Author: Prohost

Johnson & Johnson Product CARVYKTI® Improves Standard of Care Therapies for Relapsed or Refractory Multiple Myeloma

Johnson & Johnson On December 9, 2024, Johnson & Johnson (JNJ) announced new results from the Phase 3 CARTITUDE-4 study demonstrating that a single infusion of CARVYKTI®  has significantly increased minimal residual disease (MRD) negativity rates in patients with relapsed or refractory multiple myeloma (RRMM) patients who were lenalidomide-refractory and had received one to three prior lines . . . This content is for paid subscribers. …

At ASH 2024, Gilead Sciences’ Kite’s Yescarta® Shows Its CAR T-Cell Therapy Uniquely Durable Response and Long-Term Survival After Five Years in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas

Gilead Sciences Kite Pharma, a Gilead Sciences Company (GILD) announced results from a five-year follow-up analysis of ZUMA-5, a Phase 2 study of Yescarta ® (axicabtagene ciloleucel) in patients with relapsed/refractory non-Hodgkin lymphomas (NHL), including follicular lymphoma (FL) or marginal zone . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

From ASH: Vertex Pharmaceuticals Presented Positive Durability Gene Editing CASGEVY for Severe Sickle Cell Disease and Transfusion-Dependent Beta-Thalassemia

Vertex Pharmaceuticals ASH Announcement Today, December 8, 2024, Vertex Pharmaceuticals (VRTX) announced longer-term data for CASGEVY™ (exagamglogene autotemcel) from global clinical trials in people with severe sickle cell disease (SCD) or transfusion-dependent beta-thalassemia (TDT). CASGEVY is the first and only approved CRISPR/Cas9 gene . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Intra-Cellular Therapies Submits Supplemental New Drug Application to the US FDA for CAPLYTA® Treatment of Major Depressive Disorder as Adjunctive Therapy

Intra-Cellular Therapies in the NEWS On December 3, 2024, Intra-Cellular Therapies (ITCI) announced the submission of the supplemental New Drug Application (sNDA) to the United States FDA to approve CAPLYTA as adjunctive therapy to antidepressants for the treatment of Major Depressive Disorder (MDD) in adults. Intra-Cellular Therapies is . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Nuvig Therapeutics Announces $161 Million Series B Financing, Plus Its Progression to Phase 2 with Novel, Second-Generation Immunomodulator

Nuvig Therapeutics in the NEWS Nuvig Therapeutics – a privately held biotech company, developing novel immunomodulatory therapeutics for patients with inflammatory autoimmune diseases, announced the closing of a $161 million Series B financing. The financing was co-led by Sanofi Ventures, Blue Owl Healthcare Opportunities (formerly Cowen Healthcare Investments), and Norwest Venture Partners, with participation from new investors, B Capital, Leaps by Bayer, Global BioAccess Fund, LOTTE …

Gilead and Tubulis Enter Exclusive Option and License Agreement to Develop Antibody Drug Conjugate That Targets Solid Tumors

Gilead Sciences and Tubulis Agreement Gilead Sciences (GILD) and Tubulis announced that they entered into an exclusive option and license agreement to discover and develop an antibody-drug conjugate (ADC) against a solid tumor target. Gilead will gain access to Tubulis’ proprietary Tubutecan and Alco5 platforms. The companies will collaborate to . . . This content is for paid subscribers. Please click here to subscribe or here to …

Why Keros Therapeutics is Getting $200 Million Upfront Payment and Possibly Future Payments from Takeda That Could Exceed $1.1 Billion and More

Keros Therapeutics in the NEWS Today, December 3, 2024, Keros Therapeutics (KROS) announced an exclusive global development and commercialization license agreement with Takeda (TAK) to advance elritercept. Elritercept is currently in two ongoing Phase 2 clinical trials: one in patients with very low-, low-, or intermediate-risk myelodysplastic syndrome (MDS) and one in patients with myelofibrosis (MF

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 …