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Investing.com - Dr. Reddy’s Laboratories Ltd. (NYSE:RDY) received a Notice of Non-Compliance from Health Canada for its Semaglutide ANDS injection, the company announced Tuesday. The stock, currently trading at $13.41, has fallen 14.66% year-to-date.
The notice from the Pharmaceutical Drugs Directorate requests additional information and clarifications on specific aspects of the submission, which Dr. Reddy’s stated it is confident in addressing within the required timeframe. InvestingPro identifies Dr. Reddy’s as a prominent player in the Pharmaceuticals industry with a "GREAT" overall financial health score.
Goldman Sachs maintained its Neutral rating on Dr. Reddy’s stock with a price target of INR1,225.00, noting that Semaglutide generic monetization remains crucial for the company as it faces a potential generic Revlimid revenue decline beginning January 2026. According to InvestingPro, the company appears undervalued compared to its Fair Value, despite trading at a high P/E ratio of 16.99 relative to its near-term earnings growth.
The investment bank has projected annual sales of US$250 million for Dr. Reddy’s generic Semaglutide in Canada by fiscal year 2028, representing approximately 5% of total sales and 15% of North America sales.
Dr. Reddy’s has already contracted approximately 10 million pens for calendar year 2026 and 12 million for fiscal year 2027 for the global launch of Semaglutide, with a significant portion likely intended for the Canadian market.
In other recent news, Coya Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for COYA 302, a treatment aimed at amyotrophic lateral sclerosis (ALS). This development is significant for Coya as it triggers a milestone payment of $4.2 million from its partner, Dr. Reddy’s Laboratories Ltd. The acceptance by the FDA marks a crucial step forward in the development of Coya’s proprietary immunomodulatory biologic combination therapy. This news follows the company’s ongoing efforts to advance its treatment options in the field of neurodegenerative diseases. The collaboration with Dr. Reddy’s Laboratories highlights the strategic partnerships Coya is leveraging to bring innovative therapies to market. Investors will be closely watching how this development impacts Coya’s future endeavors and financial performance.
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