Patisiran is the established name for ONPATTRO, which is approved by the FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults. Alnylam Pharmaceuticals issued an update on its FY 2023 earnings guidance on Thursday, August, 3rd. The company provided earnings per share (EPS) guidance of for the period. The company closed loop mrp means issued revenue guidance of $1.30 billion-$1.46 billion, compared to the consensus revenue estimate of $1.44 billion. 20 Wall Street analysts have issued “buy,” “hold,” and “sell” ratings for Alnylam Pharmaceuticals in the last twelve months. The consensus among Wall Street analysts is that investors should “moderate buy” ALNY shares.
Important Safety Information
Infusion-related reactions (IRRs) have been observed in patients treated with ONPATTRO. In a controlled clinical study, 19% of ONPATTRO-treated patients experienced IRRs, compared to 9% of placebo-treated https://1investing.in/ patients. The most common symptoms of IRRs with ONPATTRO were flushing, back pain, nausea, abdominal pain, dyspnea, and headache. Our experts picked 7 Zacks Rank #1 Strong Buy stocks with the best chance to skyrocket within the next days.
Shares of Alnylam Pharmaceuticals Inc. soared 57.0% in premarket trading on Wednesday after the company said its investigational RNAi therapeutic for a type of heart failure met the primary endpoint in a Phase 3 clinical … BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%. CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%. DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%. Per ALNY, the positive opinion of the CRDAC was based on a discussion of the data submitted to support the sNDA for patisiran. Such data included positive results from the phase III APOLLO-B study of patisiran to treat the cardiomyopathy of ATTR amyloidosis.
Get the most updated overview of our studies, pipeline, and therapeutic programs. The company is scheduled to release its next quarterly earnings announcement on Thursday, October 26th 2023. Use these time-tested investing strategies to grow the monthly retirement income that your stock portfolio generates. MarketRank is calculated as an average of available category scores, with extra weight given to analysis and valuation.
Alnylam Pharmaceuticals upgraded to buy from hold at UBS
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The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities. Biotech company Alnylam Pharmaceuticals Inc filed new lawsuits on Friday against Pfizer Inc and Moderna Inc in Delaware federal court, again claiming that the companies’ COVID-19 vaccines infringe its…
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has remained constant at 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. In a separate press release, Alnylam announced that NASDAQ had halted trading of its common stock on Sep 13, 2023, in anticipation of the company’s meeting with the FDA’s advisory committee regarding the patisiran sNDA. The interim analysis was carried out on the 18-month data of the APOLLO-B study. Results indicated that the previously achieved primary endpoint, health status and quality of life, observed at the end of 12 months of the same study, were sustained with continued treatment with patisiran during the OLE period (at the end of 18 months). Patisiran is currently marketed as Onpattro in the United States and Europe for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.
Only Zacks Rank stocks included in Zacks hypothetical portfolios at the beginning of each month are included in the return calculations. Certain Zacks Rank stocks for which no month-end price was available, pricing information was not collected, or for certain other reasons have been excluded from these return calculations. Alnylam has reportedly submitted the 18-month data from the interim analysis of the OLE period to the FDA as an amendment to the sNDA for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis. Alnylam Pharmaceuticals, Inc. operates as biopharmaceutical company, which engages in the discovery, development and commercialization of RNAi therapeutics.
Insiders that own company stock include Akshay Vaishnaw, Indrani Lall Franchini, Jeffrey V Poulton, Jeffrey W Dunn, John Maraganore, Laurie Keating, Phillip A Sharp, Pushkal Garg, Steven M Paul, Tolga Tanguler and Yvonne Greenstreet. Data are provided ‘as is’ for informational purposes only and are not intended for trading purposes. The group of independent experts voted 9-3 that the benefits of Alnylam’s drug, called patisiran, outweighed its risks for patients with ATTR-CM, a progressive disease that leads to fatal heart failure if left untreated. The FDA, which is not required to follow the advice of advisers, is expected to make a final decision on patisiran by Oct. 8.
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Recent stocks from this report have soared up to +178.7% in 3 months – this month’s picks could be even better. Alnylam Pharmaceuticals’ stock is owned by many different retail and institutional investors. Top institutional shareholders include Capital World Investors (13.20%), Baillie Gifford & Co. (6.74%), BlackRock Inc. (6.71%), State Street Corp (2.31%), Capital International Investors (2.30%) and Capital Research Global Investors (1.88%).
ONPATTRO Indication and Important Safety Information
ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Patisiran is the established name for ONPATTRO®, which is currently approved by the FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults. In the past 30 days, the Zacks Consensus Estimate for Better Therapeutics’ 2023 loss per share has remained constant at 98 cents. During the same period, Better Therapeutics’ 2024 loss per share has remained constant at 80 cents. In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has gone up from 75 cents to 78 cents. The estimate for Corcept’s 2024 earnings per share has also improved from 81 cents to 83 cents.
Alnylam Issues 2022 Corporate Responsibility Report
Onpattro is the first and only FDA-approved treatment for this indication. About RNAi
RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases. Patients may present with polyneuropathy, cardiomyopathy, or both manifestations of disease.
Food and Drug Administration approval in June 2022 and accounted for 43% of the quarter’s net product sales. We forecast about $1.24 billion in net product revenue for 2023, representing 38% growth from the prior year. Alnylam’s results are tracking our expectations, and we maintain our fair value estimate of $199 per share. We view shares as fairly valued, and the stock is currently trading in 3-star territory. At the center of everything we do is a strong commitment to independent research and sharing its profitable discoveries with investors.
ALNY Stock News Headlines
About LNP Technology
Alnylam has licenses to Arbutus Biopharma LNP intellectual property for use in RNAi therapeutic products using LNP technology. Adverse Reactions
The most common adverse reactions that occurred in patients treated with ONPATTRO were upper respiratory tract infections (29%) and infusion-related reactions (19%). To reduce the risk of IRRs, patients should receive premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) at least 60 minutes prior to ONPATTRO infusion. If an IRR occurs, consider slowing or interrupting the infusion and instituting medical management as clinically indicated. If the infusion is interrupted, consider resuming at a slower infusion rate only if symptoms have resolved. In the case of a serious or life-threatening IRR, the infusion should be discontinued and not resumed.
- This puts John M. Maraganore in the top 10% of approval ratings compared to other CEOs of publicly-traded companies.
- In a controlled clinical study, 19% of ONPATTRO-treated patients experienced IRRs, compared to 9% of placebo-treated patients.
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Per Alnylam, out of 12 expert panelists in the committee, nine voted in favor of the company, indicating that the benefits of patisiran outweigh its risks for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. ALNY, +3.89% said Wednesday its stock will be halted on Nasdaq through the day as a regulatory advisory committee will meet to review its new drug application for a treatm… Dividend yield allows investors, particularly those interested in dividend-paying stocks,
to compare the relationship between a stock’s price and how it rewards stockholders through dividends. The formula for calculating dividend yield is to divide the annual dividend paid per share by the stock price.
This demonstrated the favorable effects of treatment with patisiran on functional capacity and health status and quality of life in patients with ATTR amyloidosis with cardiomyopathy against placebo, as measured by the 6-MWT and the KCCQ-OS score, respectively. Furthermore, in May 2023, the company announced new positive results from an interim analysis of exploratory data from the open-label extension (OLE) period of the phase III APOLLO-B study of patisiran for the treatment of ATTR amyloidosis with cardiomyopathy. Alnylam reported strong second-quarter results highlighted by $306 million in net product revenue, representing a 43% increase year over year. Amvuttra (for hATTR amyloidosis with polyneuropathy), is continuing its strong launch since it received U.S.
It is the translation of RNAi as a new class of innovative medicines with a core focus on RNAi therapeutics for the treatment of genetically defined diseases. The company was founded by John Kennedy Clarke, Paul R. Schimmel and Phillip A. Sharp on June 14, 2002 and is headquartered in Cambridge, MA. Alnylam Pharmaceuticals, Inc. is a global commercial-stage biopharmaceutical company, which engages in the discovery, development and commercialization of RNAi therapeutics.
Alnylam Stock Rockets 50% as Trial Results Raise Hope for a Blockbuster
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- Alnylam Pharmaceuticals, Inc. (ALNY Quick QuoteALNY – Free Report) announced positive outcome from its meeting with the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) to discuss the impending supplemental new drug application (sNDA) for patisiran.
- It is the translation of RNAi as a new class of innovative medicines with a core focus on RNAi therapeutics for the treatment of genetically defined diseases.
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- Adverse Reactions
The most common adverse reactions that occurred in patients treated with ONPATTRO were upper respiratory tract infections (29%) and infusion-related reactions (19%).
65 employees have rated Alnylam Pharmaceuticals Chief Executive Officer John M. Maraganore on Glassdoor.com. John M. Maraganore has an approval rating of 99% among the company’s employees. This puts John M. Maraganore in the top 10% of approval ratings compared to other CEOs of publicly-traded companies. Dow Jones Industrial Average, S&P 500, Nasdaq, and Morningstar Index (Market Barometer) quotes are real-time.