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Relmada Therapeutics, Inc. (Nasdaq: RLMD) is a clinical-stage biotechnology company focusing on the development of treatments for central nervous system (CNS) disorders, particularly major depressive disorder (MDD). The company's lead product candidate, REL-1017, is a new chemical entity (NCE) and NMDA receptor channel blocker. It is currently being evaluated in late-stage clinical trials as an adjunctive treatment for MDD in adults.
REL-1017 has shown promise in clinical studies, demonstrating rapid and sustained improvements in depressive symptoms with a favorable safety profile. The ongoing clinical development program includes two Phase 3 trials: Reliance II (Study 302) and Relight (Study 304), which are designed to assess the efficacy and safety of REL-1017 in patients with MDD who have an inadequate response to their current antidepressant therapies.
Relmada Therapeutics is also advancing a novel non-psychedelic/low dose psilocybin program (REL-P11) for the treatment of metabolic conditions. Initial preclinical studies have shown significant therapeutic potential in improving metabolic parameters, and the company plans to initiate Phase 1 and Phase 2a trials in obese patients with steatotic liver disease.
In recent corporate updates, Relmada has reported significant progress in its clinical development plans, with study enrollments proceeding as expected and additional preclinical and Phase 1 studies supporting future regulatory submissions. The company is well-funded to continue its research and development activities, aiming for multiple clinical milestones and potential regulatory filings in the near future.
Relmada Therapeutics (Nasdaq: RLMD) announced the discontinuation of its Reliance II and Relight Phase 3 studies of REL-1017 following a data monitoring committee evaluation. The company will continue advancing the Phase 1 study of REL-P11, an investigational treatment for metabolic disease. In response to these developments, Relmada has initiated a process to explore strategic alternatives to maximize shareholder value, including potential sale of company assets, mergers, acquisitions, or other strategic transactions. The company is engaging a financial advisor for the strategic review process but has not set a specific timeline for completion.
Relmada Therapeutics (NASDAQ: RLMD) announced that the Phase 3 Reliance II trial for REL-1017, designed to evaluate its efficacy as an adjunctive treatment for major depressive disorder (MDD), is unlikely to meet its primary efficacy endpoint according to the Data Monitoring Committee's interim analysis. No new safety concerns were identified.
The company will evaluate the complete dataset to determine next steps for the REL-1017 program while continuing to advance the Phase 1 study of REL-P11 for metabolic disease. Relmada maintains a strong financial position with approximately $54.1 million in cash and cash equivalents as of September 30, 2024.
Relmada Therapeutics (Nasdaq: RLMD), a late-stage biotechnology company focusing on central nervous system diseases, has announced its participation in the Jefferies London Healthcare Conference. CEO Sergio Traversa will present on Wednesday, November 20, 2024, at 12:00 PM GMT. The presentation will be available via webcast, with a replay accessible on Relmada's website investor page for 90 days after the conference.
Relmada Therapeutics has initiated Phase 1 dosing of REL-P11, a proprietary low-dose, modified-release psilocybin formulation for metabolic disease. The Single-Ascending Dosing (SAD) study will evaluate safety and pharmacokinetics in obese and normal weight subjects. Preclinical rodent studies presented at AASLD 2023 demonstrated improved metabolic parameters without detrimental CNS effects. With positive results, the company plans to advance to a Phase 2a proof-of-concept study in H1 2025.
Relmada Therapeutics (RLMD) reported Q3 2024 financial results with a net loss of $21.7 million ($0.72 per share), compared to $22.0 million ($0.73 per share) in Q3 2023. Research and development expenses increased to $11.1 million from $10.4 million, while general and administrative expenses decreased to $11.9 million from $12.2 million. The company maintains a cash position of $54.1 million, expected to fund operations into 2025. Key upcoming milestones include a pre-planned Phase 3 Reliance II interim analysis by year-end 2024 and initiation of a Phase 1 study for REL-P11 for metabolic disease.
Relmada Therapeutics (RLMD) reported Q3 2024 financial results with a net loss of $21.7 million ($0.72 per share), compared to $22.0 million ($0.73 per share) in Q3 2023. Research and development expenses increased to $11.1 million from $10.4 million year-over-year, while G&A expenses decreased to $11.9 million from $12.2 million. The company's cash position stands at $54.1 million, expected to fund operations into 2025.
Key upcoming milestones include a pre-planned Phase 3 Reliance II interim analysis by year-end 2024 for REL-1017 in major depressive disorder, and initiation of a Phase 1 study for REL-P11 in metabolic disease.
Relmada Therapeutics (Nasdaq: RLMD), a late-stage biotechnology company focused on central nervous system diseases, has announced it will host a conference call and webcast on November 7, 2024 at 4:30 PM ET. The event will discuss business progress and financial results for the third quarter ended September 30, 2024. The company has provided dial-in numbers for US and international participants, along with a webcast option. A replay will be available in the Investors section of Relmada's website.
Relmada Therapeutics (NASDAQ: RLMD) reported its Q2 2024 financial results and provided a business update. Key highlights include:
- Anticipated outcome of Reliance II interim analysis by YE 2024
- Expected completion of Phase 3 Reliance II study enrollment by YE 2024
- Preparations for Phase 1 study of REL-P11 for metabolic disorders by YE 2024
- Cash position of $70.4 million, providing runway through key milestones into 2025
Financial results for Q2 2024:
- R&D expense: $10.7 million, down from $13.7 million in Q2 2023
- G&A expense: $8.1 million, down from $12.3 million in Q2 2023
- Net loss: $17.8 million ($0.59 per share), compared to $25.3 million ($0.84 per share) in Q2 2023
Relmada Therapeutics (Nasdaq: RLMD), a late-stage biotechnology company focusing on central nervous system (CNS) diseases, has announced its plans to host a conference call and webcast on August 7, 2024, at 4:30 PM ET. The event will discuss recent business progress and financial results for the second quarter ended June 30, 2024.
Participants can join the call using US dial-in 1-800-717-1738 or international dial-in 1-646-307-1865, with conference code 39584. Alternatively, they can use the 'Call me™' technology for instant telephone access. A webcast replay will be available in the Investors section of Relmada's website after the event.
Relmada Therapeutics announced the publication of Phase 3 clinical data for REL-1017 (esmethadone) from the Reliance I Study in The Journal of Clinical Psychiatry. The study focused on patients with Major Depressive Disorder (MDD) who had an inadequate response to standard antidepressants. The results confirmed the efficacy, safety, and tolerability of esmethadone, aligning with previous Phase 2 findings. The side-effect profile was favorable compared to current FDA-approved treatments for MDD, highlighting esmethadone's potential as an adjunctive therapy.
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