Radiopharm Reports FDA Clearance To Initiate First-in-human Phase 1 Trial Of RV-01
FDA Clearance Announcement: Radiopharm Theranostics has received FDA clearance for its Investigational New Drug application for RV-01, a Lu177-B7H3 monoclonal antibody, marking a significant milestone for the company and its joint venture with MD Anderson Cancer Center.
Clinical Trial Initiation: The clearance allows Radiopharm to initiate its first-in-human Phase 1 clinical trial of RV-01, as stated by CEO Riccardo Canevari.
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Radiopharm Theranostics Reports Interim Clinical Trial Results and Financial Update
- Clinical Trial Results: In the Phase 2b trial of RAD 101 for patients with brain metastases, 92% of evaluable participants met the primary endpoint of MRI concordance, and if confirmed, this will trigger preparations for a multi-center Phase 3 registrational trial.
- Strong Financial Position: As of December 31, 2025, Radiopharm reported cash and cash equivalents of approximately $34.52 million, up from $29.12 million at year-end, providing a runway into 2027 to advance high-value radiotherapeutic programs.
- Drug Development Progress: RAD 202 and RAD 204 have both received recommendations from the Data Safety Monitoring Committee to escalate dosing, with RAD 202 moving to 75mCi and RAD 204 showing favorable safety and tumor uptake in PD-L1-driven cancers.
- Future Outlook: Radiopharm aims to deliver meaningful data across multiple programs in 2026, focusing on expanding treatment and diagnostic options for solid tumor patients while creating long-term value for all stakeholders.
Benzinga Market Update: Carnival, Caterpillar, Meta Among Stocks as Markets See Slight Increases
Market Performance: The stock market experienced moderate gains due to softer inflation data and stable unemployment, with the Dow Jones and S&P 500 rising, while the Nasdaq rebounded, indicating investor confidence in a potential rate cut by the Federal Reserve in 2026.
Earnings Highlights: Micron Technology exceeded expectations and raised its guidance, boosting AI-related semiconductor stocks, while Nike's cautious outlook on global demand, especially in China, led to a decline in its shares.
Sector Resilience: Transportation and travel sectors showed strength, with FedEx reporting solid quarterly results and Carnival Corporation reinstating its dividend and forecasting strong demand for 2026, despite ongoing macroeconomic uncertainties.
Investor Sentiment: Reports indicated a shift in focus from hype around AI to companies demonstrating clear profitability, with notable bearish sentiments surrounding stocks like Meta and Novo Nordisk, which faced challenges in their respective markets.
Dow Declines by 50 Points; US Employment Increases by 64,000 in November
U.S. Stock Market Performance: U.S. stocks traded mostly lower, with the Dow Jones falling over 50 points, while the S&P 500 and NASDAQ also experienced slight declines. Information technology shares rose by 0.1%, but energy stocks dropped by 1.8%.
Job Market Update: The U.S. economy added 64,000 jobs in November, slightly above expectations but still below healthy job creation levels. The unemployment rate rose to 4.6%, marking the highest since September 2021.
Equities Trading Highlights: SRx Health Solutions saw a significant increase in shares by 117% after an acquisition announcement, while Zynex Inc shares plummeted 59% due to entering Chapter 11 restructuring.
Global Market Trends: European and Asian markets closed lower, with notable declines in major indices like Japan's Nikkei and Spain's IBEX 35. In commodities, oil prices fell by 1.9%, while gold saw a slight increase.
B. Riley Financial Shares Surge Approximately 25%; Check Out 20 Stocks Making Moves in Premarket Trading
B. Riley Financial Performance: B. Riley Financial Inc reported a significant turnaround with earnings of $4.50 per share for Q2, compared to a loss of $14.35 per share a year ago, and sales increased to $225.302 million from $94.885 million, leading to a 25% rise in share price during pre-market trading.
Pre-Market Stock Movements: Several stocks experienced notable pre-market trading movements, with Biodexa Pharmaceuticals gaining 51.4% and Venus Concept surging 31.1%, while Radiopharm Theranostics saw a sharp decline of 39.8%.
Other Notable Gainers: Other stocks that rose in pre-market trading included Uniqure NV (+14.1%), Adagio Medical Holdings (+11.7%), and Sunrise New Energy (+10.5%), reflecting a mix of recovery and growth in various sectors.
Significant Losers: Stocks that faced declines included iRobot Corp, which fell 23.2% after filing for Chapter 11 bankruptcy, and Saverone 2014 Ltd, which tumbled 37.8% following a previous gain, indicating volatility in the market.
What’s Behind the 140% Surge in Radiopharm Theranostics Stock?
Stock Performance: Radiopharm Theranostics Limited (NASDAQ: RADX) saw its stock rise 141.31% to $10.27 on Monday, with a trading volume significantly higher than its average.
Clinical Trial Results: The company shared promising interim data from its Phase 2b trial of RAD 101, showing that 92% of patients achieved concordance with MRI in detecting brain metastases.
Market Potential: RAD 101 is projected to have a U.S. market opportunity exceeding $500 million annually, with the company aiming to initiate a pivotal study by the end of 2026.
Regulatory Milestones: RAD 101 has received FDA Fast Track Designation, and the company has also secured approval for a Phase 1 trial of RAD 402 for treating advanced prostate cancer.
Radiopharm's RAD 101 Achieves 92% MRI Concordance in Phase 2b Trial
- Clinical Trial Results: In the U.S. Phase 2b clinical trial, 92% (11/12) of patients treated with RAD 101 achieved concordance with MRI, significantly boosting confidence in the drug's success and laying a strong foundation for initiating pivotal studies by the end of 2026.
- Market Potential Assessment: Independent commercial evaluations estimate RAD 101's U.S. market opportunity at over $500 million, indicating its potential to become one of the top three imaging agents in the market, thereby providing robust support for the company's future revenue growth.
- Patient Management Transformation: By integrating RAD 101 PET with standard MRI, it is expected to enhance treatment decisions for over 300,000 patients diagnosed with brain metastases annually in the U.S., improving patient management efficiency and optimizing treatment outcomes.
- Trial Progress: The company has achieved 50% patient enrollment in the Phase 2b trial and received FDA Fast Track Designation, further enhancing RAD 101's prospects in brain metastasis imaging.
Radiopharm Theranostics Reports Interim Clinical Trial Results and Financial Update
- Clinical Trial Results: In the Phase 2b trial of RAD 101 for patients with brain metastases, 92% of evaluable participants met the primary endpoint of MRI concordance, and if confirmed, this will trigger preparations for a multi-center Phase 3 registrational trial.
- Strong Financial Position: As of December 31, 2025, Radiopharm reported cash and cash equivalents of approximately $34.52 million, up from $29.12 million at year-end, providing a runway into 2027 to advance high-value radiotherapeutic programs.
- Drug Development Progress: RAD 202 and RAD 204 have both received recommendations from the Data Safety Monitoring Committee to escalate dosing, with RAD 202 moving to 75mCi and RAD 204 showing favorable safety and tumor uptake in PD-L1-driven cancers.
- Future Outlook: Radiopharm aims to deliver meaningful data across multiple programs in 2026, focusing on expanding treatment and diagnostic options for solid tumor patients while creating long-term value for all stakeholders.
Benzinga Market Update: Carnival, Caterpillar, Meta Among Stocks as Markets See Slight Increases
Market Performance: The stock market experienced moderate gains due to softer inflation data and stable unemployment, with the Dow Jones and S&P 500 rising, while the Nasdaq rebounded, indicating investor confidence in a potential rate cut by the Federal Reserve in 2026.
Earnings Highlights: Micron Technology exceeded expectations and raised its guidance, boosting AI-related semiconductor stocks, while Nike's cautious outlook on global demand, especially in China, led to a decline in its shares.
Sector Resilience: Transportation and travel sectors showed strength, with FedEx reporting solid quarterly results and Carnival Corporation reinstating its dividend and forecasting strong demand for 2026, despite ongoing macroeconomic uncertainties.
Investor Sentiment: Reports indicated a shift in focus from hype around AI to companies demonstrating clear profitability, with notable bearish sentiments surrounding stocks like Meta and Novo Nordisk, which faced challenges in their respective markets.
Dow Declines by 50 Points; US Employment Increases by 64,000 in November
U.S. Stock Market Performance: U.S. stocks traded mostly lower, with the Dow Jones falling over 50 points, while the S&P 500 and NASDAQ also experienced slight declines. Information technology shares rose by 0.1%, but energy stocks dropped by 1.8%.
Job Market Update: The U.S. economy added 64,000 jobs in November, slightly above expectations but still below healthy job creation levels. The unemployment rate rose to 4.6%, marking the highest since September 2021.
Equities Trading Highlights: SRx Health Solutions saw a significant increase in shares by 117% after an acquisition announcement, while Zynex Inc shares plummeted 59% due to entering Chapter 11 restructuring.
Global Market Trends: European and Asian markets closed lower, with notable declines in major indices like Japan's Nikkei and Spain's IBEX 35. In commodities, oil prices fell by 1.9%, while gold saw a slight increase.
B. Riley Financial Shares Surge Approximately 25%; Check Out 20 Stocks Making Moves in Premarket Trading
B. Riley Financial Performance: B. Riley Financial Inc reported a significant turnaround with earnings of $4.50 per share for Q2, compared to a loss of $14.35 per share a year ago, and sales increased to $225.302 million from $94.885 million, leading to a 25% rise in share price during pre-market trading.
Pre-Market Stock Movements: Several stocks experienced notable pre-market trading movements, with Biodexa Pharmaceuticals gaining 51.4% and Venus Concept surging 31.1%, while Radiopharm Theranostics saw a sharp decline of 39.8%.
Other Notable Gainers: Other stocks that rose in pre-market trading included Uniqure NV (+14.1%), Adagio Medical Holdings (+11.7%), and Sunrise New Energy (+10.5%), reflecting a mix of recovery and growth in various sectors.
Significant Losers: Stocks that faced declines included iRobot Corp, which fell 23.2% after filing for Chapter 11 bankruptcy, and Saverone 2014 Ltd, which tumbled 37.8% following a previous gain, indicating volatility in the market.
What’s Behind the 140% Surge in Radiopharm Theranostics Stock?
Stock Performance: Radiopharm Theranostics Limited (NASDAQ: RADX) saw its stock rise 141.31% to $10.27 on Monday, with a trading volume significantly higher than its average.
Clinical Trial Results: The company shared promising interim data from its Phase 2b trial of RAD 101, showing that 92% of patients achieved concordance with MRI in detecting brain metastases.
Market Potential: RAD 101 is projected to have a U.S. market opportunity exceeding $500 million annually, with the company aiming to initiate a pivotal study by the end of 2026.
Regulatory Milestones: RAD 101 has received FDA Fast Track Designation, and the company has also secured approval for a Phase 1 trial of RAD 402 for treating advanced prostate cancer.
Radiopharm's RAD 101 Achieves 92% MRI Concordance in Phase 2b Trial
- Clinical Trial Results: In the U.S. Phase 2b clinical trial, 92% (11/12) of patients treated with RAD 101 achieved concordance with MRI, significantly boosting confidence in the drug's success and laying a strong foundation for initiating pivotal studies by the end of 2026.
- Market Potential Assessment: Independent commercial evaluations estimate RAD 101's U.S. market opportunity at over $500 million, indicating its potential to become one of the top three imaging agents in the market, thereby providing robust support for the company's future revenue growth.
- Patient Management Transformation: By integrating RAD 101 PET with standard MRI, it is expected to enhance treatment decisions for over 300,000 patients diagnosed with brain metastases annually in the U.S., improving patient management efficiency and optimizing treatment outcomes.
- Trial Progress: The company has achieved 50% patient enrollment in the Phase 2b trial and received FDA Fast Track Designation, further enhancing RAD 101's prospects in brain metastasis imaging.
