Submission of Nidlegy™ Marketing Authorization Application Validated by EMA

Philogen S.p.A. (BIT:PHIL) and Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma") announces that on June 20th the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy™ , which was finalized on June 3rd.

"The validation of the dossier by EMA represents the first important milestone for the MAA review process," commented Dario Neri, chief executive officer and chief scientific officer at Philogen. "Our group is committed to working with EMA throughout the review process with the goal of making Nidlegy™ available to patients in need."

Nidlegy™ is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia. Both companies jointly made the following announcements:

- October 23, 2023 - Phase III PIVOTAL trial met the primary endpoint
- May 31, 2024 - Primary results of PIVOTAL presented at ASCO
- June 4, 2024 - MAA submission to EMA
The data of the Phase III Nidlegy™ trial are expected to be published in a peer-reviewed scientific journal in 2024.

Shares of Sun Pharmaceutical Industries Limited was last trading in BSE at Rs. 1557.95 as compared to the previous close of Rs. 1532.55. The total number of shares traded during the day was 48263 in over 5655 trades.

The stock hit an intraday high of Rs. 1570.70 and intraday low of 1526.95. The net turnover during the day was Rs. 74947198.00.

Source : Equity Bulls

Keywords

SunPharmaceuticalIndustries INE044A01036 PhilogenSpA MarketingAuthorization Nidlegy