LOGO
LOGO

Slide Shows

Biotech Stocks Facing FDA Decision In August 2020

Tricida
Tricida

The FDA decision on Tricida Inc.’s (TCDA) New Drug Application for Veverimer is expected on August 22, 2020.

Veverimer is proposed for the treatment of metabolic acidosis in patients with chronic kidney disease, and is being reviewed under the accelerated approval program. The company is currently conducting its confirmatory postmarketing trial of Veverimer, dubbed VALOR-CKD.

As recently as July 14, the FDA notified Tricida of deficiencies that preclude discussion of labeling and postmarketing requirements/commitments. The notification did not specify the deficiencies identified by the regulatory agency.

It remains to be seen if Veverimer will be able to get the FDA nod in its first go.

TCDA closed Friday’s (Jul.24, 2020) trading at $13.89, down 3.47%.