Stock of Sorrento Therapeutics Advancing Today due to Unspecified Reasons
Sorrento Therapeutics' Non-Opioid Pain Reliever Granted Fast Track Designation
Sorrento Therapeutics (SRNE.Q) saw a surge in its stock price on Wednesday, following the news that the Food and Drug Administration (FDA) had granted Fast Track designation to the company's investigational drug and device product candidate, SP-103.
SP-103 is a non-opioid-based pain reliever currently in Phase 2 clinical trials for the treatment of acute low back pain. This designation, given ahead of the opening bell on Wednesday, facilitates expedited development and review, reflecting the drug's potential to address an unmet medical need.
The success of SP-103 in late-stage clinical development will be crucial to win over skeptical investors. With a significant market impact in sight, given the high prevalence of acute low back pain and the limitations of current treatment options, SP-103 could potentially rake in hundreds of millions in sales as an effective alternative to opioids in this large and underserved indication.
Acute low back pain is typically treated with highly addictive opioids, which have a questionable efficacy profile. SP-103, designed to treat acute low back pain, could potentially offer a safer alternative, reducing reliance on opioids and physical therapies with variable efficacy.
The potential approval of SP-103 as a treatment for acute low back pain could be a significant milestone for Sorrento Therapeutics. In a competitive market, with major players such as Johnson & Johnson, Bayer, and GSK active in the space, SP-103’s advancement could position Sorrento Therapeutics strongly within this market.
If approved, SP-103 would enter a sizable market for the treatment of acute low back pain. The regulatory designation allows Scilex Holding Company, a subsidiary of Sorrento Therapeutics, to seek approval for SP-103 from the FDA on a rolling basis. This could potentially lead to a faster approval under ideal conditions.
On Wednesday morning, shares of Sorrento Therapeutics increased by 8.3% during the first hour of trading. As of 11:45 a.m. ET on Wednesday, Sorrento Therapeutics' shares were up by 4.3%.
References: [1] Yahoo Finance - Sorrento Therapeutics (SRNE.Q) Stock Up 8.3% [2] BioSpace - Sorrento Therapeutics' SP-103 Granted Fast Track Designation by FDA for Acute Low Back Pain
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