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Tag: AstraZeneca PLC

  • AstraZeneca (AZN) Shares Climb In Pre-Market On Positive FDA Progress

    AstraZeneca (AZN) Shares Climb In Pre-Market On Positive FDA Progress

    Following important regulatory news, AstraZeneca PLC (NASDAQ: AZN) started to exhibit upward momentum in pre-market trading. AZN shares were worth $74.36 as of the most recent pre-market check, which is a 3.52% increase.

    The surge comes after the company announced that its supplemental biologics license application (sBLA) for IMFINZI (durvalumab) was accepted by the U.S. Food and Drug Administration (FDA) and that it was given priority review for the treatment of patients with gastric and gastroesophageal junction (GEJ) cancers that are resectable, early-stage, and locally advanced (Stages II, III, IVA).

    FDA Designation of Breakthrough Therapy and Priority Review

    Therapies that have the potential to significantly enhance safety, effectiveness, or patient outcomes above current therapy alternatives are given Priority Review by the FDA. The fourth quarter of 2025 is the target date for the regulatory decision under the Prescription Drug User Fee Act (PDUFA).

    In order to meet important unmet needs in the treatment of gastric cancer, IMFINZI has also obtained Breakthrough Therapy Designation (BTD) for this indication, accelerating the development and review process.

    Results of Clinical Trials Show Great Efficacy

    Data from the MATTERHORN Phase III study, which was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine, provide support for the sBLA filing. The trial assessed an IMFINZI and chemotherapy perioperative regimen before surgery, followed by IMFINZI treatment after surgery.

    When compared to chemotherapy alone, the risk of illness progression, recurrence, or mortality was reduced by 29%, according to interim analysis. With 24-month EFS rates of 67.4% vs 58.5%, respectively, the IMFINZI arm had not yet achieved the estimated median event-free survival (EFS), but the control arm had done so after 32.8 months.

    International Regulatory Reviews Are In Progress

    One of the primary causes of cancer death and the fifth most frequent cancer globally is still gastric cancer. An estimated 6,500 Americans had treatment for locally progressed or early-stage gastric or GEJ malignancies in 2024. IMFINZI is the only immunotherapy that exhibits a statistically significant survival advantage in this context, according to the positive results.

    Potentially opening the door to a new standard of care in the treatment of stomach cancer, regulatory applications for the medication are also being reviewed in the European Union, Japan, and other international markets.

  • AstraZeneca (NYSE:AZN) Halts COVID-19 Vaccine Trial After Volunteer’s Illness

    AstraZeneca (NYSE:AZN) Halts COVID-19 Vaccine Trial After Volunteer’s Illness

    AstraZeneca PLC (NYSE: AZN) has halted the phase 3 trials for the COVID-19 vaccine after a ‘serious adverse event’, a possible reaction to the shot was reported in the UK. AstraZeneca vaccine candidate was considered to be the leading coronavirus vaccine candidate but the hopes for a vaccine shot are vanishing.

    AstraZeneca has partnered with the University of Oxford to develop the vaccine candidate for novel coronavirus. AZN coronavirus vaccine candidate is known as ‘AZD1222’ is in the Phase III trial. It is the final stage after which the firm will submit safety, and efficacy data to regulators for approval.

    AZN unveiled that it deliberately halted the trial to allow a committee to analyze safety data. AZN has enrolled 50,000 participants for late-stage trials that are continued in the US, UK, South Africa, and Brazil. It is not clear yet what the exact nature of the reaction was but the participant is anticipated to recover soon.

    Shares of AstraZeneca traded up 2.11% as it gained +1.13 on Tuesday at a closing price of $54.71. It had a trading volume of 6.74 million as compared to the average volume of 6.62 million. In the past 52-weeks of trading, this company’s stock has fluctuated between the low of $36.15 and a high of $64.94.

    AZN has moved up 51.34% from its 52-weeks low and moved down -15.75% from its 52-weeks low. AstraZeneca market capitalization has remained high, hitting $145.29 billion at the time of writing. Looking at its liquidity, it has a current ratio of 0.80.

    AstraZeneca had earlier inked a deal with the European Commission for the supply of $300 million doses of potential COVID-19 vaccine doses. AZN had got $336 million for this deal from the European Commission. Australia has also signed a $1.2 billion supply and production agreement with AstraZeneca for the supply of over 84.8 million COVID-19 vaccine doses. But because of the latest side effect, the vaccine hopes are vanishing in thin air.

    AZN said that it is checking whether the vaccine shot caused the illness in a participant or the shot had nothing to do with the illness as the only one volunteer has developed the side effects. The company is currently working to check the safety and efficacy of shots.