Zydus Lifesciences hits all time high on USFDA nod for drug worth $2 Bn

Zydus Lifesciences stock surged as much as 2.61 per cent, hitting its all time high at Rs 1313.05 per share on the BSE in Friday’s intraday deals. The stock price surged after the company received final approval from the United States Food and Drug Administration (USFDA) to market Valbenazine capsules in the dosage of 40 mg, 60 mg, and 80 mg. The drug is a generic equivalent of US reference listed drug Ingrezza capsules. 

Valbenazine capsules are indicated for the treatment of adults with tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts). The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ - II, India, the company said in an exchange filing on Friday. 

 

The group now has 400 approvals and has so far filed over 465  abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.

“Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Valbenazine capsules, 40 mg, and 80 mg, and was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Valbenazine Capsules, 60 mg,” the company said.

Further the company stated that with this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Valbenazine capsules, 40 mg, and 80 mg, and is eligible for 180 days of sole generic drug exclusivity for Valbenazine capsules, 60 mg. 

According to IQVIA MAT June 2024 data, Valbenazine capsules had annual sales of $1993.6 million in the United States.

The share price of the company has zoomed 61.48 per cent in the last six months, while rallying 86.51 per cent in the last one year.

Zydus Lifesciences is presently trading at a price to earnings multiple of 37.41 times, while trading at an earning per share (EPS) of Rs 34.20.

At 12:52 PM; the stock price of the company was trading 1.58 per cent higher at Rs 1299.80 per share on the BSE. By comparison the BSE Sensex surged by 0.99 per cent at 79,664 levels.