CAMBRIDGE, Mass. - Sage Therapeutics, Inc. (NASDAQ: SAGE) and Biogen Inc. (NASDAQ: NASDAQ:BIIB) revealed that their investigational drug SAGE-324 (BIIB124) did not meet the primary endpoint in a Phase 2 study for essential tremor (ET), a neurological condition characterized by involuntary shaking. The KINETIC 2 Study showed no statistically significant dose-response relationship or difference between the drug and placebo in improving tremor scores.
The trial, which concluded on Day 91, involved 147 participants and tested various doses of SAGE-324 against a placebo. Despite the drug's failure to demonstrate efficacy in reducing tremor severity, the companies noted a dose-related increase in central nervous system depressant side effects, with the most common being somnolence and dizziness.
In light of these results, Sage and Biogen have decided to terminate the ongoing open-label safety study and will not pursue further clinical development of SAGE-324 for ET. The companies expressed their disappointment and gratitude towards the essential tremor community and study investigators for their contributions.
SAGE-324 is a neuroactive steroid GABAA receptor positive allosteric modulator, which was being investigated for its potential to enhance inhibitory neurotransmission in the brain. Essential tremor, which affects millions worldwide, has seen little pharmacological advancement in the past five decades, and the search for effective treatments continues.
Sage Therapeutics, known for developing FDA-approved treatments for postpartum depression, remains committed to addressing unmet needs in brain health, while Biogen continues to focus on pioneering innovative therapies for neurological diseases.
The information for this article is based on a press release statement.
In other recent news, Biogen Inc. has seen a flurry of developments. Piper Sandler lowered its price target on Biogen shares to $313 from $335, citing adoption challenges for the company's Alzheimer's drug, Leqembi. Despite this, the firm maintained its Overweight rating on the stock.
Meanwhile, Biogen completed the acquisition of Human Immunology Biosciences (HI-Bio), integrating HI-Bio's promising late-stage therapeutic candidate, felzartamab, into its immunology pipeline.
In partnership with Eisai Co (OTC:ESAIY) Ltd, Biogen launched Leqembi in China, its third market. RBC Capital maintains a positive outlook on Biogen, keeping a price target of $317.00, linked to the potential success of Leqembi. Stifel also reaffirmed a Buy rating with a $275.00 price target for Biogen, following the FDA's Advisory Committee meeting discussing another Biogen treatment, donanemab.
InvestingPro Insights
In the wake of the recent clinical trial setback for Sage Therapeutics and Biogen, it's crucial for investors to consider the financial health and market position of Biogen Inc. (NASDAQ: BIIB). According to InvestingPro, Biogen stands out as a prominent player in the biotechnology industry, known for its low price volatility and a stock price that often moves counter to market trends. These characteristics could be particularly appealing to investors looking for stability in a volatile market.
The company's financial metrics further underscore its stability. Biogen's market capitalization is a robust $32.66 billion, and the firm maintains a healthy price-to-earnings (P/E) ratio of 19.62 when adjusted for the last twelve months as of Q1 2024. Additionally, Biogen's liquid assets surpass its short-term obligations, indicating a strong liquidity position that could enable the company to weather unexpected challenges.
InvestingPro Tips highlight that analysts have recently revised their earnings predictions upwards for the upcoming period and forecast the company to be profitable this year, having been profitable over the last twelve months. While Biogen does not pay a dividend, suggesting a reinvestment strategy back into its research and development efforts, investors may find reassurance in the company's solid profitability track record.
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