GLOBAL RESEARCH ARCHIVE
Key Q1 FDA Update: H2:27 Submission For ‘002 In LM, Good NMIBC Progress
Research evidence excerpt
Key Q1 FDA Update: H2:27 Submission For ‘002 In LM, Good NMIBC Progress
Biotechnology
Protara Therapeutics
TD SECURITIES (USA) LLC QUICK TAKE: EARNINGS UPDATE
May 13, 2026
Price: $5.15 (05/12/2026) Key Q1 FDA Update: H2:27 Submission For
Price Target: $30.00 ‘002 In LM, Good NMIBC Progress
BUY (1)
ESG SCORE: 65/100
Stacy Ku, Ph.D. THE TD COWEN INSIGHT
646 562 1368
TARA has gained alignment with the FDA on LM developmental path, with data from ongoing
stacy.ku@tdsecurities.com
STARBORN-1 trial to support BLA filing in H2:27. NMIBC programs are progressing nicely, with
Vishwesh Shah, Ph.D. BCG-naive NMIBC data update in mid-May. This should have a positive read-through to BCG-
212 468 7789 unresponsive NMIBC as mgmt. believes the profiles should align, with next YE update that
vishwesh.shah@tdsecurities.com
should improve. Reit Buy.
Key Data
Symbol NASDAQ: TARA Protara's Q1 update highlights a catalyst rich 6-18 months, with key FDA alignment for 002's
Market Cap $283.6MM pivotal trial in LM. Protara will file the BLA in H2:27, supported by results from the registrational
STARBORN-1 trial, and add'tl safety/efficacy data submission to follow under BTD. Given highClick here for the full company update from
investor interest, we expect this regulatory clarity provides increased conviction in 002’sour latest quarterly report.
opportunity in LM. TARA is trading at an ~$160MM EV, which suggests a meaningful valuation
disconnect for expected success in NMIBC and LM. Mgmt will provide detailed discussion/
KOL perspectives for ‘002 in LM next week (May 19, link here) which will be helpful for the
regulatory and commercial next steps and strategy. This is encouraging progress.
As for '002 in NMIBC, the PhII ADVANCED-2 trial is progressing with updated data in BCG-
The English excerpt is extracted automatically from the cited source page and may contain layout or recognition errors. It is never batch translated.
Open report viewer