logo
APLT COURT NEWS: Applied Therapeutics has been Sued for Securities Fraud; Contact BFA Law by February 18 if You Lost Money (NASDAQ:APLT)

APLT COURT NEWS: Applied Therapeutics has been Sued for Securities Fraud; Contact BFA Law by February 18 if You Lost Money (NASDAQ:APLT)

NEW YORK, Feb. 16, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Applied Therapeutics, Inc. (NASDAQ: APLT) and certain of the Company's senior executives for potential violations of the federal securities laws.
If you invested in Applied Therapeutics, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc.
Investors have until February 18, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in Applied Therapeutics securities. The case is pending in the U.S. District Court for the Southern District of New York and is captioned Alexandru v. Applied Therapeutics, Inc., et al., No. 24-cv-09715.
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:
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, as well as $420 million from Teva Pharmaceutical Ind. Ltd.

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Argenx presents new Efgartigimod data at EULAR 2025
Argenx presents new Efgartigimod data at EULAR 2025

Business Insider

time3 hours ago

  • Business Insider

Argenx presents new Efgartigimod data at EULAR 2025

argenx (ARGX) SE 'announced the presentation of positive results from Phase 2 studies evaluating VYVGART in Sjogren's disease and idiopathic inflammatory myopathies at the European Congress of Rheumatology, EULAR 2025, from June 11 – 14 in Barcelona, Spain. argenx also announced that the FDA has granted efgartigimod Fast Track designation for the treatment of primary Sjogren's disease.' Confident Investing Starts Here: Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>

ClearPoint Neuro, Inc. (CLPT): A Bull Case Theory
ClearPoint Neuro, Inc. (CLPT): A Bull Case Theory

Yahoo

time3 hours ago

  • Yahoo

ClearPoint Neuro, Inc. (CLPT): A Bull Case Theory

We came across a bullish thesis on ClearPoint Neuro, Inc. (CLPT) on M.V. Cunha's Substack. In this article, we will summarize the bulls' thesis on CLPT. ClearPoint Neuro, Inc. (CLPT)'s share was trading at $13.93 as of 6th June. A medical doctor surrounded by advanced technology in the operating room. ClearPoint Neuro is transforming from a surgical tools provider into a critical platform company enabling the next generation of neurological treatments. In the first quarter of 2025, revenue grew 31 percent year-over-year to 8.5 million dollars, led by the rapid adoption of its SmartFrame operating room system, which increased 70 percent and allows hospitals to use ClearPoint technology in standard surgical settings. This expansion seeds a larger installed base and drives high-margin recurring revenue from disposable instruments. The biologics and drug delivery segment generated 4.7 million dollars in revenue, growing 9 percent year-over-year, and is supported by more than 60 active partnerships with gene and cell therapy developers. As these therapies move toward commercial use, ClearPoint's role as the enabling delivery infrastructure could become its most profitable revenue stream, with each procedure generating over 20,000 dollars in high-margin recurring revenue. Meanwhile, the company is intentionally moving away from capital equipment sales, which declined 63 percent, in favor of a subscription-based model that provides predictable recurring revenue. Operating cash burn fell 35 percent in 2024, with expenses rising 29 percent in the latest quarter due to targeted investments in preclinical services, therapy support, and device innovation. ClearPoint closed the quarter with 12.4 million dollars in cash and access to up to 105 million dollars in financing, providing sufficient capital to reach financial breakeven without near-term equity dilution. While risks around execution, partner dependency, and regulatory pacing remain, ClearPoint's embedded position across neurological therapy development offers investors a unique opportunity to benefit from a long-term transformation into the backbone of next-generation brain treatments. Previously, we highlighted a on ClearPoint Neuro from northeasternsvf in January 2025, which emphasized its unique position as the only FDA-cleared, MRI-guided neurosurgical platform enabling precise delivery of CNS gene and cell therapies. That thesis focused on the company's expanding biopharma partnerships, operating room penetration through SmartFrame OR, and its path to profitability via high-margin disposables. ClearPoint Neuro, Inc. (CLPT) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 21 hedge fund portfolios held CLPT at the end of the first quarter which was 13 in the previous quarter. While we acknowledge the risk and potential of CLPT as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than CLPT but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey.

Lab-grown salmon is now FDA approved — here's why this one restaurant is putting it on the menu
Lab-grown salmon is now FDA approved — here's why this one restaurant is putting it on the menu

New York Post

time7 hours ago

  • New York Post

Lab-grown salmon is now FDA approved — here's why this one restaurant is putting it on the menu

Land ho! You've heard of fresh-caught salmon and even farm-raised — but what about lab-grown? San Francisco cellular agriculture company Wildtype is the latest company to get FDA approval for its lab-grown salmon Only three other companies have gotten the stamp of approval to sell cultivated salmon so far. The company made waves in the food and culinary sectors after announcing that its hero product, saku salmon, got approved in 'a thorough pre-market safety consultation.' Curious people can find the fish on the menu at Portland, Oregon, restaurant Kann — a James Beard award-winning Haitian spot by chef Gregory Gourdet. For June, the cultured salmon will only grace the menu every Thursday night, but in July, it is slated to be a nightly offering. 'Our saku is sushi-grade and best served raw in dishes like sushi, crudo, and ceviche,' Wildtype explains on its website. 'We made it for world-class chefs who seek out the distinct flavor and freshness of raw seafood.' And according to the FDA, they view lab-grown salmon 'as safe as comparable foods produced by other methods,' the FDA wrote in its public response letter. The FDA's only gripe with Wildtype's cultivated salmon so far is that the company refers to it as 'cultured salmon cell material' — which is not 'our recommendation of that term as an appropriate common or usual name for declaring the substance in accordance with FDA's labeling requirements,' the agency said. This interest in lab-grown salmon is due to both wild-caught and farm-raised versions containing levels of mercury. Wild-caught salmon is also susceptible to picking up chemicals in local waters. So, how exactly is lab-grown salmon made? The process can be broken down into three steps: source, grow and harvest. Living cells from Pacific salmon are taken from fish and then placed into cell cultivators that mimic the temperature, pH, and nutrients of a wild fish — allowing the cells to grow, as explained by Wildtype. Once fully matured and harvested, the living 'salmon cells' are fused with plant-based ingredients that imitate the texture and appearance of true salmon. Experts warn that typically, both wild-caught and farm-raised salmon contain traceable levels of mercury and are susceptible to picking up chemicals in local waters. Oran Tantapakul – By producing synthetic seafood, Wildtype says it aims to 'sustainably meet the food security challenges of this century' and minimize the damaging environmental implications of farming and fishing practices, while reducing 'exposure to common contaminants we'd rather avoid.' According to the Washington State Department of Health, farmed salmon can sometimes be exposed to organic contaminants and pests like sea lice more often than wild-caught salmon, but rest assured: 'most of the salmon available for us to eat is farmed,' the agency says. Synthetic salmon hasn't hit the grocery store shelves just yet but given cultural interest in plant-based, meatless, and lab-grown products — that day seems to be just around the corner.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store