On Tuesday, AstraZeneca Pharma India announced that it has received clearance from the Central Drugs Standard Control Organisation (CDSCO) to import durvalumab solution for infusion (brand name: Imfinzi) in 120 mg/2.4 ml and 500 mg/10 ml strengths for an additional indication.
The CDSCO approval allows Imfinzi, in combination with carboplatin and paclitaxel, to be used as a first-line treatment for adults with primary, advanced, or recurrent endometrial cancer who are candidates for systemic therapy. The treatment will be followed by maintenance therapy using durvalumab and olaparib for patients with mismatch repair proficient (pMMR) endometrial cancer.
“This regulatory clearance enables AstraZeneca to market the approved formulation of Imfinzi in India for the specified indication, subject to other applicable statutory approvals,” the company said in a statement.
Impressive fourth-quarter earnings
The regulatory development comes on the heels of a strong earnings report by AstraZeneca Pharma India. The company posted a 47.7% year-on-year jump in net profit to Rs 58.2 crore for the quarter ended March 2025, up from Rs 39.4 crore a year earlier.
Revenue for the quarter rose 25.4% to Rs 480.4 crore compared with Rs 383.2 crore in the same period last year, supported by “continued demand across its key therapy areas and improved market penetration”.
Earnings before interest, tax, depreciation and amortisation (EBITDA) climbed 74.7% to Rs 86.3 crore, compared to Rs 49.4 crore a year ago. The EBITDA margin improved sharply to 17.96%, up from 12.89%.
The management attributed the robust financial performance to “continued investment in innovation and its portfolio of newer-generation therapies in the oncology, cardiovascular, and respiratory segments”.
Stock performance and technical setup
On Tuesday, shares of AstraZeneca Pharma India closed at Rs 8,890 on the BSE, up by Rs 18.30 or 0.21%. The stock has gained 39.2% in the past year and 23.7% over the last six months. In the last three months, the shares are up nearly 5%, and have risen 11.6% in the past one month.
From a technical perspective, the stock is currently trading below its 10-day, 20-day, and 30-day simple moving averages (SMAs), but remains above its 5-day, 50-day, 100-day, 150-day, and 200-day SMAs.
The Relative Strength Index (RSI) stands at 45.7, suggesting neutral momentum. The Moving Average Convergence Divergence (MACD) is at 1.3, above the center line but below the signal line, indicating a potential pause in recent momentum.
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