New 52-Week High: SmallCap Stock Strides Pharma Jumps Over 11% On USFDA Approval

Bengaluru-based drugmaker, Strides Pharma Science witnessed an impressive buying on Friday as the smallcap stock jumped over 11% to touch a new 52-week high. The strong bulls appeared after the pharma company's step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (USFDA).

Strides Pharma was among the top gainers on BSE.

The stock touched a new 52-week high of Rs 522.20 apiece in early trade of Friday and skyrocketed by 11.5%.

At the time of writing, the smallcap stock performed at Rs 508.80 apiece, up nearly 7% on BSE. Its market cap is over Rs 4,595 crore.

In its regulatory filing, Strides' ANDA is tentatively approved under USFDA's expedited review provision for the President's Emergency Plan for AIDS Relief (PEPFAR). Also, approval of this product complements Strides' approved range of first-line HIV treatments to now include treatment naïve patients as well.

Dolutegravir tablets belong to a class of medication knows as antiretrovirals. This medication is the first line of antiretroval therapy (ART) for treatment naïve patients. It works by preventing the multiplication of the virus in human cells, the filing explained.

Strides stated that the product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tivicay Tablets of ViiV Healthcare Company. The approval adds to a list of products that Strides has approved under the PEPFAR pathway taking the total to 13 products.

Strides mainly operate in the regulated markets and have an "in Africa for Africa" strategy and an institutional business to service donor-funded markets. The Company's global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York).

Year-to-date, Stride's stock advanced by over 42%. But in six months period, the stock zoomed by nearly 83%.

Notably, the PEPFAR tentative approval for Strides qualifies the Company to participate in global donor-funded programs that procure this lifesaving medicine and it is supplied in 126 countries. As of the full year 2022, donor procurement for the Dolutegravir 50mg tablet is estimated at a value of ~35mn USD. This product further strengthens the available offerings in HIV treatment from Strides.

Further, the Dolutegravir 50mg tablet has a market opportunity in the US of $ 1,345 million, as per IQVIA. The products will be manufactured at the company's facility in Bengaluru. The conversion of this tentative approval to a full approval is expected upon expiry of the constraining patents.

So far, Strides has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.