TG THERAPEUTICS

10 biotech companies to watch in 2025: Anavex Life Sciences (blarcamesine for neurodegenerative diseases), Candid Therapeutics (T cell engager antibodies for autoimmune diseases), Enterprise Therapeutics (ETD001 for cystic fibrosis), Jazz Pharmaceuticals (Ziihera for biliary tract cancer), Life Biosciences (ER-100 for optic neuropathies), Ovid Therapeutics (OV888 for cerebral cavernous malformation), Skye Bioscience (nimacimab for obesity), TG Therapeutics (Briumvi for multiple sclerosis), Wave Life Sciences (WVE-006 for alpha-1 antitrypsin deficiency), and Quotient Therapeutics (somatic genomics platform for drug discovery).

Global markets show mixed performance; U.S. indexes like S&P 500 and Nasdaq Composite reach record highs, while Russell 2000 Index declines. Growth stocks in IT and consumer discretionary sectors gain over 3%. High-growth tech stocks require consideration of innovation potential and financial health. Top 10 high-growth tech companies include Seojin SystemLtd, Yggdrazil Group, Ascelia Pharma, Waystream Holding, Medley, Alnylam Pharmaceuticals, TG Therapeutics, Fine M-TecLTD, Alkami Technology, and Initiator Pharma. Genmab A/S, Yubico AB, and Sharetronic Data Technology Co., Ltd. are highlighted for their strong growth and innovation in biotechnology, cybersecurity, and smart terminal technologies respectively.

The FDA issues guidance on accelerated approvals, emphasizing sponsors must have confirmatory trials underway at approval. Labels will detail drug usefulness limitations. Accelerated approval should not be considered if adequate trials are impossible. Sponsors must conduct confirmatory trials diligently, with FDA review of protocols. FDA may withdraw approval for non-compliance, safety concerns, or misleading promotions. Examples include Pfizer's Oxbryta withdrawal and Sarepta's Elevidys market retention despite trial failure.

TG Therapeutics' CEO to participate in the 7th Annual Evercore HealthCONx Conference on Dec 3-5, 2024, with a fireside chat on Dec 3 at 10:00 AM ET. A live webcast will be available on the company's website.

DelveInsight's 'Multiple Sclerosis Pipeline Insight 2024' report highlights 75+ companies developing 80+ therapies, including promising candidates like GA Depot, Remibrutinib, and IMU 838. Key events include Immunic's positive Phase 3 ENSURE trial interim analysis, Roche's FDA approval for Ocrevus injectable, and Sanofi's mixed results for tolebrutinib in Phase III trials. The report covers global pipeline stages, product types, molecule types, mechanisms of action, and routes of administration.

B.Riley Financial's Mayank Mamtani reiterates Buy rating on Altimmune (ALT) with $20.00 target, citing successful FDA End of Phase 2 meeting for pemvidutide, paving way for Phase III obesity program. UBS also initiated coverage with a Buy rating and $26.00 target.

TG Therapeutics reports Q3 2024 U.S. BRIUMVI net revenue of $83.3 million, raising full-year target to $300-$305 million. Conference call on Nov 4, 2024, at 8:30 AM ET to discuss financial results and recent developments.

Multiple sclerosis (MS) is a chronic CNS disease with varied symptoms, caused by immune system attacks on myelin. Biotech companies like Biogen, Immunic Therapeutics, Kyverna Therapeutics, Progentos Therapeutics, TG Therapeutics, and Zenas BioPharma are developing new treatments, including BTK inhibitors, CAR-T therapies, and bispecific antibodies. The global MS drug market is expected to grow significantly, offering hope for more effective treatments for different forms of MS.

Pfizer withdrew Oxbryta from global markets due to increased risk of death, joining other drugs like Aduhelm, Exkivity, Ukoniq, and Zydelig that were approved under the FDA's accelerated pathway but later withdrawn. The pathway, implemented in 1992, has helped bring nearly 300 drugs to market but faces scrutiny over delayed confirmatory trials and surrogate endpoints. Sarepta's Elevidys is an exception, securing full approval despite missing primary efficacy endpoints.

Mantle cell lymphoma (MCL) treatment outcomes improve with novel targeted therapies like BTK inhibitors. DelveInsight's 'Mantle Cell Lymphoma Pipeline Insight 2024' covers 20+ companies developing 22+ therapies, including Venetoclax and ADI-001. Key events include AstraZeneca's Phase III ECHO trial and BeiGene's AACR presentation.