Mon, Aug. 10, 4:31 PM
Sun, Aug. 9, 5:35 PM| Sun, Aug. 9, 5:35 PM | 13 Comments
Thu, Jul. 30, 10:37 AM
- Novavax (NVAX +0.4%) bucks the market's bearishness with its announcement of positive top-line data from a Phase 2 clinical trial assessing Influenza VLP, its recombinant quadrivalent (four flu virus strains) seasonal influenza virus-like (VLP) vaccine candidate. The trial met its immunogenicity targets and showed potential to meet CBER's (FDA's Center for Biological Evaluation and Research) criteria for accelerated approval.
- The primary endpoint was safety and tolerability of Influenza VLP and qualified immune responses to each of the four influenza strains as measured by hemagglutination-inhibiting (HAI) antibody titers. The HAI responses in 400 healthy adult volunteers were 50% greater that those observed in a previous Phase 2 study.
- The company plans to review the data with program funder BARDA (Biomedical Advanced Research and Development Authority) to determine the next steps in development.
Tue, Jul. 21, 9:15 AM
Tue, Jul. 21, 8:53 AM
- Top-line data from a Phase 1 trial show Novavax's (NASDAQ:NVAX) Ebola glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with the company's Matrix-M was well-tolerated and highly immunogenic in a group of 230 healthy adult volunteers. The results were presented during the World Health Organization's Fifth Teleconference on Ebola Vaccine Clinical Trials.
- Participants received either one or two intramuscular injections, with and without Matrix-M, ranging from 6.5 micrograms to 50 micrograms of antigen on study days 0 and 21. Immunogenicity was assessed at multiple times including days 28 and 35. The adjuvanted two-dose regimens induced Ebola anti-GP antibody increases of 500- to 750-fold over baseline at day 35. The adjuvanted single dose regimen induced increases of 21- to 27-fold over the same time frame.
- President & CEO Stanley Erck says, "These positive data represent the third time Novavax has leveraged the power of our platform technology to rapidly address an emerging threat. These Ebola GP Vaccine date, in combination with clinical data from our H7N9 VLP vaccine candidate and preclinical data from our vaccine candidate for Middle East Respiratory Syndrome coronavirus, provide additional validation of our nanoparticle vaccine platform."
Fri, May 8, 6:26 AM| Fri, May 8, 6:26 AM | 7 Comments
Thu, May 7, 4:28 PM
Thu, Mar. 26, 9:31 AM
- Novavax (NASDAQ:NVAX) prices its public offering of 24,137,931 shares of common stock at $7.25 per share. Underwriters over-allotment is an additional 3,620,689 shares. Closing date is March 31.
- Net proceeds of ~$165M will fund the advancement of the company's lead vaccine candidates, other research programs and general corporate purposes.
- Previously: Novavax initiates equity offering (March 24)
Thu, Mar. 26, 9:13 AM
Wed, Mar. 25, 9:11 AM
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Fri, Feb. 27, 9:15 AM
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Fri, Feb. 20, 7:15 AM
- The World Health Organization (WHO) approves the use of a 15-minute point-of-care test developed by Corgenix Medical (OTCQB:CONX) to detect the presence of the Ebola virus. The company developed the assay with funding assistance of the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.
- Procurement and roll-out in Africa will begin in a few weeks pending the completion of administrative procedures with the U.S. FDA.
- Ebola-related tickers: (NYSE:MRK) (NASDAQ:NLNK) (NYSEMKT:IBIO) (NASDAQ:NVAX) (NYSE:GSK) (NYSE:JNJ) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:BCRX) (NASDAQ:SRPT) (NASDAQ:CMRX) (NASDAQ:ABIO) (OTCQB:AEMD) (OTCPK:BVNRY) (NASDAQ:INO) (OTCQX:RHHBY)
Thu, Feb. 12, 1:18 PM
- Novavax (NVAX +1.7%) commences patient enrollment in a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M. The study, being conducted in Australia, involves 230 healthy subjects between the ages of 18 and 50. Each person will receive two intramuscular injections, one on Day 0 and one on Day 21.
- The trial will also evaluate immunogenicity as measured by serum concentrations of IgG antibodies to the Ebola Makona strain glycoprotein.
- According to CEO Stanley C. Erck, the company now has the capability to rapidly scale up manufacturing to produce millions of doses of Ebola vaccine.
- Related tickers: (GSK -1%)(JNJ -1.8%)(OTCPK:BVNRY)(MRK +0.1%)(NLNK +5.3%)
- Previously: Johnson & Johnson announces Ebola vaccine development consortia (Jan. 16)
- Previously: First Glaxo Ebola vaccine to arrive in Liberia (Jan. 23)
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