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Operating CF
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D/E Ratio
Dilution Watch
Financials
52W LOW $1.0752W HIGH $11.46
Volume
1.87 M
Value Traded
3.54 M
Short % Float
20.2%
+12.47%Week
+16.79%1 Month
+2.74%3 Month
+34.9%6 Month
-50.08%5 Year
-98.16%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
468.94 M
EPS (TTM)
-0.81
P/E Ratio
-
Ent. Value
361.14 M
Total Shares
96.25 M
Float Shares
83.22 M
Insiders
13.96%
Institutions
92.69%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
RZLT Catalyst Timeline
Dated clinical, regulatory and corporate events for Rezolute, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Rezolute, Inc.
341Total events
5Upcoming
63Tier-1 (high impact)
2013 to 2026Coverage
Upcoming catalysts 2
TBD
T2Timing Guidance
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TBD
T2Oral Presentation
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Event history 50
▲Pre BLA MeetingErsodetugFDA Meeting
FDA recommends pre-BLA meeting for ersodetug in congenital HI following sunRIZE data review
congenital hyperinsulinismsource ↗
▲Pre BLA MeetingErsodetugFDA Meeting
FDA recommends pre-BLA meeting for ersodetug in congenital HI following sunRIZE data review
congenital hyperinsulinismsource ↗
●Enrollment UpdateErsodetugTrial
upLIFT Phase 3 enrollment ongoing in tumor HI
tumor hyperinsulinism (tumor HI)source ↗
▲Additional DataErsodetugClinical Data
Seventh upLIFT participant met primary endpoint responder criterion
tumor hyperinsulinism (tumor HI)source ↗
▼Primary Endpoint MissedErsodetugClinical Data
Phase 3 sunRIZE study did not meet primary endpoint in congenital HI
congenital hyperinsulinism (congenital HI)source ↗
◆FDA Feedback ReceivedErsodetugFDA Meeting
sunRIZE data remains under review with FDA
congenital hyperinsulinism (congenital HI)source ↗
▲Poster PresentationErsodetugPresentation
Poster presentation of case series from EAP in tumor HI
tumor hyperinsulinismsource ↗
●Oral PresentationErsodetugPresentation
Oral presentation of previously reported sunRIZE results
congenital hyperinsulinismsource ↗
▲Interim AnalysisErsodetugTrial
Interim and preliminary Phase 3 upLIFT study observations in tumor HI
tumor hyperinsulinismsource ↗
◆Poster PresentationPresentation
Poster presentation on outcomes in congenital hyperinsulinism systematic review at ENDO 2026
congenital hyperinsulinismsource ↗
◆Oral PresentationErsodetugPresentation
Oral presentation of top-line results from Phase 3 sunRIZE study of ersodetug in congenital hyperinsulinism at ENDO 2026
congenital hyperinsulinismsource ↗
◆Poster PresentationErsodetugPresentation
Poster presentation on compassionate use of ersodetug in patients with malignant insulin-secreting tumors at ENDO 2026
refractory hypoglycemia due to malignant insulin-secreting tumorssource ↗
◆Poster PresentationPresentation
Poster presentation on association of early-life hypoglycemia with neurological outcomes in congenital hyperinsulinism at ENDO 2026
congenital hyperinsulinismsource ↗
▲Interim AnalysisErsodetugTrial
Interim data: 6 of 8 participants met primary endpoint responder criterion
tumor hyperinsulinismsource ↗
●Enrollment UpdateErsodetugTrial
Midway through enrollment of planned 16 participants; 8 enrolled to date
tumor hyperinsulinismsource ↗
▲Enrollment MilestoneErsodetugTrial
Study 50% enrolled (8 of 16 participants)
tumor hyperinsulinismsource ↗
●Additional DataErsodetugClinical Data
Submission of CGM source and analysis datasets to FDA
congenital hyperinsulinismsource ↗
▲Interim Efficacy DataErsodetugClinical Data
Positive interim data from upLIFT: 6 of 8 participants met responder criterion
tumor hyperinsulinism (tumor HI)source ↗
▲Poster PresentationErsodetugPresentation
Poster presentation of case series in tumor HI at ENDO Annual Meeting
tumor hyperinsulinism (tumor HI)source ↗
◆FDA Feedback ReceivedErsodetugFDA Meeting
Additional sunRIZE study data provided to FDA for independent review
congenital HIsource ↗
●Oral PresentationErsodetugPresentation
Oral presentation of sunRIZE Phase 3 results at ENDO
congenital hyperinsulinism (congenital HI)source ↗
▼Safety Data UpdateErsodetugClinical Data
One upLIFT participant withdrew consent and died of cancer progression
tumor hyperinsulinism (tumor HI)source ↗
●Poster PresentationPresentation
Two posters on natural history and adverse neurologic/health-economic outcomes in congenital HI at ENDO
congenital hyperinsulinism (congenital HI)source ↗
◆Oral PresentationErsodetugPresentation
Oral presentation of Phase 3 sunRIZE study results at PES Annual Meeting
congenital hyperinsulinismsource ↗
▼Primary Endpoint MissedErsodetugClinical Data
Phase 3 sunRIZE study did not meet primary endpoint (change in average weekly hypoglycemia events by SMBG)
congenital hyperinsulinismsource ↗
▼Secondary Endpoint DataErsodetugClinical Data
Secondary endpoint (% time in hypoglycemia by CGM) not statistically significant at Week 24
congenital hyperinsulinismsource ↗
▲Additional DataErsodetugClinical Data
Additional CGM-based outcomes presented: significant reductions in hypoglycemia events and increases in normoglycemia
congenital hyperinsulinismsource ↗
▲OLE InitiatedErsodetugTrial
Open-label extension phase ongoing; 59 completers elected to enter, 57 continue
congenital hyperinsulinismsource ↗
◆Type B MeetingErsodetugFDA Meeting
FDA Type B meeting for sunRIZE Phase 3 study of ersodetug in congenital HI
congenital hyperinsulinismsource ↗
◆FDA Feedback ReceivedErsodetugFDA Meeting
FDA encouraged submission of study reports and analysis datasets for independent evaluation
congenital hyperinsulinismsource ↗
●Type B MeetingErsodetugFDA Meeting
Type B meeting with FDA regarding sunRIZE CGM data
congenital hyperinsulinismsource ↗
◆R&D DayPresentation
Rezolute management to participate in Guggenheim Emerging Outlook: Biotech Summit 2026
▼Topline ReadoutErsodetugClinical Data
sunRIZE did not meet primary or key secondary endpoints
congenital hyperinsulinismsource ↗
▲Full ResultsErsodetugClinical Data
Cumulative data from initial 9 EAP participants presented
tumor hyperinsulinismsource ↗
▲Full ResultsErsodetugClinical Data
Aggregate data from initial 9 tumor HI patients under EAP shared in January 2026
tumor hyperinsulinismsource ↗
◆FDA Feedback ReceivedErsodetugFDA Meeting
FDA meeting planned in Q1 2026 under Breakthrough Therapy Designation
congenital hyperinsulinismsource ↗
▼Topline ReadoutErsodetugClinical Data
Topline results from Phase 3 sunRIZE study of ersodetug in congenital hyperinsulinism
congenital hyperinsulinismsource ↗
▼Primary Endpoint MissedErsodetugClinical Data
Phase 3 sunRIZE trial for ersodetug did not meet primary endpoint
hypoglycemia caused by hyperinsulinismsource ↗
▼Secondary Endpoint DataErsodetugClinical Data
Secondary endpoint not met in Phase 3 sunRIZE trial
hypoglycemia caused by hyperinsulinismsource ↗
◆Topline ReadoutErsodetugClinical Data
Topline data expected from Phase 3 sunRIZE study
congenital hyperinsulinismsource ↗
▼Primary Endpoint MissedErsodetugClinical Data
sunRIZE study did not meet primary or key secondary endpoints
congenital hyperinsulinismsource ↗
Past FDA Catalysts and PDUFA Decisions
How RZLT actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2025-12-01 | ersodetug | Phase 3 topline data readout | Phase 3 |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
D38 / 100
Pipeline Score
$30M
Pipeline Value
Richly Valued
Valuation Signal
3
Drugs Scored
0.1x
rNPV / MCap
Top 45%
Micro Cap(rank 298 of 660)
Percentile Rank
Rezolute, Inc. faces pipeline headwinds (38/100), with $75M risk-adjusted pipeline value, led by RZ402 in Diabetic Macular Edema (Phase 2).
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| RZ402 Small moleculeCompletedNCT05712720 | Diabetic Macular Edema | Phase 2 | COMPLETED | 94 | Apr 11, 2024 |
Clinical Trial Results
Readouts, endpoints and source filings for every RZLT program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| ersodetug BreakthroughOrphan | congenital hyperinsulinism | Phase 3 | 2026-06-17 | In a case series from the Expanded Access Program, 75% of 9 patients with refractory hypoglycemia due to malignant insulinoma and non-islet cell tumors achieved complete discontinuation of IV dextrose/total parenteral nutrition.Read More | Rezolute Highlights Results Presented from Natural History Outcomes Studies and its Ersodetug Clinical Program in Hyperinsulinism at Annual Meeting of the Endocrine SocietyRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| ROBERTS BRIAN KENNETHOfficer (Chief Medical Officer) | Disposition | -3,062 293,851 held | $4.99 | 07/02/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in RZLT
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| RA CAPITAL MANAGEMENT, L.P. | 0.4 % (33.3 %) | 49.11 M | 9.45 M | 2.89% ( 265.04 K) |
RZLT Institutional Ownership Trends
Options Data
Option Volume
Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-10-16 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How RZLT ranks across every disease it competes in
Competitive Position is a premium feature
See how RZLT ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialRZLT News
RZLT▲ +8%on this news
Rezolute Announces FDA Recommendation to Hold a Pre-BLA Meeting as a Precursor to Submitting a Biologics License Application (BLA) for Congenital Hyperinsulinism
Rezolute, Inc. announced that the FDA has recommended a pre-BLA meeting for its drug ersodetug, aimed at treating congenital hyperinsulinism. Despite the sunRIZE study not meeting primary endpoints, the FDA acknowledged the need for further evaluation of the data. The company is also expecting topline results from another study, which may influence its BLA submission strategy.
Read more →RZLTRezolute Reports Fourth Quarter and Full Year Fiscal 2026 Financial Results and Provides Business Update
Rezolute, Inc. reported its financial results for Q4 and full fiscal year 2026, highlighting ongoing clinical trials for refractory hypoglycemia. The upLIFT study for tumor HI shows promising interim results, while the sunRIZE study for congenital HI is under FDA review after not meeting its primary endpoint. The company continues to explore options for further development.
Read more →RZLT▼ -7.7%on this news
Rezolute Provides Update on FDA Review of its Phase 3 sunRIZE Study Results in Congenital Hyperinsulinism
Rezolute, Inc. provided an update on the FDA's review of its Phase 3 sunRIZE study for ersodetug, aimed at treating congenital hyperinsulinism. Although the study did not meet its primary endpoint, there were indications of glycemic improvement. The FDA is currently reviewing additional data submitted by the company, and the open-label extension phase is ongoing with high retention rates. Rezolute is also actively enrolling patients in its Phase 3 upLIFT study.
Read more →RZLTRezolute to Participate in Upcoming Investor Conferences
Rezolute, Inc. will participate in several upcoming investor conferences, including the Cantor Global Healthcare Conference and the H.C. Wainwright 28th Annual Global Investment Conference. Management will engage in fireside chats and one-on-one meetings with investors. The company specializes in treating refractory hypoglycemia related to hyperinsulinism.
Read more →RZLT▲ +14.4%on this news
Rezolute to Participate in the BTIG Virtual Biotechnology Conference
Rezolute, Inc. will participate in the BTIG Virtual Biotechnology Conference on July 28-29, 2026. The company focuses on treating refractory hypoglycemia linked to hyperinsulinism. During the conference, management will hold one-on-one meetings with investors, enhancing engagement and visibility in the biotechnology sector.
Read more →RZLTRezolute Highlights Results Presented from Natural History Outcomes Studies and its Ersodetug Clinical Program in Hyperinsulinism at Annual Meeting of the Endocrine Society
Rezolute, Inc. presented key findings at the Annual Meeting of the Endocrine Society, focusing on congenital hyperinsulinism and the clinical program for ersodetug. The presentations included analyses of natural history and adverse outcomes, as well as positive results from a case series in tumor hyperinsulinism. The data supports the therapeutic benefits of ersodetug and highlights the urgent need for improved treatment options.
Read more →RZLTRezolute Announces Four Presentations at the Upcoming Annual Meeting of the Endocrine Society
Rezolute, Inc. announced that it will be presenting four studies at the upcoming Annual Meeting of the Endocrine Society in Chicago, focusing on its investigational therapy, ersodetug, for treating congenital hyperinsulinism. The presentations include an oral overview of the Phase 3 sunRIZE study's interim results and various poster presentations detailing the natural history of the disease and outcomes from clinical use of ersodetug. Despite not meeting all primary endpoints in the sunRIZE study, there were nominal improvements noted, and the FDA is set to review comprehensive analysis datasets from the company.
Read more →RZLT▲ +10.8%on this news· ran to +27% by day 1shared move
Rezolute Announces Positive Interim Data for its Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism
Rezolute, Inc. has reported positive interim data from its Phase 3 upLIFT study of ersodetug for tumor hyperinsulinism. Currently, 50% of the study's participants are enrolled, with 6 out of 8 meeting the primary endpoint of reducing intravenous glucose requirements. The study is expected to conclude with topline results in the second half of 2026.
Read more →RZLT▲ +10.8%on this news· ran to +27% by day 1shared move
Positive Interim Data for its Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism have already met the responder criterion for the study's primary endpoint
Rezolute, Inc. announced positive interim data from its Phase 3 upLIFT study of ersodetug for treating tumor hyperinsulinism. Out of eight participants enrolled so far, six achieved significant reductions in their intravenous glucose requirements, supporting the drug's promising efficacy. The study remains ongoing, with full results expected in late 2026. Despite the positive findings, the withdrawal of a participant due to health complications underscores ongoing challenges in this patient population.
Read more →RZLTRezolute Reports Third Quarter Fiscal 2026 Financial Results and Provides Business Update
Rezolute, Inc. reported its financial results for Q3 fiscal 2026, highlighting positive outcomes from the Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism. The study showed significant improvements in glycemic control compared to placebo. The FDA acknowledged challenges in the study and encouraged further analysis, with an update expected in the second half of 2026.
Read more →RZLTRezolute Announces Oral Presentation of Results From its Phase 3 sunRIZE Study of Ersodetug in Patients with Congenital Hyperinsulinism at the Pediatric Endocrine Society Annual Meeting
Rezolute, Inc. presented favorable results from its Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism at the Pediatric Endocrine Society Annual Meeting. The study demonstrated significant glycemic control improvements compared to placebo, though the primary endpoint was not met. High participation rates in the open-label extension phase suggest sustained treatment benefits. The company plans to align with the FDA on the future of the study following recent discussions regarding study endpoints.
Read more →RZLTRezolute, Inc. Investigated by the Portnoy Law Firm
The Portnoy Law Firm has launched an investigation into Rezolute, Inc. for possible securities fraud following a significant drop in the company's stock price. The decline, amounting to 87.2%, was influenced by the disappointing results from a Phase 3 study of its lead product, ersodetug, which failed to meet critical efficacy measures. Investors are being encouraged to assess their legal options as the firm considers filing a class-action lawsuit on behalf of affected shareholders. The company's diminished prospects have raised concerns about its future performance.
Read more →RZLTRezolute to Present Results from its Phase 3 sunRIZE Study in Congenital Hyperinsulinism at the Pediatric Endocrine Society (PES) Annual Meeting
Rezolute, Inc. announced that it will present results from its Phase 3 sunRIZE study of ersodetug in congenital hyperinsulinism at the Pediatric Endocrine Society Annual Meeting. The presentation will include previously announced topline results and additional data updates. The study evaluated ersodetug's efficacy and safety for patients experiencing hypoglycemia, demonstrating promising engagement and potential therapeutic benefits. Enrollment included 63 participants from various countries, showcasing a global interest in the treatment's impact on this rare disease.
Read more →RZLT▲ +12.1%on this news· ran to +33% by day 1
Rezolute Provides Update on its Congenital Hyperinsulinism Program Following FDA Meeting
Rezolute, Inc. provided an update on its congenital hyperinsulinism program following a recent FDA meeting. The sunRIZE study showed reductions in hypoglycemia events, but did not meet its primary endpoint due to statistical insignificance. However, the FDA acknowledged the challenges faced and encouraged further analysis. Rezolute is optimistic about the potential for advancing its treatment, ersodetug, based on the feedback received.
Read more →RZLT▲ +6.1%on this news
Rezolute to Participate in the Citizens Life Sciences Conference
Rezolute, Inc. will participate in the Citizens Life Sciences Conference on March 10-11, 2026, in Miami, FL. The company focuses on treating hypoglycemia caused by hyperinsulinism and will conduct one-on-one investor meetings during the event. This engagement highlights Rezolute's commitment to investor relations and its innovative treatment approach.
Read more →RZLT▲ +7.7%on this news
Rezolute Reports Second Quarter Fiscal 2026 Financial Results and Provides Business Update
Rezolute, Inc. has announced its financial results for the second quarter of fiscal 2026, reporting a net loss of $22.8 million, a significant increase from the previous year's loss of $15.7 million. The company experienced heightened research and development costs, attributed to clinical trial activities and severance related to workforce reductions. As of December 31, 2025, Rezolute's cash and cash equivalents stood at $132.9 million, although overall investments decreased from earlier in the year. The company's focused therapeutic, ersodetug, continues to be studied for its application in treating hypoglycemia caused by hyperinsulinism.
Read more →RZLT▼ -7.6%on this newsshared move
Rezolute to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026
Rezolute, Inc. will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11-12 in New York. The company, which specializes in treating hypoglycemia from hyperinsulinism, will engage in one-on-one meetings with investors. This event offers an opportunity for Rezolute to showcase its innovative therapies and connect with potential investors.
Read more →RZLT▲ +23%on this news
Rezolute Provides Insights from its Phase 3 sunRIZE Study in Congenital Hyperinsulinism and Shares Findings from its Expanded Access Program in Tumor Hyperinsulinism
Rezolute, Inc. provided insights from its Phase 3 sunRIZE study and Expanded Access Program for ersodetug in congenital and tumor hyperinsulinism. Although the sunRIZE study did not meet its primary endpoints, the company believes the data supports ersodetug's activity. Rezolute plans to meet with the FDA to discuss the path forward for congenital hyperinsulinism.
Read more →RZLT▼ -87.2%on this newsshared move
Rezolute Announces Phase 3 sunRIZE Study Results in Congenital Hyperinsulinism
Rezolute announced that its Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism did not meet its primary or key secondary endpoints. Although a 45% reduction in hypoglycemia events was observed at the highest dose, it was not statistically significant compared to the placebo. Safety observations were generally favorable, but some participants experienced serious allergic reactions.
Read more →About Rezolute, Inc.
Headquarters275 SHORELINE DRIVE, SUITE 500, REDWOOD CITY, CA, 94065
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