Latest news with #Imfinzi
Business Standard
15 hours ago
- Business
- Business Standard
AstraZeneca Pharma gets CDSCO approval to import Durvalumab Solution
AstraZeneca Pharma India said that it has received permission from the Central Drugs Standard Control Organisation (CDSCO) to import for sale and distribution of Durvalumab Solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi). Through this approval, Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with Durvalumab in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). AstraZeneca Pharma is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory and Rare Disease. The companys consolidated net profit jumped 57.7% to Rs 62.27 crore on 25.4% increase in net sales to Rs 480.48 crore in Q4 FY25 over Q4 FY24. The scrip shed 0.13% to Rs 8,886.50 on the BSE.
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Business Standard
16 hours ago
- Business
- Business Standard
AstraZeneca Pharma pops 4% on CDSCO nod to import Durvalumab solution
AstraZeneca Pharma share price: Pharmaceutical company AstraZeneca Pharma share price was buzzing in trade on Wednesday, July 2, 2025, with the stock rising up to 3.83 per cent to an intraday high of ₹9,239.25 per share. At 12:31 PM, AstraZeneca Pharma share price continued to trade near day's high levels, up 3.28 per cent at ₹9,190. In comparison, BSE Sensex was trading 0.19 per cent lower at 83,535.28 levels. What triggered the up move in AstraZeneca Pharma share price? AstraZeneca Pharma shares rose after the company received regulatory approval to expand the use of its cancer drug Imfinzi (Durvalumab) in India. The Central Drugs Standard Control Organisation (CDSCO) granted permission to import and distribute Durvalumab Solution for Infusion (120 mg/2.4 ml and 500 mg/10 ml) for an additional indication. In an exchange filing, AstraZeneca Pharma said, 'This is to inform that AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Durvalumab Solution for Infusion 120 mg/2.4 ml and 500 mg/10 ml (Brand name: Imfinzi) for an additional indication.' The new approval allows Durvalumab, 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. This is followed by maintenance treatment with Durvalumab and olaparib in cases of mismatch repair proficient (pMMR) endometrial cancer. The development enables AstraZeneca Pharma to market the drug in India for the newly approved indication, subject to further statutory approvals, if required. Track Stock Market LIVE Updates About AstraZeneca Pharma AstraZeneca Pharma is a British-Swedish multinational pharmaceutical and biotechnology company, formed in 1999 through the merger of Sweden's Astra AB and Britain's Zeneca Group. The company is dedicated to developing and selling innovative medicines across various therapeutic areas, including cancer, cardiovascular diseases, gastrointestinal issues, infections, neuroscience, respiratory conditions, and inflammation. The company has had a major presence in India for 45 years. AstraZeneca Pharma India oversees manufacturing, sales, and marketing operations, while the company also gained global recognition for its role in developing the Oxford–AstraZeneca Covid-19 vaccine Leveraging data science and artificial intelligence (AI), AstraZeneca claims to boost the success rates and efficiency of its research and development (R&D) processes. The market capitalisation of AstraZeneca Pharma is ₹22,988.75 crore, according to BSE. The company falls under the BSE500 index. The 52-week high of AstraZeneca share price is ₹10,653.05, while its 52-week low is ₹6,222.35.
Business Standard
17 hours ago
- Automotive
- Business Standard
Stock Alert: Hyundai Motor India, Maruti Suzuki India, V-Mart Retail, JSW Energy
Securities in F&O Ban:RBL Bank shares are banned from F&O trading on 2 July to Watch:Hyundai Motor India has achieved total monthly sales of 60,924 units in June 2025. SUVs contributed 67.6% to HMIL total domestic sales in June 2025. Also, the total sales for the April-June quarter FY2026 were reported at 1,80,399 units. Maruti Suzuki Indias total sales declined 6.27% to 167,993 units in June 2025 as against 179,228 units sold in June 2024. Total production fell 4.17% to 127,545 units in June 2025 compared with 133,095 units in June 2024.V-mart Retails revenue from operations stood at Rs 885 crore in Q1 FY26, up 13% compared with Rs 786 crore in Q1 FY25. The same store sales growth (SSSG) stood at 1% in Q1 Energys step-down subsidiary, JSW Renew Energy Thirty Seven, has signed battery energy storage purchase agreements (BESPA) with Rajasthan Rajya Vidyut Utpadan Nigam for 250 MW / 500 MWh standalone battery energy storage system (BESS). The BESPA is signed for a duration of 12 years, with a tariff of Rs 2,24,000 per MW per month Lloyds Metals & Energy announced that iron ore production remained stable at around 4.0 million tonnes, maintaining last years robust levels. Direct reduced iron (DRI) production rose 3% to 79,033 tonnes in Q1 Indias subsidiary, Ceigall Northern Ayodhya Bypass has received construction order worth Rs 1,199.30 crore from National Highways Authority of India (NHAI) on hybrid annuity Pharma India has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Durvalumab Solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Brand name: Imfinzi) for an additional by Capital Market - Live News
Time of India
17 hours ago
- Business
- Time of India
AstraZeneca Pharma India shares rise over 2% after CDSCO clears Imfinzi for new cancer use
Shares of AstraZeneca Pharma India rose over 2% to Rs 9100 on BSE in Wednesday's trade after the company received regulatory approval for a new use of its cancer therapy Imfinzi. 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. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Trekking pants for mountain sports and adventure travel Trek Kit India Shop Now 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 Live Events 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.
Yahoo
02-06-2025
- Business
- Yahoo
AstraZeneca Highlights Significant Gains Across Three Major Cancer Trials At ASCO
AstraZeneca Plc (NASDAQ:AZN) on Monday released results from three Phase 3 clinical trials at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting: DESTINY-Breast09, MATTERHORN, and SERENA-6. In the DESTINY-Breast09 trial, Enhertu (trastuzumab deruxtecan) combined with pertuzumab was evaluated as a first-line treatment for HER2-positive metastatic breast cancer, compared to a standard regimen of a taxane, trastuzumab, and pertuzumab (THP). Topline data were shared in indicated that the Enhertu combination reduced the risk of disease progression or death by 44%. Median progression-free survival (PFS) reached 40.7 months with the Enhertu regimen versus 26.9 months for THP, a benefit observed across patient subgroups. Investigator-assessed median PFS was 40.7 months for the Enhertu arm and 20.7 months for THP. The confirmed objective response rate was 85.1% for the Enhertu combination and 78.6% for THP, with 58 complete responses in the Enhertu group compared to 33 with THP. The median duration of response was 39.2 months for the Enhertu combination and 26.4 months for THP. Overall survival data was not yet mature, though an early trend favored the Enhertu combination. The MATTERHORN trial assessed Imfinzi (durvalumab) with standard FLOT chemotherapy as a perioperative treatment for resectable, early-stage, and locally advanced gastric and gastroesophageal junction (GEJ) cancers, compared to chemotherapy alone. Topline data were released in March. A planned interim analysis showed that the Imfinzi-based regimen led to a 29% reduction in the risk of disease progression, recurrence, or death. Median event-free survival (EFS) was not reached in the Imfinzi arm, compared to 32.8 months in the chemotherapy-alone arm. The estimated 24-month EFS rate was 67.4% for the Imfinzi regimen and 58.5% for chemotherapy alone. A trend towards improved overall survival was noted for the Imfinzi-based regimen, with formal assessment to follow. The SERENA-6 trial investigated camizestrant combined with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors developed an ESR1 mutation during first-line treatment with an aromatase inhibitor (AI) and a CDK4/6 inhibitor. Topline data were shared in February. The trial compared switching to the camizestrant combination against continuing the AI plus CDK4/6 inhibitor. The camizestrant combination reduced the risk of disease progression or death by 56%. Median PFS was 16.0 months for patients who switched, versus 9.2 months for those continuing the AI combination. The median time to deterioration of global health status was 23.0 months for the camizestrant arm and 6.4 months for the AI combination arm. While data for time to second disease progression and overall survival were immature, a trend favored the camizestrant combination for PFS2. Price Action: AZN stock is trading lower by 0.95% at $72.14 at last checkMonday. Read Next:Photo by Piotr Swat Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? ASTRAZENECA (AZN): Free Stock Analysis Report This article AstraZeneca Highlights Significant Gains Across Three Major Cancer Trials At ASCO originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
