This Emerging Biotech Stock Jumped 1,300% on Monday After Major FDA Breakthrough Milestone

Spruce Bioscience (Nasdaq: SPRB) shares soared by 1,378% on Monday to $130.40 (£97). The stock is up another 82% during premarket hours on Tuesday. The monumental stock price jump in a single trading session was reflected in the trading volume of over 24 million shares compared with a daily average of 390,249.

The emerging late-stage biopharma company aims to research, develop, and commercialise novel therapies for a range of neurological disorders. Yesterday, the company announced that the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo Syndrome Type B (MPS IIIB).

MPS IIIB is a rare, inherited metabolic disorder in which the body is unable to break down the heparan sulfate sugar molecule, resulting in its accumulation in cells. This leads to progressive damage to the central nervous system, resulting in symptoms like intellectual disability, behavioural issues, brain atrophy, hearing loss, and motor skill deficits. The estimated life expectancy of individuals suffering from this disease ranges from 15 to 19 years of age.

The FDA designation is a significant milestone for the company as it will enable it to accelerate the development and regulatory review of the TA-ERT therapy. The FDA typically grants this designation when it comes across preliminary clinical data that suggest the potential for significant improvement over existing treatments. The BTD facilitates more intensive FDA guidance, cross-disciplinary collaboration, and eligibility for priority review.

'We are pleased to receive US FDA Breakthrough Therapy Designation as we prepare to submit the Biologics License Application of TA-ERT for the treatment of MPS IIIB in the first quarter of 2026. This designation highlights TA-ERT's potentially transformative clinical impact as the first disease-modifying therapy to treat MPS IIIB in children impacted by this devastating condition,' said Javier Szwarcberg, CEO of Spruce Biosciences.

The executive highlighted that the integrated clinical data showcases a rapid and durable effect of TA-ERT in normalising CSF HS-NRE, the pathogenic factor responsible for neurodegeneration, and stabilising cortical grey matter volume and cognitive function in children with MPS IIIB. Multiple studies of the TA-ERT treatment demonstrated an adequate safety profile based on integrated five years of safety data.

In August, the company reported Q2 earnings results, which revealed that it had cash and cash equivalents of $16.4 million (£12.2 million) as of June 30, 2025, sufficient to fund its current operations through the end of this year. The company also significantly narrowed its Q2 net loss to $2.1 million (£1.5 million) from a loss of $9.2 million (£6.8 million) in the prior year quarter. In per-share terms, the company reported a Q2 loss of $3.50 (£2.61) compared with a loss of $16.73 (£12.45) in the same period a year earlier.

Furthermore, Spruce Biosciences has also significantly reduced its total operating expenses. In Q2, its reported operating expenses of $2.7 million (2 million), down from $11.6 million (£8.6 million) a year earlier.

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