Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b
Lipella Pharmaceuticals Inc. (LIPO)
Company Research
Source: GlobeNewswire
PITTSBURGH, May 21, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (NASDAQ: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company, announced today the receipt of U.S. Food & Drug Administration (“FDA”) Type-C meeting guidance regarding the LP-10 (liposomal tacrolimus) clinical program. Lipella expects to initiate a Phase 2b clinical trial evaluating LP-10 as a treatment for hemorrhagic cystitis in approximately 36 patients in the second half of 2024. The FDA provided preliminary agreement on Lipella’s overall trial design, including objectives, safety monitoring, control group monitoring, the dosing protocol, the primary efficacy endpoint, and sample size considerations. Lipella’s Chief Medical Officer, Dr. Michael Chancellor, stated, “We can now proceed with the confidence that our Phase 2b study design can successfully meet its regulatory objectives. This clarity significantly advances our value proposition.” LP-10 is an intravesical liposomal formul
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- Lipella Pharmaceuticals Announces Completion of Site Initiation Visit for Phase 2a Trial of LP-310 in Oral Lichen PlanusGlobeNewswire
- Lipella Pharmaceuticals Announces Abstract Publication at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting [Yahoo! Finance]Yahoo! Finance
- Lipella Pharmaceuticals Announces Abstract Publication at 2024 American Society of Clinical Oncology (ASCO) Annual MeetingGlobeNewswire
- Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b [Yahoo! Finance]Yahoo! Finance
LIPO
Sec Filings
- 5/15/24 - Form 4
- 5/9/24 - Form 10-Q
- 5/6/24 - Form SC
- LIPO's page on the SEC website