UPDATE -- Relmada Therapeutics To Present NDV-01 Data at AUA2025
Relmada Therapeutics Announcement: Relmada Therapeutics presented an abstract for a Phase 2 study of NDV-01, a sustained-release formulation of gemcitabine and docetaxel, aimed at treating high-risk non-muscle invasive bladder cancer (NMIBC) at the American Urology Association conference in April 2025.
Potential Impact of NDV-01: NDV-01 is designed to enhance local drug concentration while minimizing systemic toxicity, potentially offering a first-line treatment option for NMIBC patients and addressing the high recurrence rates associated with current therapies.
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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.
- 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.
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.
