Puma Biotechnology PBYI Stock News

Puma Biotechnology Inc (NASDAQ: PBYI) is making a run for the top in the market this morning after the company announced late yesterday that it has received Orphan Drug Designation fromt he United States FDA. The announcement is leading to pre-market gains of nearly 9%. Here’s what’s happening:

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PBYI Stock Rockets On Orphan Drug Designation

Late Tuesday, Puma Biotechnology made a huge announcement. The company said that the FDA has granted Orphan Drug Designation to Nerlynx.

Nerlynx is being developed by PBYI as a potential option to treat breast cancer patients whos cancer has metastasized to the brain. This essentially means that the cancer has travelled from the breast to the brain.

In a statement, Alan H. Auerbach, Chairman, CEO and President at PBYI, had the following to offer:

Receiving Orphan Drug Designation from the FDA signifies our continued progress and commitment to developing treatments for patients with HER2-positive breast cancer. Despite expanded treatment options for HER2-positive breast cancer, brain metastases in these patients represent a significant clinical challenge, as well as sources of morbidity and mortality for most of these patients. The blood-tumor penetrability of NERLYNX represents a potential treatment option for these underserved patients.

Orphan Drug Designation Is A Big Deal

An announcement surrounding Orphan Drug designation is a big deal for Puma Biotechnology and any other clinical-stage biotech company looking to bring a new drug to market. The designation is only provided to drugs that are being developed to treat a patient population of 200,000 people or less in the United States.

These rare indications tend to be overwhelmingly valuable. After all, coming up with a treatment for a rare condition means that there’s a strong chance that once approved, that treatment will be the only option.

Moreover, Orphan Drug designation comes with some serious perks. In fact, as a result of the designation, PBYI receives incentives like grant funding for clinical trial costs, increased communication with the FDA through the development process, and if approved, a seven year market exclusivity period.

All in all, Orphan Drug designation is massive news. As a result of this designation, PBYI will enjoy several benefits.

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