Spruce Biosciences (SPRB) Stock Soars 1,378% on FDA Breakthrough Status

TLDR

Table of Contents

SPRB stock jumped 1,378% to $130.40 on Monday after receiving FDA Breakthrough Therapy Designation for tralesinidase alfa
The therapy treats Sanfilippo syndrome type B, a rare neurological disease affecting one in 200,000 people
Martin Shkreli disclosed a long position and predicts the stock could reach $500
The company plans to submit an application for approval in the first quarter of 2026
Stock continued rising over 90% in premarket trading Tuesday

Spruce Biosciences stock exploded on Monday with a 1,378% gain to $130.40. The biotech company received the FDA’s Breakthrough Therapy Designation for its enzyme replacement therapy.

The therapy, called tralesinidase alfa, treats Sanfilippo syndrome type B. This is a rare inherited disease that affects the brain and nervous system.

The designation speeds up the development and review process for promising treatments. It comes with intensive FDA guidance throughout the approval process.

Sanfilippo syndrome type B affects approximately one in 200,000 people in the United States. The disease causes a gradual decline in motor skills and thinking abilities.

Patients also experience hyperactivity and aggressive behavior. Without treatment, patients typically die by age 18.

Tralesinidase alfa works by restoring abnormally high levels of heparan sulfate to normal ranges. This could potentially allow patients to live normal lifespans.

Martin Shkreli Enters the Picture

The stock kept climbing in premarket trading on Tuesday, gaining over 90%. This came after investor Martin Shkreli revealed his position in the company.

Shkreli, a former hedge fund manager and pharmaceutical executive, posted his views on social media early Tuesday. He disclosed a long position in SPRB stock.

long $SPRB. my price target is $500. rare disease is my specialty. the ERT for Sanfilippo will be approved (CMC notwithstanding) and be the new standard of care.
— Martin Shkreli (@MartinShkreli) October 6, 2025

He said he believes the treatment “will be approved” and become “the new standard of care.” His price target sits at $500, though he didn’t provide a timeline.
“I was working on a presentation when the news was scooped,” Shkreli wrote. He explained that the drug restores dangerous chemical levels to normal ranges.

Shkreli has a controversial history, having served time for securities fraud. He recently revealed a short position in Opendoor Technologies.

Company Timeline and Market Position

CEO Javier Szwarcberg announced the company is preparing its application. The biologics license application for MPS IIIB treatment is slated for the first quarter of 2026.

Spruce Biosciences operates as a late-stage biopharmaceutical company. The company focuses on developing therapies for rare endocrine disorders.

The company’s market capitalization stands at $76.61 million. Its pipeline includes both tralesinidase alfa and another therapy called tildacerfont.

Revenue for the company totaled $1.3 million. The financial picture shows an operating margin of -3,900.39%.

The company’s debt-to-equity ratio sits at 0.14, indicating low leverage. Current and quick ratios both measure 2.6, suggesting decent liquidity.

Institutional ownership remains low at 4.85%. Insider ownership sits at 2.32%.

The stock shows high volatility with a beta of 3.41. The price-to-sales ratio reached 233.93.

Analyst sentiment carries a recommendation score of 3, indicating a hold position. The RSI measures 51.46, suggesting neutral momentum.

The company reported an EPS of -85.91, reflecting current losses. The Piotroski F-Score stands at 1, indicating operational challenges.

The breakthrough therapy designation application targets the first quarter of 2026 for submission.

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