Puma Biotechnology (NASDAQ: PBYI) is off to an incredibly strong start in the pre-market hours this morning, and for good reason. The FDA has approved a treatment submitted by the company. Of course, this led to excitement among investors, causing gains and prompting our partners at Trade Ideas to alert us to the movement. At the moment (9:08), PBYI is trading at $93.40 per share after a gain of 8.48% thus far today.
PBYI Rockets On FDA Approval
As mentioned above, Puma Biotechnology is having a strong start to the trading session this morning after news that the FDA has approved an experimental treatment hit center stage. The treatment that was approved is known as neratinib, a drug designed for the treatment of breast cancer. In particular, the drug is designed to reduce the risk of breast cancer recurrence after initial treatment.
Neratinib is a treatment that proves to be the first of its kind. Designed to treat early-stage breast cancer with the HER2 genetic mutation where the tumor has been surgically removed and that has been treated with Herceptin, the treatment has proven to be effective in keeping cancer away.
The data in the NDA showed that 94.2% of patients that were treated with neratinib didn’t experience any recurrence of cancer or death. This was compared to 91.9% of patients who were given a placebo. While that may seem like a relatively small difference, this is great news for those fighting breast cancer, as it gives them further hope of the ability to ward off any recurrence of cancer after treatment.
For PBYI, neratinib is a big deal. After all, breast cancer is the most frequently diagnosed form of cancer in women. Out of all women that are diagnosed with breast cancer, 20% to 25% of them are diagnosed with HER2-positive breast cancer. So, there is ultimately an incredibly dire need for a treatment like this as it will address a massive population of patients. For PBYI, that simply means that demand for this treatment will likely be strong.
In a statement, Richard Pazdur, Director of the FDA Oncology Center of Excellence, had the following to offer with regard to the newly approved PBYI treatment:
“HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan… Now, these patients have an option after initial treatment that may help keep the cancer from coming back.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on PBYI. In particular, we’re interested in following the story of neratinib, and excited to see what the company does as they move to the commercial phases. We’ll continue to follow the story closely and bring the news to you as it breaks!
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