Relmada Therapeutics Appoints Renowned Urologic Oncologist, Yair Lotan, MD, to Chair the Clinical Advisory Board and Support Development of NDV-01
Appointment of Dr. Yair Lotan: Relmada Therapeutics has appointed Dr. Yair Lotan, a renowned urologic oncologist, as Chair of its Clinical Advisory Board to enhance the clinical development strategy for NDV-01, a treatment for non-muscle invasive bladder cancer (NMIBC), ahead of its Phase 3 trial set to begin in H1 2026.
Potential of NDV-01: NDV-01 is a sustained-release formulation designed for easy administration and aims to improve patient outcomes in NMIBC, which represents a significant market opportunity due to high recurrence rates and limited treatment options.
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Helus Pharma's Psychedelic Drug Achieves Phase 3 Success
- Clinical Trial Breakthrough: Helus Pharma's SPL026 demonstrated significant efficacy in a randomized controlled trial for treatment-resistant depression, with a MADRS score difference of -7.35 (p=0.023) among 34 participants, providing clinical proof-of-concept that could shift regulatory and investor perspectives on psychedelic applications in psychiatry.
- Production Quota Increase: The DEA raised the 2026 psilocybin production quota by 67%, creating larger market opportunities for companies like Helus Pharma and accelerating their research and development efforts in psychedelic therapies.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash, ensuring continued advancement of its multi-asset clinical pipeline, particularly for key assets like HLP003 and HLP004.
- Optimistic Future Outlook: HLP003 has shown a 100% response rate and 71% remission rate in two pivotal Phase 3 studies, with topline data expected in Q4 2026, further solidifying Helus Pharma's market position in depression treatment.
Helus Pharma Achieves Breakthrough in Depression Treatment
- Clinical Trial Success: Helus Pharma's SPL026 achieved significant results in a Phase 2 trial for treatment-resistant depression, with a mean MADRS difference of -7.35 (p=0.023) among 34 participants receiving a 21.5 mg dose, indicating strong efficacy and market potential for the drug.
- FDA Breakthrough Therapy: Helus's HLP003 has received FDA Breakthrough Therapy designation and is undergoing two pivotal Phase 3 trials, with early data showing 100% response rates and 71% remission at 12 months, potentially offering new treatment options for depression and solidifying the company's position in the psychiatric drug market.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash reserves, providing robust financial support for the continued advancement of its multi-asset clinical pipeline, ensuring the company can maintain its competitive edge in a rapidly evolving market.
- Significant Market Potential: The World Health Organization estimates that depression and anxiety cost the global economy over $1 trillion annually in lost productivity, positioning Helus Pharma's innovative drugs to meet this substantial market demand and drive future growth and investment appeal.
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.
Helus Pharma's Psychedelic Drug Achieves Phase 3 Success
- Clinical Trial Breakthrough: Helus Pharma's SPL026 demonstrated significant efficacy in a randomized controlled trial for treatment-resistant depression, with a MADRS score difference of -7.35 (p=0.023) among 34 participants, providing clinical proof-of-concept that could shift regulatory and investor perspectives on psychedelic applications in psychiatry.
- Production Quota Increase: The DEA raised the 2026 psilocybin production quota by 67%, creating larger market opportunities for companies like Helus Pharma and accelerating their research and development efforts in psychedelic therapies.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash, ensuring continued advancement of its multi-asset clinical pipeline, particularly for key assets like HLP003 and HLP004.
- Optimistic Future Outlook: HLP003 has shown a 100% response rate and 71% remission rate in two pivotal Phase 3 studies, with topline data expected in Q4 2026, further solidifying Helus Pharma's market position in depression treatment.
Helus Pharma Achieves Breakthrough in Depression Treatment
- Clinical Trial Success: Helus Pharma's SPL026 achieved significant results in a Phase 2 trial for treatment-resistant depression, with a mean MADRS difference of -7.35 (p=0.023) among 34 participants receiving a 21.5 mg dose, indicating strong efficacy and market potential for the drug.
- FDA Breakthrough Therapy: Helus's HLP003 has received FDA Breakthrough Therapy designation and is undergoing two pivotal Phase 3 trials, with early data showing 100% response rates and 71% remission at 12 months, potentially offering new treatment options for depression and solidifying the company's position in the psychiatric drug market.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash reserves, providing robust financial support for the continued advancement of its multi-asset clinical pipeline, ensuring the company can maintain its competitive edge in a rapidly evolving market.
- Significant Market Potential: The World Health Organization estimates that depression and anxiety cost the global economy over $1 trillion annually in lost productivity, positioning Helus Pharma's innovative drugs to meet this substantial market demand and drive future growth and investment appeal.
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.
