Relmada Therapeutics Receives FDA Feedback on NDV-01
Relmada Therapeutics 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 with carcinoma in situ 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. This feedback provides a clear and efficient development path toward a potential NDA submission for NDV-01 as a bladder-sparing therapeutic option in a patient population with significant unmet need. The FDA also provided separate, supportive written feedback on the Company's planned single registrational study in intermediate-risk NMIBC in the adjuvant setting, which is expected to follow an open-label, randomized-to-observation design. Relmada continues to anticipate initiating both registrational trials in the first half of 2026.
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BTIG Initiates Buy Rating on Invivyd Inc with $10 Price Target
- Invivyd Rating Upgrade: BTIG analyst Thomas Shrader initiated coverage on Invivyd Inc (NASDAQ:IVVD) with a Buy rating and a price target of $10, indicating a potential upside of 335% from its closing price of $2.30, reflecting strong market optimism about its future growth prospects.
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Relmada Therapeutics Sets Price for $100 Million Underwritten Common Stock and Pre-Funded Warrant Offering
Offering Details: Relmada Therapeutics announced the pricing of an underwritten offering of 40,142,000 shares of common stock at $2.20 per share, along with pre-funded warrants for an additional 5,315,000 shares, aiming to raise approximately $100 million before expenses.
Use of Proceeds: The funds will be utilized for working capital, clinical studies for regulatory approvals, development of product candidates, and potential acquisitions or licensing of complementary technologies.
Investor Participation: Notable investors in the offering include Janus Henderson Investors, Ferring Ventures SA, and OrbiMed, with Jefferies and Leerink Partners serving as joint book-running managers.
Forward-Looking Statements: The announcement includes forward-looking statements regarding the offering's completion and intended use of proceeds, highlighting the inherent risks and uncertainties involved.
Relmada Receives FDA Feedback Endorsing Two Distinct Acceptable Pathways for NDV-01 Registration Studies in Non-Muscle Invasive Bladder Cancer
FDA Feedback on NDV-01: Relmada Therapeutics received positive feedback from the FDA regarding the planned Phase 3 trials for NDV-01 in non-muscle invasive bladder cancer (NMIBC), confirming no additional non-clinical studies are needed and supporting two potential registrational trials.
Efficacy and Safety Data: The 9-month follow-up data for NDV-01 showed a 92% overall response rate in NMIBC patients, with no progression to muscle invasive disease and no new safety signals reported.
Clinical Trial Design: The FDA indicated that a single-arm trial may be acceptable for high-grade, 2nd line BCG-unresponsive NMIBC patients, while a randomized controlled trial is acceptable for intermediate-risk NMIBC patients.
Market Potential: NDV-01, a sustained-release formulation of gemcitabine and docetaxel, aims to address the significant unmet needs in NMIBC, which represents 75-80% of bladder cancer cases and has limited treatment options.
Relmada Therapeutics Welcomes Renowned Urologic Oncologist Max Kates, MD, to Clinical Advisory Board for NDV-01 Development
Appointment of Dr. Max Kates: Dr. Max Kates has been appointed to Relmada Therapeutics' Clinical Advisory Board to support the development of NDV-01, a treatment for non-muscle invasive bladder cancer (NMIBC), with the Phase 3 program expected to start in H1 2026.
Significance of NDV-01: NDV-01 is a sustained-release formulation of gemcitabine and docetaxel designed for intravesical administration, aiming to improve treatment outcomes for NMIBC, which accounts for 75-80% of bladder cancer cases and has high recurrence rates.
Insider Buying Update for Tuesday, September 2: RLMD, STRA
Relmada Therapeutics Insider Purchase: CEO Sergio Traversa bought 265,976 shares of RLMD for $178,095, currently seeing a 119.5% gain as the stock trades at $1.47, up 26.8% on Tuesday.
Strategic Education Insider Purchase: CFO Daniel Wayne Jackson purchased 1,900 shares of Strategic Education for $154,850, with the stock up 0.6% on Tuesday.
Relmada outlines 2026 trial launches for NDV-01 and sepranolone as pipeline advances
Management Insights: Relmada Therapeutics is advancing two promising product candidates, NDV-01 for bladder cancer and sepranolone for compulsivity disorders, with plans to initiate Phase III and proof-of-concept studies in 2026. The company reported a decrease in operational costs and a net loss of $9.9 million for Q2 2025, while emphasizing the importance of regulatory engagement and strategic financial management.
Analyst Sentiment: Analysts expressed a slightly positive outlook on the company's progress, highlighting encouraging efficacy data and seeking clarity on market strategies and regulatory pathways. Management maintained a confident tone during the earnings call, focusing on upcoming milestones and the potential for both products to address significant unmet medical needs.
BTIG Initiates Buy Rating on Invivyd Inc with $10 Price Target
- Invivyd Rating Upgrade: BTIG analyst Thomas Shrader initiated coverage on Invivyd Inc (NASDAQ:IVVD) with a Buy rating and a price target of $10, indicating a potential upside of 335% from its closing price of $2.30, reflecting strong market optimism about its future growth prospects.
- Positive Outlook for Relmada Therapeutics: Jefferies analyst Farzin Haque initiated coverage on Relmada Therapeutics Inc (NASDAQ:RLMD) with a Buy rating and a price target of $9, suggesting a 106% upside from its current price of $4.35, indicating confidence in its product pipeline.
- Context Therapeutics Seen Favorably: Jones Trading analyst Soumit Roy initiated coverage on Context Therapeutics Inc (NASDAQ:CNTX) with a Buy rating and a price target of $7, representing a potential gain of 450% from its current price of $1.27, reflecting positive sentiment regarding its R&D progress.
- Investment Opportunity in BlackSky Technology: Jefferies initiated coverage on BlackSky Technology Inc (NYSE:BKSY) with a Buy rating and a price target of $23, indicating a 19% upside from its closing price of $19.25, showcasing analyst confidence in its market performance.
Relmada Therapeutics Sets Price for $100 Million Underwritten Common Stock and Pre-Funded Warrant Offering
Offering Details: Relmada Therapeutics announced the pricing of an underwritten offering of 40,142,000 shares of common stock at $2.20 per share, along with pre-funded warrants for an additional 5,315,000 shares, aiming to raise approximately $100 million before expenses.
Use of Proceeds: The funds will be utilized for working capital, clinical studies for regulatory approvals, development of product candidates, and potential acquisitions or licensing of complementary technologies.
Investor Participation: Notable investors in the offering include Janus Henderson Investors, Ferring Ventures SA, and OrbiMed, with Jefferies and Leerink Partners serving as joint book-running managers.
Forward-Looking Statements: The announcement includes forward-looking statements regarding the offering's completion and intended use of proceeds, highlighting the inherent risks and uncertainties involved.
Relmada Receives FDA Feedback Endorsing Two Distinct Acceptable Pathways for NDV-01 Registration Studies in Non-Muscle Invasive Bladder Cancer
FDA Feedback on NDV-01: Relmada Therapeutics received positive feedback from the FDA regarding the planned Phase 3 trials for NDV-01 in non-muscle invasive bladder cancer (NMIBC), confirming no additional non-clinical studies are needed and supporting two potential registrational trials.
Efficacy and Safety Data: The 9-month follow-up data for NDV-01 showed a 92% overall response rate in NMIBC patients, with no progression to muscle invasive disease and no new safety signals reported.
Clinical Trial Design: The FDA indicated that a single-arm trial may be acceptable for high-grade, 2nd line BCG-unresponsive NMIBC patients, while a randomized controlled trial is acceptable for intermediate-risk NMIBC patients.
Market Potential: NDV-01, a sustained-release formulation of gemcitabine and docetaxel, aims to address the significant unmet needs in NMIBC, which represents 75-80% of bladder cancer cases and has limited treatment options.
Relmada Therapeutics Welcomes Renowned Urologic Oncologist Max Kates, MD, to Clinical Advisory Board for NDV-01 Development
Appointment of Dr. Max Kates: Dr. Max Kates has been appointed to Relmada Therapeutics' Clinical Advisory Board to support the development of NDV-01, a treatment for non-muscle invasive bladder cancer (NMIBC), with the Phase 3 program expected to start in H1 2026.
Significance of NDV-01: NDV-01 is a sustained-release formulation of gemcitabine and docetaxel designed for intravesical administration, aiming to improve treatment outcomes for NMIBC, which accounts for 75-80% of bladder cancer cases and has high recurrence rates.
Insider Buying Update for Tuesday, September 2: RLMD, STRA
Relmada Therapeutics Insider Purchase: CEO Sergio Traversa bought 265,976 shares of RLMD for $178,095, currently seeing a 119.5% gain as the stock trades at $1.47, up 26.8% on Tuesday.
Strategic Education Insider Purchase: CFO Daniel Wayne Jackson purchased 1,900 shares of Strategic Education for $154,850, with the stock up 0.6% on Tuesday.
Relmada outlines 2026 trial launches for NDV-01 and sepranolone as pipeline advances
Management Insights: Relmada Therapeutics is advancing two promising product candidates, NDV-01 for bladder cancer and sepranolone for compulsivity disorders, with plans to initiate Phase III and proof-of-concept studies in 2026. The company reported a decrease in operational costs and a net loss of $9.9 million for Q2 2025, while emphasizing the importance of regulatory engagement and strategic financial management.
Analyst Sentiment: Analysts expressed a slightly positive outlook on the company's progress, highlighting encouraging efficacy data and seeking clarity on market strategies and regulatory pathways. Management maintained a confident tone during the earnings call, focusing on upcoming milestones and the potential for both products to address significant unmet medical needs.
