Bulletin
Investor Alert

New York Markets Close in:

Topics

Food and Drug Administration

3:28 a.m. May 6, 2021 - By Jaimy Lee
Moderna reports $1.7 billion in COVID-19 vaccine sales, posts first profit everModerna Inc. brought in $1.7 billion in sales of its COVID-19 vaccine in the first quarter of 2021, marking the company's first significant billion-dollar revenue haul this year and also the first time it's ever reported a GAAP profit. Moderna had earnings of $1.2 billion, or $2.84 per share, in the first quarter of 2021. This is compared to a loss of $124 million, or 35 cents per share, in the first quarter a year ago. The FactSet consensus was $2.39. Moderna had revenue of $1.9 billion for the quarter, up from $8 million in the same quarter a year ago. The FactSet consensus for revenue was $2.0 billion. This quarter marked the first time that the company has generated product revenue during the first three months of the year. About $1.7 billion of that came from sales of its COVID-19 vaccine. (Before receiving authorization from the Food and Drug Administration, it generated grant and collaboration revenue.) Moderna's stock is up 55.8% for the year, while the S&P 500 has gained 10.9%.
8:37 a.m. Jan. 25, 2021 - By Jaimy Lee
J&J may share findings from Phase 3 vaccine trial this weekShares of Johnson & Johnson were up 0.9% in trading on Monday, as the company nears the anticipated disclosure of interim results from a late-stage clinical trial evaluating its single-dose COVID-19 vaccine candidate. J&J said in mid-December it expects to share findings from the Phase 3 trial by the end of January, which would it the third company testing coronavirus vaccines in the U.S. to announce results from a closely watched Phase 3 trial. The other two vaccines, developed by BioNTech SE /Pfizer Inc. and Moderna Inc. , are both mRNA-based vaccines that received emergency use authorization from the Food and Drug Administration in December. J&J said in December that it will file for emergency authorization for its experimental adenovirus-based vaccine in February if results are ready by the end of January. The company is expected to release its fourth-quarter and full-year earnings on Tuesday. J&J's stock has gained 10.9% over the past year, while the S&P 500 is up 15.6%.
7:28 a.m. Jan. 12, 2021 - By Tomi Kilgore
Pfizer's earnings outlook for 2021 tops expectations, but stock fallsShares of Pfizer Inc. dropped 2.1% in morning trading Tuesday, even after the drug maker provided an upbeat earnings outlook for this year. Speaking at the J.P. Morgan Health Care Conference, Chief Executive Albert Bourla said the company projects 2021 adjusted earnings per share of $3.00 to $3.10, which is above the current FactSet EPS consensus of $2.96. The company disclosed in a filing with the Securities and Exchange Commission that the financial guidance is subject to a number of assumptions, including current expectations regarding the impact of the COVID-19 pandemic and COVID-19 vaccine supply and contracts, "which remain dynamic." Pfizer, with partner BioNTech SE , have been supplying a COVID-19 vaccine since it was authorized for emergency use by the Food and Drug Administration. The has so far fallen well short of expectations. Pfizer's stock has gained 6.1% over the past three months, while the SPDR Health Care Select Sector ETF has advanced 7.1% and the S&P 500 has tacked on 7.6%.
3:21 a.m. Jan. 11, 2021 - By Tomi Kilgore
GW Pharmaceuticals provides upbeat total and Epidiolex sales outlooks; stock turns upGW Pharmaceuticals PLC provided an upbeat outlook for fourth-quarter sales, amid strength in sales of Epidiolex, the first cannabis-based drug to be approved by the Food and Drug Administration. The stock edged up 0.2% in premarket trading, reversing earlier losses. The company now expects total product sales of $148 million, above the FactSet consensus of $141.2 million, as Epidiolex sales are expected to be $144 million, which is above expectations of $137.4 million. The company said Epidiolex sales have increased by 70% in 2020, despite challenges associated with the COVID-19 pandemic. "Our goals in 2021 include driving further Epidiolex growth and advancing multiple US pivotal trials for nabiximols in the treatment of [multiple sclerosis] spasticity, with the first data readout expected this year," said Chief Executive Justin Grover. The stock has run up 35.4% over the past three months through Friday, while the ETFMG Alternative Harvest ETF has soared 45.6% and the S&P 500 has gained 10.0%.
10:22 a.m. Nov. 10, 2020 - By Ciara Linnane
Coronavirus update: U.S. adds another 130,000 cases in a day: ‘This is what exponential math looks like,’ says expert Per capita new case numbers are highest in North Dakota, South Dakota, Iowa and Wisconsin, filling hospitals and raising concerns that systems will be overwhelmed The global tally of confirmed cases of the coronavirus illness COVID-19 climbed above 51 million on Tuesday with cases racing across the U.S. and Europe as more localities opted to impose restrictions on movement to curb the spread.
1:20 p.m. Nov. 5, 2020 - By Ciara Linnane
Aurora Cannabis soars 34% to lead weed stock rally fueled by Biden’s lead in presidential race ‘I would say this was one of the best case scenarios for cannabis investors,’ says Korey Bauer, portfolio manager of the Cannabis Growth FundAurora Cannabis led a strong rally in the cannabis sector Thursday, fueled by Democrat Joe Biden’s lead in the presidential election race and the expectation an administration led by him would achieve banking reform sooner rather than later.
2:02 a.m. Nov. 4, 2020 - By Ciara Linnane
GW Pharma shares rally on earnings and news of late-stage trial of cannabis-based treatment for MS patientsShares of GW Pharmaceuticals PLC jumped 18% Tuesday, after the biotech posted a narrower-than-expected third-quarter loss and a revenue beat and said a delayed late-stage trial of its cannabinoid-based treatment for multiple sclerosis spasticity can now proceed.
4:36 a.m. Nov. 2, 2020 - By Jaimy Lee
Gilead unexpectedly cashes in with nearly $900 million in sales of COVID-19 drug But Wall Street analysts are ambivalent about Veklury’s potential, given some unknowns about the drug’s effectivenessGilead Sciences Inc.’s prominent COVID-19 drug unexpectedly brought in $100 more million in sales than analysts had expected in the third quarter, but that doesn’t mean Wall Street’s questions about Veklury have faded away.
5:36 a.m. Oct. 31, 2020 - By Ciara Linnane
Coronavirus update: U.S. counts almost 100,000 cases in new one-day record; The Lancet says Trump pandemic response is ‘disastrous’ USA Today poll finds most Americans disapprove of Trump’s campaign rallies, prefer Biden’s more discreet approachThe U.S. death toll from the coronavirus illness COVID-19 headed toward 230,000 on Saturday and cases topped 9 million after more than 99,000 infections were counted in a record one-day tally, with infections climbing in all swing states just days ahead of the presidential election.
7:46 a.m. Oct. 29, 2020 - By Ciara Linnane
Coronavirus update: U.S. continues to set new case records as Trump remains insistent that U.S. has ‘rounded the corner’ New COVID-19 cases are rising in 47 states, and 27 states recorded 1,000 or more new diagnoses in the last 24 hoursThe U.S. death toll from the coronavirus illness COVID-19 edged closer to 228,000 on Thursday and more than 81,000 new infections were recorded in a single day, pushing the seven-day tally to record highs.
3:27 a.m. Oct. 29, 2020 - By Ciara Linnane
Coronavirus update: Pandemic sets record case numbers across the U.S. as White House suggests the crisis is over U.S. has counted a record 500,000 new cases in the past week, and hospitals in isolated areas of the Midwest are rapidly fillingThe coronavirus pandemic continued to set records across the U.S. on Wednesday, even as the administration of President Donald Trump touted its first-term accomplishments in a news release that suggested it had ended the crisis that has cost more than 226,000 American lives and shows no signs of abating.
10:14 a.m. Oct. 21, 2020 - By Jaimy Lee
Biogen's earnings tumble 55% in the third quarter of 2020Shares of Biogen were down 0.1% in premarket trading on Wednesday after the company posted a steep decline in third-quarter earnings. The drug maker had earnings of $701.5 million, or $4.46 per share, in the third quarter, a 55% decline compared with the $1.546 billion, or $8.39 per share, reported in the same quarter a year ago. Adjusted earnings per share were $8.84, ahead of the FactSet consensus of $8.03. Biogen reported revenue of $3.37 billion for the quarter, a 6% decline from the $3.60 billion it reported in the third quarter of last year. The FactSet consensus was $3.33 billion. The company cited a quarterly drop in sales of some of its multiple sclerosis drugs, including the company's flagship product, Tecfidera, which had revenue of $968 million in the third quarter, compared with $1.12 billion in the same quarter in 2019. Sales of the spinal muscular atrophy drug Spinraza also tumbled, by 10% to $495 million. However, revenue in its smaller biosimilars business was up for the quarter, led by a 7% increase in sales to $124 million of rheumatoid arthritis drug Benepali. Investors are preparing for an upcoming Food and Drug Administration advisory committee meeting for its experimental and somewhat controversial Alzheimer's disease drug aducanumab. The meeting is expected to be held Nov. 6. Biogen cut its guidance for revenue and adjusted EPS for the year, saying it now expects $13.2 billion to $13.4 billion in revenue for the year, compared with its previous guidance of $13.8 billion to $14.2 billion for 2020. It now expects adjusted EPS of $32.50 to $33.50 for the year, compared with previous guidance of $34.00 to $36.00. Biogen's stock is down 10.0% for the year, while the S&P 500 is up 6.5%.
10:45 a.m. Oct. 14, 2020 - By Ciara Linnane
Coronavirus update: U.S. death toll tops 216,000 as Midwest and Mountain West cases start to stretch hospital capacity In the last seven days, 16 states have added more new cases than at any other time since the beginning of the pandemic The U.S. death toll from the coronavirus illness COVID-19 rose above 216,000 on Wednesday, driven by a spike in new cases in the Midwest and Mountain West that are starting to fill hospital beds and squeeze health-care systems.
9:56 a.m. Oct. 13, 2020 - By Ciara Linnane
Coronavirus update: U.S. death toll tops 215,000 as Trump resumes campaign rallies even as doctors warn the test providing his negative results is not suited to that purpose ‘[Trump] should be adhering to guidelines, and they are trying to concoct a narrative to justify why he’s out there, and it’s wrong,’ says Dr. Vin GuptaThe U.S. death toll from the coronavirus-borne illness COVID-19 climbed above 215,000 on Tuesday, after President Donald Trump returned to the campaign trail with a rally in Florida late Monday, at which he again claimed to be “immune” to the virus.
11:05 a.m. Oct. 8, 2020 - By Ciara Linnane
Coronavirus update: New England Journal of Medicine says Trump should be voted out over pandemic management as U.S. death toll tops 212,000 ‘When it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent,’ say editors of prestigious medical journalThe U.S. death toll from the coronavirus illness COVID-19 moved above 212,000 on Thursday, as the editors of the prestigious New England Journal of Medicine sharply criticized the Trump administration’s handling of the pandemic.
12:42 p.m. Sept. 17, 2020 - By Mark DeCambre
Dow snaps four-day winning streak as stocks finish day with modest losses Bulls restrained by Fed outlook, lackluster U.S. economic dataU.S. stocks finished lower Thursday, but off the session lows, as investors digested the Federal Reserve’s economic outlook along with lackluster economic data.
10:03 a.m. Sept. 4, 2020 - By Ciara Linnane
Coronavirus update: Global cases climb above 26.4 million, and U.S. vaccine program’s head sees very low chance of vaccine by late October State and local officials warn Americans not to gather in large numbers over Labor Day holiday weekendThe number of confirmed cases of the coronavirus that causes COVID-19 world-wide rose above 26.4 million on Friday with the U.S. accounting for about a quarter of that total, as a key member of the government’s vaccine program said the chances of a vaccine being ready by late October are “very, very low.”
2:36 a.m. Sept. 3, 2020 - By Ciara Linnane
Coronavirus update: Global case tally nears 26 million, and experts are alarmed that U.S. isn’t joining WHO vaccine effort ‘This go-it-alone approach leaves America at risk of not getting a vaccine,’ says one expertThe number of confirmed cases of the coronavirus that causes COVID-19 worldwide edged closer to 26 million on Wednesday, as experts sounded the alarm on the Trump administration’s decision not to work with an international effort to develop and distribute a COVID-19 vaccine that is backed by the World Health Organization.
11:22 a.m. Aug. 27, 2020 - By Ciara Linnane
Coronavirus update: Global case tally tops 24 million as U.S. tally tops 5.8 million, and CDC head walks back testing change amid outcry In a second embarrassment for a major U.S. public health agency this week, CDC says asymptomatic people exposed to infection can again be testedThe number of confirmed cases of the coronavirus illness COVID-19 worldwide climbed above 24 million on Thursday, and the U.S. tally topped 5.8 million, as the head of the Centers for Disease Control and Prevention walked back a change in guidelines on testing following a storm of criticism from doctors and scientists.
12:33 p.m. Aug. 24, 2020 - By Joy Wiltermuth
Dow ends above 28,000 for first time in 6 months, S&P 500 and Nasdaq clinch new records on coronavirus treatment hopesMajor U.S. benchmarks close near their intraday peaks Monday, after the S&P 500 and Nasdaq Composite set records at the opening bell, as hopes for a potential COVID-19 treatment bolsters trading for more growth-sensitive sectors that have lagged the rest of the market.
9:14 a.m. Aug. 7, 2020 - By Ciara Linnane
Coronavirus update: Global case tally climbs above 19 million; U.S. death toll moves above 160,000 after 11 straight days with 1,000-plus fatalities Uber sees more revenue from food delivery than ride-hailing for the first timeThe number of confirmed cases of the coronavirus illness COVID-19 climbed above 19 million on Friday, the death toll rose above 715,000 and the U.S. death toll topped 160,000, after an 11th straight day in which more than 1,000 deaths were counted.
7:24 a.m. Aug. 7, 2020 - By Ciara Linnane
GW Pharma shares slide 12% after company swings to loss during pandemicShares of GW Pharmaceuticals PLC slumped 12% Friday, after the company swung to a loss in the second quarter, hurt by the effect of the coronavirus pandemic. The U.K. company is the only one to have U.S. Food and Drug Administration approval for a cannabis-based drug, Epidiolex, a treatment for severe forms of childhood epilepsy. The company posted a loss of $8.8 million, or 2 cents a share, for the quarter, after income of $79.7 million in the year-earlier period. Revenue rose to $121.3 million from $72.0 million. "We were pleased with the strength of U.S. Epidiolex sales in the second quarter in spite of the COVID-19 pandemic," Chief Executive Justin Gover said in a statement. Epidiolex sales came to $117.7 million. "Further, the recent approval and imminent launch of Epidiolex for the treatment of seizures associated with TSC provides a meaningful new opportunity to accelerate momentum through the second half of 2020 and beyond," he said. Leerink analyst Marc Goodman said the numbers were "solid" coming in the midst of the pandemic, and in line with management's guidance from its first-quarter conference call. "... we think GW executed through the volatility well, and thus we are surprised that the stock is down ~10% in the after market," he wrote in a Thursday note to clients. Leerink rates the stock as outperform with a $190 stock price target. Shares have gained 11% in the year to date, as the S&P 500 has gained 3.6%.
11:37 a.m. Aug. 4, 2020 - By Ciara Linnane
Coronavirus update: U.S. case tally at 4.74 million as New Jersey, Massachusetts and Connecticut see infections climb again Cinemark’s revenue falls 99% as theaters remain closed, and Mallinckrodt says it is looking at possible bankruptcyThe U.S. case tally for the coronavirus illness COVID-19 rose by fewer than 50,000 on Monday for a second straight day, data aggregated by Johns Hopkins University showed, although cases were rising in some states that had seemed to get the spread under control earlier this year.
7:12 a.m. July 31, 2020 - By Barbara Kollmeyer
European stocks turn lower as investors juggle tech optimism and economic gloom Nokia climbs after results European stocks drop on the final trading day of the month, as economic worries overshadow upbeat earnings in the U.S. and Europe.
2:13 a.m. July 31, 2020 - By Jaimy Lee
Gilead swings to a big loss on acquisition expense, stock falls after earnings and revenue miss The drugmaker expects to produce more than 2 million courses of COVID-19 treatment remdesivir by the end of the yearShares of Gilead Sciences Inc. fell more than 1% in after-hours trading Thursday after the drugmaker reported that it swung to a large loss during the second quarter and missed estimates even after adjusting for an acquisition.
12:32 p.m. July 27, 2020 - By Joy Wiltermuth
Dow ends 114 points higher, U.S. stocks snap 2-day losing streak, as investors await stimulus progress Gold settles at highest level in history at $1,931 an ounce U.S. stocks closed higher Monday as investors monitored efforts in Washington to craft another coronavirus rescue package and braced for tech giant to report in the busiest week of earnings season.
2:05 a.m. July 24, 2020 - By Ciara Linnane
Coronavirus update: Global COVID-19 cases top 15 million, U.S. cases pass 4 million, and California has more cases than New York Tesla surprises investors with an adjusted profit even after it was beset by pandemic-related stoppages at California plantThe number of confirmed cases of the coronavirus illness COVID-19 worldwide climbed above 15 million on Thursday and the U.S. case tally passed 4 million, as California’s case tally rose above early U.S. hot spot New York following a surge in new infections in recent weeks.
2:40 a.m. July 23, 2020 - By Ciara Linnane
Coronavirus update: U.S. case tally climbs above 3.9 million and Trump’s late move on face masks criticized by health experts The pandemic ‘will probably, unfortunately, get worse before it gets better.’ Trump reverses course on pandemic he called a hoaxThe number of U.S. cases of the coronavirus illness COVID-19 climbed above 3.9 million on Wednesday, a day after President Donald Trump finally encouraged Americans to wear face masks in public, marking a break with his approach to the pandemic thus far.
12:37 p.m. July 13, 2020 - By Joy Wiltermuth
Nasdaq, S&P 500 end lower as coronavirus cases rise and tech stock fall, erasing rally sparked by renewed vaccine hopes California Gov. Newsom ordered bars, indoor dining and more to close again as state battles COVID-19 surgeStocks closed mostly lower Monday, with the Dow booking a modest gain, after technology stocks fell and rising coronavirus cases led California’s governor to order businesses across the state to shutter once again.
2:21 a.m. July 2, 2020 - By Ciara Linnane
Coronavirus update: U.S. case tally climbs above 2.6 million, and top Republicans now call on Americans to wear face masks FedEx, General Mills and Constellation Brands benefit from pandemic buying, while Michael Kors parent Capri takes a hitThe number of confirmed cases of the coronavirus illness COVID-19 in the U.S. climbed above 2.6 million on Wednesday, a day after Dr. Anthony Fauci said it could spike to more than 100,000 a day if the fresh clusters emerging in the South and West are not brought under control.
12:21 p.m. June 16, 2020 - By Ciara Linnane
Coronavirus update: Global case tally tops 8 million and states reopen businesses even as infections and hospitalizations rise The IPO market welcomed the biggest deal of 2020, and McDonald’s said same-store sales fell 12% in the quarter through May 31The number of confirmed cases of the coronavirus illness COVID-19 globally climbed above 8 million on Tuesday, and the number of infections continued to rise in many parts of the U.S. even as officials continued their push to reopen and end lockdowns.
5:35 a.m. June 16, 2020 - By Barbara Kollmeyer
A budding recovery could run into trouble after the election, warns Goldman Sachs Critical information for the U.S. trading dayOur call of the day from Goldman Sachs says a lack of disposable income for consumers could pose a problem to those post-November election recovery hopes.
9:06 a.m. June 10, 2020 - By Ciara Linnane
Coronavirus update: Global death toll passes 412,000, as Dr. Fauci warns that COVID-19 is far from over Starbucks expects to be profitable again by the fourth quarter, and Best Buy is letting customers back into its storesThe coronavirus pandemic that has cost more than 412,000 lives globally took just one month to span the globe and is still far from over, even as countries around the world move to lift quarantines, stay-at-home orders and other restrictions on movement.
10:06 a.m. June 4, 2020 - By Ciara Linnane
Coronavirus update: Global case tally climbs above 6.6 million and California reports a rise in infections amid protests and reopening Amazon is adding to its fleet of cargo jets at a time when aircraft values are depressed; Michaels Cos. earnings fall way shortThe number of confirmed cases of the coronavirus that causes COVID-19 rose past 6.6 million on Thursday, and California reported a rise in infections after weeks of slowing, raising concerns that the protests at the death of George Floyd, and the reopening of certain counties, are helping spread the illness.
11:12 a.m. May 28, 2020 - By Ciara Linnane
Coronavirus update: U.S. marks grim milestone as Trump preps executive order on social-media companies HP’s printing business takes a hit as office workers stay home, while Dollar General and Dollar Tree enjoy sales boost The U.S. death toll from the coronavirus that causes COVID-19 rose above 101,000 on Thursday, one day after it exceeded the 100,000 level, a grim marker for the nation with the highest number of cases and deaths in the world.
11:20 a.m. May 19, 2020 - By Ciara Linnane
Coronavirus update: U.S. death toll tops 91,000; Trump slams WHO, says he’s taking hydroxychloroquine to stave off COVID-19 Walmart cheers investors with blowout quarter; Southwest Airlines says demand is showing signs of improvementThe U.S. death toll from the coronavirus that causes COVID-19 rose above 91,000 on Tuesday, as President Donald Trump again threatened to cut off funding for the World Health Organization, accusing its leaders of failing to react quickly or aggressively enough at the start of the outbreak.
10:54 a.m. May 18, 2020 - By Ciara Linnane
Coronavirus update: Global case tally reaches 4.8 million; China’s Xi supports WHO-backed probe of origins of pandemic — once the crisis is over Tesla gets green light to reopen California plant, and investors await earnings from Walmart, Target and AlibabaThe number of cases of the coronavirus that causes COVID-19 rose to 4.8 million on Monday, as Chinese President Xi Jinping said China would support an international investigation of the origins of the pandemic led by the World Health Organization, as soon as the crisis has been brought under control.
7:48 a.m. May 16, 2020 - By Ciara Linnane
Coronavirus update: New outbreaks reported in states that plan to reopen soon, while Trump suggests testing is ‘overrated’ New York Stock Exchange will reopen floor on May 26 with small group at first; Nike says online sales are boomingThe U.S. death toll from the coronavirus that causes COVID-19 rose above 87,000 on Saturday, as new outbreaks were reported from states where stay-at-home orders are set to expire and in states that never imposed them, raising concerns that the reopening of economies will spur new infections.
2:40 a.m. May 15, 2020 - By Ciara Linnane
Coronavirus update: Global death hits 300,000; poll finds most Americans disapprove of Trump’s handling of crisis Cisco says the pandemic is worse than the dot-com bust of 2000 and the 2008 crisis; Uber-Grubhub deal talks push aheadThe global death toll from the coronavirus that causes COVID-19 edged closer to 300,000 on Thursday, as a new poll found the majority of Americans disapprove of President Donald Trump’s handling of the pandemic.
10:56 a.m. May 12, 2020 - By Ciara Linnane
Coronavirus update: U.S. death toll tops 81,000; Trump defends administration’s record in testy exchange with reporters Tesla defies county ban and reopens California car-making plant, and Boeing CEO says a major airline will be pushed into bankruptcy by pandemicThe U.S. death toll from the coronavirus that causes COVID-19 climbed above 81,000 on Tuesday, as President Donald Trump, defending his record on testing in the U.S., ended his White House news conference abruptly following an angry exchange with two reporters.
Browse topics:

Filter results by

Location

Us (549)

Europe (109)

Asia Pacific (96)

Eu (83)

China (78)

Latin America (18)

Link to MarketWatch's Slice.