GLOBAL RESEARCH ARCHIVE
RZLT: Awaiting FDA REZOLUTion
Research evidence excerpt
RZLT: Awaiting FDA REZOLUTion
May 13, 2026
Debjit Chattopadhyay, Ph.D. debjit.chattopadhyay@guggenheimpartners.com RZLT: Awaiting FDA REZOLUTion
212 823 6584
Moritz Reiterer, Ph.D. Key Message: In our most recent conversation with the company following the 3Q
moritz.reiterer@guggenheimpartners.com earnings release, mgmt reiterated their belief that cHI submission is viable, with clarity
212 372 6368 by mid-26. cHI approval based on real world / OLE data, while not in our model, would
Ry Forseth, Ph.D. represent the best-case outcome, paving the path for a potential PRV. Based on recent
ry.forseth@guggenheimpartners.com transactions, a PRV sale could yield ~$200M, which could materially increase the stock
212 518 9226 price, given the RZLT current market cap of $337M. Per mgmt, FDA: (1) did not bring up
Hannah Wei or request a new study or a repeat RCT; (2) suggested an iterative approach to sunRIZE
hannah.wei@guggenheimpartners.com data analysis / review; (3) valued the opinion of advocacy / KOLs. On tHI from which we
212 518 5896 anticipate topline data during 2H26: (1) tHI clinical trial was not discussed or brought up
by the agency; (2) mgmt expects a single trial AKA upLIFT to be sufficient for BLA, with
potential approval in 2027, which is our Base case.
Recent clinical updates RZLT BUY
Rezolute, Inc. The company presented the additional sunRIZE Ph3 data at the Pediatric Endocrine Society
Sector: Biotechnology (PES) 2026 annual meeting. Our take on the data can be found HERE.
Earnings Release Valuation
Share Price $3.30
Our $6/share PT values RZLT using a 10-year DCF analysis. Our DCF utilizes a WACC Price Target $6.00
of 12.8% and terminal growth rate of 0%, which are consistent with similar, late-stage rare
disease companies under our coverage.
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