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’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 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 …

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 (

Crispr Therapeutics and Vertex Pharmaceuticals CTX001 Granted PRIME Designation by the EMA CRISPR Therapeutics (CRSP) and Vertex Pharmaceuticals (