Recludix Pharma Announces FDA Clearance of Investigational New Drug Application for REX-8756, an Oral STAT6 Inhibitor, to Enter into the Clinic




Recludix Pharma Announces FDA Clearance of Investigational New Drug Application for REX-8756, an Oral STAT6 Inhibitor, to Enter into the Clinic

• REX-8756 is a potent and selective oral STAT6 inhibitor that has shown complete 100% pathway inhibition and potent efficacy in preclinical models of asthma, acute lung inflammation and dermatitis
• Efficacy comparable to anti-IL-4/IL-13 antibody combination control with a favorable tolerability profile in preclinical models
• Being advanced under a strategic partnership with Sanofi, where Recludix has the option to participate in a 50:50 U.S. profit/loss share

SAN DIEGO, Dec. 16, 2025 (GLOBE NEWSWIRE) — Recludix Pharma, a leader in the discovery of inhibitors of challenging targets for inflammatory disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application to advance REX-8756, an oral STAT6 inhibitor, into Phase 1 clinical testing.

“With REX-8756, we are excited by the opportunity to pioneer a new therapeutic class for patients with inflammatory diseases,” said Nancy Whiting, Pharm.D., president and chief executive officer of Recludix. “We have demonstrated preclinically that our reversible, orally available STAT6 inhibitor can achieve efficacy comparable to that of clinically validated biologics. By targeting the pathological overactivation of STAT6 observed in many diseases — without necessitating protein degradation and with an anticipated improved hematologic safety profile relative to JAK inhibitors — we believe this approach could be an important therapeutic option for patients. We look forward to initiating a Phase 1 clinical study of REX-8756 in healthy volunteers very shortly.”

REX-8756 is an oral, selective STAT6 inhibitor that employs a novel therapeutic approach by targeting STAT6’s SH2 domain — a key mediator of protein-protein interactions that was long considered undruggable. In preclinical studies, REX-8756 demonstrated complete and sustained inhibition of STAT6 activity, thereby suppressing IL-4 and IL-13-induced inflammatory biomarkers. STAT6 is required for IL-4 and IL-13 signaling but is downstream in the disease pathway from other drug targets, and therefore, its inhibition has been shown in preclinical studies to be a more selective approach than Janus Kinase (JAK) family inhibitors, with the potential for fewer side effects. REX-8756 has demonstrated potent efficacy in models of asthma, acute lung inflammation and dermatitis, comparable to that of an anti-IL-4/IL-13 antibody combination control.

About STAT6
Signal transducer and activator of transcription (STAT) proteins are both signaling proteins and transcription factors that play a role in cell growth, differentiation and function. STAT6 is a key nodal transcription factor that selectively mediates downstream signaling of IL-4 and IL-13, dominant and central cytokines in the pathophysiology of Type 2 inflammatory diseases. A STAT6 inhibitor offers the potential for a novel first-in-class targeted oral therapy for patients in the treatment of Type 2 inflammatory diseases.

About Recludix
Recludix is a company with leading, innovative platform approaches to discover and develop potent and selective inhibitors of challenging protein targets. The company’s management team includes industry veterans with a track record of success, including former leaders of Seagen, Blueprint Medicines, and Lilly. Recludix has developed a unique drug discovery platform that integrates custom generated DNA-encoded libraries, massively parallel determination of structure activity relationships, and a proprietary screening tool to ensure selectivity. The company is employing this approach first in the development of SH2 domain inhibitors.

Recludix is initiating a Phase 1 study of REX-8756 (also known as SAR448755), an oral inhibitor of STAT6, in a strategic development and commercialization partnership with Sanofi where Recludix has the option to participate in an equal U.S. profit/loss share. Abnormal activation of STAT6 is found in inflammatory diseases, such as atopic dermatitis, asthma, rheumatoid arthritis and chronic spontaneous urticaria.

Recludix is also advancing a potential first-in-class BTK SH2 domain inhibitor for B cell or mast cell-driven I&I diseases, as well as additional discovery programs. Recludix was named a 2024 Fierce 15 biotech company. For more information, please visit the company’s website at https://recludixpharma.com.

Recludix Contacts
Matt Caldemeyer
Chief Business Officer
mcaldemeyer@recludix.com

Alexandra Santos 
asantos@wheelhouselsa.com

Aljanae Reynolds
areynolds@wheelhouselsa.com

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA




BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

SUNNYVALE, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) — BioCardia^®, Inc. [NASDAQ: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces it has completed a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) on our CardiAMP Cell Therapy intended for treatment of Heart Failure with Reduced Ejection Fraction (HFrEF). The meeting was held in further preparation for formal clinical consultation on acceptability of the existing clinical data for submission of an application for approval. Based on the discussions in the most recent meeting, PMDA said it will allow BioCardia to advance to formal clinical consultation. Should PMDA agree in formal consultation that the available data provides sufficient evidence of safety and efficacy, BioCardia would be able to file for regulatory approval in Japan.  

“Our autologous minimally invasive cell therapy presents a new mechanism of action of microvascular repair for ischemic heart failure patients evidencing active heart failure while on guideline directed medical therapy who have few additional therapeutic options.” said Peter Altman, PhD, BioCardia’s Chief Executive Officer. “The data from the three completed Phase I, II and III trials support positive outcomes in significant clinical efficacy endpoints, including improved survival and reduced major adverse cardiovascular events, along with improved heart function and quality of life measures relative to control patients.”

The existing clinical data supporting safety and efficacy of CardiAMP Cell Therapy for HFrEF is subject to ongoing regulatory discussions in Japan and the United States. The compilation includes data from the three clinical studies that BioCardia believes demonstrate a favorable benefit to risk profile.  

About CardiAMP Autologous Cell Therapy

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells as treatment delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use. 

CardiAMP Cell Therapy Clinical Development Highlights

Phase 1: TABMMI Heart Failure Trial; open label, n=20 (NCT00507468) ¹

• 90% of treated patients alive and well at three years
• Left ventricular ejection fraction (LVEF) improved by 7% at 24 months (p=0.001)
• Exercise tolerance improved 125 seconds at 24 months (p=0.006)

Phase 2: TACHFT Trial; double-blind placebo-controlled, n=33 with 29 randomized (NCT00768066) ^2,3

• All (100%) treated patients alive at one year (end of study); major adverse cardiac events (MACE) reduced 20% relative to controls
• Six-minute walk distance improved 56.3 meters at 12 months for treated patients compared to controls (p = 0.049)
• Quality of life measured using Minnesota Living with Heart Failure Quality of Life Questionnaire improved by 17.4 points (p=0.039) for treated patients compared to controls

Phase 3: CardiAMP HF Trial; multi-center, double-blind placebo-procedure controlled with 24-month follow-up, N=125, with 115 randomized (NCT02438306) ^{4, 5}

• Roll-in cohort patients demonstrated improved heart function measures, and the study procedure was feasible with an excellent safety profile
• Treated patients in the full study cohort had reduced fatal and nonfatal MACE, along with improved quality of life and echocardiography heart function measures on top of guideline-directed medical therapy compared to controls
• The primary Finkelstein Schoenfeld composite outcome endpoint including 6-minute walk test distance (6MWT) was not met due to potential confounding of this effort-based measure.

The subgroup of randomized patients with elevated NTproBNP before study enrollment (n=57) demonstrated strong efficacy signals, including:

• Met Finkelstein Schoenfeld composite endpoint consisting of fatal cardiac death, non-fatal MACE, and quality of life (p = 0.04)
• Demonstrated improved left ventricular systolic and diastolic volume measures at 24 months (LVESVi, p=0.01; LVEDVi, p=0.01) as assessed by the blinded echocardiography core lab, suggesting significantly improved heart function compared to controls through the end of the study

About BioCardia^®
BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP^® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph^® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com.

References

¹ De la Fuente LM, Stertzer SH, Argentieri J. et al. Transendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label phase I safety study (the TABMMI study). EuroIntervention. 2011; 7(7):805-812.

² Wong Po Foo C, Rouy D, Hare JM, et al. The transendocardial autologous bone marrow mononuclear cells in ischemic heart failure trial (TAC-HFT-BMC). Regenerative Medicine. 2015; 10(7S): S169.

³ Heldman AW, DiFede DL, Fishman JE, et al. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA. 2014; 311(1):62-73.

⁴ Raval AN, Johnston PV, Duckers HJ, Cook TD, Traverse JH, Altman PA, Dhingra R, Hematti P, Borrello I, Anderson RD, Pepine CJ. Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort. Int J Cardiol. 2021 Mar 1;326:131-138. doi: 10.1016/j.ijcard.2020.10.043. Epub 2020 Oct 20. PMID: 33091520.

⁵ Raval AN on behalf of the CardiAMP HF Investigators: A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP-HF Trial, American College of Cardiology Late Breaking Clinical Trials 2025.

Forward Looking Statements
This press release contains forward-looking statements that are subject to risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, future regulatory submissions, future regulatory meetings, and outcomes of these regulatory discussions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

CONTACT: Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

MediBeacon® Next Generation TGFR™ System Receives FDA Approval




MediBeacon® Next Generation TGFR™ System Receives FDA Approval

• MediBeacon^® TGFR™ System is a first-in-kind product for point of care kidney function assessment
• Centers of Excellence commercialization in select academic medical centers begins in early 2026

ST. LOUIS, Dec. 16, 2025 (GLOBE NEWSWIRE) — MediBeacon Inc., a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection, today announced the U.S. Food and Drug Administration (FDA) has approved the next generation MediBeacon^® TGFR™ System including the latest TGFR™ Reusable Sensor.

The TGFR System enables kidney function assessment at the point of care by measuring the clearance rate of Lumitrace^® (relmapirazin), a non-radioactive, non-iodinated fluorescent GFR agent. The TGFR Reusable Sensor placed on the skin measures the change in Lumitrace fluorescence intensity as a function of time.

The latest TGFR Reusable Sensor has been designed for patient comfort, ease of application, and reusability. It also lowers the cost compared to the single use TGFR Sensor previously approved by the FDA.

The TGFR System was the subject of the lead peer-reviewed article featured on the cover of the Journal of the American Society of Nephrology (JASN) in August 2025.¹ The article reviewed the first use of the transdermal GFR (tGFR) methodology in patients of various levels of kidney function across a wide range of skin colors.

The Company will offer early access for specific use cases at leading academic medical centers in the United States and China. Many of these medical centers have used MediBeacon’s transdermal GFR technology in preclinical research over the past 10 years. There are over 700 peer-reviewed publications and conference abstracts on preclinical use in which the tGFR methodology has been utilized.      

“We look forward to including transdermal GFR in our ongoing heart failure study where renal function is a valuable consideration in patient monitoring,” said Dr. Melana Yuzefpolskaya, cardiologist at New York Presbyterian Hospital-Columbia. “Validating transdermal GFR in this patient population offers the opportunity to expose clinically meaningful inaccuracies in estimated GFR (eGFR).”

The TGFR Reusable Sensor is validated for reuse via connection to a disposable adhesive ring. Transdermal assessment of Glomerular Filtration Rate or kidney function (tGFR) has been designed to be effective across the adult population without input of age, weight, sex, gender, race, or ethnicity. The Company received FDA approval of an earlier TGFR System version in January 2025.

“This approval is a major step for MediBeacon to achieve its goal to improve kidney health”, said Steven Hanley, CEO and Co-Founder of MediBeacon. “With this approval, we have a comprehensive, sustainable and economic technology solution to assess kidney function. We believe MediBeacon is well positioned to scale with discipline and unlock the significant market opportunity ahead in both inpatient and outpatient settings.”

MediBeacon expects to begin initial sales of the TGFR System to select academic medical centers in the first quarter of 2026 in the United States and China.

Media and Investor Contact
Carrie Mendivil / Ji-Yon Yi
investors@medibeacon.com

About MediBeacon Inc.
MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection. MediBeacon’s use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable measurement of organ function. MediBeacon owns over 60 granted U.S. patents and over 245 granted patents worldwide that provide extensive coverage of the MediBeacon^® TGFR™ System, including Lumitrace^® injection, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology. The TGFR System is approved for human use. Potential technology applications in gastroenterology, ophthalmology and surgery are in various stages of clinical development. MediBeacon is based in St. Louis, Missouri, with additional operations in Mannheim, Germany. For more information, please visit: www.medibeacon.com.

About Lumitrace^® (relmapirazin) injection
Relmapirazin is a non-radioactive, non-iodinated pyrazine-based compound, which has been engineered to be inert, highly fluorescent, and have the clearance properties of a GFR tracer agent in the body. The unique photophysical characteristics of Lumitrace have been designed to enable the collection of fluorescence data via a photodetector sensor placed on the skin. Data collected by the sensor measures the change in the intensity of Lumitrace fluorescence over time and is converted into a transdermal GFR (tGFR) by proprietary algorithms. In a phase 2 investigational study mGFR deduced from Lumitrace matched that of mGFR deduced from iohexol over a range of GFR values. See the peer reviewed article published in the October 2024 issue of Kidney International by Dorshow et al.²

About MediBeacon^® TGFR™ System
The MediBeacon^® TGFR™ System is comprised of the TGFR™ Reusable Sensor, TGFR™ Monitor, TGFR™ Disposable Ring, and Lumitrace^® (relmapirazin) injection, which together allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin. The TGFR Reusable Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the patient’s bedside or in the outpatient setting.

FOR IMPORTANT SAFETY INFORMATION FOR THE TGFR SYSTEM (U.S. FDA) see ifu.medibeacon.com.

¹ Glomerular Filtrate Rate Measurement Utilizing Transdermal Detection Methodology; Dorshow, Richard B., Debreczeny, Martin P.; Goldstein, Stuart L.; Journal of the American Society of Nephrology, 36(8):p 1592-1602, August 2025. DOI: 10.1681/ASN 0000000639

² Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102), Kidney International, Volume 106, Issue 4, P679-687, October 2024, DOI: 10.1016/j.kint.2024.06.012

MediBeacon® Next Generation TGFR™ System Receives FDA Approval




MediBeacon® Next Generation TGFR™ System Receives FDA Approval

• MediBeacon^® TGFR™ System is a first-in-kind product for point of care kidney function assessment
• Centers of Excellence commercialization in select academic medical centers begins in early 2026

ST. LOUIS, Dec. 16, 2025 (GLOBE NEWSWIRE) — MediBeacon Inc., a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection, today announced the U.S. Food and Drug Administration (FDA) has approved the next generation MediBeacon^® TGFR™ System including the latest TGFR™ Reusable Sensor.

The TGFR System enables kidney function assessment at the point of care by measuring the clearance rate of Lumitrace^® (relmapirazin), a non-radioactive, non-iodinated fluorescent GFR agent. The TGFR Reusable Sensor placed on the skin measures the change in Lumitrace fluorescence intensity as a function of time.

The latest TGFR Reusable Sensor has been designed for patient comfort, ease of application, and reusability. It also lowers the cost compared to the single use TGFR Sensor previously approved by the FDA.

The TGFR System was the subject of the lead peer-reviewed article featured on the cover of the Journal of the American Society of Nephrology (JASN) in August 2025.¹ The article reviewed the first use of the transdermal GFR (tGFR) methodology in patients of various levels of kidney function across a wide range of skin colors.

The Company will offer early access for specific use cases at leading academic medical centers in the United States and China. Many of these medical centers have used MediBeacon’s transdermal GFR technology in preclinical research over the past 10 years. There are over 700 peer-reviewed publications and conference abstracts on preclinical use in which the tGFR methodology has been utilized.      

“We look forward to including transdermal GFR in our ongoing heart failure study where renal function is a valuable consideration in patient monitoring,” said Dr. Melana Yuzefpolskaya, cardiologist at New York Presbyterian Hospital-Columbia. “Validating transdermal GFR in this patient population offers the opportunity to expose clinically meaningful inaccuracies in estimated GFR (eGFR).”

The TGFR Reusable Sensor is validated for reuse via connection to a disposable adhesive ring. Transdermal assessment of Glomerular Filtration Rate or kidney function (tGFR) has been designed to be effective across the adult population without input of age, weight, sex, gender, race, or ethnicity. The Company received FDA approval of an earlier TGFR System version in January 2025.

“This approval is a major step for MediBeacon to achieve its goal to improve kidney health”, said Steven Hanley, CEO and Co-Founder of MediBeacon. “With this approval, we have a comprehensive, sustainable and economic technology solution to assess kidney function. We believe MediBeacon is well positioned to scale with discipline and unlock the significant market opportunity ahead in both inpatient and outpatient settings.”

MediBeacon expects to begin initial sales of the TGFR System to select academic medical centers in the first quarter of 2026 in the United States and China.

Media and Investor Contact
Carrie Mendivil / Ji-Yon Yi
investors@medibeacon.com

About MediBeacon Inc.
MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection. MediBeacon’s use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable measurement of organ function. MediBeacon owns over 60 granted U.S. patents and over 245 granted patents worldwide that provide extensive coverage of the MediBeacon^® TGFR™ System, including Lumitrace^® injection, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology. The TGFR System is approved for human use. Potential technology applications in gastroenterology, ophthalmology and surgery are in various stages of clinical development. MediBeacon is based in St. Louis, Missouri, with additional operations in Mannheim, Germany. For more information, please visit: www.medibeacon.com.

About Lumitrace^® (relmapirazin) injection
Relmapirazin is a non-radioactive, non-iodinated pyrazine-based compound, which has been engineered to be inert, highly fluorescent, and have the clearance properties of a GFR tracer agent in the body. The unique photophysical characteristics of Lumitrace have been designed to enable the collection of fluorescence data via a photodetector sensor placed on the skin. Data collected by the sensor measures the change in the intensity of Lumitrace fluorescence over time and is converted into a transdermal GFR (tGFR) by proprietary algorithms. In a phase 2 investigational study mGFR deduced from Lumitrace matched that of mGFR deduced from iohexol over a range of GFR values. See the peer reviewed article published in the October 2024 issue of Kidney International by Dorshow et al.²

About MediBeacon^® TGFR™ System
The MediBeacon^® TGFR™ System is comprised of the TGFR™ Reusable Sensor, TGFR™ Monitor, TGFR™ Disposable Ring, and Lumitrace^® (relmapirazin) injection, which together allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin. The TGFR Reusable Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the patient’s bedside or in the outpatient setting.

FOR IMPORTANT SAFETY INFORMATION FOR THE TGFR SYSTEM (U.S. FDA) see ifu.medibeacon.com.

¹ Glomerular Filtrate Rate Measurement Utilizing Transdermal Detection Methodology; Dorshow, Richard B., Debreczeny, Martin P.; Goldstein, Stuart L.; Journal of the American Society of Nephrology, 36(8):p 1592-1602, August 2025. DOI: 10.1681/ASN 0000000639

² Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102), Kidney International, Volume 106, Issue 4, P679-687, October 2024, DOI: 10.1016/j.kint.2024.06.012

Humacyte Announces Credit Facility of Up to $77.5 Million with Avenue Capital




Humacyte Announces Credit Facility of Up to $77.5 Million with Avenue Capital

DURHAM, N.C., Dec. 16, 2025 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it has entered into a credit facility with Avenue Venture Opportunities Fund II, L.P., a fund of Avenue Capital Group, providing up to $77.5 million in principal amount of new financing. The credit agreement, which has a term of four years, includes an initial tranche of $40 million fully funded at close, and an additional two tranches of up to an aggregate of $37.5 million available to Humacyte, subject to the satisfaction of certain revenue, regulatory approvals, liquidity conditions and, in the case of the third tranche, lender approvals. Proceeds from the initial $40 million tranche have been used primarily to retire Humacyte’s existing debt facility.

“We are pleased to enter into this facility with Avenue as it allows us to retire our existing indebtedness while providing the opportunity for additional non-dilutive financing in the future,” said Dale Sander, Chief Financial Officer of Humacyte. “We are looking forward to an exciting 2026, including our plans for expanded use of Symvess® within the U.S. and international markets, interim results from our V012 Phase 3 trial in dialysis, and commencement of the first human study of our coronary tissue engineered vessel (CTEV) in coronary bypass graft surgery.”

“We are excited to partner with Humacyte as it embarks on its next chapter of growth. Symvess is addressing significant patient needs and we are looking forward to supporting them in achieving success,” said Chad Norman, Senior Portfolio Manager of Avenue Venture Opportunities Fund.

About Avenue Venture Opportunities

The Avenue Venture Debt Funds seek to provide creative financing solutions to high-growth, venture capital-backed technology and life science companies, focusing generally on companies within the underserved segment of the market created by the widening financing gap between commercial banks and larger debt funds. The Avenue Venture Debt funds are part of the larger group of funds of Avenue Capital Group. For additional information on Avenue Capital Group, which is a global investment firm with assets under management of more than $10 billion, visit www.avenuecapital.com.

About Humacyte

Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Forward-Looking Statements

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our cash resources, the availability of future tranches under the loan agreement and our ability to conduct future non-dilutive financings; our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs and our CTEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs and our CTEVs; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and Form 10-Q for the quarter ended September 30, 2025, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com

Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com

VIRBAC: Feline Hyperthyroidism: Virbac acquires Thyronorm




VIRBAC: Feline Hyperthyroidism: Virbac acquires Thyronorm

  About Virbac – Caring for animals together

At Virbac, we are constantly exploring new ways to prevent, diagnose and treat the majority of animal pathologies. We develop care, hygiene and nutrition products to offer complete solutions to veterinarians, farmers and pet owners around the world. Our purpose: advancing the health of animals with those who care for them every day, so we can all live better together.

More information on corporate.virbac.com

Press contacts – Libremullenlowe agency

Attachment

• Press release EN – Feline Hyperthyroidism_ Virbac acquires Thyronorm

Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026




Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026

1 A pre-NDA meeting is a routine, standard step where a drug company meets with the FDA before submitting its New Drug Application. It serves as a final check to make sure the FDA will have everything it needs for the review.
2 International Council for Harmonisation, http://www.ich.org, whose mission is “to achieve greater harmonisation worldwide to ensure that safe, effective and high-quality medicines are developed and registered.”

Attachment

• EN_NCX470NDADataGenerationDecember2025_FINAL

Acentra Health Named to Northern Virginia Technology Council’s Tech100




Acentra Health Named to Northern Virginia Technology Council’s Tech100

Award honors Northern Virginia organizations for making a positive impact on the region’s technology community

MCLEAN, Va., Dec. 15, 2025 (GLOBE NEWSWIRE) — Acentra Health, a technology and health solutions company dedicated to accelerating better outcomes for its government and commercial healthcare clients and the populations they serve, today announced that it has been named to the Northern Virginia Technology Council (NVTC)’s Tech100 list. Every year, the NVTC recognizes the region’s most innovative tech companies, visionary executives, and trailblazing rising stars who are shaping the future of technology, driving breakthrough solutions, and leading exceptional growth.

“At a time of rapid technological transformation, NVTC’s recognition is especially rewarding,” said Acentra Health CEO Todd Stottlemyer. “Acentra Health has a history of embracing new technologies and intelligently applying them to enhance our solutions and deliver more value to our clients. We are proud to be associated with the many forward-thinking organizations on the Tech100 list.”

Acentra Health envisions a healthcare ecosystem powered by modern technology that helps its clients improve care for beneficiaries nationwide. The company advances this vision through several strategic initiatives:

• A unified data platform designed to deliver governed, API-driven data for advanced healthcare analytics, quality measurement, and program integrity. This platform ensures that critical information is accessible and actionable for clients, enabling faster, more informed decisions that improve health outcomes for millions of beneficiaries.
• The evoBrix® X modular Medicaid Enterprise System (MES) platform that enables states to deploy new systems with greater speed and efficiency while maintaining the governance and compliance standards required for certification by the Centers for Medicare and Medicaid Services (CMS).
• Atrezzo, Acentra Health’s AI-enabled clinical platform that unifies utilization management, care/case management, appeals, assessments, and eligibility.
• The Safe AI in Medicaid Alliance (SAMA), a public-private partnership working to promote responsible and safe deployment and use of AI solutions in Medicaid agencies.

“We are in a moment of incredible transformation,” said Jennifer Taylor, president and CEO of NVTC. “Our region isn’t just keeping pace with change — we’re leading it. The NVTC Tech100 celebrates the people and companies making it happen. From GenAI to quantum, Northern Virginia’s innovators are building what’s needed for the nation and the world. This community doesn’t just imagine the future — it engineers it. Our honorees are transforming industries, inspiring collaboration, and proving that in Northern Virginia, innovation knows no bounds. We’re only at the beginning of witnessing AI’s extraordinary impact on our world.”

The NVTC Tech100 honorees will be celebrated at a dinner this evening.

About Acentra Health
Acentra Health combines public sector knowledge, clinical expertise, and technological ingenuity to modernize the healthcare experience for state, federal, and commercial partners and their priority populations. From designing and developing advanced claims, encounter, and provider solutions that drive efficiency and cost savings to delivering clinically focused solution models for care management, clinical assessments, and quality oversight, Acentra Health is accelerating better health outcomes. Acentra Health is backed by Carlyle (NASDAQ: CG), a global investment firm. Learn more at acentra.com.  

About the Northern Virginia Technology Council (NVTC)
NVTC is where the region’s tech community comes together. From bold startups to Fortune 100 giants, NVTC represents 500 members across sectors shaping the future of technology. NVTC drives innovation, fosters connections, and advocates for policies that fuel growth and position Northern Virginia as a global leader in technology. Through its initiatives in cybersecurity, generative AI, cloud computing, and beyond, NVTC empowers the tech community to shape the future. Whether it’s through policy advocacy, peer networks, or industry promotion, NVTC drives innovation that’s transforming the world. Learn more at www.nvtc.org. 

Media Contacts:
Marnie Keogh, Senior Vice President, Marketing
Acentra Health
703-214-3666
Marnie.Keogh@acentra.com

Janice Moore, Vice President, Corporate Communications
Acentra Health
703-214-3552
Janice.Moore@acentra.com

Tarin Horan
Northern Virginia Technology Council (NVTC)
703-946-0319
THoran@nvtc.org

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a2935f27-17dc-4ad2-95a8-27a0236ce6a1

Brain Based Health Solutions’ Dr. Clint Steele Releases “101 Brain Hacks” to Rewrite the Future of Dementia Prevention and Even Reversal




Brain Based Health Solutions’ Dr. Clint Steele Releases “101 Brain Hacks” to Rewrite the Future of Dementia Prevention and Even Reversal

Portland, Maine, Dec. 15, 2025 (GLOBE NEWSWIRE) — Most people believe dementia is a life sentence. Dr. Clint Steele once believed that, too, until a moment in his practice changed everything. Today, the #1 best-selling author, brain-health expert, and social media educator, followed by over 2 million people, is on a mission to save one million lives from dementia. His new book, 101 Brain Hacks to Prevent and Even Reverse Dementia (Including Alzheimer’s), is rapidly becoming a beacon of hope for families worldwide.

Dr. Steele’s journey began in heartbreak. In 2014, he watched his grandmother lose all sense of familiarity, her memories disappearing one by one. “She would whisper and ask if I could sneak her out to go fishing,” he recalls. “But when nurses showed her flashcards of fruit and shapes, she couldn’t recognize any of them. I kept thinking, ‘Someone needs to find a real solution.’”

He didn’t know at the time that he would become that someone.

A Case That Changed Everything

Six years later, an 80-year-old woman stepped into Dr. Steele’s clinic with anxiety, depression, high blood pressure, arthritis, and a fresh dementia diagnosis. Though he had never treated dementia, his natural protocols had reversed many of her other conditions in past patients. She and her husband agreed to try.

“Her memory was so poor that she would forget what she was saying mid-sentence,” Dr. Steele shares. “Her husband had to remind her of her own children’s names.”

But within weeks, something unexpected happened: her memory began improving. Her personality returned. Her cognitive fog lifted.

At the six-month mark, her husband walked into Dr. Steele’s office, hugged him, and said, “Thank you for giving me my wife back.”

That moment triggered a deep dive into decades of under-explored research on brain regeneration, ultimately forming the backbone of a movement Dr. Steele now leads globally.

From Heartbreak to a Global Brain-Health Movement

As he shared his discoveries online, his audience exploded from a few thousand to more than two million followers in under a year. People weren’t just interested, they were desperate for actionable, research-based help.

Dr. Steele began posting simple, daily “brain hacks.” One turned into two… then ten… then hundreds. His audience kept asking for more.

So he decided to compile the most powerful ones, 101 of them, into a single book.

The response? A resounding YES, followed by thousands of messages from people ready to take control of their cognitive future.

Introducing: 101 Brain Hacks to Prevent and Even Reverse Dementia

Part science, part story, and fully actionable, Dr. Steele’s best-selling book distills three decades of practice, cutting-edge studies, and real-life reversals into daily habits anyone can start immediately. It provides step-by-step strategies that support memory, cognitive performance, and long-term brain health, many of which readers say have already changed their lives.

Dr. Steele hopes to inspire others by showing one powerful truth: dementia may be preventable, and in some cases, even reversible when addressed early.

He backs this message not just with research, but with testimonials, case studies, and lived results.

More Than a Book – A Comprehensive Brain-Health Ecosystem

While the focus of this release is the book, 101 Brain Hacks To Prevent And Even Reverse Dementia (Including Alzheimer’s), Dr. Steele’s broader mission has grown into a full brain-health platform offering:

• Brain-focused nutritional supplements
• Essential oil inhalers to support cognitive performance
• Virtual coaching programs to guide individuals through multi-month brain-regeneration protocols

Everything circles back to one mission: empowering people with evidence-based tools to reclaim their cognitive future.

What Sets Dr. Steele Apart?

While many experts talk about dementia prevention, very few have demonstrated real reversal cases. Dr. Steele has done it and continues to. That lived experience has become the core of his brand and the reason his online community trusts him deeply.

A Life Lesson from Dr. Steele

“Just because someone tells you it can’t be done,” he says, “doesn’t make it true.”

Media Contact:
Company Name: Brain Based Health Solutions
Contact Person: Dr. Clint Steele
Email Address: drcs56@yahoo.com
City and State: Maine, USA
Website URL: https://drclintsteele.com/

CONTACT: Media Contact:
Company Name: Brain Based Health Solutions
Contact Person: Dr. Clint Steele
Email Address: drcs56@yahoo.com
City and State: Maine, USA
Website URL: https://drclintsteele.com/

Fractyl Health Announces Call of Tranche A Warrants Tied to August 2025 Public Offering Following Achievement of Clinical and Trading Milestones




Fractyl Health Announces Call of Tranche A Warrants Tied to August 2025 Public Offering Following Achievement of Clinical and Trading Milestones

Holders will have until December 30, 2025 to exercise Tranche A Warrants at $1.05 per share, enabling up to $17.9 million in potential gross proceeds

BURLINGTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) — Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company focused on pioneering pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (“T2D”), today announced that it will call all of its outstanding Tranche A Common Stock Purchase Warrants (the “Tranche A Warrants”) to purchase shares of the Company’s common stock, par value $0.00001 per share (the “Common Stock”) for cancellation for cash consideration of $0.00001 per underlying share at 6:30 p.m., New York City time, on December 30, 2025 (the “Cancellation Date”). The Tranche A Warrants were issued in connection with the Company’s underwritten public offering that priced on August 6, 2025 (the “August Offering”).

Instead of accepting the nominal consideration for cancellation of their warrants, holders of the Tranche A Warrants may instead elect to exercise their Tranche A Warrants in whole or in part at an exercise price of $1.05 per share until 6:30 p.m., New York City time, on the Cancellation Date. Any Tranche A Warrants that remain unexercised at such time will be cancelled for cash consideration of $0.00001 per underlying share.

As of the date hereof, the Company has approximately 17,063,073 Tranche A Warrants outstanding. The last reported sale price of the Common Stock on The Nasdaq Global Market on December 15, 2025 was $2.24 per share, a $1.19 premium to the exercise price of the Tranche A Warrants.

Holders of Tranche A Warrants in “street name” should immediately contact their broker to determine their broker’s procedure for exercising their Tranche A Warrants since the process to exercise is voluntary.

The call was enabled after the Company satisfied the clinical and market performance conditions, including the release of positive three-month randomized midpoint data from the ongoing REMAIN-1 study and the satisfaction of certain trading conditions, including the Common Stock exceeding an average closing price of $1.37 per share for 15 consecutive trading days with required minimum trading volumes, which conditions were met as of the close of trading today on The Nasdaq Global Market.

Any Tranche A Warrants that remain unexercised immediately after 6:30 p.m., New York City time on the Cancellation Date will be void and no longer exercisable, and the holders of those Tranche A Warrants will be entitled to receive $0.00001 per share underlying such Tranche A Warrant.

If all outstanding Tranche A Warrants are exercised prior to the Cancellation Date, Fractyl will receive approximately $17.9 million in additional gross proceeds, before deducting any applicable fees and expenses. These potential proceeds would further strengthen the Company’s balance sheet as it advances its clinical program toward key data readouts anticipated starting in January 2026.

The shares of Common Stock underlying the Tranche A Warrants have been registered by Fractyl under the Securities Act of 1933, as amended, and are covered by a registration statement filed with, and declared effective by, the Securities and Exchange Commission (the “SEC”) (File No. 333-285522).

Questions concerning call and exercise of the Tranche A Warrants can be directed to Equiniti Trust Company, LLC, 28 Liberty Street, Floor 53, New York, NY 10005, Attention: Reorganization Department. For a copy of the call notice sent to the holders of the Tranche A Warrants and a prospectus relating to the shares of Common Stock issuable upon exercise of the Tranche A Warrants, please send an email request to IR@fractyl.com.

No Offer or Solicitation

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Fractyl, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

About Fractyl Health

Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. The Company has a robust and growing IP portfolio, with 35 granted U.S. patents and approximately 45 pending U.S. applications, along with numerous foreign issued patents and pending applications. Fractyl is based in Burlington, MA. For more information, visit www.fractyl.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact are forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, without limitation, statements regarding the call of the Tranche A Warrants. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements are also subject to a number of material risks and uncertainties that are discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the Securities and Exchange Commission on November 12, 2025 and in our other filings with the SEC. These forward-looking statements are based on management’s current estimates and expectations. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause its views to change.

Contact

Brian Luque, Head of Investor Relations and Corporate Development
IR@fractyl.com, 951.206.1200