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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
9:31 a.m. Today - By Jaimy Lee
FDA committee to hold meeting about COVID-19 vaccines for children in JuneThe Food and Drug Administration advisory committee plans to hold a on June 10 to discuss authorizing COVID-19 vaccines for use in pediatric populations. Pfizer Inc.'s is the only authorized vaccine that is available to 16 and 17-year-olds at this time. The company is currently about whether it will authorize the same vaccine for 12 to 15-year-olds, which would make it the first vaccine authorized for use in this group of teens. During the meeting, FDA officials are also expected to share details about what they expect to see in applications to authorize and approve these vaccines for use in children. The advisory committee will not discuss specific vaccines, the regulator said.
4:28 a.m. Today - By Jaimy Lee
Inovio's stock is up after it shares new data from Phase 2 clinical trial for its COVID-19 vaccine candidateShares of Inovio Pharmaceuticals Inc. gained 8.0% in premarket trading on Monday after the company said its experimental COVID-19 vaccine was safe and also triggered antibody titers in 400 or so adult participants in a Phase 2 clinical trial. The were published Friday as a preprint. Inovio has largely struggled to move its two-dose, DNA-based COVID-19 vaccine candidate forward. A Phase 3 clinical study is still on hold, due to "remaining questions" from the Food and Drug Administration about a device used for administering the shots. Inovio said in April that the Department of Defense stopped funding development of its COVID-19 vaccine, and the Phase 3 clinical trial for the still-investigational shots will largely be conducted outside of the U.S. Inovio's stock is down 22.6% for the year, while the S&P 500 is up 12.7%.
2:56 a.m. May 7, 2021 - By Ciara Linnane
Pfizer and BioNTech start process of seeking full FDA approval of their COVID-19 vaccinePfizer Inc. and German partner BioNTech SE said Friday they have initiated rolling submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration for full approval of their COVID-19 vaccine in individuals 16 years of age and older. The vaccine was already granted emergency use authorization last December, a measure used by the FDA in emergency situations. "Data to support the BLA will be submitted by the Companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review," the companies said in a joint statement. Since the vaccine was granted an EUA on Dec. 11, the companies have delivered more than 170 million doses across the U.S. Pfizer and BioNTech has also submitted an application to expand the EUA to include individuals aged 12-to-15 years-old, and plan to submit a supplemental BLA to support licensure of the vaccine in that age group once the required 6 months of data after a second dose are available. Pfizer shares rose 0.6% premarket, while BioNTech shares rose 4.3%. Those shares have climbed 106% in the year to date, while the SPDR S&P Biotech ETF has fallen 11% and the S&P 500 has gained 11.9%.
3:42 a.m. May 4, 2021 - By Ciara Linnane
UPDATE: Precipio shares soar 32% premarket after rapid COVID test becomes available on AmazonShares of microcap Precipio Inc. , a specialty diagnostics company, soared 32% in premarket trade Tuesday, adding to gains of more than 170% on Monday, after the company said its COVID-19 rapid antibody test is now available on Amazon.com's business platform. The 20-minute test, which was awarded emergency use authorization from the U.S. Food and Drug Administration in December, can only be purchased by qualified medical point-of-care providers. "Physicians and other medical facilities may now purchase these items directly from Amazon, and receive them within 2 business days," the company said in a statement on Monday. The test can identify the presence of antibodies that have been developed from exposure to the coronavirus-borne illness, or from vaccination and show an immune response. "Antibodies are the body's natural biological response to an infection or vaccination, and their development begins the body's process of building immunity to protect against future infections," Precipio said in the statement. The stock has gained 139% in the year to date, while the S&P 500 has gained 11.6%.
2:22 a.m. May 4, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 153.5 million and India's death toll above 200,000The global tally for the coronavirus-borne illness rose above 153.5 million on Tuesday, according to , while the death toll rose to 3.2 million. The U.S. continues to lead the world in cases and deaths by wide margins, with 32.5 million cases and 577,523 deaths, or about a fifth of the worldwide tallies. There was positive vaccine news which said the U.S. Food and Drug Administration is expected to authorize Pfizer's COVID-19 vaccine for youngsters ages 12 to 15 by next week, citing a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year. The U.S. vaccine program has slowed as more older people have been fully vaccinated and experts say inoculating young people will go a long way toward expanding it. India is second to the U.S. by cases at 20.3 million and third by fatalities at 222,408. Indian hospitals are still overwhelmed by cases and lacking in supplies including oxygen. Brazil is third with 14.8 million cases and second by fatalities at 408,622. Mexico has the fourth-highest death toll at 217,345 and 2.3 million cases, or 15th highest tally. The U.K. has 4.4 million cases and 127,799 deaths, the fifth-highest in the world and highest in Europe.
4:13 a.m. April 26, 2021 - By Jaimy Lee
FDA to discuss whether immuno-oncology drugs with 'accelerated' approval should remain on the marketThe Food and Drug Administration advisory committee plans to hold a three-day this week to evaluate a type of quicker approval used primarily for immuno-oncology drugs that are thought to help address unmet treatment needs among people with cancer. The FDA's "accelerated approval" process requires drug makers to conduct what are called confirmatory trials to back up the limited data used to inform the initial regulatory ok. The meeting will focus on Roche Holding AG's Tecentriq; Merck & Co Inc.'s top-selling drug Keytruda, which brought in $14.3 billion in 2020; and Bristol Myers Squibb Co.'s Opdivo, which generated $6.9 billion last year. The FDA said in documents that these drugs received additional accelerated approvals to treat different types of cancers "but subsequent confirmatory trial(s) have not verified clinical benefit ... The FDA is seeking the committee's advice on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted." The meeting is scheduled for April 27 to 29.
11:36 a.m. April 22, 2021 - By Jaimy Lee
FDA approves GSK's endometrial cancer therapyU.S.-listed shares of GlaxoSmithKline were down 1.4% in trading on Thursday after the Food and Drug Administration said it had granted accelerated approval to the company's endometrial cancer treatment. The immunotherapy, which was called dostarlimab and is now named Jemperli, is approved to treat patients with severe forms of this kind of cancer who have a genetic feature known as dMMR. About one-quarter of patients with this kind of cancer have dMMR tumors, the FDA said in a statement. A clinical trial with 71 participants found that Jemperli got rid of or reduced dMMR tumors in 42% of the patients. The regulator also said that additional trials are needed to back up the clinical data -- the approval is an "accelerated" decision based on unmet need -- and those studies are already underway. A GSK spokesperson did not immediately respond to a request for Jemperli's price. GSK's stock has gained 2.4% so far this year, while the S&P 500 is up 10.2%.
6:23 a.m. April 21, 2021 - By Jaimy Lee
FDA inspection of Emergent's COVID-19 vaccine plant identifies 'potential quality issues' Shares of Emergent BioSolutions Inc. were up 1.3% in trading on Wednesday after the Food and Drug Administration said it inspected a plant in Baltimore that had been scheduled to begin producing Johnson & Johnson's COVID-19 vaccine after reports emerged of cross-contamination in vaccine production there. J&J confirmed several weeks ago that quality standards had not been met at the Emergent facility. The FDA said that none of the vaccines produced at the facility in question have been distributed, and Emergent is working to address the regulator's concerns. "At the agency's request, Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues," the FDA said in a statement. The agency's so-called identified a number of problems at the plant, including a lack of "thorough review" of how workers move throughout the facility and poor decontamination practices. Emergent is the U.S. manufacturing partner for the J&J shot in the U.S. Emergent's stock is down 25.8% for the year, while the broader S&P 500 has gained 10.1%.
2:42 a.m. April 19, 2021 - By Ciara Linnane
Emergent BioSolutions says it has agreed with FDA not to manufacture new material at Baltimore facility Drug contract company Emergent BioSolutions Inc. said Monday it has made an agreement with the U.S. Food and Drug Administration not to manufacture any new material at its Bayview facility in Baltimore. The FDA started an inspection of the plant last week, after Johnson & Johnson found Emergent workers had confused ingredients for its COVID-19 vaccine with ones used in making the vaccine developed by AstraZeneca PLC and Oxford University. J&J made the discovery in a batch that had not been distributed and immediately took over the making of its vaccine and imposed its own experts and technicians to oversee it. Emergent agreed it would shift manufacturing of the AstraZeneca vaccine elsewhere. Emergent has also agreed to quarantine existing material at the plant pending completion of the FDA inspection. Emergent shares were down 0.9% premarket, and have fallen 13% in the year to date, while the S&P 500 has gained 11.4%.
9:33 p.m. April 18, 2021 - By Quentin Fottrell
What determines when Americans reclaim their ‘liberty’? Here is Dr. Fauci’s answer Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, appeared Thursday before a House subcommittee on the coronavirus pandemicAnthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, was appearing before a House Select Subcommittee on the Coronavirus Crisis.
9:28 p.m. April 18, 2021 - By Quentin Fottrell
The public’s expectation of perfection: Risk of blood clot from Johnson & Johnson COVID-19 vaccine is 0.00009% ‘It’s the same perceptual problem when we blindly drive to the airport texting, yet worry about the airplane’‘It’s the same perceptual problem when we blindly drive to the airport texting, yet worry about the airplane.’
11:48 a.m. April 15, 2021 - By Jaimy Lee
Merck scraps two treatments for hospitalized COVID-19 patients, will focus on antiviral for non-hospitalized patientsShares of Merck & Co. were up 0.1% in premarket trading on Thursday after the drug company said the oral antiviral COVID-19 treatment it is developing with Ridgeback Biotherapeutics did not help hospitalized patients in a mid-stage clinical trial. The companies now plan to test molnupiravir in non-hospitalized COVID-19 patients in a Phase 3 trial, with plans to file for emergency authorization in the second half of the year. They are also planning to see if the experimental therapy works for post-exposure prophylaxis. In a separate news release, Merck said it is discontinuing MK-7110 as a treatment for patients hospitalized with COVID-19, saying that the Food and Drug Administration's request for additional clinical information would push the launch into 2022. "Merck is now focusing its efforts on advancing molnupiravir, which, as an oral medicine for outpatient use, represents a promising potential new approach, and on accelerating production of Johnson & Johnson's COVID-19 vaccine," Dr. Roy Baynes, chief medical officer for Merck Research Laboratories, said in the release. Merck's stock has gained 6.6% since the start of the year, while the broader S&P 500 is up 9.8%.
10:10 a.m. April 13, 2021 - By Jaimy Lee
CDC committee to hold emergency meeting for J&J's COVID-19 shot on Wednesday afternoonThe Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to hold an on Wednesday, starting at 1:30 p.m. Eastern Time, in response to a federal recommendation made Tuesday to temporarily halt immunizations using Johnson & Johnson's COVID-19 vaccine. The recommendation was made after six people who received the J&J shot were diagnosed with severe blood clots in combination with low levels of blood platelets. About 6.8 million people in the U.S. in total have been administered the J&J vaccine. The meeting, which will be publicly webcast, is expected to conclude with a vote about whether the vaccine should continue to be used, how it should be used going forward, or how people who develop blood clots as a result of the vaccine should be treated. The ACIP after the Food and Drug Administration granted the emergency authorization.
10:10 a.m. April 13, 2021 - By Jaimy Lee
CDC committee to hold emergency meeting for J&J's COVID-19 shot on Wednesday afternoonThe Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to hold an on Wednesday, starting at 1:30 p.m. Eastern Time, in response to a federal recommendation made Tuesday to temporarily halt immunizations using Johnson & Johnson's COVID-19 vaccine. The recommendation was made after six people who received the J&J shot were diagnosed with severe blood clots in combination with low levels of blood platelets. About 6.8 million people in the U.S. in total have been administered the J&J vaccine. The meeting, which will be publicly webcast, is expected to conclude with a vote about whether the vaccine should continue to be used, how it should be used going forward, or how people who develop blood clots as a result of the vaccine should be treated. The ACIP after the Food and Drug Administration granted the emergency authorization.
6:06 a.m. April 13, 2021 - By Tomi Kilgore
Moderna, BioNTech stocks surge after regulators halt use of J&J vaccine Shares of Moderna Inc. shot up 8.6% in morning trading, BioNTech SE ran up 5.7% toward a 4-month high and Pfizer Inc. climbed 1.1% toward a 3-month high, after U.S. health regulators paused the use of Johnson & Johnson's COVID-19 vaccine . Meanwhile, J&J shares shed $2.98, or 1.8%, to shave about 20 points of the Dow Jones Industrial Average's price, as the Dow dropped 132 points, or 0.4%. Moderna's two-dose COVID-19 vaccine, and the two-dose vaccine from Pfizer and partner BioNTech are mRNA vaccines while J&J's one-dose vaccine is an adenovirus vaccine. The Centers for Disease Control and Prevention and the Food and Drug Administration said there have been six cases of blood clotting out of the roughly six million people who have received the J&J vaccine, all of who were women between the ages of 18 and 48.
4:34 a.m. April 13, 2021 - By Tomi Kilgore
Novocure's stock rockets into record territory after upbeat DMC review of lung cancer treatment trialShares of Novocure Ltd. skyrocketed 80.7% toward a record high in premarket trading Tuesday, after the tumor treatment company said an independent data monitoring committee (DMC) said the interim analysis of a Phase 3 trial would be accelerated. The trial is of Novocure's Tumor Treating Fields, which are electric fields that disrupt cancer cell division, in stage 4 non-small cell lung cancer. The DMC concluded that the trail should continue with no evidence of increased systemic toxicity. Novocure plans to submit an Investigational Device Exemption (IDE) to the Food and Drug Administration. "The accelerated interim analysis with an encouraging outcome adds to the accumulating evidence of Tumor Treating Fields' broad potential across a range of hard-to-treat cancers," said Novocure Executive Chairman William Doyle. Novocure's stock, which is on track to open well above its Feb. 19 record close of $190.17, has dropped 25.5% over the past three months through Monday while the S&P 500 has gained 8.4%.
3:24 a.m. April 13, 2021 - By Ciara Linnane
UPDATE: FDA and CDC call for pause in use of J&J vaccine over blood clotting disorderThe two leading federal public health agencies called for an immediate pause in the use of the Johnson & Johnson COVID-19 vaccine on Tuesday, after six recipients in the U.S. developed a rare disorder involving blood clots within six to 13 days after being vaccinated. The news was first reported by the New York Times, citing officials briefed on the decision. The U.S. Food and Drug Administration and Centers for Disease Control and Prevention said all six were women aged between 18 and 48 and emphasized that the adverse events appear to be "extremely rare." "In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia)," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC said in a statement. So far, nearly 7 million Americans have received J&J shots, and about 9 million more have been delivered to states, CDC data shows. Scientists from the FDA and CDC will jointly investigate possible links between the vaccine and the clotting disorder and determine whether it should continue to be used or be limited. An emergency meeting of the CDC's outside advisory committee has been scheduled for Wednesday. "Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution," said the statement. Regulators in Europe are concerned about a similar issue with another coronavirus vaccine, developed by AstraZeneca PLC and Oxford University researchers. J&J shares slid 3.3% premarket, but are up 2.7% in the year to date through Monday, while the Dow Jones Industrial Average has gained 10.3%.
3:01 a.m. April 8, 2021 - By Ciara Linnane
Eli Lilly and Incyte say Phase 3 study of baricitinib in hospitalized COVID-19 patients failed to meet main goalEli Lilly & Co. and Incyte Corp. said Thursday a Phase 3 trial of rheumatoid arthritis treatment baricitinib plus standard of care (SoC) versus placebo plus SoC failed to meet its main goal. The trial's primary endpoint was defined as a difference in the number of patients needing non-invasive ventilation including high flow oxygen, or invasive mechanical ventilation or death by Day 28. Patients treated with baricitinib were 2.7% less likely than those receiving standard of care to progress to ventilation or death, a difference that was not statistically significant. The trial, involving 1,525 patients, showed 38% reduction in mortality by Day 28 in patients that were treated with baricitinib plus standard of care, including corticosteroids and remdesivir. Lilly said it will publish detailed data from the study in a peer-reviewed journal in the coming months. "Even though the study did not show a statistically-significant benefit on the primary endpoint, this trial showed the largest effect reported to date for reduction in mortality observed for this patient population with COVID-19," said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. The U.S. Food and Drug Administration has granted emergency use authorization to baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation. Baricitinib, an oral JAK inhibitor, was discovered by Incyte. It is approved as Olumiant in the U.S. as a treatment for adults with moderate to severe rheumatoid arthritis and in the EU and Japan as a treatment for atopic dermatitis. Lilly shares were up 0.4% premarket, while Incyte was up 2%.
9:35 a.m. April 5, 2021 - By Tomi Kilgore
Chembio Diagnostics stock rockets on record volume after commercial launch of rapid COVID-19 testShares of Chembio Diagnostics Inc. skyrocketed 63.8% on record volume in afternoon trading Monday, to pace all gainers listed on major U.S. exchanges, in the wake of the point-of-care diagnostics company's announcement of the commercial launch of its rapid COVID-19/flu test. The stock was on track for the biggest one-day percentage gain since it doubled, on March 12, 2004. Trading volume ballooned to 206.6 million shares, compared with the full-day average of less than 1 million shares. The company said its test has been granted emergency use authorization by the Food and Drug Administration. Chembio said after Thursday's closing bell that the product, which produces results in 15 minutes, requires no instrumentation and simultaneously differentiates SARS-CoV-2 antigens and influenza Type A and Type B infections, is immediately available for shipment. "As COVID-19 converges with the flu, it is critical for physicians to be able to quickly differentiate between these viruses at the point-of-care, which present with nearly identical symptoms, in order to take appropriate clinical actions and maximize efficient use of healthcare resources," said Charles Caso, vice president of sales and marketing at Chembio. The stock has run up 21.4% year to date, while the S&P 500 has gained 8.6%.
2:31 a.m. April 5, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 131.3 million and U.S. death toll above 555,000The global tally for the coronavirus-borne illness rose above 131.3 million on Monday, according to , while the death toll rose above 2.85 million. The U.S. continues to lead the world by cases, at 30.7 million, or about a quarter of the global tally, and fatalities, at 555,001. The U.S. added at least 36,670 new cases on Sunday, and at least 277 people died, although those numbers are likely under-reported given reduced staffing at hospitals at weekends. The U.S. has averaged 64,019 cases a day for the last week, up 18% from the average two weeks ago, as cases continue to rise despite the vaccination program, a trend experts say is due to states reopening and dropping restrictions on movement and overall pandemic fatigue. The U.S. is unlikely to face a "true" fourth wave of COVID-19 outbreaks, but the country should wait a few weeks longer before easing mitigation efforts, former Food and Drug Administration Commissioner Dr. Scott Gottlieb said Sunday. Speaking to CBS News' "Face the Nation," Gottlieb acknowledged that young people were driving new coronavirus outbreaks in many states, but that vaccination efforts should prevent another devastating surge of the virus. Outside of the U.S., Brazil is second globally in cases at 12.9 million and also second with a death toll at 331,433. India is third worldwide in cases with 12.6 million and fourth in deaths at 165,101. Mexico is third by deaths at 204,147 and 13th highest by cases at 2.3 million. The U.K. has 4.4 million cases and 127,078 deaths, the highest in Europe and fifth highest in the world.
3:02 a.m. April 1, 2021 - By Ciara Linnane
Pfizer, BioNTech say study of COVID-19 patients six months after second vaccine dose proved it is safe and effectivePfizer Inc. and German partner BioNTech SE said Thursday a study of COVID-19 patients six months after receiving a second dose of their vaccine BNT162b2 confirmed its high efficacy and lack of serious safety concerns. The companies said an analysis of 927 confirmed symptomatic cases of COVID-19 showed the vaccine had a 91.3% efficacy against the illness, measured seven days through up to six months after the second dose. The vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration. The vaccine also proved to be 100% effective in preventing COVID-19 cases when used against the South African variant, which is more infectious than the original virus. Experts have worried that new variants might prove more resistant to the vaccines that have won emergency use authorization from regulators. Pfizer and BioNTech said they have now evaluated vaccine safety in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after a second dose. "These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA," said Pfizer Chief Executive Albert Bourla. Prizer shares were up 0.2% premarket, while BioNTech shares were up 1.2%.
3:24 a.m. March 30, 2021 - By Jaimy Lee
BD gets FDA authorization for test that can detect COVID-19 and the fluBecton, Dickinson & Co. said it received emergency authorization from the Food and Drug Administration for a rapid, antigen test that can detect SARS-CoV-2 and two types of influenza. The test, which runs on the company's BD Veritor System, takes about 15 minutes to produce results and is expected to be available this summer. BD's stock has gained 10.9% over the past 12 months, while the broader S&P 500 is up 56.2%.
4:40 a.m. March 26, 2021 - By Ciara Linnane
GlaxoSmithKline and Vir Biotech seek FDA emergency authorization for COVID antibody treatmentGlaxoSmithKline PLC and Vir Biotechnology Inc. said Friday they have submitted to the U.S. Food and Drug Administration an application for emergency use authorization for their antibody treatment for mild-to-moderate COVID-19 in adults and adolescents aged 12 and older who are at risk of hospitalization or death. The companies said early data from a Phase 3 trial found the treatment showed an 85% reduction in hospitalization or death compared to placebo. There were 583 patients enrolled in the trial. Vir shares slid 0.8% premarket, but have gained 97% in the year to date, while the S&P 500 has gained 4%.
12:12 p.m. March 25, 2021 - By Claudia Assis
Pfizer, Eli Lilly say experimental arthritis drug tanezumab hits FDA snagPfizer Inc. and Eli Lilly and Co. said Thursday that a joint advisory committee of the U.S. Food and Drug Administration has voted against their investigational tanezumab drug for the treatment of certain types of arthritis in adults when use of other drugs aren't possible. "While we are disappointed with today's outcome, we continue to believe that tanezumab has a positive benefit-risk profile for patients with moderate-to-severe osteoarthritis pain for whom current treatments are ineffective or not appropriate," Ken Verburg, tanezumab development team leader at Pfizer, said in a statement. There was one voting question focused on whether the drug's benefits outweigh its risks, and the committee voted 19-1 against it, the companies said.
4:35 a.m. March 24, 2021 - By Tomi Kilgore
Second Sight Medical stock tumbles after private placement of stock at 46% discountShares of Second Sight Medical Products Inc. tumbled 25% to pace all premarket decliners on Wednesday, after the implantable visual prosthetics company announced a large private placement of common stock. The share sale comes after more than 6-fold month to date through Tuesday, after the company's Argus 2s Retinal Prosthesis System was . The company said earlier Wednesday that it will issue 4.65 million shares, which represents about 20% of the shares outstanding, at a price of $6.00, which is 45.5% below Tuesday's closing price of $11.01, for gross proceeds of $27.9 million. The company expects to use the proceeds for working capital. The stock has soared 488.8% year to date through Tuesday, while the S&P 500 has gained 4.1%.
9:36 a.m. March 22, 2021 - By Tomi Kilgore
Odonate Therapeutics stock plummets toward record low after plan to 'wind down' operationsShares of Odonate Therapeutics Inc. plummeted 79.0% in active afternoon trading Monday, after the pharmaceutical company said it will wind down operations following disappointing data from its cancer treatment. The company said it determined, following feedback from the Food and Drug Administration in a pre-New Drug Application (pre-NDA) meeting, that tesetaxel, an orally administered chemotherapy agent, is unlikely to receive FDA approval. "Therefore, the company is discontinuing the development of tesetaxel and will wind down the operations of the company," the company said in a statement. Since going public in December 2017 at an initial public offering price of $24, the stock has traded in a closing price range of $11.78 (Dec. 27, 2018) to $45.63 (June 16, 2020); on Friday, the stock closed at $19.03. The stock has lost 73.9% over the past three months, while the S&P 500 has gained 7.0%.
4:40 a.m. March 11, 2021 - By Tomi Kilgore
Johnson & Johnson COVID-19 vaccine recommended for use in the EUJohnson & Johnson said Thursday that its single-shot COVID-19 vaccine candidate has received a "positive opinion" from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). That means the CHMP recommends conditional marketing authorization (CMA) for the vaccine candidate developed by J&J's Janssen Pharmaceutical Companies. If CMA is granted, the vaccine will become available in the European Union. "The European Medicines Agency's recommendation is a landmark moment for Johnson & Johnson and for the world," said J&J Chief Scientific Officer Paul Stoffels. "Now, as we await a decision on the use of our single-dose COVID-19 vaccine in the European Union, we remain confident that the Johnson & Johnson vaccine will prove a critical tool for fighting this pandemic." The U.S. Food and Drug Administration had granted the J&J vaccine on Feb. 27. J&J's stock, which rose 0.6% in premarket trading, has gained 4.1% over the past three months while the Dow Jones Industrial Average has gained 7.5%.
9:04 a.m. March 10, 2021 - By Jaimy Lee
Vertex to begin Phase 1/2 trial of treatment for people with type 1 diabetesShares of Vertex Pharmaceuticals Inc. were down 0.2% in trading on Wednesday after the company said it started an early-stage clinical trial for its experimental treatment for people with type 1 diabetes. It also said the therapy received a fast-track designation from the Food and Drug Administration. The Phase 1/2, single-arm, open-label study will be conducted at multiple sites in the U.S. and aims to enroll 17 participants. Vertex gained access to the therapy through its roughly $1 billion acquisition of Semma Therapeutics Inc. in 2019. Vertex's stock is down 7.4% over the past year, while the S&P 500 has rallied 41.1%. The clinical trial is a Phase 1/2, single-arm, open-label study in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. This will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different doses of VX-880. Approximately 17 patients will be enrolled in the clinical trial. About Type 1 Diabetes T1D results from the autoimmune destruction of insulin-producing islet cells in the pancreas, leading to loss of insulin production and impairment of blood glucose control. The absence of insulin leads to abnormalities in how the body processes nutrients, leading to high blood glucose levels. High blood glucose can lead to diabetic ketoacidosis and over time, to complications such as kidney disease/failure, eye disease (including vision loss), heart disease, stroke, nerve damage and even death. Due to the limitations and complexities of insulin delivery systems, it can be difficult to achieve and maintain balance in glucose control in patients with T1D. Hypoglycemia often results because of the difficulty in balancing the different factors that impact glucose levels, including insulin, diet and exercise. Hypoglycemia remains a critical limiting factor in glycemic management, and severe hypoglycemia can cause loss of consciousness, coma, seizures, injury, and can be fatal. Over time, patients with T1D can develop impaired awareness of hypoglycemia, meaning they are no longer able to perceive the early signs of a hypoglycemic event, which can be dangerous and result in life threatening events. There are currently limited treatment options beyond insulin for the management of T1D.
3:48 a.m. March 10, 2021 - By Jaimy Lee
Lannett plans to file experimental insulin product with FDA sometime this yearShares of Lannett Co. Inc. gained 7.3% in premarket trading on Wednesday after the company said it received feedback from the Food and Drug Administration about the ongoing development of a biosimilar version of insulin glargine. This type of long-acting insulin is considered a biologic and was initially developed by Sanofi under the brand name Lantus. Lannett said it submitted the clinical-trial protocol to the FDA in November and has since updated it with the regulator's feedback. The company plans to file an investigational new drug application sometime in 2021, with a goal to eventually launch the product in the market in 2023. Lannett's stock is down 15.3% over the past 12 months, while the S&p 500 has gained 41.1%.
6:45 a.m. March 9, 2021 - By Tomi Kilgore
Second Sight Medical stock soars nearly 1,000% in 3 daysShares of Second Sight Medical Products Inc. shot up 30.7% to $15.38 on volume of 56.6 million shares in morning trading Tuesday, bringing its three-day gain to 975.5%, in the wake of the company's announcement that for the treatment of retinitis pigmentosa. The stock skyrocketed a record 304.9% on record volume of 739.7 million shares on March 5 after the announcement, then 103.3% on volume of 320.4 million shares on Monday, before Tuesday's gain. The stock had closed at a near 3-month low of $1.43 prior to the rally. On Tuesday, the stock had been up as much as 69.9% at an intraday high of $20.00, the highest price seen since February 2018, before paring gains. Separately, Paris-based Pixium Vision S.A. saying the business combination with Second Sight announced on Jan. 6 continues. At that time, an agreement with the developer of bionic vision systems in which Second sight will raise at least $25 million in working capital, Pixium will contribute to Second Sight certain assets in exchange for newly issued Second Sight common stock and Second Sight will transfer its Orion Assets to a newly formed subsidiary, which will be partially spun off to Second Sight shareholders. Second Sight's stock has advanced 339.4% over the past 12 months, while the S&P 500 has gained 41.6%.
4:37 a.m. March 9, 2021 - By Tomi Kilgore
Acadia Pharmaceuticals stock leads premarket losers after FDA finds undisclosed 'deficiencies' in NDAShares of Acadia Pharmaceuticals Inc. plunged 42.1% to pace all premarket decliners Tuesday, in the wake of the company's announcement that the Food and Drug Administration found undisclosed deficiencies in its supplemental New Drug Application (NDA) for pimavanserin, a treatment for hallucinations and delusions associated with dementia-related psychosis. The company said late Monday that the FDA's identification of deficiencies precluded discussion of labeling and post-marketing requirements. But the FDA did not specify the deficiencies it identified, Acadia said. That led Raymond James analyst Danielle Brill to downgrade Acadia to outperform from strong buy and slash the price target to $35 from $65. "We have no good guesses as to what 'deficiencies' the FDA found, but one thing is clear -- the regulatory outlook for DRP suddenly appears quite dire," Brill wrote in a note to clients. Stifel Nicolaus's Paul Matteis cut his rating to hold from buy and his price target to $27 from $68. "Not defending the stock on weakness; DRP prospects seem bleak, tough for us to be confident," Matteis wrote. The stock, which is on track to open at the lowest price seen during regular-session hours since September 2019, has lost 12.5% over the past three months through Monday, while the S&P 500 has gained 4.0%.
8:16 a.m. March 8, 2021 - By Tomi Kilgore
Second Sight Medical stock skyrockets 8-fold in 2 days after FDA approves retinal prosthesis systemShares of Second Sight Medical Products Inc. soared 104.2% on heavy volume in midday trading Monday, bringing its two-day gain to 728.7%, after the Food and Drug Administration approved the company's Argus 2s Retinal Prosthesis System for the treatment of retinitis pigmentosa (RP). The stock paced all gainers on major U.S. exchanges, and was the most actively traded, as trading volume swelled to 222.6 million shares, compared with the full-day average of 26.5 million shares. The stock had soared a record 304.9% on record volume of 739.7 million shares on Friday. The company said Friday it received FDA approval of its Argus 2s system, which is a redesigned set of eternal hardware -- glasses and video processing unit -- initially for use in combination with previously implanted Argus II systems to treat RP. "We are very pleased to have received this approval, as it presents an opportunity to offer external hardware that we believe enhance comfort and aesthetics compared with the legacy Argus II system," said Chief Executive Matthew Pfeffer. The stock has soared 672.6% over the past three months, while the S&P 500 has tacked on 4.3%.
3:45 a.m. March 8, 2021 - By Jaimy Lee
FDA authorizes Adaptive's T-cell test for people who have already had COVID-19The Food and Drug Administration said Friday it authorized a test developed by Adaptive Biotechnologies Corp. that can detect the presence of a T-cell immune response, which can tell if someone has previously been infected with SARS-CoV-2. Adaptive's stock was up 11.0% in premarket trading on Monday. This type of test is different than antibody tests, which search for antibodies produced in response to a COVID-19 infection. The test, which has a sensitivity rate of 97.1%, was developed as part of a partnership with Microsoft Corp. . "This is the first commercially available T-cell test that confirms recent or prior SARS-CoV-2 infections in people," Peter Lee, Microsoft's corporate VP of research and incubations, said in a news release. The test can be administered 15 days after someone experiences symptoms associated with infection. Adaptive's stock has gained 56.2% over the past 12 months, while the broader S&P 500 is up 27.0%.
5:18 a.m. March 5, 2021 - By Jaimy Lee
JAMA study: Ivermectin doesn't speed up recovery for patients with mild COVID-19New research indicates that ivermectin, a type of treatment for parasitic worms, does not help patients with mild COVID-19 recover any faster. The peer-reviewed , published Thursday in JAMA, examined the findings of a double-blind, randomized trial conducted in Cali, Colombia, in roughly 475 people with mild symptoms of COVID-19. Researchers concluded "the findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes." The drug first caught the attention of clinicians in the early days of the pandemic after an said the drug can inhibit replication of SARS-CoV-2, the virus that causes COVID-19. However, the Food and Drug Administration and others [l:cautioned back in April|https://www.fda.gov/animal-veterinary/product-safety-information/fda-letter-stakeholders-do-not-use-ivermectin-intended-animals-treatment-covid-19-humans%7CNEW] that trials needed to be conducted before the drug should be prescribed to COVID-19 patients.
11:03 a.m. March 4, 2021 - By Jaimy Lee
NIH to study three experimental COVID-19 treatmentsThe National Institutes of Health said Thursday that it is putting three more investigational COVID-19 treatments into Phase 2/3 clinical trials. The experimental therapies are: an inhalable beta interferon developed by Synairgen's ; AstraZeneca's monoclonal antibody combination, which will be tested as an infusion and also as an injection; and Sagent Pharmaceuticals Inc.'s oral serine protease inhibitor. Sagent is privately held. The NIH said it is trying to identify and study therapies aimed at treating people who develop mild or moderate forms of COVID-19. So far during the pandemic, there are few therapies available that effectively treat patients with COVID-19. Only one, Gilead Sciences Inc.'s Veklury, has received full approval from the Food and Drug Administration, though several other companies, including Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. have received emergency authorization for their antibody treatments. Over the past year, Synairgen's stock has soared 763.1%, while U.S.-listed shares of AstraZeneca are up 0.4%. The broader S&P 500 is up 27.2%.
7:33 a.m. March 4, 2021 - By Tomi Kilgore
Moderna, IBM explore blockchain tech, AI to support 'smarter' management of COVID-19 vaccinesModerna Inc. and International Business Machines Corp. announced Thursday plans to work together to find technologies to support "smarter COVID-19 vaccine management." The technologies the companies will explore include artificial intelligence, blockchain and hybrid cloud, the companies said. "Moderna is committed to working with a coalition of partners to increase education and awareness of the importance of vaccination to help defeat COVID-19," said Michael Mullette, a managing director of North America commercial operations at Moderna. "We look forward to working with IBM to apply digital innovations to build connections between organizations, governments, and individuals to instill confidence in COVID-19 vaccines." Moderna's stock rose 1.6% in midday trading and IBM shares fell 0.7%, while the Dow Jones Industrial Average gained 118 points, or 0.4%. Moderna currently has one of three COVID-19 vaccines granted emergency use authorization by the Food and Drug Administration, the others being from Pfizer Inc. and BioNTech SE and Johnson & Johnson .
4:29 a.m. March 4, 2021 - By Jaimy Lee
NIH tells Vir that experimental COVID-19 therapy may not benefit patientsShares of Vir Biotechnology Inc. tumbled 5.4% in premarket trading on Thursday, the day after the company said the experimental COVID-19 treatment that it's developing with GlaxoSmithKline may not benefit patients. U.S.-listed shares of GSK were up 0.6% in trading before the market opened on Thursday. The investigational monoclonal antibody therapy was being tested in hospitalized COVID-19 patients in a Phase 3 clinical trial conducted by the National Institutes of Health until an independent safety board recommended that the trial investigators close the study to enrollment at this time, Vir said. "While we are disappointed with the recommendation ... we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients," Vir CEO George Scangos said in a news release. (Remdesivir, which is also called Veklury, was developed by Gilead Sciences Inc. and is the only COVID-19 treatment to have a full Food and Drug Administration approval.) Vir's stock is down 6.9% over the past 12 months, while the broader S&P 500 has gained 27.2%.
5:09 a.m. March 2, 2021 - By Ciara Linnane
President Biden to announce later Tuesday that Merck will help make J&J vaccine: Washington PostPresident Joe Biden will announce later Tuesday that Merck & Co. will help make Johnson & Johnson's one-shot COVID-19 vaccine in an unusual agreement between two competitors that could lead to a significant boost in supply, citing unnamed senior administration officials. The deal was brokered by the government as it works to expand manufacturing of the vaccine, which was granted emergency use authorization by the U.S. Food and Drug Administration on Saturday. Merck is one of the world's biggest vaccine makers and its own effort to develop an effective COVID vaccine failed. Merck will dedicate two facilities in the U.S. to the effort with one providing "fill-finish" services, putting vaccine in vials for distribution, while the other will make the vaccine itself, said the paper. That could double the supply compared with what J&J can achieve on its own, it said. The U.S. vaccine program has been hampered by a shortage of supply of vaccines. J&J shares were slightly higher premarket, but have gained 14% in the last 12 months, while the S&P 500 has gained 26%. Merck shares were up 0.4%, and have fallen 11% in the last 12 months.
4:09 a.m. March 1, 2021 - By Quentin Fottrell
Dr. Fauci on J&J’s COVID-19 vaccine: ‘I would have no hesitancy whatsoever to take it’ Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said, ‘People need to get vaccinated as quickly, and as expeditiously, possible’Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said, ‘People need to get vaccinated as quickly, and as expeditiously, possible.’
2:32 a.m. March 1, 2021 - By Ciara Linnane
Coronavirus tally: Global cases of COVID-19 top 114 million and U.S. death toll above 513,000The global tally for confirmed cases of the coronavirus that causes COVID-19 climbed above 114 million on Monday, while the death toll rose above 2.53 million. The U.S. has the highest case tally in the world at 28.6 million and the highest death toll at 513,092. The U.S. added 50,925 new cases on Sunday, according to a New York Times tracker, and at least 1,129 people died. The U.S. has averaged 67,868 cases a day in the past week, down 26% from two weeks ago. The U.S. Food and Drug Administration on Saturday to the vaccine developed by Johnson & Johnson, that has the advantage of being a one-dose regimen that does not require the refrigeration required by the existing vaccines. The move has bolstered hopes that vaccination can now speed up. Brazil has the second highest death toll at 254,942 and is third by cases at 10.6 million. India is second worldwide in cases with 11.1 million, and now fourth in deaths at 157,157. Mexico has the third highest death toll at 185,715 and 13th highest case tally at 2.1 million. The U.K. has 4.2 million cases and 123,083 deaths, the highest in Europe and fifth highest in the world.
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