Matinas BioPharma’s MAT2203 Granted QIDP and Fast Track Designation by FDA

Matinas BioPharma’s MAT2203 Granted QIDP and Fast Track Designation by FDA

By: Dylan Sikes - AllPennyStocks.com News

Thursday, December 17, 2015

The biotech sector has had a mixed year. The sector has come under significant selling pressure since July this year. The initial pullback in the biotech sector was due to concerns over high valuations in the sector. Then in September this year, the sector saw another sharp pullback after Democratic Presidential candidate Hillary Clinton tweeted about the drug pricing issue. Indeed, lawmakers have been critical of some of the practices of the biotech sector, including pricing of some of the drugs. All these factors, combined with a rate hike from the Federal Reserve, is keeping the biotech sector under pressure. It must be noted though that the iShares NASDAQ Biotechnology (ETF) (NASDAQ:IBB) is still up more than 10% for the year, outperforming the broader market.


The resilience of the biotech sector highlights the fact that while valuations of some companies are unjustified, the sector as a whole remains reasonably valued. In fact, there are some companies that might even be undervalued. One such potentially undervalued company is Matinas BioPharma Holdings Inc. (OTCQB:MTNB). Based in Bedminister, New Jersey, Matinas is a clinical-stage biopharmaceutical company focused on the identification and development of safe and effective therapeutics for the treatment of serious and life-threatening infections.

This morning, MTNB announced that the FDA has designated its lead drug candidate MAT2203 a Qualified Infectious Disease Product (QIDP) with a Fast Track status for the treatment of aspergillus. MAT2203 is a novel product that has been designed to provide targeted delivery to the site of injection along with a significantly improved safety and tolerability profile.

A QIDP designation from the FDA provides certain incentives for the development of new antibacterial or antifungal drugs, including eligibility for Fast Track, priority review, and if the drug is approved, eligibility for an additional five years of marketing exclusivity.

Roelof Rongen, President and CEO of Matinas BioPharma, said that Invasive aspergillosis is the most common cause of infectious pneumonic mortality in patients undergoing hematopoietic stem cell transplantation, and untreated patients have a nearly 100 percent mortality rate and even when invasive aspergillosis is managed with antifungal therapy, mortality rates remain very high – between 39 percent and 75 percent in transplant patients – depending on the type of transplant. Rongen added that while advances in the treatment of blood-borne cancers and bone-marrow and solid-organ transplantation have prolonged the lives of patients with hematopoietic disorders and end-organ disease, the increasing number of individuals treated with immunosuppressive therapy has potentiated the spread of fungal infections such as aspergillus, candida, and drug-resistant mutant-strains.

While the stock has had a rough six months along with the general biotech sector, it is up on the year. Shares were up 13% today on the above news announcement.

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