One of the major biotech winners on Tuesday was Puma Biotechnology (NASDAQ: PBYI), a $400 million market cap biotech stock that focuses primarily on developing cures for cancer, an already exciting area for biotech stocks.
Today Puma made news when it earned a major stamp of approval from the Food and Drug Administration (FDA), granting one of their candidate drugs a special designation in the process which would give Puma a leg up over the competition.
Puma went on to say that the FDA granted an “orphan drug” designation for its candidate drug Nerlynx, which is used to treat breast cancer patients with brain metastases.
For those not familiar with the term, an orphan drug designation gives a drug maker additional incentives such as grant funding for clinical trial expenses and as much as seven years of market exclusivity for treating specific conditions that affect 200,000 patients or less in the U.S.
“Receiving Orphan Drug Designation from the FDA signifies our continued progress and commitment to developing treatments for patients with HER2-positive breast cancer,” said Alan H. Auerbach, Chairman, CEO and President of Puma in a press release. “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.”
Earlier in August, shares of the jumped had jumped as much as 20 percent on news that the company had seen strong revenue growth for their Nerlynx cancer drug. Total revenue came in at $53.9 million, with $53.8 million of that figure coming from Nerlynx sales and the remaining $0.1 million coming from other royalties. At the same time, overall operating expenses and costs for the company had gone down to $79.7 million in Q2 as opposed to the $92.2 million seen from the previous year.
While Puma has other drug candidates currently in the works, including Neratinib, an oral drug approved by the FDA in 2017 for breast cancer patients, Nerlynx seems to be the best bet for the company going forward considering its newfound status as an orphan drug.
Shares of Puma Biotech were up around 9 percent in after-hours trading on Tuesday. While a modest gain in the biotech world, where double-digit spikes are common, this development could mark a major turnaround for Puma Biotech, whose shares have been steadily declining over the past few months. Since mid-March, the stock has fallen by over 75 percent, sliding from the $40s to its current price range around $10.5 per share.
Puma Biotech Company Profile
Puma Biotechnology is a biotechnology company focused on developing novel therapeutics for the treatment of cancer. Puma licenses the commercial rights to its current drug candidates.
The company expects to augment its product pipeline by acquiring, through license or otherwise, additional drug candidates for research and development and potential commercialization. In evaluating potential drug candidates, Puma employs disciplined decision criteria favoring drug candidates that have undergone at least some clinical study. – Warrior Trading News