Vertex (VRTX) Moves Kidney Disease Drug to Phase 3 Development [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
This phase III portion will evaluate a 45 mg oral dose of Vertex's drug, on top of standard of care, in AMKD patients, compared with placebo. Management also expanded the study to include adolescents aged 10 and older with AMKD. Previously, the AMPLITUDE study only enrolled adults with the disease. The primary endpoint of the study for final analysis is the estimated glomerular filtration rate (eGFR) slope in patients receiving inaxaplin compared to placebo, with at least two years of data. The eGFR slope serves as an indicator of kidney disease progression. Vertex plans to have a pre-planned interim analysis evaluating eGFR slope at week 48. If this interim analysis is positive, management intends to pursue the FDA's approval for the drug under the accelerated pathway. The AMPLITUDE study is designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with proteinuric kidney disease mediated by two variants in the APOL1 gene, known as AMKD.
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CRSP
News
- Vertex (VRTX) to Report Q1 Earnings: What's in the Cards? [Yahoo! Finance]Yahoo! Finance
- CRISPR Therapeutics AG (CRSP) Ascends But Remains Behind Market: Some Facts to Note [Yahoo! Finance]Yahoo! Finance
- Regeneron to collaborate on gene editing therapies with Doudna-founded Mammoth [Reuters]Reuters
- Regeneron to collaborate on gene editing therapies with Doudna-founded Mammoth [Yahoo! Finance]Yahoo! Finance
- Crispr Therapeutics: Now Is The Time To Buy [Seeking Alpha]Seeking Alpha
CRSP
Earnings
- 2/21/24 - Beat
CRSP
Sec Filings
- 4/17/24 - Form 4
- 4/15/24 - Form 144
- 4/10/24 - Form SC
- CRSP's page on the SEC website