Investor Alert


Food and Drug Administration

3:46 a.m. Oct. 4, 2021 - By Tomi Kilgore
OpGen stock rockets after upbeat revenue updateShares of OpGen Inc. rocketed 31.9% in active premarket trading Monday, after the precision medicine company provided a revenue update following the recent Food and Drug Administration clearance of its Acuitas AMR Gene Panel to aid in the diagnosis of severe infections. Trading volume spiked to 5.1 million shares ahead of the open, compared with the full-day average of about 1.8 million shares. The company said preliminary third-quarter revenue was approximately $1.2 million, compared with the FactSet consensus of $800,000. The stock has rallied 35.3% year to date through Friday, while the S&P 500 has gained 16.0%.
3:12 a.m. July 28, 2021 - By Ciara Linnane
Bristol Myers swings to profit to beat second-quarter estimates as Opdivo returns to growthBristol Myers Squibb Co. said Wednesday it swung to a profit of $1.055 billion, or 47 cents a share, in the second quarter, after a loss of $85 million, or 4 cents a share, in the year-earlier period. Adjusted per-share earnings came to $1.93, ahead of the $1.89 FactSet consensus. Revenue rose to $11.703 billion from $10.129 billion, also ahead of the $11.269 billion FactSet consensus. "We delivered a strong quarter across each of our four therapeutic areas, including building momentum for our new product portfolio and Opdivo returning to growth," Chief Executive Dr. Giovanni Caforio said in a statement. Opdivo was first approved by the Food and Drug Administration in 2014 as a treatment for melanoma and has since won approval for other indications. Sales of Opdivo rose 16% in the second quarter to $1.910 billion. Bristol Myers updated its full-year EPS guidance to a range of $2.77 to $2.97 from a prior range of $3.18 to $3.38. It still expects full-year adjusted EPS of $7.35 to $7.55. It expects worldwide revenues to grow in the high-single digits. Shares were flat premarket, but have gained 8.8% in the year to date, while the S&P 500 has gained 17%.
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%.
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