Puma Biotech Increases for Upcoming FDA Ruling

Puma Biotechnology’s (NASDAQ: PBYI) stock is witnessing an exponential rise, from last week’s closing price of $37.80 to Monday’s highest price of $69.35, due to a briefing document from the US Food and Drug Administration about an upcoming review meeting for the company’s breast cancer drug Nertinib.
The briefing notes, per Reuters, indicated the positive effects of the drug compared to the use of a placebo. A full report and the actual ruling on the validity of this anti-cancer drug will be revealed on Wednesday 24.
As of 4:03 P.M EST on on Tuesday, Puma’s shares were at $57.80 and has seen a 50.13 percent increase since closing price last week.  Over a one-year period, the company’s stock is up 80.91 percent.

“Tolerability of neratinib in patient population is a concern given frequent dose interruptions, reductions, and discontinuations observed, mostly due to diarrhea,” as reported by Reuters.
Puma shared the announcement of the documents as well and will most likely comment on the outcome following the official results.

Possibility of a favorable ruling for Puma

According to Forbes, during an investor call Michael McCaughen–an analyst with Prevision –said the odds of the drug approval showing up on Wednesday is at about a coin flip, but not one decided by statistical questions.
“[McCaughan] leans toward predicting the panel will turn negative for another reason: questions over whether a drug’s first approval should be in the area of treating relatively healthy patients, whose tumors have been removed through surgery,” he said.
Some allege the push from Puma for this cancer drug came on the heels of the of the Dr. Robert Charnas hiring, head of regulatory affairs and project management. Charnas previously worked at Johnson & Johnson (NYSE:JNJ), however, he is now stepping down from the company due to health reasons.
“[Neratinib is] being considered as an extended maintenance therapy to help delay disease recurrence in breast cancer patients who have previously been treated for one year with Herceptin,” reported The Motley Fool.
Disappointingly for the company, in their trials for the drug many patients reported cases of severe diarrhea. Which, has prompted the company to research the potential use of their drug in combination with the antidiarrheal drug loperamide and steroids.

Puma Biotech – Neratinib: Meeting on Wed, FDA points wildly known, after a strong phase 3 doctors want access, large short interest. $PBYI pic.twitter.com/UndEkhQxLJ

— Anthony J. Pisciotta (@pisciotta) May 23, 2017

Neratinib is set to target breast cancer, but the company still promotes the idea of the drug being able to treat other types of cancers.

Investor Takeaway

Despite the stumbles from Puma in the past, this news should have investors excited and a little nervous about the future come Wednesday. Following the appointment of Scott Gottlieb as head of the FDA and an inclination towards speeding up the drug process in the US, there may be a chance that despite the problems with Neratinib, it can earn a positive response from the advisory panel.
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.