Seelos Therapeutics, a biopharmaceutical company in the clinical stage, has recently received the minutes from its End of Phase II Meeting with the FDA. The meeting highlighted some modifications to the primary and secondary endpoints of their Phase II study of SLS-002. The FDA has agreed that in the Phase III trial, the primary endpoint could be the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 16, instead of the previously selected 24-hour timepoint. Additionally, the key secondary endpoint could be the change from baseline at 24 hours on the suicidality scale.
This agreement with the FDA has given Seelos Therapeutics a boost of confidence for the Phase III development of SLS-002. The data from the Phase II study has shown significant treatment differences from placebo, both in the Day 16 MADRS and the 24-hour Sheehan-Suicidality Tracking Scale (S-STS).
SLS-002 is a racemic ketamine administered intranasally and has two investigational new drug applications for the treatment of Acute Suicidal Ideation and Behavior. The upcoming Phase III trial will focus on enrolling adult patients with acute suicidal ideation and behavior (ASIB).
The Phase II study of SLS-002 has successfully demonstrated meaningful treatment effects across various placebo-controlled cohorts. It has shown a significant reduction in acute suicidality when compared to the placebo. With these positive results, Seelos Therapeutics plans to continue their discussions regarding potential partnerships and expects to proceed to Phase III with SLS-002 in Adults with Major Depressive Disorder (MDD) who are at imminent risk of suicide.
SEEL Stock Faces Downward Trend and Challenges: January 22, 2024 Update
SEEL stock, as of January 22, 2024, seems to be experiencing a downward trend in its price momentum. Trading near the bottom of its 52-week range and below its 200-day simple moving average, the stock is facing some challenges in the market. The price of SEEL shares has dropped by $0.08 since the market last closed, representing a significant 5.93% decrease. However, there seems to be a slight recovery in pre-market trading, as the stock has risen by $0.07. Trading near the bottom of its 52-week range is not necessarily a positive sign for SEEL stock. Additionally, trading below its 200-day simple moving average further reinforces the bearish sentiment surrounding SEEL stock. Investors should carefully consider these factors and conduct thorough research before making any investment decisions regarding SEEL stock. It is worth noting that the information provided is based on data from CNN Money.
SEEL Stock: Analyzing Financial Performance and Factors for Investors to Consider
SEEL stock, the ticker symbol for Seelos Therapeutics, has been attracting attention in the investment community due to its recent financial performance. According to data from CNN Money, Seelos Therapeutics reported a net income of -$73.53 million over the past year. However, in the third quarter of the same year, the company managed to turn things around and achieved a net income of $10.50 million. This represents an impressive increase of 135.59% compared to the previous quarter. Another important metric to consider is the earnings per share (EPS), which provides insight into the profitability of each outstanding share of stock. Seelos Therapeutics reported an EPS of -$20.74 over the past year, indicating a loss per share. However, in the third quarter, the company’s EPS improved to $2.13, representing a substantial increase of 131.69% compared to the previous quarter. While this growth may not be as significant as the quarter-on-quarter improvement, it still demonstrates the company’s ability to generate more profits for its shareholders. It is worth noting that the lack of available data on SEEL’s total revenue makes it challenging to assess the company’s overall financial performance accurately. However, the positive trends observed in net income and EPS provide some optimism for investors. Investors should consider several factors when evaluating the performance of a stock. While financial data is crucial, it is important to also analyze other aspects such as the company’s pipeline, market potential, and competitive landscape. Conducting thorough research and seeking advice from financial professionals can help investors make informed decisions. As always, it is important to remember that investing in stocks carries risks, and past performance is not always indicative of future results. Therefore, investors should exercise caution and carefully assess all available information before making any investment decisions regarding SEEL stock or any other security.
