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.
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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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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.
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.
US Stocks Likely To Open Higher As Trump Announces Vietnam Trade Deal: S&P 500's Golden Cross 'Reason To Expect Better Than Average Returns,' Says Expert
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.
