Dr Reddys Labs - RDY STOCK NEWS

Dr. Reddy’s Laboratories has launched Ephedrine Sulfate Injection USP, a generic equivalent to Akovaz®, approved by the U.S. FDA. The U.S. market for this product generated approximately $67.5 million in sales over the last twelve months, ending August 2021. The injection is packaged in a 1 mL fill within a 2 mL single-dose vial, delivering 50 mg of ephedrine sulfate per mL. This launch aligns with Dr. Reddy’s commitment to providing affordable medications and addresses a significant market need.

Dr. Reddy’s Laboratories has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules in 2.5 mg and 20 mg strengths, with tentative approvals for other strengths. This positions the company to gain 180 days of generic drug exclusivity for these products. The approval follows a settlement with Celgene (Bristol Myers Squibb) regarding REVLIMID® patents, which also allows Dr. Reddy’s to market generic versions starting from January 31, 2026. This development aims to provide a more affordable option for patients.

Dr. Reddy’s Laboratories Ltd. has launched Carmustine for Injection, USP, a therapeutic equivalent generic of BiCNU® approved by the U.S. Food and Drug Administration. The U.S. market for BiCNU® and its generics generated approximately $19.4 million in sales for the twelve months ending August 2021. Carmustine is provided as a lyophilized powder in a single-dose package. However, it carries warnings for myelosuppression and pulmonary toxicity, necessitating careful monitoring of patients' blood counts.

Exelixis expands its oncology pipeline by exercising an exclusive option to in-license XL114, a promising anti-cancer compound, from Aurigene. The exercise involves a payment of $10 million and follows the FDA's acceptance of XL114's IND application. The upcoming phase 1 clinical trial for XL114 will target patients with Non-Hodgkin’s lymphoma. Preclinical data suggests XL114 effectively inhibits tumor growth, demonstrating its potential as a best-in-class therapy.

Aditxt, Inc. (Nasdaq: ADTX) has entered a transaction agreement to acquire AiPharma Global Holdings LLC's subsidiary, AiPharma, specializing in antiviral therapies, particularly Avigan/Reeqonus. The acquisition aims to bolster Aditxt's infectious disease segment, with a total loan amount of $15 million and share issuance of up to 65% of outstanding shares upon closing. Avigan has received marketing authorization in several countries, with a global Phase 3 trial for COVID-19 nearing completion. The transaction is subject to due diligence and necessary approvals.

Citius Pharmaceuticals, Inc. (CTXR) announced a definitive agreement to acquire Dr. Reddy's Laboratories' exclusive license for E7777, an advanced oncology immunotherapy for treating Cutaneous T-cell Lymphoma (CTCL). The acquisition involves a $40 million upfront payment, additional milestones totaling up to $110 million, and royalty payments on net sales. E7777, a reformulated version of ONTAK, is nearing FDA approval with a Biologics License Application expected by late 2022. Citius aims to enhance its pipeline and target approximately 30% of the CTCL patient population, estimated at 30,000 to 40,000 in the U.S.

Dr. Reddy’s Laboratories Ltd. announced a definitive agreement with Citius Pharmaceuticals to sell all rights to E7777, an IL-2-diphtheria toxin fusion protein, and related assets. The transaction will grant Dr. Reddy’s an upfront payment of $40 million, with potential milestone payments reaching $150 million based on approval for cutaneous T-cell lymphoma (CTCL) and other indications. Previously, Dr. Reddy’s acquired E7777 rights from Eisai Co. Ltd. in March 2016, and the CEO expresses confidence in Citius’ ability to develop the drug further.

Dr. Reddy's Laboratories has launched Reddy-Lenalidomide, a generic version of Revlimid, in Canada after receiving approval from Health Canada. This launch is significant as it aims to provide affordable treatment options for Multiple Myeloma and Myelodysplastic Syndrome (MDS) patients. The medication is available in multiple strengths and is part of a broader initiative to enhance patient access through the Reddy2Assist Platform. However, Reddy-Lenalidomide comes with important warnings and limitations, especially regarding its use in pregnant women and potential severe side effects.

Dr. Reddy’s Laboratories has launched a generic version of Librax® in the U.S., specifically Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, available in 5 mg/2.5 mg strength. This product, approved by the U.S. FDA, targets a market that generated approximately $105.9 million in sales over the last twelve months. The capsules are sold in bottles of 100. The launch aims to provide affordable medication options while addressing the significant risks associated with benzodiazepine use, including potential addiction and withdrawal reactions.