Immuron Files IND Application with FDA for Clinical Development of IMM-529
IND Application Submission: Immuron has submitted an Investigational New Drug application to the FDA for IMM-529, aimed at treating Clostridioides difficile infection (CDI) and preventing recurrent CDI, with plans to start a Phase 2 clinical trial in early 2026.
Targeted Treatment Approach: IMM-529 is designed to work alongside standard antibiotics, utilizing antibodies that target key virulence components of C. diff, potentially improving infection clearance and restoring gut microbiota, with promising pre-clinical results.
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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.
UiPath Shares Rise Approximately 9%; Check Out 20 Stocks Making Moves in Premarket Trading
UiPath Financial Results: UiPath Inc. shares rose 8.7% in pre-market trading after reporting third-quarter adjusted earnings of 16 cents per share and revenue of $411.11 million, both exceeding estimates.
Other Gainers: Several stocks saw significant pre-market gains, including Polyrizon Ltd (+158.1%), Nauticus Robotics, Inc (+34%), and Picard Medical, Inc (+22.3%), driven by positive news and developments.
Notable Losers: Virax Biolabs Group Ltd fell 16.2% after announcing a private placement, while Treasure Global Inc declined 13.3% following a reverse stock split and Nasdaq delisting notification.
Market Overview: The pre-market trading session showed a mix of gains and losses across various stocks, with some companies like Axogen, Inc and Hyster-Yale, Inc also experiencing notable increases.
Immuron Secures US Military Contract for New Oral Therapeutics Targeting Campylobacter and Shigella
- New Contract Awarded: Immuron has secured a new contract with the U.S. Department of Defense to develop oral therapeutics targeting Campylobacter and Shigella, which is expected to significantly enhance gut health protection for U.S. military personnel.
- Vaccine Development Progress: Collaboration with the Naval Medical Research Command and Walter Reed Army Institute of Research is advancing the development of new vaccines aimed at combating Shigella infections, which cause approximately 600,000 deaths annually worldwide.
- Clinical Trial Update: Topline results from the Uniformed Services University's clinical trial evaluating the effectiveness of IMM-124E in maintaining gut health are anticipated soon, potentially providing critical data for future military applications.
- Strong Market Demand: With an estimated 1.5 billion episodes of diarrhea occurring globally each year, particularly in developing countries, there is a pressing need for preventative treatments, positioning Immuron's new products to fill this market gap.
Immuron Secures US Military Contract for Oral Therapeutics Development Targeting Campylobacter and Shigella
- New Contract Award: Immuron has secured a new contract with the U.S. Department of Defense to develop two novel oral therapeutics targeting Campylobacter and Shigella, marking a significant advancement in the company's military biopharmaceutical initiatives.
- Vaccine Development Collaboration: The collaboration with the Naval Medical Research Command and Walter Reed Army Institute of Research is advancing the development of new vaccines, utilizing Immuron's proprietary technology platform to produce hyper-immune bovine colostrum products aimed at enhancing military preventive capabilities.
- Clinical Trial Update: Results from the Uniformed Services University's clinical trial evaluating the effectiveness of hyper-immune bovine colostrum in maintaining gut health are expected to be announced soon, potentially providing strong data support for future market promotion.
- Global Health Impact: With an estimated 1.5 billion episodes of diarrhea leading to 2.2 million deaths annually, particularly in developing countries, Immuron's new therapies are poised to mitigate the impact of these pathogens and enhance global public health outcomes.
FDA Grants IND Approval for Immuron's IMM-529
FDA Approval: Immuron Limited has received FDA approval for its Investigational New Drug application for IMM-529, allowing the company to proceed with a Phase 2 clinical trial targeting Clostridioides difficile infection (CDI).
Clinical Trial Details: The Phase 2 trial will involve up to 60 subjects and will assess the safety and efficacy of IMM-529 in combination with standard care for patients with first episode or recurrent CDI.
Market Potential: If successful, IMM-529 could be positioned early in treatment protocols, with an estimated annual revenue potential of $400 million, addressing a significant health threat posed by CDI, which affects over 400,000 people in the U.S. annually.
Innovative Approach: IMM-529 utilizes bovine colostrum-derived antibodies targeting multiple components of C. diff, showing promising pre-clinical results in preventing and treating CDI, and is unique in its therapeutic potential across all disease phases.
Immuron Receives FDA Approval for IND Application of IMM-529
FDA Approval: Immuron's Investigational New Drug application for IMM-529 has been approved by the FDA, allowing the company to proceed with a Phase 2 clinical trial.
Clinical Trial Details: The Phase 2 trial will focus on individuals with Clostridioides difficile infection and is set to begin in the first half of 2026, enrolling up to 60 subjects in a randomized, double-blind, placebo-controlled study.
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.
UiPath Shares Rise Approximately 9%; Check Out 20 Stocks Making Moves in Premarket Trading
UiPath Financial Results: UiPath Inc. shares rose 8.7% in pre-market trading after reporting third-quarter adjusted earnings of 16 cents per share and revenue of $411.11 million, both exceeding estimates.
Other Gainers: Several stocks saw significant pre-market gains, including Polyrizon Ltd (+158.1%), Nauticus Robotics, Inc (+34%), and Picard Medical, Inc (+22.3%), driven by positive news and developments.
Notable Losers: Virax Biolabs Group Ltd fell 16.2% after announcing a private placement, while Treasure Global Inc declined 13.3% following a reverse stock split and Nasdaq delisting notification.
Market Overview: The pre-market trading session showed a mix of gains and losses across various stocks, with some companies like Axogen, Inc and Hyster-Yale, Inc also experiencing notable increases.
Immuron Secures US Military Contract for New Oral Therapeutics Targeting Campylobacter and Shigella
- New Contract Awarded: Immuron has secured a new contract with the U.S. Department of Defense to develop oral therapeutics targeting Campylobacter and Shigella, which is expected to significantly enhance gut health protection for U.S. military personnel.
- Vaccine Development Progress: Collaboration with the Naval Medical Research Command and Walter Reed Army Institute of Research is advancing the development of new vaccines aimed at combating Shigella infections, which cause approximately 600,000 deaths annually worldwide.
- Clinical Trial Update: Topline results from the Uniformed Services University's clinical trial evaluating the effectiveness of IMM-124E in maintaining gut health are anticipated soon, potentially providing critical data for future military applications.
- Strong Market Demand: With an estimated 1.5 billion episodes of diarrhea occurring globally each year, particularly in developing countries, there is a pressing need for preventative treatments, positioning Immuron's new products to fill this market gap.
Immuron Secures US Military Contract for Oral Therapeutics Development Targeting Campylobacter and Shigella
- New Contract Award: Immuron has secured a new contract with the U.S. Department of Defense to develop two novel oral therapeutics targeting Campylobacter and Shigella, marking a significant advancement in the company's military biopharmaceutical initiatives.
- Vaccine Development Collaboration: The collaboration with the Naval Medical Research Command and Walter Reed Army Institute of Research is advancing the development of new vaccines, utilizing Immuron's proprietary technology platform to produce hyper-immune bovine colostrum products aimed at enhancing military preventive capabilities.
- Clinical Trial Update: Results from the Uniformed Services University's clinical trial evaluating the effectiveness of hyper-immune bovine colostrum in maintaining gut health are expected to be announced soon, potentially providing strong data support for future market promotion.
- Global Health Impact: With an estimated 1.5 billion episodes of diarrhea leading to 2.2 million deaths annually, particularly in developing countries, Immuron's new therapies are poised to mitigate the impact of these pathogens and enhance global public health outcomes.
FDA Grants IND Approval for Immuron's IMM-529
FDA Approval: Immuron Limited has received FDA approval for its Investigational New Drug application for IMM-529, allowing the company to proceed with a Phase 2 clinical trial targeting Clostridioides difficile infection (CDI).
Clinical Trial Details: The Phase 2 trial will involve up to 60 subjects and will assess the safety and efficacy of IMM-529 in combination with standard care for patients with first episode or recurrent CDI.
Market Potential: If successful, IMM-529 could be positioned early in treatment protocols, with an estimated annual revenue potential of $400 million, addressing a significant health threat posed by CDI, which affects over 400,000 people in the U.S. annually.
Innovative Approach: IMM-529 utilizes bovine colostrum-derived antibodies targeting multiple components of C. diff, showing promising pre-clinical results in preventing and treating CDI, and is unique in its therapeutic potential across all disease phases.
Immuron Receives FDA Approval for IND Application of IMM-529
FDA Approval: Immuron's Investigational New Drug application for IMM-529 has been approved by the FDA, allowing the company to proceed with a Phase 2 clinical trial.
Clinical Trial Details: The Phase 2 trial will focus on individuals with Clostridioides difficile infection and is set to begin in the first half of 2026, enrolling up to 60 subjects in a randomized, double-blind, placebo-controlled study.
