Sangamo Climbs on FDA Fast Track for Non-Opioid Pain Drug
The biotech firm gains momentum with a second positive regulatory update in as many weeks, accelerating the timeline for its chronic pain therapy.
Sangamo Therapeutics (NASDAQ: SGMO) saw its shares gain traction Tuesday after the company announced it received Fast Track Designation from the U.S. Food and Drug Administration for its novel chronic pain treatment. The designation is for ST-503, an investigational non-opioid therapy designed to treat intractable pain associated with small fiber neuropathy (SFN).
The regulatory boost provides a significant tailwind for the Richmond, California-based biotechnology firm, which has a market capitalization of approximately $155 million. The FDA's Fast Track program is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. For a clinical-stage company like Sangamo, this can mean more frequent interactions with the FDA and a potential path to Accelerated Approval or Priority Review.
"The FDA's decision to grant Fast Track designation to ST-503 underscores the serious and unmet need for new, non-opioid treatments for patients suffering from the debilitating pain of small fiber neuropathy," the company stated in a press release. Sangamo is currently enrolling patients in its Phase 1/2 STAND clinical trial and expects to dose the first patient in the coming months.
This marks the second major positive regulatory development for Sangamo in recent weeks. On November 21, the company announced that the FDA had accepted its request for a rolling submission of its Biologics License Application (BLA) for isaralgagene civaparvovec (ST-920), a gene therapy candidate for Fabry disease. That decision confirmed an accelerated approval pathway for the treatment, potentially shortening the time to market by several years, according to analyst commentary.
Together, the two announcements create a narrative of building regulatory momentum for Sangamo's pipeline, which focuses on genomic medicines. Small fiber neuropathy is a condition characterized by severe chronic pain due to damage to small nerve fibers. ST-503 is an epigenetic regulator delivered via an adeno-associated virus (AAV) that is designed to down-regulate the Nav1.7 sodium channel, a key target in pain signaling that has been difficult to address with traditional small molecule drugs.
Despite the positive pipeline developments, Sangamo's financial position reflects its clinical-stage status. The company reported negative earnings per share of -$0.45 and has yet to achieve profitability. The stock has traded in a wide range over the past year, from a high of $2.84 to a low of $0.39, illustrating the volatility inherent in biotechnology investments.
Wall Street analysts maintain a generally positive outlook. Of the analysts covering the stock, four currently rate it as a 'Buy' or 'Strong Buy,' with two recommending a 'Hold'. The consensus 12-month price target sits at $3.25, suggesting significant upside from its current price of around $0.43. However, some analysts have recently lowered targets, citing the need for the company to secure a commercial partnership for its Fabry disease program to ensure a successful launch, according to recent market analysis.
For now, the back-to-back regulatory wins provide a much-needed de-risking event for key assets in Sangamo's portfolio. Investors will be closely watching for the first patient to be dosed in the ST-503 study and for further progress on the rolling BLA submission for its Fabry disease therapy in the coming year.