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AstraZeneca (AZN) Gets Japan Nod for Expanded Use of 3 Drugs
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AstraZeneca PLC (AZN - Free Report) and partner Merck (MRK - Free Report) announced that the Japanese Ministry of Health, Labour, and Welfare has approved their PARP inhibitor, Lynparza for an early-stage breast cancer indication.
Lynparza is now approved in Japan for the adjuvant treatment of patients with BRCA-mutated (BRCAm), HER2-negative early breast cancer, who stand at high risk of recurrence.
Following the approval in Japan, Lynparza has now become the first and only PARP inhibitor to be available for treating patients with BRCA-mutated HER2-negative early breast cancer in the country.
The latest nod from Japan was based on data from the phase III OlympiA study. The data showed that treatment with Lynparza led to a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% as compared to placebo.
Lynparza was approved for the treatment of germline BRCAm (gBRCAm), HER2-negative high-risk early breast cancer in Europe earlier this month, while the approval in the United States for the same indication came in March. The drug is already approved for the treatment of gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy in Japan.
Apart from breast cancer, Lynparza is also approved for treating ovarian, prostate and pancreatic cancers in various patient populations. The drug is being jointly developed and commercialized by AstraZeneca and Merck.
Both AstraZeneca and MRK are evaluating Lynparza in various label expansion studies targeting a range of tumor types.
Shares of AstraZeneca have rallied 16.1% this year against the industry’s decline of 0.9%.
Image Source: Zacks Investment Research
In a separate press release, AstraZeneca announced that the Japanese Ministry of Health, Labour, and Welfare has approved Tagrisso for adjuvant early-stage EGFR-mutated lung cancer in Japan. This marks the third approved indication for Tagrisso in the country. The drug is also approved to treat early-stage lung cancer in several countries including the United States and Europe.
The latest approval was based on data from the ADAURA phase III study. Data from the same showed that treatment with Tagrisso led to a statistically significant and clinically meaningful improvement in disease-free survival in patients with stage II and IIIA EGFRm NSCLC.
In another press release, AstraZeneca announced that the Japanese Ministry of Health, Labour, and Welfare has approved its C5 complement inhibitor, Ultomiris for the treatment of adult patients with generalised myasthenia gravis (gMG) in Japan. The drug is approved to treat adult patients who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy (IVIg) or plasmaphaeresis.
The approval was based on data from the phase III CHAMPION-MG study, which demonstrated that Ultomiris was superior to placebo in the primary endpoint of change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at week 26 of treatment.
Ultomiris was approved for adults with gMG who are AChR antibody-positive in the United States in April 2022. In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency rendered a positive opinion and recommended marketing authorization of Ultomiris for gMG in July.
Achilles Therapeutics’ loss per share estimates narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
ORIC Pharmaceuticals’ loss per share estimates narrowed 5.3% for 2022 and 15.8% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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AstraZeneca (AZN) Gets Japan Nod for Expanded Use of 3 Drugs
AstraZeneca PLC (AZN - Free Report) and partner Merck (MRK - Free Report) announced that the Japanese Ministry of Health, Labour, and Welfare has approved their PARP inhibitor, Lynparza for an early-stage breast cancer indication.
Lynparza is now approved in Japan for the adjuvant treatment of patients with BRCA-mutated (BRCAm), HER2-negative early breast cancer, who stand at high risk of recurrence.
Following the approval in Japan, Lynparza has now become the first and only PARP inhibitor to be available for treating patients with BRCA-mutated HER2-negative early breast cancer in the country.
The latest nod from Japan was based on data from the phase III OlympiA study. The data showed that treatment with Lynparza led to a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% as compared to placebo.
Lynparza was approved for the treatment of germline BRCAm (gBRCAm), HER2-negative high-risk early breast cancer in Europe earlier this month, while the approval in the United States for the same indication came in March. The drug is already approved for the treatment of gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy in Japan.
Apart from breast cancer, Lynparza is also approved for treating ovarian, prostate and pancreatic cancers in various patient populations. The drug is being jointly developed and commercialized by AstraZeneca and Merck.
Both AstraZeneca and MRK are evaluating Lynparza in various label expansion studies targeting a range of tumor types.
Shares of AstraZeneca have rallied 16.1% this year against the industry’s decline of 0.9%.
Image Source: Zacks Investment Research
In a separate press release, AstraZeneca announced that the Japanese Ministry of Health, Labour, and Welfare has approved Tagrisso for adjuvant early-stage EGFR-mutated lung cancer in Japan. This marks the third approved indication for Tagrisso in the country. The drug is also approved to treat early-stage lung cancer in several countries including the United States and Europe.
The latest approval was based on data from the ADAURA phase III study. Data from the same showed that treatment with Tagrisso led to a statistically significant and clinically meaningful improvement in disease-free survival in patients with stage II and IIIA EGFRm NSCLC.
In another press release, AstraZeneca announced that the Japanese Ministry of Health, Labour, and Welfare has approved its C5 complement inhibitor, Ultomiris for the treatment of adult patients with generalised myasthenia gravis (gMG) in Japan. The drug is approved to treat adult patients who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy (IVIg) or plasmaphaeresis.
The approval was based on data from the phase III CHAMPION-MG study, which demonstrated that Ultomiris was superior to placebo in the primary endpoint of change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at week 26 of treatment.
Ultomiris was approved for adults with gMG who are AChR antibody-positive in the United States in April 2022. In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency rendered a positive opinion and recommended marketing authorization of Ultomiris for gMG in July.
Zacks Rank & Stock to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Achilles Therapeutics plc (ACHL - Free Report) and ORIC Pharmaceuticals, Inc. (ORIC - Free Report) , both carrying aZacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Achilles Therapeutics’ loss per share estimates narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
ORIC Pharmaceuticals’ loss per share estimates narrowed 5.3% for 2022 and 15.8% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.