Dr Reddy’s gets USFDA nod for HIV prevention drug

Dr. Reddy’s Laboratories Limited has received tentative USFDA approval for its twice-yearly injectable lenacapavir for HIV prevention, covering 120 countries outside the US. The generic injection will be priced at $40 per person annually under its licensing agreement with Gilead Sciences. The approval covers HIV-1 pre-exposure prophylaxis (PrEP) for adults and adolescents weighing at least 35 kg. Dr. Reddy’s received the voluntary licence from Gilead in October 2024 and later partnered with Unitaid, Wits RHI and CHAI to accelerate development and regulatory approval. Initial supplies are expected before the end of 2026, followed by wider availability in 2027. My view: This approval strengthens Dr. Reddy’s position in complex generic injectables and opens access to a large international public health market. However, the $40 annual price makes scale, procurement volumes and manufacturing efficiency important for commercial returns. The opportunity is significant, but revenue contribution will depend on how quickly countries adopt the product. Investors should watch for initial supply orders, production ramp-up and commercial progress through 2027. Dr. Reddy’s shares traded at ₹1,352.90 on the NSE, up 0.81%. Stance: Positive from a business development perspective. Execution and actual order volumes will determine the financial impact.

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