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Tue, Jan. 26, 9:22 AM
Mon, Jan. 25, 9:14 AM
Mon, Jan. 25, 7:30 AM
- Novavax (NASDAQ:NVAX) announces its intent to offer $200M aggregate principal amount of convertible senior unsecured notes due February 1, 2023. Initial buyers will have the option to purchase up to an additional $30M of the notes.
- The purpose of the offering is the beef up its balance sheet as it prepares to commercialize its RSV F Vaccine in the U.S. and engage potential partners for ex-U.S. territories. Net proceeds will used to advance late-stage studies of RSV F in older adults and pregnant women and general corporate purposes.
- A portion of the proceeds could be used to finance the cost of privately negotiated capped call transactions which should reduced the potential dilution upon the conversion of the notes in the event the company's common stock price exceeds the notes' strike price.
- Shares are down 7% premarket on increased volume.
Tue, Jan. 19, 9:17 AM
Fri, Jan. 15, 9:29 AM
Nov. 9, 2015, 9:14 AM
Nov. 4, 2015, 9:15 AM| Nov. 4, 2015, 9:15 AM | 2 Comments
Oct. 7, 2015, 7:33 AM
- An interim analysis of six-month data from a Phase 2 clinical trial evaluating Genocea Biosciences' (NASDAQ:GNCA) lead product candidate GEN-003 for the treatment of genital herpes showed a 58% reduction from baseline in the viral shedding rate (p<0.0001), the primary endpoint. The results were generated by the best performing dose of 60 ug per protein/75 ug of Matrix-M2 adjuvant. The data will be presented this Friday at IDWeek 2015 in San Diego, CA.
- In a secondary analysis based on patient-reported lesion rates, GEN-003 demonstrated statistically significant reductions from baseline in five of six dose groups ranging from 43% to 69%. The proportion of patients who received GEN-003 who were lesion-free at six months post dosing ranged from 30% to 50%, which was comparable to trial results observed with other oral antivirals. Time-to-first recurrence ranged from 152 days to more than 180 days. GEN-003 was well tolerated with no serious adverse effects seen.
- 12-month efficacy data is expected in Q1. An end-of-Phase 2 meeting with the FDA should happen in late 2016 followed by the initiation of a Phase 3 study.
- GEN-003 is a T cell-directed immunotherapy (therapeutic vaccine) designed to elicit both a T cell and B cell (antibody) response to HSV-2. It licensed the Matrix-M2 adjuvant from Novavax (NASDAQ:NVAX). Genital herpes affects ~400M people worldwide.
- The company will host a conference call this morning at 9:00 am ET to discuss the data.
- Shares are up 21% premarket on light volume.
Sep. 30, 2015, 9:13 AM
Sep. 29, 2015, 5:51 PM
- From up heavily premarket to the day's worst biotech performer, Novavax (NASDAQ:NVAX) slid 21.4% today, with most of the decline coming in the last 90 minutes of trading.
- It's the stock's biggest decline in more than six years. Early this morning Novavax posted a success in trial results showing mothers vaccinated for respiratory syncytial virus (RSV) could pass protection to newborns.
- While positive, the effect was too muted to attract demand for the vaccine, says Piper Jaffray. Analyst Edward Tenthoff says the data are a proof of concept, but the concentration of antibodies in the blood seemed low. He's still bullish on the stock, however, with an Overweight rating.
- The stock has rebounded some after hours, up 5.2%.
Sep. 29, 2015, 8:07 AM
- Novavax (NASDAQ:NVAX) is up 9% premarket on light volume in response to its announcement of positive top-line results from a Phase 2 clinical trial evaluating its RSV F-protein recombinant nanoparticle vaccine candidate, RSV-F Vaccine, to protect infants via maternal immunization. The study's objective was to assess the safety and immunogenicity of the RSV-F Vaccine in 50 healthy pregnant women who were in their third trimesters.
- The blinded, placebo-controlled trial randomized the participants to receive either 120 mcg of RSV-F Vaccine adjuvanted with 0.4 mg of aluminum phosphate or placebo. They were followed through the remainder of their pregnancies and an additional 180 days postpartum. In addition to serum and cord blood samples taken from the mothers, serum samples were taken from the infants over the six-month period to provide a preliminary estimate of the half-life of the vaccine-induced maternal antibodies.
- Women in the vaccine arm showed a geometric mean 14-fold increase in anti-F IgG antibodies, a 29-fold increase in palivizumab-competing antibodies and a two-fold increase in microneutralization titers. Palivizumab is AstraZeneca's Synagis, which is a monoclonal antibody indicated for the prevention of RSV infection.
- Half-lives of the key antibodies in the infants ranged from 30 to 41 days.
- The Bill & Melinda Gates Foundation has awarded a grant to the company valued at up to $89M to support a Phase 3 study in pregnant women. The trial is expected to commence in Q1. There are no approved RSV vaccines currently available.
- Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in infants and young children worldwide, striking 64M kids each year leading to 160K deaths.
Sep. 15, 2015, 6:30 PM
- Novavax (NASDAQ:NVAX) is up 3.2% after hours, adding on to a gain of 4.3% today, after a promising preclinical animal study came in for a candidate to vaccinate infants.
- Pregnant guinea pigs immunized with its RSV F-protein recombinant nanoparticle vaccine showed "robust transplacental antibody transfer," transmitting protection to their offspring against respiratory syncytial virus.
- Directly immunizing infants is complicated by their immature immune systems. “RSV is the leading cause of infant hospitalizations in the U.S. and a significant unmet need in full-term infants,” says Novavax's Gregory Glenn.
Sep. 15, 2015, 5:42 PM
Aug. 11, 2015, 12:45 PM
Aug. 11, 2015, 9:16 AM
Aug. 11, 2015, 8:05 AM
- Shares of Novavax (NASDAQ:NVAX) are up 12% premarket on light volume in response to its announcement that a Phase 2 clinical trial assessing its RSV (respiratory syncytial virus) vaccine candidate, RSV F, was successful in demonstrating efficacy in older adults aged 60+, a population that historically has been difficult to protect from RSV infection.
- The 1,600-subject, randomized, observer-blinded, placebo-controlled study was conducted at 10 sites in the U.S. It was designed to prospectively evaluate the incidence of all symptomatic respiratory illnesses associated with RSV in community-living older adults who were treated with placebo, the safety and immunogenicity of an unadjuvanted 135 mcg dose of RSV F versus placebo and to estimate the efficacy of RSV F in reducing the incidence of respiratory illness due to RSV.
- The trial was the first to demonstrate active RSV immunization in any clinical trial population, showing a statistically significant vaccine efficacy (44%) in preventing all symptomatic RSV disease and preventing RSV disease with symptoms of lower respiratory tract infection (46%) in older adults. RSV-F's efficacy in protecting against more severe RSV illness, defined by the presence of multiple lower respiratory tract symptoms associated with difficulty breathing, was 64% in several ad hoc analyses.
- The study also established a 4.9% attack rate for symptomatic RSV disease in older adults, 95% of which included lower respiratory track symptoms. The attack rate is a biostatistical measure of the frequency of morbidity, or speed of spread, in an at-risk population.
- As many as 2.4M older Americans are infected with RSV each year, leading to 900K medical interventions and 14K deaths.
- The company intends to proceed to Phase 3 development as soon as next quarter.
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