Arcturus Therapeutics COVID-19 Vaccine Published CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (ARCT) announced that Journal Nature Communications has
Carlisle Companies Inc and Arcturus Therapeutics in the NEWS Today, November 28, 2023, Global biotechnology leaders Carlisle Companies Inc (CSL) and Arcturus Therapeutics (ARCT) announced that . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Atea Pharmaceuticals Receives Fast Track Designation for Bemnifosbuvir Atea Pharmaceuticals (AVIR) announced that the U.S. FDA has granted Fast Track designation to its product bemnifosbuvir for the treatment of resistant COVID-19. Bemnifosbuvir is an oral, direct acting antiviral drug candidate being evaluated in the global Phase 3 SUNRISE-3 registrational trial for the treatment of COVID . . . This content is for paid subscribers. …
CureVac N.V. in the News CureVac N.V. (CVAC) announced that after more than 10 years as a member of the CureVac management board and three years as CEO, Dr. Franz Haas will step down as CEO, effective March 31, 2023. Joining CureVac from Sanofi, on April 1, 2023, is Dr. Alexander Zehnder. CureVac is a biopharmaceutical firm developing a new class . . . This …
CureVac N.V. Files Lawsuit Against BioNTech for Infringement CureVac N.V. (CVAC), a company that develops therapeutics based on messenger ribonucleic acid (mRNA), has moved to assert its intellectual property rights that have been accumulated over more than two decades of pioneering work in mRNA technology. Technology that contributed to COVID-19 vaccine development. The Company acknowledged filing a lawsuit . . . This content is for …
Gilead Sciences Receives sNDA from the FDA for Remdesivir for Pediatric Patients with COVID-19 Gilead Sciences (GILD) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury®, aka remdesivir, for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and . . . This content is for paid subscribers. …
Arcturus Therapeutics Holdings News Arcturus Therapeutics Holdings (ARCT) shared topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, Arcturus’ self-amplifying mRNA vaccine candidate against COVID-19. The ongoing Phase 1/2/3 registrational study, sponsored by Arcturus’ collaborator Vinbiocare Biotechnology Joint Stock Company – a member of Vingroup Joint Stock Company, enrolled over . . . This content is for paid subscribers. Please click here to subscribe or here to log …
The Stock Market Continues to Plummet Indeed, the Stock Market continues to decline, losing investors' profits. Each time the Market plummets it takes with it promising firms' stocks but when the biotech stocks plummet new reasons are always claimed for the decline. Today's claimed reason for the deep losses is the tension between Russia and Ukraine, which, as it happens, is not the only …
Enanta Pharmaceuticals Expectations Expecting Dosing in a First-in-Human Study of EDP-235, an Oral 3CL Protease Inhibitor Specifically Designed for the Treatment of COVID-19 The Firm Completed Enrollment in RSVP, a Phase 2b Conducted Trial of EDP-938 in Adults With Community-Acquired Respiratory Syncytial Virus (RSV) Expects Topline Data in the Second Quarter of 2022 The Firm has Plans to Initiate a Phase 1 Study of EDP-323, …
Pfizer Received Emergency Use Authorization from the FDA for Paxlovid Pills for COVID-19 Good news for Pfizer (PFE), the U.S. FDA announced it has authorized the emergency use of PAXLOVID™ for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 (the virus that cause COVID-19) viral testing …
Comprehensive Prohost Letter Issues Coronavirus Variant Omicron A lot has happened since the coronavirus variant Omicron was discovered in South Africa. After having been responsible for a severe plummeting of the stock market, Omicron boosted the market after being described by many scientists as fast spreading with different yet milder symptoms when compared to those caused by SARS-CoV-1, SARS-CoV-2 (the virus that causes COVID-19) and …
Arcturus Therapeutics Holdings Arcturus Therapeutics Holdings (ARCT) is a clinical-stage mRNA medicines company of enabling technologies with an interesting pipeline of treatments and vaccines as well as other products for diseases that have yet to find treatments. Arcturus Therapeutics’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense . . . This …
AstraZeneca Long Acting Antibody Granted FDA EUA for COVID-19 Prevention AstraZeneca (AZN) product Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination received emergency use authorization (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with the first doses expected to become available very soon. The EUA for Evusheld was granted for . . . This content is for paid subscribers. Please click here …
The Bizarre Assessment of Biotech Firms in the Stock Market The Clinical-Stage Biotechnology Firms We are witnessing inexplicable evaluations of clinical-stage biotechnology companies. Bizarre is the best description of this group’s assessment which is based on incomes that do not exist in biotech firms that are yet to have approved and marketed products anywhere in the world. Unfortunately, the most impacted firms by the bizarre …
GlaxoSmithKline and Vir Biotechnology Announces US Gov't Contracts to Purchase Sotrovimab for COVID-19 GlaxoSmithKline plc (GSK) and Vir Biotechnology (
U.S. Government to Purchase More of Merck and Ridgeback Biotherapeutics Molnupiravir for COVID-19 Merck (MRK) and Ridgeback Biotherapeutics announced that the United States government will exercise two of its options to purchase a total of 1.4 million additional courses of molnupiravir - an investigational oral antiviral medicine, if the medicine is granted Emergency Use Authorization (EUA) or . . . This content is for paid …
Merck Stock Soared Great expectations for Merck (MRK) future growth and the future of novel treatments for patients with severe devastating and life-threatening diseases. Keytruda - Merck's cancer immunotherapy drug, has reached a milestone and molnupiravir - its COVID-19 pill, sales revenues are expected to generate $5 billion to $7 billion through 2022, subject to emergency use authorization, at the end of November 2021. The …
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 …
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 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.
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 . …
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 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, …
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: 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 …
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 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 …
GlaxoSmithKline and Vir Biotechnology are Granted an EUA for Sotrovimab GlaxoSmithKline (GSK) and Vir Biotechnology (VIR) announced the U.S. FDA has . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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 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 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 …
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 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 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 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 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 Receives an EUA from the U.S. FDA We appreciate the U.S. Food and Drug Administration's emergency use authorization (EUA) for the third vaccine for the prevention of SARS-CoV-2 (the virus that causes COVID-19). Three vaccines are definitely better than two and now, the third vaccine, which belongs to Johnson & Johnson (
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 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 …
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 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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 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 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 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 …
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 …
COVID-19 Vaccine Updates Pfizer's (PFE)/BioNTech's (BNTX) and Moderna . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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 …
Pfizer, BioNTech & Moderna When asked whether we heard the news about the submission of the Emergency Use Authorization (EUA) and whether we will inform our readers about it. Our answer was that we have posted many articles about Pfizer's (PFE) and BioNTech’s (
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 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 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 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 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 …
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 …
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 …
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 …
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 …
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 …
President Trump, the First Lady and COVID-19 Indeed, the complicated, nasty SARS-CoV-2 virus managed to infect President Trump and the First Lady when we were expecting a vaccine to soon be ready to protect the country and the world from COVID-19. The president’s physicians did not treat the him with any of the investigational vaccines in late-phase trials; vaccines being developed by: Moderna (
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 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 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.
Prohost Letter 442 The Whole World Against the Blind SARS-CoV-2 Virus Investors have no doubt profited from the developers of COVID-19 vaccines which include: Moderna (MRNA), Novavax (
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 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 …
Inovio COVID-19 Vaccine Candidate Will be Manufactured by Thermo Fisher Scientific Thermo Fisher Scientific (TMO) joins other contract development and manufacturing organizations in Inovio's global manufacturing consortium enabling Inovio (
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 …
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 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. …
Moderna Presented Interim Clinical Data about mRNA-1273 for COVID-19 Moderna (MRNA) presented new Interim Clinical Data about . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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 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 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 . . . This content is for paid subscribers. Please click here to subscribe or …
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.
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 …
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 (
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 (
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