Alnylam Announces FDA Approval of OXLUMO™ Injection for PH1 Alnylam (ALNY) announced that the US FDA has approved its subcutaneous OXLUMO™ (lumasiran) injection, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. Primary Hyperoxaluria Type 1  PH1 is an ultra-rare genetic disease. It is . . . This content is for …

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 …

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 …

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 (

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 …

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 …

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 …

Exelixis and Bristol-Myers Squibb sNDA and sBLA Accepted by the FDA Exelixis (EXEL) and Bristol-Myers Squibb (

Celldex Therapeutics After an expected resurrection, Celldex Therapeutics (CLDX) stock recovered and went as high as over $19 from less than $2 after an exaggerated selloff caused by  investors following the failure to treat the still untreatable glioblastoma multiforme brain cancer. Today Celldex announced that enrollment has opened, in its randomized, double-blind Phase 1b study of CDX-0159 in patients with . . . This content …

Compugen New Addition, Dr. Nils Lonberg, PhD. Compugen (CGEN) announced the addition of Nils Lonberg, Ph.D., to its Scientific Advisory Board (SAB). Dr. Lonberg is a pioneer in the field of immuno-oncology and has more than 30 years of experience in the biopharmaceutical industry. Concurrently, Charles (Chuck) Drake, M.D., Ph.D. will be stepping down from Compugen’s . . . This content is for paid subscribers. …

Solid Biosciences Clinical Hold on IGNITE DMD is Lifted by the FDA Solid Biosciences (SLDB) - a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, announced that the U.S. FDA has lifted the clinical hold placed on the Company’s IGNITE DMD Phase 1/2 clinical trial. The FDA had requested further manufacturing information, updated safety and efficacy . . . This content …

News from Cassava Sciences, Moderna and Sorrento Therapeutics  Cassava Sciences  Cassava Sciences (SAVA) announced that clinical results of its Phase 2b study of sumifilam have been selected as a late-breaking oral presentation by the 13th international conference on Clinical Trials on Alzheimer’s Disease (CTAD). What is CTAD? CTAD is a prestigious annual conference focused on Alzheimer’s . . . This content is for paid subscribers. …

Crispr Therapeutics and Vertex Pharmaceuticals CTX001 Granted PRIME Designation by the EMA CRISPR Therapeutics (CRSP) and Vertex Pharmaceuticals (

Seattle Genetics Two New Strategic Oncology Collaborations with Merck Seattle Genetics (SGEN) and Merck (

Cassava Sciences Study Results of Sumifilam for Alzheimer's Disease Prohost is happy to inform our subscribers that our positive opinion about Cassava Sciences' product created and developed for Alzheimer’s disease happens to be right. Cassava Sciences (SAVA) announced today the final results of a Phase 2b study with its lead drug candidate, sumifilam, in Alzheimer’s disease. The results . . . This content is for paid …

Compugen Announced Encouraging News from Its Phase 1/2 Study of COM701 Compugen (CGEN) announced that the first patient has been dosed in the Phase 1/2 study of the triple combination of COM701 - Compugen’s first-in-class anti-PVRIG antibody, with Bristol Myers Squibb’s  (

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 …

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.

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 …