Rezolute

Rezolute reports Q1 FY2025 financial results: $117.8M cash, $12.8M R&D expenses, $4.2M G&A expenses, $15.4M net loss. Phase 3 sunRIZE study on track; U.S. enrollment in early 2025. Phase 3 tumor HI study to start in H1 2025.

XOMA Royalty reports Q3 2024 financials: $7.2M income, FDA approval for Zevra’s MIPLYFFA™ (arimoclomol), $15M royalty monetization with Twist Bioscience, $9.9M cash receipts in Q3, $42.3M YTD.

Precision BioSciences receives CTA approval in Moldova for PBGENE-HBV, its in vivo gene editing program for chronic hepatitis B, aiming to eliminate cccDNA and inactivate integrated HBV DNA, with additional regulatory applications pending globally.

Azitra, Inc. to present at 2024 Maxim Healthcare Virtual Summit, with COO Travis Whitfill participating in the rare disease panel on October 17, discussing innovative precision dermatology approaches.

Azitra, Inc. to present at the 2024 Maxim Healthcare Virtual Summit on October 17, 2024, at 2:00 p.m. ET, as part of the rare disease panel, alongside Quoin Pharmaceuticals, Rezolute, and Zevra Therapeutics.

Rezolute, Inc. received FDA clearance for RZ358's Phase 3 study targeting hypoglycemia in tumor hyperinsulinism patients, following positive outcomes in its Expanded Access Program. The study, starting in 2025, aims to evaluate RZ358's efficacy and safety, potentially offering a universal treatment for hypoglycemia caused by hyperinsulinism.

Small biotech companies drive rare disease treatments, facing high R&D costs and long timelines. Rezolute, focused on hyperinsulinism, used a compassionate use program (CUP) for ersodetug, benefiting patients and gathering data. Challenges include limited patient populations and high costs. Part two will discuss CUP benefits and strategies.

H.C. Wainwright reiterates Buy rating and $14.00 price target for Rezolute, a biopharmaceutical company developing therapies for chronic glucose imbalance. The FDA lifted partial clinical holds on Rezolute's lead candidate, ersodetug (RZ358), enabling U.S. trials to proceed. Patient enrollment in the U.S. is expected to begin in early 2025, with a New Drug Application (NDA) anticipated in Q2 2026 and potential market introduction in 2027. Rezolute's cash reserves and recent stock offering provide financial stability for ongoing drug development.

Sanofi partners with I-Mab for ulelimumab, a monoclonal antibody targeting CD73, focusing on China for NSCLC treatment alongside Loqtorzi. With 24 CD73 projects in development, ulelimumab aims to prove superior efficacy. Sanofi's recent oncology deals, including this, are modest in scale.