Mira Pharmaceuticals Submits Ketamir-2 Clinical Trial Protocol to FDA
Mira Pharmaceuticals announced the submission of a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration, FDA, for Ketamir-2, the Company's proprietary oral NMDA receptor modulator, in chemotherapy-induced peripheral neuropathy, XIPN.
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MIRA Submits Phase 2a Trial Protocol for Ketamir-2
- Clinical Trial Submission: MIRA Pharmaceuticals has submitted a Phase 2a clinical trial protocol to the FDA for Ketamir-2, aimed at evaluating its safety and efficacy in chemotherapy-induced peripheral neuropathy, addressing a significant gap in FDA-approved treatments.
- Patient Need: Chemotherapy-induced peripheral neuropathy affects 30% to 40% of patients, with approximately 3 million new persistent cases estimated annually worldwide, highlighting the potential market demand and necessity for Ketamir-2 to improve patient quality of life.
- Trial Design Advantage: The study employs a randomized, double-blind, crossover design where patients will receive either 300 mg or 600 mg of Ketamir-2 or a placebo, allowing for more reliable efficacy signals in a smaller sample size, with each participant's study duration lasting up to 82 days.
- Safety Record: In the previously completed MIRA-001 Phase 1 study, no serious adverse events were reported among 56 healthy volunteers, supporting the safety profile and once-daily dosing schedule for Ketamir-2, laying a solid foundation for the upcoming Phase 2a trial.
MIRA Submits Phase 2a Trial Protocol for Ketamir-2
- Clinical Trial Submission: MIRA Pharmaceuticals has submitted a Phase 2a clinical trial protocol to the FDA for Ketamir-2, aimed at evaluating its safety and efficacy in chemotherapy-induced peripheral neuropathy (CIPN), addressing a significant gap in FDA-approved treatments.
- Patient Recruitment Criteria: The trial will enroll patients who have experienced persistent CIPN for at least three months, requiring a baseline pain score of 4 or higher, ensuring the study's relevance and potential to provide new treatment options for millions of cancer survivors.
- Study Design Advantages: Utilizing a randomized, double-blind, crossover design, patients will receive either 300 mg or 600 mg of Ketamir-2 or a placebo, allowing for a more reliable efficacy signal from a smaller sample size, enhancing the scientific rigor of the study.
- Market Demand Context: CIPN affects 30% to 40% of chemotherapy patients, with no specific treatments available, and MIRA's Ketamir-2 is poised to meet this significant unmet medical need, potentially improving patients' quality of life.
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- Strategic Transformation Plan: Aurora announced plans to gradually exit select Canadian consumer cannabis markets to reduce sales and marketing costs, which is expected to significantly improve overall profit margins in the coming quarters.
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MIRA Submits Phase 2a Trial Protocol for Ketamir-2
- Clinical Trial Submission: MIRA Pharmaceuticals has submitted a Phase 2a clinical trial protocol to the FDA for Ketamir-2, aimed at evaluating its safety and efficacy in chemotherapy-induced peripheral neuropathy, addressing a significant gap in FDA-approved treatments.
- Patient Need: Chemotherapy-induced peripheral neuropathy affects 30% to 40% of patients, with approximately 3 million new persistent cases estimated annually worldwide, highlighting the potential market demand and necessity for Ketamir-2 to improve patient quality of life.
- Trial Design Advantage: The study employs a randomized, double-blind, crossover design where patients will receive either 300 mg or 600 mg of Ketamir-2 or a placebo, allowing for more reliable efficacy signals in a smaller sample size, with each participant's study duration lasting up to 82 days.
- Safety Record: In the previously completed MIRA-001 Phase 1 study, no serious adverse events were reported among 56 healthy volunteers, supporting the safety profile and once-daily dosing schedule for Ketamir-2, laying a solid foundation for the upcoming Phase 2a trial.
MIRA Submits Phase 2a Trial Protocol for Ketamir-2
- Clinical Trial Submission: MIRA Pharmaceuticals has submitted a Phase 2a clinical trial protocol to the FDA for Ketamir-2, aimed at evaluating its safety and efficacy in chemotherapy-induced peripheral neuropathy (CIPN), addressing a significant gap in FDA-approved treatments.
- Patient Recruitment Criteria: The trial will enroll patients who have experienced persistent CIPN for at least three months, requiring a baseline pain score of 4 or higher, ensuring the study's relevance and potential to provide new treatment options for millions of cancer survivors.
- Study Design Advantages: Utilizing a randomized, double-blind, crossover design, patients will receive either 300 mg or 600 mg of Ketamir-2 or a placebo, allowing for a more reliable efficacy signal from a smaller sample size, enhancing the scientific rigor of the study.
- Market Demand Context: CIPN affects 30% to 40% of chemotherapy patients, with no specific treatments available, and MIRA's Ketamir-2 is poised to meet this significant unmet medical need, potentially improving patients' quality of life.
Cannabis Sector Update: Aurora's Strategic Shift Amid Record Medical Sales
- Aurora Financial Performance: Aurora Cannabis reported net revenue of $94.2 million for Q3 2026, a 7% year-over-year increase, with global medical cannabis sales reaching $76.2 million, accounting for over 80% of total sales, indicating strong growth potential in the high-margin medical market.
- Strategic Transformation Plan: Aurora announced plans to gradually exit select Canadian consumer cannabis markets to reduce sales and marketing costs, which is expected to significantly improve overall profit margins in the coming quarters.
- Canopy Growth Results: Canopy Growth reported net revenue of $90.4 million for Q3 2026, with a nearly 50% reduction in net loss despite weak international performance, reflecting positive progress in cost control and market integration.
- Cronos Brand Expansion: Cronos Group launched its premium Lord Jones brand in Israel, marking a significant step in its global expansion strategy aimed at meeting local market demands with high-quality products while enhancing brand recognition in international markets.
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U.S. Stock Market Update: U.S. stock futures rose slightly following President Trump's announcement of a trade deal with Vietnam, while the Nasdaq and NYSE will have early closures for Independence Day. The S&P 500 reached a record high, driven by gains in materials, technology, and energy sectors, despite a decline in private sector jobs reported by ADP.
Corporate Highlights: Notable stock movements included a 21% surge for Greenbrier Companies after strong earnings, while Franklin Covey dropped 7.82% due to disappointing results. Xponential Fitness saw an 18.63% increase after an SEC investigation concluded without action, and Global Interactive Technologies skyrocketed 223.31% amid significant corporate changes.
Why Datadog Shares Are Trading Higher By Over 10%; Here Are 20 Stocks Moving Premarket
Datadog's S&P 500 Inclusion: Datadog Inc's shares rose 10.6% in pre-market trading after the announcement of its inclusion in the S&P 500 index, effective July 9, 2025, replacing Juniper Networks.
Pre-Market Stock Movements: Several stocks experienced significant movements in pre-market trading, with Global Interactive Technologies surging 217.7% and Fly-E Group tumbling 25.8% following a reverse stock split announcement.
MIRA Pharmaceuticals' Marijuana Analog Mira-55 Shows Potent Pain Relief In Preclinical Study, Stock Jumps 50% After Hours
MIRA Pharmaceuticals Stock Surge: MIRA Pharmaceuticals' stock price jumped approximately 50.8% to $1.87 after the announcement of Mira-55, a synthetic marijuana analog that provides pain relief comparable to morphine without psychoactive effects.
Regulatory Advancements and Future Prospects: The DEA confirmed that Mira-55 is not a controlled substance, facilitating its clinical development, while the company also progresses with other pain management therapies and an acquisition aimed at enhancing its market position.
