FDA Approval for APONVIE issued to HERON THERAPS INC

9/19/22 12:49:05 PM ET

$HRTX

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 216457
Company: HERON THERAPS INC

Products on NDA 216457

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APONVIE	APREPITANT	32MG/4.4ML	EMULSION;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216457

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216457Orig1s000ltr.pdf

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Recent Analyst Ratings for
$HRTX

Date	Price Target	Rating	Analyst
6/13/2024	$7.00	Buy	Rodman & Renshaw
4/23/2024	$6.00	Overweight	CapitalOne
3/13/2024	$4.00 → $5.00	Buy	Needham

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Financials

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SAN DIEGO, July 30, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company, today announced that the company will host a conference call and live webcast on Tuesday, August 6, 2024, at 4:30 p.m. ET to report second quarter 2024 financial results and discuss recent business highlights. The conference call can be accessed by dialing (646) 307-1963 in the U.S. or (800) 715-9871 internationally. Please provide the operator with the passcode 1737564 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron's website at www.herontx.com. An archive of the teleconference and webcast
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Heron Therapeutics Announces Appointment of Michael Kaseta to Board of Directors
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Heron Therapeutics to Report Third Quarter 2024 Financial Results On Tuesday, November 12, 2024
SAN DIEGO, Oct. 29, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced that the Company will host a conference call and live webcast on Tuesday, November 12, 2024, at 8:00 a.m. ET to report third quarter 2024 financial results and discuss recent business highlights. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the In
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$HRTX
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FDA Approval for APONVIE issued to HERON THERAPS INC

Products on NDA 216457

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216457

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for $HRTX

$HRTX Insider Purchases

Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

Forbes William P bought $27,250 worth of shares (25,000 units at $1.09), increasing direct ownership by 46% to 79,000 units (SEC Form 4)

Forbes William P bought $46,995 worth of shares (50,000 units at $0.94), increasing direct ownership by 1,250% to 54,000 units (SEC Form 4)

Collard Craig A bought $137,970 worth of shares (150,000 units at $0.92), increasing direct ownership by 411% to 186,496 units (SEC Form 4)

$HRTX Insider Trading

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EVP, Chief Financial Officer Duarte Ira converted options into 3,874 shares, increasing direct ownership by 4% to 108,001 units (SEC Form 4)

EVP, Chief Development Officer Forbes William P converted options into 3,874 shares, increasing direct ownership by 4% to 103,123 units (SEC Form 4)

Chief Executive Officer Collard Craig A converted options into 13,797 shares, increasing direct ownership by 5% to 290,387 units (SEC Form 4)

$HRTX Financials

Live finance-specific insights

Heron Therapeutics to Report Third Quarter 2024 Financial Results On Tuesday, November 12, 2024

Heron Therapeutics Announces Second Quarter 2024 Financial Results and Narrows Financial Guidance

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$HRTX FDA approvals

Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

FDA Approval for APONVIE issued to HERON THERAPS INC

FDA Approval for CINVANTI issued to HERON THERAPS INC

FDA Approval for ZYNRELEF KIT issued to HERON THERAPS INC

$HRTX Large Ownership Changes

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SEC Form SC 13D/A filed by Heron Therapeutics Inc. (Amendment)

SEC Form SC 13G/A filed by Heron Therapeutics Inc. (Amendment)

SEC Form SC 13G/A filed by Heron Therapeutics Inc. (Amendment)

$HRTX Press Releases

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$HRTX SEC Filings

Heron Therapeutics Announces Appointment of Michael Kaseta to Board of Directors

Heron Therapeutics to Report Third Quarter 2024 Financial Results On Tuesday, November 12, 2024

Heron Therapeutics Reaffirms Availability and Ample Supply of CINVANTI®, SUSTOL®, and APONVIE® as Alternatives During the Potential Shortage of Intravenous Fluids

Heron Therapeutics Inc. filed SEC Form 8-K: Leadership Update, Regulation FD Disclosure, Financial Statements and Exhibits

SEC Form S-8 filed by Heron Therapeutics Inc.

SEC Form 10-Q filed by Heron Therapeutics Inc.

$HRTX Market Insights

Live Market Insights

Heron Therapeutics Announces ZYNRELEF Included In Proposed 2025 Non-Opioid Policy For Pain Relief Under Medicare OPPS And ASC Payment Systems; Effective April 1, 2025; CMS Issued Proposed Rule Based On ZYNRELEF's Postoperative Pain Indication And Potential To Reduce Opioid Use

Heron Therapeutics shares are trading lower. The company announced that the FDA acknowledged the receipt of the Company's Prior Approval Supplement application for ZYNRELEF.

Heron Therapeutics Announces The FDA Acknowledged The Receipt Of The Company's Prior Approval Supplement Application For ZYNRELEF

$HRTX Analyst Ratings

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Rodman & Renshaw initiated coverage on Heron Therapeutics with a new price target

CapitalOne initiated coverage on Heron Therapeutics with a new price target

Needham reiterated coverage on Heron Therapeutics with a new price target

$HRTX Leadership Updates

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Heron Therapeutics Announces Appointment of Michael Kaseta to Board of Directors

Heron Therapeutics Announces Appointment of Brett Fleshman as Chief Business Officer

Heron Therapeutics Announces Appointment of Ira Duarte as Chief Financial Officer

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