CAMBRIDGE, Mass. - Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company, disclosed today that its Phase 2 PRECEDENT study of dalzanemdor (SAGE-718) did not meet the primary endpoint in treating mild cognitive impairment (MCI) in Parkinson’s Disease (PD).
The investigational oral medicine was evaluated against a placebo over a six-week period, involving 86 participants. Despite the setback, the drug was generally well-tolerated with no new safety concerns identified.
The study aimed to show a statistically significant difference from the baseline in participants treated with dalzanemdor compared to placebo, using the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test score at Day 42. However, the results did not demonstrate the anticipated difference.
Barry Greene, Chief Executive Officer at Sage Therapeutics, expressed disappointment in the study's outcome, recognizing the impact of cognitive impairment on individuals and families affected by Parkinson’s Disease.
He noted that the unique pathophysiology and symptoms of Parkinson’s Disease mean these results may not predict the drug's performance in other neurodegenerative conditions. The company remains focused on upcoming topline data readouts from ongoing Phase 2 studies of dalzanemdor in Huntington’s disease and Alzheimer’s disease, expected later in the year.
The PRECEDENT study's lack of significant results versus placebo in exploratory endpoints, such as SCOPA-Cog, has led Sage to discontinue further development of dalzanemdor for Parkinson’s Disease. However, Sage continues its clinical development program for the drug, with other studies progressing as planned. Mid-2024 and late 2024 are anticipated milestones for reporting topline data from studies involving cognitive impairment in Huntington’s disease and Alzheimer’s disease, respectively.
Dalzanemdor (SAGE-718) is a first-in-class investigational NMDA receptor positive allosteric modulator (PAM), being explored for potential oral therapy in cognitive disorders associated with NMDA receptor dysfunction.
This news is based on a press release statement from Sage Therapeutics and reflects the company's current expectations and projections regarding its drug development programs.
InvestingPro Insights
Following Sage Therapeutics' announcement on the PRECEDENT study, investors may be keen to understand the financial health and market sentiment surrounding the company. According to InvestingPro data, Sage Therapeutics holds a market capitalization of $939.47 million, with a rather high Price / Book ratio over the last twelve months as of Q4 2023, standing at 1.18. Despite a notable revenue growth of 1024.84% during the same period, the company's gross profit margin was significantly negative at -314.54%, indicating expenses far exceeded gross income.
Investors should note that Sage Therapeutics’ stock has experienced a substantial price decline, with a 1-month price total return of -16.88% and a 3-month price total return of -38.4%. This downtrend is further accentuated by the stock trading near its 52-week low, at only 27.67% of the high, reflecting a bearish market sentiment.
Two InvestingPro Tips that stand out for Sage Therapeutics at this juncture are the company's cash position and its current valuation state. Firstly, Sage holds more cash than debt on its balance sheet, which could provide some financial stability despite the clinical setback. Secondly, the Relative Strength Index (RSI) suggests that the stock is in oversold territory, which might interest value investors looking for potential entry points.
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