NSEGeneral Updates27 Jul 2026 · 27 Jul 2026, 04:00 pm

General Updates

Sun Pharmaceutical Industries Limited · SUNPHARMA

✦ AI SummaryProduct Launch

Sun Pharmaceutical Industries Limited's partner Philogen has resubmitted the Marketing Authorization Application (MAA) for Nidlegy, a biopharmaceutical product for the neoadjuvant treatment of locally advanced, fully resectable melanoma, to the European Medicines Agency (EMA).

Analysis Scores

Earnings Impact0/10
Growth Catalyst6/10
Governance Concern1/10
Regulatory Risk2/10
Balance Sheet Risk1/10
Liquidity Impact5/10
Market Sentiment5/10

✦ Ask a Question

Ask anything about this announcement — AI will answer based on the filing content.

0/500

Full Announcement

Sun Pharmaceutical Industries Limited has informed the Exchange about Update on Nidlegy

Attachments (1)

📄

SUNSEC_27072026155851_SEintimationPRforPhillogenupdateonnidlegy.pdf

pdf

Download →
View document text
Sun Pharmaceutical Industries Limited Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai – 400 063, Maharashtra, INDIA. Tel.: (91-22) 4324 4324 Fax: (91-22) 4324 4343 Website: www.sunpharma.com Email: secretarial@sunpharma.com CIN: L24230GJ1993PLC019050 27 July 2026 National Stock Exchange of India Limited BSE Limited Scrip Symbol: SUNPHARMA Scrip Code: 524715 Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 – Update on Nidlegy This is to inform that our partner Philogen has provided an update on Nidlegy. Enclosed herewith is a copy of the press release titled “Nidlegy Marketing Authorization Application Resubmitted to EMA,” submitted by Philogen. For Sun Pharmaceutical Industries Limited (Anoop Deshpande) Company Secretary and Compliance Officer ICSI Membership No.: A23983 Registered Office: SPARC, Tandalja, Vadodara – 390 012, Gujarat, INDIA. Reaching People. Touching Lives. Courtesy English Translation Nidlegy™ Marketing Authorization Application Resubmitted to EMA Updated application for Nidlegy™ for the neoadjuvant treatment of locally advanced, fully resectable melanoma submitted to the European Medicines Agency The submission follows Philogen’s previously communicated timelines Siena, Italy, 27 July 2026 - Philogen S.p.A. (BIT:PHIL) is pleased to announce the submission of an updated Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy™, an investigational product for the neoadjuvant treatment of adult patients with locally advanced, fully resectable melanoma. The updated submission is based on clinical data from the randomized Phase III PIVOTAL study (PH- L19IL2TNF-02/15; NCT02938299). Compared with the MAA submitted in June 2024, the updated dossier is based on a longer median patient follow-up (33 months as opposed to 21 months) and includes additional post- hoc analyses focused on event-free survival. Clinical data supporting the 2024 submission were published in Annals of Oncology (Kähler et al., Annals of Oncology, 2025, 36, 1166). The updated data forming the basis of this resubmission have been accepted for publication in the Journal of Clinical Oncology (doi 10.1200/JCO- 26-00852) and are expected to be published online in the coming weeks. In the PIVOTAL study, Nidlegy™ reduced the risk of relapse or death compared with the control arm, and its safety profile was characterized mostly by low-grade, local adverse events. The updated application also includes additional Chemistry, Manufacturing and Controls (CMC) information intended to address the outstanding questions raised during the previous procedure. Additional supporting data included in the dossier comprise efficacy and safety data from the Phase II study PH-L19IL2TNF-02/12 (NCT02076633), safety data from the ongoing Phase III NeoDREAM study PH- L19IL2TNF-01/18 (NCT03567889), and safety data from the Phase II study PH-L19IL2TNFNMSC-04/19 (NCT04362722) in non-melanoma skin cancer. Prof. Dr. Dario Neri, Chief Executive Officer and Chief Scientific Officer of Philogen, commented: “Philogen remains fully committed to advancing Nidlegy™ in melanoma and non-melanoma skin cancers. Since the previous MAA procedure, our team has worked intensively to address the clinical and CMC questions raised during the review. In parallel, we have continued to expand the global Phase III NeoDREAM PRESS RELEASE 1 melanoma study and have launched additional registrational studies in non-melanoma skin cancers. We are encouraged by the data generated to date and will continue working with our partners and regulators with the aim of bringing this innovative treatment to patients in need.” Nidlegy™ is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia. * * * About Nidlegy™ (Daromun) Nidlegy™ is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF. The two ingredients are manufactured independently and mixed prior to intralesional administration. The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are pro-inflammatory cytokines with a potent anti-tumor activity. Nidlegy™ is currently being investigated in two Phase III clinical trials for the treatment of locally advanced melanoma, and in Phase II clinical trials for the treatment of High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers. About the PIVOTAL Phase III study PIVOTAL is a phase III, international, multi-center, randomized, comparator-controlled, parallel-group study evaluating the efficacy and safety of intratumoral injections of Nidlegy™ as a neoadjuvant treatment, followed by standard-of-care treatment (surgery), as opposed to standard-of-care treatment (i.e., surgery alone), in melanoma patients with locally advanced, fully resectable cutaneous, sub-cutaneous (including satellite/in transit metastases), or nodal metastases accessible to intratumoral injection. For both arms, adjuvant treatment with approved drugs was allowed. Nidlegy™ was injected intralesionally up to four times, once a week, before surgery. The trial enrolled 256 patients in Europe across 22 clinical centers in Germany, Italy, France and Poland. About locally advanced fully resectable melanoma Melanoma is a skin tumor which begins when melanocytes start growing without control. Melanocytes are found in the basal layer of the epidermis at the boundary with the next layer (the dermis). Locally advanced melanoma is a metastatic cancer in which neoplastic lesions have spread to drainage areas of regional lymph nodes and can appear as micrometastases, satellite/in transit metastases, and/or lymph node metastases. To date, patients with resectable disease receive surgery, possibly followed by approved adjuvant systemic therapies. There is no approved drug for the treatment of locally advanced fully resectable melanoma in the neoadjuvant setting. About Philogen Philogen (https://www.philogen.com) is an Italian-Swiss biotechnology company specialized in the research and development of innovative pharmaceuticals for the treatment of cancer. The Group's main therapeutic strategy is based on the use of ligands capable to selectively deliver potent payloads (such as pro-inflammatory cytokines, drugs or radionuclides) to the tumor mass, sparing healthy tissues. Over the years, Philogen has discovered and developed monoclonal antibody and small molecule based ligands with high affinity to numerous tumor-associated antigens. The Group is headquartered in Siena, Italy, with a subsidiary and research center in Zurich, Switzerland. In addition to its main oncology focus, Philogen is also active in the development of novel pharmaceuticals for the treatment of chronic and debilitating conditions. PRESS RELEASE 2 * * * FOR MORE INFORMATION: Philogen - Investor Relations - Emanuele Puca | Investor Relator * * * Forward-Looking Statements The forward-looking statements contained in this press release may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding anticipated advancement of preclinical development efforts and initiation and progression of clinical trials; anticipated enrollment in and progression of Philogen’s clinical trials; the availability of data from clinical trials and preclinical studies; anticipated regulatory filings; the [Showing first 8,000 characters — download PDF for full document]