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3:34 a.m. Today - By Jaimy Lee
CDC committee to meet today and Thursday to again discuss BioNTech and Pfizer's COVID-19 boosterA Centers for Disease Control and Prevention committee is Wednesday and Thursday to again discuss the science and possible administration plan for BioNTech SE and Pfizer Inc.'s COVID-19 booster shot. The CDC's Advisory Committee on Immunization Practices sets out the guidelines for how vaccines should be used in the U.S. The Food and Drug Administration has not approved or authorized an extra dose of the BioNTech and Pfizer vaccine except in people who are immuno-compromised, and an influential FDA committee last week recommended that boosters to older people and those who are at higher risk of severe disease. Some experts have suggested that the FDA decision is coming this week.
1:20 p.m. Sept. 15, 2021 - By Jaimy Lee
FDA says COVID-19 vaccines continue to protect people in the U.S. from severe diseaseThe Food and Drug Administration said Wednesday that observational studies have had mixed findings assessing whether the efficacy for BioNTech SE and Pfizer Inc.'s COVID-19 vaccine is declining as a result of time or the delta variant but in general the vaccines available in the U.S. continue to protect people against severe disease and death. The FDA's was published Wednesday in advance of an advisory committee meeting set for Friday; at that meeting, a group of independent experts will discuss and then vote on whether they think the FDA should approve a COVID-19 booster dose for people who are at least 16 years old or older. The FDA is not required to follow the advice of the committee but often does. Pfizer's document for the meeting was also published on Wednesday; it cited the need to look at the when it comes to making a regulatory decision about a third dose of its vaccine. The FDA's document, on the other hand, said it has not independently verified all potentially relevant studies.
8:50 a.m. Sept. 15, 2021 - By Tomi Kilgore
Indaptus Therapeutics stock nearly triples on heavy volume after allowance for patent of platform technology Shares of Indaptus Therapeutics Inc. nearly tripled on massive volume in midday trading, to bounce off the previous session's record closing low, after the developer of treatments for hepatitis and HIV announced the allowance of a patent for its platform technology. The stock was up as much as 307.8% at a six-month high of $28.83 before paring gains to be up 184.3%. Trading volume exploded to 119.2 million shares, compared with the full-day average of just 227,600 shares. The stock was the biggest gainer and third-most active on major U.S. exchanges. The company said before the open that its patent titled "Methods of Treatment of Infections Using Bacteria," provides broad protection for the application of the company's platform technology alone and in combination with standards of care for the treatment and inhibition of hepatitus B virus and human immunodeficiency virus (HIV) infections. "This notice of allowance gives us the optionality to confidently pursue our technology in viral diseases and/or to partner it for further development," said Chief Executive Jeffrey Meckler. The stock has now gained 45.7% year to date, while the iShares Biotechnology ETF has tacked on 13.2% and the S&P 500 has advanced 19.0%.
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%.
4:38 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%.
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%.
3:21 a.m. Sept. 3, 2021 - By Tomi Kilgore
Forte Biosciences stock plunges more than 80% after 'disappointing' trial results of atopic dermatitis treatmentShares of Forte Biosciences Inc. plummeted 81.2% on heavy volume toward a record low in premarket trading Friday, after the biopharmaceutical company said it will no longer advance its lead product candidate FB-401, a treatment for atopic dermatitis. Trading volume spiked to 2.8 million shares ahead of the open, compared with the full-day average of about 754,000 shares. The company said late Thursday that a Phase 2 trial of FB-401 failed to meet statistical significance for the primary endpoint of the proportion of patients with at least 50% improvement in atopic dermatitis disease severity. The company said the primary endpoint was achieved by 58% of subjects on FB-401, compared with 60% of subjects on placebo. "The topline data is disappointing and we will continue to analyze the data; however, given this readout we will not continue to advance FB-401," said Chief Executive Paul Wagner. "We expect to provide investors with an update on the future plans for the company over the next several months." The stock, on track to open below the Dec. 19, 2019 record low close of $6.65, has dropped 25.0% over the past three months through Thursday, while the iShares Biotechnology ETF has climbed 16.7% and the S&P 500 has gained 8.2%.
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.
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%.
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.
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.
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%.
3:27 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%.
5:09 a.m. Aug. 4, 2021 - By Tomi Kilgore
BeyondSpring stock more than triples after lung cancer treatment meets endpoints in Phase 3 trialShares of BeyondSpring Inc. more than tripled -- up 242% -- on heavy volume in premarket trading Wednesday, after the New York-headquartered biopharmaceutical company said a Phase 3 trial of its lung cancer treatment met the primary and key secondary endpoints. The stock, which closed at a record low last week, was on track to open at the highest price seen during regular-session hours since April 2018. Trading volume spiked to 8.0 million shares, compared with the full-day average of about 196,000 shares. The company said plinabulin met the primary endpoint of increasing overall survival and met secondary endpoints, such as improving overall response rates, progression-free survival, 24- and 36-month overall survival rates and significant reduction in the incidence of Grade 4 neutropenia. Chief Medical Officer Ramon Mohanlal said the success of the study represents "proof-of-concept of plinabulin's immune-enhancing mechanism of action that is complimentary to that of checkpoint inhibitors, and which is the rationale for it to be combined as triple IO combinations in multiple tumor indications." The stock had dropped 21.1% year to date through Tuesday, while the iShares Biotechnology ETF has gained 11.8% and the S&P 500 has advanced 17.8%.
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%.
4:50 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%.
4:23 a.m. July 22, 2021 - By Jaimy Lee
Seres shares fall 55% after the company says its colitis drug failed in mid-stage clinical trialShares of Seres Therapeutics Inc. tumbled 55.4% in premarket trading on Thursday after the company said a mid-stage study testing its experimental ulcerative colitis drug failed. As a result, Seres closed the open-label and maintenance part of the trial. Seres' stock is down 15.0% so far this year, while the S&P 500 has gained 15.1%.
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%.
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%.
4:13 a.m. July 19, 2021 - By Jaimy Lee
Cytokinetics shares jump based on results from Phase 2 clinical trial for experimental heart-disease drugShares of Cytokinetics Inc. soared 33.0% in premarket trading on Monday after the company said a Phase 2 clinical trial for its experimental hypertrophic cardiomyopathy treatment yielded positive results. The still-investigational therapy helped improve blood flow in patients with the disease, which is considered one of the most common reasons for sudden cardiac death in people who are younger than 35. No serious adverse events have been reported in the randomized, placebo-controlled, double-blind trial. Cytokinetics plans to move the therapy into a Phase 3 clinical study sometime this year. The company's stock is down 7.4% so far this year, while the broader S&P 500 is up 15.2%.
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%.
5:41 a.m. July 15, 2021 - By Jaimy Lee
Vir initiates open-label Phase 2 study for experimental hepatitis B treatmentShares of Vir Biotechnology Inc. gained 0.6% in trading on Thursday after the company said it started an open-label Phase 2 clinical trial for its experimental hepatitis B treatment. The study combines two investigational therapies with the aim of developing what Vir calls a "functional cure." It expects to enroll 90 adult patients with chronic hepatitis B infections. Vir's stock is up 31.6% this year, while the broader S&P 500 has gained 16.4%.
4:51 a.m. July 7, 2021 - By Jaimy Lee
Moderna begins Phase 1/2 trial for experimental flu vaccineShares of Moderna Inc. were down 0.6% in premarket trading on Wednesday after the company said it began dosing patients in a Phase 1/2 clinical trial evaluating an experimental seasonal flu vaccine. The study is expected to enroll 180 adults and test a vaccine candidate against Type A and Type B influenzas. Moderna has one authorized product, its COVID-19 vaccine, and is using similar mRNA technology to test out other vaccines. Moderna's stock has soared 123.3% so far this year, while the S&P 500 is up 15.6%.
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.%
5:46 a.m. June 29, 2021 - By Jaimy Lee
In-vitro study says Moderna's COVID-19 vaccine can protect against variantsShares of Moderna Inc. gained 3.1% in trading on Tuesday after the company said an in-vitro study analyzing the sera of people who have received its COVID-19 vaccine had neutralizing antibody titers that protect against infection with several variants, including the worrisome Delta variant. The Delta variant, or B.1.617.2, was first identified in India. It is expected to become the in the U.S. within weeks. Moderna is currently testing booster shots that may help strengthen protection against variants of concern that emerged in the months after it conducted Phase 3 clinical trials of its COVID-19 shot. Moderna's stock is up 118.5% so far this year, while the S&P 500 has gained 14.2%.
5:04 p.m. June 25, 2021 - By Jaimy Lee
Vir's stock gains on early results from clinical trials for its hepatitis B treatment candidateShares of Vir Biotechnology Inc. gained 3.1% in premarket trading on Friday after the company shared positive data from mid-stage and early-stage clinical trials for its experimental hepatitis B treatments. One candidate, VIR-2218, was tested subcutaneously in 32 patients with chronic hepatitis B infections. The other, VIR-3434, enrolled 40 patients in a Phase 1 clinical trial. Vir's stock is up 85.2% so far this year, while the S&P 500 has gained 13.0%.
5:42 a.m. June 24, 2021 - By Jaimy Lee
Arcus stock jumps 19% after announcing it will move forward with trial for lung-cancer treatmentShares of Arcus Biosciences Inc. gained 19.8% in trading on Thursday, the day after the company said its experimental lung-cancer PD-L1 treatment demonstrated clinical activity in an open-label, Phase 2 clinical study. Arcus did not release specific data but said the trial will continue. Gilead Sciences Inc. recently increased its stake in Arcus to 19.% from 13% and has the exclusive option to co-develop the drug, domvanalimab. Wall Street analysts still have some questions about the viability of the research. "Limited details cloud interpretation of just how promising or competitive the program looks thus far," RBC Capital Markets analyst Brian Abrahams wrote in a note to investors. However, SVB Leerink analysts say the data, though limited, bodes well for companies developing similar therapies, including Compugen Ltd. , iTeos Therapeutics Inc. , and Merck & Co. Inc. . Shares of Arcus are down 9.8% this year, while the broader S&P 500 is up 13.0%.
4:26 a.m. June 23, 2021 - By Jaimy Lee
Biogen now says it plans to complete 'confirmatory' study for Alzheimer's drug earlier than requiredShares of Biogen Inc. were up 0.8% in premarket trading on Wednesday after the company and Eisai Inc. said they plan to speed up the completion of what is called a "confirmatory" clinical trial for its recently approved Alzheimer's disease treatment. In the weeks since the drug's approval in the U.S., Aduhelm has faced criticism over how it was priced and whether or not the clinical data were strong enough to support the approval. In the new statement, the companies said they they now plan to complete the confirmatory study in advance of the 2029 deadline. They also said they do not plan to raise Aduhelm's price for four years. The drug currently has an annual cost of $56,000. Up to 2 million people with mild Alzheimer's disease are considered potential patients for this drug. Biogen's stock is up 52.9% so far this year, while the broader S&P 500 is up 13.0%.
4:40 a.m. June 22, 2021 - By Jaimy Lee
New research says Pfizer and Moderna's mRNA vaccines don't affect sperm parametersNew published in JAMA found there was no difference in sperm parameters in 45 men who received mRNA vaccines against COVID-19. The two authorized mRNA vaccines, which were developed by Pfizer Inc. and Moderna Inc. , are the most commonly utilized COVID-19 vaccines in the U.S. Researchers at the University of Miami Miller School of Medicine say they initiated the study after hearing concerns from some people that the vaccines could impact fertility. They noted the study has some limitations, given that the number of men enrolled in the study is a small sample size, and semen analysis is "an imperfect predictor of fertility potential." Back in April, concerns about fertility were cited as a top reason to avoid COVID-19 vaccination, , with 42% of adults between the ages of 18 and 29 saying they have heard the shots can cause infertility and 5% saying they believe this is true.
3:29 a.m. June 21, 2021 - By Jaimy Lee
Vir, GSK say new data confirms their COVID-19 treatment can reduce hospitalization and deathShares of Vir Biotechnology Inc. gained 1.4% in premarket trading on Monday after the company said the COVID-19 antibody treatment it developed with GlaxoSmithKline cut the risk of hospitalization and death among adults at high risk. The confirmatory data came from a Phase 3 clinical trial that was used to inform the emergency-use authorization granted last month to sotrovimab, the companies' COVID-19 monoclonal antibody treatment. Vir also said the National Institutes of Health updated its guidelines to recommend using the monoclonal antibody in people with mild or moderate forms of the disease who are at high risk for disease progression. The companies say there are 450,000 doses of the treatment "on hand" in the U.S. at this time. Vir's stock is up 6.6% so far this year, while the broader S&P 500 has gained 12.4%.
3:18 a.m. June 21, 2021 - By Peter Loftus
Moderna plans to expand production of COVID-19 vaccine boosters, supply more countriesModerna Inc. is adding two new production lines at the rebuilt former Polaroid plant where it manufactures its COVID-19 vaccine, part of a push to prepare for making booster shots and the future of the pandemic
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%.
4:52 a.m. June 15, 2021 - By Jaimy Lee
Biogen says experimental drug for rare retinal disease fails in late-stage clinical trial Shares of Biogen Inc. were down 0.3% in premarket trading on Tuesday, the day after the company said an experimental gene therapy for choroideremia failed a late-stage clinical trial. Biogen said Monday that the Phase 3 study did not meet its primary endpoint or efficacy on secondary endpoints among study participants who have the rare, hereditary retinal disease. The news is one of several stock-moving announcements for Biogen in the last two weeks, including the Food and Drug Administration last week and Tuesday's disclosure that an experimental treatment for major depressive disorder it's developing with Sage Therapeutics Inc. in a Phase 3 clinical trial. Biogen's stock is up 65.8% so far this year, while the S&P 500 has gained 13.3%.
4:42 a.m. June 14, 2021 - By Jaimy Lee
iTeos stock jumps 60% after company announces deal with GSKShares of iTeos Therapeutics Inc. soared 58.5% in premarket trading on Monday after the company announced a deal with GlaxoSmithKline to develop and commercialize an experimental cancer therapy. GSK will make a $625 million upfront payment to iTeos, with an additional $1.4 billion in possible milestone payments available in the future. The immuno-oncology drug candidate is currently being tested in an open-label, Phase 1 clinical trial in patients with advanced solid tumors; as part of this deal, the companies plan to pair the iTeos drug with GSK's Jemperli in studies next year. (Jemperli was initially approved by the Food and Drug Administration as a treatment for endometrial cancer in April.) Shares of iTeos are down 40.8% so far this year, while the S&P 500 has gained 13.1%.
4:28 a.m. June 14, 2021 - By Jaimy Lee
Moderna hires J&J executive as chief medical officerShares of Moderna Inc. were down 2.1% in premarket trading on Monday after the company said it hired Dr. Paul Burton as its new chief medical officer. Burton, a former Johnson & Johnson executive, will report to CEO Stéphane Bancel. He replaces Dr. Zal Taks, who announced plans to leave Moderna earlier this year. Burton most recently was the chief of global medical affairs for J&J's pharmaceuticals business. Both Moderna and J&J have received authorizations for their COVID-19 vaccines in the U.S. Moderna's stock is up 109.5% so far this year, while the broader S&P 500 has gained 13.1%.
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