Boston, MA 02/25/2014 (wallstreetpr) – DARA Biosciences Inc (NASDAQ:DARA) was last seen soaring with more than 45 percent gain in the premarket and more than 30 percent boost to its stock price value around noon Tuesday. And all that was happening because of good news around the stock.
The company develops specialty drugs, more so those dedicated to offering healthcare relief to cancer patients at the risk of side effects arising from their treatments. The company has its drug KRN5500 in Phase 2 clinical trial and the drug candidate is the sources of the latest good news.
DARA Biosciences Inc (NASDAQ:DARA) is developing KRN5500 for the treatment of pain that arise from cancer treatments in patients. The drug is expected to be helpful to patients as it is to healthcare professionals. No wonder the U.S. Food and Drug Administration or FDA has acted to grant it some privileges in the latest development.
FDA privilege for KRN5500
FDA has granted what is called “Orphan Drug Designation” to KNR5500. First and foremost, this status is given to drugs whose treatment is targeted to less than 200,000 patients in the U.S. This is a perfect fit for specialty drugs.
It now means that with KRN5500 now labeled as Orphan Drug Designation, the developer DARA Biosciences Inc (NASDAQ:DARA) will enjoy seven years exclusivity marketing the drug, there will be tax credits coming to the drug and it will also receive fees waivers in such filings as PDUFA. Moreover, the drug also qualifies for federal grants. So then, all these are good news for people at DARA as well as investors who have been patiently waiting for value return on their investment.
Perhaps the first benefit that DARA Biosciences Inc (NASDAQ:DARA) management can now celebrate is increased prospects for getting funding. And indeed the company has announced its commitment to evaluating funding sources. There is need for funding for the drug’s study and various functions around it. There is no doubt however that the bulk of headache as regards sourcing for financial support has been made easier with KRN5500’s new status.
Good Remarks from FDA
KRN5500 is not new to good treatments before FDA officials. The drug was in 2011 designated as “Fast Track program” which meant that it enjoyed preferential treatment in its development stage. Among such special treatments included increased consideration for review priority and increased contact with the FDA Review Division, among many other benefits that come with Fast Track programs.
Takeaway
DARA Biosciences Inc (NASDAQ:DARA) is excited with the move by FDA to grant KRN5500 Orphan Drug Designation. The company’s chief operations officer Chris Clement observed that the new status of the specialty drug candidate will be very helpful in the forward march in the clinical trials.
