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Food and Drug Administration

3:50 a.m. Oct. 14, 2021 - By Jaimy Lee
Regeneron is seeking full FDA approval for its monoclonal antibody for two types of COVID-19 patientsShares of Regeneron Pharmaceuticals Inc. gained 2.7% in premarket trading on Thursday after the company said the Food and Drug Administration accepted its application for approval of its monoclonal antibody treatment for non-hospitalized COVID-19 patients and as a prophylaxis for some people who have been exposed to the virus. The FDA said it will decide whether to approve the therapy by April 13 based on the priority review designation it granted to the application. It plans to hold an advisory committee meeting in advance of the decision. Regeneron said it plans to submit its monoclonal antibody treatment for FDA approval for hospitalized COVID-19 patients later this year. The treatment, Regen-Cov, has received emergency authorization for all three of these indications in the U.S. Regeneron's stock is up 13.2% this year, while the broader S&P 500 has gained 16.2%.
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.
4:11 a.m. Oct. 11, 2021 - By Jaimy Lee
Protagonist Therapeutics shares soar after FDA lifts clinical hold on its experimental cancer drugShares of Protagonist Therapeutics Inc. soared 87.0% in premarket trading on Monday after the company said the Food and Drug Administration had lifted a clinical hold on clinical trials of rusfertide, its experimental blood cancer treatment. The hold was put into place over concerns of skin tumors from animal research and a deeper examination of four new cancer cases that emerged during a clinical trial. No safety concerns were identified during the hold. The investigational treatment is expected to move forward into a Phase 3 clinical trial for polycythemia vera in the first quarter of next year. SVB Leerink analyst Joseph Schwartz told investors that lifting the clinical hold is a "very welcomed surprise, given the hold was disclosed less than a month ago, and it was unclear how long it would last." Protagonist's stock is down 9.5% so far this year, while the broader S&P 500 is up 16.9%.
2:12 a.m. Oct. 11, 2021 - By Tomi Kilgore
Merck, Ridgeback submit EUA application for their pill to treat COVID-19 Merck & Co. Inc. and Ridgeback Biotherapeutics said Monday that Merck has submitted an application for Emergency Use Authorization (EUA) with the Food and Drug Administration for molnupiravir, their oral antiviral medicine for the treatment of mild-to-moderate COVID-19 in adults. The companies said the application followed positive results from a Phase 3 trial which showed that with adults at risk for progressing to severe COVID-19, molnupiravir reduced the risk of hospitalization or death by 50%. The companies said 7.3% (28 of 385) of those who received molnupiravir were hospitalized and there were not deaths after 29 days, while 14.1% of patients treated with a placebo (53 of 377) were hospitalized and there were eight deaths. "The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data," said Merck Chief Executive Robert Davis. Merck's stock, which fell 1.2% in premarket trading, has gained 3.4% year to date, while the Dow Jones Industrial Average has advanced 13.5%.
6:38 a.m. Oct. 8, 2021 - By Jaimy Lee
Giving Moderna's COVID-19 booster at the same time as Sanofi's flu is safe and effectiveU.S.-listed shares of Sanofi gained 0.4% in trading on Friday after it announced that co-administering a flu shot with Moderna Inc.'s experimental COVID-19 booster in seniors is safe and effective. Moderna's stock was down 2.7%. The interim findings came from a study of about 300 participants, and they showed a similar immune response and safety signal when giving the shots at the same time compared with giving the shots separately. Sanofi's flu shot, Fluzone High-Dose Quadrivalent, is approved in the U.S. for people who are 65 years old and older. Moderna's booster candidate is currently under review for emergency authorization at the Food and Drug Administration. So far this year, Sanofi's stock has gained 0.5% and Moderna shares have soared 187.8%, while the broader S&P 500 is up 16.1%.
4:24 a.m. Oct. 8, 2021 - By Jaimy Lee
ChemoCentryx's stock jumps 80% after receiving FDA approval for vasculitis drugShares of ChemoCentryx Inc. soared 80.3% in premarket trading on Friday after the company said that it had received approval from the Food and Drug Administration for its ANCA-associated vasculitis therapy. The company said this is the first new drug to treat the rare autoimmune disease in a decade. ChemoCentryx's stock slipped 68.3% this year, while the broader S&P 500 is up 16.1%.
4:08 a.m. Oct. 8, 2021 - By Jaimy Lee
AstraZeneca's experimental asthma gets an orphan drug designation for another diseaseU.S.-listed shares of AstraZeneca gained 0.3% in premarket trading on Friday after the company said an experimental asthma drug it is developing with Amgen has been given an orphan drug designation as a treatment for eosinophilic esophagitis, a rare inflammatory disease. The Food and Drug Administration is expected to decide whether to approve the investigational therapy, tezepelumab, for asthma in the first three months of 2022. AstraZeneca's stock is up 20.7% for the year, while the S&P 500 has gained 16.1%.
4:46 a.m. Oct. 7, 2021 - By Jaimy Lee
Pfizer, BioNTech file for FDA authorization for their COVID-19 vaccine in children Shares of Pfizer Inc. were up 0.1% in premarket trading on Thursday after the company and BioNTech SE announced they submitted an application for emergency use authorization for their COVID-19 vaccine in children between the ages of 5 and 11 years old. The Food and Drug Administration will review the safety and efficacy of the vaccine before deciding whether to authorize the shot for this age group. Pfizer's stock is up 14.1% so far this year, while the broader S&P 500 has gained 15.7%.
4:26 a.m. Sept. 30, 2021 - By Jaimy Lee
Mirim's treatment for a rare liver disorder gets FDA approvalShares of Mirim Pharmaceuticals Inc. gained 2.3% in premarket trading on Thursday, the day after the company announced that the Food and Drug Administration had approved Livmarli as a treatment for cholestatic pruritus in people with the genetic disorder Alagille syndrome. It's the first and only drug for the 2,000 to 2,500 children in the U.S. who have this rare liver disorder. Livmarli is priced at about $391,000 per year, according to Raymond James analyst Steven Seedhouse, who estimates a $300 million market for this therapy. "We expect this drug to be widely adopted amongst children with ALGS," he wrote in a note on Wednesday. "Thus, the market's relatively muted reaction to approval despite overly discounting for regulatory risk heading into approval in our view provides an opportunity to buy now." Mirim's stock is up 6.9% so far this year, while the broader S&P 500 has gained 15.5%.
2:55 a.m. Sept. 28, 2021 - By Ciara Linnane
Pfizer and BioNTech submit initial data to FDA from trial of COVID-19 vaccine in children aged 5 to 12 Pfizer Inc. and German partner BioNTech SE said Tuesday they have submitted initial data from the late-stage trial of their COVID-19 vaccine in children aged 5 to 12 to the U.S. Food and Drug Administration, and are seeking an emergency-use authorization to add that patient group to the program. The news comes after the companies released initial data from the trial last week, saying the vaccine had proved safe and effective. The companies used two doses of just 10 mg in a trial involving 2,268 participants. "Topline immunogenicity and safety readouts for the other two age cohorts from the trial -- children 2 to <5 years of age and children 6 months to <2 years of age -- are expected as soon as the fourth quarter of this year," the companies said in a statement. They are also planning to submit data from the full Phase 3 trial for scientific peer-reviewed publication. Pfizer shares were down 0.6% premarket, while BioNTech was down 3%.
5:19 a.m. Sept. 27, 2021 - By Jaimy Lee
Intra-Cellular says clinical study shows its schizophrenia drug helps patients with bipolar disorderShares of Intra-Cellular Therapies Inc. gained 1.5% in premarket trading on Monday after the company said clinical data showed that its experimental treatment for bipolar disorder reduced depressive symptoms. The Phase 3 study evaluated Caplyta, which is already approved as a treatment for schizophrenia, in 381 people with bipolar I or bipolar II disorder who were experiencing a depressive episode. There were no significant weight changes in the group of people who took the drug compared with those who got the placebo. The most common side effects were sleepiness and nausea. The drug is currently under review at the Food and Drug Administration as a bipolar therapy, and the regulator is expected to make a decision by Dec. 17. Intra-Cellular's stock has gained 15.5% so far this year, and the S&P 500 is up 18.6% for the year.
9:16 a.m. Sept. 24, 2021 - By Jaimy Lee
CDC: We are not changing the definition of 'fully vaccinated' now that COVID-19 boosters are available The Centers for Disease Control and Prevention does not plan to change the definition of what it means to be "fully vaccinated" right now that BioNTech SE and Pfizer Inc.'s COVID-19 booster shots are available for a large group of the U.S. population. During a White House briefing on Friday, CDC director Rochelle Walensky said "we need to have more experience with our third shot and have more people eligible or recommended to receive it, before we change that definition." The Food and Drug Administration on Wednesday authorized a third booster dose of Pfizer's two-dose vaccine, making it the first vaccine to receive regulatory authorization for a booster. Moderna Inc.'s application for a booster shot for its two-dose vaccine is currently under review at the FDA.
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.
3:15 a.m. Sept. 20, 2021 - By Ciara Linnane
Pfizer and BioNTech say COVID-19 vaccine safe and effective in children aged 5 to 11Pfizer Inc. and German partner BioNTech SE on Monday announced positive results in a Phase 2/3 trial of their COVID-19 vaccine in children aged 5 to 11, and said the vaccine was safe, well tolerated and produced "robust" neutralizing antibody response. The companies said participants in the trial were given a two-dose regimen of 10 ug administered 21 days apart, a smaller dose than the 30 ug given to people aged 12 and older. "The antibody responses in the participants given 10 ug doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 ug doses," the companies said in a joint statement. "The 10 ug dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group." The companies are planning to submit the data to the Food and Drug Administration and the European Medicines Agency, as well as to other regulators around the world as soon as possible. Results from a trial involving children younger than 5 are expected "as soon as later this year," said the statement. "Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. -- underscoring the public health need for vaccination," said Pfizer CEO Albert Bourla in the statement. There were 2,268 participants in the trial. Shares of both companies were lower premarket, caught up in a broad market rout sparked by fears of a default by Chinese property developer China Evergrande. Pfizer shares have gained 19% in the year to date, while BioNTech has gained 341%. The SPDR S&P Biotech ETF has fallen 6% and the S&P 500 has gained 18%.
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%.
4:00 a.m. Sept. 10, 2021 - By Tomi Kilgore
Apellis Pharmaceuticals stock plunges after disappointing result from GA treatment studies Shares of Apellis Pharmaceuticals Inc. plunged 31.6% toward a 10-month low to pace all premarket losers Friday, after one of the Phase 3 studies of the biopharmaceutical company's eye disease treatment failed to meet its primary endpoint. The company said late Thursday that the OAKS study for pegcetacoplan met the primary endpoint, as it significantly reduced geographic atrophy (GA) lesion growth, while the DERBY study missed its primary endpoint of GA lesion growth reduction. The company said it plans to submit a New Drug Application (NDA) for pegcetacoplan for GA to the U.S. Food and Drug Administration in the first half of 2022. Wedbush downgraded Apellis to neutral from outperform, saying the previous upgraded was predicated on both studies holding a "high probability of success," but the readout ended up in the "mixed bag" scenario. J.P. Morgan slashed its stock price target to $57 from $101, but kept its overweight rating, saying "patience required" but pegcetacoplan "likely gets across the goal line" eventually. Apellis' stock has shed 2.8% year to date through Thursday, while the iShares Biotechnology ETF has advanced 14.8% and the S&P 500 has gained 19.6%.
3:27 a.m. Sept. 9, 2021 - By Ciara Linnane
Moderna says it has about $15 billion in cash, working on combined COVID/seasonal flu boosterModerna Inc. said Thursday it had a cash position of about $15 billion as of Aug. 31. The company made the disclosure as it offered an update on its line of product candidates based on mRNA technology, that includes a vaccine against COVID-19, the first Moderna product to win authorization from the U.S. Food and Drug Administration. In a statement released ahead of an R&D day, the company highlighted a new product candidate that would combine a COVID-19 booster with a seasonal flu booster vaccine. The company recently submitted an application to the FDA for approval of its COVID booster shot, and said it saw "robust antibody responses" in a Phase 2 study. Overall, the company has 37 programs in development across 34 development candidates, including 22 in current clinical studies. Shares were flat premarket, but have gained 305% in the year to date, while the SPDR S&P Biotech ETF has fallen 6% and the S&P 500 has gained 20%.
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%.
4:58 a.m. Aug. 27, 2021 - By Tomi Kilgore
Cassava's stock tumbles again, after Quanterix said it 'did not' prepare data charts presented by Cassava, that are under disputeQuanterix Corp. said that while it was previously engaged by Cassava Sciences Inc. to perform sample testing, the digitized biomarker analysis company said it, or its employees, "did not interpret the test results or prepare the data charts" presented by Cassava to the Alzheimer's Association International Conference (AAIC) in July, or otherwise. Earlier this week, to a request the Food and Drug Administration halt clinical studies of Cassava's Alzheimer's treatment because of , Cassava had said that data from Alzheimer's patients were generated by Quanterix. The news of the halt request had sent Cassava's stock plunging 39.9% in two days through Thursday. Quanterix's stock dropped 9.2% on Thursday, after losing 1.5% on Wednesday. In Friday's statement, Quanterix said it is "widely recognized for its commitment to business integrity and to upholding the highest standards of quality." Quanterix's stock rose 4.5% in premarket trading, while Cassava shares tumbled 21.2%
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%.
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.
2:37 a.m. Aug. 25, 2021 - By Tomi Kilgore
Cassava Sciences stock tumbles, and company responds to allegations disputing trial dataCassava Sciences Inc. responded Wednesday to allegations posted overnight regarding the "accuracy and integrity" of trial data for its treatment of Alzheimer's disease, saying it believed the claims are "false and misleading." Cassava's stock had rallied 1.9% on Tuesday, and 16.4% over the past three days, with the company saying early Tuesday that it reached agreement with the Food and Drug Administration under a Special Protocol Assessment (SPA) for its Phase 3 studies of oral simufilam for the treatment of Alzheimer's patients. The stock then tumbled after the bell -- it was down 17.8% in Wednesday's premarket -- after requesting the FDA halt the current clinical studies of simufilam, disputing the validity of clinical biomarker data, the integrity of western blot analyses and the integrity of analyses involving human brain tissue. "As a science company, we champion facts that can be evaluated and verified," said Chief Executive Remi Barbier. "This helps people make informed choices. It is important for stakeholders to separate fact from fiction, which is why we wish to address allegations head-on." Cassava with the "fact" that data from Alzheimer's patients were generated by an independent company, Quanterix Corp., and said western blot analysis is "foundational," and a standard lab technique used to detect a protein of interest. The stock has rocketed 1,627.7% year to date through Tuesday, while the S&P 500 has gained 19.4%.
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.
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%.
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%.
5:21 a.m. Aug. 13, 2021 - By Tomi Kilgore
Moderna stock rallies after FDA OKs booster shot of COVID-19 vaccine for most at-risk adultsShares of Moderna Inc. ran up 3.4% in premarket trading Friday, after the Food and Drug Administration authorized a third shot of COVID-19 vaccines from Moderna and Pfizer-BioNTech for immunocompromised adults. The booster shot will be for people who have undergone organ transplants, who are undergoing chemotherapy and those taking chronic medications that can suppress immune systems. "We recognize the need to protect immunocompromised individuals who are at the highest risk of severe COVID-19 disease," said Moderna Chief Executive Stéphane Bancel. "It is promising to see recent studies demonstrating that a third dose of the Moderna COVID-19 vaccine may enhance immune response in immunocompromised populations." The company said a double-blind, randomized controlled trial of 120 people who had undergone solid organ transplants showed that a third dose of Moderna's COVID-19 vaccine improved immune response compared with placebo, and was generally well tolerated. Moderna's early stock rally comes as Pfizer Inc. shares rose 0.7% and BioNTech SE's stock climbed 3.6%, while futures for the S&P 500 gained 0.1%.
4:47 a.m. Aug. 9, 2021 - By Jaimy Lee
Bluebird's stock falls 21% as it says it will focus on U.S. market for gene therapies, citing 'European payers'Shares of Bluebird Bio Inc. were down 21.6% in premarket trading on Monday after the company announced several setbacks to its business as part of its second-quarter earnings announcement. Bluebird plans to wind down its gene therapy operations in Europe, citing "European payers," which are primarily governments there. "European payers have not yet evolved their approach to gene therapy in a way that can recognize the innovation and the expected life-long benefit of these products," Bluebird executive Andrew Obenshain said in a news release. The company said it may license its three investigational gene therapies to a European company. Bluebird also said the Food and Drug Administration had placed a hold on its experimental Eli-cel product after a possible adverse event from a Phase 3 clinical study. Bluebird plans to complete its submission to the U.S. regulator sometime this year when the hold is lifted. Eli-cel, or elivaldogene autotemce, is a treatment for cerebral adrenoleukodystrophy, a rare disease that affects young boys. Bluebird's stock is down 42.1% for the year, while the broader S&P 50 is up 18.2%.
4:50 a.m. July 30, 2021 - By Tomi Kilgore
Erytech Pharma stock nearly doubles on heavy volume after ALL treatment granted Fast Track designationShares of Erytech Pharma SA rocketed 98.5% on heavy volume in premarket trading Friday, enough to make them the biggest gainer and most actively traded ahead of the open, after the France-based biopharmaceutical company said it's treatment for hypersensitive acute lymphocytic leukemia (ALL) patients was granted Fast Track designation by the Food and Drug Administration. Trading volume was 11.5 million shares in recent trading, compared with the full-day average of about 66,600 shares. "This is yet another significant milestone and meaningful inflection point in advancing our lead product candidate eryaspase, further supporting our recently announced intention to submit a [Biologics License Application] for eryaspase in hypersensitive ALL patients," said Chief Executive Gil Beyen. "We believe that the FDA's Fast Track designation for eryaspase underscores its potential to address this high unmet medical need." The stock, which closed Thursday at a 16-month low, has tumbled 42.8% over the past three months through Thursday, while the iShares Biotechnology ETF has gained 7.2% and the S&P 500 has tacked on 5.7%.
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%.
10:34 a.m. July 16, 2021 - By Tomi Kilgore
Kadmon's graft-versus-host treatment gets FDA approvalKadmon Holdings Inc. said Friday that Rezurock, its treatment of chronic graft-versus-host disease (cGVHD) in adjusts and pediatric patients older than 12 was approved by the Food and Drug Administration. The biopharmaceutical company's stock, which has been halted for news until 2:45 p.m. Eastern, was up 7.6% in afternoon trading prior to the halt. Kadmon said it expects Rezurock to be available in the U.S. by late August 2021. "Patients receiving Rezurock reported significant improvements in cGVHD symptoms, showing that not only did treatment result in organ responses, but it also made people feel better," said Stephanie Lee, professor at the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine. "This is so important for a chronic disease with a high symptom burden." The stock has lost 8.0% year to date, while the S&P 500 has gained 15.5%.
5:12 a.m. July 16, 2021 - By Joseph Walker
Cleveland Clinic, Mount Sinai and Providence won’t give Biogen’s new Alzheimer’s drug The three hospital operators are holding off on administering Aduhelm amid a debate over its effectivenessThree large hospitals are declining to administer Biogen Inc.’s new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the Food and Drug Administration’s controversial approval of the drug last month.
4:54 a.m. July 16, 2021 - By Joseph Walker
Cleveland Clinic, Mount Sinai and Providence won’t give Biogen’s new Alzheimer’s drug The three hospital operators are holding off on administering Aduhelm amid a debate over its effectivenessThree large hospitals are declining to administer Biogen Inc.’s new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the Food and Drug Administration’s controversial approval of the drug last month.
9:36 a.m. July 9, 2021 - By Ciara Linnane
Biogen shares fall on report FDA head seeking investigation of her agency's approval of Alzheimer's drugBiogen Inc. shares slid 3% Friday, after a STAT report that the acting head of the U.S. Food and Drug Administration is calling for a federal investigation into her own agency's approval of a treatment for Alzheimer's disease, a month after the decision irked lawmakers, doctors and pubic health advocates and led members of an independent committee associated with the FDA to step down. In a letter, Acting Commissioner Janet Woodcock asked the Office of the Inspector General to investigate interactions between FDA staff and Biogen in the run-up to the approval of the drug Aduhelm, The agency cited reporting by STAT that said FDA officials had worked closely with Biogen to get the drug to market. "There continue to be concerns raised ... regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process," Woodcock wrote in a letter to acting Inspector General Christi Grimm. On Thursday, Biogen announced an updated label for Aduhelm that limited the patients who qualify for the drug to those with "mild cognitive impairment or mild dementia stage of disease" rather than a broader group of people diagnosed with dementia because that is the group of people who were studied in the clinical trials. The FDA has been criticized for approving Aduhelm with what some consider is questionable clinical data and Biogen for how the drug is priced, at $56,000 for a year of treatment. Biogen shares have gained 47% in the year to date, while the SPDR S&P Biotech ETF has fallen 5% and the S&P 500 has gained 15%.
4:05 a.m. July 8, 2021 - By Jaimy Lee
Biogen updates label for Alzheimer's disease drug to say it should be used in people with 'mild' diseaseShares of Biogen Inc. were down 3.6% in premarket trading on Thursday after the company updated the label for its new Alzheimer's disease treatment, Aduhelm. The Food and Drug Administration approved the label update, which now says that the therapy should be used in patients with "mild cognitive impairment or mild dementia stage of disease" because that is the group of people who were studied in the clinical trials. The FDA has been criticized for approving Aduhelm with what some consider is questionable clinical data and Biogen for how the drug is priced, at $56,000 for a year of treatment. Two lawmakers have called for an into both issues. Biogen's stock is up 45.1% so far this year, while the broader S&P 500 is up 16.0%.
5:39 a.m. June 28, 2021 - By Jaimy Lee
Moderna hires chief brand officerShares of Moderna Inc. gained 0.6% in trading on Monday after the company said it hired Kate Cronin, former global CEO of Ogilvy Health, as its first chief brand officer. Moderna has one authorized product in the U.S., its COVID-19 vaccine. If the shot is granted full approval from the Food and Drug Administration, as expected sometime this year, that will mean Moderna is allowed to move forward with advertising and marketing its COVID-19 vaccine to the public and health care prescribers. Cronin will report to CEO Stéphane Bancel. Moderna's stock is up 110.5% so far this year, while the broader S&P 500 has gained 13.9%.
4:50 a.m. June 18, 2021 - By Ciara Linnane
Edesa Biotech shares jump 14% premarket after early review of COVID treatment finds it should continue trialEdesa Biotech Inc. shares jumped 14% premarket on Friday, after the Canadian biotech, which is listed on Nasdaq, said an interim review of its one-dose COVID-19 treatment candidate found it should continue the study as planned. Toronto-based Edesa said an independent data and safety monitoring board made that determination after an initial review of the first patients enrolled in its Phase 2/3 study evaluating the drug candidate as a treatment for hospitalized patients. "While it is not possible yet to draw conclusions, we are encouraged by the monitoring board's findings as well as the robust enrollment we have achieved to date," Edesa said in a statement. The company has filed a trial amendment with the U.S. Food and Drug Administration to streamline the U.S. protocol and align it with other jurisdictions. More than 370 patients are enrolled in the trial. The drug, called EB05, is a monoclonal antibody that Edesa believes can treat acute respiratory distress syndrome, which is one of the main causes of death from COVID. Edesa shares have gained 34% in the year to date, while the SPDR S&P Biotech ETF has fallen 4% and the S&P 500 has gained 12.4%.
2:53 a.m. June 18, 2021 - By Tomi Kilgore
Orphazyme stock plunges after receiving CRL from FDA after review of NPC treatmentShares of Orphazyme A/S plummeted 54.3% in premarket trading Friday, after the Denmark-based biopharmaceutical company said overnight that it received a "Complete Response Letter" (CRL) from the U.S. Food and Drug Administration regarding its treatment for Niemann-Pick disease type C (NPC). The CRL said additional qualitative and quantitative evidence was needed to substantiate the validity and interpretation of the 5-domain NPC Clinical Severity Scale and the swallow domain, as well as additional data to confirm evidence beyond the single Phase 2/3 trial supporting the benefit-risk assessment of the New Drug Application (NDA). The company it was "disheartened" and "disappointed" with the FDA's decision, which will have a "significant influence" on the financial outlook for the year. The company said its guidance range for operating losses has widened to DKK670 million to DKK700 million ($107.4 million to $112.2 million) from DKK100 million to DKK150 million). Orphazyme's stock made the rounds in social media last week, after the stock on June 10 before closing up 301.5% in very volatile trading, even as the company said in its share price. The stock has advanced 35.7% year to date through Thursday, while the iShares Nasdaq Biotechnology ETF has gained 5.0% and the S&P 500 has tacked on 12.4%.
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