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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%.
2:34 a.m. Sept. 15, 2021 - By Tomi Kilgore
Procept BioRobotics upsized IPO prices above the expected range, valuing company at $1 billionProcept BioRobotics Corp. is set to go public Wednesday, as the California-based surgical robotics company's upsized initial public offering priced above the expected range at $25.00 per share. The company sold 6.56 million shares in the IPO to raise $163.9 million. Procept had previously expected to offer 5.5 million shares in the IPO, which was projected to price between $22 and $24 per share. The stock is expected to begin trading Wednesday on the Nasdaq under the ticker symbol "PRCT." With 41.21 million shares outstanding after the IPO, the pricing values Procept at $1.03 billion. BofA Securities and Goldman Sachs are the joint lead bookrunning managers. The company had recorded a net loss of $27.4 million on revenue of $15.7 million in the six months ended June 30, after a loss of $25.7 million on revenue of $2.4 million in the same period a year ago. The company is going public at a time that the Renaissance IPO ETF has gained 7.4% over the past three months while the S&P 500 has tacked on 4.6%.
4:38 a.m. Sept. 14, 2021 - By Jaimy Lee
Merck CEO: Authorization of its experimental antiviral COVID-19 treatment could come by year endMerck & Co. Inc. said it expects the company's experimental oral antiviral treatment for COVID-19 could get emergency authorization by the end of the year. "We expect to be able to see clinical data here in the back half of the year and still have the potential for an interim analysis and potential for emergency use authorization before year end," Merck CEO Robert Davis told investors at the Morgan Stanley Global Healthcare Conference on Monday. Merck and Ridgeback Biotherapeutics Inc. have been testing the investigational therapy, molnupiravir, in a Phase 3 clinical trial. There are few authorized or approved new COVID-19 treatments beyond the monoclonal antibodies developed by Eli Lilly & Co. , GlaxoSmithKline and Vir Biotechnology Inc. , and Regeneron Pharmaceuticals Inc. and Gilead Sciences Inc.'s Veklury. The medical community has called for easy-to-take medications that can treat the disease caused by SARS-CoV-2. The U.S. has already purchased 1.7 million courses of molnupiravir, dependent on authorization from regulators. Merck's stock is down 7.0% for the year, while the broader S&P 500 is up 18.9%.
2:28 a.m. Sept. 10, 2021 - By Tomi Kilgore
Coronavirus tally: Daily average of new COVID-19 cases dips, but deaths rise to 6-month highThe global tally for the coronavirus-borne illness climbed to 223.23 million as of early Friday, while the death toll rose to 4,606,927, according to . The U.S. continues to lead the world with a total of 40.60 million cases and 654,598 deaths. The daily average of new cases over the past seven days was 147,816 as of Thursday, down from a recent peak of 166,105 on Sept. 1 and 5% less than what it was two weeks ago, according to . The daily average for deaths kept rising to 1,579, up 28% in two weeks and the most since March 9. The daily average for hospitalizations of 100,610 was down from a peak of 102,621 on Sept. 3 but up 1% from two weeks ago. The number of people that have been fully vaccinated grew to 177.43 million, or 53.4% of the total U.S. population, according to , while the number of people who have received at least one dose of a vaccine rose to 208.31 million, or 62.7% of the total population. In a speech from the White House late Thursday, President Joe Biden rolled out a " " to fight COVID-19, including new vaccine mandates, as he warned the country about a "tough stretch" in the fight against the delta variant.
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.
2:58 a.m. Sept. 1, 2021 - By Tomi Kilgore
Merck, Ridgeback start Phase 3 trial of oral drug to prevent COVID-19Shares of Merck & Co. Inc. and Ridgeback Biotherapeutics said Wednesday that they have started a Phase 3 trial of molnupiravir, and oral antiviral therapeutics for the prevention of COVID-19 infection. Merck's stock gained 0.4% in premarket trading. The drug makers said the study is enrolling people at least 18 years old who live in the same house as someone who tested positive for SARS-CoV-2 and had symptoms. Primary endpoints include percentage of participants with COVID-19 through day 14, the percentage of those with an adverse event and the percentage of those who had to discontinue to the study because of an adverse event. ""As the pandemic continues to evolve and surges are being reported in many places around the world, it is important that we investigate new ways to protect individuals exposed to the virus from becoming infected with symptomatic disease," said Dr. Nick Kartsonis, senior vice president, vaccines and infectious diseases, clinical research, Merck Research Laboratories. "If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities." Merck's stock has slipped 2.2% year to date through Tuesday, while the SPDR Health Care Select Sector ETF has rallied 19.2% and the Dow Jones Industrial Average has advanced 15.5%.
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%.
6:03 a.m. Aug. 25, 2021 - By Jaimy Lee
J&J says new data indicates an extra dose of its COVID-19 vaccine can boost antibody levelsShares of Johnson & Johnson gained 0.8% in premarket trading on Wednesday after the company shared interim clinical data that indicates Americans who have received its single-dose COVID-19 vaccine could get a second dose. J&J said in a news release that two Phase 1/2a studies examining people who had received its shot found that a second dose boosted antibody levels. (The studies have not yet been published in a medical journal or on a preprint server.) The company said last month that people vaccinated with its shot still had strong immune responses eight months after vaccination. "We also see that a booster dose of the Johnson & Johnson COVID-19 vaccine further increases antibody responses among study participants who had previously received our vaccine," Dr. Mathai Mammen, global head of J&J's Janssen Research & Development business, said in a news release. Federal health officials last week said that Americans who have been vaccinated with the mRNA vaccines developed by BioNTech SE /Pfizer Inc. and Moderna Inc. . J&J's stock is up 11.4% so far this year, while the broader S&P 500 has gained 19.4%.
5:58 a.m. Aug. 25, 2021 - By Tomi Kilgore
Moderna completes BLA submission for full approval of COVID-19 vaccineShares of Moderna Inc. rallied 4.0% in morning trading Wednesday after the biotechnology company said it has completed the submission to the Food and Drug Administration for its Biologics License Application (BLA) for the "full licensure" of its COVID-19 vaccine, for people 18 years old and older. "This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company's history," said Chief Executive Stéphane Bancel. "We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2." The announcement comes two days after the COVID-19 vaccine developed by Pfizer Inc. and partner BioNTech SE , while Moderna's vaccine is currently granted emergency use authorization, as is Johnson & Johnson's vaccine. Moderna's stock has soared 293.1% year to date, while shares of Pfizer have climbed 28.5% and J&J have gained 10.7%. The S&P 500 has advanced 19.5% this year.
3:14 a.m. Aug. 25, 2021 - By Tomi Kilgore
Coronavirus tally: Daily average of COVID-19 cases rises to 7-month high, as J&J data supports booster shotsThe global tally for the coronavirus-borne illness climbed to 213.30 million as of early Wednesday, while the death toll rose to 4,454,812, according to . The U.S. led the world with a total of 38.08 million cases and 630,838 deaths. The daily average of new cases over the past seven days rose to 151,441 as of Tuesday, up 28% from two weeks ago, and the highest count since Jan. 29, according to . The daily average for deaths increased to 1,116, up 84% in two weeks and the most since March 19. The daily average for hospitalizations of rose to 94,082, up 35% from two weeks ago and the most since Feb. 6. The number of people that have been fully vaccinated grew to 171.4 million, or 51.6% 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 202.04 million, or 60.9% of the total population. Johnson & Johnson announced Wednesday data that supported the use of a COVID-19 vaccine booster shot, eight months after people previously received J&J's single-shot vaccine.
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.
2:45 a.m. Aug. 20, 2021 - By Tomi Kilgore
Coronavirus tally: U.S. daily average of COVID-19 cases, deaths and hospitalization rise to multi-month highsThe global tally for the coronavirus-borne illness climbed above 210 million as of early Friday, while death toll rose to 4,404,511, according to . The U.S. led the world with a total of 37.29 million cases and 625,166 deaths. The daily average of new cases over the past seven days rose to 143,827 as of Thursday, up 44% from two weeks ago and the most since Feb. 1, according to . The daily average for deaths increased to 911, up 108% in two weeks, and the most since March 31, while hospitalizations of 86,877 was up 53% from two weeks ago and the most since Feb. 9. The number of people that have been fully vaccinated rose to 169.59 million, or 51.1% of the total U.S. population, according to . AstraZeneca PLC said Friday that in a late stage trial. "There were no cases of severe Covid-19 or Covid-19-related deaths in those treated with AZD7442," the company said.
2:36 a.m. Aug. 19, 2021 - By Tomi Kilgore
Coronavirus tally: Global cases of COVID-19 tops 209 million, U.S. daily average of deaths rises to 4-month highThe global tally for the coronavirus-borne illness climbed above 209.3 million as of early Thursday, while death toll rose to 4,393,138, according to . The U.S. led the world with a total of 37.16 million cases and 624,253 deaths. The daily average of new cases over the past seven days ticked back above 140,000 on Wednesday, after a brief one-day dip below it on Tuesday, according to . At 140,893, the daily average is up 47% from two weeks ago, and up from 32,305 from a month ago. The daily average for deaths rose to 809, up 97% from two weeks ago and the highest seen since early April, while the daily average of hospitalizations of 85,118 is up 56% from two weeks ago and the highest since early February. The number of people that have been fully vaccinated rose to 169.19 million, or 51.0% of the total U.S. population, according to . Federal health officials said Wednesday that those who have received the vaccines from Moderna Inc. and from Pfizer Inc. and BioNTech SE will be , starting in September.
2:55 a.m. Aug. 18, 2021 - By Tomi Kilgore
Coronavirus tally: Daily average of new cases slips, to snap a 39-day streak of increases based on NYT dataThe global tally for the coronavirus-borne illness climbed above 208.6 million as of early Wednesday, while death toll rose to 4,383,333, according to . The U.S. remained the world leader with 37.02 million cases and 623,322 deaths. On a daily basis, the seven-day average for cases slipped to 139,872 on Tuesday from 142,414 on Monday, to snap a 39-day streak of increases. The daily average was still up 52% from two weeks ago, and 4.5 times the average of 31,138 a month ago, . The daily average of deaths slipped to 696 on Tuesday from 704 on Monday, while hospitalizations increased to 83,291 from 82,519 on Monday, the most since Feb. 11. The number of people that have been fully vaccinated rose to 168.90 million, or 50.9% of the total U.S. population, according to . The U.S. is expected to announce Wednesday that most vaccinated Americans eight months after being fully vaccinated.
2:27 a.m. Aug. 17, 2021 - By Tomi Kilgore
Coronavirus tally: Global cases of COVID-19 nears 208 million, as U.S. reportedly set to recommend boostersThe global tally for the coronavirus-borne illness climbed above 207.9 million as of early Tuesday, while death toll rose to 4,372,554, according to . In the U.S., cases reached 36.89 million while deaths increased to 622,322, with both leading the world. On a daily basis, the seven-day average for cases grew to 141,365 on Monday, more than four times the daily average of 30,901 a month ago, and the most since Feb. 2, according to . The seven-day average for deaths rose to 704, up from 273 a month ago and the most since May 4, while hospitalizations rose to 81,556, up from 23,432 a month ago and the most since Feb. 12. The number of people that have been fully vaccinated rose to 168.69 million, or 50.8% of the total U.S. population, according to . The U.S. is set to announce that most vaccinated Americans shot eight months after being fully vaccinated, according to late Monday.
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%.
7:15 a.m. Aug. 16, 2021 - By Tomi Kilgore
CureVac stock gains after upbeat preclinical data on COVID-19 vaccine candidate on primatesShares of CureVac N.V. gained 0.4% in morning trading Monday, but bucked the selloff in the biotechnology sector and the broader stock market, after the Germany-based company revealed upbeat preclinical data regarding its vaccine candidates against the coronavirus that causes COVID-19, in non-human primates. The stock's gain comes as the iShares Biotechnology ETF dropped 2.4% and the S&P 500 slid 0.7%. The first-generation vaccine candidate, CVnCoV, and second-generation vaccine candidate, CV2CoV, were developed in collaboration with U.K.-based drug maker GlaxoSmithKline PLC and is based on mRNA technology, the same in the COVID-19 vaccines developed by Moderna Inc. and Pfizer Inc. and BioNTech SE . GlaxoSmithKline's stock eased 0.1% in morning trading. The company said CV2CoV achieved better activation of immune responses, with higher antibody neutralizing capacity across all variants, including the delta variant. "The current study shows that the immune responses and resulting protection produced by our second-generation candidate, based on our mRNA technology featuring targeted optimizations, are substantially improved in non-human primates against both the original SARS-CoV-2 virus as well as the Beta and Delta Variants of Concern and the Lambda Variant of Interest," said CureVac Chief Scientific Officer Dr. Igor Splawski.
4:31 a.m. Aug. 16, 2021 - By Tomi Kilgore
Enlivex stock soars to lead premarket gainers after getting OK to start Phase 2b trial of COVID-19 treatmentShares of Enlivex Therapeutics Ltd. soared 21.4% toward a five-month high, enough to pace all premarket gainers early Monday, after the Israel-based immunotherapy company said it received the OK to start a Phase 2b clinical trial for its treatment of severe and critical COVID-19 patients with acute respiratory distressed syndrome (ARDS). The Israel Ministry of Health authorized the trial after reviewing Phase 2 trial data. The Phase 2b trial is expected to recruit up to 152 patients in Israel and certain European countries, and is designed to evaluate the safety and efficacy of Allocetra when administered in addition to standard care treatment. The stock has rallied 20.6% year to date through Friday, while the S&P 500 has gained 19.0%.
3:36 a.m. Aug. 16, 2021 - By Tomi Kilgore
Coronavirus tally: Global cases of COVID-19 top 207 million, as U.S.'s daily average rises to 6-month highThe global tally for the coronavirus-borne illness climbed above 207.2 million on Monday, while death toll rose to 4,364,409, according to . The U.S. continued to lead the world in cases with 36.68 million and in deaths with 621,635. On a daily basis, the seven-day average for new COVID-19 cases rose to 130,808 as of Sunday, , up 64% from two weeks ago, to mark the 11-straight day above 100,000 and the highest rate since Feb. 3. The 7-day average of deaths was 662 on Sunday, up 113% from two weeks ago and the highest since early May, while the number hospitalized has increased 65% to 76,088. The number of people fully vaccinated in the U.S. was 168.36 million, or 50.7% of the total population as of Sunday, according to , including 61.7% of the adult population. The number of adults receiving at least one dose grew to 185.88 million, or 72%. "We've got to get people vaccinated," said Dr. Anthony Fauci, chief medical adviser to President Biden, on CBS's "Face the Nation" on Sunday. "We have about 90 million people who are eligible to be vaccinated, who are not vaccinated. And that's very highly concentrated in the southern states, including Mississippi and other states in which you have, compared to the general average of vaccinations in the country, an under vaccinated group."
11:33 a.m. Aug. 13, 2021 - By Tomi Kilgore
Sesen Bio's stock rocked on heavy volume after shock FDA decision on BLA for cancer treatmentShares of Sesen Bio Inc. was rocked for a more than 75.4% loss on massive volume in afternoon trading Friday, after the company focused on cancer treatments shocked investors by saying it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration. Trading volume spiked to 54.5 million shares, compared with the full-day average of about 6.5 millions shares. The CRL was regarding its Biologics License Application (BLA) for Vicineum for the treatment of unresponsive non-muscle invasive bladder cancer (NMIBC). The FDA determined that it can't approve the BLA for Vicineum in its present form. "We are deeply disappointed by this unexpected result, and it is an unfortunate day for patients suffering from BCG-unresponsive NMIBC," said Sesen Chief Executive Dr. Thomas Cannell. The company said it plans to request a meeting with the FDA "as soon as possible" to discuss the next steps needed for the BLA to be approved. The stock was trading around $5.92 just prior to a trading halt for news, to mark a 20.6% intraday gain, and a 51.0% rally since the Aug. 9 close. In its second-quarter earnings report before the Aug. 9 open, the company said in a July meeting with the FDA regarding the BLA for Vicineum, there was no Advisory Committee meeting planned at that time, and that no post-marketing requirements had been identified, and said an FDA decision on the BLA was expected by Aug. 18. The stock has now lost 10.4% year to date, while the iShares Biotechnology ETF has gained 11.8% and the S&P 500 has advanced 18.8%.
3:50 a.m. Aug. 12, 2021 - By Jaimy Lee
WHO to study whether three drugs, including J&J's Remicade, can help hospitalized COVID-19 patientsThe World Health Organization plans to test three new drugs as possible treatments for people who have been hospitalized for COVID-19. This includes Ipca Laboratories Ltd.'s malaria drug artesunate; Novartis AG's cancer medication Gleevec; and Johnson & Johnson's rheumatoid arthritis drug Remicade. All of the drugs are already in use for other reasons. There are still few therapies that effectively treat COVID-19 patients, especially those who have severe enough disease that they end up hospitalized. "Finding more effective and accessible therapeutics for COVID-19 patients remains a critical need," WHO director-general Tedros Adhanom Ghebreyesus said in a news release.
3:27 a.m. Aug. 5, 2021 - By Jaimy Lee
Moderna says its COVID-19 shot provides 93% immunity after six months Moderna Inc.'s said Thursday that its COVID-19 vaccine is 93% efficacious six months after the second dose as part of its . This is different than what Pfizer Inc. said last week about its COVID-19 shot, which is that % four to six months after getting the second shot. Both vaccines are two-dose mRNA shots that had an efficacy rate of about 95% in clinical trials. "We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months," Moderna CEO Stéphane Bancel said in a statement. The figure came from a new analysis of the Phase 3 clinical trial it conducted in the U.S. At that time, Moderna said the vaccine had an efficacy rate of 94.1%. Moderna's stock is up 301.1% so far this year, while the broader S&P 500 has gained 17.2%.
4:15 a.m. Aug. 3, 2021 - By Jaimy Lee
Sanofi to buy mRNA developer for $3.2 billionShares of Translate Bio Inc. soared 29.8% in premarket trading on Tuesday after Sanofi said it will spend $3.2 billion to buy the developer of messenger RNA (mRNA) technologies. The U.S.-listed shares of Sanofi were down 0.1% in premarket trade. "A fully owned platform allows us to develop additional opportunities in the fast-evolving mRNA space," Sanofi CEO Paul Hudsons said in a statement. Investors are paying much closer attention to mRNA developments since the mRNA COVID-19 vaccines developed by Moderna Inc. and BioNTech SE /Pfizer Inc. have been authorized. Sanofi and Translate are also developing a mRNA COVID-19 vaccine; the experimental shot is currently in a Phase 1/2 clinical study. "Given the early stage of TBIO's platform, and the company's recent pivot into vaccines, the deal terms strike us as favorable for SNY and fair for TBIO," SVB Leerink's Geoffrey Porges told investors on Tuesday. So far this year, Translate's stock has gained 58.1% and Sanofi is up 5.5%. The S&P 500 has gained 17.0%.
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%.
4:01 a.m. July 28, 2021 - By Jaimy Lee
Pfizer shares limited data about its COVID-19 booster candidate, says it ups protection against the delta variantPfizer Inc. said Wednesday that a third dose of its COVID-19 vaccine likely provides further protection against the delta variant, which is more infectious and thought to be driving the recent surge in cases, hospitalizations, and deaths in the U.S. The drug maker announced the news as part of its , saying that an additional dose of its two-dose COVID-19 vaccine series produced neutralizing antibody titers against delta that are 5 times higher than getting two doses in younger people and 11 times higher than getting two doses in older people. Pfizer did not provide any additional information at this time. Pfizer's stock is up 14.3% so far this year, while the broader S&P 500 has gained 17.2%.
3:53 a.m. July 27, 2021 - By Jaimy Lee
Regeneron, AstraZeneca to develop obesity treatmentShares of Regeneron Pharmaceuticals Inc. were down 0.1% in premarket trading on Tuesday after the company announced a deal with AstraZeneca to develop and commercialize obesity treatments that target a specific gene, GPR75. The companies will split development costs and profits if the drug is successful. Regeneron's stock is up 19.6% so far this year, while the S&P 500 has gained 17.7%.
4:06 a.m. July 22, 2021 - By Jaimy Lee
Pfizer to pay at least $1 billion to develop, commercialize Arvinas' investigational breast-cancer therapyShares of Arvinas Inc. were up 6.0% in premarket trading on Thursday after the company announced a billion-dollar deal with Pfizer Inc. to develop and commercialize its experimental breast-cancer treatment. Pfizer will make a $650 million upfront payment to Arvinas, in addition to a $350 million equity investment. Separately, there are up to $1.4 billion in potential milestone payments. The therapy, ARV-471, is expected to move into Phase 3 clinical trials sometime next year. Arvinas' stock is down 8.7% for the year, while the S&P 500 is up 15.1%.
10:54 a.m. July 20, 2021 - By Tomi Kilgore
NeuroMetrix stock more than triples on massive volume after fibromyalgia treatment gets FDA boostShares of NeuroMetrix Inc. rocketed 241% toward a two-year high on record volume, after the Massachusetts-based medical device company said its Quell transcutaneous electric nerve stimulator received "Breakthrough Designation" from the Food and Drug Administration to treat fibromyalgia symptoms in adults. Trading volume ballooned to 228.3 million shares, compared with the full-day average over the past 30 days of about 125,600 shares, to make the stock the biggest gainer and most actively traded on major U.S. exchanges. Fibromyalgia is a form of chronic pain that affects 5 million to 15 million people, or 2% to 6% of the U.S. population, and is most often diagnosed in people between the ages of 30 and 50. Quell is a non-invasive wearable neurostimulator that provides flexible and precise nerve stimulation. Under the Breakthrough Designation program, the FDA will provide the company with priority review and interactive communication on device development through commercialization. In addition, there are government programs which may facilitate Medicare reimbursement. The stock has now rallied 251.9% year to date, while the SPDR Health Care Select Sector ETF has gained 13.5% and the S&P 500 has advanced 15.3%.
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%.
4:50 a.m. July 19, 2021 - By Jaimy Lee
BioNTech to buy T-cell receptor facility and platform from Gilead Sciences Shares of BioNTech SE were down 2.4% in premarket trading on Monday after the company said it plans to buy one of Gilead Sciences Inc.'s clinical manufacturing facilities and its platform for T-cell receptor therapies. The companies did not disclose financial terms of the deal, saying only that BioNTech will make a one-time payment for the platform and the facility in Gaithersburg, MD. The site will be used to support clinical trials in the U.S.; all employees at the facility will be offered jobs at BioNTech, which is a German biotechnology company. The new site is expected to be part of BioNTech's work developing new cancer therapies. BioNTech has become a well-known name outside of biotech circles since developing a COVID-19 vaccine with Pfizer Inc. . Shares of BioNTech have gained 183.9% so far this year, while the S&P 500 is up 15.2%.
8:45 a.m. July 12, 2021 - By Jaimy Lee
Prothena sells ATTR amyloidosis portfolio to Novo Nordisk for up to $1.2 billionShares of Prothena Corp. Plc were up 1.3% in premarket trading on Monday after the company announced a deal to sell its ATTR amyloidosis portfolio to Novo Nordisk in a $100 million deal that is worth up to $1.2 billion, based on milestones. ATTR amyloidosis is a rare disease that can cause a buildup of amyloid deposits in the body. One of the therapies in the portfolio is an experimental monoclonal antibody drug that has completed a Phase 1, open-label clinical trial. Prothena's stock has soared 393.2% so far this year, while the S&P 500 is up 16.3%.
3:44 a.m. July 12, 2021 - By Jaimy Lee
Celldex's stock jumps on positive data from early-stage, open-label clinical trial for hives treatmentsShares of Celldex Therapeutics Inc. soared 43.1% in premarket trading on Monday after the company shared positive data from an ongoing, open-label Phase 1b clinical trial for an experimental treatment for hives. Celldex said that 95% of participants diagnosed with two forms of chronic inducible urticaria reported a complete response to treatment and 5% had a partial response. The data was presented Friday during the European Academy of Allergy and Clinical Immunology Annual Congress. The study has 20 participants. The therapy is currently being tested intravenously but Celldex said it plans to begin testing a subcutaneous version of the drug in the third quarter. Celldex's stock has soared 84.9% this year, while the broader S&P 500 is up 16.3%.
3:48 a.m. July 7, 2021 - By Jaimy Lee
WHO recommends Roche, Sanofi/Regeneron drugs as COVID-19 treatments, calls for lower pricesThe World Health Organization began recommending the use of medicines called interleukin-6 receptor blockers as COVID-19 treatments for the severely ill, based on the findings of a large published Tuesday in JAMA. Roche Holding AG's Actemra and Sanofi and Regeneron Pharmaceuticals Inc.'s Kevzara are both approved in the U.S. as treatments for rheumatoid arthritis. The WHO said in a statement that "these are the first drugs found to be effective against COVID-19 since corticosteroids." Actemra received last month. Research indicates the drugs can reduce the risk of death by 13% and reduce the risk of needing ventilation by 28%. However, even after recommending the drugs, the health organization called on the manufacturers to reduce prices and provide the medicines to people in low- and middle-income countries.
5:20 a.m. July 6, 2021 - By Jaimy Lee
Agenus says its Bristol Myers Squibb licensing deal has up to $1.3 billion in milestone paymentsShares of Agenus Inc. were up 2.0% in premarket trading on Tuesday after the company said a licensing deal with Bristol Myers Squibb Co. had closed. As part of the agreement, Bristol plans to study an experimental Agenus immuno-oncology drug as a treatment for non-small cell lung cancer. Bristol will pay Agenus $200 million upfront, with up to $1.3 billion in possible milestones payments. Agenus' stock has gained 73.6% so far this year, while the broader S&P 500 is up 15.8.%
4:55 a.m. July 6, 2021 - By Jaimy Lee
Israel says Pfizer's COVID-19 shot is 64% effective against the infections from the delta variantIsrael's health ministry said Monday the effectiveness of the COVID-19 shot developed by BioNTech SE and Pfizer Inc. is now thought to be 64% at preventing symptomatic infections in that country. The vaccine had an efficacy rate of about 95% in clinical trials back in 2020; however, the emergence of the more transmissible delta variant in Israel has weakened the overall effectiveness of the shot, according to a statement posted on Twitter. The ministry said the vaccine remains much more effective at preventing hospitalizations and death, with an estimated effectiveness rate of 93%. Health researchers are paying close attention to vaccine performance in Israel. The country has vaccinated 57% of its residents, , and it has primarily used the BioNTech/Pfizer vaccine.
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%.
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