CARMEL, Ind., May 27, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, will participate in a webcast presentation and host one-on-one meetings with investors at the Lytham Partners Spring 2025 Investor Conference, taking place virtually on Thursday, May 29, 2025. Company Webcast The webcast presentation will take place at 9 ...

Company Overview - SpringWorks Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, with a commitment to improving the lives of patients [7] - The company has developed the first and only FDA-approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN) [7] Product Development - Mirdametinib, a MEK inhibitor, has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for conditional marketing authorization in the EU for treating symptomatic, inoperable plexiform neurofibromas in patients aged 2 years and older with NF1 [1][2] - The European Commission is expected to make a final decision regarding mirdametinib's approval in the third quarter of 2025 [1] Clinical Trial Results - The positive opinion was based on the Marketing Authorization Application (MAA) validated by the EMA in August 2024, which included results from the Phase 2b ReNeu trial involving 114 patients [2][4] - The trial demonstrated a confirmed objective response rate (ORR) of 41% in adults and 52% in children, with significant reductions in target tumor volume [2][4] - Among patients with confirmed responses, 88% of adults and 90% of children had responses lasting at least 12 months [2] Patient Demographics and Disease Impact - Neurofibromatosis type 1 (NF1) affects approximately 3 in 10,000 people in the EU, translating to an estimated 135,000 individuals [2][5] - Patients with NF1 have a 30% to 50% lifetime risk of developing plexiform neurofibromas, which can lead to severe disfigurement, pain, and functional impairment [2][5] Safety Profile - Mirdametinib has shown a manageable safety and tolerability profile, with common adverse events in adults including rash, diarrhea, and nausea, while children experienced similar side effects along with additional issues like left ventricular dysfunction [2][6]

Company Overview - Serina Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing a pipeline of drug candidates for neurological diseases and other indications, utilizing its proprietary POZ Platform for drug optimization [5]. Leadership Appointment - Dr. Stephen Brannan has been appointed to the Board of Directors, bringing over 30 years of experience in neuroscience and neuropsychiatry drug development [2][3]. - Dr. Brannan previously served as Chief Medical Officer at Karuna Therapeutics, where he led the clinical strategy for KarXT, a groundbreaking therapy for schizophrenia that contributed to Karuna's $14 billion acquisition by Bristol Myers Squibb in 2024 [2][3]. Strategic Focus - The company aims to advance long-acting treatments for movement disorders and other CNS conditions, aligning with Dr. Brannan's expertise in designing data-driven clinical trials and understanding patient and commercial needs [3]. Previous Experience - Dr. Brannan has held senior roles at Takeda, Novartis, Cyberonics (now LivaNova), and Eli Lilly, directing clinical development programs in various CNS conditions [3]. - He is a founding member of the CNS Summit Leadership Council and has served on the Executive Committee of the International Society for CNS Clinical Trials and Methodology (ISCTM) [3]. Board Changes - Remy Gross has departed from the Board of Directors, with the company expressing gratitude for his contributions during its transition from a private to a public entity [5].

Core Viewpoint - NeurAxis, Inc. has successfully closed a registered direct offering, raising approximately $5.0 million to strengthen its balance sheet and support growth initiatives, particularly for its IB-Stim therapy targeting chronic abdominal pain in pediatric patients [1][2]. Group 1: Financial Details - The offering consisted of 1,538,461 shares of common stock priced at $3.25 per share, resulting in gross proceeds of about $5.0 million before expenses [1]. - In addition to the offering, NeurAxis secured over $1 million from warrant exercises, further enhancing its financial position [2]. Group 2: Product and Market Impact - The recent FDA clearance for expanded indications of the IB-Stim treatment for Pediatric Functional Abdominal Pain (FAP) is a significant milestone for the company, addressing a critical need in pediatric care [2]. - The IB-Stim therapy is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21, with ongoing clinical trials for various pediatric and adult conditions [5]. Group 3: Future Outlook - The funds raised will be utilized to drive revenue growth for IB-Stim and prepare for the implementation of a CPT Category I code effective January 1, 2026, which is expected to enhance reimbursement and adoption of the therapy [2].

Autonomix Medical, Inc. (AMIX) recently announced that it has been granted a key U.S. patent for its innovative catheter-based platform designed to sense and differentiate nerve signals in real-time. This technology represents a significant leap forward in the field of neuromodulation, with the potential to enhance treatment precision across a wide range of chronic conditions, including cancer and pain management. The platform enables both sensing and stimulation of nerves through a single device.With the b ...

Core Viewpoint - Sanofi has entered into a definitive merger agreement to acquire Vigil Neuroscience for an upfront payment of $8.00 per share, with potential additional payments based on the commercial success of VG-3927, valuing the total equity of the transaction at approximately $600 million on a fully diluted basis [1][5][6]. Company Overview - Vigil Neuroscience is a clinical-stage biotechnology company focused on developing treatments for neurodegenerative diseases by restoring the function of microglia, the immune cells of the brain [11]. - The company is developing VG-3927, a small molecule TREM2 agonist aimed at treating Alzheimer's disease, and has a pipeline that includes therapies for both rare and common neurodegenerative diseases [11]. Transaction Details - The merger agreement stipulates that Vigil's shareholders will receive $8.00 per share in cash at closing, plus a contingent value right (CVR) that could yield an additional $2.00 per share upon the first commercial sale of VG-3927 [1][5][6]. - The acquisition is expected to close in the third quarter of 2025, subject to customary conditions including shareholder approval and regulatory clearances [8]. Strategic Rationale - Sanofi's acquisition of Vigil aligns with its strategic focus on neurology and the development of innovative therapies for critical unmet needs in neurodegenerative diseases [4]. - The TREM2 target is seen as a promising area for addressing immune dysregulation and neurodegeneration, particularly in Alzheimer's patients who currently have limited treatment options [4][2]. Development Potential - The acquisition is anticipated to strengthen the development path for VG-3927, which is positioned as a Phase 2-ready clinical candidate for Alzheimer's disease [5][6]. - Activating TREM2 is expected to enhance the neuroprotective function of microglia, potentially preventing neural degeneration associated with adult-onset neurodegenerative diseases [2][3].

Core Viewpoint - Sanofi has announced the acquisition of Vigil Neuroscience, Inc., enhancing its neurology pipeline with a focus on developing treatments for Alzheimer's disease, specifically through the investigational drug VG-3927 [1][5]. Group 1: Acquisition Details - Sanofi will acquire all outstanding common shares of Vigil for $8 per share, totaling an equity value of approximately $470 million on a fully diluted basis [8]. - Vigil's shareholders will also receive a contingent value right (CVR) entitling them to a deferred cash payment of $2 upon the first commercial sale of VG-3927 [8]. - The acquisition is expected to close in Q3 2025, subject to customary conditions including shareholder approval and regulatory clearances [9]. Group 2: Strategic Importance - This acquisition aligns with Sanofi's strategic focus on neurology and aims to address critical unmet needs in Alzheimer's treatment, where current therapies do not halt or reverse disease progression [4][2]. - The acquisition follows a $40 million strategic investment made by Sanofi in Vigil in June 2024, which included rights to negotiate for VG-3927 [5]. Group 3: Scientific Rationale - VG-3927 is an oral small molecule TREM2 agonist, which is expected to enhance the neuroprotective function of microglia in Alzheimer's disease [1]. - Activation of TREM2 is believed to improve microglial response to injury, potentially preventing neural degeneration associated with neurodegenerative diseases [3].

Core Insights - ReShape Lifesciences Inc. is progressing towards completing a merger with Vyome Therapeutics and an asset purchase agreement with Biorad Medisys, which are expected to enhance its market position and operational capabilities [3][4][6]. Financial Performance - For Q1 2025, ReShape reported revenue of $1.1 million, a decrease of 42.7% or $0.8 million compared to Q1 2024, primarily due to reduced sales volume influenced by GLP-1 pharmaceutical weight-loss alternatives and a pause in direct-to-consumer marketing [8]. - Gross profit for the same period was $0.7 million, with a gross profit margin of 61.2%, up from 59.9% in Q1 2024, attributed to lower overhead costs [9]. - Sales and marketing expenses decreased by 48.1% to $0.5 million, while general and administrative expenses fell by 13.1% to $1.6 million, reflecting cost-saving measures [10][11]. - Research and development expenses also decreased by 24.8% to $0.4 million [12]. - The company recorded a gain of $3.7 million on changes in the fair value of liability warrants during Q1 2025 [14]. Strategic Developments - The merger with Vyome will result in the combined entity being renamed Vyome Holdings, Inc., with a focus on advancing immuno-inflammatory assets and exploring opportunities between the U.S. and India [3][6]. - ReShape has expanded its product portfolio through a distribution agreement with Motion Informatics for neuromuscular rehabilitation devices and a new distribution agreement for the enhanced Lap-Band 2.0 FLEX in Canada [6][7]. - The company has received multiple Notices of Allowance from the USPTO for patents related to its Diabetes Neuromodulation technology, extending intellectual property protection through at least 2039 [7]. Asset Transactions - ReShape will sell substantially all of its assets, including the Obalon Gastric Balloon System, to Biorad, which will assume most of ReShape's liabilities [5]. - The cash purchase price from the asset sale will contribute to determining post-merger ownership allocation between ReShape and Vyome stockholders [5]. Market Position - ReShape aims to strengthen its leadership in diabetes innovation and expand access to its minimally invasive weight-loss solutions, positioning itself as a key player in the obesity and metabolic health market [6][7].

The offering is expected to close on or about May 22, 2025, subject to the satisfaction of customary closing conditions. Craig-Hallum Capital Group is acting as the exclusive placement agent for the offering. The gross proceeds from the offering are expected to be approximately $5.0 million, before deducting placement agent fees and other offering expenses payable by the Company. NeurAxis intends to use the net proceeds from the offering for working capital and general corporate purposes. A shelf registrati ...

Cash runway into Q3 2026AFFIRM-1 Phase 3 clinical trial of BNC-210 in social anxiety disorder on track for topline readout in Q3 2025α7 nicotinic acetylcholine receptor PAM MK-1167 partnered with Merck and in Phase 2 clinical trial in Alzheimer’s BURLINGTON, Mass., May 20, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today provides business updates for ...