Viking Therapeutics Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials.  Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. The firm’s clinical programs include VK2735, a novel dual agonist of the glucagon-like …

Ionis Pharmaceuticals in the NEWS Yesterday,  July 22, 2024, Ionis Pharmaceuticals (IONS) announced positive results from the completed multiple ascending dose (MAD) portion of the Phase 1/2 open-label study of ION582 in people with Angelman . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Pliant Therapeutics Pliant Therapeutics is a late-stage biopharmaceutical company focusing on the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or …

Lexeo Therapeutics in the NEWS On July 15, 2024, Lexeo Therapeutics (LXEO) announced positive interim data of LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy. Across both the Lexeo SUNRISE-FA Phase 1/2 clinical trial (NCT05445323) and the Weill Cornell Medicine investigator-initiated Phase 1A trial (

Kazia Therapeutics in the NEWS  Sydney, July 10, 2024, Kazia Therapeutics Limited (KZIA) - an oncology-focused drug development company, is pleased to announce results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard of care (SOC) for patients with the life-threatening brain cancer glioblastoma.  GBM AGILE STUDY GBM AGILE is an adaptive phase . . . This content is for …

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 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 …

Regeneron in the NEWS Regeneron Pharmaceuticals (REGN) and Sanofi (SNY . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Merck in the NEWS Merck Pharmaceuticals (MRK), known as Merck, Sharp & Dohme (MSD) outside the United States and Canada, and the Finnish pharmaceutical Company Orion Corporation announced that notice has been provided of the mutual exercise of an option to convert the companies’ ongoing co-development and co-commercialization agreement for the investigational product opevesostat into an exclusive global license . . . This content is …

SCG Cell Therapy FDA Approval SCG Cell Therapy Pte Ltd (SCG) is a biotech company developing novel immunotherapies for infectious diseases and their associated cancers, announced that United States FDA has approved its investigational New Drug (IND) application to initiate Phase 1/2 clinical trial for SCG142 – a novel next-generation human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T) cell therapy for patients with HPV-associated solid tumors. From SCG Cell Therapy Christy Ma, Chief …

From Mitsubishi Tanabe Pharma America Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at Mitsubishi Tanabe Pharma America said, “We are excited to be at the Congress of the European Academy of Neurology (EAN) this year to showcase our  research and engage with its scientific community. The findings highlight our dedication to advancing the understanding of investigational ND0612 and our commitment to recognizing …

Verona Pharma in the NEWS Yesterday, June 26, 2024, Verona Pharma plc (VRNA) announced that the US FDA has approved Ohtuvayre (ensifentrine) for maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years. The product . . . This content …

Nurix Therapeutics in the NEWS On June 16, 2024, Nurix Therapeutics (NRIX) announced the presentation of updated clinical data for NX-5948, an orally bioavailable degrader of Bruton’s tyrosine kinase (BTK), being evaluated in an ongoing Phase 1a/b clinical trial in adults with relapsed or refractory B-cell malignancies, including CLL and non-Hodgkin lymphoma (NHL

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 …