The Daily Biotech Pulse: InflaRx Begins Human Testing For COVID-induced Pneumonia, Chembio, Becton Dickinson Launch Coronavirus Tests

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs March 31)

• Athersys Inc ATHX
• Forty Seven Inc FTSV
• Ra Pharmaceuticals Inc RARX
• Quidel Corporation QDEL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 31)

• Aikido Pharma Inc AIKI
• BIOLASE Inc BIOL
• Eloxx Pharmaceuticals Inc ELOX
• Gritstone Oncology Inc GRTS
• Neovasc Inc NVCN(moved in reaction to its fourth quarter results)
• Opko Health Inc. OPK
• Phio Pharmaceuticals Corp PHIO(announced $4 million registered offering)
• Second Sight Medical Products Inc EYES

Related Link: Amarin Analysts React To Vascepa Patent Loss, See Small Chance Of Overturning Judgment

Stocks In Focus

Inflarx Begins Human Testing Of Lead Drug For COVID-19-induced Pneumonia

German biopharma Inflarx NV IFRX said it has enrolled and dosed the first patient into a randomized clinical trial investigating the safety and efficacy of IFX-1, its monoclonal anti-C5a antibody in patients with severe COVID-19-induced pneumonia. The trial is being initiated in the Netherlands.

The decision to initiate human testing follows initial positive human data from two patients suffering from COVID-19-induced pneumonia, who were treated with BDB-001, an anti-C5a antibody produced from BDB from the IFX-1 cell line, in China.

The company said it plans to initiate additional centers in Germany and potentially other European countries.

In pre-market trading Wednesday, InflaRx shares were jumping 114.66% to $8.20.

Emergent Biosolutions To Provide CDMO Services For Novavax's Flu Vaccine Candidate

Novavax, Inc. NVAX and Emergent Biosolutions Inc EBS announced an agreement, whereby the latter would provide molecule-to-market contract development and manufacturing to produce the former's recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M adjuvant.

Novavax recently announced positive results for the late-stage trial that evaluated the vaccine candidate.

Novavax shares were adding 3.09% to $14 in pre-market trading.

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Mesoblast's Regulatory Filing For Graft Vs. Host Disease Drug Accepted For Priority Review

Mesoblast limited MESO said the FDA has accepted for priority review its BLA for Ryoncil, its allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease. The PDUFA date has been set for Sept. 30, the company noted.

The stock was advancing 8.45% to $4.75 in pre-market trading.

Eisai To Co-develop And Commercialize Seikagaku's Osteoarthritis Drug In China

Eisai Co., Ltd ESALY announced an agreement with Seikagaku for co-developing and marketing of SI-613 in China. SI-613 is a therapeutic agent for osteoarthritis discovered by Seikagaku.

Chembio Launches Serological COVID-19 Detection Test In U.S.

Chembio Diagnostics Inc CEMI said it has launched in the U.S. the rapid DPP COVID-19 serological point-of-care test for the detection of IgM and IgG antibodies.

"These results can be obtained within 15 minutes from a simple finger stick utilizing Chembio's MicroReader 1 and MicroReader 2 analyzers which are produced by Chembio Germany," the company said.

The stock was jumping 23.05% to $6.30 in after-hours trading.

Becton Dickinson Releases COVID-19 Test Developed By BioMedomics

Medtech company Becton Dickinson and Co BDX and privately held diagnostics company BioMedomics announced the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes.

The new test developed and manufactured by BioMedomics will be available through BD and distributed exclusively by Henry Schein, Inc. HSIC to health care providers throughout the U.S.

BD shares were adding 0.97% to $232 in pre-market trading.

Ultragenyx Out-licenses Gene Therapy Platforms And In-licenses Gene Therapy Vectors

Ultragenyx Pharmaceutical Inc RARE announced a strategic partnership and non-exclusive license and technology access agreement with DAIICHI SANKYO/S ADR DSNKY for its AAV-based gene therapy manufacturing technologies, namely its HeLa PCL and HEK293 transient transfection manufacturing technology platforms.

The agreement provides for Daiichi Sankyo making an upfront payment of $125 million and an equity investment amounting to $75 million at about $60 per share in Ultragenyx. Daiichi Sankyo will pay an additional $25 million upon completion of the technology transfer of the HeLa PCL and HEK293 platforms as well as single-digit royalties on net sales of products manufactured in either system.

Separately, Ultragenyx and Regenxbio Inc RGNX announced a new exclusive, worldwide license agreement, extending the companies' existing gene therapy partnership. Under the agreement, REGENXBIO has granted Ultragenyx an exclusive, worldwide license, with rights to sublicense, to its NAV AAV8 and AAV9 vectors for the development and commercialization of gene therapy treatments for a rare metabolic disorder. Regenxbio will be compensated with an upfront payment of $7 million, ongoing fees, milestone payments, and royalties on net sales of products incorporating the licensed intellectual property.

On The Radar

Earnings

Ascendis Pharma A/S ASND (after the market close)