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FDA Panel Endorses Moderna’s Covid-19 Vaccine for Broad Use

  • 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
    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
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%.
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.
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%.
4:08 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%.
2:16 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%.
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.
4:59 a.m. Sept. 22, 2021 - By Jaimy Lee
Incyte gets FDA approval for atopic dermatitis drugShares of Incyte Corp. were down 4.0% in premarket trading on Wednesday, the day after the company announced that the Food and Drug Administration had approved Opzelura as a treatment for some patients with mild to moderate atopic dermatitis. The FDA approval for the topical drug came with a warning for serious adverse events - also referred to a black-box warning - that is consistent with oral JAK inhibitors, according to Mizuho Americas analysts. "Bigger picture, this marks yet another approval for INCY as the company attempts to diversify away from a prevailing over-reliance on Jakafi," J.P. Morgan analysts told investors on Wednesday morning. Information about the drug's price is expected to be disclosed at an investor call on Wednesday. Incyte's stock is down 12.5% for the year, while the broader S&P 500 is up 15.9%.
3:34 a.m. Sept. 22, 2021 - By Jaimy Lee
CDC committee to meet today and Thursday to again discuss BioNTech and Pfizer's COVID-19 boosterA Centers for Disease Control and Prevention committee is Wednesday and Thursday to again discuss the science and possible administration plan for BioNTech SE and Pfizer Inc.'s COVID-19 booster shot. The CDC's Advisory Committee on Immunization Practices sets out the guidelines for how vaccines should be used in the U.S. The Food and Drug Administration has not approved or authorized an extra dose of the BioNTech and Pfizer vaccine except in people who are immuno-compromised, and an influential FDA committee last week recommended that boosters to older people and those who are at higher risk of severe disease. Some experts have suggested that the FDA decision is coming this week.
1:20 p.m. Sept. 15, 2021 - By Jaimy Lee
FDA says COVID-19 vaccines continue to protect people in the U.S. from severe diseaseThe Food and Drug Administration said Wednesday that observational studies have had mixed findings assessing whether the efficacy for BioNTech SE and Pfizer Inc.'s COVID-19 vaccine is declining as a result of time or the delta variant but in general the vaccines available in the U.S. continue to protect people against severe disease and death. The FDA's was published Wednesday in advance of an advisory committee meeting set for Friday; at that meeting, a group of independent experts will discuss and then vote on whether they think the FDA should approve a COVID-19 booster dose for people who are at least 16 years old or older. The FDA is not required to follow the advice of the committee but often does. Pfizer's document for the meeting was also published on Wednesday; it cited the need to look at the when it comes to making a regulatory decision about a third dose of its vaccine. The FDA's document, on the other hand, said it has not independently verified all potentially relevant studies.
5:29 a.m. Sept. 15, 2021 - By Jaimy Lee
Pfizer cites 'totality' of clinical data in bid for COVID-19 booster approvalShares of Pfizer Inc. gained 0.1% in premarket trading on Wednesday after the drug maker said the "totality" of clinical data indicates that people who are at least 16 years old and were vaccinated with the COVID-19 shot that it developed with BioNTech SE should get a booster after six months. In a published Wednesday morning by the Food and Drug Administration in advance of an advisory committee meeting set for Friday, Pfizer said its Phase 3 substudy examined 306 people between the ages of 18 and 55 years old who got a third dose. It found that an extra dose is considered safe and increased neutralizing antibody titers against the original strain of the virus as well as the beta and delta variants to a higher rate than what was reported after two doses in the clinical trials last year. Younger participants were more likely to report systemic events after the second and third doses than the first dose; fever was more common after the third dose. No adverse events were reported in the first month after the third dose. Pfizer also cited research conducted by Israel, the Centers for Disease Control and Prevention, and the hospital system Kaiser Permanente in the document, saying that data from Israel "suggest reduced effectiveness against severe disease could eventually follow observed reductions in effectiveness against SARS-CoV-2 infections." Pfizer's stock is up 21.4% this year, while the S&P 500 has gained 18.9%.
11:46 a.m. Sept. 2, 2021 - By Jaimy Lee
FDA committee to discuss COVID-19 booster shotsAn influential Food and Drug Administration advisory committee plans to meet Sept. 17 to discuss extra doses of the COVID-19 vaccines, including the application filed by BioNTech SE and Pfizer Inc. for a third dose of their COVID-19 shot. Moderna Inc. on Wednesday also submitted its application for a booster dose of its COVID-19 vaccine. The FDA's Vaccines and Related Biological Products Advisory Committee traditionally recommends whether the FDA should authorize or approve a vaccine or drug. The regulator is not required to follow the advice of the committee but it often does. The Biden administration previously said that COVID-19 booster shots will be available to adults starting Sept. 20, though from the FDA and the Centers for Disease Control and Prevention. "The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner," Dr. Peter Marks, the director of the FDA's Center for Biologics Research and Evaluation, said in a on Wednesday.
1:03 p.m. Sept. 1, 2021 - By Claudia Assis
Moderna asks FDA to evaluate COVID-19 vaccine booster candidateModerna Inc. said late Wednesday it is submitting documents to the U.S. Food and Drug Administration (FDA) for the evaluation of a booster dose of its COVID-19 vaccine as a 50-microgram dose. The biotech company said it expects to submit data to European authorities and others around the world in the coming days. Data supported that the 50-microgram dose "shows robust antibody responses against the delta variant," the company said. Moderna's COVID-19 vaccination entails two shots of 100 micrograms each. has intensified in the past two months with both Moderna and Pfizer Inc. promoting their booster candidates, with support from the White House. Shares of Moderna rose 0.7% in the extended session after ending the regular trading day up 3.5%.
10:37 a.m. Aug. 26, 2021 - By Jaimy Lee
CDC: Overdoses of ivermectin are risingThere has been a "rapid increase" in prescriptions of ivermectin among people looking to treat or prevent COVID-19 cases, according to a issued Thursday by the Centers for Disease Control and Prevention. Ivermectin is an approved treatment for parasitic worms in animals and some rare conditions in humans, but not COVID-19 infections. "Adverse effects associated with ivermectin misuse and overdose are increasing, as shown by a rise in calls to poison control centers reporting overdoses and more people experiencing adverse effects," the CDC said Thursday. The Food and Drug Administration earlier this week , which is not proven to treat COVID-19. "You are not a horse," the regulator said in a tweet that has since gone viral. The drug is one of several therapies that are but have become a worrisome issue for public-health experts as people seek alternative ways to address COVID-19 infections.
3:01 a.m. Aug. 26, 2021 - By Tomi Kilgore
Pfizer, BioNTech sign LOI with Brazil's Eurofarma to make COVID-19 vaccines for use in Latin AmericaPfizer Inc. and BioNTech SE said Thursday that they have signed a letter of intent (LOI) with Brazil-based biopharmaceutical company Eurofarma Laboratórios SA to make COVID-19 vaccines for distribution in Latin America. Eurofarma will receive drug product from the U.S., and will perform manufacturing activities, with distribution expected to start in 2022. The annual production is expected to be more than 100 million doses. Pfizer and BioNTech said it will now have 20 manufacturing facilities in four continents. The companies have shipped 1.3 billion COVID-19 vaccine doses to more than 120 countries to date, and aim to provide 2 billion doses to low and middle income countries through 2022. The Pfizer-BioNTech vaccine has been by the U.S. Food and Drug Administration, and the companies have initiated an application for approval of a third dose as a booster. Shares of Pfizer are up 0.3% in premarket trading, while BioNTech's stock is down 0.8% and futures for the S&P 500 are slipping 0.1%.
8:49 a.m. Aug. 25, 2021 - By Jaimy Lee
BioNTech, Pfizer initiate application for approval of a third dose of their COVID-19 vaccineBioNTech SE and Pfizer Inc. said Wednesday that they initiated an application to U.S. regulators for a third dose of Comirnaty, their COVID-19 vaccine. BioNTech's stock was down 0.2% in trading on Wednesday, while Pfizer's stock fell 1.8%. The companies said they plan to complete the submission of a third dose for Americans who are at least 16 years old sometime this week. The supplemental application comes about two week after the Biden administration announced that adults who received the mRNA vaccines developed by BioNTech/Pfizer and Moderna Inc. will likely be allowed to get a third dose starting Sept. 20. The two-shot vaccine received full approval from the Food and Drug Administration on Monday. So far this year, BioNTech's stock has soared 353.2%, shares of Pfizer have gained 29.0%, and the S&P 500 is up 19.4%.
2:22 a.m. Aug. 24, 2021 - By Tomi Kilgore
Coronavirus tally: Daily average for new cases, deaths and hospitalizations keep climbing to multi-month highsThe global tally for the coronavirus-borne illness climbed to above 212.61 million as of early Tuesday, while death toll rose to 4,442,545, according to . The U.S. led the world with a total of 37.94 million cases and 629,411 deaths. The daily average of new cases over the past seven days rose to 150,625 as of Monday, up 29% from two weeks ago, and the highest count since Jan. 30, according to . The daily average for deaths increased to 1,057, up 91 in two weeks and the most since March 24. The daily average for hospitalizations of 93,318 was up 39% from two weeks ago and the most since Feb. 6. The number of people that have been fully vaccinated rose to 171.1 million, or 51.5% of the total U.S. population, according to , while the number of people who have received at least one dose of a vaccine edged up to 201.7 million, or 60.8% of the total population. Hopes that vaccination rates would increase were boosted by the Food and Drug Administration's developed by Pfizer Inc. and BioNTech SE on Monday for people at least 16 years old.
2:51 a.m. Aug. 23, 2021 - By Tomi Kilgore
Coronavirus tally: Average daily U.S. death toll tops 1,000 for first time in 5 months, FDA set to approve Pfizer vaccineThe global tally for the coronavirus-borne illness climbed to 211.9 million as of early Monday, while death toll rose to 4,432,694, according to . The U.S. led the world with a total of 37.71 million cases and 628,503 deaths. The daily average of new cases over the past seven days rose to 149,675 as of Sunday, up 36% from two weeks ago, but down from 150,138 on Saturday, according to . The daily average for deaths increased to 1,008, topping the 1,000 mark for a second-straight day, and up 95% in two weeks, and the most since March 25. Hospitalizations of 92,482 was up 43% from two weeks ago and the most since Feb. 6. The number of people that have been fully vaccinated rose to 170.82 million, or 51.5% of the total U.S. population, according to . The Food and Drug Administration is Pfizer Inc.'s and partner BioNTech SE's COVID-19 vaccine as early as Monday.
2:54 p.m. Aug. 20, 2021 - By Wallace Witkowski
Pfizer and BioNTech shares rise on report FDA could fully approve COVID-19 vaccine next weekPfizer Inc. and U.S.-listed shares of BioNTech SE rose in the extended session Friday following a report that the drug makers will likely get full Food and Drug Administration approval for their COVID-19 vaccine sometime next week. Pfizer shares rose more than 2% after hours, following a 0.2% decline to close at $48.72, and German-based BioNTech's ADRs rallied more than 5%, following a 5.1% gain to close at $348.68. Late Friday, that the FDA could approve the vaccine, which up until now has been distributed on an emergency basis, as early as Monday but could possibly go past that if regulators need more time to review data. The Department of Health and Human Services recently announced that to those who already received their first two shots. Back in July, Pfizer and BioNTech reported targeting the delta variant of the virus.
6:33 a.m. Aug. 18, 2021 - By Tomi Kilgore
Virpax's stock rockets nearly 5-fold in 2 days after upbeat FDA response to its SARS-CoV-2 inhibitorShares of Virpax Pharmaceuticals Inc. rocketed for a second straight day on heavy volume, after the company announced an upbeat pre-investigational new drug response from the Food and Drug Administration on its product to inhibit SARS-CoV-2 and the flu. The stock shot up 53.6% in morning trading, after soaring 265.5% on Tuesday, to mark a two-day gain of 461.4%. Trading volume was 28.0 million shares early Wednesday, after a record total of 165.9 million shares on Tuesday, compared with the full-day average over the past 30 days of 9.7 million shares. Before Tuesday's open, Virpax said the FDA indicated it may pursue a New Drug Application (NDA) for MMS019, as a once daily intranasal treatment. MMS019 is Virpax's "high-density molecular masking spray under development for the use as an anti-viral barrier product." The company said MMS019 has shown to inhibit viral replication of SARS-CoV-2 and flue in animals, even at much higher ranges that what is encountered in humans in the nasal passages, with no adverse effects. The stock, which started trading in February, as now run up 484.2% over the past three months, while the S&P 500 has gained 7.8%.
7:49 a.m. Aug. 16, 2021 - By Tomi Kilgore
Pfizer, BioNTech submit trial data on COVID-19 booster shot to FDAPfizer Inc. and partner BioNTech SE announced Monday that data from a Phase 1 study has been submitted to the U.S. Food and Drug Administration, for the evaluation of a third, booster dose of their COVID-19 vaccine. The companies said they will also submit the data to the European Union's version of the FDA, the European Medicines Agency, as well as other regulatory authorities, in the coming weeks. In the U.S., Pfizer-BioNTech plan to seek licensure of a third dose in people at least 16 years old. Last week, for some people with compromised immune systems. "This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine," said BioNTech Chief Executive Ugur Sahin. "A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season." Shares of Pfizer slipped 0.6% in midday trading and BioNTech's stock dropped 10.6%, while the S&P 500 eased 0.4%.
4:12 a.m. July 29, 2021 - By Jaimy Lee
Viatris gets FDA approval of first biosimilar version of Sanofi's insulin LantusShares of Viatris Inc. gained 3.3% in premarket trading on Thursday, the day after the Food and Drug Administration approved the first biosimilar verson of insulin glargine from Viatris and Biocon Biologics Ltd. Biocon is a privately held biopharma company based in India. The newly approved treatment, Semglee, is a biosimilar and interchangeable version of Lantus, Sanofi's once-blockbuster long-actin insulin. Semglee will be sold exclusively by the companies for 12 months before the FDA can approve another biosimilar version of Lantus. Biosimilar drugs are copies of complex biologic drugs; this is somewhat similar to how generic drugs compare to brand-name prescription medications, in that that biosimilars and generic drugs are less expensive than the brand-name alternatives. Viatris shares are down 24.0% so far this year, while the broader S&P 500 is up 17.1%.
3:12 a.m. July 28, 2021 - By Ciara Linnane
Bristol Myers swings to profit to beat second-quarter estimates as Opdivo returns to growthBristol Myers Squibb Co. said Wednesday it swung to a profit of $1.055 billion, or 47 cents a share, in the second quarter, after a loss of $85 million, or 4 cents a share, in the year-earlier period. Adjusted per-share earnings came to $1.93, ahead of the $1.89 FactSet consensus. Revenue rose to $11.703 billion from $10.129 billion, also ahead of the $11.269 billion FactSet consensus. "We delivered a strong quarter across each of our four therapeutic areas, including building momentum for our new product portfolio and Opdivo returning to growth," Chief Executive Dr. Giovanni Caforio said in a statement. Opdivo was first approved by the Food and Drug Administration in 2014 as a treatment for melanoma and has since won approval for other indications. Sales of Opdivo rose 16% in the second quarter to $1.910 billion. Bristol Myers updated its full-year EPS guidance to a range of $2.77 to $2.97 from a prior range of $3.18 to $3.38. It still expects full-year adjusted EPS of $7.35 to $7.55. It expects worldwide revenues to grow in the high-single digits. Shares were flat premarket, but have gained 8.8% in the year to date, while the S&P 500 has gained 17%.
12:53 p.m. July 19, 2021 - By Jeremy C. Owens
Pharma company's stock plunges 70% after bad news from FDAShares in Ardelyx Inc. plummeted more than 70% in after-hours trading Monday, following the biopharmaceutical company's that the Food and Drug Administration appears unlikely to approve a drug for dialysis patients. Ardelyx revealed that it received a letter from the FDA stating that deficiencies in the information provided had been found that would preclude discussion of approvals Ardelyx has sought. When Ardelyx sought a meeting with the FDA to discuss the deficiencies, the request was denied, though Ardelyx stated that "the FDA noted that a key issue is the size of the treatment effect and its clinical relevance." "This is an extremely disheartening and disappointing communication from the FDA, particularly following the weeks of label discussions that occurred in early April, the fact that our NDA submission included three pivotal trials across 1,000 patients, all which met their primary and key secondary endpoints, as well as the additional data analyses we submitted in late April in response to the FDA's requests," Ardelyx Chief Executive Mike Raab said in a statement. Ardelyx shares, which closed at $7.70 in the regular session for a market capitalization of more than $700 million, saw shares dive to less than $2.50 in the after-hours trading period.
4:57 a.m. July 19, 2021 - By Jaimy Lee
Pfizer says FDA's decision to approve its COVID-19 vaccine is expected by JanuaryPfizer Inc. said Friday that the Food and Drug Administration accepted its application for of the COVID-19 vaccine it developed with BioNTech SE . As part of the application process, the FDA sets a decision date based on the rules of the Prescription Drug User Fee Act for applications that receive what is called Priority Review. The decision date is set for an undisclosed day in January, Pfizer said. This means that Pfizer's COVID-19 shot may not be fully approved in the U.S. until then, though the decision could occur sooner. Pfizer's shot was first authorized as part of emergency rules back in December 2020. Since then, of this vaccine have been administered to people in the U.S. Pfizer's stock is up 9.6% so far this year, while the broader S&P 500 is up 15.2%.
2:46 a.m. July 16, 2021 - By Tomi Kilgore
AstraZeneca says FDA advisory committee won't support CKD treatment for approval, partner FibroGen stock plunges AstraZeneca PLC has disclosed Friday that a U.S. Food and Drug Administration advisory committee has voted 13 to 1 not to support approval of roxadustat for the treatment of anaemia in chronic kidney disease (CKD) in non-dialysis dependent adult patients. Shares of FibroGen Inc. , which was AstraZeneca's partner in developing roxadustat, plummeted 34.1% in premarket trading, while AstraZeneca's U.S.-listed shares edged up 0.4%. The Cardiovascular and Renal Drugs Advisory Committee also voted 12 to 2 that the benefit-risk profile of roxadustat didn't support approval for the treatment of anaemia in CKD in dialysis-dependent adult patients. "Although we are disappointed by today's outcome, we will work closely with our partner FibroGen and the FDA to determine the path forward for roxadustat," said Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca. The company noted that roxadustat is approved in China, Japan, Chile and South Korea for the treatment of CKD, and is under regulatory review in the European Union. FibroGen's stock has tumbled 33.0% year to date through Thursday and AstraZeneca shares have gained 13.9%, while the S&P 500 has tacked on 16.1%.
8:27 a.m. July 2, 2021 - By Jaimy Lee
Mizuho: Merck withdrawing Keytruda as a gastric cancer treatment won't impact the stockShares of Merck & Co. Inc. were up 0.7% in trading on Friday, the day after the company said it will voluntarily withdraw an accelerated approval for Keytruda as a third-line treatment for some patients with gastric cancer in the next six months. Keytruda is Merck's top-selling drug; it brought in $14.4 billion in sales in 2020. The decision to withdraw the drug for this indication is part of to assess whether certain cancer medicines that received a type of approval dependent on confirmatory post-market clinical studies should stay on the market. The withdrawal is not expected to have a material impact on company shares, according to Mizuho Americas analysts. Merck's stock is up 0.7% so far this year, while the broader S&P 500 is up 14.4%.
8:11 a.m. July 2, 2021 - By Jaimy Lee
Jazz's leukemia drug gets approved by the FDAShares of Jazz Pharmaceuticals plc gained 3.5% in premarket trading on Thursday, the day after the Food and Drug Administration said it had approved the company's acute lymphocytic leukemia treatment Rylaze. The therapy is an orphan drug, meaning it affects less than 200,000 people in the U.S. The drug is expected to be available later this month; a spokesperson for the company said that's when the price will be made public. Jazz's stock is up 7.6% so far this year, while the broader S&P 500 is up 14.4%.
1:47 p.m. June 29, 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 that trials needed to be conducted before the drug should be prescribed to COVID-19 patients.
4:30 a.m. June 25, 2021 - By Jaimy Lee
Roche's arthritis drug gets authorized as COVID-19 treatment for the severely ill Shares of Roche Holding Group were up 0.1% in trading on Friday, the day after the company said its COVID-19 drug has been authorized in the U.S. as a treatment for those who have been hospitalized with COVID-19 who are at least two years old. The drug, Actemra, is already approved by the Food and Drug Administration as a treatment for rheumatoid arthritis. The intravenous therapy is reserved for the very ill, including those patients already taking steroids, on oxygen, or being ventilated. Roche's stock is up 7.0% for the year, while the broader S&P 500 has gained 13.0%.
8:52 a.m. June 21, 2021 - By Jaimy Lee
Tarsus to submit application for new eye treatment to FDA in 2022Tarsus Pharmaceuticals Inc. said Monday that a Phase 2b/3 clinical trial evaluating an experimental treatment for a type of ocular disease met the study's primary and secondary endpoints. However, the stock was down 15.3% in trading on Monday afternoon. Tarsus is testing the investigational ophthalmic solution in patients with Demodex blepharitis. The company said in a news release that millions of people have been diagnosed with this eye disease, and there are currently no approved treatments in the U.S. Tarsus plans to submit data from this study in a new drug application to the Food and Drug Administration sometime next year. Tarsus shares are down 28.5% this year, while the broader S&P 500 is up 10.9%.
4:19 a.m. June 21, 2021 - By Jaimy Lee
Gilead says real-world data show COVID-19 drug Veklury can reduce the risk of deathShares of Gilead Sciences Inc. gained 0.3% in premarket trading on Monday after the drug manufacturer said retrospective research shows that Veklury, its COVID-19 treatment, reduces mortality among people who have been hospitalized with COVID-19. Veklury, which received full approval from the Food and Drug Administration last year, can be prescribed to people who have COVID-19, are hospitalized and are at least 12 years old. The new research examined real-world data from three databases that included roughly 98,000 patients who had been hospitalized with COVID-19, finding that the drug could reduce the risk of death. The Phase 3 clinical trial that was used to inform the FDA approval of Veklury found that the drug could help reduce the amount of time patients spent in the hospital but the data did not demonstrate that the therapy could reduce death at that time. Gilead's stock is up 14.3% so far this year, while the S&P 500 has gained 12.4%.
3:55 a.m. June 16, 2021 - By Jaimy Lee
Regeneron says its COVID-19 antibody treatment cuts the risk of death among hospitalized patientsShares of Regeneron Pharmaceuticals Inc. gained 0.1% in premarket trading on Wednesday after the company said its COVID-19 antibody therapy cut the risk of death in patients who have been hospitalized by 20%. This is the first time clinical research has demonstrated that Regeneron's antibody treatment has improved survival for hospitalized patients. The study, which is being conducted in the U.K. in patients who have not yet developed antibodies, follows other research that showed the company's antibody treatment can improve recovery times among people with mild or moderate forms of the disease. Regeneron said it is planning to ask the Food and Drug Administration to expand the emergency-use authorization in the U.S. to include these types of patients. Regeneron's stock is up 9.2% so far this year, while the broader S&P 500 has gained 13.0%.
4:42 a.m. June 14, 2021 - By Jaimy Lee
iTeos stock jumps 60% after company announces deal with GSKShares of iTeos Therapeutics Inc. soared 58.5% in premarket trading on Monday after the company announced a deal with GlaxoSmithKline to develop and commercialize an experimental cancer therapy. GSK will make a $625 million upfront payment to iTeos, with an additional $1.4 billion in possible milestone payments available in the future. The immuno-oncology drug candidate is currently being tested in an open-label, Phase 1 clinical trial in patients with advanced solid tumors; as part of this deal, the companies plan to pair the iTeos drug with GSK's Jemperli in studies next year. (Jemperli was initially approved by the Food and Drug Administration as a treatment for endometrial cancer in April.) Shares of iTeos are down 40.8% so far this year, while the S&P 500 has gained 13.1%.
7:20 a.m. June 11, 2021 - By Tomi Kilgore
J&J stock drops after report FDA said millions of COVID-19 vaccine doses need to be discardedShares of Johnson & Johnson took a 1.4% hit in morning trading Friday, after a report that health officials decided the drugmaker needs to throw out millions of doses of its COVID-19 vaccine because of possible contamination. The New York Times reported Friday, citing people familiar with the situation, that after weeks of review, the Food and Drug Administration told J&J to discard 60 million doses of its vaccine made at a Baltimore plant under federal review, which is operated by Emergent BioSolutions Inc. , because of possible contamination. The FDA said Friday that it was authorizing emergency use of two batches of vaccines made at the Baltimore facility, even though it said it is "not yet ready" to include the plant as an authorized facility for the vaccine. The NYT report comes after the , to 4 1/2 months from 3 months, as supply piled up. J&J's stock has gained 3.6% over the past three months, while the SPDR Health Care Select Sector ETF has gained 8.6% and the Dow Jones Industrial Average has tacked on 5.9%.
3:01 a.m. June 9, 2021 - By Tomi Kilgore
Merck enters $1.2 billion agreement to supply U.S. government with potential COVID-19 treatmentShares of Merck & Co. Inc. rose 0.9% in premarket trading Wednesday, after the drug maker announced a supply agreement with the U.S. government for molnupiravir, its investigational oral antiviral candidate to treat mild to moderate COVID-19. Molnupiravir, which is being developed in collaboration with Ridgeback Biotherapeutics, is currently undergoing a Phase 3 clinical trial for treating COVID-19 in non-hospitalized patients with at least one risk factor. If molnupiravir is granted Emergency Use Authorization (EUA) from the Food and Drug Administration, Merck will receive about $1.2 billion to supply the government with 1.7 million courses of molnupiravir. The company expects to have more than 10 million courses of therapy by the end of 2021. Merck's stock has lost 7.2% year to date through Tuesday, while the Dow Jones Industrial Average has gained 13.1%.
3:11 a.m. June 4, 2021 - By Barbara Kollmeyer
Pfizer-BioNTech Covid-19 vaccine approved for 12 to 15-year-olds in the U.K.The COVID-19 vaccine developed jointly by Pfizer and BioNTech has been approved for 12 to 15-year-olds in the U.K, the Medicines and Healthcare products Regulatory Agency (MHRA) . More than 2,000 children were involved in the clinical trial to determine the safety of the Pfizer-BioNTech vaccine, the chairman of the Commission on Human Medicines said. The MHRA said it would now be up to the U.K.'s Joint Committee on Vaccination and Immunisation (JCVI) to decide whether to vaccinate this age group as part of the country's inoculation program. The European Medicines Agency approved the Pfizer-BioNTech shot for use in 12 to 15-year olds last week, while the U.S. Food and Drug Administration d the Pfizer-BioNTech vaccine for 12-to-15 year-olds on May 10.
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