May. 27 at 11:41 AM
H.C. Wainwright reit'd
$UNCY Buy;
$22
$ARDX TAK AKBA MAZE
$SNY
HCW said:
Unicycive relies on third-party manufacturers to produce its lead drug candidate, oxylanthanum carbonate (OLC), including its long-term manufacturing partner, Shilpa Medicare (SLPA.IN; not rated).
Shilpa hosted an investor call and announced an additional NCE program commissioned for OLC that will be dedicated to the development for OLC, with validation batches expected to complete in 1Q FY2027 (quarter ending June 30, 2026). In June 2024, Unicycive amended its supply agreement with Shilpa, specifically to "provide certain funding to Shilpa for a new manufacturing line" in anticipation of post-approval OLC demand (see 10-K for 2025).
In our view, Shilpa's decision to advance the new site into validation, with PDUFA date now less than five weeks away, is consistent with supplier confidence in the resubmitted NDA.
We maintain our Buy rating on UNCY and our 12-month price target of
$22 per diluted share.