Evoke Pharma finally lands approval for lead and only drug
Over a year after the FDA first rebuffed Evoke’s application, the agency has approved the small biotech’s lone drug, a treatment for a common gastrointestinal complication of diabetes.
The drug, known as Gimoti, is a nasal spray for treating diabetic gastroparesis, a disorder in which the muscles in the stomach can’t properly clear food. In a Phase III study in 2016, the drug actually missed its primary endpoint but showed a “clinically meaningful benefit” in 51% of patients with moderate to severe symptoms at the outset.
The FDA rejected the company’s first application, submitted in 2018, but Evoke submitted again in December with new pharmacokinetic data and a new batch of patient reports. Critically, it also included data from the pump used for delivering the drug, after the FDA raised concerns that it hadn’t been giving stable dosing.
Long a tiny company — they received a small business waiver on the $2.4 million PDUFA fee — the initial CRL plunged them into penny stock territory. In November, they applied for and received a waiver from NASDAQ to stay above the minimum bid of $1.
With the approval, though, investor interest returned. Their stock $EVOK was up 62% Monday morning, from $2.34 to $3.82. Eversana Life Science Services has agreed to commercialize the product.