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

Share of Zydus Lifesciences hit a fresh 52-week high of ₹519.70 on the BSE in early trade on Wednesday, a day after the drug maker said that it has received final approval from the United States Food and Drug Administration (USFDA) for an osteoporosis drug. The stock has risen 63% against its 52-week low of ₹319.40 touched on May 11, 2022.

Cheering the news, the shares of Zydus Lifesciences opened higher for the second straight session at ₹519.70, up 0.76% against the previous closing price of ₹515.75 on the BSE. However, the stock soon slipped in negative terrain, tracking subdued trading in the broader market, and dropped as much as 0.4% to ₹513.60. The market capitalisation of the largecap pharma stock stood at ₹52,077 crore at the time of reporting.

In comparison, the BSE Sensex was trading 71 points, or 0.12%, lower at 59,656 levels, while the BSE healthcare index was marginally up by 0.13%.

At the current price level, Zydus Lifesciences shares have delivered 45% returns to its shareholders in the last one year, while it gained over 25% in six-month period. In the calendar year, the stock has risen 22%, while it added 8% in last one month and nearly 3% in a week.

The stock got a boost after the USFDA allowed Zydus to manufacture and market Estradiol Transdermal System USP in the United States. Estradiol Transdermal System is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness).

“Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Estradiol Transdermal System USP, 0.014 mg/day (weekly) (USRLD: Menostar Transdermal System),” the Ahmedabad-headquartered company said in a post market release on Tuesday.

With this, the group now has 363 approvals and has so far filed over 440 abbreviated new drug applications (ANDAs) since the commencement of the filing process in the financial year 2003-04.

As per the company, formerly known as Cadila Healthcare, Estradiol Transdermal System USP, 0.014 mg per day (weekly) had annual sales of $1.9 million in the U.S. Estradiol transdermal system is indicated for prevention of postmenopausal osteoporosis, it said.

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad.

Earlier on April 15, the company had received USFDA approval for Isoproterenol Hydrochloride Injection used for the treatment of bradycardia (slow heart rate) and heart block. The company has received green signal to manufacture and market Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) single-dose vials. The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara.

As per the exchange filing, Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output and for treatment of bronchospasm occurring during anaesthesia.

Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) had annual sales of USD 28.5 mn in the United States.