Adverum Biotechnologies, Inc. (NASDAQ: ADVM)
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Pfizer (PFE +0.5%) and BioNTech (BNTX +10.1%) are in talks with the U.S. FDA on how to start testing their COVID-19 vaccine in children, a group that the agency is eager to gather data on, Reuters reports, citing an interview with Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development.
Vaccines work differently in children than they do in adults. Such tests generally progress in stages, with older adolescents tested first followed by younger adolescents then children.
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There are already signs that younger adults have higher rates of reactions, such as sore arms and fevers, to the vaccine than older adults do, Gruber said.
That presents the risk that reactions could increase even more in younger patients. For example, ~75% of adults between 18 and 55 in Pfizer’s most recent trials had fevers after getting the vaccine, most of them mild.
“Younger children — maybe that’s not going to be tolerated. Maybe we’re going to have severe fevers,” he said. “That’s why we’re adopting a very thoughtful, graduated approach. Children are not just small adults.”
The company is submitting safety data to the FDA and developing a testing plan for children, which Gruber expects to start soon.
He also told Reuters that about 19% of the 11,000 people enrolled so far in a 30,000-volunteer U.S. trial for the companies’ COVID-19 vaccine are black or Latino, groups among the hardest by the coronavirus pandemic.
“Between Latinx and Black or African American populations, we’re running at about 19% or so,” Gruber said. “We’re trying to push even higher than that.”
Pfizer rises 0.4% in late afternoon trading.
Earlier today, Pfizer and BioNTEch said they may file for regulatory approval as early as October.
Results from a Phase 3 clinical trial evaluating Gilead Sciences’ (GILD -0.1%) Veklury (remdesivir) in hospitalized COVID-19 patients with confirmed severe acute respiratory syndrome (ARDS) and moderate pneumonia showed a potential treatment benefit compared to standard-of-care (SOC) treatment. The results were just published online in JAMA Network.
The 596-subject study tested five-day and 10-day courses of the antiviral, dosed intravenously at 200 mg on day 1 followed by 100 mg/day thereafter.
The primary endpoint was clinical status on day 11 as measured by a seven-point ordinal scale called Odds for Ratio for Improvement (the higher the number, the better the status; 1=death, 7=not hospitalized). Each day, the worst score from the previous day was recorded.
On day 11, patients receiving the five-day course of remdesivir showed statistically significantly higher odds of a better clinical status distribution compared to SOC (p=0.02), a trend that implied improved outcomes, but the clinical importance of the parameter is uncertain according to the authors.
The clinical status distribution on day 11 between the 10-day course of remdesivir and SOC was not statistically significant (p=0.18).
The FDA signed off on emergency use of the antiviral for severely ill COVID-19 on May 1. The company filed its marketing application for full U.S. approval on August 10.
Northwest Biotherapeutics (OTCQB:NWBO +2.0%) has completed a non-dilutive debt financing for net proceeds of additional $5M, via a 21-month note for $5.5M at an 8% annualized interest rate, with no payments due for the first 7 months.
The loan is expected to provide resources for certain readiness activities as the Company approaches the topline data readout from its Phase 3 trial of DCVax-L for Glioblastoma (brain tumor).
The loan carries a prepayment penalty of 15%.
Canadian cannabis retailers High Tide (OTCQB:HITIF +11.0%) and Meta Growth (OTCPK:NACNF +25.0%) have announced plans to merge, in a move to form the country’s largest pot shop network.
The two companies said that the combined retailer will have 63 licensed cannabis stores across Canada with plans to double that to 115 by the end of 2021 and $133M in annualized revenue.
The deal is expected to result in operational savings of ~$8-$9M, with positive adjusted EBITDA.
Meta Growth shareholders will receive 0.824 High Tide shares, implying a price per META Share of $0.133, representing a premium of 14%. Meta shareholders will own ~45% of the combined entity.
“The combination with Meta is a watershed moment in High Tide’s evolution as we become Canada’s largest and strongest cannabis retailer,” said High Tide CEO Raj Grover, who along with his team will lead the combined company.
Regulators in Russia have signed off on a 150-subject Phase 3 clinical trial evaluating AstraZeneca’s (AZN -2.2%) COVID-19 vaccine candidate AZD1222.
The study, part of the company’s large-scale development program, will be conducted at four sites in St. Petersburg and Moscow.
