| Drug / Therapy | inclisiran (LEQVIO) |
| Indication | cardiovascular sNDA |
| Decision Type | PDUFA |
| Conditions | cardiovascular sNDA |
| Interventions | inclisiran (LEQVIO) |
Alnylam Pharmaceuticals (ALNY) operates in the RNAi Therapeutics sector. The current BTS Score is 53 (Grade: C).
Biotech companies frequently raise capital through secondary offerings, ATM programs, and convertible notes. Before or after major FDA decisions, dilution events are common. Understanding a company's dilution history is critical for managing risk around catalyst dates.
The PDUFA date for inclisiran (LEQVIO) by Alnylam Pharmaceuticals (ALNY) is scheduled for January 28, 2027. This is the target date for the FDA to make a decision on this application.
inclisiran (LEQVIO) is being developed by Alnylam Pharmaceuticals for the treatment of cardiovascular sNDA. It is under FDA review.
If inclisiran (LEQVIO) receives FDA approval, Alnylam Pharmaceuticals (ALNY) would be able to market the drug in the United States for cardiovascular sNDA. This typically leads to significant stock price movement for biotech companies. Investors should monitor the PDUFA date closely.
Biotech companies often raise capital through share offerings, which can dilute existing shareholders. You can check the current dilution risk for ALNY on DilutionWatch at dilutionwatch.com/stock/ALNY.html.
You can view the full BiotechSign company profile for Alnylam Pharmaceuticals (ALNY) at biotechsign.com/app/company/ALNY, which includes the BTS Score, signal history, clinical trial data, and insider trading activity.
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