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EGRX issued CRL; IPCI receives thumbs down from Advisory Committee; Dynavax DVAX FDA briefing documents released

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Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) announced that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for RYANODEX for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods. In its letter to Eagle, the FDA requested the company to conduct an additional clinical trial. Shares closed down 24% to $53.37.

Dynavax Technologies Corporation (NASDAQ:DVAX) shares endured a volatile session, slipping over 20% in early trading before closing up 5% to $10.40 as investors digested key points noted in the FDA briefing documents released Wednesday for Friday’s Advisory Committee Meeting. The executive summary noted robust efficacy but with a lack of clarity in regard to safety:

In summary, Heplisav was shown to have a robust immune response in healthy adults 18- 70 years of age in Studies DV2-HBV-10 and-16. Heplisav met pre-specified noninferiority criteria to an active comparator vaccine, Engerix-B, in these two phase 3 clinical trials. Regarding safety, there appear to be imbalances in deaths and SAEs of MI in DV2-HBV-23, and imbalances in AESIs in DV2-HBV-16 and -23 (the studies that prospectively evaluated these events). Numbers and rates of events are low, and the lack of prospectively defined monitoring...


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