After Sage Therapeutics Inc. reported a phase II failure with oral dalzanemdor, also known as SAGE-718, in mild cognitive impairment related to Parkinson’s disease (PD), Wall Street’s eyes turned to ongoing mid-stage efforts with the same N-methyl-D-aspartate receptor-positive allosteric modulator in Huntington’s disease and Alzheimer’s disease.
In 2023, the BioWorld Neurological Diseases Index (BNDI) closed with a 4.36% increase, outperforming the Nasdaq Biotechnology Index (up 3.74%) but falling short of the surge seen in the Dow Jones Industrial Average (up 13.7%). The rebound marked a significant turnaround from November, when BNDI recorded an 18.37% year-to-date decline.
Sage Therapeutics Inc. is reducing its workforce by 40% and pausing its earlier-stage programs, just a few weeks after receiving mixed news of both a U.S. FDA approval and a complete response letter for its depression drug Zurzuvae (zuranolone). The move offers the Cambridge, Mass.-based company an annualized net savings of approximately $240 million, 60% of which is related to R&D, and will extend its runway into 2026.
Despite the U.S. FDA’s approval of Sage Therapeutics Inc.’s priority NDA for postpartum depression, the accompanying complete response letter (CRL) for major depressive disorder has undercut the company’s plans. Withholding the approval for MDD slices away a huge amount of the potential market for Sage and its collaborator, Biogen Inc.
Woebot Labs Inc. posted uplifting news for women who have suffered from baby blues and their big brother, post-partum depression. The company recently enrolled the first patient in its pivotal trial of WB001, a digital therapeutic for post-partum depression (PPD). WB001 received U.S. FDA breakthrough device designation in 2021, indicating the acute need for accessible treatment for the common condition.
Avenue Therapeutics Inc.’s takeover of Baergic Bio Inc. pursuant to the previously disclosed share contribution agreement with its parent company, Fortress Biotech Inc., highlighted the potential of targeting GABAA, an approach under investigation in various quarters.
Following a negative phase II/III study of an investigational treatment for major depressive disorder, Praxis Precision Medicines Inc. is dropping staff from the payroll and refocusing the company’s resources on tremor and epilepsy. The Aria study of PRAX-114, a positive allosteric modulator extrasynaptic GABA receptor, missed its primary endpoint, statistical significance as measured on the Hamilton Depression Rating Scale. It also missed the study’s secondary endpoints.
After hitting a low in late February, BioWorld’s Neurological Diseases Index is rebounding, although it is still down by 8.9% this year, following the same path of the broader markets.
New data from two phase II studies from two companies showed progress in their respective Parkinson’s disease programs. The data for both therapies, from Anavex Life Sciences Corp. and Sage Therapeutics Inc., were presented on opening day, March 15, at the AD/PD 2022 Advances in Science & Therapy International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, being held in Barcelona until March 20.
A phase III study of Sage Therapeutics Inc.’s zuranolone in major depressive disorder hit not only its primary endpoint but also its key secondary endpoint. Despite that, the Cambridge, Mass.-based company’s share value (NASDAQ:SAGE) closed 17.4% lower Feb. 16, at $35.91 each.