Moderna Inc Late August Announcements  On August 28, 2020 Moderna Inc (MRNA) issued a press release confirming that the Company is engaged in discussions with the Ministry of Health, Labor and Welfare of Japan (MHLW) to potentially purchase 40 million or more doses of its COVID-19 vaccine candidate, mRNA-1273. Under the terms of this arrangement the . . . This content is for paid subscribers. …

Rhythm Pharmaceuticals Inc Rhythm Pharmaceuticals (RYTM) is a late-stage biopharmaceutical company with a product pipeline that reflects its focus of developing treatments for rare genetic obesity. The firm’s lead product, setmelanotide, is a melanocortin-4 receptor (MC4R) agonist being developed for severe obesity and hyperphagia associated with rare genetic obesity. The United States FDA has accepted Rhythm’s . . . This content is for paid subscribers. Please …

Moderna Presented Interim Clinical Data about mRNA-1273 for COVID-19 Moderna (MRNA) presented new Interim Clinical Data about . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Exelixis Announces Submission of sNDA to US FDA for CABOMETYX® Exelixis (EXEL) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA for CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) for patients with advanced renal cell carcinoma (RCC). From Exelixis According to Gisela Schwab, M.D., President, Product Development and Medical . . . This content is for paid subscribers. Please click here …

The US FDA Awards Fast Track Designation to Paxalisib for Glioblastoma  Kazia Therapeutics Ltd (KZIA) – an Australian oncology biotechnology company, announced that the United States FDA has granted Fast Track Designation (FTD) to Kazia’s paxalisib for glioblastoma, the most aggressive primary brain cancer. The FTD has been granted for the treatment of newly diagnosed glioblastoma with unmethylated O6-Methylguaninemethyl transferase (MGMT) promotor status who have completed initial …

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.

Gilead Sciences Was Issued a CLR from the FDA for Filgotinib Gilead Sciences (GILD) is in receipt of a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

CureVac is Publicy Trading on the NASDAQ CureVac is now publicly trading on the NASDAQ stock exchange with the symbol CVAC, as of August 14, 2020. We assume you must have heard the name of this firm by now and of America’s attempts to buy it for its messenger ribonucleic acid (mRNA) approach. This approach creates vaccines and drugs inside the living bodies. CureVac (CVAC) mRNA-derived …

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 …

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 for Recurrent C. Difficile Infection Meets Trial Endpoint SER-109 demonstrated a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared to placebo. 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 …

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 …

Regenxbio Positive Data for RGX-314 Regenxbio (RGNX) reported positive one-year data from patients in Cohorts 4 and 5 from Phase I/IIa trial of RGX-314 for wet age-related macular degeneration (wet AMD). Regenxbio plans to initiate a pivotal program for the subretinal delivery of the gene therapy RGX-314 in patients . . . This content is for paid subscribers. Please click here to subscribe or here to log …

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 …

Inovio Inovio’s COVID-19 Vaccine INO-4800 Accomplished the Following: Durable antibody and T cell responses in rhesus macaques for 4 months. Long-term protection in non-human primates challenged with SARS-CoV-2 virus 13     weeks from vaccination. No other vaccine has demonstrated it. Reduced viral loads and faster viral clearance in macaques’ lungs and nasal passages as a result of a good Memory T and B cell …

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 …

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.

Gilead Sciences CAR T Cell Product Tecartus Gets FDA Approval The U.S. FDA approved Kite - Gilead Sciences (GILD) chimeric antigen receptor (CAR) T cell therapyTecartus™ (brexucabtagene autoleucel). Tecartus has become the first and the only approved CAR T cell therapy for adults with relapsed or refractory mantle cell lymphoma (MCL). The FDA approval of . . . This content is for paid subscribers. Please …