Brain

Medigene AG Expands Patent Portfolio in Japan for iM-TCR Technology to Directly Control TCR-T Safety and Efficacy, In Vivo

Retrieved on: 
Monday, March 4, 2024

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Key Points: 
  • “We are delighted with the receipt of the patent grant for our iM-TCR from the Japan Patent Office as we continue to expand and strengthen our IP portfolio.
  • The ability to control the level of TCR activity with our iM-TCR technology after dosing has the potential to deliver more individualized efficacy and safety for patients.
  • This patent grant is further validation of this innovative iM-TCR technology,” said Selwyn Ho, CEO at Medigene.
  • The iM-TCR technology modifies the TCR to achieve control of TCR surface expression, allowing for fine-tuning of activity against tumor cells and thereby reducing potential inflammatory responses in the body.

BioVie’s NE3107 Demonstrates Potential Improvements in Motor and Non-motor Symptoms for Parkinson’s Disease Patients and May Be Realigning Physiological Processes for Alzheimer’s Patients in Data to be Presented at the International Conference on Alzheime

Retrieved on: 
Friday, March 1, 2024

CARSON CITY, Nev., March 01, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced two upcoming presentations at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024 (AD/PD™ 2024) to be held March 5-9, 2024 in Lisbon, Portugal.

Key Points: 
  • These findings complement previously reported improvement in motor symptoms in patients treated with NE3107 and demonstrate potential intrinsic, levodopa-enhancing activity of NE3107 that is consistent with data from animal models.
  • NE3107-treated patients experienced a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS) in Parkinson’s Disease, whereas placebo patients experienced a worsening of +1.0 points (p=0.0159).
  • Sleep/fatigue domain improvements correlated with motor score improvements (r=0.51; p=0.0259).
  • More patients on NE3107 had improvements in the NMSS sleep/fatigue domain, while more patients on placebo worsened.

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

Retrieved on: 
Friday, March 1, 2024

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.

ClearPoint Neuro to Announce Fourth Quarter and Full Year 2023 Results March 12, 2024

Retrieved on: 
Friday, March 1, 2024

SOLANA BEACH, Calif., March 01, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that it will release financial results for its 2023 fourth quarter and full year on Tuesday, March 12th, after the market close.

Key Points: 
  • SOLANA BEACH, Calif., March 01, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that it will release financial results for its 2023 fourth quarter and full year on Tuesday, March 12th, after the market close.
  • Investors and analysts are invited to listen to the live broadcast review of the Company’s 2023 fourth quarter and full year results on Tuesday, March 12th, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here .
  • Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada.
  • An online archive of the broadcast will be available on the Company’s Investor website at https://ir.clearpointneuro.com

ONWARD® Medical Awarded 10th Breakthrough Device Designation for Brain-Computer Interface (BCI) from US FDA

Retrieved on: 
Thursday, February 29, 2024

This is the tenth FDA BDD awarded to ONWARD Medical.

Key Points: 
  • This is the tenth FDA BDD awarded to ONWARD Medical.
  • The designation is reserved for novel, cutting-edge therapies addressing an unmet need and provides many potential regulatory and reimbursement advantages.
  • This latest award gives ONWARD Medical priority FDA review, the opportunity to interact with FDA experts throughout the pre-market regulatory review phase, and the potential to seek additional reimbursement for its ARC-BCI System.
  • “Brain-computer interface technology unlocks the transformative potential to enhance ARC-IM with thought-driven control of movement after paralysis,” said ONWARD Medical CEO Dave Marver.

ClearPoint Neuro Announces Pricing of Public Offering of 2,307,694 Shares of Common Stock

Retrieved on: 
Thursday, February 29, 2024

SOLANA BEACH, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, announced today the pricing of its underwritten public offering of 2,307,694 shares of its common stock at a price to the public of $6.50 per share.

Key Points: 
  • SOLANA BEACH, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, announced today the pricing of its underwritten public offering of 2,307,694 shares of its common stock at a price to the public of $6.50 per share.
  • In addition, the Company has granted the underwriter a 30-day option to purchase up to an additional 346,154 shares of its common stock at the public offering price less underwriting discounts and commissions.
  • The offering is expected to close on March 4, 2024, subject to customary closing conditions.
  • An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering are available on the SEC website at www.sec.gov.

Coave Therapeutics Receives Grant from the ALS Association to Advance its CTx-TFEB Program as a Potential Treatment for All Forms of ALS

Retrieved on: 
Thursday, February 29, 2024

The grant, which will support the development of Coave’s CTx-TFEB program through to preclinical proof-of-concept, has been made through the Association’s Lawrence and Isabel Barnett Drug Development Program .

Key Points: 
  • The grant, which will support the development of Coave’s CTx-TFEB program through to preclinical proof-of-concept, has been made through the Association’s Lawrence and Isabel Barnett Drug Development Program .
  • ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.
  • Over the course of the disease, people lose the ability to move, to speak, and eventually, to breathe.
  • With this funding and invaluable support from the ALS Association, we are poised to move our CTx-TFEB program forward.

ClearPoint Neuro Launches Proposed Public Offering of Common Stock

Retrieved on: 
Wednesday, February 28, 2024

SOLANA BEACH, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, announced today the commencement of a proposed underwritten public offering of its shares of common stock.

Key Points: 
  • SOLANA BEACH, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, announced today the commencement of a proposed underwritten public offering of its shares of common stock.
  • The Company also expects to grant the underwriters a 30-day option to purchase additional shares of common stock in an amount of up to 15% of the number of shares sold in the offering.
  • The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
  • Lake Street Capital Markets, LLC is acting as the sole book-running manager for the proposed offering.

STATE OF CELIAC DISEASE IN CANADA - UNDERDIAGNOSED, UNAFFORDABLE AND UNSAFE FOOD: SURVEY

Retrieved on: 
Wednesday, February 28, 2024

Twenty years after the first comprehensive survey of Canadians living with celiac disease, new results show the condition remains largely underdiagnosed, the gluten-free diet is often unaffordable, and many risk being exposed to unsafe food.

Key Points: 
  • Twenty years after the first comprehensive survey of Canadians living with celiac disease, new results show the condition remains largely underdiagnosed, the gluten-free diet is often unaffordable, and many risk being exposed to unsafe food.
  • Celiac Canada surveyed 7,500 Canadians with celiac disease on topics like what symptoms they experience, how long they went before being diagnosed, and how they manage living with the disease (eating challenges in social settings, the availability and cost of gluten-free food, and the psycho-social challenges of managing celiac disease).
  • Have all provinces add blood tests for celiac disease to the standard requisition used by family doctors.
  • Help healthcare professionals better recognize the increasing neurological and mental health signs of celiac disease (neuropathy, migraines, depression, anxiety) and not just the traditional disease symptoms (like bloating, weight loss, diarrhea).

Voyager Therapeutics Reports Fourth Quarter and Full Year 2023 Financial and Operating Results

Retrieved on: 
Wednesday, February 28, 2024

LEXINGTON, Mass., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today reported fourth quarter and full year 2023 financial and operating results.

Key Points: 
  • ET today -
    LEXINGTON, Mass., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today reported fourth quarter and full year 2023 financial and operating results.
  • Novartis agreed to pay Voyager $80 million of consideration up front and $20 million for the purchase of newly issued equity in Voyager.
  • Collaboration Revenues: Voyager had collaboration revenue of $90.1 million for the fourth quarter of 2023, compared to $(1.6) million for the same period in 2022.
  • ET to discuss the fourth quarter and full year 2023 financial and operating results.