Biotech Stocks Facing FDA Decision In February

Motif Bio plc
Motif Bio plc

Motif Bio plc’s (MTFB) New Drug Application for Iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections, is under priority review by the FDA, with a decision slated for February 13, 2019.

More than 3.6 million patients with acute bacterial skin and skin structure infections (ABSSSI) are hospitalized annually in the U.S.
It is estimated that up to 26% of hospitalized ABSSSI patients have renal impairment.

Methicillin-resistant Staphylococcus aureus (MRSA) is the most common pathogen causing approximately 35% to 72% of skin and skin structure infections.

Some of the FDA-approved antibiotics for the treatment of ABSSSI include The Medicines Co.’s (MDCO) Orbactiv, Allergan plc’s (AGN) Dalvance, Merck’s (MRK) Sivextro, Melinta Therapeutics’ Baxdela, Paratek Pharmaceuticals’ Nuzyra.

In 2009, the FDA had turned down Iclaprim for the treatment of complicated skin and skin structure infections (cSSSI) due to safety concerns. Iclaprim was under the aegis of Arpida, a Swiss company, then. Motif Bio acquired the rights to Iclaprim in 2015.

Now, under a new owner, will Iclaprim be able to pass muster with the FDA?

MTFB closed Tuesday’s (Jan.29, 2019) trading at $9.93, down 0.70%.