Key Developments: Novavax Inc (NVAX.O)

NVAX.O on Nasdaq

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3 Sep 2015
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Latest Key Developments (Source: Significant Developments)

Novavax Inc announces positive data from phase 2 trial of quadrivalent seasonal Influenza VLP
Thursday, 30 Jul 2015 08:30am EDT 

Novavax Inc:Announces positive data from phase 2 trial of quadrivalent seasonal Influenza VLP.Says trial demonstrated that seasonal influenza VLP vaccine candidate was well-tolerated.Trial demonstrated that the seasonal influenza VLP vaccine candidate showed no vaccine-related serious adverse events.Says trial met its immunogenicity targets.  Full Article

Novavax Inc announces positive top-line data from phase 1 Ebola Vaccine Trial on WHO Teleconference
Tuesday, 21 Jul 2015 08:30am EDT 

Novavax Inc:Says positive top-line data from Phase 1 clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M as part of World Health Organization's (WHO) Fifth Teleconference on Ebola Vaccine Clinical Trials.Trial demonstrated that the Ebola GP Vaccine was highly immunogenic, well-tolerated and, in conjunction with Novavax' proprietary Matrix-M adjuvant, resulted in significant antigen dose-sparing.  Full Article

Novavax Inc closes public offering
Tuesday, 31 Mar 2015 04:01pm EDT 

Novavax Inc:Closes underwritten public offering priced on March 25.Says it issued 27,758,620 shares of common stock, including 3,620,689 shares pursuant to the underwriters' option to purchase additional shares.Shares were issued at $7.25 per share resulting in total gross proceeds from this offering of about $201,250,000 before deducting the underwriters discount and offering expenses.Intends to use a portion of the net proceeds from this offering for the advancement of its lead vaccine candidates, including the preparation and potential initiation of Phase 3 clinical trials of its elderly RSV and maternal RSV programs and general corporate purposes.J.P. Morgan and Citigroup acted as joint book-running managers of the offering. Piper Jaffray & Co. and Wedbush PacGrow acted as Co-Lead Managers, Janney Montgomery Scott and Ladenburg Thalmann acted as Co-Managers.  Full Article

Novavax Inc prices public offering of common stock
Thursday, 26 Mar 2015 08:01am EDT 

Novavax Inc:Announces that it has priced an underwritten public offering of 24,137,931 shares of common stock at a price to the public of $7.25 per share for gross proceeds of about $175 million.Expects to receive net proceeds, after deducting the underwriting discount, of about $165 million from the offering.In connection with this offering, Novavax has granted the underwriters a 30-day option to purchase up to an additional 3,620,689 shares of its common stock.Says if the underwriters exercise this option in full, Novavax will have sold 27,758,620 shares of its common stock.Intends to use the net proceeds from this offering for the advancement of its lead vaccine candidates.  Full Article

Novavax Inc proposes public offering of common stock
Tuesday, 24 Mar 2015 04:01pm EDT 

Novavax Inc:Intends to offer to sell, $175 million of common stock in an underwritten public offering.Says as part of offering intends to grant the underwriters a 30-day option to purchase up to an additional $26.25 million of common stock.J.P. Morgan and Citigroup are acting as joint book-running managers of the offering.Net proceeds from offering to be used for the advancement of lead vaccine candidates, including preparation and potential initiation of phase 3 clinical trials of its elderly RSV and maternal RSV programs, as well as other clinical and preclinical research programs and general corporate purposes.Says net proceeds also be used for working capital, product development, manufacturing and process development expenditures and capital expenditures, as well as acquisitions and other strategic purposes.  Full Article

Novavax Inc announces initiation of Ebola Vaccine Phase 1 Clinical Trial
Thursday, 12 Feb 2015 08:30am EST 

Novavax Inc:Says enrollment has begun in a Phase 1 clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M (Ebola GP Vaccine) in healthy subjects.  Full Article

Novavax initiates Phase 2 clinical trial of Quadrivalent Seasonal Influenza VLP
Monday, 17 Nov 2014 04:05pm EST 

Novavax Inc:Says enrollment has begun in a Phase 2 clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP).Trial is being conducted under company's contract with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) (Contract No. HHSO 100201100012C) for the development of recombinant vaccines for seasonal influenza and influenza strains.  Full Article

Novavax Inc initiates phase 1 clinical trial of RSV F vaccine in Pediatric Subjects
Monday, 10 Nov 2014 08:30am EST 

Novavax Inc:Says that enrollment has begun in Phase 1 clinical trial of its respiratory syncytial virus (RSV) F-protein nanoparticle vaccine candidate (RSV F Vaccine), in healthy children.Says first study of this vaccine candidate to be conducted in pediatric population.Trial, which is being conducted in Canada, is randomized, observer-blinded, dose-ranging Phase 1 study to evaluate the safety and immunogenicity of he RSV F Vaccine, with or without aluminum phosphate adjuvant, in 150 healthy pediatric subjects two to six years of age.In addition to trial's primary goal of evaluating safety in this population, the study will also evaluate immunogenicity as measured by concentrations of serum IgG antibodies to the RSV fusion, or F-protein, palivizumab-competing antibody titers and RSV microneutralization titers.  Full Article

U.S. FDA Grants Fast Track Designation to Novavax Inc's H7N9 Influenza Virus-Like Particle Vaccine Candidate Adjuvanted With Matrix-M
Wednesday, 29 Oct 2014 05:17pm EDT 

Novavax Inc:Says U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax' H7N9 Virus-Like Particle Vaccine Candidate (H7N9 VLP) adjuvanted with Matrix-M.H7N9 VLP is being developed under the company's contract with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority for the development of Novavax' recombinant vaccines to address seasonal influenza and influenza strains with pandemic potential.  Full Article

Novavax Inc initiates phase 2 clinical trial of RSV vaccine in elderly subjects
Tuesday, 14 Oct 2014 08:30am EDT 

Novavax Inc:Announces that enrollment has begun in Phase 2 clinical trial of its respiratory syncytial virus (RSV) F-protein nanoparticle vaccine candidate (RSV F Vaccine), in healthy elderly subjects.Trial is randomized, observer-blinded, placebo-controlled Phase 2 study scheduled to enroll 1,600 elderly subjects (>60 years of age) at ten sites in United States.Trial will evaluate incidence of all respiratory illnesses due to RSV, including medically-attended respiratory illnesses due to RSV, and hospitalizations for respiratory illness due to RSV in community-living elderly adults who have been treated with placebo.Study will also evaluate safety and immunogenicity of 135µg dose of the RSV F Vaccine compared with placebo.Trial will also estimate efficacy of RSV F Vaccine in reducing incidence of respiratory illnesses due to RSV.  Full Article

Novavax's vaccine first to protect against common respiratory virus

- A vaccine developed by Novavax Inc was shown to prevent a common respiratory viral infection in a mid-stage study, taking it one step closer to becoming the first vaccine for the virus that affects almost all American children.

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