Dr. Reddy's Laboratories Limited American Depositary Shares - RDY STOCK NEWS

Dr. Reddy's Laboratories (NYSE: RDY) has received approval from the Drug Controller General of India (DCGI) to import the Sputnik V vaccine for emergency use in India. This follows their collaboration with the Russian Direct Investment Fund (RDIF) since September 2020 to conduct clinical trials. Dr. Reddy's is now contributing to India's vaccination efforts amid rising COVID-19 cases. Sputnik V, which boasts an efficacy rate of 91.6%, has been approved in 60 countries globally and ranks second in vaccine approvals worldwide.

Dr. Reddy’s Laboratories has launched a generic version of Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, approved by the U.S. FDA. This product is a therapeutic equivalent to Kuvan® and reflects the company's commitment to providing affordable medications. Available in 30-count cartons, it aims to expand Dr. Reddy’s portfolio in rare disease treatments. The CEO emphasizes the importance of this launch in enhancing patient access to essential medications.

Dr. Reddy’s Laboratories announced the launch of Lansoprazole DR Orally Disintegrating Tablets, a generic version of Prevacid SoluTab, in 15 mg and 30 mg dosages. This product received approval from the U.S. FDA and targets a market that generated approximately $87 million in U.S. sales over the past year. The tablets are available in unit-dose packages of 100. Dr. Reddy’s is committed to providing affordable medicines globally, with major therapeutic focuses including gastrointestinal and oncology.

Dr. Reddy’s Laboratories has launched Fluphenazine Hydrochloride Tablets, USP, a generic version of Prolixin Tablets, approved by the U.S. FDA. Available in 1 mg, 2.5 mg, 5 mg, and 10 mg doses, these tablets are expected to cater to a market with U.S. sales of approximately $134 million for the brand and generic within the last year. The launch is part of Dr. Reddy’s commitment to providing affordable medicines. The drug carries a warning regarding increased mortality risk in elderly patients with dementia-related psychosis.

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.