Pomerantz Law Firm Announces the Filing of a Class Action against Intercept Pharmaceuticals, Inc. and Certain Officers – ICPT
NEW YORK, Nov. 22, 2020 (GLOBE NEWSWIRE) — Pomerantz LLP announces that a class action lawsuit has been filed against Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) (NASDAQ: ICPT) and certain of its officers. The class action, filed in United States District Court for the Eastern District of New York, and docketed under 20-cv-05377, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired Intercept securities between September 28, 2019 and October 7, 2020, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. If you are a shareholder who purchased Intercept securities during the class period, you have until January 4, 2021, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. [Click here for information about joining the class action]Intercept is a biopharmaceutical company that focuses on the development and commercialization of therapeutics to treat progressive non-viral liver diseases in the U.S.Intercept’s lead product candidate is Ocaliva (obeticholic acid (“OCA”)), a farnesoid X receptor agonist used for the treatment of primary biliary cholangitis (“PBC”), a rare and chronic liver disease, in combination with ursodeoxycholic acid in adults. The Company is also developing OCA for various other indications, including nonalcoholic steatohepatitis (“NASH”).In 2016, the U.S. Food and Drug Administration (“FDA”) granted accelerated approval of Ocaliva for treating PBC.Then, in late 2017, both Intercept and the FDA issued warnings concerning the risk of overdosing patients with the drug, and multiple reports of severe liver injuries and deaths linked with its use.Despite these concerns, Defendants continued to tout Ocaliva sales and purported benefits, and its potential indication for treating various other medical conditions. For example, just two years later, in September 2019, Intercept submitted a New Drug Application (“NDA”) to the FDA for OCA to treat patients with liver fibrosis due to NASH.The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Defendants downplayed the true scope and severity of safety concerns associated with Ocaliva’s use in treating PBC; (ii) the foregoing increased the likelihood of an FDA investigation into Ocaliva’s development, thereby jeopardizing Ocaliva’s continued marketability and the sustainability of its sales; (iii) any purported benefits associated with OCA’s efficacy in treating NASH were outweighed by the risks of its use; (iv) as a result, the FDA was unlikely to approve the Company’s NDA for OCA in treating patients with liver fibrosis due to NASH; and (v) as a result of all the foregoing, the Company’s public statements were materially false and misleading at all relevant times.On May 22, 2020, Intercept reported that the FDA “has notified Intercept that its tentatively scheduled June 9, 2020 advisory committee meeting (AdCom) relating to the company’s [NDA] for [OCA] for the treatment of liver fibrosis due to [NASH] has been postponed” to “accommodate the review of additional data requested by the FDA that the company intends to submit within the next week.”On this news, Intercept’s stock price fell $11.18 per share, or 12.19%, to close at $80.51 per share on May 22, 2020.On June 29, 2020, Intercept issued a press release announcing that the FDA had issued a Complete Response Letter (“CRL”) rejecting the Company’s NDA for Ocaliva for the treatment of liver fibrosis due to NASH. According to that press release, “[t]he CRL indicated that, based on the data the FDA has reviewed to date,” the FDA “has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH.” The press release further advised, among other things, that the “[t]he FDA recommends that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue.”On this news, Intercept’s stock price fell $30.79 per share, or 39.73%, to close at $46.70 per share on June 29, 2020.Then, on October 8, 2020, news outlets reported that Intercept was “facing an investigation from the [FDA] over the potential risk of liver injury in patients taking Ocaliva, [Intercept’s] treatment for primary biliary cholangitis, a rare, chronic liver disease.”On this news, Intercept’s stock price fell $3.30 per share, or 8.05%, to close at $37.69 per share on October 8, 2020.The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.CONTACT: Robert S. Willoughby Pomerantz LLP email@example.com 888-476-6529 ext. 7980
Confused by the economy during the COVID-19 pandemic? Don't worry, so are the economists – CBC.ca
The numbers can be so big, they’re hard to get your head around. The swings are so volatile, you can lose your footing.
And yet, with millions of Canadians struggling through the COVID-19 crisis, many of us want to understand what is going on with the economy.
“My head is spinning, too,” said Benjamin Tal, deputy chief economist at CIBC. “So I don’t blame people, because we’ve never seen anything like this.”
Every week, a flood of new data comes out. This week, we were inundated with the federal government’s fiscal update, GDP figures and job numbers. All trying to shape the story of the economy. Sometimes the numbers contradict each other. Sometimes they give a sort of head-fake and contradict themselves.
The fiscal update that came out on Monday had built all its projections on an average of the forecasts from the big banks. The next morning, Statistics Canada released quarterly GDP numbers that missed the forecast by a staggering seven points. By the end of the week, jobs data came out showing Canadian employers added three times as many jobs as expected.
Every economist is trying to figure out what those numbers are telling us. And they’re not always getting it right.
“Economists have never been more wrong about where the data would come through,” said Frances Donald, chief economist and head of macro strategy at Manulife Investment Management in Toronto.
Most of the time, she said, economists rely on data such as job growth and retail sales numbers to make sense of the situation. The problem is those statistics tell us what was happening months ago.
“This is a daily crisis that requires daily data points,” she said.
To combat that, economists have turned to higher frequency data such as google mobility trends, restaurant reservation tallies and public transit numbers.
But Donald said the bigger issue is the unique, unprecedented nature of this crisis.
“We don’t have a functional precedent for what is happening,” she said.
There may be other moments in the past that share some similarities, but nothing experts can use to model probable outcomes.
Change of perspective
Tal said he understands why more Canadians than usual seem to be following economic updates with bated breath. But he said the best option is to focus less on the details and think of the broader economic themes.
So, while the short term is bad, he said, the medium term looks better.
“We are buying time at this point,” he said, until the virus comes under control.
Yes, the world is headed into a long and dark winter, he said. Yes, COVID-19 cases are rising and government-imposed restrictions could spread. And, yes, households and businesses will need government support and record-low interest rates to provide them a bridge to the second half of next year, he said.
But if you zoom out and look at the longer-term forecasts, the second half of next year shows a lot of promise. Tal said the economic crisis is largely due to the fact that people aren’t spending as much as they normally would.
Some of that is because of government-mandated closures.
But some of it is also a question of confidence.
Even if the movie theatres were open, how many people would pay to sit in close contact with strangers for a two-hour film?
That spending issue is a large source of the hope for 2021. Tal calculates that Canadian households and businesses are sitting on $170 billion in savings. And once the virus comes under control, he predicts that money will spill back into the economy.
“I see this unleashing of potential demand in the economy,” he said. “Most of it will be in the services sector. And that will benefit employment for people that are struggling. It’s just a question of time.”
So, in the interim, he recommends not getting too caught up in the minutiae of the daily economic data.
That’s advice financial markets seem to be following. As COVID-19 case counts soar and government-imposed restrictions spread, the major stock market indexes are all climbing. Donald said markets seem to be looking past the short- and medium-term unknowns and banking on a solid return next year.
WATCH | The National’s report on the fall economic update:
She said the markets don’t seem to be too caught up in the daily barrage of economic information.
“The markets are thinking ahead to where we are going to be in 6, 12, 48 months,” she said. “Not where we are at this very moment.”
Besides, she said, one of the best indicators available is to just look around and see how people around you are acting. Are people nervous and scared? Are they staying home or are they out shopping? The data will catch up to our behaviour eventually.
“You don’t need a PhD in economics to look around at your friends and family and get a sense of what their behaviour is,” she said. “We don’t need numbers and releases, we just need to look out our front doors.”
Kuwaitis go to polls as economy poses challenge for new emir – The Guardian
By Ahmed Hagagy
KUWAIT (Reuters) – Kuwaitis vote in legislative polls on Saturday as the Gulf state faces its worst economic crisis in decades, posing a challenge for the government’s often stormy relationship with parliament, that has hampered fiscal reform.
Turnout is expected to be lower than in past elections due to concern over COVID-19, which along with low crude prices, has battered state finances in the wealthy oil-producing nation. Low turnout could strengthen the showing of tribal, Islamist and other candidates who can rally supporters to head to polling centres, analysts said.
“Kuwaiti opposition who boycotted (previous) polls are moving to run and vote, and this could strengthen their presence,” said Kuwaiti political analyst Mohamad al-Dosayri.
More than 300 candidates, including 29 women, are vying for 50 seats in the Gulf’s oldest and most outspoken assembly with legislative powers. Critics say parliament has long stalled investment and economic and fiscal reform in the cradle-to-grave welfare state.
Frequent clashes between the cabinet and assembly have led to successive government reshuffles and dissolutions of parliament. The emir, who has final say, picks a prime minister who selects a cabinet. The current government is due to resign after the elections.
Sheikh Nawaf al-Ahmad al-Sabah took the reins as emir in September following the death of his brother.
Campaigning, which took place mostly on social media and local TV channels due to COVID-19 measures against gatherings, has focused on the economy, corruption and demographics in a country where foreigners make up the bulk of the workforce.
“The issues are the same – health, education, housing – as none of these have been resolved yet,” government employee Hamad al-Otaibi, 43, told Reuters ahead of the elections.
The nearly $140 billion economy is facing a deficit of $46 billion this year. A priority will be overcoming legislative gridlock on a bill that would allow Kuwait to tap international debt markets.
Sheikh Nawaf has called for unity to face challenges at home and in a region experiencing heightened tension between Kuwait’s larger neighbours Saudi Arabia and Iran.
Late ruler Sheikh Sabah al-Ahmad in 2012 broke the hold of opposition groups on parliament by using executive powers to amend the voting system, sparking large protests.
Under the old electoral system, voters were allowed to cast ballots for up to four candidates, which the opposition says allowed alliances that partly made up for the absence of political parties, which are officially barred.
The system introduced in 2012 allows votes for only a single candidate, which the opposition says makes alliances difficult.
Kuwaiti opposition figures have proposed electoral reforms and a pardon for dissidents, many in self-exile, to the new emir.
“There have been some reforms in the judiciary and the Emiri Diwan,” or court, said a Kuwaiti politician who asked not to be named. “We heard echoes of more reforms after elections.”
(Reporting by Ahmed Hagagy in Kuwait; Additional reporting by Aziz El Yaakoubi in Dubai; Editing by William Mallard)
New Businesses Starting At Record Rates Despite The Pandemic's Effect On Economy – NPR
LULU GARCIA-NAVARRO, HOST:
OK. You may be surprised to hear there’s currently a startup boom in the United States. Despite the pandemic – or maybe because of it – new businesses are starting at record rates. Here’s Greg Rosalsky of NPR’s Planet Money.
GREG ROSALSKY, BYLINE: In 2019, Roberto Ortiz, a veteran software designer, was working hard on a new app with a couple of friends. They designed it. They developed it. They pitched the idea to investors and began raising money. Ortiz even moved his wife, his dog and his 3-month-old baby from Denver to San Francisco so they could launch it. By then, it was early 2020. But there was a problem.
ROBERTO ORTIZ: We were building a platform that connects wholesale food providers to restaurants.
ROSALSKY: (Laughter) Oh, no.
Oh, no because the pandemic was about to destroy the restaurant industry.
ORTIZ: So picture me and my co-founders trying to sell technology to restaurant owners when COVID just shut down their business.
ROSALSKY: The business was ruined. On Zoom call after Zoom call, they debated what to do next. And then it hit them. What if they made a better version of Zoom, one that would be a stronger replacement for high-powered business meetings, product launches or conferences at fancy hotels.
So Zoom is sort of like the Holiday Inn or something. And then like…
ORTIZ: It’s the Motel 6, yeah.
ROSALSKY: Ortiz and his co-founders decided they could build something prettier and fancier than Zoom, like the Ritz-Carlton for virtual events. And with months of hard work, they built it. It’s called Welcome. They officially launched a couple weeks ago. They’ve got numerous clients and over 30 employees. They’ve already raised $12 million. They’ve come a long way since March.
ORTIZ: It’s one of those things where we have to pinch ourselves often.
ROSALSKY: There are a lot of entrepreneurs pinching themselves these days. Welcome is just one of 4 million new businesses registered in 2020. Welcome to the startup boom. Economist John Haltiwanger has been helping the Census Bureau track all this. When it comes to new business applications, he says, they’ve never seen anything like this before.
JOHN HALTIWANGER: It’s the highest level on record.
ROSALSKY: The biggest areas of growth are in e-commerce, online retail and online services, which makes sense. The pandemic has devastated activities that require being face-to-face. Most of us don’t want to shop at stores, travel on planes or do meetings in person. It’s like these new online businesses are growing out of the ashes of old brick-and-mortar businesses. Economists have a term for this. It’s called creative destruction. Nobody likes the destruction part. It means jobs lost and dreams dashed.
HALTIWANGER: What you don’t want to have happen is destruction and then no creation.
ROSALSKY: There weren’t a lot of businesses created during the Great Recession around 2008, and it slowed down the recovery. But the pandemic recession looks like it might be different. We don’t know if all these startups will fill the hole of all the jobs lost and destroyed businesses or if they’ll even survive after the pandemic ends. But Roberto Ortiz is banking on a new era for virtual interaction in the business world.
ORTIZ: And so is travel really necessary to close a deal? Is it really necessary to gather 5,000 people in one place, or are there alternate ways of getting the same outcomes using and leveraging technology?
ROSALSKY: There’s definitely been a lot of destruction in 2020. Hopefully we’ll look back and also see it as a year of creation.
Greg Rosalsky, NPR News.
(SOUNDBITE OF DYE O’S “ARISING”)
NPR transcripts are created on a rush deadline by Verb8tm, Inc., an NPR contractor, and produced using a proprietary transcription process developed with NPR. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.
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