Compugen IND Application for Triple Combination Study Cleared by the US FDA The U.S. Food and Drug Administration has cleared Compugen’s (CGEN) investigational new drug (IND) application for its Phase 1/2 study evaluating the triple combination of COM701, Compugen’s first-in-class anti-PVRIG antibody, OPDIVO® (nivolumab) — Bristol Myers Squibb’s (BMY) PD-1 immune checkpoint inhibitor and BMS-986207, Bristol Myers Squibb’s investigational anti-TIGIT antibody, in patients with advanced …

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 DNA vaccine candidate for COVID-19” by Inovio scientists and collaborators from The Wistar …

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 (COVID-19) vaccine and of scaling-up manufacturing. We have to …

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-19) vaccine and of scaling-up manufacturing. The stock is …

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 Distress Syndrome (ARDS). According to its title, “A Randomized, Double-Blind, Placebo-Controlled, …

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 (APDN) and its vaccine development …

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 (PTCT). Today, in Part 2 our choice is Theravance Biopharma. Theravance Biopharma Theravance Biopharma’s (TBPH) upcoming PDUFA is due …

Halozyme and PTC Therapeutics: 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 the FDA approvals are expected to tremendously boost these firms’ values. Today we present two selected Biotech firms from the Prohost Portfolio.   Halozyme Halozyme (HALO) has two upcoming important PDUFAs. The first will be on May …

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™ adjuvant will be incorporated with NVX-CoV2373 in order to enhance immune responses and stimulate high levels of …

Presenting Fate Therapeutics Today we are presenting Fate Therapeutics (FATE); a clinical-stage company developing programmed cellular immunotherapies for cancer and immune disorders. Our enthusiasm for this firm is due to its announcement that it signed a global collaboration agreement with the Johnson & Johnson (JNJ) firm Janssen Biotech. This agreement is rich and meaningful and, if the outcome will be successful it will be a game-changer …

Presenting UroGen Pharma UroGen Pharma (URGN) focuses on cancers and urologic diseases. It announced its fourth quarter and full-year ended December 31, 2019 financial results. The announcement started with Liz Barrett, President and Chief Executive Officer (CEO) of UroGen who stated that the firm is waiting for the approval of its product UGN-101 designed and developed for low-grade upper tract urothelial cancer (LG UTUC). Among other …

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 …

Fluctuations and Volatility in the Market 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 …

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 infected humans who were treated with remdesivir on a compassionate basis. The …

The Market Soared Being optimistic about the greatness of American scientific capability does not mean underestimating the coronavirus’ ability to infect, devastate and threaten human lives. Today the market rebounded from fear that caused the stock market to plummet this past week. The rebounding was strong enough to demonstrate that Americans trust their country’s scientific capabilities as well as their scientists’ and physicians’ efforts towards …

COVID-19 and the Stock Market The coronavirus that causes COVID-19 is the topic that swallowed all other topics this week. The virus is spreading to many countries around the world. Some media interpreted the CDC’s warnings as being in direct conflict with the President while others showed understanding that the impact on the U.S. has so far been mild but the virus helped reveal the power …

Exelixis Announced Results from its CABOMETYX® Combination with Roche’s TECENTRIQ® News announced by Exelixis (EXEL) about encouraging results from the combination of its product cabozantinib (CABOMETYX®) with Roche’s product atezolizumab (TECENTRIQ®) on metastatic castration-resistant prostate cancer (CRPC). The results emanated from the COSMIC-021 phase 1b trial.    The data will be presented on Thursday, February 13th during Poster Session A: Prostate Cancer at 11:30 a.m. – 1:00 p.m. PT and 5:30 …

Gilead Stock Is UP Gilead Sciences’ (GILD) provided its antiviral experimental drug remdesivir to physicians for a small number of patients infected with the 2019 novel coronavirus (2019-nCoV) as a possible emergency savior. Gilead might have also signed an agreement with the Chinese authorities to conduct a clinical trial with remdesivir to treat coronavirus infected patients. Remdesivir was intended to treat the Ebola virus but …

Vertex Beats Expectations in 2019 Vertex (VRTX) reported fourth-quarter and full-year 2019 financial results yesterday. The results beat analysts’ expectations about the last quarter and the whole year 2019. In the same report the firm’s full-year financial guidance promises a thrilling future for Vertex. The report indicated that the total GAAP and Non-GAAP product revenues have increased by 63% and 45%, respectively, compared to the …

Time to Remember Compugen The time has ripened for our readers and biotech investors to remember what we posted in the past years about Compugen (CGEN). The importance of the reminder is that the firm has taken a long time to bring its target discoveries and its targeted treatments into clinical trials whose preliminary results have demonstrated promise. Compugen is headquartered in Israel with offices …