Exelixis sNDA Accepted by the US FDA for CABOMETYX® The U.S. Food and Drug Administration (FDA) accepted Exelixis (EXEL) supplemental New Drug Application (sNDA) for CABOMETYX ® (cabozantinib) as a treatment for patients 12 years and older with differentiated thyroid cancer (DTC) who have progressed following prior therapy and are radioactive iodine-refractory (if radioactive . . . This content is for paid subscribers. Please click here …

Hoth Therapeutics Hoth Therapeutics (HOTH) announced that its product, HT-003, has yielded positive results in an in vivo acne therapeutic model. The model showed that HT-003 reduces the expression of toll-like receptor 2 (TLR2

Biogen Product Adulelm Approved for Alzheimer's Disease The latest news regarding Alzheimer’s disease is that of the FDA’s approval of Biogen Inc's (BIIB) Alzheimer disease product Adulelm (aducanumab). Although the approval seemed to be great news for Biogen many analysts and researchers, in highly regarded scientific institutions and universities, called it controversial. The FDA advisory committee has voted almost . . . This content is …

The Nonsensical Downgrading of Development-Stage Firms Like Intellia Therapeutics It makes no sense to downgrade a development-stage firm such as CRiSPR gene editing IntelliaTherapeutics (NTLA) when only based on stopping short of attaining analysts’ expectations with regard to revenues and incomes. Development-stage firms yet to have products on the market to generate money, contrarily, serious development-stage firms . . . This content is for paid …

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.

Reata Pharmaceuticals The Positive News  Prohost Biotech's interest in Reata Pharmaceuticals (RETA) started when we recognized and appreciated the firm’s goals and its scientific capability. Reata Pharmaceuticals' goal is discovering molecular pathways that regulate cellular metabolism, inflammation and response to stress injury; hence, treat devastating diseases that have yet to . . . This content is for paid subscribers. Please click here to subscribe or here to …

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.

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 (

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 …

Agenus Announced Data from Phase 2 Trials of Balstilimab Agenus (AGEN) immuno-oncology company announced that data from two Phase 2 trials of balstilimab alone and in combination with zalifrelimab will be orally presented in at the upcoming European Society of Medical Oncology (ESMO) Conference on September 18, 2020.  The data will be presented by Dr. David O'Malley, Professor . . . This content is for paid subscribers. Please click here …

Recent Gene Therapy News On August 20, 2020 Audentes Therapeutics, which was taken over by Astellas (ALPMY) for over $3 billion, announced that a third patient has passed away in a clinical trial evaluating its gene therapy product AT132 for the treatment of the life-threatening neuromuscular X-linked Myotubular Myopathy (XLMTM). The neuromuscular disease is . . . This content is for paid subscribers. Please click here …

Yesterday, under Today’s Highlights, we posted that the U.S. FDA issued a Complete Response Letter (CRL) to Gilead Sciences (GILD) with regard to the New Drug Application (NDA) for . . . 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 …

When a small firm’s stock price soars, and more than doubles, curiosity pushes us to investigate.    Alterity Therapeutics Yesterday the stock soared for a firm called Alterity Therapeutics (ATHE) closing at $3.43 UP $2.08. We found that this firm’s market cap is $3.72 billion which boosted our curiosity to learn . . . This content is for paid subscribers. Please click here to subscribe or here to log …

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 …

Arbutus Biopharma and Moderna's Patent Challenge Arbutus Biopharma (ABUS) is a publicly-traded biopharmaceutical company dedicated to discovering and developing a cure for patients suffering from chronic hepatitis B infection. The stock has been in the Aggressive Table of the

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 (

CytomX Therapeutics CytomX (CTMX) is a clinical-stage oncology-focused biopharmaceutical company developing a novel class of investigational antibody therapeutics based on the firm’s Probody® technology platform for cancer treatments. CytomX’s Probody therapeutics remain inactive until they are activated by proteases in the tumor microenvironment.   Why This is Important By . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

A Comprehensive Essay  Part 4 Our fair evaluation approaches of biotechnology and biopharma companies differ depending on the sizes and statuses of the firms. We reiterate our conviction that causing a selloff of development stage biotech stocks at every announcement of quarterly financial results because of lack of income is irrelevant and unfair to the firms and their stockholders. It does not make sense that …