Dynavax (NASDAQ:DVAX) has completed the enrollment of 119 patients in a Phase 1 clinical trial evaluating a four-dose regimen of Heplisav-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] in adults with end-stage renal disease who are initiating or undergoing hemodialysis.
The primary endpoints are safety and seroprotection rate at week 20.
Final immunogenicity data should be available in Q4.
Shares up 3% premarket on modest volume.
Aytu BioScience (NASDAQ:AYTU) announces results from a National Cancer Institute evaluation of the performance of its COVID-19 IgG/IgM rapid antibody blood test. Results from a 110-sample panel (30 confirmed positives, 80 confirmed negatives):
IgG sensitivity/specificity: 96.7%/97.5%.
IgM sensitivity/specificity: 100.0%/100.0%.
Combined sensitivity/specificity: 100.0%/97.5%.
The FDA OK’d the emergency use of the test on May 29.
The American Health Care Association and the National Center for Assisted Living have sent a letter to HHS and FEMA requesting $5B in emergency funding and support for assisted living communities dealing with the COVID-19 pandemic. Residents, along with those in nursing homes, are among the most vulnerable to infection.
Operators intend to use the funds, if provided, to hire additional staff, provide overtime pay, buy PPE gear, for testing/diagnosing the respiratory infection and other uses.
There are more than 42K assisted living communities in the U.S. with more than 1M total residents.
Lakeland (NASDAQ:LAKE): Q1 GAAP EPS of $1.07 beats by $0.92.
Revenue of $45.58M (+84.7% Y/Y) beats by $17.81M.
CytoDyn (OTCQB:CYDY) will host an investment community conference call on June 11 at 4:00 p.m. ET to provide an update on several recent clinical and regulatory developments, potential uplisting and potential licensing and/or distribution agreements.