Is an EUA for Rigel’s COVID-19 Treatment in the Cards? Analyst Weighs In
Several coronavirus stocks were on the move this week in reaction to the CDC (Centers for Disease Control and Prevention) and the FDA both suggesting a halt to the use of Read More... The post Is an EUA for Rigel’s COVID-19 Treatment in the Cards? Analyst Weighs In appeared first on TipRanks Financial Blog.
Several coronavirus stocks were on the move this week in reaction to the CDC (Centers for Disease Control and Prevention) and the FDA both suggesting a halt to the use of Johnson & Johnson's COVID-19 vaccine. The recommendation followed the news that some individuals developed serious blood clots just days after receiving the one-shot vaccine.
Meanwhile, a less lauded coronavirus stock also posted some impressive gains, but its surge had less to do with a rival’s failure and based on its own achievements.
Shares of Rigel Pharmaceuticals () climbed this week after the company released positive topline data from the phase 2 clinical study of Tavalisse (fostamatinib) for the treatment of hospitalized COVID-19 patients. The trial is in collaboration with the National Institutes of Health (NIH) and Inova Health System and included 59 hospitalized COVID-19 patients, who for twice a day over a 14-day period, were given either Tavalisse plus standard of care or a placebo plus standard of care.
There were several positives in the trial. The treatment met its primary endpoint of safety, and cut the occurrence of Serious Adverse Events (SAEs) by half. There were no deaths among the patients who took Tavalisse compared to three in the placebo cohort.
Next up, Rigel will discuss with the FDA the possibility of an EUA (emergency use authorization) filing for the treatment.
H.C. Wainwright’s Joseph Pantginis says there are two main factors to consider now. On the one hand, while the trial has shown “dramatic effects,” the study was relatively small. However, standing in Tavalisse’s stead is the fact it is already approved as a treatment for adult chronic immune thrombocytopenia, with a long-term safety database numbering roughly 4,800. This means it is “not a new molecular entity seeking first approval.”
“To this end,” the 5-star analyst notes, “We believe an early case is being made for the FDA to approve an EUA. The risk to this case at this point, in our view, is that the agency requires the readout of Rigel's Phase 3, though it is in earlier stage patients with a progression endpoint. Overall, we are impressed with the data and believe that Tavalisse should make its way to COVID patients.”
Accordingly, Pantginis rates RIGL shares a Buy along with an $11 price target. Investors could be sitting on gains of 207%, should the target be met over the next 12 months. (To watch Pantginis’ track record, )
There’s widespread agreement on Wall Street regarding Rigel’s trajectory. Based on Buys only – 4, in total – the stock has a Strong Buy consensus rating. The average price target comes in at $8.75, suggesting upside of 144% within the 12-month time frame. (See RIGL stock analysis on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
The post Is an EUA for Rigel’s COVID-19 Treatment in the Cards? Analyst Weighs In appeared first on TipRanks Financial Blog.