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Rezolute’s Promising Future: FDA Approval and Strategic Valuation Drive Buy Rating

Rezolute’s Promising Future: FDA Approval and Strategic Valuation Drive Buy Rating

H.C. Wainwright analyst Douglas Tsao has reiterated their bullish stance on RZLT stock, giving a Buy rating yesterday.

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Douglas Tsao has given his Buy rating due to a combination of factors including the FDA’s approval of a streamlined Phase 3 study for Rezolute’s drug, ersodetug, which is aimed at treating hyperinsulinism. This decision by the FDA, which also granted two Breakthrough Therapy Designations earlier in the year, highlights the potential value of ersodetug in addressing this rare disease. The revised study design, which is now a single-arm, open-label trial, is expected to expedite enrollment and potentially lead to a broad label approval.
Additionally, Tsao’s valuation of Rezolute is based on a 9x multiple of the projected 2036 risk-adjusted revenue estimate of $159 million. The probability of success for Rezolute’s pipeline assets is adjusted based on their current stage and data strength, with RZ358 for congenital hyperinsulinism at 70% and the tumor-induced hyperinsulinism program at 60%. Despite risks such as financial needs, potential dilution, competition, and regulatory hurdles, the positive developments and potential market opportunities support the Buy rating.

Based on the recent corporate insider activity of 30 insiders, corporate insider sentiment is positive on the stock. This means that over the past quarter there has been an increase of insiders buying their shares of RZLT in relation to earlier this year.

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