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Biotech Stocks Facing FDA Decision In November 2020

Adamis Pharma
Adamis Pharma

Adamis Pharmaceuticals Corp.’s (ADMP) ZIMHI Injection, proposed for the reversal of opioid overdose, awaits the FDA decision on November 15, 2020.

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 currently approved dose is only 2 mg. ZIMHI is a 5 mg dose of Naloxone.

This is ZIMHI’s second go-around with the FDA. Last November, the U.S. regulatory agency had declined to approve ZIMHI, raising questions related to Chemistry, Manufacturing and Controls (CMS). Addressing the CMC issues, Adamis resubmitted the ZIMHI New Drug Application to FDA in May of this year and is awaiting the decision.

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

ADMP closed Friday’s (Oct.23, 2020) trading at $0.79, down 2.36%.