Multiple sclerosis

A.I. Supercomputer Market Projected To Reach $3.3 Billion By 2028 with Significant Growth Expected

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Monday, March 4, 2024
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A report from MarketsAndMarkets said that the AI supercomputer market is projected to grow from USD $1.2 billion in 2023 and is expected to reach USD $3.3 billion by 2028, growing at a CAGR of 22.0% from 2023 to 2028.

Key Points: 
  • A report from MarketsAndMarkets said that the AI supercomputer market is projected to grow from USD $1.2 billion in 2023 and is expected to reach USD $3.3 billion by 2028, growing at a CAGR of 22.0% from 2023 to 2028.
  • The report said: “The Government segment in the AI supercomputer market for application is expected to hold the largest market size during the forecast period in the AI supercomputer market.
  • Moreover, AI supercomputers are also being used to coordinate disaster relief efforts and provide assistance to victims of disasters.
  • AI supercomputers process vast datasets in real time, providing valuable insights into customer behavior, market trends, and operational efficiency.

TG Therapeutics Announces Presentation of Data for BRIUMVI® in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum

Retrieved on: 
Friday, March 1, 2024
CD20, Research, MD, Treatment, Multiple sclerosis, Safety, Therapy, Patient, RMS, Publication, Pharmaceutical industry

NEW YORK, March 01, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held in West Palm Beach, Florida.

Key Points: 
  • NEW YORK, March 01, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held in West Palm Beach, Florida.
  • Links to each presentation are included below.
  • Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, “We were pleased to present updated data from the ENHANCE trail evaluating patients switching from a current CD20 to BRIUMVI.
  • It was encouraging to see that patients who switched to one-hour BRIUMVI experienced a manageable safety and tolerability profile.

Alumis Presents Preclinical Data for Allosteric TYK2 Inhibitor A-005 at ACTRIMS

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Friday, March 1, 2024
Central nervous system, Research, EAE, Treatment, Rat, Multiple sclerosis, Allosteric regulation, CNS, Microdialysis, Patient, TYK2, Poster, Brain, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 01, 2024 (GLOBE NEWSWIRE) -- Alumis Inc., a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to transform the lives of patients with immune-mediated diseases, today announced preclinical data for A-005 at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) forum. A-005 is a potential first-in-class, brain penetrant tyrosine kinase 2 (TYK2) inhibitor being developed for the treatment of multiple sclerosis (MS), Parkinson’s Disease and other neuroinflammatory and neurodegenerative diseases, with Phase I clinical trial initiation planned in the first half of 2024.

Key Points: 
  • “Therapeutic inhibition of TYK2 has been clinically validated to treat immune-mediated diseases, but there remains a medical need for the clinical development of an allosteric TYK2 inhibitor targeting the central nervous system,” said David Goldstein, Ph.D., Chief Scientific Officer, Alumis.
  • Presented as a poster, results demonstrated A-005 to be highly potent and inhibit TYK2 pathway activation in human whole blood, PBMCs and microglial cells.
  • The data also underscored the ability of A-005 to reduce EAE clinical scores when administered prophylactically or therapeutically.
  • Data are being presented during ACTRIMS 2024 Poster Session 2 on March 1, 2024, from 6:00-7:30 pm ET, Poster Number 400.

Vigil Presents Poster on Impacts of Misdiagnosis and Genetic Testing on Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP) Patient Journey at ACTRIMS 2024

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Thursday, February 29, 2024
CSF1R, ALSP, Genetic testing, Approximation error, Neurodegenerative disease, Life, Multiple sclerosis, Patient, Disease, Senior counsel, Diagnosis, Microglia, Research, Medical device

WATERTOWN, Mass., Feb. 29, 2024 (GLOBE NEWSWIRE) --  Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today presented a poster detailing the impact of misdiagnosis and the importance of genetic testing at the 2024 ACTRIMS Forum being held in West Palm Beach, Florida, from February 29 – March 2.

Key Points: 
  • “We continue to hear from members of the ALSP community that the path to an accurate diagnosis can be difficult, indirect, and time consuming.
  • As with many rare diseases, the misdiagnosis of ALSP can be a significant and persistent challenge to overcome.
  • It also showed that when considering genetic testing, access to approved treatments may be a motivator for patients, family members, and clinicians.
  • A structured patient journey workshop was hosted as a means of better understanding life with ALSP, including the impact of misdiagnosis and barriers to genetic testing.

Clene Presents Clinical Results of CNM-Au8® 30mg Treatment From Visionary-MS Trial Long-Term Extension at Annual ACTRIMS Forum 2024

Retrieved on: 
Thursday, February 29, 2024
Multiple sclerosis, CNM

The data presentation, titled “CNM-Au8 VISIONARY-MS Trial | Long Term Extension Clinical Results,” includes clinical results from the VISIONARY-MS Phase 2 long-term open label extension in participants with stable relapsing multiple sclerosis (RMS) and chronic optic neuropathy who received background immunomodulatory disease-modifying therapy (DMT).

Key Points: 
  • The data presentation, titled “CNM-Au8 VISIONARY-MS Trial | Long Term Extension Clinical Results,” includes clinical results from the VISIONARY-MS Phase 2 long-term open label extension in participants with stable relapsing multiple sclerosis (RMS) and chronic optic neuropathy who received background immunomodulatory disease-modifying therapy (DMT).
  • After completion of the double-blind period, 55 of 69 (80%) LTE-eligible study participants continued on CNM-Au8 30mg for up to an additional 96 weeks.
  • Analyses are reported for the modified intent to treat (mITT) population including all study participants with valid clinical data.
  • The mMSFC scale evaluates low contrast vision, cognition, upper extremity function, and walking speed as a combined mean standardized change.

AxoSim Appoints Two Biotech Industry Veterans as Co-Chairs of Its Board of Directors

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Wednesday, February 28, 2024
Research, Doctor of Philosophy, General partnership, Drug development, Growth, Frustration, University, Chronic pain, SUNY, Biomedical sciences, Epilepsy, Neurology, Rett syndrome, Smith, Kline & French, Acadia Pharmaceuticals, School, University at Buffalo, Biotechnology, ATyr Pharma, Health, Neurotoxicity, Cell, Therapy, DSM-IV codes, Brain, Neuropharmacology, Proteostasis, Amathus, Record, Drug discovery, Peripheral neuropathy, MPS, Physics, OPKO Health, Genomics, Acquisition, EMD, LoDo, Denver, MD, Organoid, Multiple sclerosis, Prevalence, Brown University, Brandeis University, Serono, Patient, Disease, GSK plc, Pharmaceutical industry

Dr. Pfost noted, “AxoSim embodies the entrepreneur’s sweet spot--when market need, technological innovation, timing and team all align. The growing prevalence of neurological diseases places enormous burdens on patients, their families and society. Yet despite billions in investment, neurology R&D continues to disappoint. AxoSim’s transformational approach addresses a key contributor to these failures—the lack of relevant disease models—by providing functional human data from its microphysiological system (MPS) organoid technologies early in the process. AxoSim aims to become an industry leader in helping to deliver urgently needed new drugs and I welcome the opportunity to contribute to its success.”

Key Points: 
  • Dr. Pfost and Dr. Weiner have decades of experience in building successful biotechnology companies spanning therapeutics, diagnostics and life science tools and technologies.
  • “Our recent acquisition of a third platform technology positions AxoSim for growth, and we are fortunate to have these two talented industry veterans assuming key leadership roles,” said Lowry Curley, PhD, co-founder and Chief Executive Officer of AxoSim.
  • “Dale and Dave bring successful track records in building life sciences businesses, with broad and complementary skill sets.
  • Dale’s work in life science tools and venture finance is highly relevant, as is Dave’s expertise in leading neurological drug discovery and clinical development.

TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2023 Financial Results

Retrieved on: 
Wednesday, February 28, 2024
CD20, Conference call, European Commission, Patent, CD19, Precision, Precision BioSciences, Conference, Multiple sclerosis, Consultant, Therapy, Patient, Autoimmunity, Clinical trial, Finance, RMS, Prescription, Pharmaceutical industry

NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) --  TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the fourth quarter and year ended December 31, 2023, along with recent company developments.Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, “2023 was an exciting year of execution for TG, which we believe has set the stage for a successful 2024. The BRIUMVI launch exceeded our expectations, and we ended the year with approximately $89 million in U.S. net revenue and provided a BRIUMVI U.S. net revenue target of $220 - $260 million for 2024. Further executing on our corporate objectives in 2023, we presented the first data from our ENHANCE Phase 3 b trial evaluating patients who switch from prior CD20 therapy to BRIUMVI, and recently broadened our BRIUMVI clinical efforts to include subcutaneous development and potential expansion beyond MS. We look forward to sharing additional developments from these efforts throughout the year, as well as advancing our recent pipeline addition, azer-cel, an allogeneic CAR T into clinical development in autoimmune disease.” Mr. Weiss continued, “We were also pleased to see our ex-US partner, Neuraxpharm, commence the launch of BRIUMVI in Europe this week. As the year progresses, we look forward to providing continued updates on our launch of BRIUMVI in the U.S. and sharing data updates throughout the year at major medical meetings.”

Key Points: 
  • Fourth quarter and full year 2023 BRIUMVI U.S. net revenue of approximately $40 million and $89 million, respectively
    Conference call to be held today, February 28, 2024, at 8:30 AM ET
    NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) --  TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the fourth quarter and year ended December 31, 2023, along with recent company developments.
  • Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $217.5 million as of December 31, 2023.
  • The Company will host a conference call today, February 28, 2024, at 8:30 AM ET, to discuss the Company’s financial results from the fourth quarter and full year ended December 31, 2023.
  • To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics.

Tonix Pharmaceuticals Completes Clinical Stage of Phase 1 Trial for TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers

Retrieved on: 
Wednesday, February 28, 2024
Tonix Pharmaceuticals, Toxicity, CD40L, Risk, Multiple sclerosis, Protein engineering, Thrombosis, Sanofi, Haematopoietic system, Hook effect, Kidney, Pharmaceutical industry

CHATHAM, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical stage of its Phase 1, single ascending dose escalation trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy volunteers. TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplant and for the treatment of autoimmune disorders.

Key Points: 
  • TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplant and for the treatment of autoimmune disorders.
  • “Despite advancements in the field of solid organ transplantation, there remains a significant need for new treatments with improved activity and tolerability,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • “Anti-CD40L modulates T cell function and has the potential to promote tolerance of transplanted organs.
  • We are excited to have completed the clinical stage of this Phase 1 trial of TNX-1500, a third-generation Fc-modified anti-CD40L mAb that has been designed by protein engineering to eliminate the risk of thrombosis associated with first-generation anti-CD40L mAbs.

TG Therapeutics Announces Issuance of Additional Patents for BRIUMVI® (ublituximab-xiiy)

Retrieved on: 
Tuesday, February 27, 2024
European Commission, Patent, Multiple sclerosis, Civil service commission, Therapy, Patient, MHRA, RMS, Medication, Pharmaceutical industry

NEW YORK, Feb. 27, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (TG) today announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI® (ublituximab-xiiy), the first and only anti-CD20 monoclonal antibody approved in the US for patients with relapsing forms of multiple sclerosis (RMS) that can be administered in a one-hour infusion following the starting dose.

Key Points: 
  • NEW YORK, Feb. 27, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (TG) today announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI® (ublituximab-xiiy), the first and only anti-CD20 monoclonal antibody approved in the US for patients with relapsing forms of multiple sclerosis (RMS) that can be administered in a one-hour infusion following the starting dose.
  • The additional recently issued patents, US Patent Nos.
  • 11,807,689; 11,814,439; and 11,884,740, leverage the unique glycoprofile of ublituximab to extend patent protection covering the composition of matter of ublituximab and methods of treatment utilizing ublituximab into 2042.
  • Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “We are pleased to announce the issuance of these additional patents for BRIUMVI which add to our existing patent portfolio, and extend patent protection through 2042.

Ventyx Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Corporate Progress

Retrieved on: 
Tuesday, February 27, 2024
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SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced financial results for the fourth quarter and full year ended December 31, 2023, and highlighted recent pipeline and business progress.

Key Points: 
  • Fourth Quarter and Full Year 2023 Financial Results:
    Cash Position: Cash, cash equivalents and marketable securities were $252.2 million as of December 31, 2023.
  • Research and Development (R&D) expenses: R&D expenses were $42.0 million for the fourth quarter of 2023, compared to $30.2 million for the fourth quarter of 2022.
  • General and Administrative (G&A) expenses: G&A expenses were $8.3 million for the fourth quarter of 2023, compared to $8.4 million for the fourth quarter of 2022.
  • Net loss: Net loss was $46.8 million for the fourth quarter of 2023, compared to $35.2 million for the fourth quarter of 2022.