Category: Today’s Highlights

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 …

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 …

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.

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

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 …

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 …

Intellia Therapeutics: Positive Results from NTLA-2002 in CRISPR Gene Editing Treatment for Hereditary Angioedema

Intellia Therapeutics Intellia Therapeutics (NTLA) is a clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. The company’s in vivo programs use CRISPR to enable precise editing of disease-causing genes directly inside the human body. Intellia’s ex vivo programs use CRISPR to engineer human cells outside the body for the treatment of cancer and autoimmune diseases. Intellia’s . . . This content is for paid subscribers. …

Vertex Pharmaceuticals to Present Phase 3 Data Highlighting Suzetrigine’s Potential as a First-in-Class, Highly Selective Pain Signal Inhibitor at the ASA Annual Meeting.

Vertex Pharmaceuticals Announcement October 18, 2024, Vertex Pharmaceuticals  (VRTX) today announced that the company will present its pivotal Phase 3 data on suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor for the treatment of moderate-to-severe acute pain, at the annual meeting of the American Society of Anesthesiologists . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Vera Therapeutics Announces Expanded Atacicept Development Program in Multiple Autoimmune Kidney Diseases

 Vera Therapeutics in the NEWS Today, October 02, 2024, Vera Therapeutics (VERA) announced the expansion of its development pipeline for its lead asset, atacicept. This program is expected to build on the positive data reported to date from the ongoing ORIGIN Phase 2b and 3 clinical program developing atacicept to treat patients with IgAN, by extending into a broader population of IgAN and . . …

The United States FDA Approved Bristol Myers Squibb’s COBENFY™ – A First-In-Class Muscarinic Agonist for Schizophrenia in Adults

Bristol-Myers Squibb COBENFY™ Approval Bristol Myers Squibb (BMY) announced that the U.S. FDA has approved COBENFY™ (xanomeline and trospium chloride) for schizophrenia in adults.  Schizophrenia is a persistent disabling mental illness affecting how a person thinks, feels, and behaves. It is estimated to impact approximately 2.8 million people in the US. The initial symptoms appear in early adulthood and . . . This content is for …

Pfizer Has Voluntarily Withdrawn All Lots of its Sickle Cell Disease Treatment OXBRYTA® from Worldwide Markets

Pfizer OXBRYTA® Worldwide Withdrawal Pfizer (PFE) announced today that it is voluntarily withdrawing all lots of OXBRYTA® (voxelotor) for the treatment of sickle cell disease (SCD) in all markets where it is approved. Pfizer is also discontinuing all active voxelotor clinical trials and expanding access programs worldwide. Pfizer's decision is based on the totality of clinical data, which currently indicates . . . This content …

Sanofi Product Sarclisa Approved in the US as the First anti-CD38 Therapy

Sanofi Approval The United States FDA approved Sanofi (SNY) product Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). Sarclisa . . . This content is for paid subscribers. Please click here to subscribe or here to log in.