Moderna (NASDAQ:MRNA) +15.9% after-hours, as a study in the New England Journal of Medicine says the company’s mRNA-1273 experimental vaccine for COVID-19 produced antibodies to the coronavirus in all 45 patients tested in an ongoing phase 1 trial.
The neutralizing antibody levels produced were equivalent to the upper half of those seen in patients who get infected with the virus and recover, according to the report by researchers from the National Institute of Allergy and Infectious Diseases.
The study says mRNA-1273 was generally safe and well-tolerated, with no serious adverse events reported through Day 57, although more than half of those who received the middle of three doses suffered mild-to-moderate fatigue, chills, headache and muscle pain.
“That is a lot of adverse events,” Tony Moody, a doctor and researcher at the Duke Human Vaccine Institute, tells Bloomberg, but the antibody levels produced were “really encouraging.”
Moderna earlier said it would begin its phase 3 trial of mRNA-1273 on 30K adult participants on July 27.
Representing yet another shining example of the volatility risk in chasing biopharma breakouts, Osmotica Pharmaceuticals (OSMT -20.9%) has completed its round trip.
Shares jumped on July 9 after the company announced the FDA nod for Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1% for droopy eyelid, peaking at $9.67 (+52%) the next day. On cue, the company dutifully announced an equity offering at $6.55 that sent shares south. The stock is currently exchanging hands at $6.10, 4% below the closing price of $6.36 on July 8.
Moderna (MRNA +3.2%) will begin its Phase 3 trial of mRNA-1273 on 30K adult participants on July 27.
In the experimental arm, each participant will receive one injection of 100 microgram mRNA-1273 on Day 1 and on Day 29. There will also be a placebo arm. The study will take place across 87 locations.
Shares of Moderna are up more than 250% in the last six months, with the rally starting mid-March on hopes for a successful vaccine.
Dynavax Technologies (NASDAQ:DVAX) jumps 10% premarket on modest volume in reaction to its announcement that dosing is underway in a Phase 1 clinical trial evaluating Medicago’s plant-derived COVID-19 vaccine candidate that includes its CpG 1018 adjuvant (also used in HEPLISAV-B).
As previously reported, the companies plan to explore a broader collaboration aimed at other opportunities.
3M (NYSE:MMM) says it is collaborating with researchers at MIT to develop a rapid diagnostic test for the COVID-19 virus.
The company says accelerated research is underway to learn if a simple-to-use, diagnostic device can produce highly accurate results within minutes and is feasible to mass manufacture.
The U.S. National Institute of Health has selected the project for accelerated development and commercialization support, the company says.
3M last week halted a fraudulent scheme involving the promise of billions of non-existent N95 respirators and reiterated that it “has not and will not” increase the prices of its respirators as a result of the pandemic.
