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11:32 a.m. April 17, 2021 - By Quentin Fottrell
The expectation of perfection: Risk of blood clot from Johnson & Johnson COVID-19 vaccine is 0.00009% ‘It’s the same perceptual problem when we blindly drive to the airport texting, yet worry about the airplane’‘It’s the same perceptual problem when we blindly drive to the airport texting, yet worry about the airplane.’
6:06 a.m. April 13, 2021 - By Tomi Kilgore
Moderna, BioNTech stocks surge after regulators halt use of J&J vaccine Shares of Moderna Inc. shot up 8.6% in morning trading, BioNTech SE ran up 5.7% toward a 4-month high and Pfizer Inc. climbed 1.1% toward a 3-month high, after U.S. health regulators paused the use of Johnson & Johnson's COVID-19 vaccine . Meanwhile, J&J shares shed $2.98, or 1.8%, to shave about 20 points of the Dow Jones Industrial Average's price, as the Dow dropped 132 points, or 0.4%. Moderna's two-dose COVID-19 vaccine, and the two-dose vaccine from Pfizer and partner BioNTech are mRNA vaccines while J&J's one-dose vaccine is an adenovirus vaccine. The Centers for Disease Control and Prevention and the Food and Drug Administration said there have been six cases of blood clotting out of the roughly six million people who have received the J&J vaccine, all of who were women between the ages of 18 and 48.
4:34 a.m. April 13, 2021 - By Tomi Kilgore
Novocure's stock rockets into record territory after upbeat DMC review of lung cancer treatment trialShares of Novocure Ltd. skyrocketed 80.7% toward a record high in premarket trading Tuesday, after the tumor treatment company said an independent data monitoring committee (DMC) said the interim analysis of a Phase 3 trial would be accelerated. The trial is of Novocure's Tumor Treating Fields, which are electric fields that disrupt cancer cell division, in stage 4 non-small cell lung cancer. The DMC concluded that the trail should continue with no evidence of increased systemic toxicity. Novocure plans to submit an Investigational Device Exemption (IDE) to the Food and Drug Administration. "The accelerated interim analysis with an encouraging outcome adds to the accumulating evidence of Tumor Treating Fields' broad potential across a range of hard-to-treat cancers," said Novocure Executive Chairman William Doyle. Novocure's stock, which is on track to open well above its Feb. 19 record close of $190.17, has dropped 25.5% over the past three months through Monday while the S&P 500 has gained 8.4%.
10:14 p.m. April 11, 2021 - MarketWatch
Regeneron's COVID-19 treatment cuts infection riskRoche Holding AG said Monday that a Phase 3 trial involving casirivimab and imdevimab to cut risk of symptomatic Covid-19 infections yielded positive results, meeting primary and key secondary endpoints.
12:06 p.m. April 4, 2021 - MarketWatch
J&J takes over contractor's COVID-19 vaccine workJohnson & Johnson is taking over manufacturing of its Covid-19 vaccine at a contract manufacturer's plant that makes the main ingredient, after a production problem ruined a batch. In order to give J&J full control, production of AstraZeneca PLC's vaccine at the Emergent BioSolutions Inc. plant in Baltimore will move elsewhere, according to a person familiar with the matter.
5:24 a.m. March 29, 2021 - By Ciara Linnane
Moderna says it's on track to deliver second 100 million doses to US. government by end MayModerna Inc. said Monday it has shipped the 100 millionth dose of its COVID-19 vaccine to the U.S. government and expects to meet its commitment dates for all current orders, including delivering a second 100 million doses by the end of May and a third 100 million by end-July. Since the vaccine was granted emergency use authorization by the U.S. Food and Drug Administration in December, Moderna shipped more than 16 million doses in January, 26 million in February and 44 million to date in March. "Looking forward, the company expects to ship 40-50 million doses per month to the U.S. Government to fulfill its commitments. All U.S. government supply comes from Moderna's dedicated supply chain in the U.S.," Moderna said in a statement. Shares were down 1.6% premarket, but have gained 28% in the year to date, while the SPDR S&P Biotech ETF has fallen 5.5% and the S&P 500 has gained 6%.
5:40 a.m. March 19, 2021 - By Jaimy Lee
Incyte's Jakafi failed Phase 3 clinical trial as a treatment for some severely ill COVID-19 patientsShares of Incyte Corp. gained 1.6% in trading on Friday, the day after the company said its chemotherapy Jakafi did not meet the primary endpoint in a Phase 3 trial as a treatment for some severely ill COVID-19 patients. Incyte said it still plans to provide the drug on a compassionate-use basis pending approval from the Food and Drug Administration because Jakafi seems to improve mortality rates among these patients. The trial evaluated Jakafi in patients taking Gilead Sciences Inc.'s Veklury who were on mechanical ventilators and had also been diagnosed with acute respiratory distress syndrome. "There remains a significant unmet medical need for treatments that may potentially improve survival outcomes for patients suffering from severe COVID-19 related complications, specifically those requiring mechanical ventilation," Incyte CEO Steven Stein said in a news release. Incyte's shares have gained 21.2% over the past 12 months, while the broader S&P 500 is up 63.2%.
3:25 p.m. March 15, 2021 - MarketWatch
AstraZeneca vaccine suspended in much of EuropeGermany, Italy, France and Spain joined the ranks of European countries that have temporarily halted use of the Covid-19 shot made by AstraZeneca PLC over blood-clot concerns, dealing another blow to the continent's sluggish vaccination rollout and threatening the credibility of the vaccine itself.
8:49 a.m. March 10, 2021 - By Jaimy Lee
Bluebird's stock is up after saying illness reported in clinical trial wasn't likely caused by gene therapyShares of Bluebird Bio Inc. gained 6.9% in trading on Wednesday after the company said it was "unlikely" that the diagnosis of acute myeloid leukemia in a patient participating in an early-stage study can be attributed to its sickle cell disease treatment candidate. The experimental gene therapy is currently being tested in a Phase 1/2 clinical trial. "It is very unlikely our BB305 lentiviral vector played a role in this case and we have shared with the FDA that we believe these results support lifting the clinical holds on our β-thalassemia and sickle cell disease programs," Philip Gregory, Bluebird's chief scientific officer, said in a news release. The Food and Drug Administration had placed a clinical hold on the programs in February. "The findings, in our view, are pretty convincing that the vector is not responsible," Bernstein analysts told investors on Wednesday. Bluebird's stock is down 51.5% over the past 12 months, while the broader S&P 500 is up 41.1%.
3:48 a.m. March 10, 2021 - By Jaimy Lee
Lannett plans to file experimental insulin product with FDA sometime this yearShares of Lannett Co. Inc. gained 7.3% in premarket trading on Wednesday after the company said it received feedback from the Food and Drug Administration about the ongoing development of a biosimilar version of insulin glargine. This type of long-acting insulin is considered a biologic and was initially developed by Sanofi under the brand name Lantus. Lannett said it submitted the clinical-trial protocol to the FDA in November and has since updated it with the regulator's feedback. The company plans to file an investigational new drug application sometime in 2021, with a goal to eventually launch the product in the market in 2023. Lannett's stock is down 15.3% over the past 12 months, while the S&p 500 has gained 41.1%.
11:03 a.m. March 4, 2021 - By Jaimy Lee
NIH to study three experimental COVID-19 treatmentsThe National Institutes of Health said Thursday that it is putting three more investigational COVID-19 treatments into Phase 2/3 clinical trials. The experimental therapies are: an inhalable beta interferon developed by Synairgen's ; AstraZeneca's monoclonal antibody combination, which will be tested as an infusion and also as an injection; and Sagent Pharmaceuticals Inc.'s oral serine protease inhibitor. Sagent is privately held. The NIH said it is trying to identify and study therapies aimed at treating people who develop mild or moderate forms of COVID-19. So far during the pandemic, there are few therapies available that effectively treat patients with COVID-19. Only one, Gilead Sciences Inc.'s Veklury, has received full approval from the Food and Drug Administration, though several other companies, including Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. have received emergency authorization for their antibody treatments. Over the past year, Synairgen's stock has soared 763.1%, while U.S.-listed shares of AstraZeneca are up 0.4%. The broader S&P 500 is up 27.2%.
4:29 a.m. March 4, 2021 - By Jaimy Lee
NIH tells Vir that experimental COVID-19 therapy may not benefit patientsShares of Vir Biotechnology Inc. tumbled 5.4% in premarket trading on Thursday, the day after the company said the experimental COVID-19 treatment that it's developing with GlaxoSmithKline may not benefit patients. U.S.-listed shares of GSK were up 0.6% in trading before the market opened on Thursday. The investigational monoclonal antibody therapy was being tested in hospitalized COVID-19 patients in a Phase 3 clinical trial conducted by the National Institutes of Health until an independent safety board recommended that the trial investigators close the study to enrollment at this time, Vir said. "While we are disappointed with the recommendation ... we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients," Vir CEO George Scangos said in a news release. (Remdesivir, which is also called Veklury, was developed by Gilead Sciences Inc. and is the only COVID-19 treatment to have a full Food and Drug Administration approval.) Vir's stock is down 6.9% over the past 12 months, while the broader S&P 500 has gained 27.2%.
10:44 a.m. March 1, 2021 - By Tomi Kilgore
Athenex stock plunges to pace all decliners after disappointing FDA response to breast cancer treatment NDAShares of Athenex Inc. plummeted 54.6% on very active afternoon trading Monday, enough to be the biggest decliner listed on major U.S. exchanges, after the Food and Drug Administration said the biopharmaceutical company's New Drug Application (NDA) for its metastatic breast cancer treatment, oral paclitaxel plus encequidar, is not ready for approval in its present form. Trading volume spiked to 40.1 million shares, compared with the full-day average of about 1.1 million shares. The company said earlier that the FDA issued a complete response letter (CRL) expressing concerns of a safety risk to patients, and recommended a new clinical trial be conducted. Separately, the company reported a fourth-quarter net loss that widened to $49.5 million, or 53 cents a share, from $21.7 million, or 28 cents a share, in the year-ago period, wider than the FactSet consensus for a per-share loss of 44 cents. Revenue fell 36.5% to $21.8 million, topping the FactSet consensus of $20.7 million. The stock has lost 55.1% over the past 12 months, while the iShares Nasdaq Biotechnology ETF has climbed 40.2% and the S&P 500 has advanced 32.4%.
12:42 p.m. Feb. 25, 2021 - By Claudia Assis
Pfizer: FDA eases ultra-low temperature requirements for COVID-19 vaccine Pfizer Inc. said late Thursday the U.S. Food and Drug Administration is allowing the company "more flexible" storage and transportation conditions for its and BioNTech's [s:bntx] COVID-19 vaccine. The FDA will allow undiluted, frozen vials of the vaccine to be transported and stored at temperatures commonly found in pharmaceutical freezers for a period of up to two weeks, the company said. That's an alternative constrasting with the "preferred" storage of the undiluted vials in ultra-low temperature freezers. "This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions. The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites," the FDA said in the statement. Shares of Pfizer lost 0.4% in the extended session Thursday after ending the regular trading day up 0.2%.
11:48 a.m. Feb. 25, 2021 - By Claudia Assis
Sarepta stock rises after FDA approves biotech's Duchenne MD treatmentShares of Sarepta Therapeutics Inc. rose nearly 1% in late trading Thursday after the biotech company said the U.S. Food and Drug Administration has approved one of its treatments for Duchenne muscular dystrophy in patients with certain mutations. The continued approval of the injection, called amondys 45, could be contingent on confirmation of a clinical benefit in further trials, Sarepta said. A placebo-controlled trial to support the approval is ongoing and expected to end in 2024, the company said. Shares of Sarepta have lost around 26% in the last 12 months, contrasting with gains around 22% for the S&P 500 index.
6:35 a.m. Feb. 25, 2021 - By Jaimy Lee
Regeneron to share new data about COVID-19 antibody cocktail in MarchShares of Regeneron Pharmaceuticals Inc. were up 0.2% in trading on Thursday after the company said an independent committee recommended the placebo no longer be given to COVID-19 patients in a Phase 3 clinical trial because the company's antibody cocktail demonstrated "clear" efficacy. The committee said the treatment, REGEN-COV, which received emergency authorization in November, reduced hospitalizations and deaths at two dose levels, and it would continue to enroll non-hospitalized COVID-19 patients who will receive either dose of the therapy. The company said it plans to share detailed clinical data from the trial next month as part of its effort to secure a full approval from the Food and Drug Administration for the antibody cocktail. Regeneron's stock is up 3.5% over the past 12 months, while the S&P 500 has gained 21.7%.
4:56 a.m. Feb. 23, 2021 - By Jaimy Lee
J&J plans to deliver 20 million doses of its COVID-19 vaccine in the U.S. in MarchShares of Johnson & Johnson were down 0.1% in premarket trading on Tuesday after the company said in released in advance of a congressional hearing that it plans to deliver about 20 million doses of its COVID-19 vaccine by the end of March. J&J's still-investigational COVID-19 vaccine candidate is currently under review at the Food and Drug Administration, though the federal government has already agreed to purchase 100 million doses of the company's single-dose vaccine in the first half of the year. Executives from J&J, AstraZeneca , Pfizer Inc. , Moderna Inc. , and Novavax Inc. are expected to testify Tuesday in front of about the availability of COVID-19 vaccines in the U.S. J&J's stock is up 7.9% over the past 12 months, while the S&P 500 has gained 16.1%.
9:56 a.m. Feb. 22, 2021 - By Jaimy Lee
FDA sets out new rules for vaccine and test developers over variant worries The Food and Drug Administration on Monday issued a set of guidance documents for companies that are developing COVID-19 , , and as a result of new variants of the virus that have emerged. There are of SARS-CoV-2, two of which are believed to be more infectious, that have been identified in the U.S. While the number of people in the U.S. who have contracted those variants remains low, the new strains have raised concern about the effectiveness of medical products. The FDA said it believes currently authorized vaccines are still effective against these variants but said there may be a need for clinical immunogenicity studies in the future if the vaccines are no longer as effective or other variants emerge. The regulator said test developers should consider routine monitoring to better track new mutations and how they could affect the accuracy of their COVID-19 tests. A third guidance is aimed at developers of monoclonal antibody treatments, which are similar to vaccines in that their effectiveness can be dampened by new variants.
3:46 a.m. Feb. 22, 2021 - By Jaimy Lee
FDA committee to review J&J's COVID-19 vaccine candidate this weekA Food and Drug Administration advisory committee is set to meet Friday to vote on whether the regulator should authorize Johnson & Johnson's experimental single-dose COVID-19 vaccine. Shares of J&J were up 0.5% in premarket trading on Monday. The regulator is not required to follow the advice of the committee but often does. The committee is made up of a group of independent medical experts who will discuss and then vote on whether the benefits of the investigational vaccine outweigh the risks. The FDA is also expected to release its report on J&J's COVID-19 vaccine by Wednesday, in advance of the that will run all day on Friday. In the cases of the BioNTech SE and and COVID-19 vaccines, the FDA granted emergency-use authorizations one day after the advisory committee meetings on those vaccines -- this could mean that the J&J's COVID-19 vaccine candidate will be authorized by the end of the week. J&J's stock has gained 8% over the past 12 months, while the broader S&P 500 is up 15.3%.
11:33 a.m. Feb. 19, 2021 - By Jaimy Lee
Mayo Clinic: COVID-19 vaccines are 88.7% effective in the 'real world'Both of the authorized COVID-19 vaccines in the U.S. are nearly as effective at preventing infections with SARS-CoV-2 in the real world as they were in clinical trials, according to conducted by the Mayo Clinic and Nference Inc., a privately held company. The study, which was published Thursday as a preprint, found that both COVID-19 vaccines had an effective rate of 88.7% in the roughly 62,000 people included in the retrospective analysis. It also found that people who had been vaccinated had lower hospitalization rates if they did get sick. The vaccine developed by BioNTech SE and Pfizer Inc. had an efficacy rate of 95.0% in the Phase 3 clinical trial, while Moderna Inc.'s vaccine reported an efficacy rate of 94.1% in its late-stage study. Both are mRNA-based vaccines that require two doses and received emergency use authorization from the Food and Drug Administration in December. The slightly lower effectiveness rate is likely due to the fact that the vaccination was initially only open to two groups of people who are at high risk for contracting the virus: health care workers, and nursing-home residents. Over the past 12 months, shares of BioNTech have soared 249.3%, Pfizer's stock is up 0.7%, and Moderna shares have rallied 796.2% The broader S&P 500 is up 16.3%.
4:22 a.m. Feb. 19, 2021 - By Jaimy Lee
Mayo Clinic: COVID-19 vaccines are 88.7% effective in the 'real world'Both of the authorized COVID-19 vaccines in the U.S. are nearly as effective at preventing infections with SARS-CoV-2 in the real world as they were in clinical trials, according to conducted by the Mayo Clinic. The study, which was published Thursday as a preprint, found that both COVID-19 vaccines had an effective rate of 88.7% in the roughly 62,000 people included in the retrospective analysis. It also found that people who had been vaccinated had lower hospitalization rates if they did get sick. The vaccine developed by BioNTech SE and Pfizer Inc. had an efficacy rate of 95.0% in the Phase 3 clinical trial, while Moderna Inc.'s vaccine reported an efficacy rate of 94.1% in its late-stage study. Both are mRNA-based vaccines that require two doses and received emergency use authorization from the Food and Drug Administration in December. The slightly lower effectiveness rate is likely due to the fact that the vaccination was initially only open to two groups of people who are at high risk for contracting the virus: health care workers, and nursing-home residents. Over the past 12 months, shares of BioNTech have soared 249.3%, Pfizer's stock is up 0.7%, and Moderna shares have rallied 796.2% The broader S&P 500 is up 16.3%.
6:24 a.m. Feb. 18, 2021 - By Jaimy Lee
Altimmune to start early-stage trial for its COVID-19 vaccine candidateShares of Altimmune Inc. were down 4.1% in trading on Thursday, the day after the clinical-stage company said it had received regulatory approval to begin studying its COVID-19 vaccine candidate in a Phase 1 clinical trial. Altimmune said Wednesday the Food and Drug Administration had OK'ed the company's investigational new drug application for its experimental single-dose, intranasal vaccine. It expects to begin enrolling the trial's 180 participants, who will be between the ages of 18 and 55 years old, within the week. Altimmune's stock has soared 1,239.4% over the past 12 months, while the S&P 500 is up 16.3%.
3:55 a.m. Feb. 12, 2021 - By Jaimy Lee
SVB Leerink, J.P. Morgan downgrade Amicus stock after Phase 3 data for rare disease drug comes outShares of Amicus Therapeutics Inc. were down 23.1% in premarket trading on Friday, the day after the company said an experimental rare disease drug failed to perform better than the standard of care in a late-stage trial. The investigational drug, AT-GAA, is a treatment for Pompe disease, a rare, genetic disease that causes severe muscle weakness. The standard of care is Sanofi's Lumizyme, which was approved back in 2010. Though Amicus said it still plans to submit AT-GAA to the Food and Drug Administration for approval in the second quarter of 2021, analysts were concerned about the drug's performance in the pivotal Phase 3 clinical trial. SVB Leerink on Friday downgraded the stock to market perform from outperform. "This situation strikes us as reminiscent of the long and arduous path to approval for FOLD's one commercial product Amigal, which also missed its primary endpoint but was ultimately approved," SVB's Joseph Schwartz wrote in a note to investors. J.P. Morgan also downgraded the stock to neutral from overweight. "Certainly, overall, this is a disappointing outcome," analysts there wrote. "That said, we do not view AT-GAA as a 'zero' by any means." Shares of Amicus have gained 67.8% over the past 12 months, while the broader S&P 500 is up 16.6%.
4:34 a.m. Feb. 11, 2021 - MarketWatch
AstraZeneca: Jabs for new variants need 6 monthsLONDON -- AstraZeneca PLC said it was fixing problems with the manufacturing of its Covid-19 vaccine and expects to roughly double monthly production to 200 million doses by April, as it seeks to move past a rocky start to the shot's rollout.
3:26 a.m. Feb. 10, 2021 - By Ciara Linnane
Cassava Sciences to offer $200 million of shares priced at $49 each vs. $57.56 at Tuesday's closeCassava Sciences Inc. said Wednesday it is planning a registered direct offering of $200 million of shares, priced at $49 each, or a discount over Tuesday's closing price of $57.56. The company, which is developing a treatment for Alzheimer's disease, said H.C. Wainwright & Co. is exclusive placement agent for the deal. Proceeds will be used for working capital and general corporate purposes, including development of its simufilam, the company's main product candidate. On Monday, Cassava said it based on meetings with the Food and Drug Administration, sometime in the second half of this year. This trial has not been publicly granted a go-ahead by the regulator. The company said last week that simufilam improved cognition and behavior scores in 50 patients with mild-to-moderate forms of the disease after six months of treatment, according to an interim analysis of an open-label study. Shares fell 13% premarket on the news of the dilutive offering.
7:05 a.m. Feb. 5, 2021 - By Jaimy Lee
FDA to issue guidance for vaccine developers about new variantsThe U.S. government plans to provide additional guidance about new strains of SARS-CoV-2 to companies that have developed or are developing new tests, treatments, and vaccines. The Food and Drug Administration said Thursday it's already discussing with companies how the new variants may affect the efficacy of their products. This includes makers of monocolonol antibodies, which are thought by B.1.351, a more infectious strain that emerged from South Africa. Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. both have authorized COVID-19 antibody treatments. The regulator also said it believes that currently available vaccines still prevent infections with the virus and that most currently available tests are also still effective at detecting the coronavirus. It previously said that d by new variants. "We do not believe there will be the need to start at square one with any of these products," the FDA said. "We recognize we are in a pandemic."
3:24 a.m. Feb. 3, 2021 - MarketWatch
Biogen profit falls short as revenue fallsBiogen Inc. said its profit fell for the latest quarter as revenue declined and the company spent more on research and development. The Cambridge, Mass.-based pharmaceutical company on Wednesday posted a profit of $357.9 million for the fourth quarter, compared with $1.44 billion in the prior year. Earnings were $2.32 a share, compared with $8.08 a share a year earlier.
11:04 a.m. Feb. 1, 2021 - By Jaimy Lee
Bank of America downgrades Moderna stock over concerns about valuationShares of Moderna Inc. tumbled 8.2% in trading on Monday after Bank of America analysts downgraded the company's stock to underperform from neutral, citing valuation concerns. Until December, Moderna was a clinical-stage company that had yet to bring to market a single therapy, but it now has one of two authorized COVID-19 vaccines in the U.S. The company's stock is up 52.7% so far this year and has soared 677.6% over the past 12 months. Moderna "shares continue to run...attaining levels that are increasingly difficult to justify on a fundamental basis," the Bank of America analysts wrote in a Feb. 1 note to investors. They estimate that Moderna's COVID-19 vaccine will have about 14% of the COVID-19 vaccine market in the U.S. and Europe, and it will generate peak sales of $12.8 billion in 2022, a sales figure that is expected to decline to less than $1 billion by 2027. The emergence of two other viable COVID-19 vaccine candidates, which are being developed by Johnson & Johnson and Novavax Inc. , also cut into analyst expectations, though neither experimental vaccine has received emergency use authorization from the Food and Drug Administration or has so far reported efficacy rates as high as Moderna or BioNTech SE /Pfizer Inc.'s vaccines. "The number of vaccine options with compelling characteristics (single injection, lower cost, clean safety) could begin to weigh on Moderna's margins and market share longer-term," Bank of America analysts concluded. The S&P 500 is up 13.5% over the last 12 months.
7:40 a.m. Jan. 29, 2021 - By Ciara Linnane
Biogen shares jump 9% after FDA extends review period for Alzheimer's treatmentBiogen Inc. shares rose 9% Friday, after the company said the U.S. Food and Drug Administration has extended the review period for its investigational Alzheimer's disease treatment aducanumab by three months. As part of the review, Biogen submitted a response to an information request from the regulator and provided it with additional data and analyses, "which the FDA considered a Major Amendment to the application that will require additional time for review," . Leerink analysts said the news is a positive as such a move usually means the FDA wants to approve the drug. "Recall, in our preview note last October, we believed that Biogen's data package in totality was supportive of approval, and we are even more confident in that outlook now," analysts led by Marc Goodman wrote in a note to clients. Biogen shares have gained 19% in the year to date, while the SPDR S&P Biotech ETF has gained 41% and the S&P 500 has gained 16%.
2:47 a.m. Jan. 27, 2021 - MarketWatch
GlaxoSmithKline, Lilly, Vir in COVID therapy pactGlaxoSmithKline PLC said Wednesday that it is partnering with Eli Lilly & Co. and Vir Biotechnology Inc. to evaluate a combination of two Covid-19 therapies in low-risk patients with mild-to-moderate symptoms of the virus.
4:19 a.m. Jan. 26, 2021 - By Ciara Linnane
Moderna on track to deliver 200 million doses of its COVID vaccine to U.S. govt by end-JuneModerna Inc. said Tuesday it is on track to deliver 100 million doses of its COVID-19 vaccine to the U.S. government by end-March and to deliver 200 million doses by end-June. The Cambridge, Mass.-based biotech said it has already delivered more than 30 million doses of the vaccine to the U.S. government. About 10.1 million doses of the vaccine have by now been administered in the U.S., the company said, citing Centers for Disease Control and Prevention data. The vaccine was granted emergency use authorization by the U.S. Food and Drug Administration on Dec. 18, shortly after a separate vaccine developed by Pfizer Inc. and its German partner BioNTech SE won the same authorization. The U.S. government has an option to purchase up to 300 million doses of the Moderna vaccine. The vaccine has also been authorized for use in Canada, Israel, the European Union, the U.K. and Switzerland. Moderna shares were down 1.2% premarket, but have gained 596% in the last 12 months, while the SPDR S&P Biotech ETF has gained 73% and the S&P 500 has gained 17%.
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%.
10:50 a.m. Jan. 19, 2021 - By Ciara Linnane
U.S. climbs above 400,000 COVID-19 fatalities as California becomes first state with 3 million confirmed cases L.A. County air quality regulator lifts limit on how many cremations can be performed to help clear backlog of bodiesThe number of global cases of the coronavirus-borne illness COVID-19 rose above 95.9 million on Tuesday, and the U.S. edged closer to 400,000 deaths, with California becoming the first state with more than three million confirmed cases.
10:33 p.m. Jan. 17, 2021 - MarketWatch
AstraZeneca gets FDA OK for gastric cancer drugAstraZeneca PLC said Monday that the U.S. Food and Drugs Administration has approved Enhertu as a treatment for patients with gastric cancer. The pharmaceutical giant has developed Enhertu --a HER2-directed antibody drug conjugate-- in collaboration with Japan's Sankyo Company Ltd. AstraZeneca will pay $115 million to Sankyo as a combined second and third milestone payment for reaching the goal of approval in the U.S.
11:02 a.m. Jan. 15, 2021 - By Ciara Linnane
Global deaths from COVID-19 top 2 million as U.S. suffers most weekly fatalities since start of the pandemic Weekly deaths exceed CDC’s estimate for flu-related deaths for entire 2019-2020 season The global case tally for the coronavirus-borne illness COVID-19 climbed above 93 million on Friday and the death toll climbed above 2 million, with the U.S. leading all nations by cases and fatalities.
10:21 a.m. Jan. 13, 2021 - By Ciara Linnane
U.S. sees record one-day death toll and experts worry new variant may make activities like plane travel more risky Vaccine program must speed up to avoid reaching 640,000 deaths by spring, equal to lives lost in the 1918 flu pandemicThe U.S. set another grim milestone in the coronavirus pandemic on Tuesday, when more than 4,400 COVID-19 patients died, the most in a single day since the start of the outbreak, and experts said that with cases continuing to accelerate, the worst is still to come.
4:16 a.m. Jan. 12, 2021 - By Tomi Kilgore
Uber, Moderna to collaborate on supporting COVID-19 vaccine uptakeUber Technologies Inc. and Moderna Inc. said Tuesday they will collaborate to explore ways to support the uptake of COVID-19 vaccines. The ridesharing and delivery company and the biotech said they will work together to provide "credible information" on vaccine safety through Uber's in-app messaging, and will look to identify opportunities to broaden access to COVID-19 vaccines. Moderna's COVID-19 vaccine was authorized in December for emergency use by the Food and Drug Administration, along with a vaccine from Pfizer Inc. and BioNTech SE , but the . "As part of our commitment to help address COVID-19, Moderna will be working with a coalition of partners to educate, build trust around and increase awareness of the importance of vaccination in those communities significantly impacted by the pandemic," said Moderna Chief Executive Stéphane Bancel. "We look forward to combining our expertise with Uber's capabilities and platform to support this important effort." Uber's stock rose 1.5% in premarket trading Tuesday and Moderna shares advanced 0.8%, while futures for the S&P 500 edged up 0.2%.
2:03 p.m. Jan. 11, 2021 - By Claudia Assis
Quanterix stock jumps nearly 10% after company gets EUA for COVID-19 testShares of Quanterix Corp. rallied nearly 10% in the extended session Monday after the life-sciences company said the Food and Drug Administration has issued an emergency use authorization for the company's SARS-CoV-2 antigen test. The test is intended for use with nasopharyngeal samples in people suspected of being ill with COVID-19, the company said. Quanterix "will be pursuing authorization for additional sample types, including nasal swabs, saliva, and capillary dried blood obtained from a fingerstick," it said. The company last week announced it had been granted an EUA to one of its SARS-CoV-2 antibody tests, which uses blood samples. Shares of Quanterix ended the regular trading session up more than 8%.
7:42 a.m. Jan. 11, 2021 - By Jaimy Lee
Biogen's stock is up 5% after Lilly reports positive data from an Alzheimer's study Shares of Biogen Inc. gained 5.6% in trading on Monday after another drugmaker shared positive clinical data about an experimental Alzheimer's disease treatment that is similar to a Biogen therapy under review by the Food and Drug Administration. Eli Lilly & Co. on Monday said in patients with early forms of Alzheimer's in a mid-stage clinical study. The Lilly and Biogen drug candidates are in the same class of therapies. Both therapies focus on beta amyloid, which has been a somewhat controversial target for drug developers trying to figure out how best to treat people with Alzheimer's disease. The FDA is expected to decide whether to approve Biogen's drug, aducanumab, by March 7. "Though reported results are limited, today's topline is likely to reignite the bull debate on the amyloid hypothesis," RBC Capital Markets analyst Brian Abrahams told investors on Monday. "However, we believe key differences between donanemab and aducanumab and questions remain." Biogen's stock is down 9.8% over the last year. The S&P 500 is up 17.5%.
6:58 a.m. Jan. 11, 2021 - By Jaimy Lee
BioMarin's stock tumbles 6% after sharing data about experimental hemophilia A drugShares of BioMarin Pharmaceuticals Inc. tumbled 6.6% in trading on Monday, the day after the company shared positive findings from a Phase 3 clinical trial evaluating the experimental drug Roctavian as a treatment for adults with severe hemophilia A. The Food and Drug Administration in August about the drug, a decision that effectively pushed back the possibility of approval to November 2021. Wall Street analysts said the data is "encouraging;" however, RBC Capital Markets Kennen MacKay also noted that he expected a mixed market reaction to the full set of clinical data. "While we're impressed by the two-year durability data with optimism that this can improve as patients are treated with superior steroid regimens later in the trial mature, we anticipate continued debate despite this clinical de-risking," he told investors on Monday. The late-stage study had 134 participants. BioMarin's stock is down 7.6% over the last year, while the S&P 500 is up 17.5%.
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