Get Your Piece of the $5.39 Billion by March 25...

Once you hear more about what these AI firms have been up to...You'll feel like you're owed the $3,452.50 that is being paid out to folks like you every month. The opportunity to grab the next payout ends on March 25 -- so be quick.

FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell Therapy Programs

Vandana Singh
January 21, 2025

On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s (NASDAQ:ATRA) active Investigational New Drug (IND) applications.

These INDs include the EBVALLO (tabelecleucel) program for patients two years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as ATA3219, a CAR-T therapy for non-Hodgkin’s lymphoma and systemic lupus erythematosus.

Specifically, identified subjects currently enrolled in the clinical studies who have the potential to derive clinical benefit may continue to receive treatment.

Screening and enrollment of new participants in both programs have been paused.

The clinical hold for EBVALLO is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the Complete Response Letter (CRL) for EBVALLO that was announced last week.

While the ATA3219 drug product is manufactured at a separate, fully compliant GMP-certified facility, the compliance issues at the same third-party facility referenced in the CRL affect the starting materials used in its production.

These issues, which underlie both the CRL and the clinical hold, are specific to the referenced third-party manufacturing facility and do not affect Atara’s second third-party manufacturer, FUJIFILM Diosynth Biotechnologies (FDB) facility in Thousand Oaks, California.

The FDB facility remains a critical component of Atara’s long-term manufacturing strategy for both assets.

Last week, Atara engaged a financial advisor to support the assessment of opportunities to advance and realize value from Atara’s CAR-T assets.

Atara says it remains eligible to receive a $60 million milestone payment from Pierre Fabre upon FDA approval of the EBVALLO BLA, as well as significant double-digit tiered royalties as a percentage of net sales and milestones related to EBVALLO’s commercial sales.

The company added that if a strategic resolution is not reached to provide funding for its CAR-T development programs in the first quarter of 2025, Atara plans to suspend all CAR-T activities and significantly reduce company expenses and activities to only those that support the approval of EBVALLO, including through a near-term progressive transfer of all operational activities related to EBVALLO to Pierre Fabre.

Atara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding through an equity line of credit.

Price Action: ATRA stock is down 4.09% at $6.302 at last check Tuesday.

Read Next:

  • EV Startup Canoo Files For Bankruptcy After NASA, USPS, Walmart Partnerships Bear Little Fruit

Photo via Shutterstock.

Continue Reading...

Popular

Shiba Inu Coin Burns Over 58 Million Tokens As Weekly Price Increases

In the past week, the Shiba Inu (CRYPTO: SHIB) community has successfully burned, or permanently removed, 58,303,050 SHIB coins from circulation.

Is Bill Gates Missing the Big Picture? - Ad

Bill Gates calls it: "The most transformative technology any of us will see in our lifetimes." Eric Fry agrees, saying it's far more advanced than anything today... including AI. But he also warns it could send millions of Americans into poverty.

Bank of America Foresees Possible 40% S&P 500 Plunge Due To Growth-Stock Bubble

Bank of America strategists are warning of a potential 40% crash in the S&P 500, attributing it to a growth-stock bubble.

Three Companies Could Benefit Greatly From AI's Next Boom This Year - Ad

My 2025 AI Blueprint features three of what I call Nvidia's "Silent Partners." Some of the world's hottest companies are working with AI's undisputed leader, Nvidia. And I've identified three of them that appear to be well-positioned for the next AI boom in 2025. Everything you need to know about them in my 2025 AI Blueprint.

Peter Lynch's Timeless Stock Advice: 'Person That Turns Over the Most Rocks Wins the Game'

Peter Lynch, famed for his remarkable returns at the helm of the Fidelity Magellan Fund, underscores the significance of comprehensive research and a long-term approach to successful investing, especially for those in their sixties.

Massive Data Breach Exposes Americans' Financial Details — Names, Card Numbers, PINs and More at Risk

The Office of the Maine Attorney General announced that the personal, medical and financial records of more than 569,000 Americans have been exposed.

Warren Buffett's Investing Partner's Shocking Final Move - Ad

Before he passed away, Charlie Munger, Warren Buffett's investing partner of 60 years, was rumored to have quietly made one final investment... Up until now, it has remained hidden from the public. It's potentially the smartest, most profitable, and most under-valued AI investment you can make today.

In Ukraine, a potential arms-for-minerals deal inspires hope and skepticism

KIROVOHRAD REGION, Ukraine (AP) — The mineral ilmenite is extracted from mounds of sand deep in the earth and refined using a method that summons the force of gravity, resulting in a substance that glimmers like a moonlit sky.

5-Second Trump Clip will Give You Chills - Ad

If you have any money in the markets, take a moment to see this presentation with a 5-second clip of a shocking prediction President Trump made during his victory speech... Because according to legendary investor Louis Navellier, who correctly predicted Trump's win... This prediction is about to become a reality.

NAACP lists companies that dump DEI in its tactical spending guide for Black Americans

WASHINGTON (AP) — The NAACP wants Black Americans to steer their buying power toward companies that haven’t pulled back from programs under conservative pressure, and the nation’s oldest civil rights organization is listing have stood by — or reversed — past commitments to DEI.

22X Better Than Bitcoin... Without Crypto - Ad

For every $1,000 made in Bitcoin... you could have made as much as $22,000 with this strategy. legendary former hedge fund manager Larry Benedict calls it "Bitcoin Skimming." And get this... it's CRUSHING Bitcoin's returns. If you want to get in on the ground floor then watch this free interview NOW.

EPA chief says he will seek return of $20 billion in clean-energy grants awarded by Biden

WASHINGTON (AP) — In a major reversal, the new head of the Environmental Protection Agency said he will try to rescind $20 billion in grants awarded by the Biden administration for climate and clean-energy projects.

5 Stocks That Could Suffer With Canadian Tariffs

Trump plans to impose tariffs on Canada, causing businesses to scramble. Auto industry, energy, agriculture, and manufacturing will be impacted.

Trump Could Make Surprising Tech Announcement Any Day - Ad

I want to show you a free demonstration. Of one of the most incredible technologies you've ever seen. You'll be getting a peek at the cutting edge... A decade from now, you'll remember where you were when you saw this video.

Conservative Influencer Says Musk Is Father of Her Newborn Child

Conservative influencer Ashley St. Clair has declared that Elon Musk is the father of her newborn child.

Treasury watchdog begins audit of Musk DOGE team's access to federal government's payment system

WASHINGTON (AP) — The Treasury Department's Office of Inspector General on Friday said it was launching an audit of the security controls for the federal government's payment system, after Democratic senators raised red flags about to Trump aide Elon Musk's Department of Government Efficiency team.

Claim Your Share of $5.39 Billion in AI Equity Checks - Ad

Virtually every AI model is built off stolen data...so it's only fair that you deserve some kind of compensation...And the U.S. government seems to agree. Which is why you could now receive as much as $3,452.50 per month on average from "AI Equity Checks."

Stocks Head For Weekly Gains, US Treasury Yields Fall Below 4.5%: What's Driving Markets Friday?

Stocks are headed for weekly gains, with the Dow Jones dipping slightly and the S&P 500 and Nasdaq trading just above the flatline Friday.

Chaos at Justice Department as Trump-Backed Officials Push To Drop Corruption Case Against NYC Mayor Adams

The Justice Department is in crisis after Trump-appointed officials pressured attorneys to drop a corruption case against NYC Mayor Eric Adams, sparking mass resignations.

Elon's Next Millionaire-Making Project? - Ad

This could create more wealth than all of his previous ventures... combined.

AP reporter and photographer barred from Air Force One over 'Gulf of Mexico' terminology dispute

The White House barred a credentialed Associated Press reporter and photographer from boarding the presidential airplane Friday for a weekend trip with Donald Trump, saying the news agency’s stance on how to refer to the Gulf of Mexico was to blame for the exclusion. It represented a significant escalation by the White House in a four-day dispute with the AP over access to the presidency.

Musk's DOGE Under Treasury Scrutiny, Trump's Tariffs Impacting Soda Industry, And More

The past week has been a whirlwind of news, with the spotlight on Elon Musk's DOGE and its access to federal payment systems.

270x More Lucrative Than NVIDIA? - Ad

If you've missed out on NVIDIA's recent 1,600% run... Don't worry. Because there's one AI stock that could be a lot more lucrative. It's currently trading for only $20.

TRUMP Spikes 42%, Dogwifhat Up 25%: What's Going On?

Dogwifhat (CRYPTO: WIF) and the TRUMP (CRYPTO: TRUMP) meme coin are emerging as the highest gainers on Friday, putting in significant rallies from

What Bill O'Reilly Said Floored Me - Ad

Bill O'Reilly has trusted one expert for investment advice for over 20 years... Alexander Green. Now, Alex is revealing Trump's impact on YOUR Money, like how AI technology could amplify Trump's policies and details on 3 stocks that could rise 20-fold by 2029.

What's Going On With Lucid Stock Today?

Lucid Group reports the launch of its Lucid Gravity Grand Touring in Canada, showcasing impressive specs and charging capabilities.

Palo Alto Analysts Optimistic On Revenue Growth, Expanding Market Share

Palo Alto Networks Inc (NASDAQ: PANW) shares dropped despite upbeat Q2 results and strong analyst takeaways from Goldman Sachs, Needham, Rosenblatt, and Truist Securities.

This Is the "New" Gold -- "MIT Miracle Metal" - Ad

MIT scientists just developed a brand-new metal... A metal that's shaping up to be, not only the biggest breakthrough in artificial intelligence... but in human technology. It's so valuable that some are referring to it as the "new gold".

Trump creates council for 'energy dominance,' boosts natural gas exports and offshore drilling

WASHINGTON (AP) — President Donald Trump on Friday signed an executive order formally creating a and directed it to move quickly to drive up already record-setting domestic oil and gas production.

Stock Of The Day – Does Capitulation Mean A Reversal For The Trade Desk?

Shares of The Trade Desk (TTD) dropped by more than 30% on earnings. They ma be about to reverse and head higher.

Is This Defi Coin Your Next "10-Bagger" Investment? - Ad

Our #1 pick in decentralized finance is largely overlooked by mainstream investors (for now). This governance token could skyrocket as DeFi adoption surges with the smart money and institutions.

What to know about Trump's buyout proposal for federal employees

President Donald Trump's administration is offering to federal employees to quickly reduce the government workforce. They don't have a long time to decide: The deadline is Feb. 6.

Elon Musk's Final Move - Ad

Elon Musk is DONE. He's finished. Because his latest project may be the last one he'll ever take on. I'm talking about his new, secretive AI startup. Elon's AI promises to be 100 times better than ChatGPT. That's why you need to get all the urgent details on what I call "Elon's #1 AI stock."

Nvidia faces a reckoning as an upstart rival raises questions about Wall Street's darling

NEW YORK (AP) — The superstar run for Nvidia’s stock the last few years has been astonishing. So was its tumble Monday, which caused $595 billion in wealth to vanish. That’s about as much as PepsiCo, McDonalds, Starbucks and Target are worth, combined.

Trending Now

Information, charts or examples are for illustration and educational purposes only and not for individualized investment management This message contains commercial elements, such as advertising. We only send these offers to those who have opted in to our newsletter. Past performance is not indicative of future results. For these reasons we strongly suggest trading in a DEMO/Simulated account. The information provided by us is for educational and informational purposes only. We make no representations or warranties concerning the products, practices or procedures of any company or entity mentioned or recommended and have not determined if the statements and opinions of the advertiser are accurate, correct or truthful. If you use, act upon or make decisions in reliance on information contained or any external source linked within it, you do so at your own peril and agree to hold us, our officers, directors, shareholders, affiliates and agents without fault.

Copyright 2025 activatrade.ca
Privacy Policy | Terms of Service