Ever since the FDA rejected zuranolone in major depressive disorder last year, brain health specialist Sage Therapeutics has been somewhat in flux. In the wake of a recent round of layoffs, the company this week revealed that it’s discontinuing a commercial medicine and giving up hopes for a pair of pipeline prospects.
In its second-quarter earnings release Tuesday, Sage said that it and partner Biogen “will not pursue further development of zuranolone in major depressive disorder (MDD) in the U.S.” The development comes after the FDA rejected zuranolone in MDD last year but approved the medicine in postpartum depression (PPD), a smaller market. In that use, the drug carries the brand name Zurzuvae.
As for the drug the company is discontinuing, Zulresso is an older PPD drug that generated $800,000 in the third quarter of 2024. Sage is sunsetting the drug “as a part of its strategic shift to further focus on the commercialization” of its newer PPD medicine, the company said in its third-quarter earnings release. The discontinuation led to one-time costs of $3.6 million in the quarter related to excess inventory write-offs and intangible asset impairment costs.
Zulresso will be available through the end of the year, the company said.
On zuranolone, an archived version of the company’s pipeline from early October shows the medicine listed as a late-stage candidate in MDD.
The company caveated that pipeline inclusion by noting that the FDA’s rejection stipulated that “an additional study or studies” would be needed to support a potential MDD approval. No phase 3 trials were ongoing, the company noted at the time.
In the aftermath of the FDA rejection in MDD, Sage laid off 40% of its staff and moved into a smaller headquarters. Those moves happened last year, but, more recently, the company this month revealed it's cutting more than half of its R&D team.
Besides the zuranolone cut in MDD, Sage “does not plan further clinical development of dalzanemdor” in Alzheimer’s disease after reviewing midstage trial data, according to the earnings release.
Earlier this month, dalzanemdor was listed on Sage’s website as a pipeline hopeful for patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease. Sage is still pursuing dalzanemdor as a potential treatment for cognitive impairment related to Huntington’s disease.
During the most recent quarter, Sage lost $93.6 million. Its cash stood at $569 million at the end of September, enough to fund operations into 2026, according to the release.
Sage’s shares traded down about 7% early Wednesday following the after-market release on Tuesday.