Shares of Progenics Pharmaceuticals Inc. (NASDAQ: PGNX) and Valeant Pharmaceuticals International Inc. (NYSE: VRX) made handy gains in the market on Wednesday following a key U.S. Food and Drug Administration (FDA) late-stage approval. Both of these companies have had a rough run of 2016, with Valeant faring far worse out of the two. As we have said before, FDA approvals have the potential to make or break companies in the pharmaceuticals industry. This move could be a real turning point for Progenics and Valeant.

The companies announced that the FDA has approved Relistor (methylnaltrexone bromide) tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Valeant expects to commence sales of Relistor tablets in the United States in the third quarter of 2016.

Previously, Relistor subcutaneous injection was approved in 2008 for the treatment of OIC in adults with advanced illness who are receiving palliative care and in 2014 for the treatment of OIC in adults with chronic non-cancer pain.

These orally administered tablets offer a new avenue for this treatment that is far less intrusive than the previously approved injection treatment.

Mark Baker, chief executive officer of Progenics, commented:

We expect the market to be receptive to a more convenient oral tablet formulation of RELISTOR’s well-established subcutaneous preparation.

Richard L. Rauck, MD, Medical Director, Center for Clinical Research, President, Carolinas Pain Institute, President of the Sceptor Pain Foundation (of which he is a founding member) and Immediate Past President of the World Institute of Pain, added:

Relistor has a unique mechanism of action that binds to mu-opioid receptors without impacting the opioid-mediated analgesic effects on the central nervous system. This represents a true breakthrough in the treatment of OIC, and addresses a large and growing need in the field of pain management.

In terms of the year-to-date numbers, Progenics is down 19% and Valeant is down 77%, excluding Wednesday’s move.

Shares of Progenics were last trading up more than 28% at $6.34, with a consensus analyst price target of $10.75 and a 52-week trading range of $3.61 to $11.15.

Shares of Valeant were recently trading up 4% at $24.50. The stock has a consensus price target of $42.89 and a 52-week trading range of $24.30 to $25.11.

Get Our Free Investment Newsletter

I have read, and agree to the Terms of Use

Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.