Category: Today’s Highlights

Illumina Acquired Fluent BioSciences to Accelerate Single-Cell Analysis and Discovery to a Broader Customer Base

Illumina Inc The latest take over by Illumina, Inc. (ILMN) has been a company with advanced technology known as Fluent BioSciences, a developer of emerging and highly differentiated single-cell technology.   From Illumina Inc Informing the biotech world, Steven Barnard, chief technology officer of Illumina said, "The addition of Fluent BioSciences to Illumina will provide significant and new capabilities to . . . This content …

Advanced Micro Devices to Buy the Largest Private AI Lab in Europe

Advanced Micro Devices in the NEWS  Advanced Micro Devices (AMD) today announced the signing of a definitive agreement to acquire Silo AI, the largest private AI lab in Europe, in an all-cash transaction valued at approximately $665 million. The agreement represents another significant step in the company’s strategy to deliver end-to-end AI solutions based on open . . . This content is for paid subscribers. Please …

Alnylam Pharmaceuticals: Positive Topline Results from HELIOS-B Phase 3 Study of Vutrisiran

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 Announces Expanded US FDA Approval of ELEVIDYS to Duchenne Muscular Dystrophy Patients

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’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention

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 Important Upcoming Presentations

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 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. …

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 …

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 . . . …

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 …

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 …

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 …

U.S. FDA Approved Pfizer’s BEQVEZ™ – A One-Time Gene Therapy for Adults with Hemophilia B

 Pfizer Approval A one-time dose of the Pfizer product, BEQVEZ, has reduced bleeds post-treatment compared to standard of care with a median of zero bleeds (range 0 to 19) after up to three years of follow-up, providing sustained bleed protection and potentially avoiding years of treatment burden with prophylaxis for many patients. Pfizer (PFE) announced today that . . . This content is for paid …

Regeneron and Mammoth Biosciences Collaborate to Pursue Next-Generation CRISPR-Based Gene Editing for Multiple Diseases

Regeneron Pharmaceuticals and Mammoth Biosciences in the NEWS Regeneron Pharmaceuticals (REGN) and Mammoth Biosciences, Inc. announced a collaboration to research, develop and commercialize in vivo CRISPR-based gene editing therapies for multiple tissues and cell types. Regeneron develops adeno-associated viral vectors (AAVs) using antibody-based targeting to enhance delivery of genetic medicine payloads to specific tissues and cell types. Mammoth . . . This content is for paid …

The U.S. FDA Approved Immunity Bio’s ANKTIVA® for the Treatment of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Immunity Bio in the NEWS Immunity Bio (IBRX) - an immunotherapy company, announced that the U.S. FDA has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. Immunity Bio . . . This content is for paid subscribers. Please click here to …

Vertex Pharmaceuticals Announces Advancements of Its Product Suzetrigine for Acute and Neuropathic Pain

Vertex Pharmaceuticals in the NEWS Vertex Pharmaceuticals (VRTX) announced advancements across its suzetrigine pain program, which has the potential to be the first new class of medicine for acute and neuropathic pain in more than two decades. Vertex’s product suzetrigine is an oral selective NaV1.8 pain signal inhibitor, which has been granted FDA Fast Track and Breakthrough Therapy Designations in moderate-to-severe . . . This …

Madrigal Pharmaceuticals Announces U.S. Availability of its Newly Approved Product Rezdiffra

Madrigal Pharmaceuticals in the NEWS Today, April 09, 2024, Madrigal Pharmaceuticals (MDGL) announced that its NASH MASH product Rezdiffra (resmetirom) is now available in the United States. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may . . …