TG THERAPEUTICS
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1993-01-01
- Employees
- 264
- Market Cap
- $3.5B
Promising Pipeline for Mantle Cell Lymphoma Treatment: 22+ Therapies Under Development by 20+ Companies
• DelveInsight's latest report reveals a robust pipeline with 20+ companies developing 22+ therapies for mantle cell lymphoma, highlighting significant advancement in treatment options for this rare blood cancer.
• Recent approvals include AstraZeneca's CALQUENCE® (acalabrutinib) combination therapy for previously untreated MCL patients ineligible for stem cell transplantation, marking an important treatment milestone.
• Key emerging therapies include Venetoclax (AbbVie), ADI-001 (Adicet Bio), and BGB-11417 (BeiGene), with multiple compounds targeting novel mechanisms of action across various clinical development stages.
Roche's High-Dose Ocrevus Fails Phase 3 Trial for Multiple Sclerosis, Boosting TG Therapeutics
• Roche announced that its Phase 3 MUSETTE trial testing a high-dose version of Ocrevus (ocrelizumab) failed to show additional benefit in slowing disability progression in relapsing multiple sclerosis patients.
• The setback for Roche's MS therapy sent shares of rival drug developer TG Therapeutics higher, as investors reassessed competitive dynamics in the multiple sclerosis treatment landscape.
• Despite the trial failure, Roche reported that the standard 600mg dose of Ocrevus demonstrated clinically meaningful results with the lowest annualized relapse rate observed in any Phase 3 study for relapsing MS.
B-Cell Lymphoma Pipeline Expands with 300+ Therapies in Development for 2025
• DelveInsight's latest report reveals a robust B-cell lymphoma pipeline with over 295 companies developing 300+ therapies, highlighting significant industry investment in this area.
• Several major pharmaceutical companies including BeiGene, Celgene, Hoffmann-La Roche, and Allogene Therapeutics have initiated pivotal late-stage clinical trials for novel B-cell lymphoma treatments in March 2025.
• Emerging therapies include CAR-T cell approaches, bispecific antibodies, and novel targeted agents, with many incorporating dual-targeting mechanisms to overcome resistance seen with single-target therapies.
TG Therapeutics to Present New BRIUMVI Data in Multiple Sclerosis at ACTRIMS 2025 Forum
• TG Therapeutics will showcase data from ULTIMATE I & II Phase 3 trials and ENHANCE Phase 3b trial evaluating BRIUMVI in relapsing multiple sclerosis at the upcoming ACTRIMS forum in Florida.
• Key presentations will focus on the safety and tolerability of 30-minute BRIUMVI infusions, real-world experience data, and distinct disease activity trajectories compared to teriflunomide.
• The ULTIMATE trials enrolled 1,094 RMS patients across 10 countries, demonstrating BRIUMVI's potential as a novel CD20-targeting treatment option for multiple sclerosis patients.
TG Therapeutics Partners with MaxCyte to Advance Novel CAR T-Cell Therapy for Progressive MS
• TG Therapeutics has secured access to MaxCyte's flow electroporation technology to develop azercabtagene zapreleucel, an off-the-shelf CAR T-cell therapy for progressive multiple sclerosis.
• The Phase 1 clinical trial will evaluate azer-cel in up to 32 patients with progressive MS forms, focusing on determining optimal dosing and safety profiles.
• This innovative therapy targets CD19-expressing B-cells using donor-derived T-cells, potentially reducing MS-driving autoantibodies while avoiding graft-versus-host disease complications.
Catalent and Galapagos Partner to Advance Decentralized CAR-T Manufacturing for NHL Treatment
• Catalent and Galapagos NV have formed a strategic collaboration to support decentralized manufacturing of GLPG5101, an investigational CAR-T therapy for relapsed/refractory non-Hodgkin lymphoma.
• The partnership leverages Catalent's Princeton facility to deliver fresh CAR-T cells with a median vein-to-vein time of seven days, eliminating the need for cryopreservation and bridging therapy.
• This innovative manufacturing approach aims to improve patient experience by bringing production closer to cancer treatment centers across New Jersey, New York, and surrounding areas.
TG Therapeutics' Briumvi Exceeds Expectations, Eyes Subcutaneous Formulation and Azer-Cel Trial in MS
• TG Therapeutics announced that Briumvi's 2024 sales reached $310 million, surpassing initial expectations, driven by strong adoption in relapsing forms of multiple sclerosis (RMS).
• The company anticipates $540 million in total global revenue for 2025, with $525 million expected from Briumvi sales, signaling continued growth and market penetration.
• A pivotal program for a subcutaneous formulation of Briumvi is slated to begin in 2025, offering a more convenient administration route for RMS patients.
• TG Therapeutics plans to initiate a Phase 1 trial for azer-cel in progressive MS, expanding its pipeline and addressing unmet needs in more advanced stages of the disease.
Editas Medicine Achieves In Vivo Gene Editing Milestones, Plans Clinical Push
• Editas Medicine achieved in vivo preclinical proof of concept by editing hematopoietic stem cells in non-human primates, a crucial step for sickle cell disease and beta thalassemia treatment.
• The company demonstrated in vivo editing of liver cells in non-human primates and delivered to two additional cell types in humanized mice, expanding therapeutic possibilities.
• Editas anticipates declaring two in vivo development candidates by mid-2025, one for HSCs and one for the liver, alongside presenting further in vivo data.
• Strategic priorities through 2027 include submitting at least one IND/CTA and achieving human in vivo proof of concept in HSC editing for sickle cell disease and beta thalassemia.
Breakthrough Year in Multiple Sclerosis Research: Key Advances and Treatment Milestones in 2024
2024 marked significant progress in multiple sclerosis treatment and research, highlighted by the revision of McDonald diagnostic criteria and breakthrough clinical trials. Notable developments included positive results for tolebrutinib in non-relapsing SPMS and promising outcomes for ublituximab in treatment transitions, representing major steps forward in MS care.
FDA Clarifies Confirmatory Trial Requirements for Accelerated Drug Approvals
• The FDA issued draft guidance clarifying requirements for confirmatory trials needed to verify clinical benefit of drugs receiving accelerated approval.
• The guidance emphasizes early consultation with the FDA on trial design and the need for sponsors to commit sufficient resources for timely trial completion.
• The FDA intends to require confirmatory trials to be underway before granting accelerated approval, except in limited circumstances.
• The guidance also details procedures for expedited withdrawal of approval if confirmatory trials fail or other issues arise, ensuring accountability.
Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development
• The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies.
• Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS).
• Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS.
• Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.
Altimmune's Pemvidutide Shows Promise in Obesity Treatment with Strategic Phase III Development
• Altimmune's pemvidutide advances to Phase III obesity program following successful FDA meeting, incorporating an innovative design targeting diverse patient subpopulations.
• The FDA has agreed on pemvidutide's safety profile, negating the need for extensive safety studies and highlighting its favorable cardiac efficacy compared to competitors.
• Analyst Mayank Mamtani from B.Riley Financial reiterated a Buy rating with a $20.00 price target, citing pemvidutide's glucagon activity and growth prospects.
• UBS also initiated coverage with a Buy rating and a $26.00 price target, further bolstering confidence in Altimmune's strategic approach and pemvidutide's potential.
FDA's Accelerated Approval Pathway Faces Scrutiny as Some Drugs are Withdrawn
• Several drugs approved under the FDA's accelerated approval pathway have been withdrawn from the market due to safety concerns or failure to confirm clinical benefit.
• Pfizer pulled Oxbryta, a sickle cell disease therapy, after new data showed a higher risk of deaths and complications in treated patients.
• Biogen and Eisai discontinued Aduhelm, an Alzheimer's drug, after a controversial approval and inauspicious rollout, focusing instead on Leqembi.
• The FDA is now requiring confirmatory trials to be underway before granting accelerated approval to address delays and ensure clinical outcomes.
Mantle Cell Lymphoma Pipeline Shows Promise with Novel Targeted Therapies
• The Mantle Cell Lymphoma (MCL) pipeline is robust, featuring over 20 companies developing more than 22 therapies.
• Key players like AbbVie and BeiGene are advancing novel drugs, including BTK inhibitors and Bcl-2 inhibitors, to improve MCL treatment.
• Clinical trials are evaluating promising therapies such as Venetoclax, ADI-001, and Orelabrutinib across various phases.
• Recent data highlights potential for combination therapies and novel mechanisms like BTK degradation in MCL treatment.
BRIUMVI Rapid Infusion Shows Promise in Multiple Sclerosis Treatment
• Phase 3b ENHANCE study reveals that 30-minute infusions of BRIUMVI (ublituximab-xiiy) are well-tolerated in patients with relapsing forms of multiple sclerosis (RMS).
• Data suggest patients switching from prior anti-CD20 therapies can eliminate the initial BRIUMVI infusion, streamlining the treatment process.
• Rapid infusions were completed without interruptions, with infusion-related reactions being mild (Grade 1) and resolving completely, enhancing patient convenience.
• These findings support ongoing efforts to optimize BRIUMVI dosing regimens, potentially leading to label-enabling studies and improved patient outcomes.
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