Amgen (NASDAQ:AMGN) invests an additional amount of ~$421M in BeiGene’s (NASDAQ:BGNE) registered direct offering of ordinary shares, which maintains Amgen’s current pro rata ownership of BeiGene at ~20.3%.
Monday, July 13, 2020
Equillium up big on positive data on itolizumab in COVID-19
Thinly traded nano cap Equillium (NASDAQ:EQ) rockets 207% premarket on increased volume in reaction to an announcement from partner Biocon Limited (OTC:BCNQY) that results from a clinical trial in India showed that itolizumab significantly reduced mortality in hospitalized COVID-19 patients.
The Drugs Controller General of India has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS).
Equillium is planning to conduct a global randomized study testing itolizumab in COVID-19 patients. An IND is next up.
Itolizumab is a monoclonal antibody that binds to an immune checkpoint receptor called CD6 that plays a key role in a wide range of immuno-inflammatory diseases.
Axonics sees Q2 net revenue as high as $15M
Axonics Modulation Technologies (NASDAQ:AXNX) reported preliminary Q2 revenue and provided an operational update.
Net revenue is expected to be $15.2M, as compared to $1.5M in Q2 2019.
U.S. Sales accounted for ~96% of total revenue.
New order flow in April was de minimis due to COVID-19-related restrictions on elective procedures.
New order flow began a gradual recovery in early May and June as restrictions were lifted in certain states.
Average weekly new order flow in June was ~$2M, or 70% of the weekly average achieved in Q1 2020.
Over 485 unique accounts (hospitals and ambulatory surgery centers) in the U.S. have implanted patients with the Axonics r-SNM System, including more than 110 new accounts that were added in Q2 2020.
As of June 30, cash and cash equivalents were $288M.
Axonics will report complete Q2 results and provide a further operational update after the market closes on August 6.
Pfizer COVID-19 vaccine candidates nab accelerated review status in U.S.
The FDA grants Fast Track designation to Pfizer’s (NYSE:PFE) and collaboration partner BioNTech’s (NASDAQ:BNTX) two of the four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against COVID-19.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
Early data from the German trial of BNT162b1 are expected this month.
If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100M doses by year-end and potentially more than 1.2B doses by the end of 2021.
Altimmune up on positive COVID-19 vaccine data
Altimmune (NASDAQ:ALT) announces positive preclinical data AdCOVID, its intranasal COVID-19 vaccine candidate. The studies, conducted in collaboration with the University of Alabama at Birmingham, showed “strong” serum neutralizing activity and “potent” mucosal immunity in the respiratory tract.
Based on these data, it plans to start manufacturing and advance AdCOVID into Phase 1 development in Q4.
The company says AdCOVID is designed to express the receptor binding domain (RBD) of the SARS-CoV-2 virus spike protein, a key immune target that is essential for the virus to bind to cells and initiate infection.
Quest Diagnostics sees non-GAAP EPS between $1.39 – $1.42 for Q2
Q2 reported revenue is expected to be ~$1.83B, vs. consensus of $1.52B.
Volume, measured by the number of requisitions, declined ~18% versus the prior year.
Testing volumes in the company’s base business (excluding COVID-19 molecular and antibody testing) declined ~34% Y/Y.
EPS from continuing operations is expected to be between $1.33 and $1.36, compared to $1.51 in 2019.
Non-GAAP EPS is expected to be between $1.39 and $1.42, compared to S&P Capital IQ consensus of $0.25.
The company will report Q2 results on July 23, before the market opens.
NovaBay up on data for effectiveness of Avenova in killing coronavirus
Nano cap NovaBay Pharmaceuticals (NYSEMKT:NBY) announces results from testing by a third-party laboratory confirming that Avenova, its proprietary formulation of pure hypochlorous acid, kills the SARS-CoV-2 virus.
The data will be submitted to the Environmental Protection Agency (EPA) for its approved list of disinfectants against the coronavirus.
The product is commercially available via Amazon and Avenova.com.
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