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Sun Pharmaceutical Industries Limited · SUNPHARMA
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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).
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Full Announcement
Sun Pharmaceutical Industries Limited has informed the Exchange about Update on Nidlegy
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SUNSEC_27072026155851_SEintimationPRforPhillogenupdateonnidlegy.pdf
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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
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