Sun Pharma Advances Cancer Drug Pipeline with Unloxcyt Launch Planned for FY26
Key Insights
Sun Pharma is preparing to launch Unloxcyt (search) (cosibelimab) for advanced cutaneous squamous cell carcinoma (search) in the second half of FY26, pending U.S. FDA approval.
The company's global specialty business grew 16% year-on-year to $333 million, driven by flagship products including Ilumya, Cequa, Winlevi, and Odomzo.
Sun Pharma invested ₹782.7 crore in R&D during Q3, representing 5.4% of revenue, with six novel entities currently in clinical stage development.
Sun Pharmaceutical Industries is positioning itself for significant growth in the oncology market with plans to launch Unloxcyt (search) (cosibelimab), a treatment for advanced cutaneous squamous cell carcinoma (search) (cSCC), in the second half of FY26, subject to U.S. FDA approval. The announcement comes as India's largest drugmaker reported robust performance in its global specialty business despite headwinds in the U.S. generics segment.
Strong Specialty Portfolio Performance
Sun Pharma's global specialty sales demonstrated impressive momentum, growing 16% year-on-year to $333 million in the September quarter. The company's flagship products including Ilumya, Cequa, Winlevi, and Odomzo continued to outperform market expectations, driving the specialty segment's strong performance.
The company has also launched Leqselvi for alopecia areata (search), which has already received positive prescriber response. Additionally, Ilumya's label expansion for psoriatic arthritis (search) is expected in the second half of the financial year, further strengthening the dermatology portfolio.
Robust R&D Investment and Pipeline
Sun Pharma maintained its commitment to innovation with R&D spending of ₹782.7 crore during the quarter, representing 5.4% of revenue. Specialty R&D accounted for approximately 38% of the total spend, with the overall R&D expenditure expected to be 6-8% of revenue for FY26.
The company's robust pipeline includes six novel entities in clinical stage development. Its regulatory portfolio comprises 117 ANDAs awaiting U.S. FDA approval, including 31 tentative approvals. During the quarter, four ANDAs were filed and approval was received for five ANDAs.
Financial Performance and Market Position
On a year-on-year basis, Sun Pharma's revenue and net profit grew 8.6% and 2.6% to ₹14,405.2 crore and ₹3,118 crore, respectively, in the September 2025 quarter. Operating profit before depreciation and amortization (EBITDA) grew 14.9% to ₹4,527.1 crore, while EBITDA margin improved 170 basis points to 31.3%.
The domestic formulations business grew 11% year-on-year to ₹4,734.8 crore, maintaining leadership in the Indian pharmaceutical market with an increased market share of 8.3% from 8%. The company launched nine new products during the quarter, reinforcing its branded portfolio.
Challenges in U.S. Generics Segment
While the specialty segment soared, Sun Pharma's U.S. generics business remained subdued due to increased competition and declining sales of Revlimid. The company does not expect significant recovery in this segment in the near term, with operating expenses likely to remain elevated for the remainder of the financial year given the ramp-up of the specialty pipeline.
Analyst Outlook and Market Response
Despite strong fundamentals, Sun Pharma shares declined 1.96% on Monday amid heavy volumes, trading near key support levels close to 52-week lows. However, analysts remain bullish on the company's long-term prospects.
Prabhudas Lilladher Capital maintained a 'Buy' rating with a target price of ₹1,875, citing strong visibility in specialty and rest of the world (RoW) growth. Emkay retained 'BUY' with a target price of ₹2,000, while Elara Securities upgraded its estimate by 5% to ₹1,968, reflecting improved margin outlook and sustained specialty momentum.
The company is also preparing to enter the GLP-1 segment with Semaglutide in India, targeting diabetes (search) and obesity (search) markets, which could provide additional growth opportunities in the domestic market.