TARA

NEW YORK (AP) — NEW YORK (AP) — Protara Therapeutics, Inc. (TARA) on Wednesday reported a loss of $17.8 million in its first quarter. The New York-based company said it had a loss of 31 cents per share. The results surpassed Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 36 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on TARA at https://www.zacks.com/ap/TARA

The Company intends to submit a Biologics License Application (BLA) for TARA-002 in Lymphatic Malformations (LMs) in 2H 2027 Hosting virtual investor webinar discussing LMs program with key opinion leader (KOL) perspectives on May 19, 2026 at 4:30 pm ET Interim safety and durability data from STARBORN-1 trial of TARA-002 in LMs to be presented at the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026 in May Company expects to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial and initiate the ADVANCED-3 registrational trial in BCG-Naïve patients in 2H 2026 Presenting updated 12-month data from Phase 2 ADVANCED-2 trial of TARA-002 in patients with high-grade, BCG-Naïve non-muscle invasive bladder cancer (NMIBC) at the American Urological Association (AUA) Annual Meeting 2026 in May Cash, cash equivalents and investments of approximately $177 million as of March 31, 2026, expected to support planned operations into 2028 NEW YORK, May 13, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2026. “We’re pleased with the productive discussions we’ve had with the FDA around TARA-002 in LMs,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We intend to submit a BLA for TARA-002 in LMs based on the results of the pivotal STARBORN-1 trial in the second half of 2027. Later this month, we look forward to presenting updated safety and durability data from the STARBORN-1 trial at the ISSVA World Congress and hosting an investor webinar with KOL perspectives.” Mr. Shefferman added, “In NMIBC, we continue to establish TARA-002's potential as a differentiated treatment through a robust clinical data set demonstrating excellent safety, promising efficacy and encouraging durability, as well as a convenient and tolerable method of administration, in both Bacillus Calmette-Guérin (BCG)-Unresponsive and BCG-Naive patients. Looking ahead, we remain focused on completing enrollment in the BCG-Unresponsive registrational cohort in the ADVANCED-2 trial and initiating the ADVANCED-3 registrational trial in BCG-Naïve patients, both in the second half...

NEW YORK (AP) — NEW YORK (AP) — Protara Therapeutics, Inc. (TARA) on Tuesday reported a loss of $17.3 million in its fourth quarter. On a per-share basis, the New York-based company said it had a loss of 37 cents. The results missed Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 32 cents per share. For the year, the company reported a loss of $57.4 million, or $1.34 per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on TARA at https://www.zacks.com/ap/TARA

Reported interim data from ADVANCED-2 trial in non-muscle invasive bladder cancer (NMIBC); TARA-002 demonstrated 68% complete response rate at six months in BCG-Unresponsive patients Company expects to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in 2H 2026 On track to initiate the ADVANCED-3 registrational trial in BCG-Naïve patients in 2H 2026 Received Breakthrough Therapy and Fast Track designations for TARA-002 in lymphatic malformations (LMs); regulatory update expected in 1H 2026 Expect to report interim results from THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on long-term parenteral support in 2H 2026 Completed oversubscribed $86 million public offering with participation from new and existing investors Cash, cash equivalents and investments of approximately $198 million as of December 31, 2025, expected to support planned operations into 2028 NEW YORK, March 10, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, today provided a business update and announced financial results for the fourth quarter and full year ended December 31, 2025. “Over the last few months, we reported meaningful clinical and regulatory progress across our portfolio of late-stage programs and are building on this momentum as we advance toward several important milestones in 2026,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “For TARA-002 in non-muscle invasive bladder cancer (NMIBC), the clinical dataset continues to support its potential as a differentiated intravesical therapy with compelling efficacy, a favorable safety profile and a streamlined approach to administration in the clinical setting for both Bacillus Calmette-Guérin (BCG)-Unresponsive and BCG-Naïve patients. We remain on track to complete enrollment in our BCG-Unresponsive registrational cohort in the ADVANCED-2 trial and to initiate the ADVANCED-3 registrational trial in BCG-Naïve patients in the second half of 2026.” Mr. Shefferman added, “For our rare disease programs, we reported positive interim results for TARA-002 in lymphatic malformations (LMs), followed by the receipt of Breakthrough Therapy and Fast Track designations for TARA-002 in LMs from the U.S. Food and Dr...

80% of patients that completed treatment and 100% of patients that completed the eight-week response assessment achieved clinical success Clinical success achieved with one or two doses of TARA-002 in 88% of patients TARA-002 demonstrated favorable safety and tolerability profile with no serious adverse events reported Company to host conference call and webcast featuring Key Opinion Leader Dr. Jesse Jones at 8:30 a.m. ET NEW YORK, Nov. 19, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced positive interim results from its ongoing Phase 2 open-label STARBORN-1 trial assessing intracystic injection of TARA-002, the Company’s investigational cell-based therapy, in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs). “We are pleased to report these robust results from the STARBORN-1 trial that demonstrate TARA-002’s expected significant clinical benefit in treating patients with macrocystic and mixed cystic LMs,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “Treatment with TARA-002 resulted in clinically meaningful responses, with a favorable safety profile observed across all evaluable patients. The totality of available clinical data, including data from prior studies with TARA-002’s predecessor compound OK-432, an established treatment for LMs in Japan, underscore our belief in the potential for TARA-002 to emerge as an important intervention for pediatric patients suffering from LMs.” “There are currently no approved therapies for LMs, with many patients turning to invasive surgical procedures that carry high rates of complication and recurrence, or off-label use of chemotherapies and chemicals, which can have challenging side effects, especially for pediatric patients,” said Jesse G.A. Jones, M.D., Associate Professor, Department of Neurosurgery and Radiology, University of Alabama at Birmingham, and STARBORN-1 study investigator. “I am encouraged by the positive interim safety and efficacy data from TARA-002 and believe this promising candidate has the potential to help the many patients in need of FDA-approved therapeutic approaches for LMs.” STARBORN-1 Interim Results The interim analysis includes a total of 12 patients who enrolled in the trial and receive...

Results from an interim analysis in the Phase 2 STARBORN-1 trial of TARA-002 in pediatric LMs patients remain on track for 4Q 2025 Expect to present interim analysis from approximately 25 six-month evaluable BCG-Unresponsive NMIBC patients in the ongoing ADVANCED-2 trial in 1Q 2026 Dosing of first patient in THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on parenteral support now expected by year-end 2025 Cash, cash equivalents and investments of approximately $134 million as of September 30, 2025, expected to support planned operations into mid-2027 NEW YORK, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA) (“Protara” or the “Company”), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced financial results for the third quarter ended September 30, 2025, and provided a business update. “We have made important advancements across our clinical programs this year, and with many significant milestones in the near future, we remain focused on disciplined execution across our pipeline of transformative therapies for patients with cancer and rare diseases,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We continue to make progress in our ADVANCED-2 trial of TARA-002 in non-muscle invasive bladder cancer (NMIBC) and remain on track to report interim results from approximately 25 BCG-Unresponsive patients in the first quarter of 2026. With a favorable safety profile and its differentiated ease of administration, we believe TARA-002 has the potential to become a meaningful addition to the evolving NMIBC treatment landscape.” Mr. Shefferman added, “Across our rare disease pipeline, we expect to provide an interim update from our STARBORN-1 trial in pediatric patients with lymphatic malformations (LMs) and dose the first patient in our registrational THRIVE-3 trial of IV Choline Chloride in the fourth quarter of 2025.” Recent Progress and Highlights TARA-002 in NMIBC The Company anticipates reporting interim results from approximately 25 six-month evaluable NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are BCG-Unresponsive in the first quarter of 2026. The Company expects to provide an update on ongoing discussions with the U.S. Food and Drug Administration (FDA) related to the BCG-Naïve opportunity in the...

NEW YORK (AP) — NEW YORK (AP) — Protara Therapeutics, Inc. (TARA) on Monday reported a loss of $13.3 million in its third quarter. On a per-share basis, the New York-based company said it had a loss of 31 cents. The results beat Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 39 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on TARA at https://www.zacks.com/ap/TARA

NEW YORK (AP) — NEW YORK (AP) — Protara Therapeutics, Inc. (TARA) on Monday reported a loss of $15 million in its second quarter. On a per-share basis, the New York-based company said it had a loss of 35 cents. The results exceeded Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 43 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on TARA at https://www.zacks.com/ap/TARA

Presentation of interim analysis from approximately 25 six-month evaluable BCG-Unresponsive patients in the ongoing ADVANCED-2 trial expected at a medical conference in 1Q 2026 Dosing of first patient in THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on parenteral support on track for 3Q 2025 On track to provide an interim update from the Phase 2 STARBORN-1 trial of TARA-002 in pediatric LMs patients in 4Q 2025 Cash, cash equivalents and investments of approximately $146 million as of June 30, 2025, expected to support planned operations into mid-2027 NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. “As we look toward the second half of the year, we believe we are well positioned to continue to advance our pipeline of potentially transformative therapies for the treatment of patients with cancer and rare diseases,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We continue to execute on our ADVANCED-2 trial of TARA-002 in non-muscle invasive bladder cancer (NMIBC) and look forward to presenting interim results in the first quarter of 2026. In addition, we remain on track to dose the first patient in our THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on parenteral support (PS) by the end of this quarter and expect to provide an interim update from the STARBORN-1 trial in pediatric patients with lymphatic malformations (LMs) in the fourth quarter of this year.” Recent Progress and Highlights TARA-002 in NMIBC The Company expects to report interim results from approximately 25 six-month evaluable NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are BCG-Unresponsive at a medical conference in the first quarter of 2026. Following discussions with the U.S. Food and Drug Administration (FDA), the Company expects to provide an update on next steps in its BCG-Naïve program in the second half of 2025. Protara continues to investigate subcutaneous dosing through priming and maintenance combined with intravesical dosing, as well as exploring combination treatments with TARA-002 in NMIBC patients with CIS. IV Choline Chloride for...

Reported positive interim results demonstrating durable responses in the ongoing Phase 2 ADVANCED-2 trial of TARA-002 in NMIBC Results from planned interim analysis of approximately 25 six-month evaluable BCG-Unresponsive patients expected by the end of 2025 Dosing of first patient in THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on parenteral support expected in Q3 2025 Strengthened leadership team with key appointments of Leonardo Viana Nicacio, M.D., as Chief Medical Officer, and Shane Williams, Ph.D., as VP, Head of Human Resources, Chief People Officer Cash, cash equivalents and investments of $158 million as of March 31, 2025, expected to support planned operations into 2027 NEW YORK, May 08, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced financial results for the first quarter ended March 31, 2025, and provided a business update. “We have made significant progress thus far in 2025, notably with the recent presentation of positive interim results from our ADVANCED-2 trial of TARA-002 in BCG-Unresponsive and BCG-Naïve patients which demonstrated durable 12-month landmark responses,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We believe TARA-002 is well positioned to make a meaningful difference in the lives of patients with non-muscle invasive bladder cancer (NMIBC). In addition to our NMIBC program, we are pleased with the continued progress we have made across our rare disease programs and look forward to several exciting data milestones in the coming months.” Recent Progress and Highlights TARA-002 in NMIBC At the American Urological Association (AUA) 2025 Annual Meeting in April, the Company announced positive updated interim results from the ADVANCED-2 trial in evaluable NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive and BCG-Naïve. As of the April 16, 2025 data cutoff: TARA-002 demonstrated a complete response (CR) rate at any time of 100% (5/5) and 67% (2/3) at 12 months in the cohort of BCG-Unresponsive patients. As previously communicated, the BCG-Unresponsive cohort is designed to be registrational in alignment with the 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developi...

TARA-002 demonstrates 100% complete response rate at any time and 67% 12-month landmark complete response rate in BCG-Unresponsive patients TARA-002 demonstrates 76% complete response rate at any time and 43% 12-month landmark complete response rate in BCG-Naïve patients Favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events On track to present updated interim data from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025 Company to host conference call and webcast on Monday, April 28, 2025, at 8:30 a.m. ET NEW YORK, April 26, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced updated results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company’s investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients with carcinoma in situ, or CIS (± Ta/T1), who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve. The results will be featured today during an interactive poster session at the American Urological Association 2025 Annual Meeting in Las Vegas. “For patients with high-risk NMIBC, there are few effective and durable therapies available other than radical cystectomy, which we know is quite difficult for patients to tolerate,” said Tom Jayram, M.D., Director of the Advanced Therapeutics Center at Urology Associates, and ADVANCED-2 study investigator. “TARA-002 has shown impressive efficacy, safety profile, and 12-month durability in its Phase 2 trial. In the clinic, we have seen TARA-002 become easily integrated into workflow without major hurdles for the patients or staff. This combination of clinical activity and ease of use makes me optimistic about TARA-002 having a meaningful impact in clinical practice.” Interim Results BCG-Unresponsive Cohort The BCG-Unresponsive dataset includes a total of five patients, all of whom were six- and nine-month evaluable, and three of whom were evaluable at 12 months as of an April 16, 2025 data cutoff. The complete response (CR) rate at any time in BCG-Unresponsive patients was 100% (5/5). The CR rate in BCG-Unresponsive patients was 100% (5/5) at six months, 80% (4/5) at nine months, and 67% (2/3) at 12 months. BCG-...

Data to be featured during oral presentation at the American Society for Parenteral and Enteral Nutrition 2025 Nutrition Science & Practice Conference Dosing of first patient in THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on parenteral support expected in 1H 2025 NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that data from THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS), will be featured during an oral session at the American Society for Parenteral and Enteral Nutrition (ASPEN) 2025 Nutrition Science & Practice Conference, taking place March 22 through March 25, 2025 in Columbus, Ohio. Choline is an important substrate for phospholipids that are critical for healthy liver function. Patients on PS are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing choline. Protara is developing intravenous (IV) Choline Chloride, an investigational phospholipid substrate replacement therapy, as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated. THRIVE-1 was conducted to better understand the prevalence of choline deficiency and liver injury in patients on PS. Results demonstrated that 78% of patients who are dependent on PS were choline deficient, and that 63% of choline deficient participants had liver dysfunction, including steatosis, cholestasis, and hepatobiliary injury, underscoring the need for IV choline replacement therapy in this patient population. “Findings from this study reinforce that there are a significant number of people dependent on PS who have evidence of liver disease and may potentially benefit from treatment with IV Choline Chloride,” said Dejan Micic M.D., Associate Professor and Division Chief of Gastroenterology and Nutrition at Loyola University Medical Center in Maywood, Illinois. “Choline is an essential micronutrient for patients dependent on PS, as deficiency can lead to liver injury. Access to an IV formulation of choline has the potential to meaningfully impact patients for whom oral or enteral choline supplementati...