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3 Biotech Stocks Under $5 With 100%-Plus Upside Potential

3 Biotech Stocks Under $5 With 100%-Plus Upside Potential

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Biotech stocks give a whole new meaning to risk/reward plays. Unlike names inhabiting other areas of the market, these tickers can witness explosive movements in the blink of an eye, giving them a Street reputation for their high volatility.

Companies in the biotech industry are unique in that their long-term growth prospects don’t necessarily hinge on quarterly profit results. Rather, clinical trial data or verdicts from regulatory bodies can have a more meaningful impact as product approvals indicate vital revenues are on the horizon. This means any positive development can act as a catalyst that sends shares skyrocketing. The flip-side, however, does hold true, so the risk-averse tend to shy away from these names.

So, how are investors supposed to determine which biotech stocks are capable of outperforming the rest? Tracking the analyst community’s activity can be an effective strategy. The pros, who have in-depth knowledge of the industry, offer insight into many biotechs, some of which fly relatively under-the-radar.

Bearing this in mind, we used TipRanks’ database to track down affordable yet compelling biotech plays. After combing through the densely packed sector, we found three going for less than $5 apiece with bullish reviews from Wall Street analysts and over 100% upside potential.     

Spectrum Pharmaceuticals (SPPI)

Primarily targeting diseases in hematology and oncology, Spectrum Pharmaceuticals hopes its therapies will be able to address the unmet medical needs of patients. With a $3.08 share price, some analysts believe that now is the ideal time to snap up shares.

Writing for H.C. Wainwright, 5-star analyst Edward White remains focused on its novel long-acting granulocyte colony stimulating factor (GCSF) designed to stimulate neutrophil production for the treatment of chemotherapy induced neutropenia patients, Rolontis. Ahead of the candidate’s October 24 PDUFA date, the analyst highlights that Rolontis isn’t a biosimilar, and calls for 2020 sales of $3 million. Underscoring the huge potential here, he estimates sales will reach $300 million in 2026.

“Pricing in the market seems to be rational with the competition appearing more typical of a branded drug market rather than a generic drug market. Management noted that about 1 million units of GCSF are dispensed per year and that ASP price has been compressing between branded drugs and biosimilars. Despite the COVID-19 pandemic, the company has plenty of inventory available to support the commercial launch of Rolontis,” White commented.

It should also be noted that given the uncertainty surrounding COVID-19, management is planning for both a traditional and a virtual launch. In addition, SPPI is set to have a sufficient sales force on board in time for the commercial launch.

Looking at the clinical trial for Rolontis dosed on the same day as chemotherapy, White argues that the design should bode well for SPPI. “As this is an open-label study, the company can see early data before deciding to continue with development. Though data for a label change are years away, if the data are positive, this study could help dramatically change Rolontis’ market share in the future as we believe same day dosing in a post-COVID-19 world could be a game changer,” he explained.

With ZENITH20 Cohort 1 Poziotinib data at AACR demonstrating “there may be some hope yet”, the deal is sealed for White.

In addition to reiterating a Buy recommendation, he left his price target at $11. This target implies shares could climb 250% higher in the next year. (To watch White’s track record, click here)   

Overall, though not many have weighed in with an opinion on SPPI in the last 3 months, those who have are singing its praises loudly. Overall, two analysts rate the stock a Buy, and the $9.50 average price target puts the potential twelve-month gain at 202%. (See SPPI stock analysis on TipRanks)

Seres Therapeutics (MCRB)

Taking its place at the forefront of microbiome therapeutics, Seres Therapeutics wants to transform the treatment of a wide range of diseases by modulating the function of the human microbiome.

Based on the multiple catalysts slated for 2020 as well as its $4.73 share price, it’s no wonder MCRB is getting glowing reviews from several members of the Street.

Standing squarely in the bull camp is 5-star analyst Gbola Amusa, of Chardan Capital. He points out that enrollment for the Phase 3 ECOSPOR III trial evaluating SER-109's ability to prevent recurrent C. difficile infection (rCDI) is complete, with the candidate already receiving Breakthrough Therapy Designation.

As for the implications of this development, Amusa noted, “With positive results on the expected mid-2022 readout, ECOSPOR III has the potential to be a single pivotal study for the FDA; Seres plans to initiate a SER-109 Expanded Access Program.”

Adding to the good news, the company has taken strides forward when it comes to the advancement of the clinical development for its rationally-designed, fermented microbiome medicine, SER-155, for the prevention of mortality due to gastrointestinal infections, bacteremia and graft versus host disease (GvHD) in immunocompromised patients.

It should be noted that management told investors COVID-19 could impact its SER-287 Phase 2b and SER-401 Phase 1b clinical readouts. This is because the pandemic has put non-essential procedures including endoscopies on hold, and thus, it has been challenging to reach enrollment targets on time. That being said, the company doesn’t believe the availability of its product candidates for ongoing studies will experience any disruptions.

While a potential data readout delay has alarmed some investors, Amusa remains unphased. “Even with Covid-19-related uncertainties on SER-287 and SER-401, we continue to see 2020 as a catalyst rich year for Seres on the ECOSPOR III results alone, which with positive results could lead to SER-109 becoming the first FDA-approved microbiome medicine. Even with recent movements, the current MCRB market cap of $334 million to us is still modest in relation to the risk-adjusted opportunities represented by the pipeline,” he explained.

In line with his optimistic take, Amusa rates MCRB a Buy along with a $12.50 price target. This leaves room for shares to soar 151% in the next year. (To watch Amusa’s track record, click here)     

Do other analysts agree with Amusa? They do. Only Buy ratings, 4, in fact, have been issued in the last three months, so the consensus rating is a Strong Buy. At $9.63, the average price target puts the potential twelve-month gain at 91%. (See MCRB stock analysis on TipRanks)

Akari Therapeutics (AKTX)

Last up to bat we have Akari Therapeutics, which develops innovative treatments for autoinflammatory diseases involving the complement (C5) and leukotriene (LTB4) pathways. Given its strong execution and share price of only $2.14, is now the right time to get in on the action?

According to B.Riley FBR’s Mayank Mamtani, the answer is a resounding yes. At the end of May, the company provided an update on the progress of the clinical trials for bullous pemphigoid (BP), atopic keratoconjunctivitis (AKC) and pediatric transplant-induced thrombotic microangiopathy (HSCT-TMA) indications for its lead program, nomacopan. The candidate is also getting attention for its potential as a therapeutic option for COVID-19 patients.

The 5-star analyst thinks the full Phase 2 BP study results, as well as an orphan designation granted by the FDA and EMA, free AKTX up to kick off end-of-Phase 2 meetings with the FDA and EMA in Q3 2020 to discuss the pivotal Phase 3 trial design. These meetings would address important considerations including enrolling severe patients in addition to mild and moderate, increasing treatment duration from 1.5 to 6 months, an option to dose at 30 mg-plus levels and a choice of active versus comparator arms, including possibly combining or sequencing with steroids.

“There were no treatment-related serious AEs, in line with the favorable tolerability profile noted in other indications (e.g., PNH), highlighting further differentiation relative to steroid standard of care,” Mamtani stated.

However, Mamtani doesn’t dispute the fact that the COVID-19 pandemic has delayed site initiation activities for the Phase 3 HSCT-TMA trial to later in 2020 and the enrollment for the Part B placebo-controlled efficacy cohort of the Phase 1/2 study in severe AKC patients has been halted. That said, Mamtani notes “the interim update remains on track for mid-2020 in ~2/3rd of the targeted 16 patients already enrolled in the study.” He added, “The prior open-label data of nomacopan eye drops demonstrated in three severe atopic keratoconjunctivitis (AKC) patients rapid overall improvement in composite clinical scores of symptoms and signs.”

On top of this, preclinical data has found complement (C5) and leukotriene (LTB-4) pathways may play a role in severe lung inflammation and microthrombi and organ damage associated with COVID-19. This creates an opportunity for nomacopan as it has been shown to produce a “profound and broad-acting anti-inflammatory effect.”

To wrap it all up, Mamtani commented, “We believe AKTX has held up well in the volatile macro environment as investors look to take advantage of the depressed stock levels for this late-stage biotech supported by robust clinical data generated in earlier-stage trials, with incremental Phase 1/2 severe AKC placebo-controlled data anticipated in mid-2020.”

Everything the company has going for it prompted Mamtani to stay with the bulls. Along with a Buy rating, he kept his $5 price target as is, bringing the upside potential to 134%. (To watch Mamtani’s track record, click here)   

Turning now to the rest of the Street, it has been quiet when it comes to other analyst activity. Mamtani’s call was the only one issued recently.

To find good ideas for penny stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

The post 3 Biotech Stocks Under $5 With 100%-Plus Upside Potential appeared first on TipRanks Financial Blog.

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Coronavirus dashboard for October 5: an autumn lull as COVID-19 evolves towards seasonal endemicity

  – by New Deal democratBack in August I highlighted some epidemiological work by Trevor Bedford about what endemic COVID is likely to look like, based…

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 - by New Deal democrat

Back in August I highlighted some epidemiological work by Trevor Bedford about what endemic COVID is likely to look like, based on the rate of mutations and the period of time that previous infection makes a recovered person resistant to re-infection. Here’s his graph:




He indicated that it “illustrate[s] a scenario where we end up in a regime of year-round variant-driven circulation with more circulation in the winter than summer, but not flu-like winter seasons and summer troughs.”

In other words, we could expect higher caseloads during regular seasonal waves, but unlike influenza, the virus would never entirely recede into the background during the “off” seasons.

That is what we are seeing so far this autumn.

Confirmed cases have continued to decline, presently just under 45,000/day, a little under 1/3rd of their recent summer peak in mid-June. Deaths have been hovering between 400 and 450/day, about in the middle of their 350-550 range since the beginning of this past spring:



The longer-term graph of each since the beginning of the pandemic shows that, at their present level cases are at their lowest point since summer 2020, with the exception of a brief period during September 2020, the May-July lull in 2021, and the springtime lull this year. Deaths since spring remain lower than at any point except the May-July lull of 2021:



Because so many cases are asymptomatic, or people confirm their cases via home testing but do not get confirmation by “official” tests, we know that the confirmed cases indicated above are lower than the “real” number. For that, here is the long-term look from Biobot, which measures COVID concentrations in wastewater:



The likelihood is that there are about 200,000 “actual” new cases each day at present. But even so, this level is below any time since Delta first hit in summer 2021, with the exception of last autumn and this spring’s lulls.

Hospitalizations show a similar pattern. They are currently down 50% since their summer peak, at about 25,000/day:



This is also below any point in the pandemic except for briefly during September 2020, the May-July 2021 low, and this past spring’s lull.

The CDC’s most recent update of variants shows that BA.5 is still dominant, causing about 81% of cases, while more recent offshoots of BA.2, BA.4, and BA.5 are causing the rest. BA’s share is down from 89% in late August:



But this does not mean that the other variants are surging, because cases have declined from roughly 90,000 to 45,000 during that time. Here’s how the math works out:

89% of 90k=80k (remaining variants cause 10k cases)
81% of 45k=36k (remaining variants cause 9k cases)

The batch of new variants have been dubbed the “Pentagon” by epidmiologist JP Weiland, and have caused a sharp increase in cases in several countries in Europe and elsewhere. Here’s what she thinks that means for the US:


But even she is not sure that any wave generated by the new variants will exceed summer’s BA.5 peak, let alone approach last winter’s horrible wave:



In summary, we have having an autumn lull as predicted by the seasonal model. There will probably be a winter wave, but the size of that wave is completely unknown, primarily due to the fact that probably 90%+ of the population has been vaccinated and/or previously infected, giving rise to at least some level of resistance - a disease on its way to seasonal endemicity.

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Gonorrhea became more drug resistant while attention was on COVID-19 – a molecular biologist explains the sexually transmitted superbug

The US currently has only one antibiotic available to treat gonorrhea – and it’s becoming less effective.

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The _Neisseria gonorrhoeae_ bacterium causes gonorrhea by infecting mucous membranes. Design Cells/iStock Getty Images Plus via Getty Images

COVID-19 has rightfully dominated infectious disease news since 2020. However, that doesn’t mean other infectious diseases took a break. In fact, U.S. rates of infection by gonorrhea have risen during the pandemic.

Unlike COVID-19, which is a new virus, gonorrhea is an ancient disease. The first known reports of gonorrhea date from China in 2600 BC, and the disease has plagued humans ever since. Gonorrhea has long been one of the most commonly reported bacterial infections in the U.S.. It is caused by the bacterium Neisseria gonorrhoeae, which can infect mucous membranes in the genitals, rectum, throat and eyes.

Gonorrhea is typically transmitted by sexual contact. It is sometimes referred to as “the clap.”

Prior to the pandemic, there were around 1.6 million new gonorrhea infections each year. Over 50% of those cases involved strains of gonorrhea that had become unresponsive to treatment with at least one antibiotic.

In 2020, gonorrhea infections initially went down 30%, most likely due to pandemic lockdowns and social distancing. However, by the end of 2020 – the last year for which data from the Centers for Disease Control and Prevention is available – reported infections were up 10% from 2019.

It is unclear why infections went up even though some social distancing measures were still in place. But the CDC notes that reduced access to health care may have led to longer infections and more opportunity to spread the disease, and sexual activity may have increased when initial shelter-in-place orders were lifted.

As a molecular biologist, I have been studying bacteria and working to develop new antibiotics to treat drug-resistant infections for 20 years. Over that time, I’ve seen the problem of antibiotic resistance take on new urgency.

Gonorrhea, in particular, is a major public health concern, but there are concrete steps that people can take to prevent it from getting worse, and new antibiotics and vaccines may improve care in the future.

How to recognize gonorrhea

Around half of gonorrhea infections are asymptomatic and can only be detected through screening. Infected people without symptoms can unknowingly spread gonorrhea to others.

Typical early signs of symptomatic gonorrhea include a painful or burning sensation when peeing, vaginal or penal discharge, or anal itching, bleeding or discharge. Left untreated, gonorrhea can cause blindness and infertility. Antibiotic treatment can cure most cases of gonorrhea as long as the infection is susceptible to at least one antibiotic.

There is currently only one recommended treatment for gonorrhea in the U.S. – an antibiotic called ceftriaxone – because the bacteria have become resistant to other antibiotics that were formerly effective against it. Seven different families of antibiotics have been used to treat gonorrhea in the past, but many strains are now resistant to one or more of these drugs.

The CDC tracks the emergence and spread of drug-resistant gonorrhea strains.

Why gonorrhea is on the rise

A few factors have contributed to the increase in infections during the COVID-19 pandemic.

Early in the pandemic, most U.S. labs capable of testing for gonorrhea switched to testing for COVID-19. These labs have also been contending with the same shortages of staff and supplies that affect medical facilities across the country.

Many people have avoided clinics and hospitals during the pandemic, which has decreased opportunities to identify and treat gonorrhea infections before they spread. In fact, because of decreased screening over the past two and a half years, health care experts don’t know exactly how much antibiotic-resistant gonorrhea has spread.

Also, early in the pandemic, many doctors prescribed antibiotics to COVID-19 patients even though antibiotics do not work on viruses like SARS-CoV-2, the virus that causes COVID-19. Improper use of antibiotics can contribute to greater drug resistance, so it is reasonable to suspect that this has happened with gonorrhea.

Overuse of antibiotics

Even prior to the pandemic, resistance to antibiotic treatment for bacterial infections was a growing problem. In the U.S., antibiotic-resistant gonorrhea infections increased by over 70% from 2017-2019.

Neisseria gonorrhoeae is a specialist at picking up new genes from other pathogens and from “commensal,” or helpful, bacteria. These helpful bacteria can also become antibiotic-resistant, providing more opportunities for the gonorrhea bacterium to acquire resistant genes.

Strains resistant to ceftriaxone have been observed in other countries, including Japan, Thailand, Australia and the U.K., raising the possibility that some gonorrhea infections may soon be completely untreatable.

Steps toward prevention

Currently, changes in behavior are among the best ways to limit overall gonorrhea infections – particularly safer sexual behavior and condom use.

However, additional efforts are needed to delay or prevent an era of untreatable gonorrhea.

Scientists can create new antibiotics that are effective against resistant strains; however, decreased investment in this research and development over the past 30 years has slowed the introduction of new antibiotics to a trickle. No new drugs to treat gonorrhea have been introduced since 2019, although two are in the final stage of clinical trials.

Vaccination against gonorrhea isn’t possible presently, but it could be in the future. Vaccines effective against the meningitis bacterium, a close relative of gonorrhea, can sometimes also provide protection against gonorrhea. This suggests that a gonorrhea vaccine should be achievable.

The World Health Organization has begun an initiative to reduce gonorrhea worldwide by 90% before 2030. This initiative aims to promote safe sexual practices, increase access to high-quality health care for sexually transmitted diseases and expand testing so that asymptomatic infections can be treated before they spread. The initiative is also advocating for increased research into vaccines and new antibiotics to treat gonorrhea.

Setbacks in fighting drug-resistant gonorrhea during the COVID-19 pandemic make these actions even more urgent.

Kenneth Keiler receives funding from NIH.

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Measuring the Ampleness of Reserves

Over the past fifteen years, reserves in the banking system have grown from tens of billions of dollars to several trillion dollars. This extraordinary…

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Over the past fifteen years, reserves in the banking system have grown from tens of billions of dollars to several trillion dollars. This extraordinary rise poses a natural question: Are the rates paid in the market for reserves still sensitive to changes in the quantity of reserves when aggregate reserve holdings are so large? In today’s post, we answer this question by estimating the slope of the reserve demand curve from 2010 to 2022, when reserves ranged from $1 trillion to $4 trillion.

What Are Reserves? And Why Do They Matter?

Banks hold accounts at the Federal Reserve where they keep cash balances called “reserves.” Reserves meet banks’ various needs, including making payments to other financial institutions and meeting regulatory requirements. Over the past fifteen years, reserves have grown enormously, from tens of billions of dollars in 2007 to $3 trillion today. The chart below shows the evolution of reserves in the U.S. banking system as a share of banks’ total assets from January 2010 through September 2022. The supply of reserves depends importantly on the actions of the Federal Reserve, which can increase or decrease the quantity of reserves by changing its securities holdings, as it did in response to the global financial crisis and the COVID-19 crisis.

Reserves Have Ranged from 8 to 19 Percent of Bank Assets from 2010 to 2022

Sources: Federal Reserve Bank of New York; Federal Reserve Economic Data, FRED (“TLAACBW027SBOG”); authors’ calculations.

Why does the quantity of reserves matter? Because the “price” at which banks trade their reserve balances, which in turn depends importantly on the total amount of reserves in the system, is the federal funds rate, which is the interest rate targeted by the Federal Open Market Committee (FOMC) in the implementation of monetary policy. In 2022, the FOMC stated that “over time, the Committee intends to maintain securities holdings in amounts needed to implement monetary policy efficiently and effectively in its ample reserves regime.” In this ample reserves regime, the Federal Reserve controls short-term interest rates mainly through the setting of administered rates, rather than by adjusting the supply of reserves each day as it did prior to 2008 (as discussed in this post). In today’s post, we describe a method to measure the sensitivity of interest rates to changes in the quantity of reserves that can serve as a useful indicator of whether the level of reserves is ample.

The Demand for Reserves Informs Us about Rate Sensitivity to Reserve Shocks

To assess whether the level of reserves is ample, one needs to first understand the demand for reserves. Banks borrow and lend in the market for reserves, typically overnight. The reserve demand curve describes the price at which these institutions are willing to trade their balances as a function of aggregate reserves. Its slope measures the price sensitivity to changes in the level of reserves. Importantly, banks earn interest on their reserve balances (IORB), set by the Federal Reserve. Because the IORB rate directly affects the willingness of banks to lend reserves, it is useful to describe the reserve demand curve in terms of the spread between the federal funds rate and the IORB rate. In addition, we control for the overall growth of the U.S. banking sector by specifying reserve demand in terms of the level of reserves relative to commercial banks’ assets.

There is a clear nonlinear downward-sloping relationship between prices and quantities of reserves, consistent with economic theory. The chart below plots the spread between the federal funds rate and the IORB against total reserves as a share of commercial banks’ total assets.  When reserves are very low, the demand curve has a steep negative slope, reflecting the willingness of borrowers to pay high rates because reserves are scarce. At the other extreme, when reserves are very high, the curve becomes flat because banks are awash with reserves and the supply is abundant. Between these two regions, an intermediate regime–that we refer to as “ample”–emerges, where the demand curve exhibits a modest downward slope. The color coding of the chart reflects the shifts in the reserve demand curve over time. In particular, the curve appears to have moved to the right and upward around 2015 and then moved upward after March 2020, at the onset of the COVID pandemic.

Reserve Demand Has Shifted over Time

Sources: Federal Reserve Bank of New York; Federal Reserve Economic Data, FRED (“TLAACBW027SBOG,” “IOER,” and “IORB”); authors’ calculations.

This chart highlights two of the main challenges in estimating the slope of the reserve demand curve. First, the curve is highly nonlinear, which means that a standard linear estimation approach is not appropriate. Second, various long-lasting changes in the regulation and supervision of banks, in their internal risk-management frameworks, and in the structure of the reserve market itself have resulted in shifts in the reserve demand curve. A third challenge is that the quantity of reserves may be endogenous to banks’ demand for them. Therefore, to properly measure the reserve demand curve, one must disentangle shocks to supply from those to demand. As we explain in detail in a recent paper, our estimation strategy addresses all three of these challenges.

Estimating the Slope of the Reserve Demand Curve

Our approach provides time-varying estimates of the price sensitivity of the demand for reserves that can be used to distinguish between periods in which reserves are relatively scarce, ample, or abundant. The chart below presents our daily estimates of the slope of the demand curve, as measured by the rate sensitivity to changes in reserves. Although we do not have a precise criterion for when reserves are scarce versus ample, during two episodes in our sample, the estimated rate sensitivity is well away from zero. The first episode occurs early in our sample, in 2010, and the second emerges almost ten years later, in mid-2019. In two other periods—during 2013-2017 and from mid-2020 through early September 2022—the estimated slope is very close to zero, indicating an abundance of reserves. The remaining periods are characterized by a modest negative slope of the reserve demand curve, consistent with ample (but short of abundant) reserves. The overall pattern of these estimates is robust to changes in the model specification, such as including spillovers from the repo and Treasury markets or measuring reserves as a share of gross domestic product or bank deposits (instead of as a share of banks’ assets).

Rate Sensitivity Changed over Time, Following the Path of Reserves

Sources: Federal Reserve Bank of New York; Federal Reserve Economic Data, FRED (“TLAACBW027SBOG,” “IOER,” and “IORB”); authors’ calculations.

Interest Rate Spreads Alone Are Not Reliable Indicators of Reserve Scarcity

As we discuss in our paper, the time variation in the estimated price sensitivity in the demand for reserves is based on observations of small movements along the demand curve due to exogenous supply shocks. The location of the curve itself, however, also changes over time. That is, there is not a constant relationship between the level of reserves and the slope of the reserve demand curve.  

In our paper, we find evidence of both horizontal and vertical shifts in the reserve demand curve, with vertical upward shifts being particularly important since 2015. This finding implies that the level of the federal funds-IORB spread may not be a reliable summary statistic for the sensitivity of interest rates to reserve shocks, and that estimates of the price sensitivity in the demand for reserves provide additional useful information.

In summary, we have developed a method to estimate the time-varying interest rate sensitivity of the demand for reserves that accounts for the nonlinear nature of reserve demand and allows for structural shifts over time. A key advantage of our methodology is that it provides a flexible and readily implementable approach that can be used to monitor the market for reserves in real time, allowing one to assess the “ampleness” of the reserve supply as market conditions evolve.

Gara Afonso is the head of Banking Studies in the Federal Reserve Bank of New York’s Research and Statistics Group.

Gabriele La Spada is a financial research economist in Money and Payments Studies in the Federal Reserve Bank of New York’s Research and Statistics Group.   

John C. Williams is the president and chief executive officer of the Federal Reserve Bank of New York.  

How to cite this post:
Gara Afonso, Gabriele La Spada, and John C. Williams, “Measuring the Ampleness of Reserves,” Federal Reserve Bank of New York Liberty Street Economics, October 5, 2022, https://libertystreeteconomics.newyorkfed.org/2022/10/measuring-the-ampleness-of-reserves/.


Disclaimer
The views expressed in this post are those of the author(s) and do not necessarily reflect the position of the Federal Reserve Bank of New York or the Federal Reserve System. Any errors or omissions are the responsibility of the author(s).

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