Relmada Therapeutics Presents NDV-01 Data at | U.S. Finance News
Relmada Therapeutics introduced an summary on NDV-01 for high-risk NMIBC at the AUA2025 convention.Quiver AI AbstractRelmada Therapeutics, Inc. introduced the presentation of an summary at the American Urology Association (AUA2025) convention in Las Vegas, highlighting a examine on NDV-01, an investigational remedy combining gemcitabine and docetaxel for high-risk non-muscle invasive bladder most cancers (NMIBC). Scheduled for presentation on April 28, 2025, NDV-01 is designed for intravesical use, permitting for sustained drug release, aiming to improve efficacy, cut back negative effects, and improve affected person compliance. The remedy could function a first-line remedy for high-grade NMIBC and has potential purposes for sufferers who haven’t responded to different therapies. Relmada, targeted on progressive therapies, continues to develop NDV-01 and different packages like sepranolone for compulsion-related issues. The market for NMIBC therapies is seen as a substantial alternative attributable to high recurrence charges and restricted choices.
Potential Positives
Potential Negatives
FAQWhat is NDV-01?NDV-01 is an investigational sustained-release formulation combining gemcitabine and docetaxel for treating high-risk non-muscle invasive bladder most cancers.When is the presentation of NDV-01 at AUA2025?The presentation of NDV-01 will happen on April 28, 2025, from 10:04 AM to 10:12 AM PT.How does NDV-01 improve remedy for bladder most cancers?NDV-01 enhances remedy by maximizing native drug focus, prolonging publicity, and minimizing systemic toxicity in comparison with standard therapies.What is the importance of NMIBC in bladder most cancers instances?Non-muscle invasive bladder most cancers (NMIBC) accounts for about 75% of bladder most cancers instances, posing a high recurrence risk.How does Relmada Therapeutics assist innovation in biotechnology?Relmada Therapeutics advances progressive therapies, specializing in important medical advantages for focused affected person populations, like NDV-01 for NMIBC.
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CORAL GABLES, Fla., April 27, 2025 (GLOBE NEWSWIRE) — Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a clinical-stage biotechnology company, in the present day introduced the presentation of an summary at the American Urology Association (AUA2025), going down from April 26-29
th
in Las Vegas.
Abstract Overview
Abstract Title:
Prospective Open Label Study to Evaluate the Safety and Efficacy of intravesical sustained release Gemcitabine Docetaxel mixture(NDV-01) in High Risk NMIBC
Session:
Clinical Trials in Progress: Bladder Cancer
Location:
Hall C, The Square, Learning Lab
Presentation Date:
April 28, 2025
Presentation Time
10:04 AM PT to 10:12 AM PT
About NDV-01
NDV-01
is an investigational, progressive sustained-release formulation of two complementary, well-established, chemotherapy brokers, gemcitabine and docetaxel (gem/doce). It is designed for intravesical dosing and meant to be an in-office ready-to-use remedy that’s administered quickly and requires no anesthesia or new or devoted gear to make use of. NDV-01 kinds a spherical gentle matrix within the bladder that sequesters drug and releases it because the matrix steadily dissolves.
NDV-01’s formulation is particularly designed to maximise native drug focus and extend publicity to gem/doce, whereas minimizing systemic toxicity. Unlike standard intravesical instillations, NDV-01 is designed to keep away from peaks and troughs in drug focus, making certain a gradual and sustained release of gem/doce over a 10-day period. This method could doubtlessly improve general efficacy, cut back negative effects, cut back the frequency of dosing and improve affected person compliance and outcomes. NDV-01 has the potential to be a first line (1L) remedy for HG-NMIBC, with additional potential to be used in sufferers who’ve failed different therapies, together with BCG immunotherapy, and growth into different NMIBC subtypes, together with intermediate-grade illness.
NDV-01 is protected by a number of patents that exit to 2038.
About NMIBC
More than 90% of the roughly 83,000 new U.S. instances of urothelial most cancers are estimated to be bladder most cancers. For the general bladder most cancers population, 5-year survival ranges from 70 to 96% of sufferers, transferring to six% for sufferers with superior illness. Roughly 75% of bladder most cancers instances are categorised as non-muscle invasive (NMIBC) and roughly 50% of instances are categorised as high-grade illness, thought of to have elevated risk of development and recurrence. Sources point out that NMIBC has a 50-75% recurrence charge (over seven years) and that the U.S. prevalence of NMIBC is roughly 600,000 sufferers.
The U.S. NMIBC market is estimated to be a multi-billion alternative. Global numbers are increased, in keeping with projections for important growth due to the growing incidence of bladder most cancers and the demand for efficient, minimally invasive potential therapies like NDV-01. Approved remedy choices stay restricted (primarily the immunotherapy, BCG, which has been provide constrained for some time), with high recurrence charges resulting in frequent re-treatment and development. Other rising packages embrace immunotherapy mixtures, single agent chemotherapy formulations and focused therapies. NDV-01 stands out primarily based on the massive physique of printed information that assist the efficacy of remedy with gemcitabine and docetaxel, its ease of administration and potential for sturdiness of motion. Expansion past first-line remedy into use as a salvage remedy or in different subgroups of NMIBC, together with naïve sufferers, may additional increase the chance for NDV-01.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company dedicated to advancing progressive breakthrough therapies which have the potential to carry significant medical advantages to focused affected person populations.
Lead investigational program, NDV-01, for High-Grade Non-Muscle Invasive Bladder Cancer, is being evaluated in a Phase 2 examine. In addition, preparations are underway to advance sepranolone, a Phase 2b-ready investigational program for compulsion-related issues together with Tourette’s Syndrome and Prader-Willi Syndrome, into additional research.
For more info, go to
www.relmada.com
.
Forward-Looking Statements:
The Private Securities Litigation Reform Act of 1995 supplies a secure harbor for forward-looking statements made by us or on our behalf. This press release incorporates statements which represent “forward-looking statements” within the that means of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any assertion that isn’t historic in nature is a forward-looking assertion and could also be recognized by the use of phrases and phrases resembling “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and comparable expressions. These statements are primarily based on management’s present expectations and beliefs and are subject to a quantity of dangers, uncertainties and assumptions that would trigger precise outcomes to vary materially from these described within the forward-looking statements, together with potential for Phase 2 NDV-01 information to be introduced at an upcoming medical convention, potential for Phase 2 NDV-01 information to ship optimistic outcomes supporting additional development, potential for medical trials to ship statistically and/or clinically important proof of efficacy and/or security, failure of top-line outcomes to precisely replicate the entire outcomes of the trial, failure of deliberate or ongoing preclinical and medical research to exhibit anticipated outcomes, potential failure to secure FDA settlement on the regulatory path for sepranolone, and NDV-01, or that future sepranolone, or NDV-01 medical outcomes can be acceptable to the FDA, failure to secure enough sepranolone, or NDV-01 drug provide and the opposite risk components described underneath the heading “Risk Factors” set forth within the Company’s experiences filed with the SEC from time to time. No forward-looking assertion could be assured, and precise outcomes could differ materially from these projected. Relmada undertakes no obligation to publicly replace any forward-looking assertion, whether or not as a end result of new info, future occasions, or in any other case. Readers are cautioned that it isn’t potential to foretell or determine all of the dangers, uncertainties and different components which will have an effect on future outcomes and that the dangers described herein shouldn’t be a full checklist.
Investor Contact:
Brian RitchieLifeSci [email protected]
Media Inquiries:
Corporate Communications
[email protected]
This article was initially printed on Quiver News, learn the complete story.
The views and opinions expressed herein are the views and opinions of the writer and don’t essentially replicate these of Nasdaq, Inc.
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