Category: Impacting News

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 …

Myovant Sciences Recent News is Good for Prostate Cancer Patients

Myovant Sciences Good News A lot of positive news is emanating from clinical trials conducted by development-stage biotechnology firms and revenue-generating firms. The good news in the small development-stage firms becomes more interesting when the trial results are from Phase 3 trials and other late Phase trials. The cancer news that attracted the attention of the specialists and analysts who followed up on the presentations made …

Compugen: Predictive Computational Discovery Technology

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 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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 …

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 …

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 …

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 (

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 (

Be Careful NOT to Underestimate the Following Biotech Stocks (Part 1)

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

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.

The Time Has Come for Us To Present Fate Therapeutics

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 (

We Introduce UroGen Pharma and Discuss Its Pipeline of Products

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 . . . This content is for …

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 …

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 …

Optimism: The Market is Rebounding and Biotech Firms Inspiring News

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 is rebounding from the fear that caused the stock market to plummet in this past week. The rebounding was strong enough to demonstrate that Americans trust their country’s scientific capabilities as well as their scientists’ and …

COVID-19 and the Stock Market

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 …