[stocksrising]

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.

[Monksdream]

TARA under $2

[Monksdream]

TARA under $3

[stocksrising]

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

[kindo]

Funny how when ever Opaleye wants out they find a buyer @ $3.00!

[stocksrising]

Opaleye keeps blowing out blocks a touch above $3 for whatever reason!!! Overhang a hinderance until their done selling..hopefully tomorrow at Cowan conf Jesse says some magic words concerning IV Choline Clor/FDA

[Monksdream]

TARA under $3

[stocksrising]

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.

[stocksrising]

I believe this is for Ken Griffins own account

https://ir.protaratx.com/static-files/2cffa79d-9e22-4a12-a866-5308e96d8bad

[stocksrising]

--Oppenheimer Adjusts Protara
Therapeutics Price Target to $30
From $26
MT Newswires 08:44AM ET, 04/22/2024

[Monksdream]

Early Barchart https://www.barchart.com/stocks/performance/percent-change/advances?timeFrame=today&viewName=main&screener=overall&orderBy=percentChange&orderDir=desc

[stocksrising]

Almost 100% increase in share count( major dilution) …Market Cap pre offering ~$46mm and Post equals ~$75mm( todays price)…yes, better balance sheet, positive interim data..all in all good news, but Arbs will mess around for a bit until Funds buy again…
Jesse is pretty good steward of capital, so when q1 is reported we will see what intrinsic value is ..GLTA

[TIMGZ]

sometimes have to read btw the lines*****biotech*****trial,clinical trials will taketimeand money. longtimeinvestment mosttimes

[Roadtojourney]

Why would it go red even with all the good news??

[Monksdream]

Will it grow legs after 9:30

[TIMGZ]

WHY NOT AT $9

[Awl416]

Protara Therapeutics Announces Oversubscribed $45 Million Private Placement Financing

[dinogreeves]

I know Monk, this should hit 5 before data. On another note ANV*S had their 10K today.

[Monksdream]

TARA under $4

[Poundthetable]

Agreed everything in due time with TARA

[dinogreeves]

Only a few months left for the data to be released.

[dinogreeves]

I guess, I live in your head rent free now stupid peasant. Listen I just had lovely dinner and about to take a crap, going to think of you while I am taking a crap, with your mouth full open while I take a crap in it. Send whatever you want to the SEC, lets see what you got, you think they will listen to a peasant like you?

[jdcpa1]

Send the SEC your posts and your sell tickets so they can match them up.. pump and dump artist..

[dinogreeves]

Save them all dumb peasant. I helped the SEC nail Alex Delarge you peasant.

[jdcpa1]

Ok saving your post for the SEC. Thanks dummy

[dinogreeves]

This is going to hit the teens after the data read out moron. Furthermore this is a nasdaq stock not the scams you are accustomed to peasant.

[jdcpa1]

Beware folks.. there are pumpers with price predictions on here looking to close positions as they pump.. just my opinion but I think it's true.. any posts by predictors are suspect.. they are likely looking to sell..

[dinogreeves]

TARA 5 to 6 dollars before data readout.

[dinogreeves]

TARA 5-6 before data release, then once the data is confirmed easy will see the teens.

[Poundthetable]

I been adding all the way down I like the potential here on this one fingers crossed

[dinogreeves]

Hey bud, I don't have subscription anymore and refuse to pay, don't need it anymore. You got to stick out with this one and add when and if you can, news pending and they investor conference tomorrow.

[glenn1919]

TARA......................................https://stockcharts.com/h-sc/ui?s=TARA&p=D&yr=0&mn=2&dy=12&id=p84071410134

[Poundthetable]

Yup buying opportunities await

[dinogreeves]

Wait couple of more days to add.

[dinogreeves]

TARA has done exceptionally well. Only a matter of time.

[Poundthetable]

Sounds good in it here 4 future growth

[dinogreeves]

Data comes out positive look out above pound. Baker Brother still in the game and that is all we need to know.

[Poundthetable]

Looks good Dino thanks 4 posting alert

[dinogreeves]

Great action here pound. Should hit 5-6 before news.

[dinogreeves]

They probably left last year, like you said for tax harvesting, it does look like it though, the stock bottoming in the low 1.05 range, which killed the stock, but it is coming back after it bottomed. Simple logic tells me, they have 300 million dollar shelf offering right now in the pipe line and there is no way they can do it here, so I think they have colluded with the market makers to drive the price higher, 5-6 dollars before news or even higher, no one knows their trick except for themselves, it would not make sense to sell securities in this range when the volume is anemic. Take a look at MDG*L chart, started at 5 range and shot up to 300-400 dollars in less than week, that one also has Baker Brothers in it and I believe it is also bladder and Liver cancer issues. Bottom line, if these ticker has the science, it will do wonders. 4 billion market cap vs 40 million market cap, so I say easily by June we can get to double digits.

[stocksrising]

Maybe Just year end for tax harvesting ( if they can even benefit ) or YE portfolio shuffling….they were probably leaning it all the way down to $1.5 where I picked up a bunch ( sold some too early last week @ $3.55 ( can’t argue with taken a profit) …still my largest position and will hold until we get double digits ! Jesse was at those 2 conferences, plus the Bakers ( like you said, and totally agree) helps…
Data readouts coming soon ( prob by May)

[dinogreeves]

Looks like they sold. Orbimed is not as important as Baker Brothers to me, but I am curious though why Orbimed sold, we won't know until the results come out.

[stocksrising]

OrbiMed filed 13g/a but can’t tell if they added or sold??

[dinogreeves]

TARA will see the teens fairly soon.

[dinogreeves]

TARA moving nicely, should be around $5.00 before the results.