FDA panel endorses Alnylams heart drug after picking it apart

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About ONPATTRO® (patisiran)
ONPATTRO (patisiran) is an RNAi therapeutic that is approved in the United States and Canada for the treatment of the polyneuropathy of hereditary ATTR (hATTR) amyloidosis in adults. ONPATTRO is also approved in the European Union, Switzerland and Brazil for the treatment of hATTR amyloidosis in adults with Stage 1 or Stage 2 polyneuropathy, and in Japan for the treatment of hATTR amyloidosis with polyneuropathy. ONPATTRO is an intravenously administered RNAi therapeutic targeting transthyretin (TTR). It is designed to target and silence TTR messenger RNA, thereby reducing the production of TTR protein before it is made.

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.

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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%).

• Patisiran is currently marketed as Onpattro in the United States and Europe for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.
• 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.
• Alnylam Pharmaceuticals issued an update on its FY 2023 earnings guidance on Thursday, August, 3rd.

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.

Alnylam to Webcast Conference Call Discussing Second Quarter 2023 Financial Results

Important Safety Information
Infusion-Related Reactions
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 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.

A label expansion of Onpattro is likely to offset, to some extent, the declining revenue trend from its sales, as more and more patients are switching to Amvuttra (vutrisiran). Amvuttra received the FDA approval in June 2022, for the treatment of adult patients with polyneuropathy of hereditary ATTR (hATTR) amyloidosis. Amvuttra is also approved in the EU for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.

Recent News

Reducing the pathogenic protein leads to a reduction in amyloid deposits in tissues. Patisiran is also being evaluated for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis; the safety and efficacy of patisiran in this indication have not been established or evaluated by the FDA, EMA or any other health authority. In August 2022, the company reported that the APOLLO-B study met its primary endpoint of change from baseline in the 6-Minute Walk Test (6-MWT) versus placebo at 12 months. The study also met the first secondary endpoint of change from baseline in quality of life versus placebo.

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ALNY Alnylam Pharmaceuticals Inc

High-growth stocks tend to represent the technology, healthcare, and communications sectors. They rarely distribute dividends to shareholders, opting for reinvestment in their businesses. More value-oriented stocks tend to represent financial services, utilities, and energy stocks.

Style is calculated by combining value and growth scores, which are first individually calculated. Year to date, shares of Alnylam have declined 10.9% compared with the industry’s 13.1% fall. Get this delivered earnings after tax formula to your inbox, and more info about our products and services. Upgrade to MarketBeat All Access to add more stocks to your watchlist. One share of ALNY stock can currently be purchased for approximately $211.65.

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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.

The company was founded by Noble Laureate, David Bartel, Thomas Tuschl, Phillip Zamore, Paul R. Schimmel, and Phillip A. Sharp on June 14, 2002 and is headquartered in Cambridge, MA. This release discusses investigational RNAi therapeutics and uses of previously approved RNAi therapeutics in development and is not intended to convey conclusions about efficacy or safety as to those investigational therapeutics or uses. Patisiran has not been approved by any regulatory agency for the treatment of ATTR amyloidosis with cardiomyopathy. No conclusions can or should be drawn regarding its safety or effectiveness in treating cardiomyopathy in this population. There is no guarantee that any investigational therapeutics or expanded uses of commercial products will successfully complete clinical development or gain health authority approval.

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.

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.

According to 22 analysts, the average rating for ALNY stock is “Buy.” The 12-month stock price forecast is $244.0, which is an increase of 24.98% from the latest price. © 2023 Market data provided is at least 10-minutes delayed and hosted by Barchart Solutions. Information is provided ‘as-is’ and solely for informational purposes, not for trading purposes or advice, and is delayed. To see all exchange delays and terms of use please see Barchart’s disclaimer.

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. 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. You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer.

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.

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 dedication to giving investors a trading advantage led to the creation of our proven Zacks Rank stock-rating system. Since 1988 it has more than doubled the S&P 500 with an average gain of +24.32% per year. These returns cover a period from January 1, 1988 through July 31, 2023. Zacks Rank stock-rating system returns are computed monthly based on the beginning of the month and end of the month Zacks Rank stock prices plus any dividends received during that particular month. A simple, equally-weighted average return of all Zacks Rank stocks is calculated to determine the monthly return. The monthly returns are then compounded to arrive at the annual return.

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 https://1investing.in/ 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.

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