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CORAL GABLES, Fla. - Relmada Therapeutics , Inc. (NASDAQ:RLMD), a clinical-stage biotechnology firm with a market capitalization of $11.5 million, has announced the acquisition of Sepranolone, a Phase 2b ready neurosteroid, from Asarina Pharma AB. The compound is being developed as a potential first-line treatment for Tourette syndrome (TS) and other compulsive disorders. According to InvestingPro data, the company maintains a strong liquidity position with current assets exceeding short-term obligations by nearly 7x.
The Phase 2a study results have indicated that Sepranolone may improve TS symptoms and quality of life with a robust safety profile, showing no central nervous system (CNS) off-target effects. This aligns with Relmada’s mission to address unmet needs in central nervous system disorders, offering a potential alternative to current treatments that often come with significant side effects.
Sepranolone, a first-in-class GABAA Modulating Steroid Antagonist (GAMSA), selectively targets the GABAA pathway. It aims to counteract the effects of Allopregnanolone, a neurosteroid implicated in TS and other compulsive disorders. The Phase 2a clinical trial demonstrated a competitive reduction in tic severity and an improvement in patients’ quality of life over a 12-week period, compared to standard care alone.
The transaction, which saw Relmada acquire full global ownership rights to Sepranolone for EUR 3 million, is part of the company’s strategy to build shareholder value through the development of innovative compounds. While InvestingPro analysis indicates the stock is currently trading below its Fair Value, investors should note that the company faces profitability challenges, with analysts not expecting positive earnings this year. Relmada plans to provide an investor update on Sepranolone’s development later in 2025, with the next earnings report scheduled for March 25, 2025.
Sepranolone has been evaluated in multiple clinical studies with over 335 participants and has shown a favorable safety profile. It functions by normalizing GABAA receptor activity without directly interfering with GABA signaling, representing a novel approach to treatment for TS and related disorders. The compound is protected by multiple issued patents until 2038.
Tourette syndrome, a complex neurological condition with involuntary tics, affects more than 350,000 children in the U.S. Current treatments include dopamine blockers and other methods that can have significant side effects. Sepranolone’s unique mechanism of action offers a potentially safer alternative by modulating the neurosteroid Allopregnanolone, which is believed to play a role in triggering compulsive behaviors. For investors seeking deeper insights into Relmada’s potential in this market, InvestingPro offers comprehensive analysis with over 10 additional ProTips and detailed financial metrics in their Pro Research Report.
Relmada Therapeutics is committed to advancing therapies for CNS and metabolic disorders, striving to improve patient outcomes and quality of life. This acquisition marks a significant step in the company’s strategic expansion of its treatment portfolio. The information in this article is based on a press release statement.
In other recent news, Relmada Therapeutics is facing potential Nasdaq delisting due to non-compliance with the minimum bid price requirement. The company is now in a 180-day compliance period to meet the minimum bid price criterion. On the executive front, Relmada announced the appointment of Paul Kelly as Chief Operating Officer, while also freezing salary increases, cash bonuses, and long-term incentive awards for top executives to reduce expenses.
In a significant development, the company’s REL-1017 RELIANCE II Phase 3 trial for major depressive disorder (MDD) has been deemed futile by the Data Monitoring Committee (DMC), leading Mizuho (NYSE:MFG) Securities and Leerink Partners to downgrade the company’s stock rating. Despite the setback, Relmada is considering its next steps and continues development of another product, REL-P11, currently in Phase 1 trials.
These are recent developments and do not imply any endorsement of the company’s strategies or future performance. The company’s plans to maintain its Nasdaq listing and its drug development prospects are subject to risks and uncertainties, and actual outcomes could differ from those projected.
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