Senin, 16 Desember 2019

A deal for DuPont's food business will create a $45 billion giant - CNN

The deal announced Sunday values the DuPont unit at $26.2 billion. DuPont shareholders will retain a majority stake in the new entity, which will have a combined annual revenue of more than $11 billion.
New York-based IFF (IFF) develops flavors and fragrances for consumer brands. The company has 33,000 customers and hundreds of manufacturing and research facilities around the world, according to its website.
DuPont, which counts Kevlar and Styrofoam as clients, has been shaking up its business in recent years. The former giant DowDuPont is now three separate companies that focus on material sciences (now called Dow Inc. (DOW)), agriculture (now dubbed Corteva (CTVA)) and specialty goods (DuPont). Aside from its nutrition unit, DuPont also focuses on products related to electronics, transportation and construction.
IFF and DuPont want to blitz the global ingredients market while cutting down on costs significantly. The firms said in a joint statement Sunday that they are projecting savings of about $300 million within three years of closing the deal, and expect the new company to achieve a leading position in segments including soy proteins, enzymes and probiotics.
The firms want to close the deal, which is still subject to approval by regulators and IFF shareholders, by early 2021. IFF CEO Andreas Fibig will continue to serve as chairman and chief executive.
IFF employees working with perfume components at a company lab in France in 2016.
Consumers have been increasingly gravitating toward healthier and more natural flavors, a trend that the companies said played an important factor in their decision to merge. Natural flavors are "the dominating segment" in the global food flavoring industry, accounting for over 50% of the market in 2018, according to Wall Street research firm Reports and Data.
IFF reportedly beat out Irish food giant Kerry Group for the deal. As of last week, the European company had also been interested in snapping up DuPont's nutrition division, according to a Bloomberg report. Kerry Group did not immediately respond to a request for comment from CNN Business outside regular business hours.
"We conducted a very thorough process leading us to the selection of IFF as the preferred strategic partner," Ed Breen, DuPont's executive chairman, said in the statement Sunday. "I am confident that [the nutrition unit] will be well-positioned for its next phase of growth."

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2019-12-16 08:58:00Z
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Minggu, 15 Desember 2019

What's the Best Social Security Strategy for Me? - The Motley Fool

Social Security is a major income source for millions of retired seniors. If you expect to depend heavily on those benefits during your golden years, then it's crucial that you claim them at the right time. Here, we'll help you devise a Social Security filing strategy that makes sense based on your financial needs and circumstances.

How Social Security benefits are calculated

The age at which you file for benefits will determine how much income you receive from Social Security on a monthly basis. But before we get into choosing the right age, let's understand how those benefits are calculated.

To start, the Social Security Administration (SSA) takes your average monthly earnings over your 35 highest-paid years of income, and adjusts those wages to account for inflation. If you're a higher earner, it could be the case that not all of your income counts toward your benefits calculation. That's because Social Security imposes an earnings cap on wages that changes from year to year. Currently, it's $132,900, which means that any income above that level won't influence your benefits (plus, you won't pay Social Security taxes on earnings beyond that point).

Social Security cards

IMAGE SOURCE: GETTY IMAGES.

The number the SSA comes up with is called your average indexed monthly earnings, or AIME. A formula is then applied to your AIME to arrive at your primary insurance amount, which is what your full monthly benefit will entail at full retirement age, or FRA.

FRA isn't the same for everyone. It's a function of your year of birth, as follows:

If You Were Born In:

Your Full Retirement Age is:

1943-1954

66

1955

66 and 2 months

1956

66 and 4 months

1957

66 and 6 months

1958

66 and 8 months

1959

66 and 10 months

1960 or later

67

DATA SOURCE: SOCIAL SECURITY ADMINISTRATION.

Now here comes the tricky part: You don't have to claim Social Security at your precise FRA. The SSA allows you to file for benefits as early as age 62, but for each month you claim before reaching FRA, your monthly benefit will be reduced as follows:

  • 5/9 of 1% per month, or 6.67% a year, for the first 36 months you file before FRA
  • 5/12 of 1% per month, or 5% a year, for each additional month or year you file before FRA

Here's how that might play out. Let's imagine you're entitled to a full monthly benefit of $1,600 at an FRA of 67. Here's what you'll wind up collecting instead if you file early:

If You File at Age:

Your Benefits Will Be Reduced by This Much:

And You'll Wind Up With This Monthly Benefit:

66

6.67%

$1,493

65

13.34%

$1,386

64

20%

$1,280

63

25%

$1,200

62

30%

$1,120

TABLE BY AUTHOR.

Keep in mind that the monthly benefit you start off collecting will generally be the same amount you receive for life (not counting the yearly cost-of-living adjustments that are added to your benefits). The only exception is if you withdraw your benefits application within a year of filing and repay the SSA all of the benefits it paid you. In that case, you can file for Social Security again at a later point in time for a higher monthly benefit. But to be clear, if you file before FRA and don't undo your benefits application, those benefits won't be bumped up once you reach FRA.

There's also the option to delay benefits past FRA. In doing so, you'll accrue delayed retirement credits that raise your benefits by 2/3 of 1% for each month you file for Social Security after FRA. That comes to 8% a year. However, those credits cease to accrue once you reach age 70, which is why 70 is generally considered the latest age to claim benefits (even though the SSA certainly won't force you to file at that point).

Going back to our example of a full monthly benefit of $1,600 at an FRA of 67, here's what holding off on Social Security might do for you:

If You File at Age:

Your Benefits Will Be Increased by This Much:

And You'll Wind Up With This Monthly Benefit:

68

8%

$1,728

69

16%

$1,856

70

24%

$1,984

TABLE BY AUTHOR.

All of the above illustrates why it's so important to file for benefits at the right age. In our example, you could wind up with as little as $1,120 per month or as much as $1,984 per month in Social Security income depending on when you choose to sign up.

The right Social Security strategy for you

There are multiple factors that need to go into your Social Security filing decision. To come up with the best age for claiming benefits, answer each of these key questions carefully:

1. Do I need the money right away?

It could be the case that you lose your job later in life and struggle to find a new one, or you have a pressing need for money that your salary and savings can't address. If you need money right away and your only other options is to rack up costly credit card debt, then you may have no choice but to file for Social Security immediately. That may place you in the position of filing before FRA or filing after FRA, but at an earlier point than you'd like.

On the other hand, if you don't have an instant need for money, it often pays to hold off on taking benefits and let them continue growing. Keep in mind that if, for example, you require money for a home repair but have equity in your home, a loan or HELOC could provide you with instant access to cash at an interest rate that's affordable, thereby allowing you to leave your benefits alone. Make sure you consider all alternatives first.

2. Do I have a healthy amount of savings?

Social Security was never meant to sustain seniors in retirement by itself. If you were an average earner, those benefits will replace about 40% of your former income. Most seniors, however, need roughly double that amount to live comfortably while keeping up with their expenses. Of course, there is some wiggle room in that estimate -- if you're willing to lead a very modest lifestyle in retirement, you can possibly get by on 60% of your former income. But chances on, 40% won't cut it.

That's why it's crucial to save for retirement independently during your working years -- to bridge the gap between the amount of income you'll need and the amount Social Security will provide. And as such, the amount of savings you have, or don't have, should heavily drive your filing decision.

If you're at or near the end of your career and are extremely low on savings, to the point where you're likely to rely on Social Security as your primary source of income, then it pays to hold off on claiming benefits as long as you can. That way, you'll get more money each month.

On the other hand, if you have loads of money in your IRA or 401(k) plan, to the point where you're not at all reliant on your Social Security income to pay the bills, then to some extent, it almost doesn't matter when you file. However, you might choose to file on the early side to enjoy that extra money while you're younger. You can use it to travel, pursue hobbies, or do other things that will bring you enjoyment in your early 60s, because at that point, you're apt to have more energy than you will in your late 60s.

What's considered a healthy level of savings? Again, it depends on your personal circumstances, but as a general rule, it's a good idea to aim for 10 times your ending salary. This means that if you close out your career earning $100,00, you should, ideally, have a $1 million nest egg. Of course, you may be just fine with $850,000, or $900,000. But if you're sitting on $75,000, you should plan on growing your Social Security benefits as much as you can.

3. Am I still working?

The SSA does allow you to work and collect Social Security simultaneously. But if you do so prior to reaching FRA, you'll risk having a portion of your benefits withheld if your income exceeds a certain threshold known as the earnings test.

The limits attached to the earnings test change from year to year. Currently, you can earn up to $17,640 without having benefits withheld, but past that point, you'll have $1 in benefits withheld for every $2 you earn. If you'll be reaching FRA at any point this year, that threshold increases to $46,920, but once your earnings exceed that point, you'll have $1 in Social Security withheld for each $3 you earn.

The benefits you have withheld aren't forfeited permanently. Once you reach FRA, the amount you have withheld will be added back into your benefits for higher payments. But the reduction in benefits you face by filing early will remain in effect indefinitely unless you undo your application. It's for this reason that it often doesn't pay to claim benefits before FRA if you're still working. But to be clear, once you reach FRA, you can earn as much as you'd like without having it impact your benefits.

Of course, if you are still working when you reach FRA, and you don't need your benefits right away, holding off on filing can still make a lot of sense. Since you'll have your regular paycheck to rely on, you might as well accrue delayed retirement credits that boost your income later on.

Even if you've retired from your main job, if you have enough income between a part-time job and your retirement savings, it pays to grow your benefits. While withdrawing funds from your IRA or 401(k) could limit that account's growth in the future, remember that by delaying benefits past FRA, you're getting a guaranteed 8% boost, whereas investment returns in a retirement savings plan are never guaranteed.

4. Is my health in good shape?

The state of your health is something you must consider when deciding when to claim Social Security, and here's why: The program is technically designed to pay you the same lifetime total regardless of when you file for benefits. How can that be? Well, imagine you file at 62 when your FRA is 67. In doing so, you'll reduce your benefits by 30%, but you'll collect 60 more individual monthly payments. And on the flipside, if you delay benefits past an FRA of 67 all the way until 70, you'll boost them by 24%, but you'll collect 36 fewer payments.

In a nutshell, the program is designed to allow you to break even on a lifetime basis regardless of when you initially file, provided you live an average life expectancy. But if your health is poor, and you're unlikely to do that, then you're generally better off filing for Social Security on the early side, because while doing so will reduce your benefits on a monthly basis, you'll likely come out ahead on a lifetime basis.

Going back to our example, imagine you file at age 62 instead of 67, thereby reducing a $1,600 monthly benefit to $1,120. If you live until 78-1/2, you'll mostly break even under both scenarios -- meaning, you'll collect about the same total amount of income regardless of whether you claim benefits at 62 versus 67.

But watch what happens when you only live until 75. Suddenly, you stand to come out just over $21,000 ahead in your lifetime by claiming benefits at 62 instead of 67.

And on the flip side, if your health is great, and you're likely to live a long life, then it often pays to delay benefits as long as you can. In our example, filing for benefits at 70 rather than 67 will give you over $25,000 more in your lifetime if you wind up living until 88.

That's why you must consider the state of your health when making your filing decision, and also remember that while claiming benefits at one age or another might increase or decrease your income on a monthly basis, that won't necessarily be the case on a lifetime basis.

Of course, if your health is indeed poor, but you have the power to change it for the better, then holding off on Social Security could make sense. For example, if you're an overweight smoker who's unlikely to live a long life because of that, quitting that habit and shedding some pounds could produce a different outcome. But if you have a degenerative condition that's totally out of your hands, then filing earlier is likely a better bet for you.

5. Do I have a spouse to consider?

When you're single, you just have to take your own needs into account when filing for Social Security. But if you're married, you'll need to think about how your filing decision could impact your spouse.

For one thing, if you have a spouse who never worked, or who did work but earned a lot less money than you, then he or she may wind up relying on spousal benefits. Your spouse is entailed to receive up to half of your benefit at FRA, but your spouse also can't file for benefits until you file. Now let's say you're thinking of delaying benefits all the way until age 70, but your spouse is much older than you and wants to start getting that money sooner. The longer you wait, the more your spouse will need to wait as well.

Furthermore, if you pass away after filing for benefits, leaving your spouse behind, he or she will be entitled to survivors benefits equal to the same amount you were collecting. If you file for benefits early and reduce them in the process, your spouse will get less money for the rest of his or her life. And that's something to consider if you have a spouse who's much younger than you, or who is likely to outlive you by many years because your health is terrible and his or hers is fantastic.

What's the best age for you to claim benefits?

Clearly, there are pros and cons to filing for Social Security at different ages. If you claim benefits in your early 60s, you'll get your money sooner, but you'll reduce those benefits on what will likely be a lifetime basis. Filing past FRA will increase your benefits, but you'll need to wait longer to get them, and that could impact your ability to enjoy your golden years when you're younger and have more energy to do the things you've always dreamed of. The key, therefore, is to answer each of the above questions honestly and see where they lead you. There's no right or wrong answer on when to file, so the best you can do is make an informed decision that's rooted in a clear understanding of how Social Security works.

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2019-12-15 13:10:00Z
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Investment News: a Bull Market to Surpass All Others - Bloomberg

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Investment News: a Bull Market to Surpass All Others  Bloomberg
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2019-12-15 12:00:00Z
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Villains or visionaries? Hedge funds short companies they say 'greenwash' - Reuters

LONDON (Reuters) - Tens of trillions of global investment dollars are pouring into companies touting robust environmental, social and governance credentials. Now short-sellers spy an opportunity.

FILE PHOTO: Carson Block, Chief Investment Officer, Muddy Waters Capital LLC., speaks at the Sohn Investment Conference in New York City, U.S. May 4, 2016. REUTERS/Brendan McDermid/File Photo

Such hedge funds, often cast as villains of the piece because they bet against share prices, scent a profit from company valuations they believe are unduly inflated by ESG promises or which they say ignore risks that threaten to undermine the company’s prospects.

The fact short-sellers, who look to exploit information gaps, are targeting the ESG sphere underlines the complexities facing investors in accurately gauging companies’ sustainability credentials. Teenage climate activist Greta Thunberg last week spoke of CEOs masking inaction with “creative PR”.

Against a backdrop of growing public and political concerns about climate change and economic inequality, companies are under increasing pressure to show they are taking greater responsibility for how they generate their profits.

Investments defined as “sustainable” account for more than a quarter of all assets under management globally, according to the Global Sustainable Investment Alliance. About $31 trillion has been invested, buoyed by analyst reports that show companies with strong ESG narratives outperform their peers.

Some short-sellers, including Carson Block of Muddy Waters, Josh Strauss of Appleseed Capital and Chad Slater of Morphic Asset Management, argue share prices can be bolstered by corporate misrepresentation about sustainability, or so-called “greenwashing”.

“Greenwashing is absolutely rampant now,” says Slater, whose fund bets on both rising and falling share prices. If companies fail to engage with long-term investors, he sees a red flag.

“From the short side, it’s quite interesting.”

Analytics companies that provide corporate ESG ratings use a combination of company disclosures, news sources and qualitative analysis of third-party data. They are a major source of information for investors, but it is not an exact science.

Hedge funds have various strategies for selecting targets, often focusing on those they think show both ESG and more traditional financial or operational weakness. A high ESG rating can attract short interest.

A Reuters analysis of data from financial information company Refinitiv and national regulators in Britain, France, Germany, Spain and Italy shows the five companies in each country with the best ESG scores collectively were being shorted more than those with the worst scores.

The short positions against the companies deemed to have the best ESG credentials were 50% greater in size than those placed against the worst-performers.

(Graphic: ESG shorts - UK: here)

For an interactive version of the graphic, click here tmsnrt.rs/2RwpBDj. For additional graphics covering the other countries mentioned, see related content.

PATCHY DATA

ESG data providers compile ratings based on a slew of measures ranging from energy usage to board gender make-up, salary gap data and the scale of negative press reports on the company from newspapers across the world.

Refinitiv, part-owned by the parent company of Reuters News, factors in more than 400 ESG measures for each company, taken from a range of sources including company reports, regulatory filings, NGO websites and news articles.

A key problem, though, is scant regulations governing what ESG measures and risks companies must disclose and their patchy nature, said Diederik Timmer, executive vice president of client relations at Sustainalytics, a major ESG data provider.

    “When things go well, companies report quite well on those, when things don’t go so well it gets awfully quiet,” he added.

Some policymakers, largely in Europe, are pushing for standardized disclosures to help investors better gauge the risks, something which will leave less wriggle room for companies and make scores even more reliable.

    Two leading global asset managers interviewed by Reuters, who manage nearly $1 trillion in assets but declined to be identified, said they had tested their portfolios using several data providers and found the correlation between ESG ratings to be so low, they are building their own ranking system.

Peter Hafez, chief data scientist at RavenPack, which helps hedge funds analyze data to get a trading edge, agreed.

“There’s no perfect ESG rating out there,” he said.

The influence of news flows on investor sentiment was underlined by a Deutsche Bank study here published in September that mapped 1,600 stocks and millions of company announcements and climate-related media reports over two decades.

It found companies that had a greater proportion of positive announcements and press over the preceding 12 months outperformed the MSCI World Index by 1.4% a year, on average, while those with more negative news underperformed by 0.3%.

For graphics of the data, click here tmsnrt.rs/2ncsFY0 and here tmsnrt.rs/2nd5hcT.

BIG RISKS FOR SHORTS

Short-sellers borrow shares, pay the lender a fee and sell them on, betting the price will fall before buying them back and returning them to the original lender - pocketing the difference, minus the fee.

But it is not for the faint-hearted. If funds trigger a share price fall, they can earn millions, but the downside, should shares rise, is unlimited.

The perils of the practice were shown by the shorts burnt by a 17% surge in the shares of Elon Musk’s Tesla in October after a surprise quarterly profit. Short-sellers suffered paper losses of $1.4 billion, erasing most of their 2019 profits, according to analytics firm S3 Partners.

And in a decade-long stock market bull-run, short-selling can be tricky.

Morphic’s joint chief investment officer Slater said the Sydney-based money manager’s standalone short positions in its Trium Morphic ESG long-short fund had weighed on the portfolio over the past 12 months.

Niche activist short-sellers, who can torpedo company valuations by publishing negative reports on targets - often alleging fraud or serious failures - are often criticized for undermining long-term company objectives and blurring the lines between whistleblower and market manipulator.

Short-sellers agree they are biased, but argue no more than long investors, the banks that raise money for the company and the company’s management.

Carson Block, founder of American short-seller Muddy Waters, who shot to prominence spotting wrongdoing in some Chinese-run companies, is now seeking a “morality short” on ESG - branching out from a traditional focus on corporate governance issues to targets whose success he says hinges on secretly harming society.

As an example of what he is seeking, he points to the U.S. opioid crisis, which has triggered around 2,500 lawsuits by authorities seeking to hold drugmakers responsible for stoking a scandal that has claimed almost 400,000 overdose deaths between 1999 and 2017.

“I’m really skeptical of ESG,” he says, likening the use of the acronym by the corporate world to the token straw slipped into a large plastic cup with a plastic lid.

“ESG is the paper straw of investing,” he says. “I definitely want to find companies like that because I know they’re out there and I want to help put them down.”

Reporting by Kirstin Ridley and Simon Jessop; Editing by Pravin Char

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2019-12-15 10:05:00Z
CBMinQFodHRwczovL3d3dy5yZXV0ZXJzLmNvbS9hcnRpY2xlL3VzLWdsb2JhbC1oZWRnZWZ1bmRzLXN1c3RhaW5hYmxlLWFuYWx5c2kvdmlsbGFpbnMtb3ItdmlzaW9uYXJpZXMtaGVkZ2UtZnVuZHMtc2hvcnQtY29tcGFuaWVzLXRoZXktc2F5LWdyZWVud2FzaC1pZFVTS0JOMVlKMDk30gE0aHR0cHM6Ly9tb2JpbGUucmV1dGVycy5jb20vYXJ0aWNsZS9hbXAvaWRVU0tCTjFZSjA5Nw

China Threatens Germany With Retaliation If Huawei 5G Is Banned - Bloomberg

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China Threatens Germany With Retaliation If Huawei 5G Is Banned  BloombergView full coverage on Google News
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2019-12-14 23:09:00Z
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Sabtu, 14 Desember 2019

In surprise decision, US approves muscular dystrophy drug - The Associated Press

WASHINGTON (AP) — U.S. health regulators approved a second drug for a debilitating form of muscular dystrophy, a surprise decision after the medication was rejected for safety concerns just four months ago.

The ruling marks the second time the Food and Drug Administration has granted preliminary approval for the disease based on early results and is likely to stoke questions about its standards for clearing largely unproven medications.

The FDA said late Thursday it approved Sarepta Therapeutics’ Vyondys 53 for patients with a form of Duchenne’s muscular dystrophy. Duchenne’s affects about 1 in every 3,600 boys in the U.S., causing muscle weakness, loss of movement and early death, usually when patients are in their 20s or 30s. The drug is for a specific type that affects about 8 percent of boys with Duchenne’s.

In August, the FDA appeared to reject the injectable medication, sending a letter to the company that flagged risks of infections and cases of kidney injury in animal studies. But Sarepta disputed the decision, raising it to FDA’s drug center leadership. The company resubmitted its application and data, and the FDA reversed its decision, according to a Sarepta press release.

The FDA said Thursday doctors should monitor the kidney function of patients taking the drug. The drug’s most common side effects include headache, fever, abdominal pain and nausea. Other reactions include rash, fever, hives and skin irritation.

The surprise approval sent company shares rocketing more than 36% in trading Friday. But some Wall Street analysts said the approval suggests loosening standards at the agency.

“The abruptness of the decision making at the agency does not inspire confidence, in our view,” analyst Debjit Chattopadhyay wrote in a note to investors.

It’s the second time a Sarepta drug has followed an unusual path to approval. In 2016, FDA leaders cleared the company’s first muscular dystrophy drug, overruling agency reviewers who said there was little evidence it worked. The decision also followed an intense lobbying campaign by patients’ families, politicians and physicians. Agency critics suggested the FDA may have bowed to outside pressure.

Vyondys received “accelerated approval” based on preliminary results showing it boosts a protein that aids the growth of muscle fibers. But the drug has not yet been shown to improve patients’ mobility or health. The FDA is requiring Sarepta to conduct followup studies on those measures for both drugs. If the company fails to show the drugs help patients, the FDA can withdraw approval — though it rarely does so.

The follow-up study for Vyondys is due by 2024. The drug will cost $300,000 per year for the typical patient — a child weighing 44 pounds, the company said. That’s the same price as Sarepta’s earlier drug.

Analysts said the unexpected decision could bode well for other experimental drugs with questionable study results, including a closely watched drug Alzheimer’s drug that will soon come before the agency.

The drug’s developers reported results in October suggesting their medication could be the first to slow mental decline in Alzheimer’s. But many experts are skeptical, noting unusual study changes and analyses used during the drug’s development.

___

Follow Matthew Perrone on Twitter: @AP_FDAwriter

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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2019-12-14 14:52:34Z
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In surprise decision, US approves muscular dystrophy drug - The Associated Press

WASHINGTON (AP) — U.S. health regulators approved a second drug for a debilitating form of muscular dystrophy, a surprise decision after the medication was rejected for safety concerns just four months ago.

The ruling marks the second time the Food and Drug Administration has granted preliminary approval for the disease based on early results and is likely to stoke questions about its standards for clearing largely unproven medications.

The FDA said late Thursday it approved Sarepta Therapeutics’ Vyondys 53 for patients with a form of Duchenne’s muscular dystrophy. Duchenne’s affects about 1 in every 3,600 boys in the U.S., causing muscle weakness, loss of movement and early death, usually when patients are in their 20s or 30s. The drug is for a specific type that affects about 8 percent of boys with Duchenne’s.

In August, the FDA appeared to reject the injectable medication, sending a letter to the company that flagged risks of infections and cases of kidney injury in animal studies. But Sarepta disputed the decision, raising it to FDA’s drug center leadership. The company resubmitted its application and data, and the FDA reversed its decision, according to a Sarepta press release.

The FDA said Thursday doctors should monitor the kidney function of patients taking the drug. The drug’s most common side effects include headache, fever, abdominal pain and nausea. Other reactions include rash, fever, hives and skin irritation.

The surprise approval sent company shares rocketing more than 36% in trading Friday. But some Wall Street analysts said the approval suggests loosening standards at the agency.

“The abruptness of the decision making at the agency does not inspire confidence, in our view,” analyst Debjit Chattopadhyay wrote in a note to investors.

It’s the second time a Sarepta drug has followed an unusual path to approval. In 2016, FDA leaders cleared the company’s first muscular dystrophy drug, overruling agency reviewers who said there was little evidence it worked. The decision also followed an intense lobbying campaign by patients’ families, politicians and physicians. Agency critics suggested the FDA may have bowed to outside pressure.

Vyondys received “accelerated approval” based on preliminary results showing it boosts a protein that aids the growth of muscle fibers. But the drug has not yet been shown to improve patients’ mobility or health. The FDA is requiring Sarepta to conduct followup studies on those measures for both drugs. If the company fails to show the drugs help patients, the FDA can withdraw approval — though it rarely does so.

The follow-up study for Vyondys is due by 2024. The drug will cost $300,000 per year for the typical patient — a child weighing 44 pounds, the company said. That’s the same price as Sarepta’s earlier drug.

Analysts said the unexpected decision could bode well for other experimental drugs with questionable study results, including a closely watched drug Alzheimer’s drug that will soon come before the agency.

The drug’s developers reported results in October suggesting their medication could be the first to slow mental decline in Alzheimer’s. But many experts are skeptical, noting unusual study changes and analyses used during the drug’s development.

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Follow Matthew Perrone on Twitter: @AP_FDAwriter

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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2019-12-14 13:45:38Z
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