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Dr. Reddy's Laboratories (RDY) maintains its position as a global pharmaceutical innovator through strategic developments in generic medicines, biosimilars, and active pharmaceutical ingredients. This news hub provides investors and industry professionals with essential updates on corporate milestones, regulatory filings, and market expansions.
Access real-time information about earnings announcements, partnership agreements, and product pipeline advancements. Our curated collection features official press releases covering FDA approvals, manufacturing facility certifications, and therapeutic area breakthroughs in oncology and gastroenterology.
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Dr. Reddy's Laboratories Ltd. (NYSE: RDY) has launched Treprostinil Injection in the U.S., marking its introduction as a therapeutic equivalent generic version of Remodulin® (treprostinil) Injection, which has been approved by the U.S. Food and Drug Administration.
The drug is available in multiple vial strengths: 20 mg/20 mL, 50 mg/20 mL, 100 mg/20 mL, and 200 mg/20 mL. This strategic launch is positioned to enhance the company's portfolio in the cardiovascular treatment domain, reinforcing its commitment to providing affordable medicines.
For detailed prescribing information and additional insights into Dr. Reddy's offerings, please visit the company’s official website.
Aditxt, Inc. (NASDAQ: ADTX) has signed an asset purchase agreement with Cellvera, granting Aditxt a 50% stake in Global Response Aid (GRA), a partnership with Agility. The deal involves a total transaction value of $24.5 million, which includes the forgiveness of a $14.5 million loan and $10 million in cash, alongside future royalties over seven years. This strategic acquisition aims to expand Aditxt’s capabilities in developing effective antiviral therapies, particularly focusing on the drug Avigan, which is licensed for use in multiple markets excluding Japan, China, and Russia. The agreement is contingent upon various approvals, including board and regulatory consents. Aditxt's CEO emphasizes that this acquisition is pivotal for driving future growth and addressing the rising demand for antiviral solutions.
Coya Therapeutics (Nasdaq: COYA) reported its fiscal year 2022 results, highlighting key developments in its drug pipeline. The company achieved positive results in a clinical study of COYA 302 for ALS, showing halted disease progression over 6 months. Coya also entered into a worldwide agreement with Dr. Reddy's Laboratories (NYSE: RDY) to out-license its COYA 301 product candidate.
The company raised approximately $16.4 million from its IPO in January 2023, with cash and equivalents of $5.9 million as of December 31, 2022. However, Coya reported a net loss of $12.2 million for 2022, attributed to increased R&D and administrative expenses.
Coya Therapeutics, Inc. (NASDAQ: COYA) has entered into a worldwide agreement with Dr. Reddy’s Laboratories (NYSE: RDY) to develop COYA 302, an investigational combination biologic for neurodegenerative diseases. This product consists of COYA 301 and CTLA4-Ig (Abatacept), targeting chronic inflammation. Coya retains exclusive rights for commercialization in North America, Europe, and Japan, while Dr. Reddy’s can commercialize outside these territories. Coya plans to file an IND in the second half of 2023, aiming for a phase 1b/2 trial in Amyotrophic Lateral Sclerosis (ALS) shortly thereafter. The partnership is expected to enhance Coya’s development efforts.
Dr. Reddy's Laboratories SA, a wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd., has signed a definitive agreement to acquire the U.S. generic prescription product portfolio from Mayne Pharma Group Limited for approximately $90 million in cash. The portfolio includes 45 commercial products, 4 pipeline products, and 40 approved non-marketed products, with a total revenue of $111 million reported for the last financial year. This acquisition aims to enhance Dr. Reddy’s presence in the women’s health market and accelerate access to affordable medications.