Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) is having a relatively strong start to the trading session this morning, and for good reason. The company announced that it has received FDA approval, exciting investors who are sending the stock screaming for the top. Today, we’ll talk about:
- The FDA approval;
- what we’re seeing from the stock as a result; and
- what we’ll be watching for with regard to PGNX ahead.
PGNX Announces FDA Approval
As mentioned above, Progenix Pharmaceuticals is having a strong start to the trading session in the pre-market hours this morning after the company announced FDA approval. In a press release issued late last night, the company announced that the United States Food and Drug Administration (FDA) has approved its New Drug Application (NDA) surrounding AZEDRA (iobenguane I 131) 555 MBq/mL injection for intravenous use.
Azedra is a radiotherapeutic that PGNX designed for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.
In the release, PGNX announced that AZEDRA is the first and only approved therapy for this condition. However, there is a bit of a drawback. AZEDRA was shown in clinical study to have the potential to cause serious side effects. These include risk of radiation exposure, bone marrow problems and other cancers (myelosuppression and secondary malgnancies), thyroid problems, elevations in blood pressure, kidney problems, respiratory problems, issues with regard to pregnancy and fertility problems. Nonetheless, as the only FDA approved option for these cancers, the side effects may be worth the benefits. In a statement, Mark Baker, CEO at PGNX, had the following to offer:
As the first FDA approved therapy for unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy, AZEDRA provides a new treatment option for physicians and their patients… AZEDRA has been shown to decrease the need for blood pressure medication and reduce tumor size in some patients. We are extremely grateful to the patients, their families and the investigators who participated in AZEDRA’s clinical development program. We also thank those who have contributed to the development of AZEDRA over many years.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In the case of PGNX, the news proved to be overwhelmingly positive. After all, the company has received FDA approval, meaning that AZEDRA will now move toward commercialization, generating revenue. So, it’s no surprise that excited investors are sending the stock on a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:10), PGNX is trading at $8.54 per share after a gain of $0.23 per share or 2.77% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on PGNX. In particular, we’re interested in following the company as it moves AZEDRA toward commercialization. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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