Sorrento’s Subsidiary Scilex Gets FDA Nod For ZTlido Label Expansion

Sorrento Therapeutics’ subsidiary, Scilex Holding, has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for ZTlido to expand its efficacy label. Sorrento owns around 99% of Scilex Holding.

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Sorrento Therapeutics’ (SRNE) subsidiary, Scilex Holding’s Chief Medical Officer, Dmitri Lissin, MD, said, “We are very pleased with the trial outcome and labeling revision that attests to characteristics of ZTlido superior to other topical systems, to give patients a more reliable and uninterrupted drug delivery to alleviate pain associated with post-herpetic neuralgia.”

ZTlido is a polymer-based lidocaine topical drug that will now have an FDA-approved label reflecting its usage while showering, bathing and swimming. Scilex’s clinical trial of ZTlido indicated that the drug on immersing in water, “can be successfully reapplied” and could remain on the skin for upto 12 hours, cause “benign” skin irritation and could also be used while showering. (See Sorrento Therapeutics stock analysis on TipRanks)

Last week, Dawson James analyst Jason Kolbert reiterated a Buy rating with a price target of $19 on the stock. Kolbert commented on SRNE’s $38 million acquisition of Acea Therapeutics, “ACEA brings to Sorrento Abivertinib (oral), a next generation, dual EGFR mutant [Estimated glomerular filtration rate] and BTK [Bruton’s tyrosine kinase] inhibitor (BTKi) with a completed NSCLC [Non-small-cell lung carcinoma] registrational/Phase 3 trial.”

“The compound is also in a Phase 1 B-cell lymphoma study, ongoing Phase 2 trials in COVID-19 patients with ARDS [Acute respiratory distress syndrome], and Phase 2 studies for prostate cancer, systemic lupus erythematosus and the ultra-orphan indication of hairy cell leukemia. We also note that ACEA brings a state-of-the-art cGMP [Current Good Manufacturing Practice] facility located in Quzhou, China, on a 23-acre campus with five buildings,” Kolbert added.

Overall, the rest of the Street is bullish on the stock with a Strong Buy consensus rating based on 4 Buys. The average analyst price target of $28 implies that SRNE shares have approximately 272.8% upside potential to current levels.