Applied Therapeutics Inc (APLT) ニュース

aplt.............................................https://stockcharts.com/h-sc/ui?&s=aplt&id=p80904663129&listNum=4&a=1431976465

What is the Lawsuit About?

Applied Therapeutics is a clinical-stage biopharmaceutical company specializing in the development of novel drug candidates against validated molecular targets in rare diseases. The Company's lead drug candidate, govorestat, is a central nervous system penetrant Aldose Reductase Inhibitor for the treatment of CNS rare metabolic diseases, including Galactosemia.

During the relevant period, the Company stated that its New Drug Applications submitted to regulators for govorestat were“supported by rapid and sustained reduction in galactitol, which resulted in a meaningful benefit on clinical outcomes across pediatric patients, alongside a favorable safety profile.” Applied Therapeutics also assured investors that its tests were“performed properly” and that the Company“felt good about the quality of the data,” stating that it“took really extensive steps” and“actually videotaped” and had“master trainers” review all of the performances of the 10-meter walk-run test-the primary endpoint of the Company's Phase III INSPIRE study for govorestat.

The Stock Declines as the Truth is Revealed
On November 27, 2024, Applied Therapeutics issued a press release stating that the FDA issued a Complete Response Letter for the NDA for govorestat. The Complete Response Letter stated that the FDA completed its review of the application and determined that it was unable to approve the NDA due to“deficiencies in the clinical application.”

This news caused the price of Applied Therapeutics stock to fall more than 80% over the course of multiple trading days, from a closing price of $10.21 per share on November 26, 2024 to a closing price of $1.75 per share on December 2, 2024.

Then, on December 2, 2024, Applied Therapeutics revealed that it received a warning letter from the FDA relating to its govorestat study discussing“issues related to electronic data capture” and“a dosing error in the dose-escalation phase of the study resulting in slightly lower levels than targeted in a limited number of patients[.]”

This news caused the price of Applied Therapeutics stock to fall more than 26% over the course of multiple trading days, from a closing price of $1.75 per share on December 2, 2024 to a closing price of $1.29 per share on December 5, 2024.

Click here for more information: .

What Can You Do?

If you invested in Applied Therapeutics you may have legal options and are encouraged to submit your information to the firm.

All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.

Submit your information by visiting:


Or contact:
Ross Shikowitz
...
212-789-3619

Why Bleichmar Fonti & Auld LLP?

Bleichmar Fonti & Auld LLP is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs' Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.'s Board of Directors (pending court approval), as well as $420 million from Teva Pharmaceutical Ind. Ltd.

For more information about BFA and its attorneys, please visit .


Attorney advertising. Past results do not guarantee future outcomes.




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1/1/2025

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APLT on the move here.

I see a great opportunity here at these levels. That price drop was quite exaggerated.

Option trade today 1/17/25, $12.50 @1,000

Option trade today 1/17/25, $12.50 @1,000

APLT: 200%-up, for sure today.

Applied Therapeutics Provides Regulatory Update on Govorestat for the Treatment of Classic Galactosemia

APLT under $7

APLT under $5

I have held this for several years and there are many prospects progressing. I like the significant CEO ownership position.

APLT new 52 week high

APLT new 52 week high

Outstanding

Applied Therapeutics Announces $100 Million Private Placement

OMG.. really..

yup.. my mistake that i overlooked you.. you will financial crisis for the next 3 years..

APLT what a beast and not one ihubber talking. The best kind!

APLT...NEXT MONSTER BIO BEAST!!!

APLT...HUGE BREAK OUT PLAY

APLT..THE NEXT BIO BEAST THAT WILL BEAST THROUGH BEASTVILLE

APLT...4.47 HERE WE COME

APLT...ANOTHER MONSTER IN THE MAKING

APLT..HERE WE GO

APLT STRONG TREND IN PLACE

Maybe this could run back up to where it was 4 years ago.

APLT...HERE WE GO

APLT READY TO BLOW UP ONCE AGAIN

Aplt $3.10 pending news

back in on break out

APLT...THE MONSTER IS RUNNING HARD NOW

APLT..HERES THE BREAK OUT...WEEKLY TRAND IN PLACE LIKE YOU HAVE NEVER SEEN

APLT HAS THE BEST WEEKLY CHART OF ANY BIO OUT THERE

Trend $$$ Great Pick with APLT $$$, I agree 100% here... Could easily Go To $10.00+ or Higher....EOD & After_Hours could get Wild..

wowza...look at her go

APLT...READY FOR 2.67...MONSTER

APLT MONSTER IN THE MAKING...WEEKLY BLOW OUT TREND IN PLACE

APLT BIO BEAST READY TO BEAST

took the news a few days to sink in,no date yet on fda meeting(says,this summer smh) ema marketing application in fall for other drug,update is good,just a bit more time

Up up some

Buy rating $23-$29 Citigroup,the Barclays $7-$9 is more believable,omg the greed will be strong,any hint of fda news like fast track will make heads explode lol

Pps above 200ma,golden cross coming ,greatest long chart indicator ever,macd about to cross bullish line,short algos wouldn’t touch a ticker like this and shorts gotta cover! Lions tigers and bulls OHHH MYYY!!!

Look at what happens with green vol on 1 year chart below,high reward/no risk in past,that’s amazing!!! Every time up !!

Trading natural/no naked shorting atm

Pre mkt today$1.40ish/$1.25ave,tonight and tomorrow continues up as word spreads and scanners blowing up

Looking good for week long run like in past with near record volume