Author: Prohost

Vera Therapeutics Acquires Global Rights to Novel, Next Generation Dual BAFF/APRIL Inhibitor

Vera Therapeutics in the Market Today Today, many investors in the biotechnology market caused a selloff of Vera Therapeutics (VERA) following its announcement of an exclusive license agreement with Stanford University to acquire a next generation fusion protein targeting BAFF and APRIL, known as VT-109. VT-109 has wide therapeutic potential across the spectrum of B cell mediated diseases. What Vera Therapeutics . . . This …

Compugen Announces First Patient Dosed in Phase 1 Clinical Trial to Evaluate COM503 as Monotherapy and in Combination with Zimberelimab in Advanced Solid Tumors.

Compugen  January 8, 2025, Compugen (CGEN), announced that the first patient was dosed in a Phase 1 clinical trial with COM503, a potential first-in-class antibody against IL-18 binding protein licensed by Compugen to Gilead. Compugen is responsible for running the Phase 1 trial. This Phase 1 multi-center dose escalation and dose expansion trial will evaluate the safety, tolerability . . . This content is for …

Halozyme Therapeutics Reiterates 2024 Financial Guidance and Raises 2025 and Multi-Year Financial Guidance

Halozyme Therapeutics Today, January 8, 2025 /PRNewswire/ - Halozyme Therapeutics, Inc. (HALO) provided a financial update, reiterating full year 2024 financial guidance and raising full year 2025 and multi-year financial guidance. The Company has also announced that. it has recently entered into . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Prescribing Specialists Confirm Success of Verona Pharma Product Ohtuvayre in Maintaining COPD Treatment

Verona Pharma Today, January 7, 2024 Verona Pharma (VRNA) announced preliminary unaudited net product sales for the fourth quarter and full year ended December 31, 2024, and provides a corporate update. Let’s read what the Company’s President stated: David Zaccardelli, Pharm. D., President and Chief Executive Officer said,“2024 was another transformational year for Verona with the approval and US . . . This content is …

A Reminder: Verastem Oncology Announced FDA Acceptance and Priority Review of the NDA Avutometinib (in Combination with Defactinib) for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

Verastem Oncology in the NEWS On December 30, 2024, Verastem Oncology (VSTM) announced that the U.S. FDA has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib. The drug is in combination with defactinib, an oral FAK inhibitor, for the treatment of adult patients with recurrent low-grade serous ovarian cancer (LGSOC . . . This content is for paid …

Vertex Announces US FDA Approval of ALYFTREK™ Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis

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.

Revisiting Bluebird Bio Inc

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’s Greatest Day

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: European Regulatory Authority Adopts Positive Opinion for an Update of Ozempic® Label to Reflect Risk Reduction of Kidney Disease-Related Events

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 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. …