RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
The independent Data Safety Monitoring Committee (DSMC) has completed its first interim analysis of a Phase 2b/3 clinical trial evaluating CytoDyn’s (OTCQB:CYDY) leronlimab in severe-to-critical COVID-19 patients. The analysis was performed on data from the first 50% (n=195) of participants.
The DSMC recommends that the study continue unchanged.
The next safety review will be conducted when enrollment reaches 75% (n=293).
Full enrollment (n=390) should be achieved before year-end.
Quant rating is Very Bearish.
Novavax (NASDAQ:NVAX) announces that R&D chief Gregory Glenn, M.D., will present data on NVX-CoV2373, its COVID-19 vaccine candidate, at the World Vaccine Congress Europe this week.
The presentation is scheduled for 8:10 am ET but the specific day is not provided.
NVX-CoV2373 is currently being tested in a Phase 3 trial in the U.K. and two Phase 2 studies (South Africa and the U.S./Australia) that launched in August.
Shares up 1% premarket on light volume.
Nano cap Astrotech (NASDAQ:ASTC) rockets 79% after hours in reaction to its partnership with Cleveland Clinic to develop a rapid screening test for COVID-19 based on breathing into a tube.
The test will leverage Astrotech’s BreathTest-1000 mass spectrometer which, the company says, can potentially screen patients in as little as 60 seconds.
A clinical trial should launch in the coming months.
Financial terms are not disclosed.
Affimed (AFMD -2.2%) and NKMax America have entered into a clinical collaboration agreement to investigate the combination of former’s AFM24 with later’s autologous NK cell product SNK01.
The companies plan to explore the combination in a first-in-human proof-of-concept trial in patients with EGFR-expressing tumors, to establish safety and recommended dose.
Under the agreement, the companies will contribute their respective product candidates and resources towards submitting an Investigational New Drug application to the FDA.
The clinical trial will combine SNK01 with AFM24 in the autologous setting with the option to expand the clinical trial to the allogeneic setting. The cost of the clinical study will be shared by Affimed and NKMax America.
AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding ICE, activates innate immunity to kill solid tumors, inducing both antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
First-in-human Phase 1/2a multiple ascending dose escalation/expansion study is underway evaluating AFM24 as monotherapy in patients with advanced solid EGFR-expressing malignancies whose disease has progressed after treatment with previous anticancer therapies.
Tenet Healthcare (NYSE:THC): Q3 Non-GAAP EPS of $0.64 beats by $0.40; GAAP EPS of -$1.87 misses by $2.04.
Revenue of $4.56B (-0.2% Y/Y) beats by $170M.
