Biodexa Announces Filing of CTA in Europe for Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP)
Biodexa's Clinical Trial Application: Biodexa Pharmaceuticals has filed a Clinical Trial Application (CTA) with the European Medicines Agency for its Phase 3 Serenta trial, aimed at treating familial adenomatous polyposis (FAP), a hereditary condition that significantly increases the risk of colorectal cancer.
eRapa Development and Support: The trial will evaluate the safety and efficacy of eRapa, an oral formulation of rapamycin, with support from a $20 million grant from the Cancer Prevention and Research Institute of Texas, as Biodexa aims to address the unmet medical needs of FAP patients.
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Biodexa Secures Exclusive License for Otsuka's OPB-171775, a Novel GIST Treatment
- Exclusive Licensing Agreement: Biodexa has entered into an exclusive licensing agreement with Otsuka Pharmaceutical to develop and commercialize OPB-171775 globally, except in Japan, which is expected to significantly enhance the company's market position in rare diseases.
- Innovative Mechanism: MTX240 utilizes molecular glue technology to effectively overcome TKI resistance by inducing interactions between PDE3a and SLFN12 proteins, offering a novel therapeutic approach that may benefit a large number of GIST patients.
- Market Potential: With approximately 3,000-4,000 GIST patients annually in the U.S., MTX240's unique mechanism is poised to address the treatment gap for TKI-resistant patients, and the global GIST market is projected to grow at an annual rate of 6-10% to reach about $1.3 billion by 2032.
- Patent Protection: MTX240 is protected by composition of matter patents in the U.S., Europe, and Japan, extending through 2037, ensuring its competitive advantage in the market while providing legal safeguards for future development and commercialization.
Biodexa Pharmaceuticals Appoints Fiona Sharp as CFO, Shares Rise 3.45%
- Executive Transition: Biodexa Pharmaceuticals has promoted Fiona Sharp to Chief Financial Officer and Company Secretary, effective immediately, aiming to strengthen financial management and enhance operational efficiency within the company.
- Succession Plan: Sharp succeeds Stephen Stamp, who will continue as Chief Executive Officer, ensuring stability and continuity in the company's leadership during this transition.
- Financial Expertise: Having served as Group Financial Controller since December 2019, Sharp brings extensive financial management experience, previously holding the position of Assistant Director of Finance at Hywel Dda University Health Board, which is expected to enhance the company's financial strategy.
- Market Reaction: BDRX shares are currently trading at $2.54, reflecting a 3.45% increase from the previous trading day, indicating positive market sentiment regarding the new CFO's appointment and confidence in the company's future growth prospects.
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.
Mama's Creations Stock Rises Over 13%; Check Out 20 Stocks Making Moves in Premarket Trading
Mama's Creations Inc Performance: Shares of Mama's Creations Inc rose 13.3% in pre-market trading after reporting third-quarter earnings of 1 cent per share, surpassing analyst expectations of a loss of 2 cents, along with sales of $47.269 million exceeding the $43.203 million estimate.
Other Notable Gainers: Several stocks saw significant gains in pre-market trading, including Alphatime Acquisition Corp (up 388.8%), Exicure Inc (up 103.4%), and Netcapital Inc (up 88.5%), driven by positive news such as merger approvals and favorable trial results.
Stocks Experiencing Losses: Conversely, Top Wealth Group Holding Ltd experienced a sharp decline of 49.3% after a previous surge, along with other companies like Orangekloud Technology Inc and Biodexa Pharmaceuticals PLC, which fell 36.1% and 17.2%, respectively.
Market Movements: Ares Management Corp will replace Kellanova in the S&P 500, while Sezzle Inc will replace Vital Energy in the S&P SmallCap 600, indicating ongoing shifts in market indices.
Biodexa Activates First European Site for Phase 3 Serenta Trial in FAP
- Trial Activation: Biodexa Pharmaceuticals has activated its first European site for the Phase 3 Serenta clinical trial at the University of Bonn, Germany, focusing on familial adenomatous polyposis (FAP). This milestone offers new hope for FAP patients who currently lack approved non-surgical treatment options.
- Funding Support: The trial's launch is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas, along with collaborations with Emtora Biosciences and Precision for Medicine. This backing strengthens Biodexa's competitive position in the cancer treatment landscape in Europe.
- Trial Design: The Serenta trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy of eRapa in preventing disease progression in FAP patients. Given that untreated FAP leads to colorectal cancer in nearly all patients by age 50, the trial's success could significantly enhance patient quality of life.
- Future Plans: Nine additional European sites are expected to activate over the next 2-3 months across the Netherlands, Spain, Denmark, and Italy. This expansion will further bolster Biodexa's presence in the European market and provide treatment opportunities for more FAP patients.
Biodexa Pharmaceuticals submits $100M shelf registration for versatile securities sales
Biodexa Pharmaceuticals Filing: Biodexa Pharmaceuticals has filed a $100 million shelf registration with the SEC for future offerings of various securities.
Types of Securities: The securities may include ordinary shares, ADS representing ordinary shares, debt securities, warrants, rights, and units.
Biodexa Secures Exclusive License for Otsuka's OPB-171775, a Novel GIST Treatment
- Exclusive Licensing Agreement: Biodexa has entered into an exclusive licensing agreement with Otsuka Pharmaceutical to develop and commercialize OPB-171775 globally, except in Japan, which is expected to significantly enhance the company's market position in rare diseases.
- Innovative Mechanism: MTX240 utilizes molecular glue technology to effectively overcome TKI resistance by inducing interactions between PDE3a and SLFN12 proteins, offering a novel therapeutic approach that may benefit a large number of GIST patients.
- Market Potential: With approximately 3,000-4,000 GIST patients annually in the U.S., MTX240's unique mechanism is poised to address the treatment gap for TKI-resistant patients, and the global GIST market is projected to grow at an annual rate of 6-10% to reach about $1.3 billion by 2032.
- Patent Protection: MTX240 is protected by composition of matter patents in the U.S., Europe, and Japan, extending through 2037, ensuring its competitive advantage in the market while providing legal safeguards for future development and commercialization.
Biodexa Pharmaceuticals Appoints Fiona Sharp as CFO, Shares Rise 3.45%
- Executive Transition: Biodexa Pharmaceuticals has promoted Fiona Sharp to Chief Financial Officer and Company Secretary, effective immediately, aiming to strengthen financial management and enhance operational efficiency within the company.
- Succession Plan: Sharp succeeds Stephen Stamp, who will continue as Chief Executive Officer, ensuring stability and continuity in the company's leadership during this transition.
- Financial Expertise: Having served as Group Financial Controller since December 2019, Sharp brings extensive financial management experience, previously holding the position of Assistant Director of Finance at Hywel Dda University Health Board, which is expected to enhance the company's financial strategy.
- Market Reaction: BDRX shares are currently trading at $2.54, reflecting a 3.45% increase from the previous trading day, indicating positive market sentiment regarding the new CFO's appointment and confidence in the company's future growth prospects.
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.
Mama's Creations Stock Rises Over 13%; Check Out 20 Stocks Making Moves in Premarket Trading
Mama's Creations Inc Performance: Shares of Mama's Creations Inc rose 13.3% in pre-market trading after reporting third-quarter earnings of 1 cent per share, surpassing analyst expectations of a loss of 2 cents, along with sales of $47.269 million exceeding the $43.203 million estimate.
Other Notable Gainers: Several stocks saw significant gains in pre-market trading, including Alphatime Acquisition Corp (up 388.8%), Exicure Inc (up 103.4%), and Netcapital Inc (up 88.5%), driven by positive news such as merger approvals and favorable trial results.
Stocks Experiencing Losses: Conversely, Top Wealth Group Holding Ltd experienced a sharp decline of 49.3% after a previous surge, along with other companies like Orangekloud Technology Inc and Biodexa Pharmaceuticals PLC, which fell 36.1% and 17.2%, respectively.
Market Movements: Ares Management Corp will replace Kellanova in the S&P 500, while Sezzle Inc will replace Vital Energy in the S&P SmallCap 600, indicating ongoing shifts in market indices.
Biodexa Activates First European Site for Phase 3 Serenta Trial in FAP
- Trial Activation: Biodexa Pharmaceuticals has activated its first European site for the Phase 3 Serenta clinical trial at the University of Bonn, Germany, focusing on familial adenomatous polyposis (FAP). This milestone offers new hope for FAP patients who currently lack approved non-surgical treatment options.
- Funding Support: The trial's launch is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas, along with collaborations with Emtora Biosciences and Precision for Medicine. This backing strengthens Biodexa's competitive position in the cancer treatment landscape in Europe.
- Trial Design: The Serenta trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy of eRapa in preventing disease progression in FAP patients. Given that untreated FAP leads to colorectal cancer in nearly all patients by age 50, the trial's success could significantly enhance patient quality of life.
- Future Plans: Nine additional European sites are expected to activate over the next 2-3 months across the Netherlands, Spain, Denmark, and Italy. This expansion will further bolster Biodexa's presence in the European market and provide treatment opportunities for more FAP patients.
Biodexa Pharmaceuticals submits $100M shelf registration for versatile securities sales
Biodexa Pharmaceuticals Filing: Biodexa Pharmaceuticals has filed a $100 million shelf registration with the SEC for future offerings of various securities.
Types of Securities: The securities may include ordinary shares, ADS representing ordinary shares, debt securities, warrants, rights, and units.
