is...(single)
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STRONG.......As the move back to where this stock should be. continues.
Good week,should continue gaining.Watching for another pharma .to enter
perhaps do what Genetech is doing with us now.
GLTA
Matinas BioPharma Announces Positive Opinion by the European Medicines Agency on Orphan Drug Designation for MAT2203 for the Treatment of Cryptococcosis
July 25 2022 - 06:30AM
GlobeNewswire Inc.
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Matinas BioPharma (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of nucleic acids and small molecules with its lipid nanocrystal (LNC) platform technology, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending MAT2203 for designation as an orphan medicinal product for the treatment of cryptococcosis. The U.S. Food and Drug Administration (FDA) previously granted Orphan, Qualified Infectious Disease Product (QIDP) and Fast Track Designations to MAT2203 for the treatment of cryptococcosis. Matinas is currently preparing to evaluate MAT2203 in a pivotal Phase 3 trial in patients with cryptococcal meningitis.
“The positive opinion for Orphan Drug Designation from the EMA is another important milestone for MAT2203 and reflects our commitment to position MAT2203 for global development and approval,” said Theresa Matkovits, Ph.D., Chief Development Officer of Matinas BioPharma. “We believe that MAT2203 has the potential to transform the treatment of cryptococcosis, as well as other deadly invasive fungal infections. This designation reflects the significant need for new therapies to treat fungal disease and we look forward to working with the EMA and FDA to potentially deliver MAT2203 to patients.”
The orphan medicinal product designation by the European Commission is granted to medicines that treat, prevent, or diagnose a life-threatening or chronically debilitating rare disease, with a prevalence in the EU of not more than five in 10,000 people, and with either no currently approved method of diagnosis, prevention, or treatment or with significant benefit to those affected by the disease. The designation potentially provides certain benefits to Matinas, including 10-year EU market exclusivity upon regulatory approval, if received, reductions in EMA application fees, and access to protocol assistance.
The FDA has previously designated MAT2203 as a QIDP with Fast Track Status and Orphan Drug Disease designation for three additional indications: the treatment of invasive candidiasis, and treatment of invasive aspergillosis, and the prevention of invasive fungal infections due to immunosuppressive therapy.
About MAT2203
MAT2203 is Matinas’ orally administered formulation of the broad-spectrum fungicidal medication amphotericin B, which is currently completing Phase 2 clinical development. This oral formulation utilizes the Company’s proprietary LNC technology to deliver amphotericin B in a way that targets infected tissues and avoids the toxicity normally seen with intravenously administered amphotericin B. This novel mechanism of oral delivery has the potential to make MAT2203 an important and invaluable treatment for invasive fungal infections like cryptococcal meningitis, mucormycosis, and invasive aspergillosis.
The entire market was off today,got a few shares in the .83 -.84 range.
Next week may bring BIG changes ,and the beginning of a transformation.
Stay tuned, & GLTA
Well another good day.Wait till NEWS starts coming out.The remaining months of 2022 are going to be a BLAST! The pipe line is full.This is a GROUND FLOOR OPT. THAT IS LAGIT,NOT SOME BS SHELL COMPANY.
Lot of up side potential here at the current SP.
GLTA
Not a bad day,we are going to be hit by a LOT of news very soon.
Are we about to get a substantial move here? STAY TUNED!
Just got in,see there is a lot of insider buying.
GLTA
BIONTECH + MTNB// LETS GET THIS DONE!
Always a good sign when the TOP DOGS are hitting it off so to speak.Look forward to more details as this moves into mid,and end of year..
Very impressive. THANKS RFF
As Axsome's first marketed drug, it will help the company begin its pivot from a clinical-stage biopharmaceutical company to a commercial-stage company. Sunosi, approved in 2019, brought in $59 million last year in sales, up 110% year over year, so the move should pay for itself by 2023, and that doesn't count any additional label indications the drug may be useful for. Ultimately, Axsome said that Sunosi has the potential to be a more-than $1 billion drug.
First Midwest Bank Trust Division acquired a new position in Axsome Therapeutics, Inc. (NASDAQ:AXSM – Get Rating) in the 4th quarter, according to the company in its most recent filing with the Securities and Exchange Commission (SEC). The institutional investor acquired 115,028 shares of the company’s stock, valued at approximately $4,346,000.
Other large investors have also added to or reduced their stakes in the company. LPL Financial LLC purchased a new position in shares of Axsome Therapeutics in the second quarter valued at $261,000. State Street Corp increased its position in shares of Axsome Therapeutics by 1.7% in the second quarter. State Street Corp now owns 639,757 shares of the company’s stock valued at $43,158,000 after buying an additional 10,589 shares in the last quarter. Charles Schwab Investment Management Inc. increased its position in shares of Axsome Therapeutics by 1.8% in the second quarter. Charles Schwab Investment Management Inc. now owns 186,095 shares of the company’s stock valued at $12,554,000 after buying an additional 3,253 shares in the last quarter. Schonfeld Strategic Advisors LLC purchased a new position in shares of Axsome Therapeutics in the second quarter valued at $263,000. Finally, Morgan Stanley increased its position in Axsome Therapeutics by 122.8% during the 2nd quarter. Morgan Stanley now owns 317,446 shares of the company’s stock worth $21,414,000 after purchasing an additional 174,980 shares in the last quarter. Hedge funds and other institutional investors own 48.45% of the company’s stock.
Thanks RFF
WOW! MARKET'S GONE KOOKOO HERE IMO THIS WILL BE BACK INTO THE 40.00 RANGE BEFORE MARCH IS OUT.
GLTA
Moderna news may have joLted MTMB TODAY A TAD.
Looking Good !eom
Friday was a VERY INTERESTING trade day,is something about to happen here?/
Monday,and next week may get REALLY EXCITING>WATCHING
December 16 2021 - 06:30AM
GlobeNewswire Inc.
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Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced that the independent Data and Safety Monitoring Board (DSMB) of the EnACT trial (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) has completed a prespecified review of the third cohort and unanimously recommended progression to the fourth and final cohort of patients. Enrollment in the next randomized EnACT cohort, with 40 active-treatment patients, is expected to begin early first quarter 2022.
“Unanimous DSMB approval to proceed to cohort four in the EnACT trial is a strong statement that MAT2203 continues to exceed the prespecified efficacy and safety thresholds assessed in the first two cohorts,” said Theresa Matkovits, Ph.D., Chief Development Officer of Matinas BioPharma. “We have made significant progress advancing MAT2203 through clinical development, and the fourth cohort of EnACT represents a meaningful opportunity to further validate an all-oral treatment regimen with amphotericin B, and position MAT2203 as a potential first-line treatment for cryptococcal meningitis. Ultimately, our goal is to develop MAT2203 to become the preferred therapeutic option for the treatment of most invasive fungal infections and provide physicians and patients with an effective, convenient and safe oral formulation of one of the most potent antifungal agents available.”
“Our team continues to be pleased with the performance of oral MAT2203 for the treatment of cryptococcal meningitis,” commented David Boulware, M.D., M.P.H, Professor of Medicine at the University of Minnesota and Principal Investigator for the trial. “Cohort 3 of the ENACT trial tested whether starting with an all-oral regimen of amphotericin and flucytosine would be possible. Participants received 5 days of oral combination therapy before a scheduled switch to intravenous amphotericin. In this cohort with 10 participants receiving MAT2203, the direct antifungal therapy activity measured in cerebrospinal fluid continued to be above our pre-defined target threshold for success. We are excited to begin the fourth cohort testing the all-oral regimen of MAT2203 in a larger number of patients beginning in early January.”
“The continued progression of EnACT and the impressive data generated to date in this highly vulnerable patient population are a clear demonstration of how our LNC platform can unlock the full therapeutic potential of life-saving medicines,” remarked Jerome D. Jabbour, Chief Executive Officer of Matinas. “We believe this is further validation of how our proprietary technology can be used to overcome significant drug delivery challenges and we remain excited by the interest shown in the application of the LNC platform beyond anti-infective therapies.”
About the EnACT Study
GILD and MTNB have been working on ORAL remdesivir ,results to date look outstanding ,if this is green lighted by FDA,should really give GILD a SP jump as well as MTNB
GLTA
WATCH VERY CLOSELY
WELCOME DECEMBER !
LETS DO THIS MATINAS!
Does this not trade pre market? TIA
Heavy duty pre market...more news in the works???
LET'R RIP!!!!!!!!!!!!!!11
Its been a slow ride now for a while.I am looking forward to some substantial movement up very very soon,and not just for the short term..
GLTA