Eagle Pharmaceuticals, inc. (EGRX)

[biotech2020]

The biggest takeaway from ER is that 'Ryanodex for EHS could be on the market as early as next year':
US Food and Drug Administration (“FDA”) determined that no additional human safety and efficacy data is required for the submission of Eagle’s New Drug Application (“NDA”) for Ryanodex® for the treatment of exertional heat stroke (“EHS”), further confirming that a hybrid development program comprised of clinical data from EHS patients and positive preclinical data from animal studies constitutes an adequate regulatory pathway for the NDA submission;

The only negative development is that Eagle will require new trial for Kangio, but I think the market has already discounted this news based on the drop when the CRL came out:
Discussions with the FDA regarding the design of a human study for RTU bivalirudin are underway;