Protara Therapeutics Inc Stock Price, News & Analysis

Protara Therapeutics (Nasdaq: TARA) has received Fast Track designation from the FDA for its Intravenous (IV) Choline Chloride therapy. This investigational treatment is designed for adult and adolescent patients on parenteral support (PS) who cannot receive sufficient nutrition orally or enterally. The designation highlights the urgent need for such treatment, as approximately 80% of PS-dependent patients experience choline deficiency, which can lead to severe health complications.

Protara plans to initiate the registrational THRIVE-3 clinical trial in Q1 2025. This seamless Phase 2b/3 trial will assess the safety and efficacy of IV Choline Chloride in a double-blinded, randomized, placebo-controlled study. The primary endpoint will measure the change in plasma choline concentration from baseline compared to placebo. Currently, there are no FDA-approved IV choline products for PS-dependent patients globally, despite recommendations from major nutrition societies.

Protara Therapeutics (Nasdaq: TARA) has completed the first cohort of its Phase 2 STARBORN-1 trial for TARA-002, an investigational cell-based immunopotentiator for treating pediatric lymphatic malformations (LMs). The initial results are promising, with two out of three patients achieving complete responses after a single dose. The safety profile was consistent with historical data, showing mild to moderate, resolvable adverse events.

The trial aims to enroll about 30 patients aged 6 months to 18 years, with initial results from the next cohort expected in 1H'25. The primary endpoint is the proportion of participants demonstrating clinical success, defined as a substantial or complete reduction in LM volume. This development is significant as there are currently no FDA-approved treatments for LMs, a rare condition primarily affecting children.

Protara Therapeutics (Nasdaq: TARA) announced results from THRIVE-1, a study evaluating choline deficiency and liver injury in patients dependent on parenteral support (PS). Key findings:

• 78% of PS-dependent patients were choline deficient
• 63% of choline-deficient participants had liver dysfunction

These results underscore the need for intravenous (IV) choline supplementation. Protara is developing IV Choline Chloride as a treatment when oral or enteral nutrition is insufficient. The company plans to initiate a registrational trial in Q1 2025. Currently, there are no approved IV choline products for PS-dependent patients globally, despite recommendations from medical societies.

Protara Therapeutics (Nasdaq: TARA), a clinical-stage company focused on developing therapies for cancer and rare diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's management will present on Monday, September 9, 2024, at 1:30 pm ET in New York.

Investors and interested parties can access a live webcast of the presentation through the Events and Presentations section of Protara's website at https://ir.protaratx.com. The webcast will be available for a time after the presentation concludes, providing an opportunity for those unable to attend the live event to catch up on the company's latest developments and strategic outlook.

Protara Therapeutics (Nasdaq: TARA) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. On track to report preliminary data from ADVANCED-2 trial of TARA-002 in NMIBC in Q4 2024.
2. Expect to dose first patient in pivotal trial for IV Choline Chloride in Q1 2025.
3. Cash resources of ~$90 million, expected to fund operations into 2026.
4. Q2 2024 net loss of $9.5 million, or $0.45 per share, compared to $11.3 million, or $1.00 per share, in Q2 2023.
5. R&D expenses decreased to $6.4 million from $7.2 million year-over-year.
6. G&A expenses decreased to $4.3 million from $4.9 million year-over-year.

Protara Therapeutics (Nasdaq: TARA) announced the grant of inducement non-qualified stock options to Lisa Schlesinger, the new VP, Head of New Product Development and Market Access. She was awarded options to purchase 118,400 shares at $2.23 per share, Protara's closing price on June 24, 2024. The options vest over four years with 25% vesting after one year, and the remaining 75% vesting monthly over the following three years, contingent on continued service. The grant was approved by Protara's independent Board members under NASDAQ Listing Rule 5635(c)(4).

Protara Therapeutics (Nasdaq: TARA) announced its participation in the TD Cowen 5th Annual Oncology Innovation Summit. The company, focused on developing transformative therapies for cancer and rare diseases, will have its management team engage in a virtual fireside chat on May 28, 2024, at 3:00 pm ET. This event will be available via live webcast through Protara's website and archived temporarily after the presentation.

Protara Therapeutics, Inc. announced positive three-month data from TARA-002 clinical program in NMIBC, aligned with FDA on IV Choline Chloride path forward, and closed $45.0 million private placement. Cash resources expected to fund operations into 2026. Financially, cash, cash equivalents, and investments total $55.2 million, with $7.7 million increase in R&D expenses and $4.1 million decrease in G&A expenses for Q1 2024.