Biotech Stocks Facing FDA Decision In October 2019

Adamis Pharmaceuticals
Adamis Pharmaceuticals

The FDA decision on Adamis Pharmaceuticals Corp.’s (ADMP) ZIMHI Injection, proposed for the reversal of opioid overdose, is expected on October 31, 2019.

ZIMHI is a high dose Naloxone injection product candidate administered using a patented Symject device. Naloxone has been used as the standard treatment for opioid overdose for more than 45 years, and the current approved dose is only 2 mg.

Given the fact that there are more potent opioids such as fentanyl, which are linked to high mortality, Adamis has proposed a novel high dose of Naloxone.

The drug overdose epidemic is a public health crisis in the U.S. According to the CDC, there were over 72 thousand drug overdose-related deaths in 2017 with greater than 40% caused by synthetic opioids like fentanyl.

According to IQVIA (IMS) National Sales Perspective, the addressable market opportunity for ZIMHI is estimated to be $330 million.

In July of this year, Adamis settled all patent infringement cases filed by kaléo, a privately-held pharmaceutical company, related to ZIMHI.

ADMP closed Friday’s (Sep.27, 2019) trading at $0.74, down 0.99%.