Latest news with #Zefylti


Business Standard
25-06-2025
- Business
- Business Standard
Aurobindo Pharma gets UK MHRA approval for neutropenia treatment drug Dyrupeg
Aurobindo Pharma said that wholly owned step-down subsidiary CuraTeQ Biologics s.r.o. has obtained marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for Dyrupeg. Dyrupeg contains the active substance pegfilgrastim and is a biological medicine. It is a 'biosimilar medicine'; this means that Dyrupeg is highly similar to another biological medicine (the 'reference medicine) that is already authorised in the area of the regulatory agency. Dyrupeg is intended for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Earlier in April 2025, Dyrupeg received marketing authorization in the European Union from the European Commission (EC). This is CuraTeQs third biosimilar to be approved by MHRA after the approval of Bevqolva in December 2024 and Zefylti in May 2025. Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The companys consolidated net profit fell 0.6% to Rs 903.47 crore despite a 11.9% jump in net sales to Rs 8,381.12 crore in Q4 FY25 over Q4 FY24. The scrip advanced 0.84% to currently trade at Rs 1113.25 on the BSE.


Time of India
25-06-2025
- Business
- Time of India
Aurobindo Pharma shares in focus after subsidiary CuraTeQ gets UK nod for Dyrupeg
Aurobindo Pharma shares will be in focus on Wednesday after its wholly-owned step-down subsidiary, CuraTeQ Biologics s.r.o., received marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for Dyrupeg , a biosimilar of pegylated filgrastim . "CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma Ltd, has obtained marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for Dyrupeg™, its pegylated filgrastim biosimilar version," according to a stock exchange filing. This is CuraTeQ's third biosimilar approval from the UK regulator, following the authorisations of Bevqolva in December 2024 and Zefylti in May 2025. Dyrupeg is used to reduce the risk of infection in cancer patients undergoing chemotherapy and had earlier received marketing approval from the European Commission in April 2025. Also Read: Coforge among 10 high-conviction stock ideas that can rally up to 52% Aurobindo Pharma Q4 earnings For the March quarter, Aurobindo Pharma reported an 11% year-on-year rise in consolidated revenue to Rs 8,382.1 crore, broadly in line with Street expectations. The growth was mainly driven by a 13.5% YoY increase in US formulation sales and a 17.2% jump in European formulations. Net profit for the quarter stood at Rs 902.8 crore, marginally lower than Rs 907.4 crore in the same quarter last year. EBITDA rose 7.1% YoY to Rs 1,792 crore, with an EBITDA margin of 21.38%, slightly down from the previous year. Also Read: 11 Nifty mid & smallcap stocks that can rally 40-90% over the next 12 months Aurobindo Pharma shares price target According to Trendlyne, the average target price for Aurobindo Pharma shares is Rs 1,403, indicating a potential 27% upside from current levels. Among 27 analysts covering the stock, the consensus rating is 'Buy'. On Tuesday, the stock closed 0.4% higher at Rs 1,104 on the BSE. While it has declined 18% year-to-date, it has more than doubled—rising 110%—over the past three years. The company's current market capitalisation is around Rs 64,120 crore. ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of the Economic Times)


Business Standard
24-06-2025
- Health
- Business Standard
CuraTeQ Biologics receives UK MHRA approval for biosimilar Dyrupeg
Aurobindo Pharma announced that CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma, has obtained marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for Dyrupeg, its pegylated filgrastim biosimilar version. Earlier in April 2025, Dyrupeg received marketing authorization in the European Union from the European Commission (EC). This is CuraTeQ's third biosimilar to be approved by MHRA after the approval of Bevqolva in December 2024 and Zefylti in May 2025.


The Hindu
13-05-2025
- Business
- The Hindu
Aurobindo Pharma arm's biosimilar gets marketing nod from U.K.'s MHRA
Aurobindo Pharma subsidiary CuraTeQ Biologics s.r.o. has received marketing authorisation for Zefylti, its filgrastim biosimilar version, from Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K. In February 2025, Zefylti had received the marketing authorisation in the European Union from the European Commission (EC). This is CuraTeQ's second biosimilar to be approved by MHRA. Bevqolva was the first in December 2024, Aurobindo Pharma said in a filing on Tuesday. In December, announcing receipt of positive opinion for Zefylti from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the company had said the product is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs).