With partner Biogen mum on zuranolone’s prospects as an FDA August 5 review deadline approaches, Sage Therapeutics’ stock fell Wednesday to its lowest level in months.
Pictured: Person holding a cell phone in front of computer with stock data/iStock
Sage Therapeutics endured a tough trading session Wednesday, with its stock down approximately 13% at market close, reaching its lowest level since November 2022.
The price drop comes after Biogen CEO Christopher Viehbacher seemed to avoid the topic of Sage-partnered depression drug zuranolone in his prepared statements during the company’s second-quarter earnings call Tuesday, mentioning the drug candidate only once in his closing remarks. Biogen also left zuranolone out completely from its news release announcing second-quarter financial results.
In response to an analyst pointing out the lack of discussion on zuranolone, Viehbacher said that it was due to “a little bit of superstitiousness” on his side, wanting first to hear the FDA’s verdict before talking about the drug.
“We’re in late-stage review, so I think it’s pretty normal that we don’t want to disturb that process,” Viehbacher said during Biogen’s Tuesday earnings call. “We don’t want to say anything that affects the FDA.”
Sage and Biogen are developing zuranolone under a November 2020 global license agreement addressing major depressive disorder (MDD) and postpartum depression (PPD). The drug is a neuroactive steroid that binds to the GABA-A receptor and modulates its response to the inhibitory neurotransmitter GABA.
In depression, zuranolone’s mechanism of action could potentially rebalance dysregulated neuronal networks, particularly those responsible for mood, cognition, behavior and arousal.
The FDA is currently reviewing zuranolone’s New Drug Application, which the pharma partners completed and filed in December 2022, with a target action deadline of August 5. The regulator indicated in March 2023 that it would not need to convene an advisory panel for zuranolone.
Supporting zuranolone’s regulatory bid are two robust clinical programs: LANDSCAPE for MDD and NEST for PPD. The LANDSCAPE program spans five studies, including the Phase III CORAL trial, the topline data for which were posted in February 2022. Patients in CORAL saw a statistically significant improvement in depressive symptoms after treatment with 50-mg zuranolone, as compared with standard of care.
CORAL built on the findings of another LANDSCAPE study, SHORELINE. In December 2022, Sage and Biogen announced that zuranolone’s effects were durable for up to a year, with 80% of patients who responded to an initial 14-day course needing at most one additional dose.
For PPD, the partners’ NEST program covers two studies, one of which is the Phase III SKYLARK trial, which in October 2022 demonstrated significant improvements in depressive symptoms with zuranolone relative to placebo.
Additional Phase III data, published Wednesday in the American Journal of Psychiatry, also showed that zuranolone treatment led to significant symptom improvements after 15 days, as opposed to placebo. The study found that zuranolone was safe, inducing no loss of consciousness, suicidal ideation or withdrawal symptoms.
If approved, zuranolone would be the first depression treatment on the market that takes effect within 14 days, whereas current options often need six to eight weeks, Sage Chief Business Officer Chris Benecchi told BioSpace in a previous interview.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
