Allison:
We believe that Heron will be able to file the HTX-019 NDA in 2H16, once long-term stability data are generated, since that should take longer than the bioequivalence trial to injectable Emend.
Mandie:
The biotechnology company reported ($0.74) EPS for the quarter, missing the consensus estimate of ($0.65) by $0.09. On average, analysts forecast that Heron Therapeutics will post ($2.80) EPS for the current fiscal year.
Merrill:
We do not intend to update them except as required by law.
Lena:
These risks and uncertainties include, but are not limited to, those associated with: the acceptance of the Company's resubmission of its New Drug Application (NDA) for SUSTOL, whether the U.S.
Valeria:
Food and Drug Administration (FDA) in July 2015. HTX-019, also being developed for the prevention of CINV, has the potential to become the first polysorbate 80-free, intravenous formulation of aprepitant, a neurokinin-1 (NK1) receptor antagonist.
Roxy:
Heron's goal is to build on therapeutics with well-known pharmacology by improving their tolerability and efficacy as well as broadening their potential field of use.
Eneida:
Quart, Pharm.D., Chief Executive Officer of Heron.
Dorothy:
In May 2015, the FDA accepted Heron's proposal to use the 505(b)(2) regulatory pathway for HTX-019, Heron's proprietary intravenous formulation of the NK1 receptor antagonist aprepitant for the prevention of CINV.
Gladys:
We caution investors that forward-looking statements reflect our analysis only on their stated date.
Meta:
Heron expects to report results from both of these trials in the second half of 2015. HTX-003, a long-acting formulation of buprenorphine, is being developed for the management of chronic pain and opioid addiction.
Heron Therapeutics Inc. (NASDAQ:HRTX)
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