Key Q1 FDA Update: H2:27 Submission For ‘002 In LM, Good NMIBC Progress

研报英文原文证据摘录

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-