Pharma Stocks in Focus: Three Companies to Watch Today

Pharmaceutical stocks are drawing attention this Monday, December 15th, following regulatory updates for two companies and a significant settlement agreement for another.

Dr. Reddy's Laboratories and Aurobindo Pharma have both received Form 483 notices from the U.S. Food and Drug Administration (FDA). Meanwhile, Biocon Ltd.'s subsidiary, Biocon Biologics, has reached an agreement with Regeneron and Bayer concerning Aflibercept for markets in Europe and other regions.

Dr. Reddy's Laboratories

The USFDA issued a Form 483 to Dr. Reddy's, including five observations, after inspecting its formulations manufacturing facility in Srikakulam, Andhra Pradesh. The inspection, which combined a review of good manufacturing practices (GMP) and a pre-approval inspection (PAI), took place between December 4th and December 12th, 2025. Dr. Reddy's has stated that it will address the FDA's observations within the specified timeframe.

On its previous trading day, Dr. Reddy's stock closed 0.5% higher at ₹1,280 per share. That said, the reality is a bit more complicated. the stock has experienced a 6.5% decline year-to-date.

Aurobindo Pharma

Aurobindo Pharma also received a Form 483 from the USFDA, which included three observations. These followed the completion of an inspection at Unit-V, an active pharmaceutical ingredient (API) manufacturing facility owned by its subsidiary, Apitoria Pharma Pvt. Ltd., located in Telangana. The inspection was conducted from December 1st to December 12th, 2025.

Aurobindo Pharma characterized the FDA's observations as procedural and stated that it would respond to the regulator within the given timeframe. The company also clarified that the observations are not expected to impact the facility's operations.

In the previous session, Aurobindo Pharma's shares closed nearly 2% higher at ₹1,195.1 apiece. Year-to-date, the stock is down 11.7%.

Biocon

Biocon announced on Saturday that its subsidiary, Biocon Biologics, has entered into a settlement and licensing agreement related to the global commercialization of its biosimilar Aflibercept. This new agreement with Regeneron and Bayer, which covers Europe and other parts of the world, builds upon a previous settlement that included the United States and Canada.

The agreement allows Biocon Biologics to proceed with the commercial launch of Yesafili, its biosimilar version of Aflibercept (40mg/ml), in markets worldwide. Yesafili is a vascular endothelial growth factor (VEGF) inhibitor used in the treatment of various ophthalmologic conditions.

Biocon Biologics, Regeneron, and Bayer have agreed to dismiss all pending litigation as part of the agreement. This will allow Biocon to launch Yesafili in the UK in January 2026, and in other settled countries by March 2026, or possibly earlier under certain conditions. The specific details of the settlement remain confidential.

Biocon's shares closed the previous trading session up 0.9% at ₹385.35 apiece. The stock has decreased by 8.5% over the past month.