Bulletin
Investor Alert

New York Markets Open in:

Topics

Food and Drug Administration

Video

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
    Moderna Delivers Covid-19 Shots, Boosts Vaccination Campaign Moderna Delivers Covid-19 Shots, Boosts Vaccination Campaign 1:52
    FDA Panel Endorses Moderna’s Covid-19 Vaccine for Broad Use FDA Panel Endorses Moderna’s Covid-19 Vaccine for Broad Use 3:23
    Hospitals Face Hurdles With Covid-19 Vaccine Rollout Hospitals Face Hurdles With Covid-19 Vaccine Rollout 3:40
4:52 a.m. Oct. 25, 2021 - By Jaimy Lee
Moderna says its COVID-19 shot generates 'robust' response in children 6 to 11Shares of Moderna Inc. gained 0.9% in premarket trading on Monday after the company shared interim data from a Phase 2/3 clinical study evaluating its COVID-19 vaccine in children between the ages of 6 and 11 years old. The trial, which has 4,753 participants between the ages of 6 and 11, evaluated the immune response one month after the second dose. Moderna said the vaccine met the trial's endpoint and generated a "robust neutralizing antibody response" but it did not provide an efficacy rate in the news release. The company also said it plans to submit the clinical data to the FDA in the "near term." The news was announced one day before a Food and Drug Administration advisory committee is set to of BioNTech SE and Pfizer Inc.'s COVID-19 vaccine in children between the ages of 5 and 11. The Moderna and BioNTech/Pfizer COVID-19 vaccines both require two shots and use mRNA technology. Moderna's stock has soared 212.5% so far this year, while the broader S&P 500 is up 21.0%.
4:09 a.m. Oct. 25, 2021 - By Jaimy Lee
FDA committee to discuss BioNTech/Pfizer's COVID-19 shot in children 5 to 11A Food and Drug Administration advisory committee to discuss and then recommend whether the benefits outweigh the risks of BioNTech SE and Pfizer Inc.'s COVID-19 vaccine in children between the ages of 5 and 11 years old. The FDA is not required to follow the advice of the committee but often does. The regulator's decision has come within a week of the advisory committee's recommendation in the past. The BioNTech/Pfizer vaccine is currently authorized for teens between the ages of 12 and 15 years old and fully approved for those individuals 16 years and older. If it receives emergency-use authorization, Comirnaty would be the first COVID-19 shot available in the U.S. for this age group. The FDA that the vaccine generated an efficacy rate of 90.7% against symptomatic infection in 2,268 elementary school-age children seven days after they got the second shot. The most common side effects occurred after the second dose and included pain at the injection site, fatigue, and headache. There were no serious adverse events associated with the vaccine, according to the FDA. The proposed dose for 5- to 11-year-olds is 10 µg, compared with 30 µg used in those 12 years old and older.
2:55 a.m. Oct. 25, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 near 244 million; Fauci says kids aged 5 to 11 should start getting shots in early-to-mid NovemberThe global tally for the coronavirus-borne illness climbed above 243.7 million on Monday, while the death toll edged above 4.95 million, according to . The U.S. continues to lead the world with a total of 45.4 million cases and 735,941 deaths. The U.S. is averaging more than 1,500 deaths a day, although cases and hospitalizations are declining. Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases and President Joe Biden's chief medical adviser, said he expects children aged 5 to 11 to become eligible for vaccines by early-to-mid November. A review panel to the U.'S. Food and Drug Administration found last week that the benefits of the shots outweigh risks, and an advisory committee will convene Tuesday to discuss the matter. If they vote in favor and the CDC grants final approval by next week, Fauci told ABC's "This Week with George Stephanopoulos" that children could start getting their shots shortly after. India is second by cases after the U.S. at 34.2 million and has suffered 44,712 deaths. Brazil has second highest death toll at 605,644 and 21.7 million cases. In Europe, Russia has the most fatalities at 227,506 deaths, followed by the U.K. at 139,950.
2:13 a.m. Oct. 22, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 242.5 million and CDC approves expanded booster programThe global tally for the coronavirus-borne illness climbed above 242.5 million on Friday, while the death toll edged above 4.93 million, according to . The U.S. continues to lead the world with a total of 45.3 million cases and 733,218 deaths. The U.S. is averaging more than 1,500 deaths a day, although cases and hospitalizations are declining. The Centers for Disease Control and Prevention on Thursday agreed to extend COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine and said anyone eligible for an extra dose can get a brand different to the one they got as primary dose, The Food and Drug Administration had already authorized such an expansion of the nation's booster campaign on Wednesday, and it was also endorsed Thursday by a CDC advisory panel. CDC Director Dr. Rochelle Walensky had the final word on who gets the extra doses. India is second by cases after the U.S. at 34.1 million and has suffered 453,042 deaths. Brazil has second highest death toll at 604,679 and 21.7 million cases. In Europe, Russia has the most fatalities at 224,369 deaths, followed by the U.K. at 139,562.
2:57 a.m. Oct. 21, 2021 - By Ciara Linnane
Pfizer and BioNTech say Phase 3 trial found booster dose of COVID vaccine had 95.6% efficacy against disease Pfizer Inc. and German partner BioNTech SE said Thursday a late-stage trial of a 30 mg booster dose of their COVID-19 vaccine showed efficacy of 95.6% compared with those who received a placebo. The companies said the Phase 3 trial involved more than 10,000 people aged 16 and older, who had already received the primary two-dose series, and found the booster restored vaccine protection against COVID to the high levels achieved after the second dose. The booster was found to be safe. "These important data add to the body of evidence suggesting that a booster dose of our vaccine can help protect a broad population of people from this virus and its variants," said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech, in a joint statement with Pfizer CEO Albert Bourla. The companies are planning to submit the data to the Food and Drug Administration, the European Medicines Agency and other regulators around the world. Pfizer shares jumped about 1% premarket, while BioNTech was up 1.8%. Pfizer shares have gained 16% in the year to date, while BioNTech has gained 230.5%. The SPDR S&P Biotech ETF has fallen 12% and the S&P 500 has gained 21%.
4:48 a.m. Oct. 20, 2021 - By Jaimy Lee
White House: Children will be able to get COVID-19 shots from their pediatriciansThe White House on Wednesday announced a plan detailing how the U.S. plans to roll out COVID-19 vaccines for children between the ages of 5 and 11 years old if and when COVID-19 shots are authorized for this age group. White House officials said there is enough vaccine to immunize all 28 million children in this age group, and kids will be able to get a shot at 25,000 pediatricians' offices, in addition to 100 children's hospitals, "tens of thousands" of pharmacies, and some school and community sites. A Food and Drug Administration advisory committee is scheduled to meet Tuesday to discuss BioNTech SE and Pfizer Inc.'s application for authorization for elementary school-aged children; it will vote on whether the vaccine is safe and effective in this age group, and then the FDA will issue its decision. The Centers for Disease Control and Prevention also has to weigh in.
2:12 a.m. Oct. 19, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 241 million and U.S. FDA may soon allow mix-and-match boostersThe global tally for the coronavirus-borne illness climbed above 241.2 million on Tuesday, while the death toll edged above 4.90 million, according to . The U.S. continues to lead the world with a total of 45 million cases and 726,201 deaths. The U.S. is averaging more than 1,600 deaths a day, although cases and hospitalizations are declining. The Food and Drug Administration is moving to soon allow people to receive booster shots that are different from their first COVID-19 vaccine doses, citing people familiar with the matter. The FDA won't recommend any booster over the others but will permit people to get a booster shot that is different from the shot they first received, one of the people said. The agency is trying to greenlight mixing and matching as soon as this week, the people said, and is also expected to approve Moderna Inc. , and Johnson & Johnson boosters this week India is second by cases after the U.S. at 34 million and has suffered 452,454 deaths. Brazil has second highest death toll at 603,465 and 21.7 million cases. In Europe, Russia has most fatalities at 221,314, mostly due to a low vaccination rate, followed by the U.K. at 139,042.
7:42 a.m. Oct. 18, 2021 - By Jaimy Lee
MannKind's stock falls 18% after FDA says it will not approve application for hypertension drugShares of MannKind Corp. tumbled 18.3% in trading on Monday after the company said the Food and Drug Administration would not approve a pulmonary arterial hypertension treatment it is developing with United Therapeutics Corp. . United's stock was down 2.6%. MannKind said in a news release that the FDA had issued a complete response letter to United Therapeutics, citing a problem with a third-party testing center for the substance used to make Tyvaso DPI. MannKind said it looks "forward to supporting United Therapeutics' efforts in securing approval of Tyvaso DPI in the coming months." MannKind's stock is up 32.7% for the year, while the broader S&P 500 has gained 19.0%.
4:55 a.m. Oct. 18, 2021 - By Tomi Kilgore
Adamis Pharmaceuticals stock rockets on heavy volume after opioid overdose treatment gets FDA approvalShares of Adamis Pharmaceuticals Corp. soared 20.4% on massive volume toward an eight-month high in premarket trading Monday, after the biopharmaceutical company said Zimhi, it's high-dose naloxone injection for the treatment for opioid overdose, has been approved by the Food and Drug Administration. Trading volume spiked to 32.8 million shares, enough to make the stock the most actively traded ahead of the open, and compared with the full-day average of about 2.0 million shares. "We are very excited by this approval and are working with our commercial partner, US WorldMeds, to make this much-needed, lifesaving product readily available to the market," said Adamis Chief Executive Dennis Carlo. "Zimhi provides the highest systemic levels of naloxone compared to any of the nasal or intramuscular products currently available." The stock has soared 132.9% year to date through Friday, while the iShares Biotechnology ETF has tacked on 3.7% and the S&P 500 has gained 19.0%.
4:31 a.m. Oct. 18, 2021 - By Tomi Kilgore
Revance Therapeutics plummets after FDA said it can't approve BLA of treatment for frown linesShares of Revance Therapeutics Inc. plummeted 34.7% toward an 18-month low in premarket Monday, which puts them on track for a record one-day selloff, after the company said the the Food and Drug Administration issued a Complete Response Letter (CRL) regarding the biotechnology company's treatment of glabellar, or frown, lines. The company said late Friday that FDA determined it could not approve the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection in its present form, citing deficiencies related to an inspection of Revance's manufacturing facility. The announcement comes after the company said late on Oct. 12, after Revance's stock plunged 25.1% that day, that it continued to expect the FDA to approve DaxibotulinumtoxinA for Injection this year. The stock, which is on track to open at the lowest price seen during regular-session hours since April 2020, has dropped 19.9% year to date through Friday, while the iShares Biotechnology ETF has gained 3.7% and the S&P 500 has rallied 19.0%.
4:19 a.m. Oct. 18, 2021 - By Jaimy Lee
Revance's stock falls 35% after FDA says it won't approve the company's frown-line injectionShares of Revance Therapeutics Inc. tumbled 35.3% in premarket trading on Monday after the company said Friday that the Food and Drug Administration had declined to approve Revance's application for a frown-line treatment. The FDA issued a complete response letter that the company received Oct. 15, citing issues with Revance's manufacturing facilities. Revance said it plans to address those concerns. Revance's stock is down 19.9% for the year, while the broader S&P 500 is up 19.0%.
1:00 p.m. Oct. 17, 2021 - By MarketWatch
The tech earnings boom is fizzling out, as Apple and Amazon face the same issues as everyone elseThe boom in Big Tech has been a huge part of Wall Street's surge in the past year, but it now appears that other sectors beyond semiconductors are as susceptible to the supply chain problems hurting other industries.
8:00 a.m. Oct. 17, 2021 - By MarketWatch
The Dow is on track for its best October in 6 years and third-quarter earnings are strong so far. What could go wrong?A traditionally troublesome month is turning out to be anything but for the stock market…so far.
5:00 a.m. Oct. 17, 2021 - By MarketWatch
The Dow is on track for its best October in 6 years and third-quarter earnings are strong so far. What could go wrong?A traditionally troublesome month is turning out to be anything but for the stock market…so far.
1:00 p.m. Oct. 16, 2021 - By MarketWatch
The Dow is on track for its best October in 6 years and third-quarter earnings are strong so far. What could go wrong?A traditionally troublesome month is turning out to be anything but for the stock market…so far.
8:00 a.m. Oct. 16, 2021 - By MarketWatch
How to beat inflation: Favor stocks of companies that have the luxury of pricing power — but whose costs aren’t risingInvestors and analysts recommend shares of Comcast, Air Lease and Matson, among others.
5:00 a.m. Oct. 16, 2021 - By MarketWatch
First U.S. Bitcoin ETF looks set to debut Monday or Tuesday from ProShares TrustProShares looked set to be the first bitcoin exchange-traded fund, according to sources and fund specialists.
5:35 a.m. Oct. 15, 2021 - By Jaimy Lee
FDA: Abbott is recalling two lab-based COVID-19 tests due to the possibility of false positive resultsShares of Abbott Laboratories were up 0.6% in premarket trading on Friday, the day after the Food and Drug Administration the company is recalling two laboratory COVID-19 test kits because of concerns about false positives. The tests are the Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits. The FDA previously issued a warning about the potential for false positives with these tests in September. Abbott's stock is up 7.8% for the year, while the broader S&P 500 has gained 18.1%.
3:42 a.m. Oct. 15, 2021 - By Jaimy Lee
FDA to hold advisory committee for Merck's experimental COVID-19 pillShares of Merck & Co. Inc. were down 0.1% in premarket trading on Friday, the day after the Food and Drug Administration said it plans to convene an advisory committee on Nov. 30 to discuss the company's experimental COVID-19 pill, molnupiravir. Merck is developing the antiviral with the privately held Ridgeback Biotherapeutics; it recently applied for emergency authorization. The FDA requested advisory committee meetings for each of the authorized COVID-19 vaccines but it did not convene one ahead of the authorizations of the monoclonal antibodies or Gilead Sciences Inc.'s remdesivir, an antiviral used to treat severely ill COVID-19 patients that is now fully approved. "We believe that, in this instance, a public discussion of these data with the agency's advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement. Merck's stock is up 0.4% for the year, while the S&P 500 has gained 18.1%.
2:16 a.m. Oct. 15, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 head toward 240 million and FDA panel endorses Moderna boosters for someThe global tally for the coronavirus-borne illness climbed above 239.6 million on Friday, while the death toll edged above 4.88 million, according to . The U.S. continues to lead the world with a total of 44.8 million cases and 721,567 deaths. The U.S. is averaging more than 1,800 deaths a day, , although new cases and hospitalizations are declining. A Food and Drug Administration advisory committee said Thursday that some Americans who received Moderna COVID-19 vaccine at least six months ago should get a half-dose booster to rev up protection against the coronavirus. The panel of outside advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, as well as younger adults with other health problems, jobs or living situations that put them at increased risk from COVID-19.The committee will reconvene on Friday to discuss boosters for the Johnson & Johnson shot. India is second by cases after the U.S. at 34 million and has suffered 451,814 deaths. Brazil has second highest death toll at 602,099 and 21.6 million cases. In Europe, Russia has most fatalities at 216,402, followed by the U.K. at 138,647.
3:50 a.m. Oct. 14, 2021 - By Jaimy Lee
Regeneron is seeking full FDA approval for its monoclonal antibody for two types of COVID-19 patientsShares of Regeneron Pharmaceuticals Inc. gained 2.7% in premarket trading on Thursday after the company said the Food and Drug Administration accepted its application for approval of its monoclonal antibody treatment for non-hospitalized COVID-19 patients and as a prophylaxis for some people who have been exposed to the virus. The FDA said it will decide whether to approve the therapy by April 13 based on the priority review designation it granted to the application. It plans to hold an advisory committee meeting in advance of the decision. Regeneron said it plans to submit its monoclonal antibody treatment for FDA approval for hospitalized COVID-19 patients later this year. The treatment, Regen-Cov, has received emergency authorization for all three of these indications in the U.S. Regeneron's stock is up 13.2% this year, while the broader S&P 500 has gained 16.2%.
2:16 a.m. Oct. 14, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 239 million as FDA panel meets on Moderna boosterThe global tally for the coronavirus-borne illness climbed above 239 million on Thursday, while the death toll edged above 4.87 million, according to . The U.S. continues to lead the world with a total of 44.7 million cases and 719,530 deaths. The U.S. is averaging close to 1,900 deaths a day, , although new cases and hospitalizations are declining. a Food and Drug Administration advisory committee will meet later Thursday to discuss and take a vote on whether to authorize a booster dose for people vaccinated with the Moderna vaccine. The committee will reconvene on Friday to discuss boosters for the Johnson & Johnson shot. India is second by cases after the U.S. at 34 million and has suffered 451,435 deaths. Brazil has second highest death toll at 601,574 and 21.6 million cases. In Europe, Russia has most fatalities at 215,438, followed by the U.K. at 138,487.
7:32 a.m. Oct. 13, 2021 - By Jaimy Lee
White House says an estimated 7 million people have received a COVID-19 boosterThe number of people in the U.S who are eligible to get a COVID-19 but have not been vaccinated has decreased to 66 million individuals, compared with 97 million people who met these criteria back in late July, according to White House officials. "There's stronger evidence that vaccination requirements are working," Jeff Zients, the White House's COVID-19 response coordinator, said Wednesday during a press briefing. "They're driving up vaccination rates." He also said that an estimated 7 million people in the U.S. have gotten a COVID-19 booster shot; 3 million of those shots were administered in the last week. The only COVID-19 shot that is currently authorized is the one developed by BioNTech SE and Pfizer Inc. . A Food and Drug Administration advisory committee is scheduled to meet Thursday and Friday to discuss whether the regulator should authorize Moderna Inc.'s and Johnson & Johnson's booster shots.
1:00 p.m. Oct. 11, 2021 - By MarketWatch
JP Morgan CEO Jamie Dimon says ‘bitcoin is worthless’ amid crypto bull runJPMorgan Chase & Co. started giving its wealth management clients access to crypto funds in July.
8:00 a.m. Oct. 11, 2021 - By MarketWatch
Merck seeks authorization for what would be first pill to treat COVID-19, and AstraZeneca reports positive results for antibody treatmentThe global tally of confirmed cases of the coronavirus-borne illness COVID-19 edged closer to 238 million on Monday, as Merck submitted an application to the Food and Drug Administration for emergency authorization of what would be the first pill-based treatment for the deadly illness.
4:11 a.m. Oct. 11, 2021 - By Jaimy Lee
Protagonist Therapeutics shares soar after FDA lifts clinical hold on its experimental cancer drugShares of Protagonist Therapeutics Inc. soared 87.0% in premarket trading on Monday after the company said the Food and Drug Administration had lifted a clinical hold on clinical trials of rusfertide, its experimental blood cancer treatment. The hold was put into place over concerns of skin tumors from animal research and a deeper examination of four new cancer cases that emerged during a clinical trial. No safety concerns were identified during the hold. The investigational treatment is expected to move forward into a Phase 3 clinical trial for polycythemia vera in the first quarter of next year. SVB Leerink analyst Joseph Schwartz told investors that lifting the clinical hold is a "very welcomed surprise, given the hold was disclosed less than a month ago, and it was unclear how long it would last." Protagonist's stock is down 9.5% so far this year, while the broader S&P 500 is up 16.9%.
2:29 a.m. Oct. 11, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 near 238 million as Merck sees FDA approval for antiviralThe global tally for the coronavirus-borne illness climbed above 237.9 million on Monday, while the death toll rose above 4.85 million, according to . The U.S. continues to lead the world with a total of 44.3 million cases and 713,350 deaths. The U.S. is again averaging 2,000 deaths a day, , although new cases and hospitalizations are declining. Merck & Co. Inc. submitted an application for Emergency Use Authorization (EUA) with the Food and Drug Administration for molnupiravir, their oral antiviral medicine for the treatment of mild-to-moderate COVID-19 in adults. The company had disclosed that data from a Phase 3 trial found the treatment reduced the risk of of hospitalization or death in adults at risk for progressing to severe COVID-19 by 50%. India is second by cases after the U.S. at 33.9 million and has suffered 450,782 deaths. Brazil has second highest death toll at 601,011 and 21.6 million cases. In Europe, Russia has most fatalities at 213,522, followed by the U.K. at 138,139.
2:12 a.m. Oct. 11, 2021 - By Tomi Kilgore
Merck, Ridgeback submit EUA application for their pill to treat COVID-19 Merck & Co. Inc. and Ridgeback Biotherapeutics said Monday that Merck has submitted an application for Emergency Use Authorization (EUA) with the Food and Drug Administration for molnupiravir, their oral antiviral medicine for the treatment of mild-to-moderate COVID-19 in adults. The companies said the application followed positive results from a Phase 3 trial which showed that with adults at risk for progressing to severe COVID-19, molnupiravir reduced the risk of hospitalization or death by 50%. The companies said 7.3% (28 of 385) of those who received molnupiravir were hospitalized and there were not deaths after 29 days, while 14.1% of patients treated with a placebo (53 of 377) were hospitalized and there were eight deaths. "The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data," said Merck Chief Executive Robert Davis. Merck's stock, which fell 1.2% in premarket trading, has gained 3.4% year to date, while the Dow Jones Industrial Average has advanced 13.5%.
6:38 a.m. Oct. 8, 2021 - By Jaimy Lee
Giving Moderna's COVID-19 booster at the same time as Sanofi's flu is safe and effectiveU.S.-listed shares of Sanofi gained 0.4% in trading on Friday after it announced that co-administering a flu shot with Moderna Inc.'s experimental COVID-19 booster in seniors is safe and effective. Moderna's stock was down 2.7%. The interim findings came from a study of about 300 participants, and they showed a similar immune response and safety signal when giving the shots at the same time compared with giving the shots separately. Sanofi's flu shot, Fluzone High-Dose Quadrivalent, is approved in the U.S. for people who are 65 years old and older. Moderna's booster candidate is currently under review for emergency authorization at the Food and Drug Administration. So far this year, Sanofi's stock has gained 0.5% and Moderna shares have soared 187.8%, while the broader S&P 500 is up 16.1%.
4:24 a.m. Oct. 8, 2021 - By Jaimy Lee
ChemoCentryx's stock jumps 80% after receiving FDA approval for vasculitis drugShares of ChemoCentryx Inc. soared 80.3% in premarket trading on Friday after the company said that it had received approval from the Food and Drug Administration for its ANCA-associated vasculitis therapy. The company said this is the first new drug to treat the rare autoimmune disease in a decade. ChemoCentryx's stock slipped 68.3% this year, while the broader S&P 500 is up 16.1%.
4:08 a.m. Oct. 8, 2021 - By Jaimy Lee
AstraZeneca's experimental asthma gets an orphan drug designation for another diseaseU.S.-listed shares of AstraZeneca gained 0.3% in premarket trading on Friday after the company said an experimental asthma drug it is developing with Amgen has been given an orphan drug designation as a treatment for eosinophilic esophagitis, a rare inflammatory disease. The Food and Drug Administration is expected to decide whether to approve the investigational therapy, tezepelumab, for asthma in the first three months of 2022. AstraZeneca's stock is up 20.7% for the year, while the S&P 500 has gained 16.1%.
4:46 a.m. Oct. 7, 2021 - By Jaimy Lee
Pfizer, BioNTech file for FDA authorization for their COVID-19 vaccine in children Shares of Pfizer Inc. were up 0.1% in premarket trading on Thursday after the company and BioNTech SE announced they submitted an application for emergency use authorization for their COVID-19 vaccine in children between the ages of 5 and 11 years old. The Food and Drug Administration will review the safety and efficacy of the vaccine before deciding whether to authorize the shot for this age group. Pfizer's stock is up 14.1% so far this year, while the broader S&P 500 has gained 15.7%.
2:42 a.m. Oct. 5, 2021 - By Ciara Linnane
J&J amends FDA EUA submission for COVID-19 booster with data showing 94% protection against moderate to severe illnessJohnson & Johnson said Tuesday it has submitted an amendment to the emergency use authorization it's seeking from the U.S. Food and Drug Administration for a booster shot of its COVID-19 vaccine with additional data showing it increased protection to 94% against moderate to severe or critical COVID-19 in the U.S. The submission includes recent data from a Phase 3 trial that found the booster given 56 days after primary dose provided 94% protection against symptomatic illness in moderate to severe/critical COVID-19 and 100% protection against severe/critical COVID-19, at least 14 days post-booster vaccination. The submission further includes Phase 1/2 data that shows a booster given six months after the single shot vaccine increases antibody levels nine-fold a week after the booster that climbs to 12-fold higher four weeks after the booster. J&J is planning to submit the data to other regulators, to the World Health Organization and National Immunization Technical Advisory Groups. Shares were up 0.5% premarket and have gained 1.2% in the year through Monday, while the Dow Jones Industrial Average has gained 11%.
2:19 a.m. Oct. 5, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 235 million and AstraZeneca seeks FDA EUA for antibodyThe global tally for the coronavirus-borne illness climbed above 235.4 million on Tuesday, while the death toll rose above 4.8 million, according to . The U.S. continues to lead the world with a total of 43.8 million cases and 703,285 deaths, after passing 700,000 late Friday. The U.S. is now averaging almost 2,000 deaths a day, , a slight improvement over recent trends and new cases and hospitalizations are declining. AstraZeneca has requested an Emergency Use Authorization to the U.S. Food and Drug Administration for its Covid-19 prophylaxis AZD7442, If granted, AZD7442 would be the first long-acting antibody to receive an EUA for Covid-19 prevention. Data from a Phase 3 trial showed a 77% reduction in the risk of developing symptomatic Covid-19 with long-acting antibody combination, the drug company said. India is second by cases after the U.S. at 33.8 million and has suffered 449,260 deaths. Brazil has second highest death toll at 598,152 and 21.5 million cases. In Europe, Russia has most fatalities at 207,932, followed by the U.K. at 137,378.
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%.
2:16 a.m. Oct. 1, 2021 - By Ciara Linnane
Merck shares jump 3.5% premarket after it reveals positive data in trial of COVID-19 antiviralMerck shares jumped 3.5% in premarket trade Friday, after the company said the oral antiviral it developed as a treatment for COVID-19 with partner Ridgeback Biotherapeutics reduced the risk of hospitalization or death in at risk adult patients with mild-to-moderate COVID by about 50% in an interim analysis of data from a Phase 3 trial. Some 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of patients given a placebo. Through Day 29, no patients given molnupiravir died, compared with eight patients who died on placebo. The company is now planning to submit an application for an emergency use authorization for the treatment from the Food and Drug Administration and will also seek it from other regulatory bodies around the world. The interim analysis looked at data from 775 patients enrolled in the trial on or prior to Aug. 5. Merck is planning to produce 10 million courses of treatment by year-end with more to come in 2022. Shares have fallen 3.7% in the year to date, while the S&P 500 has gained 14.7%.
4:26 a.m. Sept. 30, 2021 - By Jaimy Lee
Mirim's treatment for a rare liver disorder gets FDA approvalShares of Mirim Pharmaceuticals Inc. gained 2.3% in premarket trading on Thursday, the day after the company announced that the Food and Drug Administration had approved Livmarli as a treatment for cholestatic pruritus in people with the genetic disorder Alagille syndrome. It's the first and only drug for the 2,000 to 2,500 children in the U.S. who have this rare liver disorder. Livmarli is priced at about $391,000 per year, according to Raymond James analyst Steven Seedhouse, who estimates a $300 million market for this therapy. "We expect this drug to be widely adopted amongst children with ALGS," he wrote in a note on Wednesday. "Thus, the market's relatively muted reaction to approval despite overly discounting for regulatory risk heading into approval in our view provides an opportunity to buy now." Mirim's stock is up 6.9% so far this year, while the broader S&P 500 has gained 15.5%.
2:55 a.m. Sept. 28, 2021 - By Ciara Linnane
Pfizer and BioNTech submit initial data to FDA from trial of COVID-19 vaccine in children aged 5 to 12 Pfizer Inc. and German partner BioNTech SE said Tuesday they have submitted initial data from the late-stage trial of their COVID-19 vaccine in children aged 5 to 12 to the U.S. Food and Drug Administration, and are seeking an emergency-use authorization to add that patient group to the program. The news comes after the companies released initial data from the trial last week, saying the vaccine had proved safe and effective. The companies used two doses of just 10 mg in a trial involving 2,268 participants. "Topline immunogenicity and safety readouts for the other two age cohorts from the trial -- children 2 to <5 years of age and children 6 months to <2 years of age -- are expected as soon as the fourth quarter of this year," the companies said in a statement. They are also planning to submit data from the full Phase 3 trial for scientific peer-reviewed publication. Pfizer shares were down 0.6% premarket, while BioNTech was down 3%.
5:19 a.m. Sept. 27, 2021 - By Jaimy Lee
Intra-Cellular says clinical study shows its schizophrenia drug helps patients with bipolar disorderShares of Intra-Cellular Therapies Inc. gained 1.5% in premarket trading on Monday after the company said clinical data showed that its experimental treatment for bipolar disorder reduced depressive symptoms. The Phase 3 study evaluated Caplyta, which is already approved as a treatment for schizophrenia, in 381 people with bipolar I or bipolar II disorder who were experiencing a depressive episode. There were no significant weight changes in the group of people who took the drug compared with those who got the placebo. The most common side effects were sleepiness and nausea. The drug is currently under review at the Food and Drug Administration as a bipolar therapy, and the regulator is expected to make a decision by Dec. 17. Intra-Cellular's stock has gained 15.5% so far this year, and the S&P 500 is up 18.6% for the year.
9:16 a.m. Sept. 24, 2021 - By Jaimy Lee
CDC: We are not changing the definition of 'fully vaccinated' now that COVID-19 boosters are available The Centers for Disease Control and Prevention does not plan to change the definition of what it means to be "fully vaccinated" right now that BioNTech SE and Pfizer Inc.'s COVID-19 booster shots are available for a large group of the U.S. population. During a White House briefing on Friday, CDC director Rochelle Walensky said "we need to have more experience with our third shot and have more people eligible or recommended to receive it, before we change that definition." The Food and Drug Administration on Wednesday authorized a third booster dose of Pfizer's two-dose vaccine, making it the first vaccine to receive regulatory authorization for a booster. Moderna Inc.'s application for a booster shot for its two-dose vaccine is currently under review at the FDA.
Browse topics:

Filter results by

Location

Us (354)

Europe (44)

Eu (33)

Asia Pacific (29)

China (23)

Canada (7)

Link to MarketWatch's Slice.