Scynexis Announces Federal Funding of Collaboration Between Hackensack Meridian CDI and Johns Hopkins Researchers to Develop New Therapeutics, Including Novel Fungerps, for Resistant Fungal Infections




Scynexis Announces Federal Funding of Collaboration Between Hackensack Meridian CDI and Johns Hopkins Researchers to Develop New Therapeutics, Including Novel Fungerps, for Resistant Fungal Infections

• Five-year grant of $7 million annually to the academic researchers is aimed at accelerating the development of new therapeutics to combat resistant fungal infections, including the Company’s next generation of triterpenoid antifungals (fungerps).
• Next-generation fungerps, in preclinical stages of development, are targeted to have enhanced pharmacological properties to treat fungal infections where current therapies are limited or not effective, while maintaining broad spectrum of activity against resistant fungal pathogens.

 
JERSEY CITY, N.J., Nov. 17, 2025 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that a novel series of antifungal compounds utilizing SCYNEXIS’ proprietary triterpenoid antifungal platform are among the five projects funded by the federal grant awarded to the new accelerator consortium led by researchers from Hackensack Meridian Center for Discovery and Innovation (CDI) and the Johns Hopkins Bloomberg School of Public Health. A five-year federal grant will establish a Center of Excellence in Translational Research (CETR) jointly between researchers from the Bloomberg School and the CDI, and other academic and commercial collaborators. The CETR expects to receive about $7 million annually, contingent upon the availability of funds, with the support coming from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID).

“With approximately four million annual deaths attributable to fungal infections globally¹, this new grant from the NIH provides essential funding to support the development of new therapeutics that can address the growing threat from resistant fungal infections,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “As part of this research collaboration, we are pleased to note that a series of next-generation fungerp candidates are included, with the aim to progress their development from early preclinical stage to IND ready candidates. For this collaboration we have selected a few fungerps with key attributes including activity against resistant fungi and differentiated pharmacological properties, critical for addressing significant limitations of currently available antifungal armamentarium. We are very pleased to collaborate with this CETR in tackling one of the world’s most pressing health threats.”

^{1 https://scienceline.org/2025/01/fungal-infections-treatment-options/}

About Triterpenoid Antifungals (Fungerps)

Triterpenoid antifungals (fungerps) are a novel class of structurally-distinct glucan synthase inhibitors being developed to address the significant threat posed by antimicrobial resistance (AMR) in systemic fungal diseases with high mortality. The triterpenoid class of antifungals represents the first new class of antifungal compounds approved since 2001. These agents combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC) in 2021 and for reduction in the incidence of recurrent VVC in 2022. SCY-247 is a second-generation fungerp, in Phase 1 of development and has demonstrated in vitro and in vivo broad-spectrum antifungal activity, including against multidrug resistant fungal pathogens. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phases of development.

About the Center for Discovery and Innovation

The Center for Discovery and Innovation, a member of Hackensack Meridian Health, translates current innovations in science to improve clinical outcomes for patients. More than 34 laboratories, 200+ professional researchers and physician-scientists at the CDI have set their sights on cancer, infectious diseases, autoimmune disorders, and other acute and chronic diseases. Clinical need drives scientific insights and their application for these researchers, leading to the development of new diagnostics, therapies, and surveillance capabilities in response to emerging health challenges. The CDI harnesses cutting-edge advances in genetics, molecular biology, clinical immunology, imaging, and behavioral sciences to better diagnose, treat and prevent disease through personalized medicine approaches. For additional information, please visit www.hmh-cdi.org.

About SCYNEXIS

SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” For more information, visit www.scynexis.com.

Forward-Looking Statements

Statements contained in this press release regarding expected future events or results are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: SCYNEXIS’ anticipation that the U.S. Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the IV and oral formulations of SCY-247. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS’ filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 12, 2025, including under the caption “Risk Factors.” All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT: 

Investor Relations
Irina Koffler
LifeSci Advisors
Tel: 917-734-7387
ikoffler@lifesciadvisors.com

Scynexis Announces Federal Funding of Collaboration Between Hackensack Meridian CDI and Johns Hopkins Researchers to Develop New Therapeutics, Including Novel Fungerps, for Resistant Fungal Infections




Scynexis Announces Federal Funding of Collaboration Between Hackensack Meridian CDI and Johns Hopkins Researchers to Develop New Therapeutics, Including Novel Fungerps, for Resistant Fungal Infections

• Five-year grant of $7 million annually to the academic researchers is aimed at accelerating the development of new therapeutics to combat resistant fungal infections, including the Company’s next generation of triterpenoid antifungals (fungerps).
• Next-generation fungerps, in preclinical stages of development, are targeted to have enhanced pharmacological properties to treat fungal infections where current therapies are limited or not effective, while maintaining broad spectrum of activity against resistant fungal pathogens.

 
JERSEY CITY, N.J., Nov. 17, 2025 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that a novel series of antifungal compounds utilizing SCYNEXIS’ proprietary triterpenoid antifungal platform are among the five projects funded by the federal grant awarded to the new accelerator consortium led by researchers from Hackensack Meridian Center for Discovery and Innovation (CDI) and the Johns Hopkins Bloomberg School of Public Health. A five-year federal grant will establish a Center of Excellence in Translational Research (CETR) jointly between researchers from the Bloomberg School and the CDI, and other academic and commercial collaborators. The CETR expects to receive about $7 million annually, contingent upon the availability of funds, with the support coming from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID).

“With approximately four million annual deaths attributable to fungal infections globally¹, this new grant from the NIH provides essential funding to support the development of new therapeutics that can address the growing threat from resistant fungal infections,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “As part of this research collaboration, we are pleased to note that a series of next-generation fungerp candidates are included, with the aim to progress their development from early preclinical stage to IND ready candidates. For this collaboration we have selected a few fungerps with key attributes including activity against resistant fungi and differentiated pharmacological properties, critical for addressing significant limitations of currently available antifungal armamentarium. We are very pleased to collaborate with this CETR in tackling one of the world’s most pressing health threats.”

^{1 https://scienceline.org/2025/01/fungal-infections-treatment-options/}

About Triterpenoid Antifungals (Fungerps)

Triterpenoid antifungals (fungerps) are a novel class of structurally-distinct glucan synthase inhibitors being developed to address the significant threat posed by antimicrobial resistance (AMR) in systemic fungal diseases with high mortality. The triterpenoid class of antifungals represents the first new class of antifungal compounds approved since 2001. These agents combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC) in 2021 and for reduction in the incidence of recurrent VVC in 2022. SCY-247 is a second-generation fungerp, in Phase 1 of development and has demonstrated in vitro and in vivo broad-spectrum antifungal activity, including against multidrug resistant fungal pathogens. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phases of development.

About the Center for Discovery and Innovation

The Center for Discovery and Innovation, a member of Hackensack Meridian Health, translates current innovations in science to improve clinical outcomes for patients. More than 34 laboratories, 200+ professional researchers and physician-scientists at the CDI have set their sights on cancer, infectious diseases, autoimmune disorders, and other acute and chronic diseases. Clinical need drives scientific insights and their application for these researchers, leading to the development of new diagnostics, therapies, and surveillance capabilities in response to emerging health challenges. The CDI harnesses cutting-edge advances in genetics, molecular biology, clinical immunology, imaging, and behavioral sciences to better diagnose, treat and prevent disease through personalized medicine approaches. For additional information, please visit www.hmh-cdi.org.

About SCYNEXIS

SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” For more information, visit www.scynexis.com.

Forward-Looking Statements

Statements contained in this press release regarding expected future events or results are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: SCYNEXIS’ anticipation that the U.S. Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the IV and oral formulations of SCY-247. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS’ filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 12, 2025, including under the caption “Risk Factors.” All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT: 

Investor Relations
Irina Koffler
LifeSci Advisors
Tel: 917-734-7387
ikoffler@lifesciadvisors.com

Vital Nutrients Releases Clinical Findings Showing Plant-Based Cortisol Balance Improves Sleep, Mood, and Stress Response




Vital Nutrients Releases Clinical Findings Showing Plant-Based Cortisol Balance Improves Sleep, Mood, and Stress Response

MIDDLETOWN, Conn., Nov. 17, 2025 (GLOBE NEWSWIRE) — Vital Nutrients, a leading practitioner-founded nutritional supplement company, has released new research highlighting the potential benefits of Cortisol Balance, a plant-based dietary supplement formulated to support healthy energy, stress response, and recovery.*

A randomized, double-blind, placebo-controlled study evaluated Cortisol Balance in 499 healthy adults seeking support for anxiety and stress. Over six weeks, participants received either Cortisol Balance or a placebo. The supplement, which contains clinically effective levels of ashwagandha, B vitamins, magnesium, boswellia, vegan omega-3, eleuthero extract, and copaiba extract, was assessed using validated measures of anxiety, stress, sleep and mood.

Findings showed that Cortisol Balance led to significant improvements in feelings of anxiety, perceived stress, sleep disturbance, and mood, compared to placebo, among participants who reported moderate levels of anxiousness. In this group, up to 85% of respondents reported improvement in both the levels and frequency of anxiousness and stress.

“This study provides important evidence that a comprehensive, systems-based approach to stress management can help people better adapt to the pressures of daily life,” said John P. Troup, Ph.D., chief science and innovation officer of Blueroot Health, the parent company of Vital Nutrients. “By supporting cortisol balance and healthy adrenal function, we can help the body manage stress where it starts—not just mask the symptoms—and improve overall well-being without relying on single-ingredient solutions.”

Unlike many supplements that draw on isolated ingredient data, Cortisol Balance was evaluated as a finished formula in a large and diverse U.S. population, a notable advancement in supplement research design. Troup says the product’s blend of adaptogenic herbs and nutrients works synergistically to help the body recover, reset and rebalance after stress, supporting the hypothalamic-pituitary-adrenal (HPA) axis, endocannabinoid system, and circadian rhythm.

“Especially during the holidays, shifting routines and added pressures can throw off the body’s natural stress response,” said Troup. “Cortisol Balance helps bring those systems back to equilibrium, supporting calm, focus and quality sleep.”

Available for $24.90 (30 capsules) or $67.90 (90 capsules) at https://www.vitalnutrients.co or through healthcare providers, Cortisol Balance is vegan, free of hemp-derived ingredients, and manufactured in Vital Nutrients’ NSF-certified facility in Middletown, Conn., where the company has been making clean, clinically backed nutritional supplements for more than 25 years.

About Vital Nutrients®
Vital Nutrients was founded in 2000, by healthcare practitioners on a mission to positively impact the health of both people and the planet. Based in Middletown, Conn., Vital Nutrients produces a diverse portfolio of premium quality, clinically relevant, clean-label formulas, trusted and recommended by healthcare practitioners and individuals worldwide. Known for its efficacy-first formulations and rigorous quality assurance, Vital Nutrients has built a long-standing reputation for excellence. Learn more at https://www.vitalnutrients.co.

About Blueroot Health®
Blueroot Health is a consumer health company with a diverse portfolio of brands that fuel lasting happiness and health for people and the planet. The company’s industry-leading brands – including Vital Nutrients®, Bariatric Fusion®, and Fairhaven Health® – offer a suite of clean, innovative, and clinically relevant nutritional supplements that work. The portfolio includes specialized solutions for women’s health, metabolic health and weight management, and a full range of clinically relevant, specialized formulas and single ingredients trusted by health care practitioners, patients and consumers worldwide. Blueroot Health is committed to making a lasting, positive impact on the communities it serves, without leaving a negative footprint on the planet. Learn more at: https://blueroothealth.co.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/fd15d034-2c74-4f92-86fe-e334da2a3c7c

https://www.globenewswire.com/NewsRoom/AttachmentNg/3c68b097-41c8-4e68-83df-4110a58900db

CONTACT: Media Contact:
Amy Summers
212-757-3419 | amy@pitchpublicitynyc.com
Pitch Publicity®

Ashvattha Therapeutics to Showcase Topline Phase 2 Data and Recent FDA Alignment at Upcoming Investor and Ophthalmology Meetings




Ashvattha Therapeutics to Showcase Topline Phase 2 Data and Recent FDA Alignment at Upcoming Investor and Ophthalmology Meetings

Company to present 40-week topline results from the Phase 2 study of migaldendranib (MGB), a first-in-class subcutaneous nanomedicine, being developed for the treatment of DME and nAMD

FDA alignment on Phase 2b/3 trial design provides a clear regulatory path for two well-controlled studies under a single protocol, strengthening the Company’s position with ophthalmology-focused strategics and venture firms

REDWOOD CITY, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) — Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company developing a nanomedicine therapeutic that traverses the blood-retinal barrier in regions of inflammation selectively targeting and reprogramming activated cells in the retina, today announced upcoming panel participation at Eyenovate at FLORetina, taking place in Florence, Italy on December 4 2025, and a scientific presentation at FLORetina ICOOR Congress 2025, taking place December 5, 2025.

Ashvattha will also be attending the Jefferies Global Healthcare Conference taking place in London, UK on November 17 – 19, 2025 and Ophthalmology Innovation Summit (OIS), taking place in San Diego, CA on November 21-22, 2025. Ashvattha leadership will be available for meetings at both conferences. To arrange an appointment, please reach out to meetings@avttx.com.

The presentation at FLORetina will review the recent topline, 40-week Phase 2 study data of migaldendranib (MGB), the company’s investigational first-in-class subcutaneous nanomedicine being developed for diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). MGB is designed to cross the blood-retinal barrier in regions of inflammation and to selectively target activated cells in the retina to normalize VEGF expression. This approach has the potential to offer patients a safe, convenient, at-home alternative to intravitreal, in-office injections.

The schedule of presentations is as follows:

Eyenovate 2025
Thursday, December 4, 2025 | 9:00 – 9:45 AM CEST

Panel: The Horizon to Access Sustainable Treatment Strategies in Retinal Vascular Diseases: TKIs, Gene Therapies, Topical Options & Sustained Drug Delivery Devices
Speaker: Robert Dempsey, Interim CEO of Ashvattha Therapeutics
Session: 9-9:45am CEST, Fortezza da Basso

FLORetina ICOOR Congress 2025
Friday, December 5, 2025 | 9:03 AM CEST

Phase 2 results of chronic subcutaneous Migaldendranib (MGB), a first-in-class nanomedicine, for the treatment of Diabetic Macular Edema (DME) and neovascular Age-Related Macular Degeneration (nAMD): topline presentation of a 40-week clinical Study
Presenter: Michael Singer, MD
Session: Paper Session 1, Del Carmine Room

About Migaldendranib
Migaldendranib (MGB) is a novel first-in-class nanomedicine in clinical development for the treatment of DME and nAMD. Administered subcutaneously, MGB has a differentiated mechanism of action that crosses the blood-retinal barrier in regions of inflammation and selectively normalizes VEGF expression in activated macrophages, microglia, and retinal pigment epithelial cells in the retina. Phase 2 clinical results demonstrate that subcutaneous MGB is safe and well-tolerated across multiple doses, with the potential for convenient once-monthly at-home administration that could significantly reduce intravitreal injection burden for patients, including those with bilateral disease.

About Ashvattha Therapeutics 
Ashvattha Therapeutics is advancing a new class of clinical-stage nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells only in regions of inflammation. Our targeted nanomedicine approach seeks to redefine precision medicine, empowering a new standard of care in ophthalmology. Ashvattha Therapeutics was founded by Kannan Rangaramanujam, Sujatha Kannan, and Jeff Cleland and incubated by Natural Capital. For more information, visit: www.avttx.com.

Media Inquiries

Please contact info@avttx.com

Silo Pharma Partners with Allucent to Support Planned FDA Investigational New Drug Application for SPC-15 as a Therapeutic for PTSD




Silo Pharma Partners with Allucent to Support Planned FDA Investigational New Drug Application for SPC-15 as a Therapeutic for PTSD

SARASOTA, FL, Nov. 17, 2025 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company), a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company, today announced that it has selected Allucent, a global full-service clinical research organization (CRO), to support the Company’s final preparations and planned submission of its investigational new drug application (IND) to the FDA for a Phase 1 clinical trial of its intranasal prophylactic SPC-15 as a treatment for PTSD. The Company currently expects to submit the IND in 2026 and commence its first-in-human (FIH) SPC-15 trial subsequent to FDA approval.

“We believe that a partnership with Allucent, is a significant move forward in bringing our novel PTSD therapeutic to the clinic,” said Silo CEO Eric Weisblum. “With Allucent’s expertise, we believe our IND will provide a sound rationale for clinical development, beginning with protocols for dose-ranging studies to assess the pharmacokinetics and safety profile for SPC-15. We expect to receive positive preclinical results in these categories which should meet the FDA’s clinical trial standards.”

Data from an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic study, along with findings from a drug-device study of the formulation-specific intranasal spray system used for SPC-15 drug delivery, are expected in early 2026. Silo intends to pursue the FDA’s 505(b)(2) accelerated regulatory pathway for clinical development of SPC-15.

About Silo Pharma

Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company. Its therapeutic focus is on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company’s portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease and multiple sclerosis. Silo’s research is conducted in collaboration with leading universities and laboratories. silopharma.com

About Allucent

Allucent is on a mission to help bring new therapies to light by solving the distinct challenges faced by biopharma and government clients. A global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a range of therapeutic areas, Allucent brings more than 30 years of experience in over 60 countries. With an A-Team of former regulators, leading scientists, and clinical experts, Allucent’s individualized partnership approach delivers deep insights and hands-on expertise to help clients navigate the complexities of bringing innovative treatments to patients. Learn more at allucent.com.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law.

Contact
800-705-0120
investors@silopharma.com

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Third Quarter 2025 Financial Results and Provides Corporate Update




NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Third Quarter 2025 Financial Results and Provides Corporate Update

• NRx has refiled its Abbreviated New Drug Application for KETAFREE™ (preservative free ketamine), received supportive correspondence from FDA, and expects Q2 2026 GDUFA date.
• HOPE Therapeutics is now operating three revenue-generating facilities in Florida and expects six or more by year-end providing neuroplastic drugs, transcranial magnetic stimulation, hyperbaric therapy, and digital therapeutics to treat suicidal depression and PTSD.
• NRx has secured operating capital anticipated to be sufficient for drug development operations through July 2026. The Company additionally expects to increase revenue from clinical operations.
• NRx received FDA grant of Fast Track Designation for NRX-100 in the treatment of suicidal ideation in patients with depression, including bipolar depression.
• New Real-World Data support the effect of D-cycloserine (NRX-101 active ingredient) in doubling the effectiveness of Transcranial Magnetic Stimulation (TMS). Company has expanded access program for NRX-101 in augmenting TMS in depression, suicidality, and PTSD. 

WILMINGTON, Del., Nov. 17, 2025 (GLOBE NEWSWIRE) — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals,” the “Company”), a clinical-stage biopharmaceutical company, today announced financial results for the quarter ended September 30, 2025, and provided a corporate update.

“In 2025 we have advanced each of our corporate objectives and entered into revenue-generating activity for the first time. For NRX-100 in suicidal depression, we received an expanded Fast Track designation, opened an Expanded Access program and enhanced our regulatory package. Additionally, FDA granted our Suitability Petition for a single patient, preservative free ketamine strength and we have received validation that our ANDA filing is on track with no major deficiencies. In parallel, the Real World Data demonstrating a doubling of antidepressant and antisuicidal effect of Transcranial Magnetic Stimulation (TMS) when D-cycloserine is added creates a new and significant indication for NRX-101 that has potential for approval, if confirmed in an additional phase 3 trial. For HOPE, we continue to execute on building our delivery platform of three active facilities in Florida, with three more planned by year-end. Dr. Rebecca Cohen and LTC Charles Paul, RN (US Army, Ret.) are assembling a network of best-in-class interventional psychiatrists to meet the needs of people, including active duty military, first responders, and veterans, across Florida and beyond,” said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals.

Key Research and Development and Corporate Activities
NRX-100 (intravenous ketamine)
NRx is pursuing two paths to market for NRX-100: a distinct innovative pathway via a New Drug Application (NDA) under FDA Fast Track designation to develop NRX-100 for suicidal ideation in depression, including bipolar depression, and a generic pathway via an Abbreviated New Drug Application (ANDA) to supply a preservative-free ketamine (KETAFREE™) into the existing ketamine market. Recent correspondence from the FDA suggests that the latter pathway is on track for a Q2 2026 GDUFA date. The current generic ketamine market is estimated at approximately $750 million, as previously disclosed. By contrast, the innovative ketamine-based product SPRAVATO^® is expected to generate over $1.6 billion in 2025 sales, although its labeling states that effectiveness in preventing suicide or reducing suicidal ideation has not been demonstrated. This highlights a differentiated opportunity for NRX-100, specifically in suicidal ideation.

A New Drug Application (“NDA”) for NRX-100 for suicidal depression, originally initiated during the fourth quarter of 2024, is expected to be completed in the fourth quarter 2025 with the addition of Real World Efficacy Data drawn from more than 60,000 patients treated for depression with intravenous ketamine compared to 6,000 patients treated with intranasal S-ketamine to be submitted as part of the NDA. An interim analysis drawn from the first 20,000 patients suggests that IV ketamine may have a more rapid onset of action and larger magnitude of effect than nasal S-ketamine. The Company has applied to receive a Commissioner’s National Priority Voucher (CNPV), which could significantly reduce review time.

The Abbreviated New Drug Application (“ANDA”) for NRX-100 was filed, with Priority Review requested, during the third quarter of 2025. After meeting with the FDA in August 2025, the Company re-filed the ANDA, following FDA notification of approval of a Suitability Petition for NRx’s proposed strength of preservative-free ketamine, KETAFREE™. On November 6, 2025, the Company received a communication from FDA in which no significant deficiencies were identified in the revised filing. The Company has additionally submitted a Citizen Petition seeking to have benzethonium chloride, a toxic preservative, removed from all commercial presentations of ketamine.

The Company has manufactured multiple commercial lots of NRX-100 and KETAFREE™ with ongoing stability data supporting a room temperature shelf life of three years.

NRX-101: Oral Treatment for Suicidal Bipolar Depression
Bipolar depression affects over seven million people in the US. Current treatment options carry the risk of suicide and akathisia, a side-effect of serotonin active antidepressants, which is closely related to suicide. People with bipolar depression and akathisia or suicidality are at imminent risk of self-harm. These patients need better treatment options urgently.

An NDA filing for NRX-101 has been initiated with the submission of the Module 3 manufacturing file to publishing. The drug was previously awarded Breakthrough Therapy Designation, and accordingly the Company is requesting rolling review of the NDA. Breakthrough Therapy Designation is granted by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions meet an unmet medical need and have demonstrated preliminary evidence of efficacy, as determined by the FDA.

Recently published Real World Efficacy data provides confirmatory evidence from a prior randomized controlled trial that low-dose D-cycloserine (the active ingredient in NRX-101) more than doubles the anti-depressant and anti-suicidal effect of Transcranial Magnetic Stimulation. The company has more than 25,000 manufactured doses of NRX-101 at the appropriate strength on hand and has launched a nationwide expanded access program to enable physicians to access this medication at no charge to the patient under Expanded Access and Federal Right to Try laws. A confirmatory phase 3 trial of NRX-101 to augment the effects of TMS is planned for early 2026. The market estimate for this newly validated indication for NRX-101 is in excess of $1 Billion.

HOPE Therapeutics: Interventional Psychiatry Clinic Network
HOPE Therapeutics, Inc., is a medical care delivery organization providing cutting-edge interventional psychiatric treatment of the above conditions with neuroplastic drugs, such as ketamine, Spravato and NRX-101, neuromodulatory devices, such as Transcranial Magnetic Stimulation (“TMS”), hyperbaric therapy, digital therapeutics, and medication management.

On September 8, 2025, HOPE initiated revenue-generation through its acquisition of Dura Medical, LLC (“Dura”) in Naples and Ft. Myers, Florida and subsequently added Cohen and Associates in Sarasota, FL to the HOPE Network. Dr. Rebecca Cohen has been appointed as HOPE’s Medical Director.

Last week, HOPE was the first organization in Florida to launch one day TMS treatment for severe depression with the ONE-D protocol using the Ampa TMS device. The ONE-D protocol has been reported in the peer-reviewed literature to achieve 87% response and 72% remission from severe depression at 6 weeks following a single day of TMS treatment, combined with D-cycloserine. HOPE is in the process of adding three more facilities in 2025 and is in active discussion with numerous acquisition opportunities around the country.

Financial Results for the Quarter Ended September 30, 2025

For the three months ended September 30, 2025, the Company reported a loss from operations of $4.0 million versus a loss from operations of $3.0 million for the comparable quarter in 2024. The difference was primarily attributable $800,000 of additional research and development expense to support our FDA initiatives for NRX-100 and NRX-101, including the previously discussed ANDA submission for preservative-free IV ketamine; and, $400,000 of additional general and administrative expense, which included our efforts to close, operate and identify clinic acquisition targets for HOPE. As of September 30, 2025, NRx Pharmaceuticals had approximately $7.1 million in cash and cash equivalents. Including approximately $3.1 million from a subscription receivable, for which the Company received the cash in early October, total cash as of September 30, 2025 would have been $10.3 million. For the third quarter ended September 30, 2025, the Company reported revenue for the first time in its history driven by the acquisition of Dura Medical, which closed September 8, 2025. While revenue of approximately $240,000 was relatively modest, it only reflects twenty-two days of the full quarter and a single clinic group. Management anticipates the ability to include results from the full period for Dura in future quarters; closing anticipated additional acquisitions; and organic growth of previously acquired clinics will drive meaningful revenue growth in the fourth quarter and through 2026. Transactions where we acquire a non-controlling interest are expected to improve our overall financial condition but not directly increase revenue. Finally, we remain in active discussions with several additional potential acquisition candidates, and while no assurances can be given that we will close any or all such opportunities, together they represent total revenue of more than $20 million on an annual basis.

The Company believes that its current cash position will support operations at least through the second quarter of 2026, as well as provide sufficient capital to reach expected regulatory inflection points and complete potential additional select acquisition opportunities to expand the growing footprint of HOPE clinics.

Detailed financials can be found in our recent Form 10-Q filing, available on our website, at https://ir.nrxpharma.com/sec-filings.

Conference Call and Webcast Details
A live webcast of the conference call will be available on the Company’s website at 8:30am ET today, at NRx Events . An archive of the webcast will be available on the Company’s website for 30 days. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically 1-800-717-1738 or internationally +1-646-307-1865.

About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has recently re-filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.

About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com), a subsidiary of NRx Pharmaceuticals, is a healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine and other neuroplastic medications, transcranial magnetics stimulation (TMS), Hyperbaric Oxygen Therapy, and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. HOPE is the first network in Florida to offer the AMPA One Day (ONE-D) treatment that combines TMS, physician-prescribed D-cycloserine, and lisdexamfetamine to achieve remission from treatment resistant depression.

Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. These statements relate to future events or to the Company’s future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company’s current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company’s operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.

For further information:

LifeMD® to Offer Market-Leading Pricing for GLP-1 Medications Wegovy® and Ozempic® in Continued Collaboration with Novo Nordisk




LifeMD® to Offer Market-Leading Pricing for GLP-1 Medications Wegovy® and Ozempic® in Continued Collaboration with Novo Nordisk

LifeMD expands access to Wegovy and Ozempic at the lowest cash-pay pricing, reinforcing its commitment to patient affordability and high-quality care

NEW YORK, Nov. 17, 2025 (GLOBE NEWSWIRE) — LifeMD, Inc. (Nasdaq: LFMD), a leading provider of virtual primary care services and pharmacy, today announced a new, lower cash-pay price for GLP-1 medications, Wegovy^® and Ozempic^®, made possible through its ongoing collaboration with Novo Nordisk. LifeMD will now offer the 0.25 mg and 0.5 mg doses at $199 per month—the lowest cash-pay pricing available nationwide—for two fills for new patients. The offering is designed to support patients who pay out of pocket.

These medications are available through the LifeMD Weight Management Program, which provides comprehensive support including virtual consultations with LifeMD’s dedicated clinical team, access to diagnostic testing, secure messaging through a personalized patient portal, and educational resources on diet and lifestyle changes that are important for sustained weight loss and metabolic health.

This update follows recent national efforts to improve affordability and access to GLP-1 therapies, including initiatives led by the White House and leading pharmaceutical manufacturers such as Novo Nordisk and Eli Lilly. As these developments continue to shape the market, LifeMD’s infrastructure, partnerships, and virtual care model position the company as a key player in supporting patients seeking clinically guided weight-loss care.

“We are proud to continue offering the most competitive cash-pay pricing for GLP-1 therapies in America,” said Justin Schreiber, Chairman and Chief Executive Officer of LifeMD. “Our goal remains the same: to maximize access to safe, FDA-approved medications through a frictionless virtual care experience that delivers long-term and sustainable weight loss and health benefits for our patients.”

LifeMD’s shift from compounded GLP-1s to direct partnerships with leading pharmaceutical manufacturers is central to its long-term growth strategy, reinforcing its commitment to emerging regulatory and reimbursement frameworks and to meeting rising demand for authentic obesity and metabolic care medications.

“These policy shifts not only validate our strategic direction but also demonstrate our alignment with both market needs and the future of healthcare,” added Anthony Puopolo, M.D., President, LifeMD Affiliated P.C.s. “As demand for obesity and metabolic care continues to rise, LifeMD is exceptionally well positioned to deliver high-quality, affordable treatment options through a scalable, integrated virtual care platform.”

About LifeMD, Inc.

LifeMD^® is a leading provider of virtual primary care. LifeMD offers telemedicine, access to laboratory and pharmacy services, and specialized treatment across more than 200 conditions, including primary care, men’s and women’s health, mental health, and weight management. The Company leverages a vertically integrated, proprietary digital care platform, a 50-state affiliated medical group, a state-of-the-art affiliated compounding pharmacy, and a U.S.-based patient care center to expand access to high-quality, affordable care. For more information, please visit LifeMD.com.

Cautionary Note Regarding Forward Looking Statements

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended; Section 21E of the Securities Exchange Act of 1934, as amended; and the safe harbor provision of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this news release may be identified by the use of words such as: “believe,” “expect,” “anticipate,” “project,” “should,” “plan,” “will,” “may,” “intend,” “estimate,” “predict,” “continue,” and “potential,” or, in each case, their negative or other variations or comparable terminology referencing future periods. Examples of forward-looking statements include, but are not limited to, statements regarding our financial outlook and guidance, short and long-term business performance and operations, future revenues and earnings, regulatory developments, legal events or outcomes, ability to comply with complex and evolving regulations, market conditions and trends, new or expanded products and offerings, growth strategies, underlying assumptions, and the effects of any of the foregoing on our future results of operations or financial condition.

Forward-looking statements are not historical facts and are not assurances of future performance. Rather, these statements are based on our current expectations, beliefs, and assumptions regarding future plans and strategies, projections, anticipated and unanticipated events and trends, the economy, and other future conditions, including the impact of any of the aforementioned on our future business. As forward-looking statements relate to the future, they are subject to inherent risk, uncertainties, and changes in circumstances and assumptions that are difficult to predict, including some of which are out of our control. Consequently, our actual results, performance, and financial condition may differ materially from those indicated in the forward-looking statements. These risks and uncertainties include, but are not limited to, “Risk Factors” identified in our filings with the Securities and Exchange Commission, including, but not limited to, our most recently filed Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any amendments thereto. Even if our actual results, performance, or financial condition are consistent with forward-looking statements contained in such filings, they may not be indicative of our actual results, performance, or financial condition in subsequent periods.

Any forward-looking statement made in the news release is based on information currently available to us as of the date on which this release is made. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as may be required under applicable law or regulation.

Investor Contact
Marc Benathen, Chief Financial Officer
marc@lifemd.com

Media Contact
Jessica Friedeman, Chief Marketing and Product Officer
press@lifemd.com

Calidi Biotherapeutics Announces Exclusive Live Investor Webinar and Q&A Session on November 19, 2025




Calidi Biotherapeutics Announces Exclusive Live Investor Webinar and Q&A Session on November 19, 2025

SAN DIEGO, Nov. 17, 2025 (GLOBE NEWSWIRE) — Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, is pleased to invite investors to a webinar on November 19, 2025, at 1:15 p.m. PT.

The exclusive event, hosted by RedChip Companies, will feature Calidi’s CEO, Eric Poma, Ph.D. Attendees will gain insights into Calidi’s pioneering approach to precision genetic medicine, enabled by its RedTail platform—an engineered, systemically delivered viral therapy designed to avoid immune detection and reach metastatic sites in the tumors Once at the tumor, the platform expresses potent genetic medicines, such as IL-15 superagonist, to drive an anti-tumor immune response.

Preclinical data showcased at the Society of Immunotherapy for Cancer (SITC) annual conference demonstrated that in syngeneic murine models, the RedTail platform is protected from immune clearance after systemic administration and can find and specifically replicate in tumor cells at metastatic sites. The data also demonstrate that the platform can effectively express genetic medicines at the tumor site in concentrations that are similar to what is achievable with localized dosing while avoiding systemic exposure. With its scalable, non-integrating viral backbone and ability to deliver multiple genetic payloads, RedTail will position Calidi to penetrate a vast oncology market projected to exceed $560 billion by 2033 by Spherical Insights research. The Company is advancing toward IND filing by the end of 2026. Calidi’s third quarter 2025 earnings release reported a strengthened balance sheet with reduced debt and higher cash balance, and also a reduction in G&A spending.

A live question and answer session will follow the presentation.

To register for the free webinar, please visit: https://www.redchip.com/webinar/CLDI/85897126502

Questions can be pre-submitted to CLDI@redchip.com or online during the live event.

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company’s proprietary Redtail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent gene therapies to metastatic locations.

The lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical need. Additionally, Calidi is developing protected virotherapies, in clinical-stage, for intratumoral and localized administration, focusing on a subset of injectable cancer indications.

Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.

Forward-Looking Statements
This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning key milestones, including certain pre-clinical data, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 31, 2025, as may be amended or supplemented by other reports we file with the SEC from time to time.

Contact:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com

FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5




FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5

• Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026
• If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2

WESTLAKE VILLAGE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA acceptance of a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3%, a once-daily, advanced targeted topical phosphodiesterase-4 (PDE4) inhibitor, to expand the indication for the topical treatment of plaque psoriasis to include children 2 to 5 years old. The FDA has set a PDUFA target action date of June 29, 2026, for this application.

“Plaque psoriasis in young children can be particularly challenging to manage, as it often affects sensitive areas such as the face and intertriginous skin,” said Amy Paller, MS, MD, attending physician, dermatology, Walter J. Hamlin Professor and chair of dermatology, professor of pediatrics, Northwestern University Feinberg School of Medicine. “Effective and well-tolerated treatment options that are gentle enough for these areas are critical to support long-term disease control and improve quality of life for children and their families.” 

“This milestone brings us closer to helping families and clinicians caring for young children with plaque psoriasis,” said Frank Watanabe, president and CEO of Arcutis. “If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for children as young as two, offering a steroid-free option that delivers both efficacy and tolerability for this particularly vulnerable group. We remain deeply committed to advancing care for people of all ages living with immune-mediated skin diseases, offering innovative, advanced targeted topicals to elevate the standard of care—including children as young as age two.”

ZORYVE cream 0.3% is currently approved for plaque psoriasis in adults and children down to age 6. This sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 years with plaque psoriasis, as well as data from a long-term open-label study that included children in that age range. Results from this long-term study demonstrate consistent favorable long-term safety and tolerability as well as persistence of efficacy across all age ranges studied.

About Plaque Psoriasis
Psoriasis is a common, chronic, inflammatory skin disease that affects nearly 9 million people in the United States. Symptoms include itch, scaling, redness, flaking, and pain. On darker skin tones, plaques may appear more grayish, purplish, or brown. Psoriasis can appear anywhere on the body, including the knees, elbows, torso and thin-skinned areas like the face, genitals and intertriginous areas, which are areas where skin touches skin, such as the armpits, under the breasts, stomach folds, between the buttocks, and in the groin. In children, psoriasis more commonly affects these sensitive areas and intertriginous regions, posing treatment challenges and quality-of-life burdens for patients and families.

About ZORYVE® (roflumilast)
ZORYVE is the number one prescribed branded topical therapy across three major inflammatory dermatoses combined—atopic dermatitis, seborrheic dermatitis, and plaque psoriasis.  ZORYVE cream is a topical formulation of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. Inhibiting PDE4, an intracellular enzyme that is an established target in dermatology, decreases the production of pro-inflammatory mediators. This decreases inflammation in the skin and balances the skin’s immune system.

Demonstrating both clinical impact and broad industry recognition, ZORYVE has been honored with multiple prestigious awards and recommendations. ZORYVE was recently awarded by Allure with the “2025 Best of Beauty Breakthrough Award,” making it the first FDA-approved medication for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis to win this prominent award. ZORYVE cream 0.3% and ZORYVE foam 0.3% were also awarded the National Psoriasis Foundation’s Seal of Recognition—the first FDA-approved prescription brand to receive the honor. Additionally, the American Academy of Dermatology (AAD) issued a strong recommendation for the use of ZORYVE cream 0.15% in adult patients with mild to moderate atopic dermatitis, according to updated guidelines released in June 2025. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Best Eczema Product.”

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.

INDICATIONS
ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

Please see full Prescribing Information for ZORYVE cream.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential FDA approval of ZORYVE cream 0.3% for plaque psoriasis for children ages 2 to 5 years, and the potential of ZORYVE cream to advance the standard of care for plaque psoriasis and other inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

Investors
Brian Schoelkopf, Head of Investor Relations
ir@arcutis.com

Solid Biosciences Announces Licensing Agreement with Andelyn Biosciences for the Use of Proprietary Next-Generation Capsid AAV-SLB101




Solid Biosciences Announces Licensing Agreement with Andelyn Biosciences for the Use of Proprietary Next-Generation Capsid AAV-SLB101

– Non-exclusive license providing Solid’s proprietary, next-generation capsid, AAV-SLB101, to Andelyn Biosciences, a full-service cell and gene therapy Contract Development and Manufacturing Organization (CDMO) –

– AAV-SLB101 has been generally well tolerated in the 23 participants dosed in the Phase 1/2 INSPIRE DUCHENNE clinical trial as of a safety cutoff of October 31, 2025 –

– Solid continues to expand collaborative efforts for AAV-SLB101 with over 30 agreements including licenses executed –

CHARLESTOWN, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced a non-exclusive worldwide license and collaboration agreement with Andelyn Biosciences (Andelyn), a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), for the use of Solid’s proprietary, next-generation capsid, AAV-SLB101.

Under the terms of the agreement, Solid grants Andelyn a non-exclusive worldwide license to provide its gene therapy clients with access to utilize AAV-SLB101 in combination with Andelyn’s suspension and adherent modular platform process, the AAV Curator® Platform, which brings a modular approach to gene therapy CMC processes by optimizing manufacturing and using configurable materials. Specific financial terms of the agreement have not been disclosed.

AAV-SLB101 is Solid’s rationally designed capsid developed for enhanced skeletal muscle and cardiac tropism and reduced biodistribution to the liver. As of the recently reported safety cutoff of October 31, 2025, AAV-SLB101 has been generally well tolerated in the 23 pediatric participants who have been dosed in Solid’s Phase 1/2 INSPIRE DUCHENNE clinical trial (NCT06138639) evaluating investigational Duchenne muscular dystrophy gene therapy SGT-003, which utilizes AAV-SLB101. Robust cardiac and skeletal muscle transduction and biodistribution have been demonstrated in preclinical studies as well as in early clinical data from INSPIRE DUCHENNE.

Bo Cumbo, President and CEO of Solid Biosciences, said, “We are excited to announce a new non-exclusive license for AAV-SLB101 with Andelyn Biosciences. This collaboration reflects our shared mission to accelerate the next generation of gene therapies built upon cutting-edge technologies designed to enhance safety and efficacy. With more than 30 agreements and licenses already in place for the use of AAV-SLB101, we expect our partnership with Andelyn to help trailblaze a brighter future for gene therapy. Their pioneering and configurable CDMO model will broaden access to our proprietary capsid, enabling early-stage gene therapy programs to harness next-generation technology and benefit from the differentiated profile of AAV-SLB101.”

Matt Niloff, Chief Commercial Officer of Andelyn, said, “We are eager to provide our clients with access to Solid’s novel capsid, AAV-SLB101. By integrating this next-generation technology into our AAV Curator® Platform, we can offer an advanced gene therapy vector that has been clinically validated and ultimately may allow for faster and more cost-effective development. Our collaboration with Solid underscores our commitment to providing best-in-class solutions for our clients, empowering researchers and helping to advance transformative medicines for patients.”

About AAV-SLB101
AAV-SLB101 is a proprietary, rationally designed capsid developed for enhanced skeletal muscle and cardiac tropism and reduced liver biodistribution. With a robust preclinical package in mice and nonhuman primates, AAV-SLB101 has demonstrated increased transduction speed, enhanced skeletal and cardiac muscle tropism, decreased liver biodistribution and improved efficiency when compared to first generation capsids. The incorporation of AAV-SLB101 into AAV delivered therapies has the potential to be a step forward in the treatment of neuromuscular and cardiac diseases. Solid Biosciences aims to license AAV-SLB101 broadly to both companies and academic institutions pursuing treatments for rare diseases. Solid has existing agreements, including licenses, with more than 30 corporations, institutions and academic labs for the use of AAV-SLB101.

About Solid Biosciences
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including SGT-003 for Duchenne muscular dystrophy (Duchenne), SGT-212 for Friedreich’s ataxia (FA), SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), SGT-601 for TNNT2-mediated dilated cardiomyopathy and additional fatal, genetic cardiac diseases. The Company is also focused on developing innovative libraries of genetic regulators and other enabling technologies with promising potential to significantly impact gene therapy delivery cross-industry. Solid is advancing its diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. For more information, please visit www.solidbio.com.

About Andelyn Biosciences, Inc.
Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization, and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn’s deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing. Andelyn can accelerate programs and deliver high-quality products by developing and manufacturing processes on its configurable, data-driven AAV Curator^® Platform or tech transfer in an established client program. Capabilities include cGMP manufacturing for suspension processes up to a 2,000-liter and adherent processes. A rigorous quality system, regulatory support, and supply chain vertical integration further advantages clients in bringing their critical therapies to market. For more information, visit andelynbio.com.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future expectations, plans and prospects for the Company; the ability to successfully achieve and execute on the company’s goals, priorities and achieve key clinical milestones; the Company’s pipeline of capsid products, including SLB-101, and programs for neuromuscular and cardiac diseases, including its SGT-003 candidate and other clinical and pre-clinical programs and expectations for clinical development, initiation and enrollment in clinical trials, dosing, availability of clinical trial data and potential accelerated approval;; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the company’s ability to advance and license AAV-SLB101 and advance SGT-003 and its other clinical and preclinical programs and capsid libraries on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies and early-stage clinical trials of the company’s product candidates; obtain, maintain or protect intellectual property rights related to its capsid libraries and product candidates; compete successfully with other companies that are seeking to develop capsids, capsid libraries, Duchenne, Friedreich’s ataxia and other neuromuscular and cardiac treatments and gene therapies;, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.

Solid Biosciences Investor Contact:
Nicole Anderson
Director, Investor Relations and Corporate Communications
Solid Biosciences Inc.
investors@solidbio.com

Media Contact:
Glenn Silver
FINN Partners
glenn.silver@finnpartners.com