iHub News
3月前
Protara reports encouraging Phase 2 results for TARA-002 in bladder cancer studyFebruary 24, 2026 10:23 AM
IH Market News
Protara Therapeutics (NASDAQ:TARA) on February 23, 2026, announced updated interim data from its ongoing Phase 2 ADVANCED-2 trial evaluating intravesical TARA-002 in patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ who are either BCG-unresponsive or BCG-naïve.The open-label study results, based on a data cutoff of January 28, 2026, will be presented on February 27 at the ASCO Genitourinary Cancers Symposium. The company reported strong complete response rates and encouraging durability across both patient groups.Among patients in the BCG-unresponsive cohort, TARA-002 achieved a complete response at any time in 65.7% of evaluable participants, with a 68.2% response rate at six months and evidence of sustained responses through 12 months among those with longer follow-up.In the BCG-naïve cohort, the therapy delivered a complete response rate of 72.4% at any timepoint, with rates of 66.7% at six months and 57.9% at 12 months. Re-induction treatment converted a majority of initial non-responders in both cohorts, further supporting the therapy’s potential effectiveness.Safety findings indicated favorable tolerability, with most treatment-related adverse events limited to transient Grade 1 bladder or systemic symptoms. The study reported no Grade 3 or higher treatment-related adverse events, no related serious adverse events, and no discontinuations linked to toxicity.Protara said the results, combined with a streamlined intravesical administration approach, reinforce TARA-002’s potential role as a new treatment option for non-muscle invasive bladder cancer and strengthen the company’s clinical and commercial outlook.Operationally, the company expects to complete enrollment of the BCG-unresponsive registrational cohort in the ADVANCED-2 study during the second half of 2026. Enrollment in the BCG-naïve cohort has already been completed with 31 patients. Protara also plans to launch the ADVANCED-3 registrational trial in BCG-naïve patients in the second half of 2026, marking a further step toward potential regulatory approval.More about Protara TherapeuticsProtara Therapeutics, Inc. is a New York–based clinical-stage biotechnology company developing therapies for cancer and rare diseases. Its lead program, TARA-002, is an investigational cell-based therapy being studied for non-muscle invasive bladder cancer and lymphatic malformations. The company is also advancing an intravenous choline chloride therapy for patients receiving parenteral nutrition. Protara is focused on addressing significant unmet needs in high-risk bladder cancer, particularly among patients who are unresponsive to or have not received Bacillus Calmette-Guérin treatment.Protara Therapeutics stock price
Original: Protara reports encouraging Phase 2 results for TARA-002 in bladder cancer study
stocksrising
6月前
Protara Therapeutics Announces Updated Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients
December 03 2025 - 8:00AM
Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced updated interim data from the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) non-muscle invasive bladder cancer (NMIBC). These results in Bacillus Calmette-Guérin (BCG)-Naïve NMIBC patients will be featured during a poster session at the 26th Annual Meeting of the Society of Urologic Oncology (SUO) in Phoenix, Arizona.
“These positive results continue to support TARA-002’s potential in the NMIBC treatment landscape, and we look forward to finalizing a regulatory pathway for TARA-002 in BCG-Naïve patients,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We remain on track to provide an update on the registrational BCG-Unresponsive patient cohort in the ADVANCED-2 trial in the first quarter of 2026 and expect to complete enrollment of this cohort in the second half of 2026.”
“These encouraging TARA-002 results demonstrate meaningful and durable activity in BCG-Naïve NMIBC patients,” said Mark Tyson, M.D., MPH, Vice Chair for Research and a Professor in the Department of Urology with the Mayo Clinic in Phoenix, Arizona, and ADVANCED-2 study investigator. “The clinically meaningful response rates at six and 12 months, coupled with a favorable safety and tolerability profile and simple administration that is even more streamlined than BCG, make TARA-002 a compelling potential treatment option in the BCG-Naïve setting.”
Updated Interim Results
The dataset includes 31 BCG-Naïve patients who received at least 1 dose of TARA-002; 29 patients completed at least one response assessment and were evaluable for efficacy as of a November 7, 2025 data cutoff. Patients received an induction course of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months. Re-induction was permitted for eligible patients with residual CIS and/or recurrent high-grade Ta disease. Complete response (CR) rates at the six months and 12 months landmark time points include all participants who were either evaluable at that time point or had experienced disease progression or treatment failure prior to the scheduled visit.
The CR rate at any time was 72% (21/29).
The CR rate was 69% (18/26) at six months and 50% (7/14) at 12 months.
Among initial responders, 88% (14/16) maintained their response through six months and 100% (3/3) through 12 months.
Re-induction therapy successfully salvaged most initial non-responders, resulting in high conversion rates and durable responses: 80% (4/5) of re-induced patients converted to a CR at 6 months, and 100% (4/4) of those responders maintained their CR at 12 months.
Safety and Tolerability
The majority of treatment-related adverse events (TRAEs) were Grade 1 and transient with no Grade 3 or greater TRAEs as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most commonly occurring TRAEs were dysuria (13%), fatigue (13%), and hematuria (6%).
Regulatory Update
The Company remains in ongoing dialogue with the U.S. Food and Drug Administration (FDA) on an expansion of the agreed upon registrational path forward for TARA-002 beyond the BCG-Unresponsive NMIBC patient population. The FDA has provided written feedback supporting a registrational design for a controlled trial in BCG-Naïve patients (who have never been exposed and those who have not received BCG within the last 24 months and are ineligible to receive BCG or contraindicated, cannot tolerate BCG, do not have access to BCG, or refuse BCG). The FDA has agreed that BCG is not required as a comparator and that intravesical chemotherapy is an acceptable comparator to TARA-002 in BCG-Naïve patients. The FDA also is aligned with the primary endpoint of the trial as the CR rate at month 6 with duration of response as a key secondary endpoint. The Company has engaged the FDA to determine how to include BCG-Exposed patients in its clinical trials of TARA-002, for whom no FDA-approved treatments are available and who have limited options to access investigational treatment through clinical trials.
About ADVANCED-2
ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive (Cohort B N=75-100) or BCG-Naïve (Cohort A N=31). Trial subjects received an induction course, with or without a reinduction, of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months.
The Company remains on track to report interim results from approximately 25 six-month evaluable NMIBC patients from ADVANCED-2 with carcinoma in situ or CIS (± Ta/T1) who are BCG-Unresponsive in the first quarter of 2026 and expects to complete enrollment in this cohort in the second half of 2026.
Invest-in-America
2年前
TARA: Hey, Dude, see film-clip, below, of iHub's Legendary Mr. Monkster --- at that precise moment when he SCORED HUGELY on this TARA puppy!!! (Is he GREAT, or what, Bro!!!???)
"And the OLD-FART scores again, Mr. TrendTrade!!!"
tw0122
2年前
TARA $4.39 + 20% .. NEW YORK, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced results from its ongoing Phase 2 open-label ADVANCED-2 trial. The trial is 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 complete response (CR) rate across BCG exposures was 72% (13/18) at six months and 70% (14/20) at any time with 100% (9/9) of patients maintaining a CR from three months to six months. In addition, two of three patients maintained a CR at nine months. These results will be featured today during a poster session at the 25th Annual Meeting of the Society of Urologic Oncology (SUO) in Dallas, Texas.
stocksrising
2年前
PROTARA
THERAPEUTICS
Protara Therapeutics Granted FDA Fast Track Designation for Intravenous Choline Chloride for Patients Receiving Parenteral Support
October 21, 2024
• Remain on track to initiate registrational THRIVE-3 trial in 1Q' 2025
desaquation do iteen a lent on pa mierade, up pe ly investigation en V hosphol id subrate rep, incene i ron a a soured in choline
U.S. alone, there are approximately 40,000 patients on long-term parenteral support.
"Receipt of Fast Track designation underscores the urgent need in these patients and our belief that IV Choline Chloride has the potential to serve as the first FDA-approved IV choline therapy for patients dependent on PS," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics
"Approximately 80% of patients dependent on PS experience choline deficiency, the long-term consequences of which can lead to serious hepatic injury, neuropsychological impairment, muscle damage, and thrombotic abnormalities, yet there are no currently approved IV choline products for patients dependent on PS globally. Looking ahead, we remain on track to initiate our registrational THRIVE-3 clinical trial in the first quarter of 2025.'
IV choline is recommended for patients receiving PS by the American Society for Parenteral and Enteral Nutrition in its Recommendations for
Changes in commercia Avalade rareneral Muramn and mut race cement Producis. as well as ov ne european sode or Mlnica
nutrition ane Meravolism condress in is Guiceline on rome rarenteral Nutrition.
Based on feedback from the FDA. Protara intends to assess the safety and efficacy of IV Choline Chloride in THRIVE-3. a seamless registrational Phase 2b/3 trial with dose confirmation followed by a double-blinded, randomized, placebo-controlled trial in adolescents and adults receiving parenteral support. The primary endpoint of the trial is the change in plasma choline concentration from baseline compared to placebo About FDA Fast Track Designation
The FDAs Fast Track program facilitates the development and expedites the review of drugs that treat serious conditions and have the potential to address an unmet medical need. Programs with Fast Track designation may benefit from early and frequent interactions with the FDA over the course of drug development. In addition, the Fast Track designation program allows for the eligibility for accelerated approval and priority review if relevant criteria are met and enables a company to submit individual sections of a New Drug Application for review on a rolling-submission basis.
About IV Choline Chloride
IV Choline Chloride is an investigational, intravenous phospholipid substrate replacement therapy in development for patients receiving parenteral support (PS). Choline is a known important substrate for phospholipids that are critical for healthy liver function that also play an important role in modulating gene expression, cell membrane signaling, brain development and neurotransmission, muscle function, and bone health. PS patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing choline. Approximately 80% of patients dependent on PS are choline-deficient and have some degree of liver damage, which can lead to hepatic failure. In the U.S. alone there are approximately 40,000 patients on long-term parenteral support who could benefit from an IV formulation of choline. IV Choline Chloride has
Ine porental o become ne rsi u.s. Food and Drua Aaministraton FDA) approved v coline formulation or Ps patenis. Iv choline cnioride nas been granted Orphan Drug Designation by the FDA for the prevention of choline deficiency in PS patients. The Company was issued a U.S. patent Claiming a choline composition with a term expiring in 2041.
Protara recently presented results from THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on PS, which found that 78% of patients who are dependent on PS were choline deficient, with 63% of these patients demonstrating liver dysfunction including steatosis, cholestasis, and signs of hepatobiliary injury.
About Protara Therapeutics, Inc.
Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases.
Protara's portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in patients with NMIBC with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin, as well as a Phase 2 trial in pediatric patients with LMs. Additionally. Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs through oral or enteral routes.
stocksrising
2年前
For sure a brick wall @ 3ish!!
31,200 sold
Balance :2,282,159
By
Opaleye
05/21/2024
1,800 sold @ $3.0557
124,250
Manage account (2)
05/22/2024
9,300 sold @ $3.021
2,272,859 : balance
Very surprised seeing they are typically long term holders, and the future seems bright…perhaps they are reallocating to other losers they have (RVNC for one)
This is a $25+ PP prob in 2025…oh well, less overhead , some fund is buying I’m sure( prob the groups from recent offering) GLTA
stocksrising
2年前
Protara Therapeutics to Present at the TD Cowen 5th Annual Oncology Innovation Summit
May 21, 2024
Download PDF
NEW YORK, May 21, 2024 (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 management will participate in a virtual fireside chat at the TD Cowen 5th Annual
Oncology Innovation Summit on Tuesday, May 28,
2024 at 3:00 pm ET.
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