Welcome to our dedicated page for Dr Reddys Labs news (Ticker: RDY), a resource for investors and traders seeking the latest updates and insights on Dr Reddys Labs stock.
Dr. Reddy's Laboratories Limited (RDY) generates a steady flow of news across product launches, clinical collaborations, financial results and regulatory updates. As a global pharmaceutical company headquartered in Hyderabad, India and active in APIs, generics, branded generics, biosimilars and OTC products, its announcements span multiple therapeutic areas and regions.
News coverage for Dr. Reddy's often includes product and portfolio updates, such as the first-to-market U.S. launch of over-the-counter olopatadine hydrochloride ophthalmic solution USP, 0.7%, the generic equivalent of Extra Strength Pataday Once Daily Relief. The company also reports on new brands and in-licensed assets in India and Emerging Markets, including vaccines and allergy immunotherapy products.
Investors and industry followers will find regular earnings and financial disclosures, where Dr. Reddy's presents consolidated IFRS results, segment performance for Global Generics and Pharmaceutical Services and Active Ingredients, and commentary on regional trends in North America, Europe, India and Emerging Markets. These releases provide insight into pricing dynamics, product launches and contributions from acquisitions such as nicotine replacement therapy portfolios.
Another important stream of news relates to biosimilar and biotech partnerships. Dr. Reddy's announces collaborations with companies like Alvotech, Shanghai Henlius Biotech and Bio-Thera Solutions for biosimilar candidates targeting denosumab, daratumumab, ustekinumab and golimumab, among others. Updates from Aurigene Oncology, its wholly owned subsidiary, cover early clinical data and platform presentations in oncology.
Regulatory and safety communications also appear in the news feed, including recalls of specific product lots and summaries of inspection outcomes at manufacturing and API facilities. For readers tracking RDY, this page offers a consolidated view of these developments, making it easier to follow how the company’s strategy, pipeline and operations evolve over time.
Dr. Reddy's (NYSE:RDY) launched OTC Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% in the U.S. as a first-to-market generic equivalent to Extra-Strength Pataday once-daily relief, following USFDA approval.
The product is indicated for temporary relief of itchy eyes from pollen, ragweed, grass and animal dander, is sold in a 2.5 mL bottle, and expands Dr. Reddy's existing OTC eye-care portfolio that includes 0.2% and 0.1% olopatadine strengths.
The Pataday brand had U.S. sales of approximately $69.9 million for the 52-week period ending December 27, 2025, per NIQ retail data.
Aurigene Oncology (NASDAQ:RDY) reported initial Phase 1 data for AUR112, an oral MALT1 inhibitor, in relapsed/refractory lymphoid malignancies as of Nov 21, 2025 cutoff. In 11 efficacy-evaluable patients across the first two cohorts, the overall response rate was 63.6% (six partial responses, one complete response); intent-to-treat ORR was 58.3%. Safety was described as generally well tolerated: 84.6% experienced TEAEs, with 14 treatment-related events in seven patients, one DLT (Grade 3 neutropenia) and two DLT-equivalent events. Pharmacodynamics showed rapid, sustained IL-2 suppression; drug exposure at 200 mg appears in the efficacious range. Dose-expansion cohorts for select lymphoid malignancies are planned.
Aurigene Oncology (NASDAQ:RDY) will present new preclinical and platform data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Oct 22–26, 2025.
Highlights include updates from the A-PROX targeted protein degradation platform and poster data on an orally bioavailable SMARCA2-selective degrader (Abstract C025; Oct 25 12:30–4PM ET). The company cites US FDA IND approval for a SMARCA2-selective degrader and US-FDA clearance for first-in-human studies of LAI candidate AUR110.
Coya Therapeutics (NASDAQ:COYA) has received FDA acceptance of its Investigational New Drug (IND) application for COYA 302, a proprietary immunomodulatory biologic combination therapy for treating Amyotrophic Lateral Sclerosis (ALS). The acceptance enables the company to proceed with a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the treatment's efficacy and safety.
The milestone triggers a $4.2 million payment to Coya from its partner Dr. Reddy's Laboratories (DRL). The development represents a significant step in Coya's partnership with DRL to advance potential treatments for ALS patients.
Dr. Reddy's Laboratories (NYSE:RDY) reported Q1 FY26 financial results with revenues of ₹85,452 Mn, showing an 11% year-over-year growth. The company's gross margin stood at 56.9%, down from 60.4% in Q1FY25. Key highlights include:
The Global Generics segment revenue grew 10% YoY to ₹75,620 Mn, while North America revenues declined 11% YoY due to increased price erosion in products like Lenalidomide. European operations saw significant growth of 142% YoY, largely driven by the acquired Nicotine Replacement Therapy portfolio.
Notable developments include expanded partnerships with Alvotech for biosimilar pembrolizumab and Sanofi for BeyfortusTM launch in India. The company maintained strong financial health with ₹73,169 Mn in cash and investments and achieved an improved 'A' rating in CDP's Climate category.
Bio-Thera Solutions and Dr. Reddy's Laboratories have announced an exclusive commercialization agreement for two biosimilar products: BAT2206 (proposed Stelara® biosimilar) and BAT2506 (proposed Simponi® biosimilar). Under the partnership, Bio-Thera will handle development, manufacturing, and supply, while Dr. Reddy's (RDY) will manage regulatory approvals and commercialization in Southeast Asian territories including Cambodia, Indonesia, Malaysia, Philippines, Thailand, and Vietnam.
Additionally, Dr. Reddy's has secured exclusive commercial rights for BAT2206 in Colombia. This marks Bio-Thera's first partnership focused exclusively on Southeast Asia, aiming to expand access to affordable medicines in emerging markets.
The FDA has accepted a Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab), jointly announced by Dr. Reddy's Laboratories and Alvotech. AVT03 aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.
Under a License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in applicable markets, including the U.S. Upon FDA approval, AVT03 will be available in two formulations: a 60 mg/1 mL single-dose prefilled syringe and a 120 mg/1.7 mL single-dose vial.
Dr. Reddy's Laboratories (NYSE: RDY) has initiated a nationwide recall of one batch (Lot No: A1540076) of Levetiracetam in 0.75% Sodium Chloride Injection in the United States due to critical mislabeling. The infusion bags are incorrectly labeled as containing 500 mg/100 mL when they actually contain 1,000 mg/100 mL.
The affected batch was distributed nationwide between November 4-6, 2024. This mislabeling could result in patients receiving double the intended dose, potentially leading to serious side effects including hypersensitivity reactions, liver injury, hematological toxicity, and respiratory depression. Patients receiving high doses for status epilepticus treatment are at highest risk.
While no adverse events have been reported, Dr. Reddy's is instructing wholesalers, distributors, hospitals, and pharmacies to immediately stop use, quarantine, and return affected products. The medication is indicated for adjunct therapy in adults with partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures when oral administration isn't feasible.
Dr. Reddy's Laboratories has entered into a license agreement with Shanghai Henlius Biotech for HLX15, a biosimilar candidate to Darzalex® & Darzalex Faspro®. The agreement grants Dr. Reddy's exclusive commercialization rights for both subcutaneous and intravenous formulations in the U.S. and Europe.
Under the agreement, Henlius will handle development, manufacturing, and commercial supply. The deal includes an upfront payment of $33 million, with potential milestone payments bringing the total to $131.6 million, plus royalties on annual net sales. HLX15 is a recombinant anti-CD38 human monoclonal antibody injection developed for multiple myeloma treatment.
This collaboration strengthens Dr. Reddy's biosimilars portfolio in regulated markets, following their recent pegfilgrastim launch in the U.S. and bevacizumab in the UK, as well as their denosumab biosimilar partnership with Alvotech.
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