Key Developments: Novavax Inc (NVAX.O)

NVAX.O on Nasdaq

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Latest Key Developments (Source: Significant Developments)

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 Inc Initiates Phase 2 Clinical Trial of RSV F-Protein Nanoparticle Vaccine Candidate in Healthy Third-Trimester Pregnant Women
Tuesday, 16 Sep 2014 04:05pm EDT 

Novavax Inc:Says that enrollment has begun in a Phase 2 clinical trial of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine), in healthy women in the third trimester of pregnancy.Purpose of this study is to evaluate the safety and immunogenicity of the RSV F Vaccine, in women in their third trimester of pregnancy.Trial will also assess the impact of maternal immunization on infant safety and RSV-specific antibody levels through one year and six months of life, respectively.  Full Article

Novavax Inc announces exercise of option to purchase additional shares and closing of public offering
Wednesday, 11 Jun 2014 04:01pm EDT 

Novavax Inc:Announced the closing of the underwritten public offering priced on June 5.Issued 28,750,000 shares of its common stock, including 3,750,000 shares pursuant to the underwriters' option to purchase additional shares.Shares were issued at $4.00 per share resulting in total gross proceeds from this offering of $115,000,000, before deducting the underwriters discount and offering expenses.Intends to use a portion of the net proceeds from this offering to expand the clinical development of its RSV F-protein nanoparticle vaccine candidate through the initiation of a Phase 2 clinical trial in elderly subjects later this year.  Full Article

Novavax Inc prices public offering of common stock
Thursday, 5 Jun 2014 08:55pm EDT 

Novavax Inc:Says that it has priced an underwritten public offering of 25 mln shares of common stock at a price to the public of $4.00 per share for gross proceeds of about $100 mln.Expects to receive net proceeds, after deducting the underwriting discount, of about $94 mln from the offering.Expects to grant to underwriters a 30-day option to purchase up to additional 3.75 mln shares of its common stock.Intends to use net proceeds from offering for general corporate purposes, advancement of its clinical-stage vaccine candidates and its pre-clinical research programs, manufacturing and process development activities, capital expenditures and other strategic purposes.Expects to close offering on or about June 11.Citigroup and JP Morgan are acting as joint book-running managers of offering.Piper Jaffray & Co. will act as Lead Manager and FBR and Ladenburg Thalmann & Co. Inc. as co-managers.  Full Article

Novavax announces proposed public offering of common stock
Wednesday, 4 Jun 2014 04:01pm EDT 

Novavax Inc:Intends to offer to sell, subject to market and other conditions, $100 million of its common stock in an underwritten public offering.Intends to grant the underwriters a 30-day option to purchase up to an additional $15 million of its common stock.Citigroup and JP Morgan are acting as joint book-running managers of the offering.  Full Article

Novavax announces independent registered public accounting firm change - Form 8-K
Wednesday, 30 Apr 2014 05:23pm EDT 

Novavax Inc:On April 24, Audit Committee selected Ernst & Young LLP as independent registered public accounting firm for fiscal year ending Dec. 31, 2014, subject to completion of standard client acceptance procedures.Also on April 24, Grant Thornton LLP was notified that they would be dismissed as auditors upon completion of the work relating to company’s interim financial statements for period ending March 31on quarterly report on Form 10-Q.  Full Article

Novavax announces positive top-line data from dose-confirmatory phase 2 clinical trial of RSV vaccine candidate in women of childbearing age
Monday, 28 Apr 2014 04:13pm EDT 

Novavax Inc:Says positive top-line safety and immunogenicity data from its RSV-F protein nanoparticle vaccine candidate in a Phase 2 clinical trial in women of childbearing age.Randomized, blinded, placebo-controlled Phase 2 study was designed to evaluate the immunogenicity and safety of multiple formulations of Novavax' RSV-F protein nanoparticle vaccine adjuvanted with aluminum phosphate.Primary outcome of the trial was safety and immune response (measured by levels of serum IgG antibody specific for the F protein).These top-line data relate to the safety and immunogenicity over the 91-day period following first immunization and support Novavax' maternal immunization strategy.  Full Article

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