CAMBRIDGE, Mass. – Sage Therapeutics, a biopharmaceutical company, announced today the results from its Phase 2 SURVEYOR study, which met its primary endpoint, demonstrating a statistically significant cognitive difference in Huntington's Disease (HD) patients compared to healthy participants.
The study, involving 40 participants with HD and 29 healthy controls, used the HD-Cognitive Assessment Battery (HD-CAB) to measure cognitive impairment. Results showed a marked difference in baseline cognitive scores between the two groups, confirming the substantial cognitive impact of HD.
In the trial's second phase, HD patients received either the investigational drug dalzanemdor or a placebo for 28 days. While the study wasn't designed to show a significant difference between the drug and placebo in this timeframe, dalzanemdor was noted to be generally well-tolerated with no new safety concerns.
Preliminary findings indicated a slight numerical improvement in HD-CAB scores for those treated with dalzanemdor. Additional exploratory analyses hinted at possible positive effects on individual cognitive tests and some functional assessments, though further research is needed to understand these observations.
Dalzanemdor, an NMDA receptor positive allosteric modulator, is being developed by Sage as a potential treatment for cognitive disorders linked to NMDA receptor dysfunction, including HD and Alzheimer's Disease (AD). The company plans to continue analyzing the SURVEYOR study data and apply insights to its ongoing dalzanemdor program.
Sage Therapeutics, founded in 2010, focuses on developing brain health medicines and has two FDA-approved treatments for postpartum depression. The company anticipates reporting topline data from additional studies on dalzanemdor's effects on cognitive impairment in HD and mild cognitive impairment and mild dementia in AD by late 2024.
This news is based on a press release statement from Sage Therapeutics.
In other recent news, Sage Therapeutics has been a focal point for several analyst firms, following the launch of its postpartum depression treatment, Zurzuvae. Baird initiated coverage on the biopharmaceutical company, setting a price target of $15, and projected gradual sales growth for Zurzuvae, expecting it to reach $262 million by 2029. Citi, however, initiated coverage with a Sell rating and a price target of $8, expressing caution over the company's high rate of cash consumption and potential for further decline.
Mizuho Securities adjusted its outlook on Sage Therapeutics, reducing the price target to $18 from $20, despite acknowledging better-than-expected quarterly results. The firm chose not to raise its forecast for peak sales above the current projection of over $300 million, needing greater clarity on the drug's potential market adoption. Truist Securities also revised its stock price target for Sage Therapeutics to $18 from $22, citing limited potential for significant profit growth due to a profit-share agreement with Biogen (NASDAQ:BIIB) on Zurzuvae.
Scotiabank reduced its price target on Sage Therapeutics shares to $19 from $34, following the results from the Phase 2 PRECEDENT trial. Despite the trial not demonstrating improved cognitive performance, the firm maintained its Sector Outperform rating for the company. These developments highlight the ongoing scrutiny and mixed expectations surrounding Sage Therapeutics' financial performance and pipeline potential.
InvestingPro Insights
As Sage Therapeutics progresses with its Phase 2 SURVEYOR study, financial metrics and analyst insights from InvestingPro paint a detailed picture of the company's market position. With a market cap of approximately $655.98 million, Sage stands as a notable player in the biopharmaceutical industry. Despite the promising study results, analysts have revised their earnings downwards for the upcoming period, reflecting caution about the company's near-term financial performance. Additionally, the company's price/book ratio as of the last twelve months stands at 0.93, indicating that the stock is potentially undervalized relative to its assets.
InvestingPro Tips suggest that while Sage holds more cash than debt, indicating a solid balance sheet, it is quickly burning through cash, which could raise concerns about long-term sustainability. Furthermore, the company is trading near its 52-week low, which might represent an entry point for investors believing in the company's potential to rebound. For those considering an investment, Sage does not pay a dividend, which is typical for companies focused on growth and reinvestment.
For readers interested in exploring further, there are 12 additional InvestingPro Tips available that could provide deeper insights into Sage's financial health and stock performance. To access these insights and more, visit InvestingPro Sage Therapeutics and consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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