Spruce Biosciences

06/08/2026

We are grateful for Dr. Nicole Maria Muschol’s presentation of long-term clinical data on Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) in patients with in patients with Sanfilippo Syndrome Type B (MPS IIIB) over the weekend at the 18th International MPS Symposium.

Sustained normalization of CSF HS-NRE, the anticipated surrogate marker for accelerated approval, alongside long-term stabilization of cognitive function, communication, and motor skills strengthens our confidence in the potential of TA-ERT and reinforces our dedication to working closely with the Sanfilippo community to responsibly advance this program through a biologics license application submission and potential U.S. FDA approval.

We are also incredibly grateful to the children, families, caregivers, and study investigators who participated in the TA-ERT clinical development program.

https://investors.sprucebio.com/news-releases/news-release-details/spruce-biosciences-announces-long-term-tralesinidase-alfa-enzyme

05/15/2026

May 15th is International MPS Awareness Day.

At Spruce Biosciences, our commitment to patients and their families are at the heart of everything we do. We hope to deliver medicines that make meaningful impacts
for families affected by Sanfilippo Syndrome Type B (MPS IIIB), a devastating pediatric neurodegenerative disorder that currently has no FDA‑approved therapies.

This year, we joined National MPS Society and put on our dancing shoes to help spread awareness. On this day and every day, we stand with the MPS community, listen to families and caregivers, and work tirelessly to bring hope where it’s needed most.

05/13/2026

Today, our CEO Javier Szwarcberg shared a letter with the Sanfilippo Syndrome Type B community about recent progress of our TA-ERT program.

He highlighted our ongoing regulatory progress, the latest encouraging clinical data from our clinical program and outlined our plans for both a U.S. expanded access program and global confirmatory study.

We’re grateful for the generous support of the patients, families and community, as well as ongoing partnership with Cure Sanfilippo Foundation and National MPS Society.

05/12/2026

Our CEO Javier Szwarcberg recently joined Karen Jagoda on the Empowered Patient Podcast to discuss Sanfilippo Syndrome Type B (also known as MPS IIIB), the challenges of delayed diagnosis and the urgent unmet need for an effective treatment.

Javier speaks to his own personal commitment to rare disease and the company’s driving mission to develop transformative therapies that lead to meaningful changes in patient lives.

Listen to the full episode here: http://empoweredpatientradio.com/enzyme-replacement-therapy-for-sanfilippo-syndrome-type-b-with-dr-javier-szwarcberg-spruce-biosciences

02/27/2026

Today our CEO, Javier Szwarcberg, shared a letter to the Sanfilippo community ahead of Rare Disease Day.

He reaffirmed our commitment to this community and dedication to the pursuit of better treatment options for Sanfilippo Syndrome Type B.

Read the full letter below.

Cure Sanfilippo Foundation, National MPS Society

08/14/2025

We’re pleased to share results from a long-term data integration of tralesinidase alfa enzyme replacement therapy (TA-ERT) clinical program in patients with Sanfilippo Syndrome Type B (MPS IIIB).

Paul Harmatz, M.D., Principal Investigator, Professor in Residence, Department of Pediatrics, University of California, San Francisco (UCSF) and UCSF Benioff Children's Hospital Oakland, and Cara O’Neill, M.D., FAAP, Co-Founder and Chief Science Officer of Cure Sanfilippo Foundation, share their thoughts on the importance of this data and the urgent need for a treatment for MPS IIIB.

Read more here: https://investors.sprucebio.com/news-releases/news-release-details/spruce-biosciences-announces-integrated-long-term-clinical-data

04/15/2025

Today, we announced our new corporate strategy and acquisition of tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Type B (MPS IIIB).

With no FDA-approved treatments currently available, TA-ERT has the potential to be a groundbreaking advancement for patients and families impacted by MPS IIIB. We anticipate submitting a Biologics License Application (BLA) for TA-ERT to the FDA in the first half of 2026.

Tune in to our conference call today at 8:30 a.m. ET: https://wsw.com/webcast/cc/sprb3/register.aspx?conf=cc&page=sprb3&url=https://wsw.com/webcast/cc/sprb3/1437948

Read the full announcement: https://investors.sprucebio.com/news-releases/news-release-details/spruce-biosciences-announces-new-corporate-strategy-and

11/22/2024

: In a recent episode of the CAH Pulse podcast, hosts Stephanie and Dina speak with Lydia, who shares the story of her diagnosis and how her journey changed with the CARES Foundation.

Listen to Lydia’s story as she helps others with CAH so that they know that they can live typical, full lives filled with milestones, hope, and, most of all, love as she does. Full episode here:

In this episode of CAH Pulse, Stephanie and Dina speak with Lydia who was diagnosed with classic CAH at birth and although she received relatively good medical care from the start, she had little understanding about her condition. As a young adult, Lydia reveals that she foolishly decided to test th...

11/15/2024

To all families, medical professionals and loved ones who care for pediatric CAH patients: thank you. Your compassion, resilience, and selflessness are the backbone of your child’s health journey. This National Family Caregivers Month, we celebrate you.

Caregivers are true pillars of strength, providing love, guidance, and around-the-clock support that makes an immeasurable difference in their child’s life. Thank you for your continued efforts to provide for, care, and love pediatric patients.

11/08/2024

Dr. Jung Hee Kim: Shaping the Future of Rare Disease Treatment

Meet Dr. Jung Hee Kim, whose commitment to research and education not only advances treatment for CAH but also aims to improve overall patient care in complex endocrinology areas. With over 3,200 citations to date, Dr. Kim’s extensive research focuses on neuroendocrinology, adrenal gland diseases, and bone metabolic disorders.Bridging the gap between research and practice in Congenital Adrenal Hyperplasia ( ), Dr. Kim is making a lasting impact on the care of patients with CAH and other adrenal gland diseases.

Dr. Kim is an active member of the Korean Endocrine Society (Aoce Sicem), serving on multiple committees, and currently holding the roles of Vice-Secretary General of the Adrenal Gland-Endocrine Hypertension Study Group and Chair of the Research Committee of the Korean Adrenal Study Group. Her innovative approaches to address complex disorders are helping advance CAH treatments and improving overall patient care.

Dr. Kim’s extensive work has accelerated the advancement of treatment options, bringing hope to families affected by these complex conditions, and helped shape the future of rare disease management.