FDA Approval for PYRUKYND issued to AGIOS PHARMACEUTICALS INC

2/17/22 2:39:08 PM ET

$AGIO

Biotechnology: Pharmaceutical Preparations

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New Drug Application (NDA): 216196
Company: AGIOS PHARMACEUTICALS INC

Products on NDA 216196

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PYRUKYND	MITAPIVAT	5MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216196

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2022	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

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Recent Analyst Ratings for
$AGIO

Date	Price Target	Rating	Analyst
10/16/2024		Sector Outperform	Scotiabank
10/10/2024	$51.00	Outperform	Raymond James
9/27/2024	$60.00 → $56.00	Outperform → Market Perform	Leerink Partners
2/8/2024		Overweight	Cantor Fitzgerald
2/3/2023	$41.00	Overweight	Piper Sandler
11/17/2022	$17.00 → $32.00	Sell → Neutral	Goldman
7/27/2022	$33.00	Mkt Perform → Outperform	SVB Leerink
3/7/2022	$37.00 → $23.00	Sell	Goldman Sachs

More analyst ratings

Expert Ratings For Agios Pharmaceuticals
Agios Pharmaceuticals (NASDAQ:AGIO) has been analyzed by 4 analysts in the last three months, revealing a diverse range of perspectives from bullish to bearish. The table below provides a concise overview of recent ratings by analysts, offering insights into the changing sentiments over the past 30 days and drawing comparisons with the preceding months for a holistic perspective. Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 0 1 3 0 0 Last 30D 0 0 0 0 0 1M Ago 0 1 2 0 0 2M Ago 0 0 1 0 0 3M Ago 0 0 0 0 0 Analysts provide deeper insights through their assessments of 12-month price targets, revealing an average target of $46.25, a high estimate
6/17/24 10:01:38 AM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care
Cantor Fitzgerald Reiterates Overweight on Agios Pharmaceuticals
Cantor Fitzgerald analyst Eric Schmidt reiterates Agios Pharmaceuticals (NASDAQ:AGIO) with a Overweight.
6/17/24 9:31:59 AM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care
Agios Announced Earlier Results From Its Phase 3 ENERGIZE Study Of Mitapivat In Non-Transfusion-Dependent Thalassemia; Study Achieved Its Primary Endpoint
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today presented detailed results from the global Phase 3 ENERGIZE study of mitapivat in adults with non-transfusion-dependent (NTD) alpha- or beta-thalassemia in a plenary session (abstract #S104) at the European Hematology Association 2024 (EHA2024) Hybrid Congress, which is being held June 13-16, 2024, in Madrid, Spain. In a related poster presentation (abstract #P1529), the company presented additional data from the ENERGIZE study highlighting clinically meaningful improvements in health-related quality of life measures and patient-reported
6/15/24 12:38:25 PM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care

$AGIO
Press Releases

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Agios to Present New Data on Mitapivat and Tebapivat in Rare Blood Disorders at 66th ASH Annual Meeting and Exposition
– Results from Phase 3 ENERGIZE-T Study of Mitapivat in Transfusion-dependent Thalassemia will be Presented in Oral Session – – Tebapivat Phase 1 Data in Sickle Cell Disease and Phase 2b Trial-in-progress Update in Lower-risk Myelodysplastic Syndromes will be Presented and Published – – Live and Webcast Investor Event with Agios Leadership and Medical Experts will be Hosted Onsite on Monday, December 9 – CAMBRIDGE, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced that new data on mitapivat and tebapivat (AG-946), the company
11/5/24 9:05:00 AM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care
Agios Reports Business Highlights and Third Quarter 2024 Financial Results
– Completed Enrollment of the Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease; Topline Data from 52-Week Study Expected in Late 2025 – – Received $1.1 Billion in Payments from Royalty Pharma and Servier, Following FDA Approval of Vorasidenib – – Commenced Enrollment of the Phase 2b Study of Tebapivat in Lower-Risk Myelodysplastic Syndromes (LR-MDS); Granted FDA Orphan Drug Designation for Treatment of MDS – – PYRUKYND® (Mitapivat) Net Revenue of $9.0 Million in Q3; Cash, Cash Equivalents and Marketable Securities of $1.7 Billion as of September 30, 2024 – CAMBRIDGE, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in cellular metabo
10/31/24 6:30:00 AM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care
Agios Completes Enrollment of Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease
– Topline Data from 52-week Phase 3 Study Expected in Late 2025 – CAMBRIDGE, Mass., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced that enrollment is complete for the Phase 3 RISE UP study. This global, double-blind, randomized, placebo-controlled trial is evaluating the efficacy and safety of mitapivat, an oral, small molecule PK activator, in sickle cell disease patients who are 16 years of age or older. Agios expects to report topline results from this 52-week Phase 3 study in late 2025. Sickle cell disease is an inherited, lifelong
10/23/24 7:00:00 AM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care

Agios Reports Business Highlights and Third Quarter 2024 Financial Results
– Completed Enrollment of the Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease; Topline Data from 52-Week Study Expected in Late 2025 – – Received $1.1 Billion in Payments from Royalty Pharma and Servier, Following FDA Approval of Vorasidenib – – Commenced Enrollment of the Phase 2b Study of Tebapivat in Lower-Risk Myelodysplastic Syndromes (LR-MDS); Granted FDA Orphan Drug Designation for Treatment of MDS – – PYRUKYND® (Mitapivat) Net Revenue of $9.0 Million in Q3; Cash, Cash Equivalents and Marketable Securities of $1.7 Billion as of September 30, 2024 – CAMBRIDGE, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in cellular metabo
10/31/24 6:30:00 AM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care
Agios to Webcast Conference Call of Third Quarter 2024 Financial Results on October 31, 2024
CAMBRIDGE, Mass., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced the company will host a conference call and live webcast on Thursday, October 31, 2024, at 8:00 a.m. ET to report its third quarter 2024 financial results and business highlights. A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company's website at www.agios.com. A replay of the webcast will be archived on the company's website for at least two weeks following the presentation. About AgiosAgios is the pioneering leader in pyr
10/17/24 7:00:00 AM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care
Agios Reports Business Highlights and Second Quarter 2024 Financial Results
– Reported Positive Topline Data from Phase 3 ENERGIZE-T Study; Expect to File sNDA Based on ENERGIZE and ENERGIZE-T Studies Encompassing All Thalassemia Subtypes by End of 2024 – – Announced $905 Million Purchase Agreement for Vorasidenib Royalty with Royalty Pharma; Agios to Receive a Total of $1.1 Billion in Payments Upon FDA Approval of Vorasidenib – – Reported Results from Phase 3 ACTIVATE-KidsT Study of Mitapivat in Children with Pyruvate Kinase (PK) Deficiency Who are Regularly Transfused – – PYRUKYND® (Mitapivat) Net Revenue of $8.6 Million in Q2; Cash, Cash Equivalents and Marketable Securities of $645.3 Million as of June 30, 2024 – CAMBRIDGE, Mass., Aug. 01, 2024 (GLOBE NEWS
8/1/24 6:31:00 AM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care

$AGIO
Leadership Updates

Live Leadership Updates

Agios Appoints Catherine Owen to Board of Directors
– John Maraganore Completes Tenure on Agios Board After Nearly a Dozen Years of Service – – Kaye Foster to Be Appointed Lead Independent Director – CAMBRIDGE, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that Catherine Owen has been appointed to its board of directors, effective June 13, 2023. Agios also announced that, following a collaborative succession planning process, John Maraganore, Ph.D., who has served as a valuable board member and advisor to the company since 2011, will step down from the board of directors, effective immediately, and
5/25/23 7:00:00 AM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care
Agios Appoints Jeffrey Capello to Board of Directors
– Board Member Paul Clancy Will Step Down at the End of His Term – CAMBRIDGE, Mass., April 19, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that Jeffrey Capello has been appointed to its board of directors. Agios also announced that Paul Clancy will step down from the board of directors at the end of his term, effective June 13, 2023. "Agios is dedicated to cultivating a diverse board that is focused on the company's long-term value creation for patients and shareholders. As such, we are thrilled to welcome Jeff, whose nearly 30-year track record of driving profitab
4/19/23 7:00:00 AM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care
Totus Medicines Expands its Scientific Advisory Board with the Addition of Dr. Lewis Cantley, Dr. Hope Rugo, and Dr. Josep Tabernero
EMERYVILLE, Calif., April 12, 2023 /PRNewswire/ -- Totus Medicines, the drug discovery and development company committed to ending the era of untreatable disease, announced today the appointment of Dr.Lewis Cantley, Dr. Hope Rugo, and Josep Tabernero to the company's Scientific Advisory Board (SAB). Totus has created the first biosearch technology that scans, maps, and decodes effective new drugs thousands of times faster than traditional drug discovery processes. To start, Totus has focused on oncology with an early breakthrough for the most mutated oncogene in cancer, PI3Kα, using the Totus Accel™ Platform.
4/12/23 8:00:00 AM ET
$AGIO
Biotechnology: Pharmaceutical Preparations
Health Care

FDA Approval for PYRUKYND issued to AGIOS PHARMACEUTICALS INC

Products on NDA 216196

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216196

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $AGIO

$AGIO Analyst Ratings

Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

Scotiabank initiated coverage on Agios Pharma

Raymond James resumed coverage on Agios Pharma with a new price target

Agios Pharma downgraded by Leerink Partners with a new price target

$AGIO Market Insights

Live Market Insights

Expert Ratings For Agios Pharmaceuticals

Cantor Fitzgerald Reiterates Overweight on Agios Pharmaceuticals

Agios Announced Earlier Results From Its Phase 3 ENERGIZE Study Of Mitapivat In Non-Transfusion-Dependent Thalassemia; Study Achieved Its Primary Endpoint

$AGIO FDA approvals

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

FDA Approval for PYRUKYND issued to AGIOS PHARMACEUTICALS INC

FDA Approval for TIBSOVO issued to AGIOS PHARMS INC

$AGIO Press Releases

Fastest customizable press release news feed in the world

Agios to Present New Data on Mitapivat and Tebapivat in Rare Blood Disorders at 66th ASH Annual Meeting and Exposition

Agios Reports Business Highlights and Third Quarter 2024 Financial Results

Agios Completes Enrollment of Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease

$AGIO SEC Filings

SEC Form 10-Q filed by Agios Pharmaceuticals Inc.

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

SEC Form 10-Q filed by Agios Pharmaceuticals Inc.

$AGIO Insider Trading

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

$AGIO Financials

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Principal Accounting Officer Washburn Theodore James Jr. sold $43,301 worth of shares (772 units at $56.09), decreasing direct ownership by 49% to 813 units (SEC Form 4)

Director Ballal Rahul D. exercised 20,000 shares at a strike of $25.99 and sold $1,117,147 worth of shares (20,000 units at $55.86) (SEC Form 4)

Chief Legal Officer Burns James William sold $1,135,775 worth of shares (21,752 units at $52.21), decreasing direct ownership by 58% to 15,700 units (SEC Form 4)

Agios Reports Business Highlights and Third Quarter 2024 Financial Results

Agios to Webcast Conference Call of Third Quarter 2024 Financial Results on October 31, 2024

Agios Reports Business Highlights and Second Quarter 2024 Financial Results

$AGIO Leadership Updates

Live Leadership Updates

Agios Appoints Catherine Owen to Board of Directors

Agios Appoints Jeffrey Capello to Board of Directors

Totus Medicines Expands its Scientific Advisory Board with the Addition of Dr. Lewis Cantley, Dr. Hope Rugo, and Dr. Josep Tabernero

$AGIO Large Ownership Changes

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Amendment: SEC Form SC 13G/A filed by Agios Pharmaceuticals Inc.

Amendment: SEC Form SC 13G/A filed by Agios Pharmaceuticals Inc.

SEC Form SC 13G/A filed by Agios Pharmaceuticals Inc. (Amendment)

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