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HRTX

Heron Therapeutics

$21.68 /

+0.54 (+2.56%)

16:42
02/19/20
02/19
16:42
02/19/20
16:42

Heron Therapeutics: FDA extends review period for NDA for HTX-011

Heron Therapeutics announced that the U.S. FDA has extended the review period for the New Drug Application for HTX-011 by up to three months. The new PDUFA goal date is June 26, 2020. A Complete Response Letter was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information. Heron is pleased to report that the contract manufacturing site used to manufacture HTX-011 has been reinspected by the FDA with no Form 483 observations issued and with a recommendation by the FDA inspector for approval of the site. Heron has not been informed of any other manufacturing concerns. There were no clinical efficacy or safety issues in the CRL.

  • 06

    Mar

  • 26

    Mar

HRTX Heron Therapeutics
$21.68 /

+0.54 (+2.56%)

01/08/20 Stifel
Stifel names Momenta and Principia top 2020 SMID cap Biotech picks
10/03/19 JMP Securities
Heron Therapeutics price target lowered to $32 from $38 at JMP Securities
10/01/19 JMP Securities
Heron Therapeutics price target increased to $38 from $33 at JMP Securities

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Initiation
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Periodicals
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Initiation
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