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Amneal Announces Positive Topline Results for Parkinson’s Disease Study

Amneal Pharmaceuticals Inc announced positive topline results from the pivotal Phase 3 RISE-PD clinical trial that evaluated the novel formulation, IPX-203, in patients with Parkinson’s disease (PD) who have motor fluctuations.

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Amneal Announces Positive Topline Results from Pivotal Phase 3 RISE-PD Clinical Trial of IPX-203 in Patients with Parkinson’s Disease Who Experience Motor Fluctuations

– Study was successful in demonstrating statistically significant improvement in efficacy for IPX-203 compared to immediate-release CD/LD, even when IPX-203 was dosed on average three times per day and immediate-release CD/LD was dosed on average five times per day

– New Drug Application submission to the FDA planned for mid-2022

– Company to host conference call to discuss trial results today at 4:30 p.m. ET

BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced positive topline results from the pivotal Phase 3 RISE-PD clinical trial that evaluated the novel formulation, IPX-203, in patients with Parkinson’s disease (PD) who have motor fluctuations. The trial met its primary endpoint, demonstrating superior “Good On” time from baseline in hours per day at the end of the 13-week double-blind treatment period with IPX-203 CD/LD extended-release capsules compared with immediate-release CD/LD. Based on these topline results plus other supportive data, Amneal plans to submit a New Drug Application (NDA) for IPX-203 with the U.S. Food and Drug Administration (FDA) in mid-2022.

Phase 3 topline results showed the study was successful in demonstrating statistically significant improvement in efficacy for IPX-203 compared to immediate-release CD/LD, even when IPX-203 was dosed on average 3 times per day and immediate-release CD/LD was dosed on average 5 times per day. IPX-203 treatment resulted in 0.53 more hours of “Good On” time than immediate-release CD/LD (p=0.0194), when comparing change from baseline (Week 7) in both study arms.

The secondary endpoint for change from baseline in “Off” time showed IPX-203 resulted in significantly less “Off” time compared with immediate-release CD/LD (-0.48 hr, p=0.0252). In addition, analysis of the secondary endpoint for Patients’ Global Impression of Change (PGI-C) scores showed 29.7% of patients treated with IPX-203 were “much improved” or “very much improved” compared with 18.8% of patients treated with immediate-release CD/LD (p=0.0015). IPX-203 change from baseline scores for Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III or sum of MDS-UPDRS Part II and III were similar to those of immediate-release CD/LD.

A post-hoc analysis of Least Squares Mean difference at Week 20 (EOS/ET) showed IPX-203 increased “Good On” time by 1.55 hours per dose compared with immediate-release CD/LD (p<0.0001).

Table 1. RISE-PD efficacy results: Primary and key secondary endpoints

 

Week 0
Enrollment

 

Week 7
Baseline
(Randomization)

Week 20
End of Study
(or Early Termination)

p-value

Mean “Good On” time (h)

IPX-203

9.46

11.67

11.35

 

0.0194

immediate-release CD/LD

9.61

11.72

10.77

Mean “Off” time (h)

IPX-203

6.15

3.95

4.18

 

0.0252

immediate-release CD/LD

6.05

4.02

4.75

Percentage of patients who reported “much improved” or “very much improved” scores on the PGI-C scale

IPX-203

N/A

N/A

29.7%

 

0.0015

immediate-release CD/LD

N/A

N/A

18.8%

Mean MDS-UPDRS part III score

IPX-203

29.6

26.9

27.8

 

0.9587

immediate-release CD/LD

29.7

27.0

28.0

Mean MDS-UPDRS Sum of part II + III score

IPX-203

42.9

38.9

40.6

 

0.9668

immediate-release CD/LD

42.9

39.3

41.1

∆ = p-value based on change from Week 7 (Baseline) to Week 20 (End of Study or Early Termination [EOS/ET])

□ = p-value based on comparison of treatments at Week 20 (EOS/ET)

The trial was conducted at 108 clinical sites in the U.S. and European countries, including Czechia, France, Germany, Italy, Poland, Spain and the United Kingdom. The study randomized 506 patients with PD age 40 and older. The study design was reviewed by the FDA and conducted pursuant to a Special Protocol Assessment.

In the randomized patient population, eight (3.1%) subjects reported serious adverse events (SAEs) in the IPX-203 study arm and four (1.6%) subjects reported SAEs in the immediate-release CD/LD arm. Treatment-emergent adverse events (TEAEs) were reported for both study arms (108 [42.2%] for IPX-203, 79 [31.6%] for immediate-release CD/LD). The most common AEs (≥3%) were nausea, dry mouth, urinary tract infection, and fall.

“Despite the introduction of several new medications for Parkinson’s disease in recent years, new treatment options are needed that provide longer-lasting duration of benefit with each dose and simplify medication regimens for patients affected by this devastating disease,” Alberto Espay, MD, FAAN, Professor of Neurology at the University of Cincinnati, Director of James J. and Joan A. Gardner Family Center, and Research Chair for Parkinson’s Disease and Movement Disorders.

“The topline data from RISE-PD indicates that IPX-203 has the potential to offer patients superior ‘Good On’ time with reduced dosing frequency, compared to immediate-release CD/LD,” said Robert A. Hauser, M.D., Professor of Neurology at the University of South Florida and Director of the Parkinson’s Disease and Movement Disorders Center.

“These positive data from the Phase 3 trial of IPX-203 represent a substantial step forward in strengthening Amneal’s Specialty Pharma portfolio, which is heavily focused on medicines for central nervous system disorders,” said Chirag and Chintu Patel, Co-Chief Executive Officers, Amneal. “We look forward to submitting an NDA with the FDA and potentially making this treatment available to the PD community.”

Conference Call Details
Amneal will host a conference call today, Wednesday, August 25, 2021, at 4:30 p.m. ET that will feature members of Amneal’s management team as well as Alberto Espay, MD, MSc, FAAN, FANA (University of Cincinnati), and Robert A Hauser, MD, MBA, FAAN (University of South Florida) to discuss topline results from the pivotal Phase 3 RISE-PD clinical trial. The presentation will be followed by a live Q&A session.

Please visit https://lifesci.rampard.com/WebcastingAppv5/Events/eventsDispatcher.jsp?Y2lk=MTM2Mg== to register and access the live webinar. A replay will be made available on the company’s website for six months. The presentation materials will be posted on the Investor Relations website following the conclusion of the event.

About the Pivotal Phase 3 RISE-PD Trial
The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of IPX-203 CD/LD extended-release capsules compared with immediate-release CD/LD in the treatment of patients with PD who have motor fluctuations.

The trial consisted of a 3-week, open-label immediate-release CD/LD dose adjustment period and a 4-week, open-label period for conversion to IPX-203. This was followed by a 13-week double-blind treatment period in which patients were randomized 1:1 to receive either IPX-203 (with matching immediate-release CD/LD placebo) or immediate-release CD/LD (with matching IPX-203 placebo). Baseline for all endpoints was Week 7 (Visit 4), which occurred pre-randomization.

The primary endpoint of the trial assessed the change from baseline in “Good On” time in hours per day at the end of the double-blind treatment period (Week 20 or early termination). “Good On” time is defined as the sum of “On” time without dyskinesia and “On” time with non-troublesome dyskinesia. Secondary endpoints assessed the change from baseline in “Off” time in hours per day, proportion of patients who were either “much improved” or “very much improved” in Patients’ Global Impression of Change (PGI-C) scores, change from baseline in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score, and the change from baseline in sum of MDS-UPDRS Parts II and III scores.

The trial was conducted at 108 clinical sites in the U.S. and European countries, including Czechia, France, Germany, Italy, Poland, Spain and the United Kingdom. The study randomized 506 patients with PD age 40 and older. The study design was reviewed by the FDA and conducted pursuant to a Special Protocol Assessment. A nine-month safety extension study is ongoing.

About IPX-203
IPX-203 is a novel, oral formulation of CD/LD extended-release capsules for patients with PD who have motor fluctuations. IPX-203 was developed with an innovative formulation that contains immediate-release and extended-release granules, and mucoadhesive polymers, to provide rapid absorption and maximize levodopa absorption. This formulation is distinct from RYTARY®(carbidopa/levodopa) extended-release capsules, Amneal’s extended-release CD/LD treatment for PD approved by the U.S. FDA in 2015.

About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has an extensive portfolio of approximately 250 generic product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com.

Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including among other things: discussions of future operations; expected operating results and financial performance; impact of planned acquisitions and dispositions; the Company’s strategy for growth; product development; regulatory approvals; market position and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

Such risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic; the impact of global economic conditions; our ability to successfully develop, license, acquire and commercialize new products on a timely basis; our ability to obtain exclusive marketing rights for our products; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our dependence on third-party agreements for a portion of our product offerings; our ability to identify and make acquisitions of or investments in complementary businesses and products on advantageous terms; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the significant amount of resources we expend on research and development; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Contacts

Investor Contact
Anthony DiMeo
Senior Director, Investor Relations
anthony.dimeo@amneal.com

Media Contact
Julie Normart
Group Director, Media and Engagement, Real Chemistry
jnormart@realchemistry.com

Amneal Medical Affairs
888-990-AMRX (2679)
askamrx@amneal.com

 

 

Business Wire source:

https://www.businesswire.com/news/home/20210825005679/en

 

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What does good cybersecurity look like in 2022?

The pharma industry is becoming an increasingly hot commodity for cybercriminals. In recent years, digital adoption has accelerated
The post What does…

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The pharma industry is becoming an increasingly hot commodity for cybercriminals. In recent years, digital adoption has accelerated at a rapid pace, with companies racing to integrate cloud-based platforms and telehealth services to expand the delivery of modern healthcare. Combined with the sudden arrival of COVID-19, this perfect storm of events handed cybercriminals an opportunity to exploit weaknesses in fledging systems and processes.

Pharma companies hold masses of vital data sets, from classified intellectual property to proprietary information about drugs and clinical trial developments. The value of such data is not lost on cybercriminals. This was illustrated in 2021, amid growing awareness of the pharma industries’ efforts to develop and distribute COVID-19 vaccines. According to cybersecurity firm Critical Insights, the number of cybersecurity breaches in healthcare reached an all-time high in 2021, exposing an unprecedented amount of protected health information.

Cyber attacks can be highly damaging, both financially and to a company’s reputation. Therefore, it is essential that necessary steps are taken, both at a company and individual level, to understand and prevent the risk of cyber threats. But what does good cybersecurity actually look like? To help navigate the complex world of digital crime, Adarma’s threat consultant Mike Varley, KnowBe4 lead security awareness advocate Javvad Malik, CEO and founder of CyberSmart Jamie Akhtar, and senior engineer at Trend Micro Simon Walsh offer their insights into key trends and best practises for pharma companies.

Why is the healthcare industry a particular target for cyberattacks?

Javvad Malik (JM): Historically cybercriminals were after money, so they often ignored healthcare providers. However, with increasing sophistication within the criminal economies and the ability to monetise data through ransomware, other means of extortion, or resale, healthcare providers have become an almost ideal target for criminals.

Simon Walsh (SW): Despite statements from would-be attackers to the contrary, the healthcare and pharma industries became prime targets during the COVID pandemic, particularly for ransomware operators, as we saw during the breach of the Irish Healthcare Service Executive in May 2021.

There are several reasons for this: they’re seen as easy targets because of their relative lack of security maturity; the COVID pandemic-induced strain they’re already under makes them more likely to pay the ransom; and the fact that the data they hold – patient records – is extremely valuable and opens additional paths to extortion.

Jamie Akhtar (JA): Many healthcare providers have weak or limited defences. These range from poor staff awareness of threats to creaking, outdated operating systems and tech, but whatever the reason, cybercriminals are aware that many healthcare providers make for easy pickings.

Mike Varley (MV): We can expect to see a rising number of ransomware attacks on the healthcare sector. Healthcare is recognised as national critical infrastructure, which makes it an attractive target to malicious foreign entities looking to create chaos and harm. Similarly, when human life is put at risk by an attack, organisations are more likely to pay up, so attackers often view these structures as a quick pay-day.

Where do you see the most mistakes being made in healthcare when it comes to addressing cyber threats?

JM: Perhaps the biggest mistakes or challenges healthcare faces when addressing cyber threats are having outdated or unpatched software running, being too quick to purchase or adopt internet-connected devices without demanding rigorous security testing, and, finally, the lack of security awareness and training amongst IT staff.

SW: Security maturity and the ability to successfully detect and withstand attacks comes from understanding cyber risk and building and developing a cyber security strategy around that understanding. This of course needs to be adopted and driven by the board and C-level executives and too often this is not the case, with a lack of understanding and investment resulting in a weakened security posture.

Over-reliance on security technology without adequate human oversight further weakens this posture. The Irish hospitals who successfully prevented the attack in May 2021 were those who not just detected stages of the attack but also understood what those detections meant and acted as a result.

Developing a human oversight function – for example a Security Operations Centre – in house is costly, difficult, and takes time. So, for many in the healthcare/pharma industry, the quickest route to success on this front is working with the correct partner who will provide that function.

JA: There are two areas in which most organisations, not just healthcare providers, could be doing better. Many aren’t doing the simple things that can thwart most cyber-attacks. For example, regularly updating software and operating systems, using strong passwords and MFA, developing clear policies for staff to follow, and ensuring security tools are configured properly.

On top of this, employee awareness of cyber threats just isn’t widespread enough. An organisation can have the best cybersecurity software around but, if an employee doesn’t know what a phishing email looks like and clicks a malicious link, it’ll be hacked just the same. The way to counter this is basic cybersecurity training. It doesn’t have to be comprehensive, just enough to help your people make informed choices.

“Perhaps the biggest mistakes or challenges healthcare faces when addressing cyber threats are having outdated or unpatched software running, being too quick to purchase or adopt internet-connected devices without demanding rigorous security testing, and, finally, the lack of security awareness and training amongst IT staff.”

 

What trends are you seeing in cybersecurity at the moment?

JA: The most worrying trend is the rise in supply chain attacks. Cybercriminals have worked out that the best way to target large enterprises with solid defences, is to attack a smaller, less well-defended supplier who can give them a backdoor in. As a result, we’re seeing more major attacks originate in this way.

Alongside this, phishing continues to be the single most common form of attack. Due to the general lack of awareness in the working population, many organisations are still struggling to contain the threat.

MV: Increasingly I think we will see healthcare sector organisations turning to managed security service providers who have the expertise, capability, and technology to deal with an increasingly complex and harmful cyber landscape.

The healthcare sector is expected to provide an elevated level of cyber protection and with a shortage of cyber talent and the prohibitive cost of establishing a Security Operations Centre internally, organisations will need a trusted security partner that can provide that level of proactive protection.

What advice would you give to companies looking to improve their cybersecurity policies, both on a company-wide scale and individual basis?

JA: Above all, make them clear and easy to follow. Avoid technical jargon, where possible, as this will only disengage people. And, explain why the company has adopted the policies it has; your staff will find it much easier to follow them if they know why. Also, store them somewhere that’s easy to access from anywhere. There’s little use in a policy if it’s buried deep in a shared drive where nobody reads it.

MV: Cybersecurity policies should be informed by a threat-led approach. Regular threat modelling will highlight what threats you are facing and how adversaries are likely to target your organisation. With this information on areas of commonality, your security teams can focus on implementing layered security and monitoring.

Your policy should consider asset awareness. As basic as it sounds, it can be easy for a small handful of assets to fall under the radar within vast enterprises, which leads to out-of-date operating systems and software.

JM: Organisations should look to take a data-driven approach. That means, that in addition to following what is occurring externally in terms of attacks, they should look through a year or two worth of internal security logs to see what was the root cause of the incidents during this time period.

Once the root causes have been identified, they should be prioritised, and then controls be put in place to address those specific root causes. Those should inform the cybersecurity policies and tailor them to the specific risks the organisation is facing.

SW: For companies, start at the top and ensure that the board and C-level executives are capable of understanding and assessing risk. This will drive investment in cyber strategy and improve your chances of mitigating that risk. Human oversight of security-related activity in the organisation is also fundamental.

For individuals, heightened awareness and ongoing education are key. We all have a role to play in cyber-security as 100% reliance on technology is unfortunately never enough.

The post What does good cybersecurity look like in 2022? appeared first on .

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WEF 2022, May 24: Latest updates from the Cointelegraph Davos team

The third day of WEF 2022 will see the OECD secretary-general share his thoughts on a reimagined global tax system and industry experts discussing DeFi…

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The third day of WEF 2022 will see the OECD secretary-general share his thoughts on a reimagined global tax system and industry experts discussing DeFi as the future of decentralized governance.

Disclaimer: This article is being updated all day long. All timestamps are in the UTC time zone, with updates in reverse order (the latest update is placed at the top).

WEF 2022, the first in-person World Economic Forum event since the pandemic started, continues to bridge traditional finance with the future of money on its third day.

The Cointelegraph ground team, including editor-in-chief Kristina L. Corner, head of video Jackson DuMont and news reporter Joseph Hall, is deployed in Davos, where the event is held, to get the most recent developments from WEF 2022.

Check out all the important details from May 23 in one easy-to-read page!

The third day of WEF 2022 will see the OECD secretary-general Mathias Cormann share his thoughts on a reimagined global tax system and industry experts discussing decentralized finance (DeFi) as the future of decentralized governance.

Crypto’s Carbon Footprint, one of the most anticipated sessions of the event, will see chief executives from FTX, Stellar Development Foundation, SkyBridge Capital, DataKing and Cambridge Centre for Alternative Finance talk about the environmental sustainability goals of crypto mining operations.

Don’t forget to check this article regularly to get notified about the most recent announcements from the event.

  • 08.30 am UTC

The ‘Strategic Outlook on the Digital Economy’ panel discussed building socially inclusive and environmentally sustainable economic growth. The panel included the likes of Nicholas Thompson, publisher and CEO of The Atlantic, Arvind Krishna, chairman and CEO of IBM Corporation, and Julie Sweet, CEO of Accenture.

The primary discussion revolved around the evolution of metaverse and its potential at the industrial level. Accenture CEO talked about numerous use cases of the virtual reality world and their future plans of integrating employees into the Accenture metaverse.

“Metaverse has a ton of potential and it could prove to be beneficial in many domains. 100,000 Accenture employees would be integrated into the Accenture metaverse over time.”

She went on to cite the example of the pandemic and how metaverse helped them connect and complete meetings in three dimensions.

IBM CEO Arvind Krishna talked about the role of artificial intelligence and augmented reality (metaverse) in handling tasks that are dangerous for the humans, citing the example of nuclear powerplants, which could be inaccessible in case of a tragedy, and this is where metaverse and AI could be of great help.

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Bitcoin Back Below $30,000 After A Record 8 Weeks In The Red

Bitcoin decoupled from equity markets to the downside on Monday after ending last week as the eighth consecutive weekly loss.

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Bitcoin decoupled from equity markets to the downside on Monday after ending last week as the eighth consecutive weekly loss.

Bitcoin has failed to hold the $30,000 level on Monday after scoring its eighth consecutive week in the red for the first time ever.

During these eight weeks, which began in late March and ended on Sunday, bitcoin has lost over 35% of its U.S. dollar value according to TradingView data. Before the beginning of the losing streak, BTC was trading at around $46,800.

Bitcoin has scored losses for eight consecutive weeks for the first time in its history and it is starting the ninth with yet another red candle. Image source: TradingView.

Bitcoin is changing hands slightly below $30,000 at the time of writing. The peer-to-peer currency climbed as high as $30,600 earlier on Monday to trade at around $29,400 as the trading in equity markets nears its end in New York.

While bitcoin turns south, major U.S. stock indices have been in the green. The Nasdaq, which is said to be highly correlated with bitcoin, decoupled from the digital money along with the S&P 500 to denote modest gains near market close on Monday, per TradingView data.

While bitcoin, Nasdaq and S&P 500 were trading in tandem for some time on Monday, the P2P currency saw a sharp sell-off decouple it from the two indices and take it to a more than 3% loss for the day. Image source: TradingView.

A Tough Year For Bitcoin

Despite making two new all-time highs in 2021, bitcoin already erased nearly all of those gains in 2022.

Bitcoin’s choppy trading year so far can be partly attributed to a broader sentiment of economic uncertainty as the Federal Reserve tightens the U.S. economy, withdrawing liquidity from the market after almost two years of quantitative easing.

The central bank has already raised its basic interest rates two times this year, the last of which was double the magnitude of the previous one and represented the largest hike in two decades: While the Fed increased interest rates by 0.25% in March, it raised them by 0.50% earlier this month.

Image source: Federal Reserve Economic Data (FRED).

When the Fed raises or lowers interest rates through its Federal Open Markets Committee (FOMC), what it is actually doing is setting a target range. The graph above depicts the lower and upper bounds of that target range in red and blue, respectively.

While the U.S. central bank system sets the target, it cannot mandate that commercial banks use it — rather, it serves as a recommendation. Therefore, what banks end up using for lending and borrowing excess cash between them overnight is called the effective rate. This is shown by the green line in the graph above.

The Fed previously hiked interest rates consistently from 2016 to 2019, until plunging it near zero in the aftermath of the COVID-19 pandemic outbreak, as noted in the graph.

Bitcoin’s higher sensitivity to liquidity and therefore interest rates can be explained by a greater participation of institutional investors in the market, whose allocations are based on the availability of capital and broader economic conditions, Morgan Stanley reportedly said.

Therefore, while Bitcoin was able to sustain a bull market in the midst of the Fed increasing interest rates in 2017, raising nearly 2,000% from January to December that year, the odds aren’t on the side of the bulls this year.

For two weeks, bitcoin has now closed below a level of weekly support it formed over a year ago and had respected since, indicating it might be turning into a zone of resistance. Image source: TradingView.

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