indication.

We remind investors that the FDA issued a complete response letter (CRL) for the new drug application (NDA) for zuranolone for treating adults with major depressive disorder in August 2023. Per the FDA, the data supporting the NDA filing did not provide substantial evidence of effectiveness to support a potential approval. FDA recommended conducting additional clinical studies. Such setbacks do not bode well for the company.

SAGE currently markets the depression drug Zurzuvae (zuranolone) in partnership with Biogen.

Zurzuvae, the first and only oral treatment indicated for adults with postpartum depression (PPD), was approved by the FDA in August 2023 and commercially launched in December.

Sage Therapeutics, Inc. Price

Sage Therapeutics, Inc. price | Sage Therapeutics, Inc. Quote

SAGE's Zacks Rank & Stocks to Consider

Sage Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the drug/biotech sector are ANI Pharmaceuticals, Inc. ANIP and Bioventus Inc. BVS, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.