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Dr. Reddy's Laboratories Limited (RDY) is a leading multinational pharmaceutical company headquartered in Hyderabad, Telangana, India. Founded by Kallam Anji Reddy, the company has grown to become one of the largest generic drug manufacturers globally. Dr. Reddy's offers a diverse product portfolio that includes not only generic medications but also injectables and active pharmaceutical ingredients (APIs).
Dr. Reddy's has a substantial footprint in North America, which accounts for approximately 50% of its generics sales. The company also serves markets in India (22% of generics sales), Russia (12%), and various European and Latin American countries. In North America, injectables constitute 25% of its sales, showcasing the company’s ability to innovate and meet various healthcare needs.
Within branded generic markets, particularly in India, Dr. Reddy's has secured a top-five position in critical therapeutic areas such as oncology and gastroenterology. The company’s strong brand reputation has empowered it to achieve significant success in these sectors.
Furthermore, Dr. Reddy's operates a robust API business, manufacturing over 150 APIs and distributing them in more than 75 countries worldwide. This extensive network highlights the company's commitment to quality and global health.
Dr. Reddy's continues to advance its mission through ongoing projects and innovations. Recent achievements, partnerships, and financial health indicators demonstrate a stable and growing enterprise. Investors keen to stay informed about the latest developments in Dr. Reddy's Laboratories can find up-to-date news from various sources, ensuring they remain well-informed on company performance and growth trajectories.
Dr. Reddy’s Laboratories has launched Vigabatrin Tablets USP, 500 mg, a generic version of Sabril®, after receiving approval from the U.S. FDA. This product has been designated as a Competitive Generic Therapy, granting Dr. Reddy's 180-day exclusivity for marketing. The Sabril® brand had U.S. sales of approximately $141 million for the year ending December 2020. Vigabatrin poses risks of permanent vision loss, necessitating careful patient monitoring.
Dr. Reddy’s Laboratories reported consolidated revenues of Rs. 4,930 Cr for Q3 FY21, up 12% YoY, with a gross margin of 53.8%. However, the profit after tax was significantly impacted, resulting in Rs. 198 Cr, primarily due to a deferred tax asset non-recognition linked to an impairment charge of Rs. 6,000 Cr. The company is progressing on phase 3 clinical trials for the Sputnik V vaccine. Overall, SG&A expenses rose 14% YoY, highlighting increased operational costs.
Dr. Reddy’s Laboratories has terminated the Avigan Trial Study in Kuwait, which focused on moderate to severe COVID-19 patients, due to a lack of statistically significant results. The study found no difference in time to hypoxia resolution between Avigan and placebo groups. However, a subgroup analysis showed that Avigan may facilitate earlier hospital discharge for low-risk patients. The ongoing Phase 3 PRESECO study in North America aims to evaluate Avigan's efficacy as an early treatment for mild to moderate COVID-19 symptoms.
Dr. Reddy’s Laboratories has received approval from the Drugs Control General of India to begin a phase 3 clinical trial for the Sputnik V vaccine, involving 1500 subjects in a placebo-controlled study. This follows positive recommendations from the Data and Safety Monitoring Board after reviewing phase 2 trial data, confirming no safety concerns. The trial aims to expedite the availability of this vaccine, which boasts an efficacy rate of 91.4%. The partnership with the Russian Direct Investment Fund is pivotal for conducting these trials and ensuring vaccine distribution in India.
Dr. Reddy’s Laboratories has announced that the Data and Safety Monitoring Board (DSMB) has reviewed the phase 2 clinical trial data for the Sputnik V vaccine and has recommended advancing to phase 3 recruitment. The phase 2 trial, involving 100 subjects, met its primary safety endpoints with no concerns identified. The safety data has been submitted to the Drugs Controller General of India for approval. The trial is part of a larger global study involving 31,000 subjects and aims to fast-track the vaccine's launch in India.
Dr. Reddy’s Laboratories Ltd. has launched Febuxostat Tablets, a generic version of Uloric, approved by the USFDA. The Uloric brand and its generic had US sales of approximately $108 million for the 12 months ending October 2020, according to IQVIA Health. Febuxostat Tablets are available in two strengths: 40 mg and 80 mg, in bottles of 30 tablets. Warning: Gout patients with cardiovascular disease may face higher rates of cardiovascular death when treated with Febuxostat compared to allopurinol. Prescribers should consider risks and benefits before use.
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is set to announce its third-quarter financial results on January 29, 2021. Following the Board Meeting, results will be made available through various media outlets, including the company’s website and Business Wire.
An earnings call will be hosted at 5:30 PM IST on the same day to discuss the financial performance. Playback of the call will be accessible until February 5, 2021. The company focuses on providing affordable and innovative medicines across multiple therapeutic areas.
Dr. Reddy’s Laboratories announced the secondary listing of its American Depository Receipts (ADRs) on NSE IFSC Limited under the symbol 'DRREDDY' effective December 9, 2020. This initiative aims to facilitate overseas investors in trading Dr. Reddy’s ADRs, which are already issued by J.P. Morgan Chase Bank N.A. The listing does not involve any new capital raising or issuance of additional securities. The settlement of these ADRs will be managed by NSE IFSC Clearing Corporation through various domestic and international links.
Dr. Reddy's Laboratories (NYSE: RDY) and the Russian Direct Investment Fund (RDIF) have initiated adaptive phase 2/3 clinical trials for the Sputnik V vaccine in India, following approval from the Central Drugs Laboratory. The multicenter study will assess safety and immunogenicity, with JSS Medical Research as the clinical partner. Recent data from RDIF indicates a 91.4% efficacy on day 28 and over 95% efficacy after 42 days post-first dose. This partnership aims to expedite vaccine availability in India through import and local production.
Dr. Reddy’s Laboratories has entered a definitive agreement to acquire several brands from Glenmark Pharmaceuticals, including Momat Rino and Glenspray, across Russia, Kazakhstan, Uzbekistan, and Ukraine. This acquisition aims to enhance Dr. Reddy’s anti-allergy product portfolio, leveraging the recent OTC registration of Momat Rino in Russia to improve patient access. The deal is subject to completion of certain actions and marks a strategic move into core markets.
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