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 email@example.com 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 firstname.lastname@example.org 888-476-6529 ext. 7980
U.S. Set to Push Global Economy Over the Recovery Line – The Wall Street Journal
The U.S. economy likely returned to its late-2019 size during the three months through June, helping to lift global output above its pre-pandemic level for the first time.
Economists surveyed by The Wall Street Journal estimate that figures to be released Thursday will show that the U.S. gross domestic product rose at an 8.5% seasonally adjusted annual rate in the second quarter. That likely left U.S. GDP—the value of all goods and services produced across the economy, adjusted for seasonality and inflation—above the $19.2 trillion level reached in the final quarter of 2019, the last before the spread of Covid-19 pushed large parts of the global economy to shut down and contract, they say.
The combined economic output of the Group of 20 leading economies exceeded its pre-pandemic level in the first quarter, according to estimates by the Organization for Economic Cooperation and Development. With the U.S. and a number of other large economies crossing that threshold in the second quarter, it is likely that global output is now higher than the level recorded in the final quarter before the coronavirus struck, the group says.
Europe’s economy, however, likely remains smaller than before the pandemic, according to the European Commission, while the spread of the new Delta variant of the coronavirus across Asia threatens to slow its recovery in the second half of the year.
The International Monetary Fund Tuesday will release new forecasts for the global economy. Kristalina Georgieva, the fund’s managing director, on Wednesday told a webinar that while its projection for world economic growth in 2021 will stay at the 6% forecast in April, the outlook for rich countries with speedy vaccination programs has improved, while the outlook for poor countries has weakened.
“Despite the fact that of course the new Delta variant is significant, what we are projecting is a remarkable recovery in 2021,” she said. “But between April and July the composition of this 6% has changed.”
In the U.S., widespread business reopenings, rising vaccination rates and a big infusion of government pandemic aid helped fuel the spring burst of economic growth, and will likely support a solid expansion through this year and into next year, according to economists surveyed by the Journal.
U.S. GDP will likely even be higher by the end of 2022 than was forecast before the pandemic, says the OECD. That robust recovery, however, is unlikely to be shared by much of Europe, or many other parts of the world, it says.
“That’s the return for the big fiscal stimulus, and also the fact that the U.S. never really locked down as fully as Europe did,” said Christian Keller, chief economist at Barclays.
According to the European Commission, the combined economic output of the European Union’s 27 members will return to its precrisis level in the final quarter of this year. But individual countries will get there sooner than others, depending on how much their economies count on tourism and related services, which were more hobbled by the pandemic’s effects than manufacturing and other heavy industries.
The commission said that Poland might already have recovered in the second quarter and is likely to be followed in the third quarter by Germany. What the two have in common is a relatively large factory sector that has benefited from the global surge in demand for goods during the pandemic, when households sharply curtailed their spending on in-person services.
“There is a very close correlation between the share of industry in GDP and performance over the last year,” said
chief economist at the European Bank for Reconstruction and Development.
By contrast, the Commission expects Spain and Italy to recover only in the third quarter of next year. Both countries have large tourism sectors, and broader hospitality industries.
“The recovery is characterized by great divergences across and within countries and remains exposed to downside risks, in particular the spread of new variants of the COVID-19 virus and different paces of vaccination,” said finance chiefs from the Group of 20 largest economies earlier this month.
India offers the clearest recent example of the economic cost of a fresh surge in infections through a largely unvaccinated population. Of all the G-20’s members, India suffered the largest economic contraction during the second quarter of 2020, but bounced back strongly to end the first three months of this year with output 2.7% higher than its pre-pandemic level.
But the pandemic and government restrictions returned with a vengeance in the second quarter of this year, driven by the fast-spreading Delta variant, with the result that surveys of purchasing managers point to declines in services activity throughout the three-month period, and even in manufacturing toward its end.
Across Asia more broadly, new restrictions are being imposed as infections rise. Earlier this month, Indonesia’s government announced new curbs in hard-hit areas of Java and Bali. Around the same time in Vietnam, the government imposed new curbs on movement in Hanoi, the capital, and other cities. Japan’s delayed Olympic Games started Friday without spectators after the government declared a state of emergency that will last through the event.
“The stringency of restrictions in Asia is even tougher than it was a year ago,” said
Alicia Garcia Herrero,
chief Asian economist at French financial services firm
“Asia may fall behind in returning to normality.”
Write to Paul Hannon at email@example.com
Tunisians protest as COVID surges, economy suffers | Coronavirus pandemic News – Al Jazeera English
Police used pepper spray on protesters in Tunis who threw stones and demanded Prime Minister Hichem Mechichi quit, parliament be dissolved.
Police and protesters have clashed in several Tunisian cities as demonstrators demanding the government step down after a spike in COVID-19 cases that has aggravated economic troubles attacked offices of Ennahda, the biggest party in parliament.
In Tunis on Sunday, police used pepper spray against protesters who threw stones and shouted slogans demanding that Prime Minister Hichem Mechichi quit and parliament be dissolved.
Witnesses said protesters stormed or tried to storm Ennahda offices in Monastir, Sfax, El Kef and Sousse, while in Touzeur they set fire to the party’s local headquarters.
The protests raise pressure on a fragile government that is enmeshed in a political struggle with President Kais Saied, who is trying to avert a looming fiscal crisis amid a weeks-long spike in COVID-19 cases and increased death rates.
The pandemic has hit Tunisia as it struggles to lift an economy that has suffered since its 2011 revolution, undermining public support for democracy as unemployment surged and state services declined.
“Our patience has run out … there are no solutions for the unemployed,” Nourredine Selmi, 28, a jobless protester, told Reuters news agency. “They cannot control the epidemic … They can’t give us vaccines.”
Last week, Mechichi sacked the health minister after chaotic scenes at walk-in vaccination centres during the Muslim Eid al-Adha holiday, where large crowds queued for inadequate supplies of vaccine.
The ministry said earlier this month that Tunisia’s health system had “collapsed” under the weight of the pandemic, which has caused more than 17,000 deaths in a population of about 12 million.
After a year of wrangling with Mechichi and the leader of Ennahda, Rached Ghannouchi, who is also parliament speaker, President Saied declared the army would take over the pandemic response.
Some analysts saw the move by Saied as an attempt to expand his powers beyond the foreign and military role assigned to the president in the 2014 constitution.
Government paralysis could derail efforts to negotiate an International Monetary Fund loan seen as crucial to stabilising state finances but which could also involve spending cuts that would aggravate economic pain for ordinary people.
Biden Faces Fresh Challenges on Covid-19, Economy – The Wall Street Journal
WASHINGTON—President Biden took office with the goals of overcoming the coronavirus pandemic, spurring economic growth and winning legislative approval for trillions in new spending.
Six months in, all three of his major objectives are being tested.
Covid-19 cases and hospitalizations are on the rise, spurred by the Delta variant and vaccine resistance from a slice of the population. Concerns over the spread of the pandemic have caused some turbulence in the financial markets and consumer prices are ticking up, prompting warnings about long-term inflation. A bipartisan infrastructure deal and a broader Democratic spending bill remain deep in negotiations and a long way from Mr. Biden’s desk.
During a cabinet meeting last week, the president in his public remarks highlighted his work so far but acknowledged some of the current pressure points. “I know it seems like a constant uphill climb…we’re making progress, but we’ve got a way to go yet,” Mr. Biden said of the vaccination effort.
He emphasized the need for “constant vigilance” against the virus, asserted that his economic program would “generate significant continued economic growth” and defended his infrastructure and antipoverty legislative plans as popular.
Since Mr. Biden took office, more than three million jobs have been created and nearly 60% of American adults are now fully vaccinated. When he reached an agreement with Republicans in June on a bipartisan framework for a roughly $1 trillion infrastructure proposal, he said it showed that bipartisanship was possible.
Now, Mr. Biden appears to be moving into a more challenging phase of his presidency. A Gallup poll released Friday put Mr. Biden’s job approval at 50%, the lowest mark since he took office. He is trying to convince skeptics—many of whom don’t support him politically—to get vaccines. He is seeking to ease public worries about price increases. And after investing much time in a bipartisan framework on infrastructure reached with Republican and Democratic senators, the White House now must help steer the bill to the finish line.
A new poll from ABC News/Ipsos released Sunday found that 45% of Americans were optimistic about the direction of the country—a drop from 64% expressing optimism in the spring.
Republicans say Mr. Biden’s policies will damage the economy. House Minority Leader Kevin McCarthy (R., Calif.) tweeted recently that “the Democrats’ inflation is destroying Americans’ hope for financial security.” And Senate Minority Leader Mitch McConnell (R., Ky.) has taken to calling the spending plans a “reckless tax and spending spree.”
Mr. Biden’s allies note that part of governing is dealing with the unexpected, and they give him credit for managing the pandemic and pushing his agenda in a divided Congress.
“All presidents have to deal with these external factors that just careen into their presidency,” said Sen. Ed Markey (D., Mass.). “But on this big agenda which he has for infrastructure and for family, he’s right on pace.”
The White House continues to express optimism. White House senior adviser Anita Dunn briefed Democratic lawmakers Thursday about the president’s economic plans, with a slideshow that emphasized the administration’s arguments that the agenda will boost jobs and help working families, including polling data showing the popularity of the initiatives.
But the White House acknowledges the depth of Mr. Biden’s challenges. “He has a lot on his plate, and he is fully focused on all of it. And so we just keep pressing on,” senior adviser Mike Donilon said during a briefing call with reporters.
On vaccinations, the White House has been on the defensive in recent days as cases rise again after having fallen earlier in the year, and amid news of breakthrough infections at the White House and the Capitol. The country still hasn’t quite reached Mr. Biden’s goal, initially set for July 4, of reaching 70% of Americans with at least one dose of the Covid-19 vaccine. So far, over 68% of adults aged 18 and older have received one shot and nearly 60% have been fully vaccinated.
Mr. Biden has been asked repeatedly whether mask guidelines should be reconsidered. Some local governments have reimposed masking rules as the spread of the highly contagious Delta variant drives up cases in every state in the country.
Budget reconciliation may offer Democrats a way to sidestep some partisan gridlock and advance President Biden’s policy objectives. WSJ explains how the process works and why divisions in the party could scuttle the process. Photo Illustration: Carlos Waters / WSJ
The Wall Street Journal Interactive Edition
Before a meeting at the White House on Thursday, he said the administration would follow the scientific advice. He repeated his argument that the current situation is a “pandemic among the non-vaccinated,” adding that the vaccinated were protected against infection in most cases, and from serious illness if they do contract the virus.
Mr. Biden has also tussled with
over the social media company’s role in policing misinformation about Covid-19 and vaccines.
William Galston, a former aide to President Bill Clinton, said the president faced risks if he wasn’t able to meet his public goals.
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“Expectations have been raised,” he said. “If those expectations are dashed, my fear is there could be a reaction.”
White House officials have long said the pandemic and economy are intertwined, and success in vaccinations would bolster job growth. The president has delivered remarks at the start of each month to highlight the rebound in hiring—with employers adding an average of about 600,000 jobs a month since the start of his presidency.
But the turbulence and polls showing growing concern over inflation have prompted Mr. Biden to push back against critics who say his spending policies, and pursuit of tax increases, are the wrong economic prescription.
He has acknowledged inflation in the short term but asserted that it won’t be a long-term issue for Americans—a message that could become difficult to maintain if consumers continue to face higher prices in the coming months.
“People are paying more for everything—when they can get it. If there’s one thing Americans don’t like doing, it’s standing in lines and paying more for something,” said
a Virginia-based Republican strategist. Virginia holds a gubernatorial election in November that could serve as an early test of Mr. Biden’s political strength.
The White House views Mr. Biden’s legislative agenda as the best way to position Democrats in next year’s midterms. Mr. Biden notched an early victory with the passage of a $1.9 trillion Covid-19 relief law during his first 100 days and has used executive action to overturn many actions taken by former President Donald Trump.
Enacting the next major planks of his agenda rests on whether he can secure support for a roughly $1 trillion infrastructure package and a separate $3.5 trillion measure to fund projects to address climate change and provide access to education and affordable child care. Each will test Mr. Biden’s deal-making skills: The first package would need the support of at least 10 Republicans to advance in the Senate, while the second will require unanimous Democratic support to make it through the chamber.
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