Aankondiging • Apr 09
Relmada Therapeutics, Inc., Annual General Meeting, May 27, 2026 Relmada Therapeutics, Inc., Annual General Meeting, May 27, 2026. Aankondiging • Mar 13
Relmada Therapeutics, Inc. announced that it has received $159.999996 million in funding from a group of investors On March 12, 2026, Relmada Therapeutics, Inc. closed the transaction. The transaction has been oversubscribed, with participation from leading healthcare investors. Aankondiging • Mar 12
Relmada Therapeutics, Inc. to Report Q4, 2025 Results on Mar 19, 2026 Relmada Therapeutics, Inc. announced that they will report Q4, 2025 results on Mar 19, 2026 Aankondiging • Mar 10
Relmada Therapeutics Reports 12-Month Phase 2 Interim Data For NDV-01 In Non-Muscle Invasive Bladder Cancer Relmada Therapeutics, Inc. announced 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC). The Phase 2 trial of NDV-01 demonstrated a 12-month complete response (CR) rate of 76% with a favorable safety profile. Notably, a 12-month CR rate of 80% was achieved in the BCG-unresponsive population, one of the most difficult-to-treat segments of NMIBC. Taken together, these findings support the potential best-in-class profile of NDV-01 and support advancement into the Phase 3 RESCUE registrational program evaluating NDV-01 in both 2L BCG-unresponsive and adjuvant intermediate-risk NMIBC. Highlights of the 12-month follow-up data from the Ongoing Phase 2 study of NDV-01: Clinical Results (Response Data) Complete Response Anytime 95% (36/38) 3 month 87% (33/38) 6 month 86% (25/29) 9 month 85% (22/26) 12 month 76% (19/25) 12-month KM analysis 83% N=48 patients dosed in overall population; KM: Kaplan-Meier analysis Efficacy in BCG-Unresponsive Subpopulation: Clinical Results (Response Data) Complete Response Anytime 94% (16/17) 3 month 82% (14/17) 6 month 86% (12/14) 9 month 91% (10/11) 12 month 80% (8/10) 12-month KM analysis 84% N=20 patients dosed in BCG-UR subpopulation; BCG-UR defined by FDA definition; BCG-UR: Bacillus Calmette-Guérin (BCG) – Unresponsive; KM: Kaplan-Meier analysis No patient had progression to muscle-invasive disease No patient underwent a radical cystectomy No patients had a = Grade 3 treatment related adverse event (TRAE) No patients discontinued treatment due to AEs Of the 48 patients who received = 1 dose, 30 (63%) experienced a treatment-related adverse event (AE). Aankondiging • Mar 09
Relmada Therapeutics, Inc. announced that it expects to receive $159.999996 million in funding from a group of investors Relmada Therapeutics, Inc. entered into a securities purchase agreement for a private investment in public equity financing by issuing 29,474,569 shares at a price of $4.75 per share for gross proceeds of $ 140,004,202.75 and pre-funded warrant of 4,210,527 at a price of $4.749 per pre-funded warrant for gross proceeds of $ 19,995,792.723 and total aggregate of $ 159,999,995.473 on March 9, 2026. Each warrant is converted into common shares and Each warrant entitles the holder thereof to acquire one additional common share at an exercise price of $0.001 per share. The offering involves investor participation from Venrock Healthcare Capital Partners, Commodore Capital, Janus Henderson Investors, RA Capital Management, Balyasny Asset Management, OrbiMed, Spruce Street Capital, Squadron Capital Management, Columbia Threadneedle Investments, Adage Capital Management, Marshall Wace, Braidwell LP, Great Point Partners, LLC and Eventide Asset Management. The PIPE financing is expected to close on or about March 11, 2026, subject to satisfaction of customary closing conditions. Aankondiging • Jan 13
Relmada Therapeutics, Inc. Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications Relmada Therapeutics, Inc. announced that it has received written feedback from the U.S. Food and Drug Administration (FDA) regarding the registrational development pathway for NDV-01 in 2nd-line refractory, high-grade BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) -- one of the highest-risk and most treatment-resistant NMIBC populations -- and in intermediate risk NMIBC in the adjuvant setting, where there are currently no approved therapies. In its written response to Relmada's Type B pre-IND submission, the FDA indicated that a single-arm, open-label clinical trial in this high-grade, BCG-unresponsive with CIS population is an appropriate registrational approach for NDV-01. The planned pivotal Phase 3 study in 2nd-line, refractory, high- grade BCG-unresponsive NMIBC with carcinoma in situ (CIS) will be an open-label, single-arm trial evaluating: Primary endpoint: Complete response (CR) rate at any time; Key secondary endpoint: Duration of response (DOR); Assessments: Cystoscopy, cytology, and biopsy per protocol. The design reflects FDA's written guidance on the study population, endpoint selection, and evaluation methodology and is consistent with prior FDA precedents for single-arm registrational trials in NMIBC. The planned pivotal Phase 3 trial in intermediate-risk NMIBC in the adjUvant setting will be an open label randomized-to-observation study: Primary endpoint: Disease Free Survival (DFS); Key secondary endpoint: Duration of responses (DOR); Assessment: Cystoscopy, Cystoscopy, cytological, and biopsy per protocol; The design reflects FDA's writing guidance on the study population, end-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to continue to secure FDA agreement on the regulatory path for NDV-01 and/or sepranolone, or that future NDV-01 and//or sepranolone clinical results will be acceptable to the FDA, failure to secure adequate NDV-01 and/or/or sepranolone drug supply, the Company's cash runway and sufficiency of the Company's cash resources and uncertainties inherent in estimating the Company's cash runway, estimating the Company's cash runway. Aankondiging • Nov 08
Relmada Therapeutics, Inc. to Report Q3, 2025 Results on Nov 13, 2025 Relmada Therapeutics, Inc. announced that they will report Q3, 2025 results on Nov 13, 2025 Aankondiging • Nov 06
Relmada Therapeutics, Inc. Announces Fda Feedback Supporting 2 Separate Acceptable Registrational Study Paths for Ndv-01 in Non-Muscle Invasive Bladder Cancer Relmada Therapeutics, Inc. announced the receipt of written minutes from a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the planned Phase 3 program for NDV-01 in non-muscle invasive bladder cancer (NMIBC) patients. The Company will be requesting follow-up meetings with FDA to discuss each development path. Relmada secured FDA alignment on certain key elements of the planned Phase 3 pivotal program for NDV-01, expected to begin in H1 2026 and incorporating two independent studies for approval in two separate indications: High-grade, 2nd line BCG-unresponsive NMIBC patients; Intermediate risk NMIBC in the adjuvant setting. Key Outcomes from the FDA Type B pre-IND meeting (specific study design details to be further discussed with the agency): In high-grade, 2nd lineBCG-unresponsive setting, the FDA stated that a single arm trial might be acceptable in a more refractory patient population; In the intermediate risk NMIBC setting, the FDA agreed that a proposal to randomize patients post-TURBT to adjuvant NDV-01 vs observation, evaluating a time-to-event endpoint, is generally acceptable. FDA indicated that no further non-clinical studies are required to support a 505(b)(2) New Drug Application (NDA). Aankondiging • Nov 04
Relmada Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $100.000085 million. Relmada Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $100.000085 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 40,142,000
Price\Range: $2.2
Discount Per Security: $0.132
Security Name: Pre-funded warrants
Security Type: Equity Warrant
Securities Offered: 5,315,000
Price\Range: $2.199
Discount Per Security: $0.132 Aankondiging • Oct 07
Relmada Therapeutics, Inc. Appoints Distinguished Urologic Oncologist, Max Kates, Md, to the Clinical Advisory Board Relmada Therapeutics, Inc. announced the appointment of Max Kates, MD, Associate Professor of Urology and Oncology at Johns Hopkins University School of Medicine, to Relmada’s Clinical Advisory Board (CAB) to support the development of NDV-01 for the potential treatment of non-muscle invasive bladder cancer (NMIBC). Relmada intends to initiate the Phase 3 program for NDV-01 in H1 2026. Dr. Kates is a nationally recognized clinician-scientist in bladder cancer with one of the largest surgical bladder cancer practices in the U.S., integrating clinical care with translational research. Dr. Kates serves as chair of the Phase 3 EA8212 BRIDGE Trial (NCT05538663) trial, comparing Gemcitabine/Docetaxel to BCG (Bacillus Calmette-Guérin) in non–muscle invasive bladder cancer (over 900 patients enrolled across >65 centers). He has also been the Principal Investigator on numerous studies evaluating new potential treatments for NMIBC. Dr. Kates has pioneered improvements in surgical innovation for robotic intracorporeal cystectomy and neobladder as well as novel techniques and early recovery programs for TURBT translational research, has advanced understanding of immune resistance in BCG-unresponsive disease, pioneered novel intravesical therapies, and explored antibody–drug conjugates and immunotherapy for bladder preservation. Throughout his career, Dr. Kates has published more than 150 peer-reviewed manuscripts in leading journals such as Clinical Cancer Research, Cancer Immunology Research, Journal of Urology, and European Urology. Dr. Kates also serves as a reviewer for prominent journals including the New England Journal of Medicine, and the Journal of Clinical Oncology. Dr. Kates is the R. Christian B. Evensen Professor of Urology and Director of the Division of Urologic Oncology at Johns Hopkins Hospital, and Associate Professor, Urology and Oncology and Co-Director of the Greenberg Bladder Cancer Institute. He received his medical degree from Mount Sinai School of Medicine in New York. He trained in general surgery and urologic surgery at John Hopkins Hospital in Baltimore, Maryland and completed a Clinical Research Fellowship at Columbia University College of Physicians and Surgeons in New York. Dr. Kates graduated with High Distinction with a B.A. from Wesleyan University. Aankondiging • Jul 31
Relmada Therapeutics, Inc. to Report Q2, 2025 Results on Aug 07, 2025 Relmada Therapeutics, Inc. announced that they will report Q2, 2025 results on Aug 07, 2025 Aankondiging • Jul 24
The Nasdaq Stock Market Approves Relmada Therapeutics' Application to Transfer its Listing to the Nasdaq Capital Market As previously disclosed, on January 21, 2025, Relmada Therapeutics, Inc. (the ‘Company’) received a written notification from the Listing Qualifications Department of the Nasdaq Stock Market (‘Nasdaq’) notifying the Company that, for the 30 consecutive business days ended January 17, 2025, the Company’s security did not maintain a minimum bid price of $1 per share. Nasdaq stated in its letter that in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company had a compliance period of 180 calendar days from the date of the notice (‘Initial Compliance Period’), and that it may regain compliance if the closing bid of the Company’s security is at least $1 for a minimum of ten consecutive business days during the Initial Compliance Period, which ended on July 21, 2025. On July 22, 2025, Nasdaq notified the Company that it had approved the Company’s application to transfer its listing to the Nasdaq Capital Market. The Company’s securities will be transferred to the Nasdaq Capital Market at the opening of business on July 24, 2025. Nasdaq also approved a 180-day extension, or until January 19, 2026 (the ‘Compliance Period’), to regain compliance with the minimum bid price in accordance with Nasdaq Listing Rule 5550(a)(2). To regain compliance, the Company’s common stock must maintain a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days at any time prior to the expiration of the Compliance Period. The Company intends to actively monitor the Company’s bid price during the Compliance Period and intends to take all reasonable measures available to regain compliance with the requirements for continued listing on the Nasdaq Capital Market. While the Company plans to make diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with the applicable continued listing standards set forth in the Nasdaq Listing Rules. Aankondiging • Jul 17
Relmada Therapeutics, Inc. Appoints Yair Lotan as to Chair of its Clinical Advisory Board Relmada Therapeutics, Inc. announced the appointment of Yair Lotan, MD, a distinguished urologic oncologist, as Chair of Relmada’s Clinical Advisory Board (CAB). Dr. Lotan’s deep expertise in bladder cancer care and clinical research will be invaluable as Relmada prepares to initiate a Phase 3 trial for NDV-01 in H1 2026, building on positive Phase 2 data, presented at the American Urology Association 2025 Annual Meeting (AUA 2025) on April 28, 2025. Dr. Lotan brings more than two decades of experience in bladder cancer care, clinical development and academic medicine. As a nationally recognized expert in molecular biomarkers, with involvement in the establishment of practice guidelines for the management of bladder cancers and health economics research, Dr. Lotan is well suited to Chair Relmada’s Clinical Advisory Board and to help shape the clinical development strategy for NDV-01. Yair Lotan, MD, is a urologic oncologist with over 20 years of experience caring for bladder cancer patients. Dr. Lotan graduated with high honors from the University of Texas at Austin and with honors from Baylor College of Medicine in Houston. He trained in general surgery and urology at UT Southwestern Medical Center in Dallas. Dr. Lotan heads a clinical research office and is involved in many clinical trials related to bladder cancer. Dr. Lotan is known nationally for his research on urine markers and molecular markers, which will help determine which patients are at higher risk for recurrent cancer. He is also involved in health economics research, which evaluates the cost-effectiveness of surgery and cancer prevention. Dr. Lotan has participated in multiple collaborative studies involving early detection of bladder cancer. He is also a co-investigator on several NIH funded trials evaluating urine-based tumor markers. Dr. Lotan is the primary investigator on several investigator-initiated studies evaluating the role of urine and tissue markers in the management of bladder cancer. He is a member of panels that establish guidelines for the evaluation of hematuria and management of muscle invasive bladder cancer. Dr. Lotan has published over 650 peer reviewed papers and multiple reviews and book chapters. Dr. Lotan is a frequent guest speaker at medical conferences around the world and belongs to numerous professional organizations, including the American Urological Association, the Society of Urologic Oncology, and the Bladder Cancer Advocacy Network. He also serves as editorial reviewer for medical periodicals such as the Journal of Urology, European Urology, Cancer, Urologic Oncology, and the British Journal of Urology International. Dr. Lotan has been included in D Magazine’s Best Doctors list multiple times over the last decade. Aankondiging • Jun 18
Relmada Therapeutics, Inc. Appoints Raj S. Pruthi as Chief Medical Officer-Urology Relmada Therapeutics, Inc. announced the appointment of Raj S. Pruthi, MD as Chief Medical Officer-Urology (CMO). Dr. Pruthi’s expertise will be instrumental in the development of Relmada’s lead program, NDV-01, for non-muscle invasive bladder cancer (NMIBC). The Company presented positive initial Phase 2 data at the American Urology Association 2025 Annual Meeting (AUA 2025) on April 28, 2025. Dr. Pruthi is a highly regarded physician-scientist with over 25 years of experience in industry and academic medicine, specializing in urologic oncology, clinical trials and robotic surgery. Raj has been contributing to the development of the American Urological Association (AUA) practice guidelines for NMIBC, and he brings to Relmada a broad track record of designing and executing global clinical studies for potential bladder cancer treatments. Raj previously served as Chief Medical Officer at enGene Holdings Inc., and as Global Medical Affairs leader at Johnson and Johnson Innovative Medicine. Raj Pruthi is an accomplished physician, surgeon and clinical scientist with an extensive career in academic medicine and industry and long publication history. Prior to joining Relmada, Dr. Pruthi was Chief Medical Officer at enGene Holdings Inc., where he led a global team in the development of a registrational therapeutic trial for bladder cancer. Prior to that, he was the Global Medical Affairs Leader, Bladder Cancer and Senior Medical Director, Oncology (Global – Prostate and Bladder Cancer) at Johnson and Johnson Innovative Medicine. Dr. Pruthi holds multiple leadership roles within the urology community. He is the Chair of the Advisory Council for Urology of the American College of Surgeons and serves on its Board of Governors. He is currently an Adjunct Professor in the Department of Urology at the Donald and Barbara Zucker School of Medicine at Hofstra University/Northwell and Professor, Department of Health System Sciences, Thomas F. Frist, Jr. College of Medicine at Belmont University. Previously, he served as Professor and Chair of the Department of Urology at the University of California at San Francisco and at the University of North Carolina, Chapel Hill. Dr. Pruthi is a former member of the American Board of Urology/American Urological Association Examination Committee and is Past-President for the Society of Academic Urology. He served on the Guidelines Committee and helped to develop the AUA Guidelines on the Management of NMIBC, and also served on the Bladder Cancer Guidelines Committee of the International Consultation on Urological Diseases. Dr. Pruthi graduated from Duke University School of Medicine and completed his residency and post-graduate training in Urologic Surgery at Stanford University. He also holds a Master of Health Administration from the University of North Carolina at Chapel Hill. Aankondiging • May 08
Relmada Therapeutics, Inc. to Report Q1, 2025 Results on May 12, 2025 Relmada Therapeutics, Inc. announced that they will report Q1, 2025 results on May 12, 2025 Aankondiging • Apr 29
Relmada Therapeutics, Inc. Presents Positive Initial Phase 2 NDV-01 Data at AUA2025 Relmada Therapeutics, Inc. announced that positive initial data from the Phase 2 study of NDV-01 showed that 90% of patients achieved high-grade disease-free status at any time point following treatment, demonstrating strong clinical activity and supporting further development of NDV-01 for the treatment of non-muscle invasive bladder cancer (NMIBC). Highlights of Phase 2 data presented at AUA2025: Efficacy Data: 3-month Assessment: Overall Response Rate (ORR): 85% (17/20 patients at 3 months); High-Grade Recurrence-Free Survival (HGRFS) in papillary disease: 83.3% (15/18 patients); Complete Response (CR) in CIS patients: 100% (2/2 patients); At any time point: ORR: 90% (18/20 patients); HGRFS in papillary disease: 88.8% (16/18 patients); CR in CIS patients: 100% ("2/2 patients); Disease status at 6 months: 100% (2/2 patients); Disease status at 6 years: 100% (n=7) of evaluable patients (1 CIS, 6 Ta/T1) achieved disease free status. One of these patients was re-treated at 3 months. Aankondiging • Apr 14
Relmada Therapeutics, Inc., Annual General Meeting, May 23, 2025 Relmada Therapeutics, Inc., Annual General Meeting, May 23, 2025. Aankondiging • Mar 26
Relmada Therapeutics, Inc. to Report Q4, 2024 Results on Mar 27, 2025 Relmada Therapeutics, Inc. announced that they will report Q4, 2024 results on Mar 27, 2025 Aankondiging • Jan 28
Relmada Therapeutics Receives Written Notification from Nasdaq Regarding Minimum Bid Price Requirement On January 21, 2025, Relmada Therapeutics, Inc. (the Company") received a written notification from the Listing Qualifications Department of the Nasdaq Stock Market (Nasdaq") notifying the Company that, for the 30 consecutive business days ended January 17, 2025, the Company's security did not maintain a minimum bid price of $1 per share. Nasdaq stated in its letter that in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days from the date of the notice (Compliance Period"), and that it may regain compliance if the closing bid of the Company's security is at least $1 for a minimum of ten consecutive business days during the Compliance Period, which will end on July 21, 2025. If the Company chooses to implement a reverse stock split, it must complete the split no later than ten business days prior to the expiration of the Compliance Period, in order to regain compliance. The notification from Nasdaq does not impact the listing of the Company's common stock at this time. The Company intends to actively monitor the Company's bid price during the Compliance Period and intends to take all reasonable measures available to regain compliance with the requirements for continued listing on the Nasdaq Global Market. If the Company does not regain compliance with the continued listing requirements for the minimum bid price by the end of the Compliance Period, the Nasdaq Staff will provide the Company with written notification that the Company's common stock is subject to delisting from the Nasdaq Global Market. Alternatively, Nasdaq Marketplace Rules may permit the Company to transfer the Company's common stock to the Nasdaq Capital Market prior to the Compliance Date, if the Company's common stock satisfies the criteria for continued listing on such market. While the Company plans to make diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with the applicable continued listing standards set forth in the Nasdaq Listing Rules. Aankondiging • Jan 07
Relmada Therapeutics, Inc. Elects Paul Kelly as Chief Operating Officer Relmada Therapeutics, Inc. announced that effective January 1, 2025, Paul Kelly was elected by the Board of Directors to the position of Chief Operating Officer of the company. Mr. Kelly serves as a director of the Company and prior to his election as Chief Operating Officer served as Special Advisor to the Chief Executive Officer of the Company. Aankondiging • Dec 10
Relmada Therapeutics to Discontinue the Reliance Ii and Relight Phase 3 Studies of Rel-1017 Relmada Therapeutics, Inc. announced that in light of the recent data monitoring committee evaluation of the full dataset from the Reliance II Phase 3 study of the Company's REL-1017 program, the Company will discontinue the Reliance II and Relight Phase 3 studies. The Company will continue to advance the Phase 1 study of REL-P11, an investigational agent for the treatment of metabolic disease, currently in a Phase 1 first-in-human study. In connection with this decision, the Company has commenced a process to explore strategic alternatives to maximize shareholder value. As part of this process, the Company plans to consider a wide range of options with a focus on maximizing shareholder value, including, but not limited to, the sale of Company assets, a sale of the Company, a merger or a reverse merger, the acquisition of assets or rights for the development of other products, or other strategic transaction(s). There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such agreements or transactions. The Company is in the process of engaging a financial advisor to assist in the strategic review process.
The Company has not set a timetable for completion of the evaluation process and does not intend to disclose further developments or guidance on the status of its exploration of strategic alternatives unless and until it is determined that further disclosure is appropriate or necessary.