Search Results for: COVID-19

Don’t Miss the Enanta Pharmaceuticals Virtual Conference on October 19th – October 21st

Don’t Miss Enanta Pharmaceuticals Virtual Conference Enanta Pharmaceuticals (ENTA) – a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced that new preclinical data for EDP-235 – its lead oral protease inhibitor, which is specifically designed for the treatment of COVID-19, will be presented at the International Society for Influenza and Other Respiratory Virus Diseases (ISIRV)-World Health …

Atea Pharmaceuticals and Xenon Pharmaceuticals: Two Clinical-Stage Firms That Rallied Instead of Crashing Yesterday

Two Clinical-Stage Firms Rallied Yesterday On a day when the Stock Market was crushed, taking down with it shareholders’ money for no reason other than the self-serving untouchable agendas, two small biotechnology companies staged rallies. Atea Pharmaceuticals and Xenon Pharmaceuticals deserved the boosting of their stocks.   Atea Pharmaceuticals Atea Pharmaceuticals (AVIR) - a clinical-stage biopharmaceutical company, reported for the first time . . . …

Merck and Ridgeback Biotherapeutics Announced Successful Phase 3 Trial Results of Molnupiravir for Mild or Moderate COVID-19

Merck and Ridgeback Biotherapeutics COVID-19 News  Merck (MRK) and Ridgeback Biotherapeutics today announced that molnupiravir (MK-4482, EIDD-2801) - an investigational oral antiviral medicine, has significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

The World Health Organization Recommends Regeneron Pharmaceuticals Antibody Cocktail for COVID-19

Regeneron Welcomes the World Health Organization's Recommendation for Use of REGEN- COVTM to Treat COVID-19 The World Health Organization (WHO) updated its Therapeutics and COVID-19: living guideline to include the casirivimab and imdevimab monoclonal antibody cocktail, known as REGEN-COVTM in the U.S. and Ronapreve® in other countries. The guideline conditionally recommends REGEN-COV to treat high-risk non-hospitalized patients with non-severe COVID-19 and seronegative (no measurable . …

Comprehensive Prohost Letter Issues

The Comprehensive Prohost Letter Issues The Comprehensive Prohost Letter Issues will constitute a chain of 7 issues. Today’s issue will include the following: Pinpointing and selecting the biotech firms that demonstrate readiness to treat untreatable, devastating diseases. Presenting an important antibody cocktail for the treatment of COVID-19. Stating our position regarding the Alzheimer’s disease firm Cassava Sciences. Pinpointing Prohost’s . . . This content is …

Can-Fite Biopharma Has Encouraging News but Will It Enthuse Investors?

Can-Fite Biopharma Good News We learned, from Petach Tikva, Israel, that Can-Fite Biopharma (CANF) – a biotechnology company advancing its pipeline of small molecule drugs that address inflammatory, cancer and liver diseases, announced its completion of enrollment of all patients (>400) planned for its Phase 3 Comfort™ study with the firm’s product Piclidenoson in patients with moderate to severe plaque psoriasis.  Piclidenoson is a novel, …

Why Virpax Pharmaceuticals Stock Soared on Two Consecutive Days

Virpax Pharmaceuticals  Virpax Pharmaceuticals (VRPX) - a company specializing in developing product candidates for pain management, CNS and anti-viral indications, announced the receipt of a written pre-investigational new drug (pre-IND) response from the U.S. Food and Drug Administration (FDA) for MMS019, its patented and proprietary high-density molecular masking spray under development for use . . . This content is for paid subscribers. Please click here to subscribe …

Immunome Inc Stock Rallied After Announcing it Neutralized the SARS-CoV-2 Delta Variant.

Immunome Inc: Neutralizing SARS-C0V-2 Delta Variant Immunome Inc (IMNM) is a small biotech firm whose stock soared after announcing today that its three-antibody cocktail (IMM-BCP-01) demonstrated potent neutralizing activity against the SARS-CoV-2 (the virus that cause COVID-19) Delta variant in pre-clinical pseudovirus testing. The IMM-BCP-01 cocktail demonstrated in-vitro activity via non-neutralizing mechanisms, such as complement fixation, which Immunome expects will enable viral clearance. From the …

Important Steps Forward Taken by Vir Biotechnology and Separately by Compugen

Vir Biotechnology Vir Biotechnology (VIR) announced the dosing of the first patient in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial to evaluate VIR-2218 together with VIR-3434 for the treatment of patients with chronic hepatitis B virus (HBV) infection – a combination designed to achieve a functional cure. VIR-2218 is an investigational . . . This content is for paid subscribers. …

Vir Biotechnology: Promising Clinical Data from Ongoing Trials of VIR-2218 and VIR-3434 for Chronic HBV Infection  

Vir Biotechnology Announced Positive Safety Findings from its Ongoing Trials for Chronic HBV Vir Biotechnology (VIR) announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection. The results comprised positive safety findings in addition to a reduction in hepatitis . . . This content is for paid …

Vir Biotechnology

Prohost Portfolio PLUS #5 Vir Biotechnology Vir Biotechnology (VIR) combines cutting-edge technologies with immunologic insights to prevent and treat serious infectious diseases. Proof of concept and feasibility has been offered as demonstrated in early and mid-trial results; the firm, together with GlaxoSmithKline, have applied for the approval . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Humanigen Inc Product Lenzilumab Combination with CAR T in DLBCL Protects from Severe Cytokine Syndrome

Humanigen Product Lenzilumab Combination with CAR-T At the recommended Phase 2 dose, lenzilumab in combination with CAR-T demonstrated a 100% objective response rate and no severe cytokine release syndrome or severe neurotoxicity Lenzilumab reduced IL-6, CRP, ferritin, MCP-1, IL-8, and IP-10 (CXCL-10) among others Humanigen now plans to conduct a randomized, potentially registrational, Phase 2 study with lenzilumab combined with all commercially available CD19 CAR-T …

Vir Biotechnology and GlaxoSmithKline: The European Medicines Agency Started a Review of VIR-7831 for COVID-19

Vir Biotechnology and GlaxoSmithKline in April 2020  In April 2020, Vir Biotechnology and GlaxoSmithKline entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19). The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic …

CureVac N.V.

Prohost Portfolio PLUS #3 CureVac N.V. We were looking forward to learning more important details about the German firm, CureVac N.V. (CVAC), when the company announced business updates and financial results for its fourth quarter and full-year 2020. The reason for our interest was the fact that the U.S. was looking to take over this firm two years ago to no avail. A more important …

Inovio DNA Vaccine Candidate INO-4800 has Promising Results. Read Also: Sutro Biopharma Good News

Inovio Pharmaceuticals Promising Results for INO-4800 for COVID-19 Inovio Pharmaceuticals (INO) announces promising results of a study focusing on the human immune responses induced by Inovio DNA vaccine candidate, INO-4800, against COVID-19, and variants of concern. The results demonstrated that INO-4800 induced a robust T . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

CureVac Has Very Interesting Future Plans

CureVac CureVac B.V. (CVAC) is a global biopharmaceutical company specializing in messenger RNA (mRNA) technology. The firm has more than 20 years of expertise in developing and optimizing versatile biological molecules for prevention and treatment purposes. CureVac’s proprietary technology principle is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce . . . This content is for …

AstraZeneca to Supply Half a Million Additional Doses of the Potential COVID-19 Antibody Treatment AZD7442 to the U.S.  

AstraZeneca to Supply Additional Doses of AZD7442 to the U.S. for COVID-19  AstraZeneca (AZN) has modified an existing agreement with the U.S. Government to supply up to 500,000 additional doses of AZD7442 - a long-acting antibody (LAAB) combination in late-stage development, for the prevention and treatment of COVID-19. We stress . . . This content is for paid subscribers. Please click here to subscribe or here to …

Prohost Letter #444

Prohost Letter #444 The End of the Year Issue was delayed because our 2020 Prohost Portfolio stocks’ targets for the year failed to materialize; nobody not even the authorities were capable of predicting the pandemic, which continues to plague the world. As 2021 approached, we were unable to the End of the Year issue on time as we lacked the information required for the fair …

Johnson & Johnson COVID-19 Vaccine Voting Tomorrow with Expected Approval on Saturday

Johnson & Johnson COVID-19 Vaccine According to a new analysis posted online by the FDA, the Johnson & Johnson (JNJ) vaccine is providing strong protection against severe disease and death related to COVID-19 infection. The vaccine may reduce the spread of the virus from vaccinated people. The vaccine is said to have a 72% efficacy rate in the U.S. and 64% in South Africa. The …

Novavax is Bringing its COVID-19 Vaccine to the World’s Markets

Novavax Inc The Novavax (NVAX) COVID-19 Vaccine NVX-CoV2373 is on its way to reaching worldwide markets.  The Serum Institute of India (SII) and the Vaccine Alliance (Gavi) are to ensure equitable access to Novavax’s, NVX-CoV2373, vaccine worldwide across the low-, middle- and high-income countries. Memorandum of Understanding (MOU) between Gavi and Novavax to make available a cumulative volume of 1.1 billion doses of the Novavax vaccine to the COVAX Facility. The …

The Reasons for the Immunome, Inc Stock Rally

Immunome, Inc. Immunome, Inc (IMNM) announced today that its discovery engine has isolated potent antibodies capable of neutralizing several SARS-CoV-2 (the virus that causes COVID-19) variants, including the South African Variant (B.1.351), in pseudovirus testing.  This effort is part of the company’s ongoing program to develop a cocktail of antibodies targeting spike and non-spike proteins that can serve as prophylaxis or treatment for COVID-19. Immunome’s …

Vir Biotechnology and GlaxoSmithKline Expanded Agreement

Vir Biotechnology and GlaxoSmithKline Expanded Collaboration  Vir Biotechnology (VIR) and GlaxoSmithKline plc (GSK) announced the signing of a binding agreement to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses. The Expanded Collaboration This new collaboration builds on a 2020 agreement to research and develop therapies for coronaviruses and provides GlaxoSmithKline exclusive rights to collaborate …

Moderna COVID-19 Vaccine Produced Neutralizing Titers Against Key Emerging Variants Tested

Moderna COVID-19 Vaccination News A vaccination with the Moderna (MRNA) COVID-19 produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and the Republic of South Africa, respectively. The study showed no significant impact on neutralizing titers against the B.1.1.7 variant relative to prior variants. A six-fold reduction in neutralizing titers was observed with the B.1.351 variant …

Merck Has Interesting News and Impressive Results

Merck Discontinues Development of COVID-19 Vaccine Candidates Merck (MRK) known as MSD outside the United States and Canada announced yesterday that the company is discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 . . . This content is for paid subscribers. Please click here …

Inovio: Exciting News Published in The Lancet

Inovio Phase 1 Data of INO-4800 for COVID-19 Peer-reviewed Phase 1 data shows Inovio COVID-19 DNA Vaccine Candidate, INO-4800, to be immunogenic in 100% of subjects, inducing neutralizing antibody and/or T cell responses. INO-4800 demonstrates favorable safety and tolerability. No serious adverse events reported. Offers best-in-class thermostability, including a five-year projected shelf life at normal refrigeration temperature and no frozen transport or storage requirements. INOVIO …

Why Intellia Therapeutics’ and Moderna’s Stocks Moved South Yesterday

Intellia Therapeutics Intellia Therapeutics (NTLA) stock price headed south probably because some robots learned that the firm commenced an underwritten public offering of $150 million of shares of its common stock. In addition to the commenced public offering Intellia announced its intention to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares . . . This content is …

A New COVID-19 Vaccine is Showing Successful Results. See Also: More Details About the Effective COVID-19 Vaccines

COVID-19 Vaccine Updates Pfizer’s (PFE)/BioNTech’s (BNTX) and Moderna’s (MRNA) COVID-19 vaccines have demonstrated safety at around 95% efficacy.   AstraZeneca (AZN) and Oxford University announced today that their COVID-19 vaccine was 90% effective in preventing infections. The efficacy average, however, was 70%, leading the stock to travel south rather than north.     Regardless of the efficacy differences AstraZeneca stated that it would immediately prepare …

Regeneron Granted FDA Emergency Use Authorization for its COVID-19 Antibody Cocktail Therapy

Regeneron Pharmaceuticals Receives EUA from the FDA for REGEN-COV2 Regeneron Pharmaceuticals’ (REGN) antibody cocktail therapy casirivimab and imdevimab, known also REGN-COV2 or REGEN-COV2, received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The FDA EUA is for the treatment of mild to moderate COVID-19 in adults as well as pediatric patients at least 12 years of age and weighing at least …

PTC Therapeutics’ Many Attractive Achievements and Approvals

PTC Therapeutics Approvals and Achievements PTC Therapeutics (PTCT) has achieved a lot recently. The latest is the August approval from the U.S. FDA of its product Evrysdi (risdiplam), the first orally administered at-home treatment for spinal muscular atrophy (SMA) in adults and children 2 months and older.   Evrysdi has been granted approvals in Brazil, Chile and Ukraine as . . . This content is …

Inovio to Proceed with Phase 2 Trial of INO-4800 Vaccine Candidate for COVID-19

Inovio Announced FDA Clearance to Proceed with Trial for COVID-19 Vaccine Candidate Inovio (INO) announced the receipt of the U.S. FDA clearance to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine candidate. Inovio Planned Phase 2/3 INNOVATE Trial The INNOVATE trial - a . . . This content is for paid subscribers. Please click here to …

Moderna’s Successful COVID-19 Vaccine Results

Moderna Has Successful COVID-19 Vaccine Results and News Moderna’s Phase 3 study met statistical criteria with a vaccine efficacy of 94.5%. Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months. Moderna (MRNA) announced that …

Moderna’s Future Growth

Moderna Inc COVID-19 Vaccine Candidate Moderna Inc (MRNA) announced the completion of the case accrual for the first interim analysis of Phase 3 COVE study of mRNA-1273, its COVID-19 vaccine candidate. The firm announced a significant increase in the rate of case identification across sites in the last week. As a result, the Company expects the first interim analysis will include substantially more than 53 …

Pfizer and BioNTech Vaccine Candidate Against COVID-19 Achieved a Sweet Success

Pfizer and BioNTech Good News Regarding COVID-19 Vaccine Candidate Pfizer (PFE) and BioNTech (BNTX) announced that their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 (the virus that causes COVID-19) has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of the SARS-CoV-2 infection; this is based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee …

Tracking the News from AstraZeneca About Experimental Vaccine, AZD1222, for COVID-19

News from AstraZeneca About COVID-19 Vaccine, AZD1222 From AstraZeneca (AZN) we learned that its COVID-19 vaccine, AZD1222, which is being developed in collaboration with Oxford University, has produced a similar immune response in older and younger adults. A spokesman from the firm stated that the results have further built the body of evidence for the safety and immunogenicity of AZD1222. On October 23, 2020 AstraZeneca’s …

The U.S. FDA Approves Gilead Sciences Antiviral Veklury® (remdesivir) for COVID-19

Gilead Sciences Veklury® (Remdesivir) was Approved by the US FDA The U.S. FDA approved Gilead Sciences (GILD) antiviral drug Veklury® (remdesivir) for COVID-19 infected patients who require hospitalization. Veklury halts the SARS-CoV-2 replication that causes COVID-19. Veklury is the first and only approved COVID-19 treatment (not vaccine) in the U.S.. The news announced that the drug is widely available in hospitals across the country. The …

We Continue to Track the COVID-19 Vaccines. See Also: CRISPR Therapeutics Immuno-Oncology Results are Good.

The Latest on the COVID-19 Vaccines AstraZeneca (AZN): After pausing for more than a month, AZN is expected to resume its Phase 3 US study of its COVID-19 vaccine. The trial was paused after a patient, who received the vaccine, developed an illness suspected to be a serious spinal inflammatory condition known as transverse myelitis. The patient was . . . This content is for …

Tracking COVID-19 Vaccines

COVID-19 Vaccines from Pfizer/BioNTech and Moderna The three products whose trials were halted are not vaccines but, rather, antibodies that treat patients who already have COVID-19. With regard to the COVID-19 vaccines we believe we have encouraging news from Pfizer/BioNTech’s and Moderna’s mRNA vaccines. The Pfizer/BioNTech Vaccine  Pfizer (PFE) Chairman and CEO, Albert Bourla, stated that the mRNA vaccine developed together with BioNTech (BNTX) will …

An Acquisition & a Collaboration You Must Know About

Bristol-Myers Squibb Increased activity being observed at Bristol-Myers Squibb (BMY) is aimed at further empowering the firm's various franchises. It all started with the firm’s attempt to empower its oncology franchise with the creation and approval of its checkpoint protein inhibitor Opdivo (nivolumab) - a programmed Death-1 (PD-1) inhibitor. This antibody has been the most successful attempt . . . This content is for paid …

Enlivex Therapeutics Product AllocetraTM Saves Severe/Critical COVID-19 Patients

Enlivex Therapeutics Positive Results for Severe and Critical COVID-19 Patients Enlivex Therapeutics (ENLV) – a clinical-stage immunotherapy company, reported positive results of an investigator-initiated clinical trial of the firm’s product AllocetraTM in severe/critical COVID-19 patients. The clinical trial included as few as five COVID-19 patients, three of whom were in severe condition, and two in critical condition. The good news is that all five patients …

Cassava Sciences, Moderna and Sorrento Therapeutics All Have News

News from Cassava Sciences, Moderna and Sorrento Therapeutics  Cassava Sciences  Cassava Sciences (SAVA) announced that clinical results of its Phase 2b study of sumifilam have been selected as a late-breaking oral presentation by the 13th international conference on Clinical Trials on Alzheimer’s Disease (CTAD). What is CTAD? CTAD is a prestigious annual conference focused on Alzheimer’s . . . This content is for paid subscribers. …

Sorrento Therapeutics Releases Preclinical Data from STI-1499 and STI-2020 Demonstrating Potent Neutralizing Antibodies Against SARS-CoV-2

Sorrento Therapeutics Preclinical Data of Neutralizing Antibodies Against SARS-CoV-2 In preclinical studies, both STI-1499 and STI-2020 demonstrated potent neutralizing activity against SARS-CoV-2 virus isolates, including the emerging Spike D614G variant virus. Both STI-1499 and STI-2020 demonstrated protective activities against SARS-CoV-2 infection in Syrian golden hamsters. At day 5, STI-2020 at 500 µg reduced virus load in hamster lungs to undetectable levels in 100% of animals …

Johnson & Johnson Launches a Large Scale Phase 3 Trial of Its COVID-19 Vaccine. See Also: Intellia to Prove the Advantages of CRISPR Gene-Editing

Johnson & Johnson ENSEMBLE Trial for Its COVID-19 Vaccine Candidate Johnson & Johnson (JNJ) announced the launch of its large-scale, pivotal, multi-country Phase 3 trial, ENSEMBLE, for its COVID-19 vaccine candidate, JNJ-78436735. The initiation of the ENSEMBLE trial follows positive interim results from Phase 1 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Eli Lilly Neutralizing Antibody LY-CoV555 Promises a Reduction in the Rate of COVID-19 Hospitalizations  

Eli Lilly and AbCellera Collaboration Result LY-C0V555  A lot of discoveries, followed by thorough experimentation beyond the vaccines, are taking place in the biotechnology and large biopharmaceutical companies to defeat COVID-19. The most recently discovered product by AbCellera, which was developed by Eli Lilly (LLY), is LY-CoV555 - a potent, neutralizing IgG1 monoclonal antibody (mAb), directed . . . This content is for paid subscribers. …

Gilead Sciences Could Acquire Immunomedics at $20 Billion. See Also: AstraZeneca Vaccine Trial Resumed

Gilead Sciences News Is Not Just Gossip Real news, not just gossip, is spreading today about Gilead Sciences (GILD) nearing a deal to acquire the biotech firm Immunomedics (IMMU) for $20 billion. Immunomedics current market value is around $10 billion which means that Gilead is buying it at double its value. The deal could be announced on Monday, if not sooner, if the talks go …

Sanofi and GlaxoSmithKLine COVID-19 Vaccines are Advancing in Clinical Trial

Sanofi and GlaxoSmithKline Have COVID-19 Vaccines Advancing in Clinical Trial Sanofi (SNY) and GlaxoSmithKline (GSK) started Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate developed by both firms uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines, with GSK’s established pandemic adjuvant technology. The Phase 1/2 clinical trial is a randomized, double-blind and placebo-controlled trial. It is …

The U.S. CDC Tells the 50 States to Prepare for COVID-19 Vaccines by the End of October

CDC Is Asking States to Prepare for COVID-19 Vaccines The U.S. Center of Disease Control and Prevention (CDC) has asked the 50 states’ public health officials to be ready to distribute potential COVID-19 vaccines to high-risk people, healthcare workers and others as soon as late October, as showed in a document yesterday. The New York Times (NYT) has also reported today that the CDC has …

Moderna Inc Stock is Tanking After Rallying

Moderna Inc Late August Announcements  On August 28, 2020 Moderna Inc (MRNA) issued a press release confirming that the Company is engaged in discussions with the Ministry of Health, Labor and Welfare of Japan (MHLW) to potentially purchase 40 million or more doses of its COVID-19 vaccine candidate, mRNA-1273. Under the terms of this arrangement the . . . This content is for paid subscribers. …

An Important Announcement from Sorrento Therapeutics

Sorrento Therapeutics Announcement Sorrento Therapeutics (SRNE) announced that it believes it has uncovered fraudulent attempts to manipulate the Company’s stock.  In a press release from August 12, 2020 Sorrento informed that, on August 11, 2020 it was reported that an organization calling itself “Hindenburg Research” published claims regarding one of Sorrento’s COVID-19 diagnostic products. The report is believed to include false and/or misleading statements for …

Monopar Therapeutics: A Plan for a Test that Predicts COVID-19 Patients Who Might Likely Develop Severe Respiratory Failure

A Predictive COVID-19 Test? COVID-19 infected people are not all affected to the same degree with regards to the severity of the disease complications. There is no doubt that a test that can predict which patients will be severely affected and which will not might save a lot of lives, money and unnecessary time spent in crowded hospitals.    Monopar Therapeutics in the NEWS  Monopar …

Inovio: Good News About the Firm’s COVID-19 Vaccine’s Capability and Durability

Inovio Inovio’s COVID-19 Vaccine INO-4800 Accomplished the Following: Durable antibody and T cell responses in rhesus macaques for 4 months. Long-term protection in non-human primates challenged with SARS-CoV-2 virus 13     weeks from vaccination. No other vaccine has demonstrated it. Reduced viral loads and faster viral clearance in macaques’ lungs and nasal passages as a result of a good Memory T and B cell …

Edesa Biotech Stock Price Soared. Will It Continue to Rise?

Edesa Biotech Filed an IND for EB05 Edesa Biotech (EDSA), a clinical-stage biopharmaceutical company, has filed an investigational new drug (IND) application with the U.S. FDA for the initiation of a Phase 2/3 clinical study of its investigational drug EB05. Edesa has recently received expedited approval to begin the Phase 2/3 study in Canada and is seeking government grants to accelerate site selection and initiate …

Moderna News. See Also: Regeneron Antibody Cocktail Could Reach the Market in October

SARS-CoV-2 Virus Vaccines Moderna On Monday Moderna (MRNA) started its Phase 3 clinical trial on 30,000 people with its product mRNA-1273. Separately, in a press release Moderna announced a preclinical study evaluating its product mRNA-1273 has been published in The New England Journal of Medicine. This study . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

A New Gene Therapy Series Starts Today with Regenxbio

Beyond the firms that are speeding towards bringing prophylactic vaccines against the COVID-19 infection into the clinic we have to consider the other firms that have been negatively affected by the virus pandemic; we expect them to rebound and surge when the virus loses its ability to kill. We decided to start with gene therapy companies that we believe have suffered from the delays of …

There Is A Lot More To Say About the COVID-19 Vaccines

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 …

A Novel Immunotherapy Approach for the Treatment of COVID-19

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.

Are We Saying Goodbye to Common Sense?

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. …

We Are Not Yet in Bizarro World

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

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 …

The COVID-19 Vaccines’ Developing Firms’ Bizarre Evaluations

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 $71 Million in Funding from the U.S. Department of Defense

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 Four Companies: Jazz, Celldex, Inventiva & Illumina

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’s COVIDSeq Test Granted Emergency Use Authorization. See Also: CRISPR Therapeutics and Vertex Encouraging News

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 Speeding Towards Delivering the Awaited Novel Coronavirus Prophylactic Vaccine

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 …

Why Sonoma Pharmaceuticals and Adaptimmune Stock Prices Skyrocketed

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 …

Questions & Answers

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: INO-4800 DNA Vaccine Against the Novel Coronavirus Has Promising News. Moderna Still Has the Front-Runner

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: Positive Interim Phase 1 Data for its mRNA-1273 Vaccine Against Novel Coronavirus

Moderna: Positive Interim Phase 1 Data for its mRNA-1273 Vaccine Against Novel Coronavirus

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: STI-1499 ~ An Encouraging Anti-SARS-CoV-2 Antibody

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. …

The Impacting News of the Day

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 …

Novel Coronavirus: The Therapeutics

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: The FDA Cleared Phase 2 Study of Its PLX Cells in Treating the Respiratory Complications of COVID-19

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 …

The FDA Cleared Moderna’s Coronavirus Vaccine for a Phase 2 Trial. The Stock Surged in Pre-market Hours

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.

Applied DNA Sciences and Takis Biotech: A DNA Vaccination Injection in Animals Induced Antibodies That Block SARS-CoV-2

Applied DNA Sciences and Takis Biotech Announce the Production of Neutralizing Antibodies Against SARS-CoV-2 After DNA Vaccination in Animals Beyond expectations, a single injection of DNA in mice induced antibodies that block the infection of cultured human cells by SARS-CoV-2. The press release, from Stony Brook, N.Y. and Rome, Italy, about a vaccine against COVID-19 developed by Applied DNA Sciences (

Moderna: Speeding down the Road Towards Developing a Prophylactic Vaccine Against the Novel Coronavirus (SARS-CoV-2)

Moderna Submitted an IND for Its mRNA Vaccine Candidate for Novel Coronavirus  Moderna (MRNA) announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its mRNA vaccine candidate, mRNA-1273, against the novel coronavirus, SARS-CoV-2. The filing is for the evaluation in Phase 2 and for late-stage studies if supported by safety data from the Phase …

Be Careful NOT to Underestimate the Following Biotech Stocks (Part 2)

Theravance Biopharma: Near-Term Game-Changing PDUFAS Some of the Prohost Portfolio selected companies are having near term PDUFAS which we believe will have a positive outcome. Indeed we expect the FDA approvals to tremendously boost these firms’ values. In Part 1 we chose Halozyme (HALO) and PTC Therapeutics (
The World Focus is on COVID-19 Treatments and Vaccines

The World Focus is on COVID-19 Treatments and Vaccines

The Week in Review #50 The World FOCUS is COVID-19 The world FOCUS right now is on life-saving accomplishments for COVID-19. In addition to safety measures that are being adopted by most citizens the following realizations that accomplishments might lead to a clear victory over the life-threatening novel coronavirus. They are: Successful Treatments that will alleviate the severity of symptoms from COVID-19 that is causing …
Why Gilead’s and Moderna’s Stocks Rallied Today

Why Gilead’s and Moderna’s Stocks Rallied Today

Gilead Sciences Gilead (GILD) stock soared after market hours adding $11 to the $1.90 the stock had gained during trading hours. Investors’ enthusiasm was raised when very promising results came out of a clinical trial for Gilead’s drug remdesivir given to COVID-19 infected people.   According to the news the University of Chicago’s Phase 3 trial results demonstrated that most COVID-19 infected patients treated with …

Novavax: A Hand-Picked Vaccine on the Road Towards Human Clinical Trial Against Coronavirus

Novavax Identified an "Ideal" Coronavirus Vaccine Candidate The news from Novavax (NVAX) informs that the firm has identified an "ideal" coronavirus vaccine candidate, NVX-CoV2373, that is a stable, prefusion protein made using Novavax’s proprietary nanoparticle technology. The firm will initiate a first-in-human trial in mid-May. Novavax’s proprietary Matrix-M . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Encouraging News About the COVID-19 Outbreak. See Also: Important News from Gilead

Encouraging News About the COVID-19 Outbreak. See Also: Important News from Gilead

COVID-19 at Its Peak? The number of deaths from the COVID-19 outbreak in NYC are expected to peak soon. This expectation is coming from a prestigious trustworthy Washington University. The news also stated that Italy is turning the corner if it has not already turned it. They are reporting the lowest death toll for two weeks. France also reported a slowing of daily deaths while …
Two Companies Coronavirus Will Fail To Disrupt

Two Companies Coronavirus Will Fail To Disrupt

Vertex and Regeneron Will Survive the Coronavirus Market Vertex We picked Vertex (VRTX) on March 18, 2011 at $44.39. The stock closed at $218 at the end of 2019. It rallied in mid-February reaching $247.78 then the unexpected and unseen novel coronavirus started infecting the world. Our 2020 target is still $280. We decided upon this new target in . . . This content is …
Why We Are Still Optimistic. See Also: Inovio’s Good News

Why We Are Still Optimistic. See Also: Inovio’s Good News

COVID-19 and the Nation's Hospitals Disagreeable news with regard to the nation's hospitals is their unpreparedness to face a sudden crisis, let alone an unexpected and unprecedented pandemic. The system the hospitals are running on has been causing problems for a some time now, not just since the Coronavirus pandemic. Since the COVID-19 cases have been rushed to hospitals many unwarranted, unacceptable, intolerable and dangerous …
Its All About Coronavirus

Its All About Coronavirus

Coronavirus: The Possible Treatments While Moderna’s (MRNA) vaccine is being tested and its stock price continued to rise in the worst market performance day; other companies demonstrated readiness to bring their vaccines against the life-threatening virus into human clinical trials in the next few months. Regeneron (REGN) is one of the most trusted companies. In collaboration with Sanofi (SNY) the companies are on the top of …

A Market in Chaos. Moderna’s Human Trial Began Today

A Market in Chaos The Market is in chaos. When this happens the market needs to be stopped from causing massive unwarranted harm to countries' economies, the firms and investors in the stock market. A healthy market does not drop over 2,500 points one day and then back up the same amount within the next few days. The current market is behaving like a drunk …

Market Frustration, Volatility and Chaos

Stock Market Fluctuations and Volatility  Only history can remind us that what’s going on recently with the stock market is not new. Similar situations have taken place during the terms of every president since Ronald Reagan. Indeed, the same stock market's unexpected tumbling occurred during Reagan, Bush the father, Clinton, Bush the son, Obama and now Trump. As a matter of fact, history reminds us …
How the Stock Prices of Firms Developing Treatments or Vaccines Have Started the Day

How the Stock Prices of Firms Developing Treatments or Vaccines Have Started the Day

NanoViricides and COVID-19 NanoViricides (NNVC), a development-stage nano-biopharmaceutical company with a proprietary and patented drug development focused on viral diseases, is among the few firms that are actively working on developing products that can treat the coronavirus disease COVID-19 which is caused by SARS-CoV-2 virus, or 2019-nCoV, now known also known as the . . . This content is for paid subscribers. Please click here to …

Fighting COVID-19. See Also: Stocks Gains Following the Market’s Rebounding

Treating and Preventing COVID-19 Treating COVID-19, Gilead Sciences With regard to treating patients with COVID-19 we believe the most expected product to be used during this virus' outbreak will be Gilead Sciences’ (GILD) product remdesivir. This product has reduced the severity of the coronavirus infection symptoms in animal testing and in a few . . . This content is for paid subscribers. Please click here to …