Category: Impacting News

Intellia Therapeutics: Realizing the Dream of Curing Devastating Diseases

Intellia Therapeutics  Reporting operational highlights and financial results for the second quarter ended June 30, 2020, Intellia Therapeutics (NTLA) announced its first Clinical Trial Application to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 1 study of NTLA-2001 for transthyretin . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Seres Therapeutics Oral Microbiome Product SER-109 Meets Trial Endpoint In Treating Recurrent C Difficile

The efficacy results Support BLA filing as a single pivotal trial. The Company will meet with the FDA to discuss filing for product approval as soon as possible. Positive SER-109 Phase 3 provides validation for the Seres microbiome therapeutics platform and further development of its pipeline of product candidates. SER-109 was well tolerated with a safety profile comparable to placebo. SER-109 demonstrated a highly statistically …

Compugen: A Stock To Keep

Compugen Compugen (CGEN) cancer immunotherapy’s predictive target computational discovery platforms enabled it to identify two checkpoint proteins, PVRIG and TIGIT, when nobody else could. Compugen’s technological capability has also enabled it to create therapeutic inhibitors of its two discovered targets. The discoveries happened to be important in improving cancer immunotherapy. The lead therapeutic candidate, COM701 . . . This content is for paid subscribers. Please …

Moderna News. See Also: Regeneron Antibody Cocktail Could Reach the Market in October

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.

A New Gene Therapy Series Starts Today with Regenxbio

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 …

CRiSPR Therapeutics Stock is Skyrocketing

CRiSPR Therapeutics Rally  For those who wonder why CRiSPR Therapeutics (CRSP) is soaring we remind that they should have been expecting this rally and for it to be followed by its two sisters Intellia Therapeutics (

We Are Not Yet in Bizarro World

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 …

The COVID-19 Vaccines’ Developing Firms’ Bizarre Evaluations

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 $71 Million in Funding from the U.S. Department of Defense

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 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 (