Zydus Lifesciences gets USFDA nod for cancer drug; stock hits 52-week high

Shares of Zydus Lifesciences, formerly known as Cadila Healthcare, jumped over 5% to hit a fresh 52-week high in intraday trade on Thursday after the pharmaceutical company received final approval from the United States Food and Drug Administration (USFDA) for its cancer drug. The stock has maintained buying momentum for the last four sessions and gained 7% during the same period.

Continuing its gaining streak, Zydus Lifesciences shares opened marginally higher at ₹625.95 against the previous closing price of ₹622.45 on the BSE. The pharma stock, however, surged as much as 5.5% to touch a fresh 52-week high of ₹656.50 following the announcement. The counter also witnessed a spurt in volume trade with 0.75 lakh shares changing hands compared to a two-week average of 0.29, while the market capitalisation increased to ₹66,365 crore.

Zydus Lifesciences' share price has risen 92% in the last one year from its 52-week low of ₹340.60 touched on July 27, 2022. In the calendar year 2023, the largecap stock gained 56%, while it climbed 52% in six months and 15% in a month. In the last week, the stock gained nearly 6%.

In an exchange filing today, Zydus says it has received final approval from the USFDA for Plerixafor Injection, which is used by patients with certain types of cancer (non-Hodgkin's lymphoma and multiple myeloma) to prepare them for a stem-cell transplant. The American drug regulator has given a nod for 24 mg/1.2 mL (20 mg/mL) single-dose vial of plerixafor injection.

“Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial (USRLD: Mozobil Injection, 24 mg/1.2 mL [20 mg/mL]),” it says in a BSE filing.

As per the company, the drug will be manufactured at the group’s injectable manufacturing facility of Zydus Lifesciences (Alidac) at SEZ, Ahmedabad, Gujarat.

“Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial had annual sales of USD 210 mn in the United States (IQVIA MAT May 2023),” it says in the filing.

As of now, the group has 374 approvals and has so far filed over 442 ANDAs (as on March 31, 2023), since the commencement of the filing process in FY04.

In a separate filing today, Zydus says Bayer Zydus Pharma Private Limited, a joint venture between Zydus Lifesciences and Bayer (South East Asia) PTE Limited, has entered into an agreement to set up a joint venture company for marketing pharmaceutical products.

“The purpose of entering into the joint venture agreement (JVA) is for carrying on the business of marketing of pharmaceutical products,” it says.

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