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J&J Single-Dose Covid-19 Vaccine One Step Closer to Emergency Use

  • J&J Single-Dose Covid-19 Vaccine One Step Closer to Emergency Use J&J Single-Dose Covid-19 Vaccine One Step Closer to Emergency Use 2:37
    First U.S. Covid-19 Vaccines Roll Out First U.S. Covid-19 Vaccines Roll Out 4:33
    FDA Authorizes Pfizer-BioNTech Covid-19 Vaccine for U.S. Use FDA Authorizes Pfizer-BioNTech Covid-19 Vaccine for U.S. Use 2:59
    Emergency Use of Covid-19 Vaccine One Step Closer After FDA Panel Vote Emergency Use of Covid-19 Vaccine One Step Closer After FDA Panel Vote 3:33
8:44 p.m. April 15, 2021 - By Quentin Fottrell
What determines when Americans reclaim ‘liberty’? Jim Jordan demands of Dr. Fauci — here is his answer Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, appeared Thursday before a House subcommittee on the coronavirus pandemicAnthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, was appearing before a House Select Subcommittee on the Coronavirus Crisis.
3:21 p.m. April 15, 2021 - By Quentin Fottrell
Mass vaccination was never expected to go perfectly — or provide 100% protection against COVID-19 Health professionals say the Johnson & Johnson and AstraZeneca sagas, reports of vaccinated people catching the virus, and other risks are built into the entire processHealth professionals say the Johnson & Johnson and AstraZeneca sagas, reports of vaccinated people catching the virus, and other risks are built into the entire process.
11:48 a.m. April 15, 2021 - By Jaimy Lee
Merck scraps two treatments for hospitalized COVID-19 patients, will focus on antiviral for non-hospitalized patientsShares of Merck & Co. were up 0.1% in premarket trading on Thursday after the drug company said the oral antiviral COVID-19 treatment it is developing with Ridgeback Biotherapeutics did not help hospitalized patients in a mid-stage clinical trial. The companies now plan to test molnupiravir in non-hospitalized COVID-19 patients in a Phase 3 trial, with plans to file for emergency authorization in the second half of the year. They are also planning to see if the experimental therapy works for post-exposure prophylaxis. In a separate news release, Merck said it is discontinuing MK-7110 as a treatment for patients hospitalized with COVID-19, saying that the Food and Drug Administration's request for additional clinical information would push the launch into 2022. "Merck is now focusing its efforts on advancing molnupiravir, which, as an oral medicine for outpatient use, represents a promising potential new approach, and on accelerating production of Johnson & Johnson's COVID-19 vaccine," Dr. Roy Baynes, chief medical officer for Merck Research Laboratories, said in the release. Merck's stock has gained 6.6% since the start of the year, while the broader S&P 500 is up 9.8%.
10:10 a.m. April 13, 2021 - By Jaimy Lee
CDC committee to hold emergency meeting for J&J's COVID-19 shot on Wednesday afternoonThe Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to hold an on Wednesday, starting at 1:30 p.m. Eastern Time, in response to a federal recommendation made Tuesday to temporarily halt immunizations using Johnson & Johnson's COVID-19 vaccine. The recommendation was made after six people who received the J&J shot were diagnosed with severe blood clots in combination with low levels of blood platelets. About 6.8 million people in the U.S. in total have been administered the J&J vaccine. The meeting, which will be publicly webcast, is expected to conclude with a vote about whether the vaccine should continue to be used, how it should be used going forward, or how people who develop blood clots as a result of the vaccine should be treated. The ACIP after the Food and Drug Administration granted the emergency authorization.
10:10 a.m. April 13, 2021 - By Jaimy Lee
CDC committee to hold emergency meeting for J&J's COVID-19 shot on Wednesday afternoonThe Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to hold an on Wednesday, starting at 1:30 p.m. Eastern Time, in response to a federal recommendation made Tuesday to temporarily halt immunizations using Johnson & Johnson's COVID-19 vaccine. The recommendation was made after six people who received the J&J shot were diagnosed with severe blood clots in combination with low levels of blood platelets. About 6.8 million people in the U.S. in total have been administered the J&J vaccine. The meeting, which will be publicly webcast, is expected to conclude with a vote about whether the vaccine should continue to be used, how it should be used going forward, or how people who develop blood clots as a result of the vaccine should be treated. The ACIP after the Food and Drug Administration granted the emergency authorization.
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%.
3:24 a.m. April 13, 2021 - By Ciara Linnane
UPDATE: FDA and CDC call for pause in use of J&J vaccine over blood clotting disorderThe two leading federal public health agencies called for an immediate pause in the use of the Johnson & Johnson COVID-19 vaccine on Tuesday, after six recipients in the U.S. developed a rare disorder involving blood clots within six to 13 days after being vaccinated. The news was first reported by the New York Times, citing officials briefed on the decision. The U.S. Food and Drug Administration and Centers for Disease Control and Prevention said all six were women aged between 18 and 48 and emphasized that the adverse events appear to be "extremely rare." "In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia)," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC said in a statement. So far, nearly 7 million Americans have received J&J shots, and about 9 million more have been delivered to states, CDC data shows. Scientists from the FDA and CDC will jointly investigate possible links between the vaccine and the clotting disorder and determine whether it should continue to be used or be limited. An emergency meeting of the CDC's outside advisory committee has been scheduled for Wednesday. "Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution," said the statement. Regulators in Europe are concerned about a similar issue with another coronavirus vaccine, developed by AstraZeneca PLC and Oxford University researchers. J&J shares slid 3.3% premarket, but are up 2.7% in the year to date through Monday, while the Dow Jones Industrial Average has gained 10.3%.
3:01 a.m. April 8, 2021 - By Ciara Linnane
Eli Lilly and Incyte say Phase 3 study of baricitinib in hospitalized COVID-19 patients failed to meet main goalEli Lilly & Co. and Incyte Corp. said Thursday a Phase 3 trial of rheumatoid arthritis treatment baricitinib plus standard of care (SoC) versus placebo plus SoC failed to meet its main goal. The trial's primary endpoint was defined as a difference in the number of patients needing non-invasive ventilation including high flow oxygen, or invasive mechanical ventilation or death by Day 28. Patients treated with baricitinib were 2.7% less likely than those receiving standard of care to progress to ventilation or death, a difference that was not statistically significant. The trial, involving 1,525 patients, showed 38% reduction in mortality by Day 28 in patients that were treated with baricitinib plus standard of care, including corticosteroids and remdesivir. Lilly said it will publish detailed data from the study in a peer-reviewed journal in the coming months. "Even though the study did not show a statistically-significant benefit on the primary endpoint, this trial showed the largest effect reported to date for reduction in mortality observed for this patient population with COVID-19," said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. The U.S. Food and Drug Administration has granted emergency use authorization to baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation. Baricitinib, an oral JAK inhibitor, was discovered by Incyte. It is approved as Olumiant in the U.S. as a treatment for adults with moderate to severe rheumatoid arthritis and in the EU and Japan as a treatment for atopic dermatitis. Lilly shares were up 0.4% premarket, while Incyte was up 2%.
4:32 a.m. April 7, 2021 - By Tomi Kilgore
Anthem to provide employees with an incentive to be fully vaccinated against COVID-19Anthem Inc. said Wednesday it will provide an incentive to any of its employees who are fully vaccinated against COVID-19. The health insurer said the incentive will be in the form of a one-time credit toward medical premiums or a donation to the Anthem Cares Fund that helps support fellow employees in need, at the employees choice. "Anthem is committed to empowering our associates to live a healthy lifestyle, therefore it was important that we provided an incentive to those who receive the COVID-19 vaccination. I am impressed and grateful for everything our associates have done and continue to do for the customers and communities we serve," said Chief Human Resources Officer Leah Stark. There are currently three COVID-19 vaccines that have been granted emergency use authorization by the Food and Drug Administration, two-dose vaccines from Pfizer Inc. and partner BioNTech SE and Moderna Inc. , and Johnson & Johnson's one-dose vaccine. Anthem's stock, which was indicated down 0.4% in premarket trading, has rallied 9.7% year to date while the S&P 500 has gained 8.5%. (This replaces an earlier item that removes the dollar amount of the incentive provided by the company, after the company said the amount noted in a previous release resulted from a "publishing mistake.")
9:35 a.m. April 5, 2021 - By Tomi Kilgore
Chembio Diagnostics stock rockets on record volume after commercial launch of rapid COVID-19 testShares of Chembio Diagnostics Inc. skyrocketed 63.8% on record volume in afternoon trading Monday, to pace all gainers listed on major U.S. exchanges, in the wake of the point-of-care diagnostics company's announcement of the commercial launch of its rapid COVID-19/flu test. The stock was on track for the biggest one-day percentage gain since it doubled, on March 12, 2004. Trading volume ballooned to 206.6 million shares, compared with the full-day average of less than 1 million shares. The company said its test has been granted emergency use authorization by the Food and Drug Administration. Chembio said after Thursday's closing bell that the product, which produces results in 15 minutes, requires no instrumentation and simultaneously differentiates SARS-CoV-2 antigens and influenza Type A and Type B infections, is immediately available for shipment. "As COVID-19 converges with the flu, it is critical for physicians to be able to quickly differentiate between these viruses at the point-of-care, which present with nearly identical symptoms, in order to take appropriate clinical actions and maximize efficient use of healthcare resources," said Charles Caso, vice president of sales and marketing at Chembio. The stock has run up 21.4% year to date, while the S&P 500 has gained 8.6%.
2:31 a.m. April 5, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 131.3 million and U.S. death toll above 555,000The global tally for the coronavirus-borne illness rose above 131.3 million on Monday, according to , while the death toll rose above 2.85 million. The U.S. continues to lead the world by cases, at 30.7 million, or about a quarter of the global tally, and fatalities, at 555,001. The U.S. added at least 36,670 new cases on Sunday, and at least 277 people died, although those numbers are likely under-reported given reduced staffing at hospitals at weekends. The U.S. has averaged 64,019 cases a day for the last week, up 18% from the average two weeks ago, as cases continue to rise despite the vaccination program, a trend experts say is due to states reopening and dropping restrictions on movement and overall pandemic fatigue. The U.S. is unlikely to face a "true" fourth wave of COVID-19 outbreaks, but the country should wait a few weeks longer before easing mitigation efforts, former Food and Drug Administration Commissioner Dr. Scott Gottlieb said Sunday. Speaking to CBS News' "Face the Nation," Gottlieb acknowledged that young people were driving new coronavirus outbreaks in many states, but that vaccination efforts should prevent another devastating surge of the virus. Outside of the U.S., Brazil is second globally in cases at 12.9 million and also second with a death toll at 331,433. India is third worldwide in cases with 12.6 million and fourth in deaths at 165,101. Mexico is third by deaths at 204,147 and 13th highest by cases at 2.3 million. The U.K. has 4.4 million cases and 127,078 deaths, the highest in Europe and fifth highest in the world.
3:02 a.m. April 1, 2021 - By Ciara Linnane
Pfizer, BioNTech say study of COVID-19 patients six months after second vaccine dose proved it is safe and effectivePfizer Inc. and German partner BioNTech SE said Thursday a study of COVID-19 patients six months after receiving a second dose of their vaccine BNT162b2 confirmed its high efficacy and lack of serious safety concerns. The companies said an analysis of 927 confirmed symptomatic cases of COVID-19 showed the vaccine had a 91.3% efficacy against the illness, measured seven days through up to six months after the second dose. The vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration. The vaccine also proved to be 100% effective in preventing COVID-19 cases when used against the South African variant, which is more infectious than the original virus. Experts have worried that new variants might prove more resistant to the vaccines that have won emergency use authorization from regulators. Pfizer and BioNTech said they have now evaluated vaccine safety in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after a second dose. "These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA," said Pfizer Chief Executive Albert Bourla. Prizer shares were up 0.2% premarket, while BioNTech shares were up 1.2%.
3:24 a.m. March 30, 2021 - By Jaimy Lee
BD gets FDA authorization for test that can detect COVID-19 and the fluBecton, Dickinson & Co. said it received emergency authorization from the Food and Drug Administration for a rapid, antigen test that can detect SARS-CoV-2 and two types of influenza. The test, which runs on the company's BD Veritor System, takes about 15 minutes to produce results and is expected to be available this summer. BD's stock has gained 10.9% over the past 12 months, while the broader S&P 500 is up 56.2%.
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%.
4:40 a.m. March 26, 2021 - By Ciara Linnane
GlaxoSmithKline and Vir Biotech seek FDA emergency authorization for COVID antibody treatmentGlaxoSmithKline PLC and Vir Biotechnology Inc. said Friday they have submitted to the U.S. Food and Drug Administration an application for emergency use authorization for their antibody treatment for mild-to-moderate COVID-19 in adults and adolescents aged 12 and older who are at risk of hospitalization or death. The companies said early data from a Phase 3 trial found the treatment showed an 85% reduction in hospitalization or death compared to placebo. There were 583 patients enrolled in the trial. Vir shares slid 0.8% premarket, but have gained 97% in the year to date, while the S&P 500 has gained 4%.
12:12 p.m. March 25, 2021 - By Claudia Assis
Pfizer, Eli Lilly say experimental arthritis drug tanezumab hits FDA snagPfizer Inc. and Eli Lilly and Co. said Thursday that a joint advisory committee of the U.S. Food and Drug Administration has voted against their investigational tanezumab drug for the treatment of certain types of arthritis in adults when use of other drugs aren't possible. "While we are disappointed with today's outcome, we continue to believe that tanezumab has a positive benefit-risk profile for patients with moderate-to-severe osteoarthritis pain for whom current treatments are ineffective or not appropriate," Ken Verburg, tanezumab development team leader at Pfizer, said in a statement. There was one voting question focused on whether the drug's benefits outweigh its risks, and the committee voted 19-1 against it, the companies said.
9:36 a.m. March 22, 2021 - By Tomi Kilgore
Odonate Therapeutics stock plummets toward record low after plan to 'wind down' operationsShares of Odonate Therapeutics Inc. plummeted 79.0% in active afternoon trading Monday, after the pharmaceutical company said it will wind down operations following disappointing data from its cancer treatment. The company said it determined, following feedback from the Food and Drug Administration in a pre-New Drug Application (pre-NDA) meeting, that tesetaxel, an orally administered chemotherapy agent, is unlikely to receive FDA approval. "Therefore, the company is discontinuing the development of tesetaxel and will wind down the operations of the company," the company said in a statement. Since going public in December 2017 at an initial public offering price of $24, the stock has traded in a closing price range of $11.78 (Dec. 27, 2018) to $45.63 (June 16, 2020); on Friday, the stock closed at $19.03. The stock has lost 73.9% over the past three months, while the S&P 500 has gained 7.0%.
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%.
4:40 a.m. March 11, 2021 - By Tomi Kilgore
Johnson & Johnson COVID-19 vaccine recommended for use in the EUJohnson & Johnson said Thursday that its single-shot COVID-19 vaccine candidate has received a "positive opinion" from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). That means the CHMP recommends conditional marketing authorization (CMA) for the vaccine candidate developed by J&J's Janssen Pharmaceutical Companies. If CMA is granted, the vaccine will become available in the European Union. "The European Medicines Agency's recommendation is a landmark moment for Johnson & Johnson and for the world," said J&J Chief Scientific Officer Paul Stoffels. "Now, as we await a decision on the use of our single-dose COVID-19 vaccine in the European Union, we remain confident that the Johnson & Johnson vaccine will prove a critical tool for fighting this pandemic." The U.S. Food and Drug Administration had granted the J&J vaccine on Feb. 27. J&J's stock, which rose 0.6% in premarket trading, has gained 4.1% over the past three months while the Dow Jones Industrial Average has gained 7.5%.
9:04 a.m. March 10, 2021 - By Jaimy Lee
Vertex to begin Phase 1/2 trial of treatment for people with type 1 diabetesShares of Vertex Pharmaceuticals Inc. were down 0.2% in trading on Wednesday after the company said it started an early-stage clinical trial for its experimental treatment for people with type 1 diabetes. It also said the therapy received a fast-track designation from the Food and Drug Administration. The Phase 1/2, single-arm, open-label study will be conducted at multiple sites in the U.S. and aims to enroll 17 participants. Vertex gained access to the therapy through its roughly $1 billion acquisition of Semma Therapeutics Inc. in 2019. Vertex's stock is down 7.4% over the past year, while the S&P 500 has rallied 41.1%. The clinical trial is a Phase 1/2, single-arm, open-label study in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. This will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different doses of VX-880. Approximately 17 patients will be enrolled in the clinical trial. About Type 1 Diabetes T1D results from the autoimmune destruction of insulin-producing islet cells in the pancreas, leading to loss of insulin production and impairment of blood glucose control. The absence of insulin leads to abnormalities in how the body processes nutrients, leading to high blood glucose levels. High blood glucose can lead to diabetic ketoacidosis and over time, to complications such as kidney disease/failure, eye disease (including vision loss), heart disease, stroke, nerve damage and even death. Due to the limitations and complexities of insulin delivery systems, it can be difficult to achieve and maintain balance in glucose control in patients with T1D. Hypoglycemia often results because of the difficulty in balancing the different factors that impact glucose levels, including insulin, diet and exercise. Hypoglycemia remains a critical limiting factor in glycemic management, and severe hypoglycemia can cause loss of consciousness, coma, seizures, injury, and can be fatal. Over time, patients with T1D can develop impaired awareness of hypoglycemia, meaning they are no longer able to perceive the early signs of a hypoglycemic event, which can be dangerous and result in life threatening events. There are currently limited treatment options beyond insulin for the management of T1D.
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%.
6:45 a.m. March 9, 2021 - By Tomi Kilgore
Second Sight Medical stock soars nearly 1,000% in 3 daysShares of Second Sight Medical Products Inc. shot up 30.7% to $15.38 on volume of 56.6 million shares in morning trading Tuesday, bringing its three-day gain to 975.5%, in the wake of the company's announcement that for the treatment of retinitis pigmentosa. The stock skyrocketed a record 304.9% on record volume of 739.7 million shares on March 5 after the announcement, then 103.3% on volume of 320.4 million shares on Monday, before Tuesday's gain. The stock had closed at a near 3-month low of $1.43 prior to the rally. On Tuesday, the stock had been up as much as 69.9% at an intraday high of $20.00, the highest price seen since February 2018, before paring gains. Separately, Paris-based Pixium Vision S.A. saying the business combination with Second Sight announced on Jan. 6 continues. At that time, an agreement with the developer of bionic vision systems in which Second sight will raise at least $25 million in working capital, Pixium will contribute to Second Sight certain assets in exchange for newly issued Second Sight common stock and Second Sight will transfer its Orion Assets to a newly formed subsidiary, which will be partially spun off to Second Sight shareholders. Second Sight's stock has advanced 339.4% over the past 12 months, while the S&P 500 has gained 41.6%.
4:37 a.m. March 9, 2021 - By Tomi Kilgore
Acadia Pharmaceuticals stock leads premarket losers after FDA finds undisclosed 'deficiencies' in NDAShares of Acadia Pharmaceuticals Inc. plunged 42.1% to pace all premarket decliners Tuesday, in the wake of the company's announcement that the Food and Drug Administration found undisclosed deficiencies in its supplemental New Drug Application (NDA) for pimavanserin, a treatment for hallucinations and delusions associated with dementia-related psychosis. The company said late Monday that the FDA's identification of deficiencies precluded discussion of labeling and post-marketing requirements. But the FDA did not specify the deficiencies it identified, Acadia said. That led Raymond James analyst Danielle Brill to downgrade Acadia to outperform from strong buy and slash the price target to $35 from $65. "We have no good guesses as to what 'deficiencies' the FDA found, but one thing is clear -- the regulatory outlook for DRP suddenly appears quite dire," Brill wrote in a note to clients. Stifel Nicolaus's Paul Matteis cut his rating to hold from buy and his price target to $27 from $68. "Not defending the stock on weakness; DRP prospects seem bleak, tough for us to be confident," Matteis wrote. The stock, which is on track to open at the lowest price seen during regular-session hours since September 2019, has lost 12.5% over the past three months through Monday, while the S&P 500 has gained 4.0%.
8:16 a.m. March 8, 2021 - By Tomi Kilgore
Second Sight Medical stock skyrockets 8-fold in 2 days after FDA approves retinal prosthesis systemShares of Second Sight Medical Products Inc. soared 104.2% on heavy volume in midday trading Monday, bringing its two-day gain to 728.7%, after the Food and Drug Administration approved the company's Argus 2s Retinal Prosthesis System for the treatment of retinitis pigmentosa (RP). The stock paced all gainers on major U.S. exchanges, and was the most actively traded, as trading volume swelled to 222.6 million shares, compared with the full-day average of 26.5 million shares. The stock had soared a record 304.9% on record volume of 739.7 million shares on Friday. The company said Friday it received FDA approval of its Argus 2s system, which is a redesigned set of eternal hardware -- glasses and video processing unit -- initially for use in combination with previously implanted Argus II systems to treat RP. "We are very pleased to have received this approval, as it presents an opportunity to offer external hardware that we believe enhance comfort and aesthetics compared with the legacy Argus II system," said Chief Executive Matthew Pfeffer. The stock has soared 672.6% over the past three months, while the S&P 500 has tacked on 4.3%.
3:45 a.m. March 8, 2021 - By Jaimy Lee
FDA authorizes Adaptive's T-cell test for people who have already had COVID-19The Food and Drug Administration said Friday it authorized a test developed by Adaptive Biotechnologies Corp. that can detect the presence of a T-cell immune response, which can tell if someone has previously been infected with SARS-CoV-2. Adaptive's stock was up 11.0% in premarket trading on Monday. This type of test is different than antibody tests, which search for antibodies produced in response to a COVID-19 infection. The test, which has a sensitivity rate of 97.1%, was developed as part of a partnership with Microsoft Corp. . "This is the first commercially available T-cell test that confirms recent or prior SARS-CoV-2 infections in people," Peter Lee, Microsoft's corporate VP of research and incubations, said in a news release. The test can be administered 15 days after someone experiences symptoms associated with infection. Adaptive's stock has gained 56.2% over the past 12 months, while the broader S&P 500 is up 27.0%.
5:18 a.m. March 5, 2021 - By Jaimy Lee
JAMA study: Ivermectin doesn't speed up recovery for patients with mild COVID-19New research indicates that ivermectin, a type of treatment for parasitic worms, does not help patients with mild COVID-19 recover any faster. The peer-reviewed , published Thursday in JAMA, examined the findings of a double-blind, randomized trial conducted in Cali, Colombia, in roughly 475 people with mild symptoms of COVID-19. Researchers concluded "the findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes." The drug first caught the attention of clinicians in the early days of the pandemic after an said the drug can inhibit replication of SARS-CoV-2, the virus that causes COVID-19. However, the Food and Drug Administration and others [l:cautioned back in April|https://www.fda.gov/animal-veterinary/product-safety-information/fda-letter-stakeholders-do-not-use-ivermectin-intended-animals-treatment-covid-19-humans%7CNEW] that trials needed to be conducted before the drug should be prescribed to COVID-19 patients.
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%.
7:33 a.m. March 4, 2021 - By Tomi Kilgore
Moderna, IBM explore blockchain tech, AI to support 'smarter' management of COVID-19 vaccinesModerna Inc. and International Business Machines Corp. announced Thursday plans to work together to find technologies to support "smarter COVID-19 vaccine management." The technologies the companies will explore include artificial intelligence, blockchain and hybrid cloud, the companies said. "Moderna is committed to working with a coalition of partners to increase education and awareness of the importance of vaccination to help defeat COVID-19," said Michael Mullette, a managing director of North America commercial operations at Moderna. "We look forward to working with IBM to apply digital innovations to build connections between organizations, governments, and individuals to instill confidence in COVID-19 vaccines." Moderna's stock rose 1.6% in midday trading and IBM shares fell 0.7%, while the Dow Jones Industrial Average gained 118 points, or 0.4%. Moderna currently has one of three COVID-19 vaccines granted emergency use authorization by the Food and Drug Administration, the others being from Pfizer Inc. and BioNTech SE and Johnson & Johnson .
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%.
5:09 a.m. March 2, 2021 - By Ciara Linnane
President Biden to announce later Tuesday that Merck will help make J&J vaccine: Washington PostPresident Joe Biden will announce later Tuesday that Merck & Co. will help make Johnson & Johnson's one-shot COVID-19 vaccine in an unusual agreement between two competitors that could lead to a significant boost in supply, citing unnamed senior administration officials. The deal was brokered by the government as it works to expand manufacturing of the vaccine, which was granted emergency use authorization by the U.S. Food and Drug Administration on Saturday. Merck is one of the world's biggest vaccine makers and its own effort to develop an effective COVID vaccine failed. Merck will dedicate two facilities in the U.S. to the effort with one providing "fill-finish" services, putting vaccine in vials for distribution, while the other will make the vaccine itself, said the paper. That could double the supply compared with what J&J can achieve on its own, it said. The U.S. vaccine program has been hampered by a shortage of supply of vaccines. J&J shares were slightly higher premarket, but have gained 14% in the last 12 months, while the S&P 500 has gained 26%. Merck shares were up 0.4%, and have fallen 11% in the last 12 months.
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%.
4:09 a.m. March 1, 2021 - By Quentin Fottrell
Dr. Fauci on J&J’s COVID-19 vaccine: ‘I would have no hesitancy whatsoever to take it’ Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said, ‘People need to get vaccinated as quickly, and as expeditiously, possible’Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said, ‘People need to get vaccinated as quickly, and as expeditiously, possible.’
2:40 p.m. Feb. 26, 2021 - By Jaimy Lee
FDA tells J&J it's working on an emergency authorization for its COVID-19 vaccine Shares of Johnson & Johnson gained 1.3% in after-hours trading on Friday after the Food and Drug Administration said it has contacted the company to say it is "rapidly" working toward issuing an emergency use authorization for J&J's COVID-19 vaccine candidate. The FDA statement was sent out Friday evening about an hour after an advisory committee that the benefits of the experimental vaccine outweigh the risks. "The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution," FDA officials said in the statement. J&J said earlier this week that it plans to deliver 20 million doses of its single-dose vaccine in the U.S. by the end of March. J&J's stock is up 10.7% over the past 12 months, while the broader S&P 500 has gained 22.4%.
1:08 p.m. Feb. 26, 2021 - By Jaimy Lee
FDA committee votes unanimously, says benefits of J&J's COVID-19 vaccine outweigh the risksShares of Johnson & Johnson were up 1.3% in after-hours trading on Friday after a Food and Drug Administration advisory committee vote 22-0 in favor of the regulator authorizing the company's COVID-19 vaccine candidate. The FDA is not required to follow the advice of the committee but often does. The single-dose vaccine had an overall efficacy rate of about 66% in the Phase 3 clinical trial, and the U.S. arm of the trial showed an efficacy rate of about 72% and of 85% when protecting against severe or critical disease. The most common adverse events were pain at the injection site and fatigue. The trial was conducted in the U.S., South Africa, and several Central and South American countries. If the FDA moves forward with authorizing the experimental vaccine, it will be the third COVID-19 vaccine to be available in the U.S. - and the first to require only one dose. Both the Moderna Inc. and BioNTech SE and Pfizer Inc.'s vaccines, which were separately authorized in December, require two doses spaced several weeks apart. J&J's stock has gained 10.7% over the past 12 months, while the broader S&P 500 is up 22.4%
2:30 a.m. Feb. 26, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 113 million and U.S. death toll atop 508,000The global tally for confirmed cases of the coronavirus that causes COVID-19 climbed above 113 million on Friday, while the death toll rose above 2.50 million. The U.S. has the highest case tally in the world at 28.4 million and the highest death toll at 508,314, after surpassing the 500,000 level late Monday. The U.S. added 77,804 new cases on Thursday, according to a New York Times tracker, and at least 2,465 people died. The U.S. has averaged 69,450 cases a day in the past week, down 32% from two weeks ago. There was good news on the vaccine front, when the Food and Drug Administration eased the ultra-low temperature requirements for the Pfizer Inc./BioNTech vaccine. An FDA advisory committee will meet all day Friday to review and vote on the Johnson & Johnson vaccine, which requires just one dose. Brazil has the second highest death toll at 251,498 and is third by cases at 10.4 million. India is second worldwide in cases with 11.1 million, and now fourth in deaths at 156,825. Mexico has the third highest death toll at 183,692 and 13th highest case tally at 2.1 million. The U.K. has 4.2 million cases and 122,303 deaths, the highest in Europe and fifth highest in the world.
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%.
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