Category: Today’s Highlights

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.

Gilead Therapeutics and Genesis Therapeutics Announced Strategic Collaboration to Discover and Develop Novel Therapies

Gilead Sciences and Genesis Therapeutics Gilead Sciences (GILD) and Genesis Therapeutics, Inc. announced today that the companies have entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets. Genesis Therapeutics is pioneering generative and predictive artificial intelligence (AI) technologies to help create therapeutics for challenging targets. This collaboration will deploy Genesis’ field-leading AI platform . . . This content …

Gilead Sciences Livdelzi Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA

Gilead Sciences Approval Gilead Sciences (GILD) today announced that the U.S. FDA has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA taken alone, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended . . . This content is …

Akero Therapeutics Reports Q2 2024 Financial Results and Business Update

Akero Therapeutics Q2 and Business Update Akero Therapeutics (AKRO) reported second-quarter financial results for the period ending June 30, 2024,  and provided business updates. From Akero Therapeutics Andrew Cheng, president and CEO said, “The second quarter of 2024 brought important progress for EFX with the initiation of the . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Illumina Acquired Fluent BioSciences to Accelerate Single-Cell Analysis and Discovery to a Broader Customer Base

Illumina Inc The latest take over by Illumina, Inc. (ILMN) has been a company with advanced technology known as Fluent BioSciences, a developer of emerging and highly differentiated single-cell technology.   From Illumina Inc Informing the biotech world, Steven Barnard, chief technology officer of Illumina said, "The addition of Fluent BioSciences to Illumina will provide significant and new capabilities to . . . This content …

Advanced Micro Devices to Buy the Largest Private AI Lab in Europe

Advanced Micro Devices in the NEWS  Advanced Micro Devices (AMD) today announced the signing of a definitive agreement to acquire Silo AI, the largest private AI lab in Europe, in an all-cash transaction valued at approximately $665 million. The agreement represents another significant step in the company’s strategy to deliver end-to-end AI solutions based on open . . . This content is for paid subscribers. Please …

Alnylam Pharmaceuticals: Positive Topline Results from HELIOS-B Phase 3 Study of Vutrisiran

Alnylam Pharamceuticals Announcement June 24, 2024, Alnylam Pharmaceuticals (ALNY) announced positive topline results from its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). The study met the primaary endpoint. It demonstrated a statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular . . . This content is for paid …

Sarepta Therapeutics Announces Expanded US FDA Approval of ELEVIDYS to Duchenne Muscular Dystrophy Patients

Sarepta Therapeutics in the NEWS On June 20, 2024, Sarepta Therapeutics (SRPT) announced that the U. S. FDA has approved an expansion to the labeled indication for ELEVIDYS (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least 4 years of age. Confirming the functional benefits, the FDA granted . . . This …

Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention

Gilead Sciences' Lenacapavir Demonstrated 100% Efficacy in Preventing HIV Gilead Sciences, Inc. (GILD) today announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women. PURPOSE 1 met its key efficacy endpoints . . . This content is …