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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$HRTX
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Heron Therapeutics Announces Third Quarter 2024 Financial Results and Narrows Financial Guidance
Reported positive YTD 2024 Adjusted EBITDA of $1.4 millionCompany expects Q4 2024 Net Revenue in the range of $37 million - $43 millionZYNRELEF® (bupivacaine and meloxicam) extended-release solution Vial Access Needle ("VAN") approved in September and on track for Q4 2024 launchCMS Final Rule Non-Opioid Policy for Pain Relief includes ZYNRELEF as a qualifying product for separate payment in both the hospital outpatient department and ambulatory surgical center settings of careSAN DIEGO, Nov. 12, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced financial results for the three and nine months ended
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Heron Therapeutics Announces Appointment of Michael Kaseta to Board of Directors
SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company, announced today the appointment of Michael Kaseta to its Board of Directors. Mr. Kaseta has an extensive background spanning corporate finance, business strategy, and the commercialization of biopharma products in large pharmaceutical companies and small biotech companies. Mr. Kaseta currently serves as the Chief Financial Officer and Chief Operating Officer of Liquidia Corporation, a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary diseases. Prior to Liquidia, Mr. Kaseta served as the Chief Financial Officer at Aerami Thera
11/4/24 5:00:00 PM ET
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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
10/29/24 4:05:00 PM ET
$HRTX
Biotechnology: Pharmaceutical Preparations
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Heron Therapeutics Announces Appointment of Michael Kaseta to Board of Directors
SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company, announced today the appointment of Michael Kaseta to its Board of Directors. Mr. Kaseta has an extensive background spanning corporate finance, business strategy, and the commercialization of biopharma products in large pharmaceutical companies and small biotech companies. Mr. Kaseta currently serves as the Chief Financial Officer and Chief Operating Officer of Liquidia Corporation, a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary diseases. Prior to Liquidia, Mr. Kaseta served as the Chief Financial Officer at Aerami Thera
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$HRTX
Biotechnology: Pharmaceutical Preparations
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Heron Therapeutics Announces Appointment of Brett Fleshman as Chief Business Officer
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Heron Therapeutics Announces Appointment of Ira Duarte as Chief Financial Officer
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$HRTX
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Heron Therapeutics Announces Third Quarter 2024 Financial Results and Narrows Financial Guidance
Reported positive YTD 2024 Adjusted EBITDA of $1.4 millionCompany expects Q4 2024 Net Revenue in the range of $37 million - $43 millionZYNRELEF® (bupivacaine and meloxicam) extended-release solution Vial Access Needle ("VAN") approved in September and on track for Q4 2024 launchCMS Final Rule Non-Opioid Policy for Pain Relief includes ZYNRELEF as a qualifying product for separate payment in both the hospital outpatient department and ambulatory surgical center settings of careSAN DIEGO, Nov. 12, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced financial results for the three and nine months ended
11/12/24 7:55:00 AM ET
$HRTX
Biotechnology: Pharmaceutical Preparations
Health Care
Heron Therapeutics to Report Third Quarter 2024 Financial Results On Tuesday, November 12, 2024
SAN DIEGO, Oct. 29, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced that the Company will host a conference call and live webcast on Tuesday, November 12, 2024, at 8:00 a.m. ET to report third quarter 2024 financial results and discuss recent business highlights. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the In
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$HRTX
Biotechnology: Pharmaceutical Preparations
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Heron Therapeutics Announces Second Quarter 2024 Financial Results and Narrows Financial Guidance
Second quarter Net Product Sales of $36.0 million, which increased from $31.8 million for the same period in 2023ZYNRELEF® Vial Access Needle ("VAN") PDUFA goal date set for September 23, 2024ZYNRELEF included in the proposed 2025 Non-Opioid Policy for Pain Relief ("NOPAIN Act")SAN DIEGO, Aug. 6, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced financial results for the three and six months ended June 30, 2024, and highlighted recent corporate updates. "We have had an exciting start to 2024 with many encouraging milestones that provide the foundation for ongoing commercial success. We are improvi
8/6/24 4:05:00 PM ET
$HRTX
Biotechnology: Pharmaceutical Preparations
Health Care

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

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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 Press Releases

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

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

$HRTX SEC Filings

SEC Form 10-Q filed by Heron Therapeutics Inc.

Heron Therapeutics Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

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

$HRTX Insider Purchases

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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 Large Ownership Changes

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SEC Form SC 13G filed by Heron Therapeutics Inc.

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

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

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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

FDA Approval for ZYNRELEF KIT issued to HERON THERAPS INC

FDA Approval for APONVIE issued to HERON THERAPS INC

FDA Approval for CINVANTI issued to HERON THERAPS INC

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

Director Kaseta Michael was granted 37,879 shares (SEC Form 4)

SEC Form 3 filed by new insider Kaseta Michael

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

$HRTX Financials

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

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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