Alnylam Pharmaceuticals $ALNY Stock Swinging Higher

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ALNY stock bounced off lower channel support last week and is continuing its move higher on December 31, 2021.

Alnylam remains top pick for 2022 at Bank of America

On December 30, 2021, BofA analyst Tazeen Ahmad maintained a Buy rating on Alnylam Pharmaceuticals (ALNY) with a $211 price target after BridgeBio (BBIO) recently announced that acoramidis, a stabilizer, missed its primary endpoint at month 12 in the Phase 3 ATTRibute-CM trial. Two doctors the analyst spoke to questioned the reliability of the six minute walking distance test as an endpoint and believe silencers should be better than stabilizers on efficacy, which favors Alnylam. The volatility this week in Alnylam shares is from the acoramidis miss given that the company is also using the same primary endpoint, but Alnylam’s “more stringent enrollment criteria is an advantage,” Ahmad tells investors in a research note. Additionally, the analyst thinks silencers are more potent than stabilizers and notes that Alnylam has already shown success in amyloid polyneuropathy patients. Ahmed believes the FDA may put greater emphasis on mortality and hospitalization data over the six minute walking distance test and believes Alnylam “remains competitive in ATTR with several other data also expected in 2022.” The stock remains a top pick for the analyst in 2022.

Alnylam shares appear oversold on BridgeBio update, says Oppenheimer

On December 27, 2021, Oppenheimer analyst Leland Gershell said news that Alnylam’s (ALNY) competitor BridgeBio’s (BBIO) Phase 3 ATTRibute-CM trial of acoramidis missed its primary endpoint “came as a surprise,” but he contends that today’s selloff in Alnylam shares is “disproportionate to any incremental concerns” around the prospects for success for its APOLLO-B trial. Gershell, who thinks Alnylam’s 18% pullback from Thursday’s close is likely due to increased investor concern that a similar placebo response could interfere with upcoming results from Onpattro’s APOLLO-B trial that uses the same primary endpoint measure, would look to take advantage of current levels to add to a position and keeps an Outperform rating on Alnylam shares.

Alnylam Comments on FDA Approval of Leqvio®, the First siRNA (RNAi Therapeutic) Approved to Reduce LDL-C

On December 22, 2021, Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, highlighted the significance of the U.S. Food and Drug Administration’s (FDA) approval of Leqvio® (inclisiran), the fourth small interfering RNA (siRNA) therapy (or RNAi therapeutic) approved in the U.S., and the first and only to lower low-density lipoprotein cholesterol (also known as “bad cholesterol” or LDL-C). Leqvio is indicated in the U.S. as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of LDL-C. Alnylam scientists discovered inclisiran and published the first clinical data. Alnylam also supported early clinical development. As of January 2020, Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement. Novartis AG continues to develop inclisiran and commercialize Leqvio worldwide, with Alnylam eligible to receive tiered royalties between 10 and 20 percent on global sales.

Leqvio is the fourth Alnylam-discovered medicine using its RNAi therapeutic platform to be approved to date. The Leqvio approval marks the first U.S. approval of an RNAi therapeutic indicated to treat a major risk factor for a highly prevalent disease. Alnylam launched its first RNAi therapeutic in 2018 with the FDA approval of ONPATTRO® (patisiran) for treatment of the polyneuropathy caused by hATTR amyloidosis, a progressive and life-threatening, rare, genetic disease. Leqvio was approved to lower LDL cholesterol and has the potential to benefit millions of people with ASCVD and also those with HeFH around the world.

“The approval of Leqvio, a potentially transformational medicine for lowering LDL-C is a historic event for Alnylam and its RNAi therapeutics platform. The demonstrated ability of Leqvio to lower LDL cholesterol up to 52% versus placebo on top of maximally tolerated statins with just two doses per year after an initial dose and another at three months represents a breakthrough that carries the potential to treat millions of people with ASCVD who are struggling to control elevated LDL cholesterol,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “More broadly, we believe the approval of Leqvio validates the future potential of RNAi therapeutics in large population diseases, and facilitates Alnylam’s advancement toward its bold Alnylam P5x25 strategy and goals. We are proud to share in the significance of this milestone with Novartis who made this approval a reality.”

Inclisiran was discovered by Alnylam and, in collaboration with The Medicines Company, advanced into clinical development in 2014. Upon successful completion of Phase 1 clinical studies, the ORION clinical program was launched in 2015. The FDA approval was based on results from the comprehensive Phase III ORION-9, -10 and -11 clinical trials, where all of the 3,457 participants with ASCVD or HeFH had elevated LDL-C while being on a maximally tolerated dose of statin therapy. This comprehensive Phase 3 program represents the largest clinical program conducted to date for an investigational RNAi therapeutic program. Two complementary Phase 3 cardiovascular outcomes trials, ORION-4 and the Novartis initiated VICTORION-2-PREVENT are currently ongoing.

“We believe that the creation of Leqvio was made possible by the development of our ESC-GalNAc conjugate delivery platform,” said Kevin Fitzgerald, Ph.D., Chief Scientific Officer of Alnylam, and scientist who led the initial development of Leqvio at Alnylam. “The U.S. approval of Leqvio will bring RNAi therapeutics to even more patients with elevated or inadequately controlled LDL-C. Moreover, this approval highlights the potential for additional Alnylam RNAi therapeutic programs in prevalent disease indications.”

In the U.S., Leqvio is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia HeFH or clinical ASCVD, who require additional lowering of LDL-C. The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.

The European Medicines Agency (EMA) granted inclisiran marketing authorization in December 2020 for adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, as an adjunct to diet in combination with a statin or statin with other lipid‑lowering therapies in patients unable to reach LDL‑C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid‑lowering therapies in patients who are statin‑intolerant, or for whom a statin is contraindicated. Leqvio has now been approved in more than 50 countries.

As part of Alnylam’s strategic financing agreement with Blackstone, a leading private equity firm, 50 percent of Leqvio-related Alnylam royalties will flow to Blackstone.

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. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylam’s commercial RNAi therapeutic products are ONPATTRO® (patisiran), GIVLAARI® (givosiran), and OXLUMO® (lumasiran), as well as Leqvio® (inclisiran), with Alnylam’s partner Novartis, which has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its “Alnylam P5x25” strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA.

📽 Alnylam CEO on drug prices: Has to be some type of reward for innovator at the end


📈 ALNY Stock Technical Analysis

Alny Stock

The long-term trend is neutral, but the short-term trend is negative.

There is a resistance zone ranging from 181.39 to 183.26. This zone is formed by a combination of multiple trend lines and important moving averages in multiple time frames. There is resistance at 194.58 from a horizontal line in the weekly time frame. There is also resistance at 198.35 from a trend line in the daily time frame. Finally, there is resistance at 207.73 from a horizontal line in the daily time frame.

There is a support zone ranging from 169.73 to 171.04. This zone is formed by a combination of multiple trend lines in multiple time frames. There is also a support zone ranging from 159.55 to 161.72. This zone is formed by a combination of multiple trend lines in multiple time frames.

ALNY is part of the Biotechnology industry. There are 630 other stocks in this industry. ALNY outperforms 84% of them. ALNY is currently trading in the middle of its 52-week range. The S&P500 Index however is currently trading near new highs, so ALNY is lagging the market.

The technical rating of ALNY is bad and it also does not present a quality setup at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first. Click here to sign up for email alerts on when ALNY stock consolidates and is a good long entry.

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