Month: November 2024

AstraZeneca Product Trugap+Abiraterone and Androgen Deprivation Therapy Improved Primary Endpoint of Radiographic PFS in PTEN-Deficient Metastatic Hormone-Sensitive Prostate Cancer

AstraZeneca in the NEWS AstraZeneca (AZN) Phase III trial CAPItello-281, which combines Truqap (capivasertib), abiraterone, and androgen deprivation therapy (ADT), demonstrates statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) vs. abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer . . . This content is for paid subscribers. Please click here to subscribe or here to …

The U.S. FDA Approved BridgeBio Pharma Product Attruby to Treat Adults with ATTR-CM to Reduce Cardiovascular Death and Hospitalization

BridgeBio Pharma in the NEWS BridgeBio Pharma (BBIO) focused on genetic diseases, announced that the United States FDA approved Attruby™ (acoramidis), an orally administered near-complete stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM. The aim is to reduce cardiovascular death and cardiovascular-related hospitalization. The approval is based on positive results seen in the ATTRibute-CM Phase 3 . . . This content is …

Viking Therapeutics Presented Results from Phase 2b VOYAGE Study of VK2809 in Biopsy-Confirmed NASH/MASH at the 75th Liver Meeting® 2024

Viking Therapeutics Announcement On Nov. 19, 2024, Viking Therapeutics, Inc. (VKTX) announced that the final results from the company's Phase 2b clinical trial of VK2809, the firm’s novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) referred to also as metabolic dysfunction associated steatohepatitis (MASH) were highlighted in an oral late . . . This content is for paid subscribers. …

Intellia Announces First Clinical Evidence from Phase 1 Study That an In Vivo CRISPR/Cas9-Based Gene Editing Therapy May Favorably Impact Disease Progression in Amyloidosis

Intellia Therapeutics Announcement On Nov. 16, 2024,  Intellia Therapeutics (NTLA), a clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, announced positive new clinical data from the ongoing Phase 1 trial of nexiguran ziclumeran (nex-z, also known as NTLA-2001) in patients with transthyretin (ATTR) amyloidosis. Nex-z is an investigational in vivo CRISPR-based . . . This content is for paid subscribers. Please click here to …

Adaptimmune’s Lete-cel Achieves Primary Endpoint in Pivotal Trial Treating Advanced Sarcomas and Other Solid Cancers

Adaptimmune Therapeutics Announcement Today, November 13, 2024, Adaptimmune Therapeutics plc (ADAP), a company working to redefine the treatment of solid tumor cancers with cell therapy announced data from the primary analysis of its pivotal Phase 2 IGNYTE-ESO trial of lete-cel in people with synovial sarcoma or the myxoid/round cell liposarcoma (MRCLS) who received previous anthracycline . . . This content is for paid subscribers. Please …

PTC Therapeutics: U.S. FDA Approved a First-Time Gene Therapy Administered directly into the Brain to Treat Children and Adults

PTC Therapeutics Announcement Today, November 13, 2024, PTC Therapeutics, Inc. (PTCT) announced that the U.S. FDA accelerated approval of the first gene therapy for the treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency. This is the first-ever gene therapy to be approved in the United States that is directly administered to the brain. From PTC . . . This content is for paid subscribers. Please click here …

Altimmune Third Quarter 2024 Financial Results and Provides Business Update  

Altimmune Third Quarter Financial Results Yesterday, October 12, 2024, Altimmune (ALT) announced financial results for the third quarter ended September 30, 2024, and provided a business update. From Altimmune Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune said,  “In the third quarter, we reached several important milestones, most notably the completion of enrollment in the Phase . . . This content is for …

BioStem Technologies Reports Record Third Quarter 2024 Revenue of $82.6 Million

BioStem Technologies Third Quarter 2024 Report Today, November 12, 2024, BioStem Technologies (BSEM), a leading MedTech company focused on developing, manufacturing, and commercializing placental-derived biologics, reported financial results for the third quarter ended September 30, 2024. The Company will host a webcast and conference call on Tuesday, November 12, 2024, at 4:30 pm ET.  From BioStem Technologies Jason Matuszewski, CEO of . . . This …

InflaRx Reports Third Quarter 2024 Financial Results and Provides Business Update 

InflaRX  In March 2024, InflaRx Biopharmaceutical (IFRX) announced that it will pursue two initial immuno-dermatology indications with INF904 in a single Phase 2a basket trial expected to begin by the end of 2024, with initial data anticipated in the summer of 2025.  The trial will be a multi-center, open-label study on 75 patients. We will be evaluating multiple INF904 dosing regimens over . . . …

Gilead Sciences 3rd Quarter Financial Results

From Gilead Sciences  Gilead Sciences (GILD) Chairman and CEO Daniel O’Day, said, “Gilead’s third-quarter results are the strongest of the year to date, with 7% year-over-year revenue growth, including 13% year-over-year growth for Biktarvy. Based on this strong topline growth and disciplined operating expense management . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Anavex Life Sciences: Blarcamesine Achieves Pre-specified Efficacy in Phase IIb/III Alzheimer’s Trial 

Anavex Life Sciences Anavex Life Sciences (AVXL) presented new data from the Phase IIb/III study showing that blarcamesine (ANAVEX®2-73), once daily orally, demonstrates pre-specified clinical efficacy through upstream SIGMAR1 activation. Anavex Life Sciences Corp. is a publicly traded biopharmaceutical company developing novel therapeutics to treat neurodegenerative, neurodevelopmental, and neuropsychiatric disorders. The company aims at treating pain, Alzheimer's . . . This content is for paid …