AstraZeneca's Calquence sNDA Gets FDA Priority Tag for Expanded Use [Yahoo! Finance]
AstraZeneca PLC - American Depositary Shares (AZN)
Last astrazeneca plc - american depositary shares earnings: 2/5 04:00 pm
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Source: Yahoo! Finance
AstraZeneca AZN announced that the FDA has accepted the supplemental new drug application (sNDA), seeking approval for the expanded use of Calquence (acalabrutinib) in mantle cell lymphoma (MCL). The company is seeking approval for Calquence for the treatment of adult patients with previously untreated MCL, a rare and aggressive form of non-Hodgkin lymphoma. In the MCL indication, Calquence is currently approved for treating adult patients with MCL who have received at least one prior therapy in the United States and some other countries. The drug is also approved for treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma in several countries across the world. With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the first quarter of 2025. Year to date, shares of AstraZeneca have risen 18.1% compared with the industry's growth of 20.1%. Image Source: Zacks Investment Research Filing Based on AZN's ECHO
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- CALQUENCE® (acalabrutinib) granted Priority Review in the US for patients with untreated mantle cell lymphomaBusiness Wire
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AZN
Sec Filings
- 10/1/24 - Form 6-K
- 9/26/24 - Form 6-K
- 9/23/24 - Form 6-K
- AZN's page on the SEC website