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It’s been a volatile week for investors in drug maker Curis (CRIS). On Wednesday, shares took off by a massive 65% after the company announced an update from the mid-stage clinical trial of its cancer drug CA-4948.
The orally administered protein kinase inhibitor is currently in an ongoing open-label, single-arm, Phase 1/2 study, indicated for the treatment of acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS).
The data showed that at the cutoff date, four objective responses were noted with signs of hematologic recovery in 15 patients (8 MDS and 7 AML). All tested doses – 200mg, 300mg, 400mg and 500mg twice daily - caused bone marrow blast reductions.
Last month, the FDA granted the drug Orphan Drug Designation in AML and MDS, and the trial’s main objective is to decide the maximum tolerated dose (MTD) and recommended dose for Phase 2.
However, issues with the MTD were the reason why the stock returned a portion of the gains back to the market on Thursday after the company offered another update.
Turns out Curis surpassed the maximum tolerated dose in the 500mg cohort, causing two patients to display dose-limiting toxicities. One was shown to have severe rhabdomyolysis (when muscle tissue breaksdown), while the second suffered from severe syncope – basically, fainting - following a temporary drop in the amount of blood flow to the brain. After discontinuing the dosing, both adverse events were resolved.
Nevertheless, the issue is of no concern to H.C. Wainwright’s Edward White.
“We believe that CA-4948 200mg, 300mg, and 400mg are all likely therapeutic doses, which is a high class problem for the company,” the 5-star analyst said. “Curis announced that the Phase 1/2 study has been expanded to include both a combination dose escalation and a monotherapy dose expansion. We believe CA-4948 has an opportunity in an all-comers population in combination therapy and that it could target spliceosome mutations with monotherapy in later lines of treatment.”
White also believes the shares are still undervalued. The analyst rates CRIS shares a Buy along with a $20 price target. The figure suggests a 12-month returns of 44%. (To watch White’s track record, click here)
All 3 other recent Curis reviews have reached the same conclusion – Buy. Accordingly, the stock has a Strong Buy consensus rating, backed by a $21 average price target. Investors could be pocketing gains of 54%, should the target be met over the coming months. (See CRIS 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.