Gilead Submits New Drug Application to the FDA
by H.S. Ayoub
BioHealthInvestor.com
Gilead Sciences (GILD) announced after markets closed on Monday that it had filed a New Drug Application (NDA) with the FDA for ambrisentan, a once-a-day treatment for Pulmonary Arterial Hypertension (PAH).
The application follows two Phase III clinical trials and three phase II studies. About 400 patients continue to recieve ambrisentan in longer term clinical studies.
Ambrisentan works by blocking Endothelin, a small peptide hormone that helps regulate blood flow and cell growth. High levels of Endothelin has been implicated in PAH.
It is estimated that about 200,000 suffer from PAH world wide.
Shares of Gilead Sciences closed at $63.79 on Monday, near the 52-week high of $70.
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Related BHI articles:
- Gilead Sciences Acquires Myogen
- Gilead to Licese Generic Viread to Companies in India
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BioHealthInvestor.com
Gilead Sciences (GILD) announced after markets closed on Monday that it had filed a New Drug Application (NDA) with the FDA for ambrisentan, a once-a-day treatment for Pulmonary Arterial Hypertension (PAH).The application follows two Phase III clinical trials and three phase II studies. About 400 patients continue to recieve ambrisentan in longer term clinical studies.
Ambrisentan works by blocking Endothelin, a small peptide hormone that helps regulate blood flow and cell growth. High levels of Endothelin has been implicated in PAH.It is estimated that about 200,000 suffer from PAH world wide.
Shares of Gilead Sciences closed at $63.79 on Monday, near the 52-week high of $70.
__________
Related BHI articles:
- Gilead Sciences Acquires Myogen
- Gilead to Licese Generic Viread to Companies in India
__________
posted by Nico at
7:27 AM
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