Author: Prohost

RegenxBio Announced Completion of a Successful Pre-BLA Meeting with the FDA for RGX-121 for Mucopolysaccharidosis Type II

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. …

 AstraZeneca: The U.S. FDA Approved IMFINZI in Combination with Carboplatin and Paclitaxel followed by IMFINZI Monotherapy for Adults with Primary Advanced or Recurrent Endometrial Cancer

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. Announces 2Q Fiscal Year 2024 Financial Results, Quarterly Dividend and Stock Split 10-1

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 …

Eli Lilly Product Tirzepatide Has Impressive Clinical Trial Results Treating MASH

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 …

What About Agenus?

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 Pharmaceuticals Presented Positive Results from Two Late Studies of investigational Product Donidalorsen

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 Preclinical Study Successfully Demonstrates That Nerve Ablation Can Slow Tumor Metastasis in Pancreatic Cancer 

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 Announces Data to be Presented at 2024 ASCO Annual Meeting 

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 …

Verrica Pharmaceuticals: Collaboration and License Agreements for the Treatment of Skin Diseases Other Than Molluscum Contagiosum

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 …

Jennifer Schneider Elected to Vertex Pharmaceuticals Board of Directors. Why It’s Good News

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: Improved Hearing to Normal Levels in a Child with Profound Genetic Deafness 

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 Highlights ASGCT Oral Presentation and Announces New Programs Utilizing In Vivo Gene Editing Approach

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 …

Vertex Pharmaceuticals Reports First Quarter 2024 Financial Results

Vertex Pharmaceuticals Vertex Pharmaceuticals (VRTX) reported consolidated financial 2024 results for the first quarter ended March 31, 2024, and reiterated full year 2024 financial guidance. Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex Pharmaceuticals said, “Vertex delivered a strong start to 2024 with 13 percent product revenue growth and outstanding execution across the business. This quarter, we continued to expand our leadership . …

CytomX is Rallying Today! The Firm Will Report Q1 2024 Results and Provide an Initial CX-904 Phase 1a Clinical Data Update on May 8, 2024  

CytomX Therapeutics  CytomX Therapeutics, Inc. (CTMX) announced that it will report first quarter 2024 results and provide an initial CX-904 Phase 1a dose escalation update on Wednesday, May 8, 2024, after the close of U.S. markets. Following the announcement the company will host a conference call and webcast at 5:00 p.m. ET / 2:00 p.m. PT.  Participants may access the . . . This content …

TG Therapeutics Stock Price is Rising as Q1 Revenues from BRIUMVI U.S. Have Exceeded Expectations

TG Therapeutics Financial Results for Q1 2024 TG Therapeutics, Inc. (TGTX) announced its financial results for the first quarter of 2024, along with recent company developments. Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, “We were extremely pleased with the strong sales of just over $50 million in BRIUMVI U.S. net revenue for the first . . . This content is for …

Akero Therapeutics Appoints Scott Gangloff as Chief Technology Officer

From Akero Therapeutics  Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero Therapeutics remarked, "I am delighted to welcome Scott Gangloff to Akero. His depth of experience leading drug manufacturing for both national and multi-national biopharmaceutical organizations enrich our company with an invaluable perspective during the late-stage clinical development of efruxifermin.  The entire leadership team looks forward to partnering with Scott to advance …

INmune Bio Inc. Update on Two Alzheimer Disease Patients Who Continued to Receive XPro Product

INmune Bio Press Release  INmune Bio (NASDAQ: INMB) is pleased to share an update on two patients from the Phase 1b trial completed in 2021 who have continued to receive XPro™ for treatment of Alzheimer’s Disease (AD) for more than three years under the Australian compassionate use program known as the Special Access Scheme (SAS).  Both patients, herein referred to as “Patient 1” and “Patient 2,” was …