Pfizer and BioNTech Vaccines Were Granted FDA Fast Track Designation Against SARS-CoV-2 (COVID-19) A large Phase 2b/3 safety and efficacy study may begin as early as July 2020 Pfizer (PFE) and BioNTech (BNTX) announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed against SARS-CoV-2 (COVID-19) received Fast Track designation from the U.S. Food …

Corvus Pharmaceuticals: FDA Granted IND Application for COVID-19 Trial The United States FDA granted approval of Corvus Pharmaceuticals (CRVS) investigational new drug (IND) application for a COVID-19 trial. Corvus announced the beginning of the Phase 1 study that intends to enroll up to 30 patients. The . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Prohost Letter #441 Biotechnology Companies’ Evaluations Are We Saying Goodbye to Common Sense? The SARS-CoV-2 Vaccines It is said that the difference between the SARS-CoV-2 coronavirus (COVID-19), which is causing the pandemic around the world we are currently suffering from, and other coronaviruses like SARS and/or MERS is that SARS-CoV-2 ability to replicate in the human bodies' respiratory system’s upper airways more than the others. …

Unclear Reasoning for the Inovio Selloff Though Inovio (INO) announced positive interim clinical data of INO-4800 (its vaccine candidate against novel coronavirus (SARS-CoV-2)) from the first of two Phase 1 clinical trial cohorts, the stock still fell around 11%. The reason for the selloff is still unclear to us. Some have said the reason for the stock . . . This content is for paid …

A Letter to Subscribers The complex brutal circumstances we are currently living in has made it imperative that we communicate with you so that you can understand how we at Prohost Biotech are acting in these difficult times. Current news announcing that the SARS-CoV-2 virus is infecting more, not fewer, people in many U.S. states and overseas. In the meantime, we are observing the tremendous …

Novel Coronavirus Vaccines and Wall Street Vaccines against novel coronavirus are recognized now as the only way to return disrupted human lives back to normal. Vaccines have become the most important topic for Wall Street’s investors and analysts especially at times when the virus demonstrates its capability to continue disrupting human lives on the entire planet. Betting up and down on the firms that are …

Inovio Received US DoD Funding for CELLECTRA® 3PSP Smart Device Inovio (INO) announced today it has received $71 million in funding from the U.S. Department of Defense (DoD) to support the large-scale manufacture of the company's proprietary CELLECTRA® 3PSP smart device and the procurement of CELLECTRA® 2000 devices. CELLECTRA® 3PSP was created to deliver the INO-4800 . . . This content is for paid subscribers. …

Good News for Jazz, Celldex, Inventiva & Illumina Jazz Pharmaceuticals Good News Jazz Pharmaceuticals (JAZZ) announced along with its partner PharmaMar (MSE: PHM) that the U.S. FDA has approved Zepzelca™ (lurbinectedin) for adults with metastatic small cell lung cancer (SCLC) and disease progression on or after platinum-based chemotherapy.  Zepzelca was granted accelerated approval based on the overall response rate (ORR) and duration of response. <Continued approval for this indication may be contingent upon verification and …

Illumina Diagnostic Test COVIDSeq to Detect SARS-CoV-2 Illumina (ILMN) was issued an Emergency Use Authorization (EUA) from the FDA for the first COVID-19 diagnostic test utilizing next-generation sequence technology. The authorization was granted for the Illumina COVIDSeq Test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from individuals suspected . . . This content is for paid subscribers. Please click here to subscribe …

Moderna mRNA-1273 Vaccine for COVID-19  The market is expected to open DOWN today. Moderna’s (MRNA) stock price, however, is expected to post gains as news coming from the company is highly encouraging. Moderna announced progress on the late-stage development of mRNA-1273, the Company’s mRNA vaccine candidate against COVID-19. Based on feedback from the . . . This content is for paid subscribers. Please click here to …

Sonoma Pharmaceuticals and MicroSafe Group, Dubai Sonoma Pharmaceuticals (SNOA) develops stabilized hypochlorous acid (HOCl) products for a wide range of applications including: wound care, eye care and dermatological conditions. Together with MicroSafe Group, Dubai, announced the receipt of approval from Australia for Nanocyn® Disinfectant & Sanitizer, manufactured by Sonoma using its . . . This content is for paid subscribers. Please click here to subscribe or …

The Week in Review #51 Questions & Answers About CytomX Q: Is there any reason for the CytomX stock selloff that occurred in early May? In order to answer this question we need to explain CytomX’s (CTMX) Probody therapeutics. These novel treatments are designed to remain inactive until they are activated only . . . This content is for paid subscribers. Please click here to subscribe …

Inovio DNA Vaccine Candidate INO-4800 for SARS-CoV-2 Inovio (INO) announced the publication of the preclinical study data for its novel coronavirus SARS-CoV-2 DNA vaccine INO-4800 which is demonstrating robust neutralizing antibody and T cell immune responses against COVID-19. The study was published in the peer-reviewed journal Nature Communications titled, "Immunogenicity of a . . . This content is for paid subscribers. Please click here to subscribe …

Moderna Postive News for mRNA-1273 Vaccine Against Novel Coronavirus (COVID-19) Moderna (MRNA) announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2 or COVID-19), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID) which is part of the National Institutes of Health (NIH). According to the firm’s press release, Immunogenicity data are currently available …

Sorrento Therapeutics Anti-SARS-CoV-2 Antibody STI-1499 Sorrento Therapeutics (SRNE) announced that its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100% inhibition of SARS-CoV-2 (COVID-19) virus infection in an in vitro virus infection experiment at a very low antibody concentration. Sorrento has screened billions of antibodies in its proprietary G-MAB™ fully human antibody library and has so far identified hundreds of antibody candidates that bind the S1 subunit of the SARS-CoV-2 Spike protein. …

Novavax Still Rallying After Grant The Grant That Continues To Rally the Stock Novavax (NVAX) stock continues its ascent following yesterday's announcement that the firm was granted up to $384 million by the coalition for Epidemic Preparedness innovation. We remind that the grant is to help the advancement in the clinical development of the firm’s SARS-CoV-2 (

Impacting News from Novavax, CymaBay Therapeutics and Sanofi SA Novavax  The Grant That Rallied the Stock Novavax (NVAX) stock jumped sky-high following the announcement that the firm has been granted up to $384 million by the coalition for Epidemic Preparedness innovation. The grant is to help the advancement in the clinical development of the firm’s SARS-CoV-2 (COVID . . . This content is for paid …

Prohost Letter #440 Coronavirus The Therapeutics Gilead’s Remdesivir Treating COVID-19 patients requires therapeutic products that can deal with moderate and severe persistent symptoms that are unwilling to ease or completely disappear after weeks of isolation, when following the distancing and wearing masks. The first product proven effective and safe to be granted FDA Emergency Use Approval (EUA) happens to be remdesivir from Gilead Sciences (

Pluristem Therapeutics IND Cleared by FDA for PLX Cells in COVID-19 Treatment From Pluristem Therapeutics (PSTI) we learned that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a Phase 2 study of its PLX cells in the treatment of severe COVID-19 cases complicated by Acute Respiratory . . . This content is for paid subscribers. Please click here …

Moderna Coronavirus Vaccine Cleared for Phase 2 Moderna (MRNA) provided business updates for the first quarter of 2020 and highlighted pipeline progress. The current most important of the news is that the FDA has cleared Moderna’s coronavirus vaccine to proceed with the central Phase 2 study.   The . . . This content is for paid subscribers. Please click here to subscribe or here to log in.