Nacuity Pharmaceuticals Granted U.S. FDA Breakthrough Therapy Designation for NPI-001 (N-acetylcysteine amide) Tablets for the Treatment of Retinitis Pigmentosa




Nacuity Pharmaceuticals Granted U.S. FDA Breakthrough Therapy Designation for NPI-001 (N-acetylcysteine amide) Tablets for the Treatment of Retinitis Pigmentosa

FORT WORTH, Texas, Oct. 02, 2025 (GLOBE NEWSWIRE) — Nacuity Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts and other diseases caused by oxidative stress, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s proprietary, investigational therapy for the treatment of patients with retinitis pigmentosa (RP).

“Breakthrough Therapy Designation represents objective assessment by the FDA that early clinical evidence supports the potential of NPI-001 tablets to deliver substantial treatment effects for patients with retinitis pigmentosa, a serious blinding disease,” said G. Michael Wall, Ph.D., Senior Vice President and Chief Scientific Officer of Nacuity Pharmaceuticals. “This recognition represents a key value-creating milestone for Nacuity and underscores our commitment to efficiently advancing NPI-001 toward late-stage development.” 

A drug may receive BTD if the drug is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

In addition to the benefits of Fast Track Designation previously granted to NPI-001, a drug that receives BTD is eligible for intensive guidance on efficient drug development and organizational commitment from FDA.

About Retinitis Pigmentosa
Often diagnosed in childhood or adolescence, retinitis pigmentosa (RP) is a heterogeneous group of inherited retinal diseases involving nearly 3,100 different mutations in more than 50 genes (Daiger et al., 2013), causing progressive night and peripheral vision loss. RP often leads to legal blindness and, in some cases, complete blindness. Forms of RP and related diseases include Usher syndrome, Leber congenital amaurosis and Bardet-Biedl syndrome. According to Foundation Fighting Blindness, an estimated 100,000 people in the U.S. have RP. There are no FDA-approved or standard treatments for RP. A curative gene therapy, voretigene neparvovec (LUXTURNA), is available for patients with the RPE65 mutation, which affects approximately 1-6% of patients with RP (Cross et al., 2022).

About NPI-001
NPI-001 is a proprietary, GMP-grade formulation of N-acetylcysteine amide (NACA) tablets being developed to target oxidative stress associated with diseases such as retinitis pigmentosa (RP). Preclinical studies indicate that NPI-001 boosts glutathione, the body’s most powerful endogenous antioxidant, to stop chemically aggressive oxygen molecules from damaging retinal cells (Wood et al., 2024). NPI-001 is formulated as a stable tablet, easy for patients to self-administer, with well-established manufacturing processes and convenient packaging options. In addition to Breakthrough Therapy Designation, NPI-001 has also been granted Fast Track and Orphan Drug Designations for the treatment of RP, the latter of which provides seven years of U.S. FDA regulatory exclusivity for the product upon regulatory approval.

About Nacuity Pharmaceuticals, Inc.
Nacuity Pharmaceuticals is a clinical-stage leader in innovative treatments for diseases and conditions involving oxidative stress. The company’s powerful, targeted therapies aim to attenuate oxidative tissue damage, a driver of blinding eye diseases and a broad spectrum of serious chronic conditions. Nacuity has operations in Fort Worth, TX, USA, and Australia, and extensive managerial and scientific domain expertise as well as backing from Foundation Fighting Blindness (https://www.fightingblindness.org/) and its venture arm RD Fund (https://www.retinaldegenerationfund.org). For more information, please visit www.nacuity.com.

Trademarks are property of their owners.

Media Contact
Julia Clements
267.626.1085
jclements@6degreespr.com

The International Myeloma Foundation Welcomes Heather Cooper Ortner as New President & CEO




The International Myeloma Foundation Welcomes Heather Cooper Ortner as New President & CEO

STUDIO CITY, Calif., Oct. 02, 2025 (GLOBE NEWSWIRE) — The International Myeloma Foundation (IMF) announced today that Heather Cooper Ortner — President & CEO of Alzheimer’s Los Angeles, and former CEO of the Dr. Susan Love Research Foundation — has been named as the IMF’s new President and Chief Executive Officer.

Ms. Cooper Ortner has longstanding ties with the IMF, having spent seven years with the organization, including serving as Executive Vice President of Development. She is excited to return and honored to lead the IMF into a new era as its President & CEO.

A Media Snippet accompanying this announcement is available by clicking on this link.

“I am honored to return to the International Myeloma Foundation as President & CEO — a full-circle moment with an organization that was formative in my career. It is a privilege to bring my experience leading healthcare nonprofits back to a mission that inspires me deeply. Together with our Board of Directors, dedicated staff, and the extraordinary community of professionals and volunteers around the world, we will continue to advance research, education, support, and advocacy — always with urgency and determination to accelerate the search for a cure. I am humbled to serve alongside so many who are making a difference every day for patients and families affected by myeloma, and I look forward to building on the IMF’s legacy of impact,” said Ms. Cooper Ortner.

As President & CEO of Alzheimer’s Los Angeles, Ms. Cooper Ortner was responsible for “overseeing all organizational and administrative duties, providing direct oversight of all programs and staff, and initiating and implementing strategic planning.”

As the former CEO of the Dr. Susan Love Research Foundation, she was responsible for overseeing all activities of the organization, including management of annual and long-term strategic positioning.

She also served as Director of Development for The Brandeis-Bardin Institute, and as Director of the Western Area Development Center for Hadassah. Ms. Cooper Ortner graduated from the University of California, Los Angeles (UCLA) with a Bachelor of Arts degree in English.

After thoroughly screening a multitude of highly competent candidates and subsequently, choosing Ms. Cooper Ortner to fill the role, IMF Board Member and chair of the search committee Andy Kuzneski III had this to say: “As chair of the search committee, I can attest to the rigor of our comprehensive and global search, and our exhaustive review of a roster of truly exceptional candidates. Our primary goal was to identify a visionary leader with a proven track record of innovation — someone who could build on the IMF’s incredible 35-year legacy by pioneering new ways to serve our community. Heather stood out as that leader — affirming that the ideal candidate was one with deep roots in our mission. Having served on the IMF Board for over a decade and worked alongside Heather during her first tenure with the IMF, it is my personal and professional privilege to welcome her back as our new President and CEO. Heather has built an impressive record of innovative CEO leadership, developing novel platforms for research engagement and community-based patient education. She returns to us as a proven leader, ready to apply her unique expertise and unwavering commitment to the global myeloma community. Her appointment feels like a strategic and welcome homecoming.”

“As a member of the IMF Board of Directors and search committee, I am delighted to welcome back Heather to the IMF, as our new President & CEO. Her proven leadership and expertise make her the ideal choice to guide the IMF into its next phase — elevating education, advocacy, and support for patients and families, and advancing research toward prevention and a cure,” said IMF Board of Directors and Scientific Advisory Board Member Sagar Lonial, MD, FACP.

IMF Chairperson of the Board Dr. S. Vincent Rajkumar expressed: “I am thrilled that Heather Cooper Ortner will assume the role of President and CEO of the IMF. She is a visionary leader who has a wealth of experience and knows our organization well. She has also dedicated her career to non-profit organizations. I look forward to working with her to grow and fulfill our mission.”

“I am overjoyed to welcome Heather as the new President and CEO of the International Myeloma Foundation. Having worked with Heather in the past, when she was IMF Executive VP of Development, we are assured of her remarkable leadership and deep commitment to the IMF’s mission and vision. As we celebrate our 35th year and welcome a new chapter under Heather’s prudent and thoughtful direction, we remain confident in accomplishing our mission: improving the quality of life of myeloma patients while working toward prevention and a cure,” said IMF Interim CEO and Senior Vice President of Strategic Planning Diane Moran, RN, MA, EdM.

Ms. Cooper Ortner’s appointment as IMF President & CEO comes at an opportune and historic moment — the IMF is celebrating 35 years of serving the myeloma community through its concerted efforts in myeloma research, education, support, and advocacy.

Under Ms. Cooper Ortner’s leadership as the IMF’s incoming President & CEO, the organization looks forward to a new chapter, as we continue to fulfill our mission and aim to achieve our vision: A world where every myeloma patient can live life to the fullest, unburdened by the disease.

Learn more about multiple myeloma and what the IMF is doing in the fight against this lesser-known blood cancer by visiting myeloma.org. 

ABOUT MULTIPLE MYELOMA       
Multiple myeloma is a cancer of the bone marrow plasma cells — white blood cells that make antibodies. A cancerous or malignant plasma cell is called a myeloma cell. Myeloma is called “multiple” because there are frequently multiple patches or areas in bone where it grows. It can appear as both a tumor and/or an area of bone loss, and it affects the places where bone marrow is active in an adult: the hollow area within the bones of the spine, skull, pelvis, rib cage, and the areas around the shoulders and hips.      

ABOUT THE INTERNATIONAL MYELOMA FOUNDATION      
Founded in 1990, the International Myeloma Foundation (IMF) is the first and largest global foundation focusing specifically on multiple myeloma. The Foundation’s reach extends to more than 525,000 members in 140 countries worldwide. The IMF is dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure by focusing on four key areas: research, education, support, and advocacy. The IMF has conducted more than 250 educational seminars worldwide, maintains a world-renowned InfoLine, and in 2001, established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. In 2012, the IMF launched the Black Swan Research Initiative®, a groundbreaking research project aimed at curing myeloma. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org.  

Media Contacts: 

Peter Anton 
Panton@myeloma.org

Jason London 
Jlondon@myeloma.org 

AM-Pharma Completes Enrollment in Phase 2 Study of Ilofotase Alfa for Prevention of Cardiac Surgery-Associated Renal Damage




AM-Pharma Completes Enrollment in Phase 2 Study of Ilofotase Alfa for Prevention of Cardiac Surgery-Associated Renal Damage

Utrecht, The Netherlands, October 2, 2025 – AM-Pharma B.V. today announced that it has successfully completed enrollment of patients in its ongoing Phase 2 clinical trial evaluating ilofotase alfa for the prevention of cardiac surgery-associated renal damage (CSA-RD). CSA-RD, a common cause of Acute Kidney Injury (AKI), is a serious complication of cardiac surgery occurring in up to 40% of patients. AKI following surgery is associated with both short- and long-term impairment of kidney function, an increased risk of requiring renal replacement therapy, sometimes lifelong, and higher mortality rates. Ilofotase alfa is the company’s proprietary therapeutic candidate that has consistently demonstrated safety, tolerability and reno-protective effects, including a reduction in Major Adverse Kidney Events (MAKE), across global clinical trials involving more than 1,000 patients diagnosed with AKI.

“CSA-RD represents a serious post-surgical complication, often leading to prolonged hospitalization, increased complications such as the need for renal replacement therapy and a higher long-term risk of chronic kidney disease, end stage renal disease, and mortality,” said Peter Pickkers, MD, PhD, Principal Investigator in the Phase 2 study and Professor of Experimental Intensive Care Medicine at Radboud University Nijmegen Medical Centre, The Netherlands. “With no pharmacological therapies currently available, there is a clear need for novel approaches. This trial is designed to confirm and expand upon the reno-protective effects observed with ilofotase alfa in prior studies, with the goal of developing a meaningful treatment option for patients at risk of kidney injury following cardiac surgery.”

The study (NCT06168799) is a multicenter, multinational, randomized, double-blind, placebo-controlled trial that randomized 244 patients at high risk for renal damage following open-heart surgery. Patients received two intravenous (IV) doses, one before and one after surgery, of either 128 mg ilofotase alfa or placebo, and are being followed for 60 days to assess efficacy, safety and pharmacokinetics. The primary endpoint is serum creatinine ratio (sCrR), a sensitive measure of kidney function changes that closely correlates with Major Adverse Kidney Events at 60 days (MAKE60). MAKE60 is an FDA-registrable endpoint, which would serve as the primary endpoint in the expected pivotal Phase 3 trial for ilofotase alfa. Topline data, including data on MAKE60 measured in this study as a secondary endpoint, are expected in early 2026, and the full dataset will be presented thereafter at a scientific conference.

“Reaching this enrollment milestone is a key inflection point in the clinical development of ilofotase alfa, bringing us closer to addressing a significant unmet need in hospital care,” said Juliane Bernholz, PhD, Chief Executive Officer of AM-Pharma. “We are grateful to our dedicated clinical partners and the patients for their vital support and trust. With recruitment now complete, we are focused on the data that will inform our next steps to realize the potential for ilofotase alfa to become the first approved therapy to prevent CSA-RD.”

About ilofotase alfa

Ilofotase alfa is a recombinant alkaline phosphatase, engineered from two human isoforms of the enzyme, which has demonstrated to be highly active and stable in multiple clinical trials. The recombinant enzyme acts by dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs)—including lipopolysaccharide (LPS), ATP, ADP, and other extracellular substrates—that drive acute inflammation, coagulation, and microvascular ischemia in the kidney following sepsis or ischemia-induced injury.

Dephosphorylation of ATP by ilofotase alfa provides dual reno-protective benefits: clearance of pro-inflammatory ATP and generation of adenosine, which activates the tissue-protective adenosine A2a receptor pathway. Through this mechanism, ilofotase alfa has consistently demonstrated safety, tolerability, and reno-protective effects, including a reduction in Major Adverse Kidney Events (MAKE), across clinical studies in patients with sepsis associated-acute kidney injury (SA-AKI), with an even greater effect observed in patients with pre-existing chronic kidney disease (CKD)¹.

AM-Pharma is developing ilofotase alfa as two distinct therapeutic products: an intravenous (IV) formulation for AKI and a highly concentrated subcutaneous (SC) formulation designed for chronic dosing as enzyme replacement therapy in hypophosphatasia (HPP). A Phase 1b study in adult HPP patients, supported by recent preclinical findings, has reinforced the therapeutic potential of the SC formulation by demonstrating dose-dependent, clinically meaningful effects on key biomarkers (PPi, PLP, and PEA) and showing benefits beyond bone health, including improvements in muscle metabolism and stamina. These effects are particularly relevant for adults with HPP, who often suffer from fatigue and mobility limitations.

About cardiac surgery-associated renal damage (CSA-RD)

CSA-RD is a clinical complication that arises from acute kidney injury (AKI) following open heart surgery performed with the use of a cardiopulmonary bypass (CPB) pump. Apart from sepsis, this type of surgery is the most frequent cause of AKI. CSA-AKI occurs in about 1 in 3 patients undergoing this surgical procedure.² There is currently no pharmacological therapy to prevent AKI, and the kidney injury can result in long-term renal impairment as well as the need for renal replacement therapy (RRT) such as dialysis. Notably, mortality can be up to 50% in CSA-AKI patients who require RRT post-operatively.

About AM-Pharma

AM-Pharma strives to develop medicines for patients confronted with severe medical conditions. Our proprietary asset, ilofotase alfa, is being developed for the treatment of patients with acute kidney injury (AKI) and has been granted FDA fast-track status. We also develop ilofotase alfa in the severe rare disease HPP where ilofotase alfa has orphan drug status in the US and EU. With approximately 1,000 subjects evaluated to date in clinical trials, ilofotase alfa has a proven safety profile and a demonstrated kidney benefit. We are a dedicated team driven to bring treatment options to severely ill patients, their families, and acute care professionals. Find out more about us online at: www.am-pharma.com.

Contacts

Investors:
Juliane Bernholz, Chief Executive Officer
j.bernholz@am-pharma.com

Media:
Trophic Communications
Eva Mulder
Phone: +31 6 52 33 15 79
am-pharma@trophic.eu

1 Pickkers, P et al., Intensive Care Med., 2024
2 Andújar A et al., Front. Nephrol., 2023

AM-Pharma Completes Enrollment in Phase 2 Study of Ilofotase Alfa for Prevention of Cardiac Surgery-Associated Renal Damage




AM-Pharma Completes Enrollment in Phase 2 Study of Ilofotase Alfa for Prevention of Cardiac Surgery-Associated Renal Damage

Utrecht, The Netherlands, October 2, 2025 – AM-Pharma B.V. today announced that it has successfully completed enrollment of patients in its ongoing Phase 2 clinical trial evaluating ilofotase alfa for the prevention of cardiac surgery-associated renal damage (CSA-RD). CSA-RD, a common cause of Acute Kidney Injury (AKI), is a serious complication of cardiac surgery occurring in up to 40% of patients. AKI following surgery is associated with both short- and long-term impairment of kidney function, an increased risk of requiring renal replacement therapy, sometimes lifelong, and higher mortality rates. Ilofotase alfa is the company’s proprietary therapeutic candidate that has consistently demonstrated safety, tolerability and reno-protective effects, including a reduction in Major Adverse Kidney Events (MAKE), across global clinical trials involving more than 1,000 patients diagnosed with AKI.

“CSA-RD represents a serious post-surgical complication, often leading to prolonged hospitalization, increased complications such as the need for renal replacement therapy and a higher long-term risk of chronic kidney disease, end stage renal disease, and mortality,” said Peter Pickkers, MD, PhD, Principal Investigator in the Phase 2 study and Professor of Experimental Intensive Care Medicine at Radboud University Nijmegen Medical Centre, The Netherlands. “With no pharmacological therapies currently available, there is a clear need for novel approaches. This trial is designed to confirm and expand upon the reno-protective effects observed with ilofotase alfa in prior studies, with the goal of developing a meaningful treatment option for patients at risk of kidney injury following cardiac surgery.”

The study (NCT06168799) is a multicenter, multinational, randomized, double-blind, placebo-controlled trial that randomized 244 patients at high risk for renal damage following open-heart surgery. Patients received two intravenous (IV) doses, one before and one after surgery, of either 128 mg ilofotase alfa or placebo, and are being followed for 60 days to assess efficacy, safety and pharmacokinetics. The primary endpoint is serum creatinine ratio (sCrR), a sensitive measure of kidney function changes that closely correlates with Major Adverse Kidney Events at 60 days (MAKE60). MAKE60 is an FDA-registrable endpoint, which would serve as the primary endpoint in the expected pivotal Phase 3 trial for ilofotase alfa. Topline data, including data on MAKE60 measured in this study as a secondary endpoint, are expected in early 2026, and the full dataset will be presented thereafter at a scientific conference.

“Reaching this enrollment milestone is a key inflection point in the clinical development of ilofotase alfa, bringing us closer to addressing a significant unmet need in hospital care,” said Juliane Bernholz, PhD, Chief Executive Officer of AM-Pharma. “We are grateful to our dedicated clinical partners and the patients for their vital support and trust. With recruitment now complete, we are focused on the data that will inform our next steps to realize the potential for ilofotase alfa to become the first approved therapy to prevent CSA-RD.”

About ilofotase alfa

Ilofotase alfa is a recombinant alkaline phosphatase, engineered from two human isoforms of the enzyme, which has demonstrated to be highly active and stable in multiple clinical trials. The recombinant enzyme acts by dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs)—including lipopolysaccharide (LPS), ATP, ADP, and other extracellular substrates—that drive acute inflammation, coagulation, and microvascular ischemia in the kidney following sepsis or ischemia-induced injury.

Dephosphorylation of ATP by ilofotase alfa provides dual reno-protective benefits: clearance of pro-inflammatory ATP and generation of adenosine, which activates the tissue-protective adenosine A2a receptor pathway. Through this mechanism, ilofotase alfa has consistently demonstrated safety, tolerability, and reno-protective effects, including a reduction in Major Adverse Kidney Events (MAKE), across clinical studies in patients with sepsis associated-acute kidney injury (SA-AKI), with an even greater effect observed in patients with pre-existing chronic kidney disease (CKD)¹.

AM-Pharma is developing ilofotase alfa as two distinct therapeutic products: an intravenous (IV) formulation for AKI and a highly concentrated subcutaneous (SC) formulation designed for chronic dosing as enzyme replacement therapy in hypophosphatasia (HPP). A Phase 1b study in adult HPP patients, supported by recent preclinical findings, has reinforced the therapeutic potential of the SC formulation by demonstrating dose-dependent, clinically meaningful effects on key biomarkers (PPi, PLP, and PEA) and showing benefits beyond bone health, including improvements in muscle metabolism and stamina. These effects are particularly relevant for adults with HPP, who often suffer from fatigue and mobility limitations.

About cardiac surgery-associated renal damage (CSA-RD)

CSA-RD is a clinical complication that arises from acute kidney injury (AKI) following open heart surgery performed with the use of a cardiopulmonary bypass (CPB) pump. Apart from sepsis, this type of surgery is the most frequent cause of AKI. CSA-AKI occurs in about 1 in 3 patients undergoing this surgical procedure.² There is currently no pharmacological therapy to prevent AKI, and the kidney injury can result in long-term renal impairment as well as the need for renal replacement therapy (RRT) such as dialysis. Notably, mortality can be up to 50% in CSA-AKI patients who require RRT post-operatively.

About AM-Pharma

AM-Pharma strives to develop medicines for patients confronted with severe medical conditions. Our proprietary asset, ilofotase alfa, is being developed for the treatment of patients with acute kidney injury (AKI) and has been granted FDA fast-track status. We also develop ilofotase alfa in the severe rare disease HPP where ilofotase alfa has orphan drug status in the US and EU. With approximately 1,000 subjects evaluated to date in clinical trials, ilofotase alfa has a proven safety profile and a demonstrated kidney benefit. We are a dedicated team driven to bring treatment options to severely ill patients, their families, and acute care professionals. Find out more about us online at: www.am-pharma.com.

Contacts

Investors:
Juliane Bernholz, Chief Executive Officer
j.bernholz@am-pharma.com

Media:
Trophic Communications
Eva Mulder
Phone: +31 6 52 33 15 79
am-pharma@trophic.eu

1 Pickkers, P et al., Intensive Care Med., 2024
2 Andújar A et al., Front. Nephrol., 2023

Precision Neuroscience Reports First High-Bandwidth Brain–Computer Interface Achieved Without Open Surgery




Precision Neuroscience Reports First High-Bandwidth Brain–Computer Interface Achieved Without Open Surgery

Study in Nature Biomedical Engineering details Precision’s surface-based system and shows results from the first five patients

NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) — Precision Neuroscience Corporation (Precision), a leading brain–computer interface (BCI) company, today announced the publication of a study in Nature Biomedical Engineering describing the company’s high-bandwidth BCI system designed for minimally invasive delivery. The paper reports both preclinical animal studies using a novel “micro-slit” surgical technique and the first five human patients implanted with the device during standard neurosurgical procedures.

The study marks a significant advance for the BCI field. For decades, high-performance BCIs have depended on penetrating electrodes—an approach that can expose patients to surgical risk and limit adoption. Precision’s work demonstrates, for the first time, that high-resolution brain signals can be captured and used for decoding and stimulation with an array that rests safely on the brain’s surface. This combination of bandwidth and safety challenges longstanding assumptions in neuroscience and points toward a more practical, scalable path for bringing BCI technology to patients.

“Brain–computer interfaces could be life-changing for people with paralysis—helping them speak, work, and live more independently—but until now the technology has required highly invasive brain surgery,” said Benjamin Rapoport, MD, PhD, co-founder and Chief Science Officer of Precision Neuroscience. “People are told that they have to choose between brain safety and performance. Our goal was to prove that you can have both. This paper shows that it’s possible to get the same high-quality brain signals without opening the skull or piercing the brain.”

The study in Nature Biomedical Engineering details the design, preclinical validation, and early human implantation of Precision’s ultra-thin, surface-based cortical electrode array. Unlike conventional BCI systems, which rely on needle-like electrodes that penetrate brain tissue, Precision’s array rests on the brain’s surface and is designed for minimally invasive delivery. Each postage stamp-sized module contains 1,024 electrodes, and in early clinical studies researchers placed up to four modules on a patient’s brain, covering approximately 8 cm² of cortex with more than 4,000 electrodes. In animal studies, the system supported high-accuracy sensory and motor decoding as well as focal electrical stimulation. In human patients, the arrays were implanted during surgeries for other conditions, where they were used to safely record high-resolution neural activity in both asleep and awake patients.

“What makes this study so exciting is the resolution of the signals we’re getting from the brain,” said Craig Mermel, PhD, Precision’s President and Chief Product Officer and a co-author of the study. “The more detail you can capture, the better you can translate thoughts into actions—whether that’s moving a cursor, generating speech, or controlling a device. This paper shows that it’s possible to collect high-resolution data safely and at scale, which is exactly what’s needed to bring brain–computer interfaces out of the lab and into everyday clinical use.”

Since the manuscript was accepted, Precision has advanced significantly beyond the five patients reported in the paper. The company has now implanted its device in more than 50 patients and, earlier this year, received FDA clearance for up to 30-day implantation. These extended-use studies, now underway at six major medical centers across the United States, allow patients recovering from neurosurgery to use Precision’s device for tasks such as typing, playing video games, or controlling robotic devices, all with their thoughts. These capabilities are expected to initially benefit people with paralysis from conditions such as spinal cord injury, stroke, or ALS.

To read the full study, visit https://www.nature.com/articles/s41551-025-01501-w  

About Precision Neuroscience
Precision Neuroscience is working to provide breakthrough treatments for the millions of people worldwide suffering from neurological illness. The company is building the only brain–computer interface designed to be minimally invasive, safely removable, and capable of processing large volumes of data. To learn more about how Precision is connecting human intelligence and artificial intelligence, visit www.precisionneuro.io.

Media Contact:
media@precisionneuro.io

Precision Neuroscience Reports First High-Bandwidth Brain–Computer Interface Achieved Without Open Surgery




Precision Neuroscience Reports First High-Bandwidth Brain–Computer Interface Achieved Without Open Surgery

Study in Nature Biomedical Engineering details Precision’s surface-based system and shows results from the first five patients

NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) — Precision Neuroscience Corporation (Precision), a leading brain–computer interface (BCI) company, today announced the publication of a study in Nature Biomedical Engineering describing the company’s high-bandwidth BCI system designed for minimally invasive delivery. The paper reports both preclinical animal studies using a novel “micro-slit” surgical technique and the first five human patients implanted with the device during standard neurosurgical procedures.

The study marks a significant advance for the BCI field. For decades, high-performance BCIs have depended on penetrating electrodes—an approach that can expose patients to surgical risk and limit adoption. Precision’s work demonstrates, for the first time, that high-resolution brain signals can be captured and used for decoding and stimulation with an array that rests safely on the brain’s surface. This combination of bandwidth and safety challenges longstanding assumptions in neuroscience and points toward a more practical, scalable path for bringing BCI technology to patients.

“Brain–computer interfaces could be life-changing for people with paralysis—helping them speak, work, and live more independently—but until now the technology has required highly invasive brain surgery,” said Benjamin Rapoport, MD, PhD, co-founder and Chief Science Officer of Precision Neuroscience. “People are told that they have to choose between brain safety and performance. Our goal was to prove that you can have both. This paper shows that it’s possible to get the same high-quality brain signals without opening the skull or piercing the brain.”

The study in Nature Biomedical Engineering details the design, preclinical validation, and early human implantation of Precision’s ultra-thin, surface-based cortical electrode array. Unlike conventional BCI systems, which rely on needle-like electrodes that penetrate brain tissue, Precision’s array rests on the brain’s surface and is designed for minimally invasive delivery. Each postage stamp-sized module contains 1,024 electrodes, and in early clinical studies researchers placed up to four modules on a patient’s brain, covering approximately 8 cm² of cortex with more than 4,000 electrodes. In animal studies, the system supported high-accuracy sensory and motor decoding as well as focal electrical stimulation. In human patients, the arrays were implanted during surgeries for other conditions, where they were used to safely record high-resolution neural activity in both asleep and awake patients.

“What makes this study so exciting is the resolution of the signals we’re getting from the brain,” said Craig Mermel, PhD, Precision’s President and Chief Product Officer and a co-author of the study. “The more detail you can capture, the better you can translate thoughts into actions—whether that’s moving a cursor, generating speech, or controlling a device. This paper shows that it’s possible to collect high-resolution data safely and at scale, which is exactly what’s needed to bring brain–computer interfaces out of the lab and into everyday clinical use.”

Since the manuscript was accepted, Precision has advanced significantly beyond the five patients reported in the paper. The company has now implanted its device in more than 50 patients and, earlier this year, received FDA clearance for up to 30-day implantation. These extended-use studies, now underway at six major medical centers across the United States, allow patients recovering from neurosurgery to use Precision’s device for tasks such as typing, playing video games, or controlling robotic devices, all with their thoughts. These capabilities are expected to initially benefit people with paralysis from conditions such as spinal cord injury, stroke, or ALS.

To read the full study, visit https://www.nature.com/articles/s41551-025-01501-w  

About Precision Neuroscience
Precision Neuroscience is working to provide breakthrough treatments for the millions of people worldwide suffering from neurological illness. The company is building the only brain–computer interface designed to be minimally invasive, safely removable, and capable of processing large volumes of data. To learn more about how Precision is connecting human intelligence and artificial intelligence, visit www.precisionneuro.io.

Media Contact:
media@precisionneuro.io

Igyxos Biotherapeutics Awarded EUR 5.7 Million from the French Government to Accelerate Development of its First-in-class Monoclonal Antibody for the Treatment of Infertility




Igyxos Biotherapeutics Awarded EUR 5.7 Million from the French Government to Accelerate Development of its First-in-class Monoclonal Antibody for the Treatment of Infertility

TOURS, France, Oct. 02, 2025 (GLOBE NEWSWIRE) — Igyxos Biotherapeutics, a biotechnology company dedicated to developing innovative monoclonal antibodies for infertility treatment, today announced that it has secured a EUR 5.7 million grant under the France 2030 programme, via the “Biotherapies and Bioproduction of Innovative Therapies” call for projects (AAP), operated by Bpifrance on behalf of the French Government.

The non-dilutive funding will support Phase 2 clinical trials, in France and Europe, of the Company’s lead asset, IGX12. IGX12 is a first-in-class potentiating monoclonal antibody developed to enhance the potency and efficacy of follicle stimulating hormone (FSH), a critical hormone involved in female and male gametogenesis.

Florent Ferré, Chief Executive Officer of Igyxos Biotherapeutics, said, “This funding marks another important new milestone in the clinical development of our innovative approach to treating infertility. Unlike current IVF treatment regimes, our approach addresses both female and male infertility. Male infertility accounts for nearly half of all infertility cases and currently has no approved treatment. Our goal is to advance IGX12 through Phase 2 clinical trials in both men and women, with the long term ambition of bringing to market a new therapeutic option for the millions of couples facing fertility challenges around the world.”

In the fourth quarter of 2025, Igyxos expects the latest results from its Phase 1 clinical trial in healthy volunteers. Interim results have demonstrated good safety and tolerability of IGX12 both in men and women.

About Igyxos Biotherapeutics

Igyxos Biotherapeutics is dedicated to developing innovative treatments for infertility in both men and women. Its lead asset, IGX12, is a first-in-class potentiating monoclonal antibody designed to enhance the potency and efficacy of follicle-stimulating hormone (FSH), an essential hormone for reproduction both in men and women

Since its foundation in France in 2017, the company has raised EUR 25 million in funding, including EUR 19 million in equity from business angels and investors including Bpifrance via its Biotechnology Health Acceleration Fund, GO Capital, UI Investissement, and EUR 7 million in grants, loans and repayable advances from Bpifrance and regional funding bodies.

For more information, visit our website, and follow us on LinkedIn.

About France 2030

Reflects a dual ambition: to sustainably transform key sectors of our economy (health, energy, automotive, aerospace, and space) through technological innovation, and to position France not merely as a participant but as a leader in the world of tomorrow. From fundamental research and the emergence of an idea to the production of a new product or service, France 2030 supports the entire innovation lifecycle up to industrialisation.

Unprecedented in scale: EUR 54 billion will be invested to ensure that our companies, universities, and research organisations can fully succeed in their transitions within these strategic sectors. The goal: to help them respond competitively to the ecological and attractiveness challenges of the future and to foster the emergence of future leaders in our areas of excellence. France 2030 is guided by two cross-cutting objectives: 50% of its spending is dedicated to the decarbonisation of the economy, and 50% to emerging players driving innovation, without any harmful impact on the environment (as defined by the Do No Significant Harm principle).

Implemented collaboratively: Designed and deployed in consultation with economic, academic, local, and European stakeholders to define strategic priorities and flagship actions. Project leaders are invited to submit their applications through open, rigorous, and selective procedures to benefit from state support.

Led by the General Secretariat for Investment on behalf of the Prime Minister and implemented by ADEME (the French Agency for Ecological Transition), ANR (the National Research Agency), Bpifrance, and the Banque des Territoires.
More information: france2030.gouv.fr | @SGPI_avenir

About the “Innovation in Biotherapies and Bioproduction” Call for Projects

The “Innovation in Biotherapies and Bioproduction” call for projects is a funding mechanism within the France 2030 acceleration strategy “Biotherapies and Bioproduction of Innovative Therapies,” overseen by the Health Innovation Agency. Its goal is to catalyse and sustain excellence in biotherapy research, notably by accelerating technology transfer and ensuring a steady flow of innovations from bench to bedside.

About Bpifrance

Bpifrance finances businesses — at every stage of their development — through loans, guarantees, and equity.

Bpifrance supports them in their innovation and international expansion projects. Bpifrance also assists with export activities through a wide range of products.

Advisory services, training, networking opportunities, and acceleration programs for startups, SMEs, and mid-sized companies (ETIs) are also part of the support offered to entrepreneurs.

Thanks to Bpifrance and its 50 regional offices, entrepreneurs benefit from a local, single, and efficient point of contact to support them and help them face their challenges.

More information at: http://www.bpifrance.fr/

Media contacts

Igyxos Biotherapeutics
Florent Ferré, CEO
Florent.ferre@igyxos.com

Scius Communications 
Katja Stout
+44 778 943 5990
katja@sciuscommunications.com
Daniel Gooch
+44 7747 875479
daniel@sciuscommunications.com

Nicox’s NCX 470 Demonstrates Sustained Efficacy through 12 Months in Denali Clinical Trial with no new Safety Observations




Nicox’s NCX 470 Demonstrates Sustained Efficacy through 12 Months in Denali Clinical Trial with no new Safety Observations

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• EN_NicoxDenaliPrePlannedAnalysisOctober2025_PR_FINAL

HUTCHMED Highlights Clinical Data to be Presented at the ESMO Congress 2025




HUTCHMED Highlights Clinical Data to be Presented at the ESMO Congress 2025

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 02, 2025 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology (“ESMO”) Congress 2025, taking place on October 17-21, 2025 in Berlin, Germany.

Results from the FRUSICA-2 registration study of the fruquintinib and sintilimab combination as a second-line treatment for locally advanced or metastatic renal cell carcinoma will be presented in a Mini Oral session. Additionally, further analyses of the fruquintinib FRUSICA-1 study in endometrial cancer and the savolitinib SACHI and SAVANNAH studies in non-small cell lung cancer will be presented during the poster sessions.

Details of the presentations are as follows:

About Fruquintinib

Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE^®. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA^®.

About Savolitinib

Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS^®.

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA^®. HUTCHMED currently retains all rights to surufatinib worldwide.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, surufatinib and savolitinib, the further clinical development for fruquintinib, surufatinib and savolitinib, its expectations as to whether any studies on fruquintinib, surufatinib and savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, surufatinib and savolitinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, surufatinib and savolitinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as sintilimab and toripalimab as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

CONTACTS

New Imprivata Report Finds that Australian Hospitals Save More Than $1.2 Million AUD Annually with Shared-Use Mobile Devices, but Strategic Gaps Still Pose Security and Operational Risk




New Imprivata Report Finds that Australian Hospitals Save More Than $1.2 Million AUD Annually with Shared-Use Mobile Devices, but Strategic Gaps Still Pose Security and Operational Risk

The 2025 Imprivata State of Shared Mobile Devices in Healthcare Report identifies the benefits as well as the challenges Australian healthcare organisations face when implementing shared-use mobile devices for clinical staff

MELBOURNE, Australia, Oct. 01, 2025 (GLOBE NEWSWIRE) — Imprivata, a leading provider of access management solutions for healthcare and other mission-critical industries, today released new research which finds that each Australian healthcare facility that leverages shared-use mobile devices for its clinical staff saves an average of about $1,207,150 AUD annually versus using dedicated personal devices. Nearly all survey respondents (97%) agree that mobile devices are essential clinical tools, but significant security, operational, and workflow challenges persist due to the lack of a comprehensive strategy — more than half (53%) of organisations have not fully implemented a policy for managing shared-use mobile devices.

The “2025 State of Shared Mobile Devices in Healthcare Report” provides a comprehensive view of how hospitals and healthcare systems in Australia, the UK, Canada, and the US are using mobile devices in clinical care — and where gaps in security, user experience, and policy are limiting success. Research conducted by Vanson Bourne, which includes responses from 400 clinical and IT leaders in total (including 75 in Australia), reveals both the potential and the risks of using shared mobile devices in care delivery.

“Shared-use mobile devices are powerful tools to help streamline workflows, reduce inefficiencies, and allow clinicians to spend more of their time to patient care,” said Daniel Johnston, associate chief nursing informatics officer and director of clinical operations at Imprivata. “Yet realising this potential depends on effective device management. Our research shows that while both clinical and IT teams in Australia recognize the significant value of mobile technology in improving care delivery, many organisations are still working to determine the best way to scale these solutions.”

The benefits of shared-use mobile devices
Mobile technology is now considered foundational to Australian healthcare delivery organisations, and the primary clinical benefits of shared-use devices include improved access to clinical applications (as cited by 74% of respondents), increase mobility/flexibility (68%), and increased coordination and communication between clinical staff (61%).

A shared-use device model also has benefits for IT teams, including improved data security (according to 86% of respondents), increased alignment with regulations/compliance (64%), and improved asset management in locating lost mobile devices (64%)

In addition, nearly all (96%) of respondents think shared-use mobile devices deliver a greater ROI than individual-use or BYOD devices, resulting in an average annual savings of $1,207,150 per Australian healthcare facility. However, those organisations with a fully implemented strategy for managing shared devices report annual savings of about $1M (in-line with the global average), while those without a fully implemented strategy save about $524,000 annually, on average.

Lack of strategy creates security, workflow, and device management challenges
While shared-use devices deliver many benefits, more than half of healthcare organisations in Australia (53%) do not have a fully implemented policy for managing shared-use devices, resulting in challenges for both clinical staff and IT teams. These include concerns such as data security (according to 51% of survey respondents), lack of a centralised system for managing mobile devices (49%), and lack of visibility on mobile device usage (48%).

For clinical staff specifically, the biggest challenges they face with shared-use devices include getting locked out of mobile devices (as experienced to some extent by 92% of respondents), dealing with broken, uncharged, and/or misconfigured devices (92%) and missing or unavailable devices (95%).

These challenges result in potentially significant security gaps, with 83% of respondents stating that users share credentials when accessing shared mobile devices, and 77% revealing that shared-use mobile devices are frequently left signed in by staff after use. As a result, more than half of respondents (52%) say they are not completely confident that patient data is fully protected on shared-use mobile devices.

And, despite the inherent device-tracking advantages of shared-use vs. individual devices, facilities lose, on average, about 15% of their devices annually, resulting in delays in clinical communication (as cited by 58% of respondents), risk to patient data security (55%), and disruption to shift handover/documentation (52%).

“The difficulties organisations face with shared-use devices are expected at this early stage of adoption,” added Johnston. “What’s critical now is moving beyond ad-hoc solutions to a formal, robust strategy. Australian healthcare organisations need to combine strong identity and access management with enterprise-grade device management and workflow optimisation if they want to take full advantage of mobile devices at scale.”

Download the 2025 State of Shared Mobile Devices in Healthcare Report.

Methodology
For this global report, researchers surveyed 400 leaders from acute care facilities with 100+ beds across the United States, Canada, the United Kingdom, and Australia. The respondent pool consisted of 242 IT decision makers and 158 clinical leaders (including 75 respondents from Australia). Survey objectives included assessing current adoption and usage of shared-use mobile devices, exploring benefits across clinical, operational, and security domains, and identifying key challenges and barriers to effective implementation of shared-use mobile devices.

About Imprivata  
Imprivata delivers simple and secure access management solutions for healthcare and other mission-critical industries to ensure every second of crucial work is both frictionless and secure. Imprivata’s platform of innovative, interoperable access management and privileged access security solutions enable organisations to fully manage and secure all enterprise and third-party identities to facilitate seamless user access, protect against internal and external security threats, and reduce total cost of ownership. For more information, visit www.imprivata.com.     
  
Media Contact  
press@imprivata.com