BTAI On Track To Report SERENITY Data, REGN Hits All-time High, THMO On Watch

Today’s Daily Dose brings you news about BioXcel’s near-term catalyst; validation of Co-Diagnostics’ CoPrimer technology for use with saline oral rinse samples; Regeneron Pharma’s regulatory catalyst; and FDA allowing ThermoGenesis’ SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit for distribution.

Read on…

Shares of BioXcel Therapeutics, Inc. (BTAI) jumped nearly 15 percent on Thursday as the Company gears up to report top-line data from SERENITY I & II trials in mid-2020.

The SERENITY I trial is evaluating BXCL501 in patients with agitation associated with schizophrenia, while SERENITY II is testing BXCL501 in patients with agitation associated with bipolar disorder.

BTAI closed Thursday’s trading at $27.50, up 14.97%.

OralDNA Labs, a CLIA-certified laboratory, has recently validated a COVID-19 PCR test based on Co-Diagnostics Inc.’s (CODX) patented CoPrimer technology for use with saline oral rinse samples and has notified the FDA of their intent to use the validated test in their CAP-accredited high-complexity laboratory.

Commenting on the development, Dwight Egan, Co-Diagnostics CEO, remarked “This validation on the OraRisk line of salivary diagnostics showcases the versatility and flexibility of our CoPrimer platform and COVID-19 test. Saliva specimens are easily collected with a simple swish and gargle, as opposed to more invasive collection methods such as nasal swabs. We are pleased that our technology is being deployed in so many areas in the United States and countries across the world, providing the type of quality, high-throughput diagnostic solutions that many experts agree is the most important step to curbing the spread of COVID-19 and saving lives.”

Early this month, the Company’s Logix Smart Coronavirus COVID-19 Test obtained Emergency Use Authorization by the FDA to be used for the diagnosis of SARS-CoV-2. The Logix Smart Coronavirus COVID-19 Test uses the Company’s patented CoPrimer technology to target the RdRp gene of the SARS-CoV-2 virus.

CODX closed Thursday’s trading at $13.65, up 43.68%.

Pulmatrix Inc. (PULM), on Thursday, entered into a Collaboration and License Agreement with Sensory Cloud Inc., a privately held company, to develop and commercialize a potential nasal prophylactic and anticontagion product for COVID-19.

Under the terms of the agreement, Pulmatrix has granted Sensory Cloud an exclusive, worldwide, royalty-bearing license to PUR 003 and PUR 006 (NasoCalm), the Company’s proprietary salt formulations for aerosol nasal administration.

In other news, the Company announced that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 4.79 million shares of the Company’s common stock, at a purchase price of $1.671 per share, in a registered direct offering.

Pulmatrix has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 4.79 million shares of common stock. The closing of the offering is expected to occur on or about April 20, 2020, subject to the satisfaction of customary closing conditions.

PULM closed Thursday’s trading at $1.77, up 5.99%. In after-hours, the stock fell 20.90% to $1.40.

Regeneron Pharmaceuticals Inc.’s (REGN) Biologics License Application for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection, has been accepted for priority review by the FDA, with a decision date set for October 25, 2020.

Developed with funding provided by the Biomedical Advanced Research and Development Authority (BARDA), REGN-EB3, in clinical trials, has proven to be of superior efficacy compared to ZMapp, an experimental treatment of Ebola virus disease, across multiple measures, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream.

REGN-EB3 has been developed using Regeneron’s proprietary VelociSuite rapid response technologies, and the same approach is being applied by the Company to develop an antibody medicine that can potentially prevent and treat COVID-19, with initial clinical trials expected to begin in June 2020.

REGN touched an all-time high of $541.94 in intraday trading before closing the day at $539.93, up 5.52%.

Shares of ThermoGenesis Holdings Inc. (THMO) jumped to a new high of $8.78, gaining as much as 91% in intraday trading on Thursday, on receipt of an acknowledgment letter from the FDA allowing its SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit for distribution.

The SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit is intended for in vitro qualitative detection of IgM and IgG antibodies in human serum, plasma or whole blood from individuals suspected of COVID-19 by their healthcare point of care provider.

The COVID-19 Kit will be jointly marketed by ThermoGenesis and ImmuneCyte Life Sciences, Inc.

ThermoGenesis is also developing a convalescent plasma strategy for COVID-19 with its SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit, which, together with ImmuneCyte’s newly acquired technologies, can quickly identify individuals who have developed protective immunity against the virus. The plasma and immune cells of the convalescent patients will be isolated using ThermoGenesis’ proprietary cell processing platform for potential anti-COVID-19 antibody development.

Some of the research organizations are testing if convalescent plasma transfusions are effective in the treatment of COVID-19. According to Marcia Lucia Madariaga, University of Chicago Medicine, until vaccines or therapeutics are approved, the convalescent plasma therapy can be a stopgap measure to treat COVID-19 patients who are still in the hospital with severe disease symptoms.

THMO closed Thursday’s trading at $6.60, up 43.79%.

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