• Amarin, Apotex Settle Vascepa Dispute; Analyst Stays Sidelined

    Amarin, Apotex Settle Vascepa Dispute; Analyst Stays SidelinedAmarin (AMRN) has announced a settlement agreement with Apotex Inc. that resolves a patent litigation over Apotex’s abbreviated new drug application (ANDA) seeking US approval of a generic form of Vascepa capsules. Shares in Amarin rose 5% in Tuesday’s after-market trading.Amarin’s lead product Vascepa was initially launched in the US in 2013 as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. A new, cardiovascular risk indication for the fish-oil derivative was approved by the FDA in December 2019 based on the results of the landmark Reduce-It trial.The company is currently appealing to the U.S. Court of Appeals a March 2020 patent invalidity ruling in favor of generic companies, Hikma Pharmaceuticals USA Inc. and Dr. Reddy’s Laboratories, Inc. Because Apotex is not a party to that litigation, it is not directly subject to related rulings.As part of the new settlement agreement, Apotex can not sell a generic Vascepa in the US until August 9, 2029 (the same date as Amarin’s 2018 settlement agreement with Teva (TEVA)) or earlier under certain customary circumstances.  These circumstances include if Amarin is not successful in its pending appeal of the March 2020 Nevada district court decision.The agreement also substantially resolves future litigation with Apotex that relating to the December 2019 cardiovascular risk reduction indication of Vascepa, says Amarin.“This settlement involves no financial payment from Amarin to Apotex and allows Amarin to avoid incremental litigation expense and distraction associated with Apotex’s participation in patent litigation related to the MARINE and REDUCE-IT indications,” said John F. Thero, Amarin CEO.Year-to-date shares in Amarin have plunged 68%, but analysts retain a cautiously optimistic Moderate Buy outlook on the stock. This breaks down into 7 recent buy ratings vs 5 hold ratings. Meanwhile the average analyst price target of $18 translates into 155% upside potential. (See Amarin stock analysis on TipRanks)Stifel Nicolaus analyst Derek Archila reiterated his Amarin Hold rating following the settlement announcement. “While this is a slight positive, we don’t see this a major stock moving catalyst” he wrote, adding that he expects AMRN shares to remain range bound until it gets closer to the critical appeal hearing later this year.Related News: Too Much Uncertainty Keeps This 5-Star Analyst Watching Amarin Stock From the Sidelines Jazz Pharma Scores Surprise Early Approval For Lung Cancer Treatment Merck’s Gardasil Receives FDA Nod For Expanded Cancer Indications More recent articles from Smarter Analyst: * Itron Partners With Accell To Boost Business In Latin America * Kamada’s Covid-19 Therapy Approved For Compassionate Use In Israel * Chembio Sinks 59% In Pre-Market As FDA Revokes Its Covid-19 Test; Top Analyst Cuts Rating * HSBC Resumes Plans To Cut 35,000 Jobs Postponed By Pandemic

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  • Qatar Airways won’t take new aircraft in 2020 or 2021, CEO says

    Qatar Airways won't take new aircraft in 2020 or 2021, CEO saysQatar Airways will not take any new planes ordered from Boeing or Airbus in 2020 or 2021, chief executive Akbar al-Baker said on Wednesday, adding there would be a knock-on effect to future deliveries due to the COVID-19 pandemic. Qatar Airways has ordered tens of billions of dollars of aircraft from the world’s two biggest planemakers.

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  • Stock market news live updates: Stocks fall after Texas reports spike in Covid-19 hospitalizations

    Stock market news live updates: Stocks fall after Texas reports spike in Covid-19 hospitalizationsStocks cut earlier gains, and the S&P 500 and Dow turned negative, after new data showed a spike in Covid-19 hospitalizations in Texas.

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  • Banks Face $300 Million Shortfall on Luckin Margin Loans

    Banks Face $300 Million Shortfall on Luckin Margin Loans(Bloomberg) — Banks including Credit Suisse Group AG and Morgan Stanley face a $300 million shortfall on margin loans to the embattled founder of Luckin Coffee Inc.The lenders, which also include Haitong International Securities Group and Goldman Sachs Group Inc., raised about $210 million over the past two months selling Luckin shares that Chairman Lu Zhengyao had pledged as collateral, people familiar with the matter said. Lu defaulted on $518 million of margin debt in early April, Goldman said in a statement at the time, after revelations of accounting fraud caused the Chinese coffee chain’s stock to plunge.The share sales represent the latest attempt by Lu’s creditors to limit losses from a scandal that has fueled calls in Washington for tougher scrutiny of financial ties between the U.S. and China. Luckin’s fall from grace blindsided some of the biggest names on Wall Street just as they were gearing up for a historic expansion into Asia’s largest economy.Spokespeople for the lenders declined to comment. Luckin didn’t immediately respond to multiple requests.Goldman, tapped by lenders to oversee the stake disposal, said in April that it would sell as many as 76.35 million of Luckin’s U.S.-listed shares. The firm has now liquidated the entire position, one of the people said, asking not to be identified discussing private information.A back of the envelope calculation suggests the shares were sold for $2.75 apiece on average. That compares with the closing price of $26.20 before the Luckin scandal emerged and the $3.18 average price since April 6, when Goldman announced plans to offload the stake.Luckin gained 8.3% to $4.32 in pre-market trading as of 5:12 a.m. in New York. The share sales by banks remove one potential overhang for the stock.Credit Suisse and Morgan Stanley each put up about $97 million for the margin loans, while Haitong International lent about $134 million, one of the people said. Goldman and Barclays Plc lent $73 million and $78 million, respectively, while China International Capital Corp. contributed $39 million.It’s still unclear whether the banks will ultimately lose money on the loans. They’re also pursuing the assets of an investment company controlled by Lu’s family trust, Bloomberg News reported last month. The investment company has disputed that it’s in default and has requested an injunction in Hong Kong to prevent liquidation proceedings, according to a May 6 court filing.Lu became a billionaire after his fast-growing Starbucks rival went public in the U.S. last year. But much of his wealth has since been wiped out by the 85% plunge in Luckin’s stock since April, when the company disclosed that some of its employees may have fabricated billions of yuan in sales.Chinese regulators have obtained emails purporting to show Lu instructed financial fraud, business news outlet Caixin reported this month, citing unidentified people close to the agencies. Regulators found evidence of fraud at Luckin in their investigation, Caixin cited several people as saying.Lu has previously denied deceiving investors. “My personal style may have been too aggressive and led the companies to run too fast, which has triggered many problems,” he said in a statement last month. “But I never lied to investors with the idea of ‘selling concepts.’ I’m working hard to make the company bigger and better to create value for society.”(Updates with pre-market gain in Luckin shares in seventh paragraph)For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.

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  • Powell: Women, minorities face largest economic recovery hurdles

    Powell: Women, minorities face largest economic recovery hurdlesSenator Elizabeth Warren questioned Fed Chairman Jerome Powell about the economic struggles minorities have faced amid the coronavirus pandemic.

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  • DraftKings Drops 7% In Pre-Market Amid Public Share Offering

    DraftKings Drops 7% In Pre-Market Amid Public Share OfferingShares in DraftKings (DKNG) sank almost 7% in pre-market trading after the U.S. sports betting company announced a public offering to sell its common stock.The stock dropped to $37.80 in early market trading. DraftKings said it has commenced an underwritten public offering of 33 million shares of its Class A common stock, consisting of 14 million shares offered by DraftKings and 19 million shares offered by some of the company’s shareholders.The stockholders intend to grant the underwriters a 30-day option to purchase up to an additional 4.95 million shares of Class A common stock. DraftKings will not receive any proceeds from the sale of Class A common stock offered by the stockholders. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.DraftKings said it intends to use the net proceeds it receives from the offering for general corporate purposes. Goldman Sachs & Co. and Credit Suisse Securities (USA) are acting as joint book-running managers.The share sale offering comes after the sports gambling went public at the end of April. Since the Nasdaq debut, the stock has more than doubled and is trading at $40.57 as of Tuesday’s close.Five-star analyst Jed Kelly at Oppenheimer last week initiated coverage of the stock with a Buy rating and a $48 price target.“As more states legalize sports gambling, we believe competencies in product development and customer acquisition will allow the company to be a critical player in accelerating the shift in US sports betting from ~$150 billion wagered illegally/ offshore to licensed domestic operators,” Kelly wrote in a note to investors.Although legalized sports betting and iGaming markets are in their very early stages of growth, Kelly estimates for the US legal sports wagering market to grow about 43% annually, reaching about $8 billion by 2025, and $14.4 billion by 2028 as more states regulate sports gaming. The analyst expects DraftKings to achieve about 25% market share.“While a premium valuation and high cash flow burn likely create above-average volatility near term, we emphasize the long-term nature of our rating,” Kelly added.The stock scores 7 Buy ratings versus 1 Hold rating adding up to a Strong Buy analyst consensus. The $43.29 average price target implies 6.7% upside potential in the shares over the coming year. (See DraftKings stock analysis on TipRanks).Related News: iQIYI Pops 35% In Pre-Market On Report Tencent Seeks To Buy Big Stake Nio Completes $428M ADS Offering, Stock Now Up 70% YTD Google Mulling Purchase of Stake in Indian Vodafone Idea More recent articles from Smarter Analyst: * Kamada’s Covid-19 Therapy Approved For Compassionate Use In Israel * Chembio Sinks 59% In Pre-Market As FDA Revokes Its Covid-19 Test; Top Analyst Cuts Rating * HSBC Resumes Plans To Cut 35,000 Jobs Postponed By Pandemic * Oracle Sinks Post-Earnings As Cloud Push Drags On

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  • Amarin, Apotex Settle Vascepa Dispute; Analyst Stays Sidelined

    Amarin, Apotex Settle Vascepa Dispute; Analyst Stays SidelinedAmarin (AMRN) has announced a settlement agreement with Apotex Inc. that resolves a patent litigation over Apotex’s abbreviated new drug application (ANDA) seeking US approval of a generic form of Vascepa capsules. Shares in Amarin rose 5% in Tuesday’s after-market trading.Amarin’s lead product Vascepa was initially launched in the US in 2013 as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. A new, cardiovascular risk indication for the fish-oil derivative was approved by the FDA in December 2019 based on the results of the landmark Reduce-It trial.The company is currently appealing to the U.S. Court of Appeals a March 2020 patent invalidity ruling in favor of generic companies, Hikma Pharmaceuticals USA Inc. and Dr. Reddy’s Laboratories, Inc. Because Apotex is not a party to that litigation, it is not directly subject to related rulings.As part of the new settlement agreement, Apotex can not sell a generic Vascepa in the US until August 9, 2029 (the same date as Amarin’s 2018 settlement agreement with Teva (TEVA)) or earlier under certain customary circumstances.  These circumstances include if Amarin is not successful in its pending appeal of the March 2020 Nevada district court decision.The agreement also substantially resolves future litigation with Apotex that relating to the December 2019 cardiovascular risk reduction indication of Vascepa, says Amarin.“This settlement involves no financial payment from Amarin to Apotex and allows Amarin to avoid incremental litigation expense and distraction associated with Apotex’s participation in patent litigation related to the MARINE and REDUCE-IT indications,” said John F. Thero, Amarin CEO.Year-to-date shares in Amarin have plunged 68%, but analysts retain a cautiously optimistic Moderate Buy outlook on the stock. This breaks down into 7 recent buy ratings vs 5 hold ratings. Meanwhile the average analyst price target of $18 translates into 155% upside potential. (See Amarin stock analysis on TipRanks)Stifel Nicolaus analyst Derek Archila reiterated his Amarin Hold rating following the settlement announcement. “While this is a slight positive, we don’t see this a major stock moving catalyst” he wrote, adding that he expects AMRN shares to remain range bound until it gets closer to the critical appeal hearing later this year.Related News: Too Much Uncertainty Keeps This 5-Star Analyst Watching Amarin Stock From the Sidelines Jazz Pharma Scores Surprise Early Approval For Lung Cancer Treatment Merck’s Gardasil Receives FDA Nod For Expanded Cancer Indications More recent articles from Smarter Analyst: * Kamada’s Covid-19 Therapy Approved For Compassionate Use In Israel * Chembio Sinks 59% In Pre-Market As FDA Revokes Its Covid-19 Test; Top Analyst Cuts Rating * HSBC Resumes Plans To Cut 35,000 Jobs Postponed By Pandemic * DraftKings Drops 7% In Pre-Market Amid Public Share Offering

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  • Chembio Sinks 59% In Pre-Market As FDA Revokes Its Covid-19 Test; Top Analyst Cuts Rating

    Chembio Sinks 59% In Pre-Market As FDA Revokes Its Covid-19 Test; Top Analyst Cuts RatingShares in Chembio Diagnostics (CEMI) sank 59% after the U.S. Food and Drug Administration revoked the Emergency Use Authorization (EUA) of its DPP (Dual Path Platform) COVID-19 serology test.The stock plunged to $4.10 in pre-market trading after the FDA said that there were performance concerns with the accuracy of Chembio’s SARS-CoV-2 antibody test. The U.S. regulator added that it made the decision to revoke the EUA authorization for the serology test as “benefits no longer outweigh its risks”.“This test generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device,” the FDA said in a statement. “Under the current circumstances of the public health emergency, it is not reasonable to believe that the test may be effective in detecting antibodies against SARS-CoV-2.”The antibody test was one of the first to be granted EUA by the FDA in April. Chembio had been touted as one among a list of companies with the potential to bring a viable COVID-19 test to the market. The potential to deliver a reliable test has fueled impressive gains for the stock this year helping the value to almost double.Chembio’s share price dropped 5% to $9.93 at the close on Tuesday.In response to the FDA decision, five-star analyst Max Masucci at Canaccord Genuity downgraded the stock to a Hold and slashed the price target to $7 (30% downside potential) from $22, saying that his Buy thesis is no longer intact.“While the FDA’s revocation of CEMI’s EUA for its serology test comes as a surprise, it serves as a humble reminder that execution and transparency risks are magnified for micro-cap companies,” Masucci wrote in a note to investors. “Following the update, we materially reduce our revenues and have diminished expectations for CEMI’s ability to seed the market with analyzers for future test launches.”For now, the stock still scores a Moderate Buy analyst consensus with 3 Hold ratings versus 2 Buy ratings. The $16.33 average price target indicates 64% upside potential in the shares in the coming year.  (See Chembio stock analysis on TipRanks)Related News: Fulgent Pops 18% In After-Market On FDA Nod For Covid-19 Home Test AstraZeneca Inks Europe Deal For 400M Covid-19 Vaccine Doses Israel Is Said To Be In Talks To Buy Moderna’s Covid-19 Vaccine Candidate More recent articles from Smarter Analyst: * Kamada’s Covid-19 Therapy Approved For Compassionate Use In Israel * HSBC Resumes Plans To Cut 35,000 Jobs Postponed By Pandemic * DraftKings Drops 7% In Pre-Market Amid Public Share Offering * Oracle Sinks Post-Earnings As Cloud Push Drags On

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  • U.S. FAA chief to testify at hearing on jet certification after 737 MAX crashes

    U.S. FAA chief to testify at hearing on jet certification after 737 MAX crashesThe head of the Federal Aviation Administration is set to testify on Wednesday before a Senate committee on the safety certification of jetliners like Boeing Co’s 737 MAX, still grounded after fatal crashes. The Senate Commerce committee hearing at 10 a.m. EDT (1400 GMT) gives lawmakers a chance to question FAA Administrator Steve Dickson about bipartisan legislation introduced Tuesday that would grant the FAA more power over Boeing’s aircraft designs.

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