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Rezolute Stock: FDA Fast Track Fuels 2025 Breakout
Written by Thomas Hughes. Published 9/17/2025.
Key Points
- Rezolute, Inc. is on track to receive FDA approval, but there are still hurdles to overcome.
- Increased short interest offset a rapidly improving outlook and rising stock price.
- A stock price pullback would open a better buying opportunity: Analysts and institutional trends suggest this stock is a Buy.
Rezolute, Inc.’s (NASDAQ: RZLT) stock has rallied steadily in 2025 and appears poised to continue its advance, driven by a rapidly improving outlook. Its lead pharmaceutical candidate, Ersodetug, recently received the FDA’s Breakthrough Therapy designation, putting it on an accelerated path toward approval.
Ersodetug is slated for two Phase III trials—one currently enrolling patients and the other gearing up to begin enrollment shortly.
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Get this free, 43-minute training on the next page. Just put in your email.So what exactly is Ersodetug? It is a novel therapy targeting hard-to-treat hyperinsulinism. The initial Breakthrough Therapy designation applies to tumor-induced hyperinsulinism, but Ersodetug's mechanism of action may make it effective against other forms of the disease as well.
Rezolute projects that peak sales for the first two target markets could exceed $1 billion, positioning Ersodetug as a potential blockbuster and significant revenue driver for the company.
Although Rezolute remains pre-revenue through late 2025, analysts expect the company to report its first revenues next year and to see sequential growth over the following eight to ten years—potentially longer as additional indications receive approval.
Revenue is forecast to grow at a breakneck pace through 2028, then moderate to a sustainable double-digit rate over the next five to seven years, with profitability improving alongside. Analysts anticipate the company turning its first profit in 2027, followed by high-double-digit earnings growth for several years thereafter.
Analysts Are Bullish on RZLT Stock
MarketBeat currently tracks five analysts covering Rezolute stock, and all rate it as a Buy. Despite a slight downward adjustment in price targets over the past year, consensus estimates have remained relatively steady and imply an average 55% upside.
The latest note comes from H.C. Wainwright’s Douglas Tsao, who reiterated a Buy rating and set a $14 price target—at the high end of the range—suggesting roughly 20% upside above the consensus.
Institutional ownership also supports the thesis: over 80% of shares are held by institutions, and their net purchases have climbed to record levels each quarter so far in 2025. This steady buying momentum bodes well for the stock’s continued uptrend.
On the flip side, short interest has risen to a record high above 10% as of August. While this could weigh on the shares in the near term, it also raises the possibility of a sharper correction—potentially creating a favorable entry point ahead of Phase III readouts.
Does Rezolute Have Enough Cash on Hand?
Rezolute’s balance sheet indicates it can fund operations for approximately six more quarters at its current burn rate, but risks remain. The company posts a net loss each quarter and may need to raise additional capital or secure a corporate partner to extend its runway.
Year-to-date through Q3, the share count has increased by 36%, reflecting prior financing rounds. On the positive side, Rezolute carries zero corporate debt, which provides flexibility for future financings.
Technically, RZLT remains in a strong uptrend for 2025—up more than 200% year-to-date, with bullish MACD convergence. However, resistance has emerged near the $8 level and could cap gains in the short term.
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