FDA Approval for AMVUTTRA issued to ALNYLAM PHARMS INC

6/14/22 9:45:06 AM ET

$ALNY

Biotechnology: Pharmaceutical Preparations

Health Care

Get the next $ALNY alert in real time by email

New Drug Application (NDA): 215515
Company: ALNYLAM PHARMS INC

Products on NDA 215515

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMVUTTRA	VUTRISIRAN	25MG	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215515

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2022	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Get the next $ALNY alert in real time by email

Chat with this insight

Save time and jump to the most important pieces.

Recent Analyst Ratings for
$ALNY

Date	Price Target	Rating	Analyst
11/12/2024		Peer Perform → Underperform	Wolfe Research
10/16/2024		Sector Outperform	Scotiabank
8/16/2024	$198.00 → $370.00	Neutral → Buy	Goldman
2/16/2024	$173.00	Buy → Neutral	Goldman
2/15/2024		Peer Perform	Wolfe Research
12/8/2023	$171.00	Equal Weight	Wells Fargo
12/8/2023		Equal Weight	Wells Fargo
10/11/2023		Outperform → Perform	Oppenheimer

More analyst ratings

$ALNY
Market Insights

Live Market Insights

Ionis' Rare Development Disorder Drug Candidate 'Could Be Differentiated' From Peer Ultragenyx: Analyst
Ionis Pharmaceuticals Inc (NASDAQ:IONS) released results Monday from the completed multiple ascending dose (MAD) portion of the Phase 1/2 open-label study of ION582 in people with Angelman syndrome (AS). AS is a rare neurodevelopmental disorder caused by a loss of function in the maternal UBE3A gene. It affects an estimated 1 in 21,000 people worldwide. The data demonstrated consistent and encouraging clinical improvement on assessing all functional domains, including communication, cognition, and motor function measures. Also Read: Ionis Pharmaceuticals Reveals Late-Stage Donidalorsen Data, Analyst Says Results Show Competitive Hereditary Angioedema Profile. Overall, 97% of peop
7/22/24 1:04:26 PM ET
$ALNY
$AZN
$BIIB
$IONS
Biotechnology: Pharmaceutical Preparations
Health Care
Biotechnology: Biological Products (No Diagnostic Substances)
Cantor Fitzgerald Maintains Neutral on Alnylam Pharmaceuticals, Raises Price Target to $220
Cantor Fitzgerald analyst Olivia Brayer maintains Alnylam Pharmaceuticals (NASDAQ:ALNY) with a Neutral and raises the price target from $150 to $220.
7/22/24 11:19:55 AM ET
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care
$100 Invested In This Stock 20 Years Ago Would Be Worth $4,100 Today
Alnylam Pharmaceuticals (NASDAQ:ALNY) has outperformed the market over the past 20 years by 12.59% on an annualized basis producing an average annual return of 21.02%. Currently, Alnylam Pharmaceuticals has a market capitalization of $29.88 billion. Buying $100 In ALNY: If an investor had bought $100 of ALNY stock 20 years ago, it would be worth $4,144.21 today based on a price of $236.22 for ALNY at the time of writing. Alnylam Pharmaceuticals's Performance Over Last 20 Years Finally -- what's the point of all this? The key insight to take from this article is to note how much of a difference compounded returns can make in your cash growth over a period of time. This article was generate
7/18/24 1:30:23 PM ET
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care

Alnylam Pharmaceuticals Reports Third Quarter 2024 Financial Results and Highlights Recent Period Activity
− Achieved Third Quarter 2024 Global Net Product Revenues of $420 Million, Representing 34% Year-Over-Year Growth Compared to Q3 2023, Driven by Continued Momentum from TTR Business – − Submitted Regulatory Applications in U.S. and EU for AMVUTTRA® (vutrisiran) for the Treatment of Transthyretin Amyloidosis with Cardiomyopathy – − Reiterated 2024 Financial Guidance, Including Combined Net Product Revenues of $1,575 Million to $1,650 Million – Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the third quarter ended September 30, 2024 and reviewed recent business highlights. "Alnylam continued to deli
10/31/24 8:00:00 AM ET
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care
Alnylam to Webcast Conference Call Discussing Third Quarter 2024 Financial Results
Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, announced today that it will report financial results for the third quarter ending September 30, 2024 on Thursday, October 31, 2024, before the U.S. financial markets open. Management will provide an update on the Company and discuss third quarter 2024 results as well as expectations for the future via conference call on Thursday, October 31, 2024 at 8:30 am ET. A live audio webcast of the call will be available on the Investors section of the Company's website at www.alnylam.com/events. An archived webcast will be available on the Alnylam website approximately two hours after the event. About Alnylam Phar
10/17/24 8:00:00 AM ET
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care
Alnylam Presents Detailed Results from the Positive HELIOS-B Phase 3 Study of Vutrisiran▼ in Patients with ATTR Amyloidosis with Cardiomyopathy at the European Society of Cardiology Congress
− In the Overall Population, Achieved 28% Reduction in Primary Composite of All-Cause Mortality and Recurrent Cardiovascular Events, and 31% and 36% Reductions in All-Cause Mortality During the 33-36-Month Double-Blind Period and up to Month 42, Respectively – − In the Monotherapy Population, Reduced Composite Primary Endpoint by 33% and All-Cause Mortality up to Month 42 by 35% – − Strong Trends of Additive Efficacy on Top of Tafamidis Across Primary and Secondary Endpoints – − Demonstrated Statistically Significant Benefits on Multiple Measures of Disease Progression – − Encouraging Safety and Tolerability Profile, Consistent with Established Profile – − Results from HELIOS-B Si
8/30/24 6:00:00 AM ET
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care

ByHeart Appoints Amy Schulman as Chair of the Board of Directors, Further Solidifying its Position as a Leader in the Infant Nutrition Category
As former leader of Pfizer's infant nutrition and consumer healthcare businesses, Schulman brings extensive experience in the space, in addition to serving on the boards of several biotech and pharmaceutical companies; This marks ByHeart's first non-executive Board chair appointment In addition to Schulman, ByHeart appoints Niall Mullane, PhD, as Chief Quality Officer to join the experienced executive team; Mullane brings 15 years of quality and food safety experience in the infant nutrition category NEW YORK, March 5, 2024 /PRNewswire/ --Today, ByHeart, the next-generation baby nutrition company, announced the appointment of Amy Schulman, managing partner at Polaris partners, as Chair of th
3/5/24 9:06:00 AM ET
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care
Alnylam Announces Appointment of Peter Kellogg to Board of Directors
– Experienced Business and Financial Leader, Kellogg Served as Chief Financial Officer at Biogen, Merck, and Celgene – Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) the leading RNAi therapeutics company, announced today the appointment of Peter Kellogg to its Board of Directors. Mr. Kellogg is an accomplished industry executive with extensive global financial and strategic management experience. "Mr. Kellogg joins our Board at a pivotal moment for Alnylam as we continue on the path to achieving our P5x25 strategy and fulfilling our ambition to become a top-tier biopharmaceutical company," said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam. "His financial expertise and experi
3/8/23 7:00:00 AM ET
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care
Alnylam Announces Preliminary* Fourth Quarter and Full Year 2022 Global Net Product Revenues and Provides Additional Updates
– Achieved Full Year 2022 Preliminary Global Net Product Revenues of $894 Million for ONPATTRO®, AMVUTTRA®, GIVLAARI®, and OXLUMO®, Representing 35% Annual Growth (43% Using Constant Exchange Rate**) – – Strength of AMVUTTRA Launch Drove 37% Total TTR Annual Revenue Growth – – Maintained Strong Balance Sheet with Year-End Cash and Investments Balance of Approximately $2.2 Billion – Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, today announced its preliminary* fourth quarter and full year 2022 global net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO and provided additional updates on the products' commercial launches. Preliminary Four
1/8/23 6:00:00 PM ET
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care

Alnylam Announces Interim Phase 1 Data of Nucresiran (ALN-TTRsc04) Showing Rapid Knockdown of TTR that is Sustained at Six Months Following a Single Dose
− Single Dose of Nucresiran 300mg or Higher Led to Rapid Knockdown of Mean TTR Levels of Greater than 90% by Day 15 that was Sustained at Six Months − − At These Doses, Peak Reduction of Mean TTR Levels of Greater than 96% were Achieved by Day 29 − − Data Support Potential for Biannual or Annual Subcutaneous Dosing, Representing a New Paradigm in the Treatment of ATTR Amyloidosis − − Encouraging Safety and Tolerability Observed − − Alnylam Continues to Expect to Share Phase 3 Development Plans in Q1 2025 – Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, today announced the presentation of new results from its Phase 1 study of nucresiran (formerl
11/17/24 9:30:00 AM ET
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care
Alnylam to Webcast Presentations at Upcoming November Investor Conferences
Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, announced today that management will present company overviews at the following conferences: UBS Global Healthcare Conference on Tuesday, November 12, 2024 at 8:45 am PT (11:45 ET) at the Terranea Resort in Ranchos Palos Verdes, CA Jefferies London Healthcare Conference on Wednesday, November 20, 2024 at 9:30 am GMT (4:30 am ET) in London A live audio webcast of each presentation will be available on the Investors section of the Company's website at www.alnylam.com/events. A replay will be available on the Alnylam website within 48 hours after each event. About Alnylam Pharmaceuticals Alnylam Pharmac
11/4/24 8:00:00 AM ET
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care
Alnylam Pharmaceuticals Reports Third Quarter 2024 Financial Results and Highlights Recent Period Activity
− Achieved Third Quarter 2024 Global Net Product Revenues of $420 Million, Representing 34% Year-Over-Year Growth Compared to Q3 2023, Driven by Continued Momentum from TTR Business – − Submitted Regulatory Applications in U.S. and EU for AMVUTTRA® (vutrisiran) for the Treatment of Transthyretin Amyloidosis with Cardiomyopathy – − Reiterated 2024 Financial Guidance, Including Combined Net Product Revenues of $1,575 Million to $1,650 Million – Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the third quarter ended September 30, 2024 and reviewed recent business highlights. "Alnylam continued to deli
10/31/24 8:00:00 AM ET
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care

FDA Approval for AMVUTTRA issued to ALNYLAM PHARMS INC

Products on NDA 215515

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215515

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $ALNY

$ALNY Market Insights

Live Market Insights

Ionis' Rare Development Disorder Drug Candidate 'Could Be Differentiated' From Peer Ultragenyx: Analyst

Cantor Fitzgerald Maintains Neutral on Alnylam Pharmaceuticals, Raises Price Target to $220

$100 Invested In This Stock 20 Years Ago Would Be Worth $4,100 Today

$ALNY Large Ownership Changes

This live feed shows all institutional transactions in real time.

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

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

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

$ALNY FDA approvals

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

FDA Approval for GIVLAARI issued to ALNYLAM PHARMS INC

FDA Approval for OXLUMO issued to ALNYLAM PHARMS INC

FDA Approval for AMVUTTRA issued to ALNYLAM PHARMS INC

$ALNY Insider Trading

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

CMO & EVP Dev & Med Affairs Garg Pushkal was granted 96 shares, increasing direct ownership by 0.62% to 15,705 units (SEC Form 4)

EVP, CLO and Secretary Hesslein Robert W. was granted 7,245 shares (SEC Form 4)

SEC Form 3 filed by new insider Hesslein Robert W.

$ALNY Financials

Live finance-specific insights

$ALNY Analyst Ratings

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

Alnylam Pharmaceuticals Reports Third Quarter 2024 Financial Results and Highlights Recent Period Activity

Alnylam to Webcast Conference Call Discussing Third Quarter 2024 Financial Results

Alnylam Presents Detailed Results from the Positive HELIOS-B Phase 3 Study of Vutrisiran▼ in Patients with ATTR Amyloidosis with Cardiomyopathy at the European Society of Cardiology Congress

Alnylam Pharma downgraded by Wolfe Research

Scotiabank initiated coverage on Alnylam Pharma

Alnylam Pharma upgraded by Goldman with a new price target

$ALNY SEC Filings

SEC Form 10-Q filed by Alnylam Pharmaceuticals Inc.

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

SEC Form 10-Q filed by Alnylam Pharmaceuticals Inc.

$ALNY Leadership Updates

Live Leadership Updates

$ALNY Press Releases

Fastest customizable press release news feed in the world

ByHeart Appoints Amy Schulman as Chair of the Board of Directors, Further Solidifying its Position as a Leader in the Infant Nutrition Category

Alnylam Announces Appointment of Peter Kellogg to Board of Directors

Alnylam Announces Preliminary* Fourth Quarter and Full Year 2022 Global Net Product Revenues and Provides Additional Updates

Alnylam Announces Interim Phase 1 Data of Nucresiran (ALN-TTRsc04) Showing Rapid Knockdown of TTR that is Sustained at Six Months Following a Single Dose

Alnylam to Webcast Presentations at Upcoming November Investor Conferences

Alnylam Pharmaceuticals Reports Third Quarter 2024 Financial Results and Highlights Recent Period Activity

Recent Analyst Ratings for
$ALNY

$ALNY
Market Insights

$ALNY
Large Ownership Changes

$ALNY
FDA approvals

$ALNY
Insider Trading

$ALNY
Financials

$ALNY
Analyst Ratings

$ALNY
SEC Filings

$ALNY
Leadership Updates

$ALNY
Press Releases