Healthcare Roundup – FDA OKs emergency use of Siemens COVID-19 blood test, Short regimen of Gilead’s remdesivir beats standard-of-care in COVID-19 study

Published on: June 1, 2020
Author: Amy Liu

FDA OKs emergency use of Siemens COVID-19 blood test

The FDA has signed off on the emergency use of Siemens Healthineers’ (OTCPK:SMMNY) lab-based blood test that detects the presence of IgG and IgM antibodies to the SARS-CoV-2 virus.

The company says the test, run on automated high-throughput instruments, sports 100% sensitivity and 99.8% specificity.

The company is a bit late to the COVID-19 blood test game, already crowded with competitors.

Short regimen of Gilead’s remdesivir beats standard-of-care in COVID-19 study

Gilead Sciences (NASDAQ:GILD) is under modest pressure premarket, down 2% on light volume, on the heels of results from an open-label Phase 3 clinical trial evaluating antiviral remdesivir in hospitalized patients with moderate COVID-19 pneumonia.

Patients receiving the five-day regimen were 65% more likely to experience clinical improvement at day 11 compared to standard-of-care (SOC) treatment, a statistically significant outcome (p=0.017).

Patients receiving the 10-day course showed a trend of clinical improvement but the separation from SOC was not statistically significant (p=0.18).

Clinical improvement was assessed via a seven-point scale including hospital discharge, increased levels of oxygen, ventilatory support and death.

No new safety signals were observed.

AbbVie files marketing applications for new use of Rinvoq

AbbVie (ABBV -1.6%) has submitted marketing applications in the U.S. and Europe seeking approval to use Rinvoq (upadacitinib) 15 mg for the once-daily treatment of adults with active psoriatic arthritis.

The JAK inhibitor is currently approved in both territories for rheumatoid arthritis.

ReWalk Robotics jumps 24% on FDA nod for latest exoskeleton

In a bit of a delayed reaction, ReWalk Robotics (RWLK +24.4%) breaks out of consolidation on a 7x surge in volume in apparent reaction to FDA clearance of its Exoskeleton Personal 6.0 on May 26.

On the working capital front, at the end of March, it had $16.6M in cash while operations consumed $4.3M during the quarter. The balance includes the proceeds from its public offering in February.

Sensus Healthcare up 13% after it rejects buyout offer at $4/share

Sensus Healthcare (SRTS +13.0%) had received an unsolicited offer to acquire all the outstanding shares at a price of $4/share, in cash.

Following consideration by and at the direction of its Board of Directors, Sensus rejected the offer.

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