argenx in the NEWS argenx SE (ARGX) announced that the U.S. FDA has approved VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker . . . This content is for paid subscribers. Please click here …

Alnylam Pharamceuticals Announcement June 24, 2024, Alnylam Pharmaceuticals (ALNY) announced positive topline results from its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). The study met the primaary endpoint. It demonstrated a statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular . . . This content is for paid …

Sarepta Therapeutics in the NEWS On June 20, 2024, Sarepta Therapeutics (SRPT) announced that the U. S. FDA has approved an expansion to the labeled indication for ELEVIDYS (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least 4 years of age. Confirming the functional benefits, the FDA granted . . . This …

Gilead Sciences' Lenacapavir Demonstrated 100% Efficacy in Preventing HIV Gilead Sciences, Inc. (GILD) today announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women. PURPOSE 1 met its key efficacy endpoints . . . This content is …

Altimmune Today, June 18, 2024, Altimmune (ALT) announced oral presentations on pemvidutide, an investigational GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH, at the American Diabetes Association’s (ADA) 84thScientific Sessions, to be held in Orlando, FL from June 21-24, 2024. Details for the oral presentations are as follows: Session Title: Leveling Up . . . This content is for paid …

RegenxBio Today RegenxBio (RGNX) announced it completed a successful Pre-Biologics License Application (BLA) meeting with the FDA for the RGX-121 treatment of Mucopolysaccharidosis Type II (MPS II).  The FDA continues to be aligned with RegenxBio's plan to use cerebrospinal fluid (CSF) levels of heparan sulfate (HS) D2S6, a key biomarker of brain disease activity, as a . . . This content is for paid subscribers. …

US FDA Approval for AstraZeneca’s IMFINZI AstraZeneca (AZN): The trial results of the FDA newly approved combination products demonstrated a reduction in the risk of disease progression or death by 58% in patients with dMMR endometrial cancer versus chemotherapy alone.   Endometrial cancer is the fourth most common cancer in women In the United States.  More than 66,000 patients diagnosed and almost 12,000 deaths in …

Broadcom Inc Announcements What analysts heard from the Artificial Intelligence (AI) firm Broadcom Inc is promising and exciting news about the past and excellent expectations regarding the future. The Story The Artificial Intelligence Broadcom Inc. (AVGO) reported financial results for its second quarter of fiscal year 2024 ended May 5, 2024. Broadcom provided guidance for its fiscal year 2024 and . . . This content …

Innovent Biologics Announcement at ASCO Innovent Biologics , Inc. (HKEX: 01801)(OTC: IVBXF) announced that the clinical . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Eli Lilly in the NEWS Eli Lilly and Company (LLY) announced detailed results from the SYNERGY-NASH phase 2 study having 190 patients with or without type 2 diabetes to evaluate the investigational use of tirzepatide in adults with biopsy-proven metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis.  The clinical trial results demonstrated that 51.8%, 62.8% and . . . This content is for …

Gilead Sciences and Arcus Biosciences in the NEWS Gilead Sciences (GILD) and Arcus Biosciences (RCUS) announced longer-term efficacy and safety results from Arm A1 of Phase 2 EDGE-Gastric . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Answering Questions and Our Opinion About Agenus We believe that Agenus' (AGEN) frozen stock price for several years has and will continue to move up based on the recent news regarding the firm's promising oncology products. That's in addition to the firm's current collaboration with five stars biotechtechnology and biopharmaceuticals collaborators. We believe it is important that . . . This content is for paid subscribers. …

Ionis Parmaceuticals Treating Hereditary Angioedema On May 31, 2024, Ionis Pharmaceuticals (IONS) announced positive results from two Phase 3 OASIS-HAE and OASIS plus studies of the firm’s Donidalorsen in patients with hereditary angioedema (HAE). Donidalorsen demonstrating a sustained significant reduction in monthly HAE attack rates and continued attack rate improvement of >90% after one year treatment . . . This content is for paid subscribers. …

Autonomix Medical Announcement May 23, 2024, Autonomix Medical (AMIX) announced successful completion of an animal study evaluating the ability of targeted nerve ablation to impact tumor metastases and growth. Two groups in a preclinical study of mice received human pancreatic tumor cells  into the pancreatic region in the heads. The experimental group received peri-pancreatic neural ablation (ethanol infusion over the pancreatic nerves . . . …

Moderna to Host Investor Event Via Webcast Moderna, Inc. (MRNA) announced that three abstracts on mRNA-4157 (V940), an investigational mRNA individualized neoantigen therapy, have been accepted for presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.   The meeting  will be held May 31 - June 4 in Chicago, IL. mRNA-4157 (V940) is being . . . This content is for paid …

Arcturus Therapeutics COVID-19 Vaccine Published CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (ARCT) announced that Journal Nature Communications has

Verrica Pharmaceuticals Verrica Pharmaceuticals’ (VRCA) product YCANTH (cantharidin) is the only commercially available treatment approved by the FDA for the treatment of adults and pediatric patients two years of age and older with Molluscum Contagiosum. Molluscum Contagiosum is a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. The firm’s product VP-102 is in . . . This …

Vertex Pharmaceuticals News Today, May 15, 2024, Vertex Pharmaceuticals (VRTX) announced that Jennifer Schneider, M.D., M.S., has been elected to its Board of Directors as an independent director. Why is this news Great News? Dr. Schneider has more than two decades of experience in the health care industry as a physician, scientist and health care executive. She co-founded . . . This content is for …

Regeneron in the NEWS Regeneron Pharmaceuticals (REGN) announced today that the investigational gene therapy DB-OTO improved hearing to normal levels in one child (dosed at 11 months of age) within 24 weeks, and initial hearing improvements were observed in a second child (dosed at 4 years of age) at a 6-week assessment. Both children were born with profound genetic deafness due to variants of the …

Crispr Therapeutics in the NEWS CRISPR Therapeutics (CRSP) announced new preclinical data presented at the 27th Annual Meeting of the American Society of Cell and Gene Therapy (ASGCT) highlighting the Company’s approach to developing lipid nanoparticle (LNP) based delivery for in vivo ocular gene editing. In addition, CRISPR Therapeutics announced the expansion of its in vivo pipeline with two . . . This content is …