Category: Today’s Highlights

Why Gilead Sciences Product Lenacapavir Deserves the FDA Granted Breakthrough Therapy Designation. See Also: Cellectis and Sanofi

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 to Proceed with Phase 2 Trial of INO-4800 Vaccine Candidate for COVID-19

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 …

A First in Class Antibody for a Difficult to Treat Stomach Cancer and Maybe Others

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 (

What We Expect to Hear at the Regenxbio Conference Call Today

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 Achievements and Q3 Financial Results

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 …

Why We Expect a Lot from the Following Biotech Firms

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 …

We Continue to Track the COVID-19 Vaccines. See Also: CRISPR Therapeutics Immuno-Oncology Results are Good.

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 …

Celldex Therapeutics Doses the First Patient with its CDX-0159 Product for Chronic Spontaneous Urticaria

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 Adds an Immuno-Oncology Pioneer to its Scientific Advisory Board. See Also: The New War Against Aging

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. …

The FDA Lifted the Clinical Hold on Solid Biosciences’ IGNITE DMD Phase 1/2 Trial Sending the Stock Price Over 131%

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 …

Cassava Sciences, Moderna and Sorrento Therapeutics All Have News

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. …

Cassava Sciences Promising and Encouraging Results of Its Alzheimer’s Disease Product Sumifilam

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 Has Encouraging News

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 U.S. FDA for Cabozantinib in Combination with Nivolumab for Advanced RCC

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 …

Regenxbio: Positive One-Year Data from the Firm’s Gene Therapy RGX-314 for Wet AMD

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 …

The FDA Approved Gilead Sciences CAR T Cell Product Tecartus for Adults with Relapsed or Refractory Mantle Cell Lymphoma

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 …