Vertex Pharmaceuticals Vertex Pharmaceuticals (VRTX) announced a United States FDA has approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily triple combination Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people 6 years and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Bluebird Bio Inc For investors who thought that bluebird bio Inc (BLUE) stock price jumped up from less than $1, to over $7, we inform those who didn't know and remind those who knew that on December 13, bluebird bio stock started a 1-for-20 reverse stock split of its common stock. Every 20 shares of BLUE . . . This content is for paid subscribers. …
Broadcom Inc Q4 Financial Results for Broadcom Inc (AVGO) reported financial results for its fourth quarter and fiscal year ended November 3, 2024, provided guidance for its first quarter of fiscal year 2025, and announced its quarterly dividend. From Broadcom Hock Tan, President and CEO of Broadcom Inc. Said, "Broadcom's fiscal year 2024 revenue grew 44% year-over-year . . . This content is for paid subscribers. …
Novo Nordisk Bagsværd, Denmark, 12 December 2024 – Novo Nordisk (NVO) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly subcutaneous semaglutide) label to reflect data from the FLOW kidney outcomes trial. The FLOW trial assessed the risk reduction . . . This content is for paid …
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. …
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.
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 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 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 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 …
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
PTC Therapeutics in the NEWS Today, December 2, 2024, PTC Therapeutics (PTCT) announced the signing of an exclusive global license and collaboration agreement with Novartis Pharmaceuticals Corporation, a subsidiary of Novartis AG (
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 …
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 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. …
Biogen & UCB Announcement Today, November 19, 2024, UCB (Euronext Brussels: (UCB) and Biogen (BIIB) presented . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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 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 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 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 …
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