Regeneron Pharmaceuticals Receives EUA from the FDA for REGEN-COV2 Regeneron Pharmaceuticals’ (REGN) antibody cocktail therapy casirivimab and imdevimab, known also REGN-COV2 or REGEN-COV2, received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The FDA EUA is for the treatment of mild to moderate COVID-19 in adults as well as pediatric patients at least 12 years of age and weighing at least …

Pfizer, BioNTech & Moderna When asked whether we heard the news about the submission of the Emergency Use Authorization (EUA) and whether we will inform our readers about it. Our answer was that we have posted many articles about Pfizer's (PFE) and BioNTech’s (

Gilead Sciences News Results from Phase 2/3 CAPELLA trial evaluating Gilead Sciences (GILD) lenacapavir achieved the primary endpoint in heavily treatment-experienced people with multidrug-resistant HIV-1 infection. The study showed that 88% of participants receiving lenacapavir experienced at least a 0.5 log10 reduction in HIV-1 viral load by the end of 14 days of functional monotherapy as . . . This content is for paid subscribers. Please click here …

PTC Therapeutics Approvals and Achievements PTC Therapeutics (PTCT) has achieved a lot recently. The latest is the August approval from the U.S. FDA of its product Evrysdi (risdiplam), the first orally administered at-home treatment for spinal muscular atrophy (SMA) in adults and children 2 months and older.   Evrysdi has been granted approvals in Brazil, Chile and Ukraine as . . . This content is …

Inovio Announced FDA Clearance to Proceed with Trial for COVID-19 Vaccine Candidate Inovio (INO) announced the receipt of the U.S. FDA clearance to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine candidate. Inovio Planned Phase 2/3 INNOVATE Trial The INNOVATE trial - a . . . This content is for paid subscribers. Please click here to …

Moderna Has Successful COVID-19 Vaccine Results and News Moderna’s Phase 3 study met statistical criteria with a vaccine efficacy of 94.5%. Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months. Moderna (MRNA) announced that …

Moderna Inc COVID-19 Vaccine Candidate Moderna Inc (MRNA) announced the completion of the case accrual for the first interim analysis of Phase 3 COVE study of mRNA-1273, its COVID-19 vaccine candidate. The firm announced a significant increase in the rate of case identification across sites in the last week. As a result, the Company expects the first interim analysis will include substantially more than 53 …

Five Prime Therapeutics Antibody Plus Chemotherapy for Stomach Cancer Five Prime Therapeutics (FPRX) announced positive topline results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial compared mFOLFOX6 chemotherapy in combination with bemarituzumab (bema, FPA144) - a first-in-class targeted therapy, in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non-HER2 positive (

bluebird bio bluebird bio (BLUE) financial results and business highlights for the third quarter 2020 are important to be aware of when volatility and negative analysis lack common sense. The stock selloff has been steady and progressive while there was no bad news emanating from the clinical trials on gene therapy that would provide cures or from any FDA . . . This content is …

Pfizer and BioNTech Good News Regarding COVID-19 Vaccine Candidate Pfizer (PFE) and BioNTech (BNTX) announced that their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 (the virus that causes COVID-19) has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of the SARS-CoV-2 infection; this is based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee …

CRISPR Therapeutics Dr. Emmanuelle Charpentier, Co-Founder CRISPR Therapeutics (CRSP) announced on October 7, 2020 that Dr. Emmanuelle Charpentier has been awarded the 2020 Nobel Prize in Chemistry for her groundbreaking work on the CRISPR/Cas9 system.  Dr. Emmanuelle Charpentier is the co-founder of CRISPR Therapeutics together with Rodger Novak and Shaun Foy. Dr. Charpentier is the Founding, Scientific and Managing . . . This content is …

Compugen Compugen (CGEN) presented its third-quarter achievements and financial results. We believe the firm is on the right track towards clinically confirming that its discovered targets, PVRIG and TIGIT when inhibited, will extend the capability of the current checkpoint inhibitors into treating cancers resistant to immunotherapy by checkpoint inhibition.   From Compugen Anat Cohen-Dayag, Ph.D., President and CEO of Compugen . . . This content is …

Regenxbio Conference Call Information Regenxbio will host a conference call today, at 4:30 pm est today, November 4, 2020, to discuss its financial results for the quarter, ended September 30, 2020, and recent operational highlights. To access the live call by phone dial (855) 422-8964 (domestic) or (210) 229-8819 (international) and enter the passcode 4107819. To access a live or recorded webcast of the call …

Rhythm Pharmaceuticals Rhythm Pharmaceuticals (RYTM) reported financial results and provided a business update for the third quarter ended September 30, 2020. The firm develops treatments of rare genetic disorders of obesity. The FDA has accepted the firm's filed New Drug Application (NDA) for it's product, setmelanotide, for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and . . . This content is for paid subscribers. Please click here …

Important Quarterly Results Announcements Monday, November 2, 2020 at 8:PM ET IVERIC bio IVERIC bio’s (ISEE) management team will host a live conference call and webcast following the announcement to discuss the Company’s financial results and provide a general business update. To participate in this conference call please dial 866-575-6539 (USA) or 323-794-2575 (International) using passcode 6339331. A live, listen-only, audio webcast of the conference …

Compugen Compugen (CGEN) announced the presentation of new research data that further support PVRIG as a potentially promising target for cancer immunotherapy. These data suggest that PVRIG inhibition may enhance T cell priming and infiltration into tumors and provide further evidence supporting the potential advantages of targeting PVRIG alone and in combination with TIGIT and PD-1 inhibitors, in tumors . . . This content is for …

News from AstraZeneca About COVID-19 Vaccine, AZD1222 From AstraZeneca (AZN) we learned that its COVID-19 vaccine, AZD1222, which is being developed in collaboration with Oxford University, has produced a similar immune response in older and younger adults. A spokesman from the firm stated that the results have further built the body of evidence for the safety and immunogenicity of AZD1222. On October 23, 2020 AstraZeneca’s …

Gilead Sciences Veklury® (Remdesivir) was Approved by the US FDA The U.S. FDA approved Gilead Sciences (GILD) antiviral drug Veklury® (remdesivir) for COVID-19 infected patients who require hospitalization. Veklury halts the SARS-CoV-2 replication that causes COVID-19. Veklury is the first and only approved COVID-19 treatment (not vaccine) in the U.S.. The news announced that the drug is widely available in hospitals across the country. The …

Ionis Pharmaceuticals Dosed First Patients with ION541 for ALS Ionis Pharmaceuticals (IONS) announced that the first patients have been dosed with ION541 (also known as BIIB105) – an investigational antisense medicine being developed as a potential therapy to treat most forms of amyotrophic lateral sclerosis (ALS), regardless of family history. This is another milestone in the continuing progress of Ionis’ ambitious program to develop novel …

The Latest on the COVID-19 Vaccines AstraZeneca (AZN): After pausing for more than a month, AZN is expected to resume its Phase 3 US study of its COVID-19 vaccine. The trial was paused after a patient, who received the vaccine, developed an illness suspected to be a serious spinal inflammatory condition known as transverse myelitis. The patient was . . . This content is for …