Rezolute Stock: FDA Fast Track Fuels 2025 Breakout
Rezolute, Inc.’s (NASDAQ: RZLT) stock price is steadily moving higher in 2025 and is expected to continue its run because of what adds up to a rapidly improving outlook. Its lead pharmaceutical candidate, Ersodetug, was granted the FDA’s Breakthrough Therapy designation, which puts it on a fast track for approval.
The drug is set up for two Phase III trials, which are currently enrolling patients or have patients enrolled and ready to start.
What is Ersodetug? It is a therapy for hard-to-treat hyperinsulinism universally. The initial designation is for a hard-to-treat tumor-induced version, but the way it works makes it a potential candidate for any form of the disease.
The company forecasts sales to potentially peak at over $1 billion for the first two target markets, making Ersotug a potential blockbuster and money-making product for Rezolute.
The company is still pre-revenue in late 2025, but the analysts are hopeful. Assuming the company remains on its current path, revenue should begin next year and then ramp sequentially for the next eight to ten years, potentially longer as the number of conditions approved for treatment expands.
Growth will run at a hyper pace until 2028 and then slow to a more sustainable double-digit figure for the next five to seven years, compounded by improving profitability. Profits are expected by 2027 and to expand at a high-double, nearly-triple-digit pace for several years afterward.
Analysts Like the Potential in RZLT Stock
MarketBeat does not track many analysts covering Rezolute stock, but the five with current ratings are sufficient to get a good idea of which way the wind is blowing. They rate the stock unanimously as a Buy, and the price target, although down minimally compared to the prior year, has been relatively steady for the past twelve months and forecasts a 55% upside.
The most recent update is from H.C. Wainwright’s Douglas Tsao, who reiterated a Buy rating and $14 price target. The $14 price target is significant because it is the high end of the range, offering an additional 20% upside relative to the consensus figure.
The institutional trends align with the analysts’ sentiment and provide support for RZLT stock in 2025. They include more than 80% ownership and bullish activity each quarter of the year. Their buying has, on balance, ramped to record highs as the year progressed and suggests the uptrend in the price action will continue.
The offset is that the short interest is also rising, hitting a record high above 10% in August, but it may not be sufficient to cap the market in the long term. The most significant risk is that short sellers will cause a correction before the Phase III trials are released, creating a better buying opportunity.
Does Rezolute Have Enough Cash to Make It Through to the End?
Rezolute’s balance sheet suggests it can survive, but there is risk. The company produces a net loss each quarter and has sufficient capital to operate at its F2025 quarterly average for about six more quarters.
The most significant risk is additional dilution, which could come from a major corporate partner and a cash injection to the balance sheet.
As it stands, the share count was up 36% year-to-date at the end of Q3.
Other balance sheet highlights include zero corporate debt and an otherwise positive outlook.
The stock price action is bullish in 2025. The market is up more than 200% and looks strong with MACD bullish and converging to the high. The technical risk is that resistance has appeared near $8 and may cap gains in the near-to-short term.
Learn more about RZLT
