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AVDL Stock Forecast: FDA Decision Soon, Is It a Buy?

With an FDA decision right around the corner, is it time to buy AVDL stock? Keep reading to learn more and what to expect going forward.
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With an FDA decision right around the corner, is it time to buy AVDL stock? The pharmaceutical firm is making swift progress on its lead drug candidate for excessive daytime sleepiness, a disorder affecting up to 20% of the population. Avadel Pharmaceuticals (Nasdaq: AVDL) also develops innovative drug delivery tech to improve how current medication is taken.

In February 2021, the FDA accepted Avadel’s New Drug Application (NDA) for faster approval with a target date of October 15, 2021. But, instead of a decision, the drugmaker received a notice the review is still under review.

At this time, Avadel has yet to hear back from the FDA. Should you consider AVDL stock with a decision coming soon? Keep reading to learn more about Avadel and what to expect next going forward.

AVDL Stock Drops 36%, Then Gains 20%

Last week, AVDL stock made headlines after falling over 35% intraday on Monday. The move came as a surprise with no apparent news to note. The only Avadel Pharmaceutical news released on April 25 was a patient survey from an open-label study.

Presenting author Asim Roy, M.D. highlights the “burden that the second dose (from twice nightly oxybates) places on some patients.” Furthermore, he notes a “once-at-bedtime option like FT218 would ease this burden and potentially be a major advance for the entire narcolepsy community.”

Given these points, does a 35% selloff sound warranted? For this reason, CEO Greg Divis released a statement the next day (Tuesday, April 26). Davis claims Avadel is “unaware of any new information” about the FDA’s decision on FT218, causing share prices to bounce.

As a result, AVDL shares rallied on heavy volume but have yet to find support. Since the rally, AVDL stock is falling to near yearly lows, around $4.4 per share.

At the same time, many growth stocks are down since then, with the iShares Russell 1000 Growth ETF giving up 5%.

Is this the buying opportunity you have been waiting for? If the FDA approves FT218, it could be an immediate market upgrade.

A Treatment for Excessive Daytime Sleepiness?

If you find yourself falling asleep behind your desk, it could be due to several reasons. Maybe you didn’t sleep well the night before, or have a lot of stress on your mind.

But, when it happens consistently, it can be a serious disorder known as Excessive Daytime Sleepiness (EDS). More importantly, it can be caused by a neurological disorder called Narcolepsy. With this in mind, Narcolepsy affects about 3 million worldwide, with hard-to-diagnose symptoms.

Currently, medication for Narcolepsy is available in twice-nightly formulas. However, the issue is that users need to take the second dose in the middle of the night. So, the routine can cause more problems on top of the original diagnosis.

So, Avadel’s FT218 uses the company’s superior drug release tech to allow for a single dose. The product’s NDA is still under FDA review while the company prepares for launch.

  • Jan 2018: FDA grants FT218 orphan status.
  • Jul 2020: The first patient dosed.
  • Dec 2020: Avadel submits NDA to FDA.
  • Feb 2021: FDA accepts NDA.
  • April 2021: Positive top-line data from Phase 3 Trials.
  • Oct 2021: Avadel announces ongoing FDA review.
  • April 2022: Avadel releases a patient study, indicating patients prefer FT218.

At this point, AVDL stock is awaiting approval from the FDA while preparing to launch the drug. So far, data suggests FT218 may have an opportunity, with one study claiming almost 95% of patients prefer it.

AVDL Stock Analysis

With a major FDA decision looming, AVDL stock is sitting right above its lowest price since the pandemic. In fact, after soaring to highs over $13 a share in April 2020, AVDL stock has yet to reach those levels.

Shares of AVDL were essentially stuck in a channel, floating between $5 to $11 a share. The channel held support and resistance levels until now, but that changed last week. After falling to $4.2, AVDL stock sits below all major trendlines with heavy distribution.

Meanwhile, most stocks are selling off with the Federal Reserve raising interest rates again yesterday. Though stocks bounced yesterday after the announcement, all sectors are in the red today.

Despite the gloomy outlook, AVDL stock may be positioned for growth in 2022. If they receive FDA approval, it will be an immediate market upgrade. As of right now, the market value is around $1.8 billion, with Avadel estimating only 40% of eligible patients. With positive data and patient support so far, FT218 looks like a win for Avadel.

Not So Fast

Although this seems like an easy win, the drug approval process is never easy. First, nobody knows how long the FDA will take to approve. With the FDA focusing on the pandemic, several approval dates are pushed back.

Until we hear more, AVDL stock is likely dead weight. Furthermore, suppose the FDA, for some reason, denies the approval or requests more information. In that case, it can put further pressure on AVDL shares.

We’ve seen it too many times before, new drug makers with promising new treatments losing significant market value. But, with Avadel Pharmaceuticals stock already down over 45% this year, will we see some relief? At the same time, we saw a glimpse of how fast AVDL stock can fall last week after rumors of an FDA decision.

AVDL Stock Forecast: Boom or Bust?

A major part of Avadel’s success hinges on the FDA decision for FT218. The results look promising so far. Patients like it, and it has a market. AVDL stock looks cheap at these levels with a multi-billion dollar market if everything goes according to plan.

Although an FDA rejection would be a significant blow to the company, I wouldn’t necessarily say Avadel is a boom or bust. Another key thing to consider is the firm’s drug delivery technology.

If Avadel can apply it to Narcolepsy treatments, what else could they use it for? It may have a more prominent role to play in the healthcare industry.

The post AVDL Stock Forecast: FDA Decision Soon, Is It a Buy? appeared first on Investment U.

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Economics

Looming Global Food Crisis Requires Immediate and Coordinated Action from All Sectors

Looming Global Food Crisis Requires Immediate and Coordinated Action from All Sectors
PR Newswire
BOSTON, May 17, 2022

The War in Ukraine Exposes an Urgent Need to Rethink and Improve the Structure and Resilience of Our Food SystemsPublic, Private,…

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Looming Global Food Crisis Requires Immediate and Coordinated Action from All Sectors

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  • The War in Ukraine Exposes an Urgent Need to Rethink and Improve the Structure and Resilience of Our Food Systems
  • Public, Private, and Social Sectors Must Collaboratively Reshape Food Systems to React Quickly When Humanitarian Needs Are Most Pressing
  • New BCG Report Provides 30 Near- and Medium-Term Solutions to Make Global Food Systems More Resilient

BOSTON, May 17, 2022 /PRNewswire/ -- Russia's invasion of Ukraine is testing the capacity of global food systems to feed the world in times of crisis. An estimated 1.7 billion people—most of them in developing economies—could suffer severely increased food insecurity, higher energy prices, or greater debt burdens, according to the UN Task Team for the Global Crisis Response Group. Each of these individual factors adversely affects people's ability to feed themselves. At the same time, there is a critical need to address them more holistically and across all sectors in order to reshape our food systems so that we can counteract this humanitarian crisis—and future ones.

A new report from Boston Consulting Group (BCG), titled The War in Ukraine and the Rush to Feed the World, explores in detail the multiple direct and indirect impacts of the turmoil in Ukraine and provides 30 near- and medium-term solutions to help respond to the crisis and improve the resilience of global food systems. As the report notes, the looming global food crisis isn't about the world's capacity to produce enough food. Rather, it is about our food systems' inability to securely and equitably store and distribute enough food—and the inputs needed to produce it—in the face of the disruption caused by the ongoing war.

Together, Russia and Ukraine account for about 12% of the total food calories traded around the world, and both are critical exporters of key commodities such as wheat (28% of global trade) and sunflower oil (69%), according to the International Food Policy Institute. The UN's World Food Programme (WFP) buys from Ukraine half of the wheat it distributes around the world. Further, as exports from these countries tumble, some other leading exporting countries have announced export bans or licensing restrictions designed to protect their own food stockpiles.

As a result, prices are skyrocketing—not just for food, but also for essential agricultural inputs, such as fertilizer and fuel, that Russia has long been a key supplier of. About half of the world's people rely on food outputs that use fertilizer, and a drop in fertilizer supply could severely affect exposed populations for up to four years unless action is taken immediately to boost supplies. Moreover, the ripple effects of disruptions to the fertilizer supply chain will reach consumers worldwide.

The war's impact on fuel prices has been equally dramatic. Aside from the added cost to farmers of fuel they need to power their equipment, last-mile inland transportation account for as much as 40% of food costs in many developing countries. So as fuel prices go up, the total cost of food increases, creating a vicious cycle.

Making matters worse, the current crisis coincides with high debt levels in many developing economies around the world. Largely due to public spending to address the challenges presented by COVID-19, about 60% of low-income countries are currently in, or at high risk of, debt distress, compared with just 30% in 2015, according to the International Monetary Fund.

"While this crisis will impact all of us around the world in significant ways, low-income economies risk devastation and potential unrest," said Ertharin Cousin, CEO and founder of Food Systems for the Future, and a coauthor of the report. "We're not just talking about the poorest of the poor, who are already suffering from hunger. We're also talking about people who could recently afford a loaf of bread for their families and who now will literally be unable to do so."

Relieving the current crisis requires, most importantly, a coordinated and immediate emergency humanitarian response by all stakeholders—governments, development institutions and banks, NGOS, and private companies—to meet the most pressing needs for humanitarian aid. They must provide not only food and financial support, but also the seeds, inputs, tools, and technical assistance needed to support in-country sustainable intensification and other crop substitution actions. The report outlines a solution set of 30 key recommendations for all stakeholders. (See the exhibit.)

"There is a lot of talk about the individual components of the crisis, but it is critical that we look at things holistically and recognize the interdependence of factors ranging from rising costs of food, fertilizer, and fuel, to maxed-out debt, climate-related issues, ongoing conflicts elsewhere in the world, and COVID-19. There are multiple prongs of failure at risk of being tipped over by Russia's invasion of Ukraine," said Shalini Unnikrishnan, a managing director and partner at BCG, the global leader for Food and Nature in the firm's Social Impact practice, and a coauthor of the report.

"Just as critically, we need a coordinated effort across all sectors to rethink and repair our food systems, making them more equitable, more resilient, and more responsive in times of great need," Unnikrishnan continued. "Avoiding more such crises will require diversifying food production across diets, supply chains, and markets, and addressing the indebtedness, economic inequities, and market distortions that have contributed to the current crisis."

Download the publication here: https://www.bcg.com/publications/2022/how-the-war-in-ukraine-is-affecting-global-food-systems

For media queries, please contact Eric Gregoire at +1 617 850 3783 or gregoire.eric@bcg.com.

About Boston Consulting Group
Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we work closely with clients to embrace a transformational approach aimed at benefiting all stakeholders—empowering organizations to grow, build sustainable competitive advantage, and drive positive societal impact.

Our diverse, global teams bring deep industry and functional expertise and a range of perspectives that question the status quo and spark change. BCG delivers solutions through leading-edge management consulting, technology and design, and corporate and digital ventures. We work in a uniquely collaborative model across the firm and throughout all levels of the client organization, fueled by the goal of helping our clients thrive and enabling them to make the world a better place.

About Food Systems for the Future
Food Systems for the Future (FSF) was founded to catalyze, enable, and scale market-driven agtech, foodtech, and innovative businesses across the value chain to improve nutrition outcomes in underserved and low-income communities. Through wraparound support to enterprises and broader ecosystem building, FSF addresses barriers to affordability, availability, and awareness of healthy, nutrient dense foods through our core services: financing, business acceleration, public policy & education, partnerships & community engagement, and nutrition expertise. FSF currently operates in the United States and Sub-Saharan Africa. To find out more, visit fsfinstitute.net.

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SOURCE Boston Consulting Group (BCG)

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Economics

Morgan Stanley: SPX could return to its pre-pandemic 3,400 level

The S&P 500 index could return to its pre-pandemic 3,400 level in the coming months that translates to another 15% downside from here, warned a Morgan…

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The S&P 500 index could return to its pre-pandemic 3,400 level in the coming months that translates to another 15% downside from here, warned a Morgan Stanley analyst on Monday.

Don’t be fooled by the bear market rally

Michael Wilson dubs the recent bounce (about 4.0%) in U.S. equities a “bear market rally” and says investors should brace for more pain ahead as inflation and supply constraints remain a significant headwind. In his note, the analyst said:

With valuations now more attractive, equity markets so oversold an rates potentially stabilizing below 3.0%, stocks appear to have begun another material bear market rally. After that, we remain confident that lower prices are still ahead.

Last week, the U.S. Bureau of Labour Statistics said inflation stood at 8.30% in April – a marginal decline versus the prior month but still ahead of the Dow Jones estimate.

How to navigate the current environment?

Wilson continues to see a recession as unlikely, but agrees that the risk of such an economic downturn has certainly gone up. The U.S. economy unexpectedly shrank 1.40% in the first quarter of 2022.

That is just another reason why equity risk premium is too low, and stocks are still overpriced. The bear market won’t be over until valuations fall to levels (14 – 15x) that discount the kind of earnings cuts we envision, or earnings estimates get cut.

He recommends increasing exposure to real estate, health care, and utilities stocks to navigate the current environment, while tech and consumer discretionary stocks remain a big “no” for him.

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Jelenew becomes the only sports brand as the Signature Sponsor of amfAR Gala during the 75th Festival de Cannes

Jelenew becomes the only sports brand as the Signature Sponsor of amfAR Gala during the 75th Festival de Cannes
PR Newswire
WILMINGTON, Del., May 16, 2022

Jelenew x Stéphane cycling-pants dress will be auctioned off to support the fight against AID…

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Jelenew becomes the only sports brand as the Signature Sponsor of amfAR Gala during the 75th Festival de Cannes

PR Newswire

Jelenew x Stéphane cycling-pants dress will be auctioned off to support the fight against AIDS and COVID-19

WILMINGTON, Del., May 16, 2022 /PRNewswire/ -- AmfAR announced on April 26 that Jelenew would be an amfAR Signature sponsor during the 75th Cannes Film Festival. It is reported that Jelenew is the only athletic brand among them. And Jelenew will jointly create a cycling-pants dress newlook with Stéphane Rolland, and one of the cycling-pants dresses will auction at the dinner. This helps amfAR raise funds for the American AIDS Research Foundation to contribute to the global fight against AIDS (AIDS) and COVID-19.

As a pioneer challenger in the professional cycling apparel industry, Jelenew has always adhered to the brand concept of "born for women." It focuses on solving clothing and equipment problems in professional cycling for women. It is committed to providing women with cycling products that perfectly integrate "sport functionalism, comfort, and 3D structural aesthetics". The earliest motivation for Jelenew to develop "1+1 model" detachable outer padded cycling pants (1 pair of tight-fitting leggings + 1 pair of detachable outer padded cycling shorts) came from Jelenew's social responsibility and industry mission.

In tracing the evolution history of cycling pants, the Jelenew R&D team found that although there are significant structural differences and needs between men and women. In the past 100 years, male and female riders have worn the same built-in pad cycling pants structure. They know that the "cycling pad" significantly impacts cyclists; it is the core element that affects cycling pants' comfort, sports performance, and health and hygiene index. Unscientific structure and design will obliterate women's health, comfort, and beauty. The women's cycling apparel industry urgently needs a cycling brand that is "truly made for women," which can solve the pain points of female consumers from a female perspective. So those female cyclists can enjoy the same healthy riding as male cyclists.

Jelenew's creative director Di Liu, a former Chanel Haute Couture designer, established Jelenew's research team and product development team in Paris, France. According to the different physiological structures of men and women and the differentiated needs in the riding process, he took the lead in introducing the moulage technique into the design of professional cycling pants. He led the development of the first professional cycling pants for women, the Jelenew 1+1 model: detachable outer padded cycling pants. These cycling pants subvert the built-in pad structure of traditional cycling pants. They are the first professional cycling pants truly created for women globally. 

As the world's top charity dinner, amfAR has become one of the most anticipated events during the Cannes Film Festival. Each session has attracted many international celebrities to show up to help out. As a high-profile event, amfAR is also cautious in selecting cooperative brands. The list of official partners used to be Chopard, Bvlgari,Harry Winston and Louis Vuitton, the top brands loved by celebrities. This year, in the official invitation letter of amfAR, the cutting-edge brand Jelenew is listed, and it is the only signature sponsor other than Chopard.

Di Liu said: "Jelenew is honored to be the amfAR signature sponsor during the 75th Cannes Film Festival. Over the years, this good foundation has been dedicated to advocating the impact of AIDS and HIV, providing financial support to HIV/AIDS researchers worldwide, and seeking to translate their research findings into effective policy, prevention, and a therapeutic education program that benefits the world. Each of us has the power to drive transformation. As an individual, the power may not be that great. However, when we come together, we become world game-changers. Jelenew is proud to be a part of it. "

It is understood that the cycling-pants dress newlook of Jelenew x Stéphane Rolland, which will be auctioned at the charity dinner this time, draws inspiration from the golden age of Spain in the 17th century and is a "dark cycling bride" dress look with a sense of the times. Stéphane Rolland designs the black dress on the upper body according to the paintings of Goya and Velasquez and the large black tunic with more stripes. And sleeves are embroidered with Art Deco crystals. Jelenew is based on the first professional outer padded cycling pants. It is inspired by the "Goddess of Victory" in the Louvre Museum. It draws inspiration from the Spanish 17th-century noble knight pants to create a pair of cycling pants with feminine avant-garde. This is the first cross-field cooperation between Sports Technology and Haute Couture, a milestone in the fashion field. 

It is reported that all proceeds from the cycling-pants dress newlook auction will be donated to the "amfAR AIDS Research Fund."

About JELENEW 

Jelenew is an American avant-garde cycling brand born for women. It creates the first cycling pants truly made for women in the world. It brings the groundbreaking combination of "Haute Couture and Sportswear" and carefully designs each product with "luxury moulage technique" to provide a more refined sports experience and promote a healthy lifestyle for cyclists to enjoy elegant and stylish suburban cycling.

About amfAR and amfAR Gala 

amfAR, The Foundation for AIDS Research, is one of the world's leading nonprofit organizations dedicated to the support of AIDS research, HIV prevention, treatment education, and advocacy. Since 1985, amfAR has invested nearly $617 million in its programs and has awarded more than 3,500 grants to research teams worldwide.

Celebrities frequently donate items to be auctioned off for the foundation. Past donors have included Uma Thurman, Karlie Kloss, and Milla Jovovich. The 25th annual gala embraced the #MeToo movement. 25 prominent women chaired it on stage and screen, namely: Alessandra Ambrosio, Poppy Delevigne, Linda Evangelista, Sylvia Fendi, Aileen Getty, Kate Hudson, Scarlett Johansson, Milla Jovovich, Heidi Klum, Daphna Krim (daughter of Mathilde Krim), Karolina Kurkova, Sienna Miller, Angela Missoni, Mary Parent, Katy Perry, Natasha Poly, Aishwarya Rai, Vanessa Redgrave, Joely Richardson, Carine Roitfeld, Caroline Scheufele, Irina Shayk, Lara Stone, Donatella Versace, and Michelle Yeoh. Past items auctioned have included numerous photographs by Andy Warhol, Annie Leibovitz portrait sessions, stays in fashion moguls and celebrity houses, and 53-karat diamond jewelry. Heidi Klum notably donated her Bentley S3 convertible to garner one of the highest bids at €200,000.

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SOURCE Jelenew

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