Rezolute Inc

Rezolute Inc (RZLT) News & Events

$3.700

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RZLT News

RZLT Events

10/14 20:00

Investor Sentiment Hit by Bond Market, Oracle Shares Down 9%

Investor sentiment buckled under a one-two punch from fixed income markets on Wednesday.  Hotter than expected CPI inflation data goosed up Treasury yields, with the 10-year spiking to 5.30% and Fed Funds futures pricing in a higher probability of more FOMC tightening.  CME Fed Funds tool estimates October hike at 32% vs. 22% prior and the case for two more consecutive hikes this year at 26% vs. 19% prior.  Then, headlines concerning the corporate bond market spooked investors further as CoreWeave'sunsecured notes due 2032 slid below 80 cents on the dollar, a level broadly viewed as a distress marker, compounding the recent pressure seen in the Tech space.  Oracle, one of the more heavily indebted AI buildout linked names, ended the day down 9% at the lowest level since August.Technology was by far the worst-performing sector in the S&P 500, balanced by the defensively-oriented Consumer Staples and Healthcare.  Tech-heavy Nasdaq Composite ended the day down 2% at the lowest level in nearly a month.  Cautious tone is extending into the evening session - in the opening hours, S&P e-minis are down 0.2% and the Nasdaq 100 contract is down by 0.7%.Check out this evening's top movers from around Wall Street, compiled by The Fly.HIGHER -Rezoluteup 5.9% after completing enrollment in study of ersodetugViking Therapeuticsup 1.4% after being initiated at Buy by UBSDOWN AFTER EARNINGS -Home BancSharesdown 2.5%Equity Bancsharesdown 1.4%ALSO LOWER -Rocket Labdown 6.6% after delaying Neutron launch to 2027 from Q4Spotify Technologydown 1% after downgrade to Hold at StoneXAlbertsons Companiesdown 0.8% after downgrade to Neutral at Goldman Sachs

10/14 16:30

Rezolute Completes Enrollment for Phase 3 Study of ersodetug

Rezolute announced that the open-label Phase 3 study of ersodetug in tumor HI, or upLIFT, is now fully enrolled and topline data are expected mid-December. The company plans to continue its expanded access program for purposes of providing ersodetug on a compassionate use basis to individuals living with serious and refractory hypoglycemia due to tumor HI.

10/5 07:30

Rezolute to Hold Pre-BLA Meeting with FDA

Rezolute announced that following a preliminary review of detailed data from the Phase 3 sunRIZE study of ersodetug for the treatment of hypoglycemia due to congenital HI, the FDA recommended a pre-BLA meeting with the company as a precursor to submitting a BLA. As previously reported, sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI, demonstrated glycemic improvements, but did not meet the primary endpoint because the reductions in hypoglycemia events by finger-stick self-monitored blood glucose were not statistically significant compared to placebo. Although the key secondary endpoint of time in hypoglycemia by continuous glucose monitoring was not met in the Week 24 End-of-Treatment evaluable window, consistent and clinically relevant improvements in hypoglycemia were observed for this and multiple other CGM-based hypoglycemia endpoints in both treatment arms. At a March Type B meeting with FDA, the agency acknowledged the challenges posed by behavioral factors in clinical trials in this patient population, including limitations associated with SMBG based measures of hypoglycemia. At the meeting, the agency requested that the company provide the continuous CGM data for its independent review. In June, the company submitted source and analysis datasets, and summary results from a substantial number of pre-specified, post-hoc, and sensitivity analyses. The agency has reviewed the data and, despite the trial's failure to meet the prespecified primary and key secondary endpoints, as a next step, encouraged the company to request a Type B pre-BLA meeting as a precursor to submitting a BLA for congenital HI. The agency explicitly did not opine on the approvability of ersodetug for congenital HI and noted that any such determination would only be made as a part of an in-depth evaluation of the supporting data during a formal BLA review, as is customary during a BLA process. In light of expected topline results this quarter from the company's upLIFT study in tumor HI and the potential for an additional pre-BLA meeting for that indication should the study results support a submission, the Company will evaluate its overall BLA submission strategy for potentially both programs following the announcement of upLIFT study results.

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