FDA will not meet ahead of bluebird bio's sickle cell disease gene therapy PDUFA date [Yahoo! Finance]
CRISPR Therapeutics AG - Common Shares (CRSP)
Last crispr therapeutics ag - common shares earnings: 8/7 05:01 pm
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Source: Yahoo! Finance
Administration (FDA) will not schedule an advisory committee meeting (FDA) to discuss the therapy. An approval decision can now be expected for lovo-cel or lovotibeglogene autotemcel before the Prescription Drug User Fee Act (PDUFA) goal date of 20 December 2023. If greenlit, it will be bluebird bio's third FDA-approved gene therapy, adding to Zynteglo (betibeglogene autotemce) and Skysona (elivaldogene autotemcel) for the treatment of thalassemia and cerebral adrenoleukodystrophy, respectively. According to bluebird bio, lovo-cel is the most extensively studied gene therapy in development for sickle cell disease – a condition where long term survival is achieved by bone marrow transplants, a somewhat risky procedure. A range of medicines approved for the disease focus on preventing red blood cells from clumping together or seek to reduce symptoms. bluebird bio's therapy aims to treat the underlying genetic cause of the disease that approximately 100,000 Americans currently live
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CRSP
Earnings
- 8/5/24 - Miss
CRSP
Sec Filings
- 8/12/24 - Form 4
- 8/5/24 - Form S-3ASR
- 8/5/24 - Form S-8
- CRSP's page on the SEC website