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Neuralink logo displayed on a phone screen, a silhouette of a paper in shape of a human face and a binary code displayed on a screen are seen in this multiple exposure illustration photo taken in Krakow, Poland on December 10, 2021.

Jakub Porzycki | Nurphoto | Getty Images

Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday it has received approval from the Food and Drug Administration to conduct its first in-human clinical study.

Neuralink is building a brain implant called the Link, which aims to help patients with severe paralysis control external technologies using only neural signals. This means patients with severe degenerative diseases like ALS could eventually regain their ability to communicate with loved ones by moving cursors and typing with their minds.

“This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” the company wrote in a tweet.

The FDA and Neuralink did not immediately respond to CNBC’s request for comment. The extent of the approved trial is not known. Neuralink said in a tweet that patient recruitment for its clinical trial is not open yet.

Neuralink is part of the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Neuralink is perhaps the best-known name in the space thanks to the high profile of Musk, who is also the CEO of Tesla, SpaceX and Twitter.

Scientists have been studying BCI technology for decades, and several companies have developed promising systems that they hope to bring to market. But receiving FDA approval for a commercial medical device is no small task — it requires companies to successfully conduct several extremely thorough rounds of testing and data safety collection.

No BCI company has managed to clinch the FDA’s final seal of approval. But by receiving the go-ahead for a study with human patients, Neuralink is one step closer to market.

Neuralink’s BCI will require patients to undergo invasive brain surgery. Its system centers around the Link, a small circular implant that processes and translates neural signals. The Link is connected to a series of thin, flexible threads inserted directly into the brain tissue where they detect neural signals.

Patients with Neuralink devices will learn to control it using the Neuralink app. Patients will then be able to control external mice and keyboards through a Bluetooth connection, according to the company’s website.

The FDA’s approval for an in-human study is a significant win for Neuralink after a series of recent hurdles at the company. In February, the U.S. Department of Transportation confirmed to CNBC that it had opened an investigation into Neuralink for allegedly packaging and transporting contaminated hardware in an unsafe manner. Reuters reported in March that the FDA had rejected Neuralink’s application for human trials, and reportedly outlined “dozens” of issues the company needed to address.

Neuralink has also come under fire from activist groups for its alleged treatment of animals. The Physician’s Committee for Responsible Medicine, which advocates against animal testing, has repeatedly called on Musk to release details about experiments on monkeys that had resulted in internal bleeding, paralysis, chronic infections, seizures, declining psychological health and death.

A representative for PCRM did not immediately respond to CNBC’s request for comment.

In addition to helping patients with paralysis, experts believe BCIs could someday help treat maladies like blindness and mental illness. Musk has expressed his intent for Neuralink to explore these future use cases, as well as potential applications for healthy people.

At a “show and tell” recruitment event late last year, Musk even claimed he plans to someday receive one of Neuralink’s implants himself.

“You could have a Neuralink device implanted right now and you wouldn’t even know,” Musk said at the time. “In fact, in one of these demos, I will.”

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Anthropic reportedly preparing for one of the largest IPOs ever in race with OpenAI: FT

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Anthropic reportedly preparing for one of the largest IPOs ever in race with OpenAI: FT

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Anthropic, the AI startup behind the popular Claude chatbot, is in early talks to launch one of the largest initial public offerings as early as next year, the Financial Times reported Wednesday. 

For the potential IPO, Anthropic has engaged law firm Wilson Sonsini Goodrich & Rosati, which has previously worked on high-profile tech IPOs such as Google, LinkedIn and Lyft, the FT said, citing two sources familiar with the matter.

The start-up, led by chief executive Dario Amodei, was also pursuing a private funding round that could value it above $300 billion, including a $15 billion combined commitment from Microsoft and Nvidia, per the report. 

It added that Anthropic has also discussed a potential IPO with major investment banks, but that sources characterized the discussions as preliminary and informal. 

If true, the news could position Anthropic in a race to market with rival ChatGPT-maker OpenAI, which is also reportedly laying the groundwork for a public offering. The potential listings would also test investors’ appetite for loss-making AI startups amid growing fears of a so-called AI bubble. 

However, an Anthropic spokesperson told the FT: “It’s fairly standard practice for companies operating at our scale and revenue level to effectively operate as if they are publicly traded companies,” adding that no decisions have been made on timing or whether to go public.

CNBC was unable to reach Anthropic and Wilson Sonsini, which has advised Anthropic for a few years, for comment. 

According to one of the FT’s sources, Anthropic has been working through internal preparations for a potential listing, though details were not provided. 

The FT report follows several notable changes at the company of late, including the hiring of former Airbnb executive Krishna Rao, who played a key role in the firm’s 2020 IPO.

CNBC also reported last month that Anthropic was recently valued to the range of $350 billion after receiving investments of up to $5 billion from Microsoft and $10 billion from Nvidia. 

In its race to overtake OpenAI in the AI space, the startup has also been expanding aggressively, recently announcing a $50 billion AI infrastructure build-out with data centers in Texas and New York, and tripling its international workforce.

According to the FT report, investors in the company are enthusiastic about Anthropic’s potential IPO, which could see it “seize the initiative” from OpenAI.

While OpenAI has been rumoured to be considering an IPO, its chief financial officer recently said the company is not pursuing a near-term listing, even as it closed a $6.6 billion share sale at a $500 billion valuation in October.

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We’re raising our CrowdStrike price target following a beat and raise quarter

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We're raising our CrowdStrike price target following a beat and raise quarter

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Okta shares fall as company declines to give guidance for next fiscal year

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Okta shares fall as company declines to give guidance for next fiscal year

Cheng Xin | Getty Images

Okta on Tuesday topped Wall Street’s third-quarter estimates and issued an upbeat outlook, but shares fell as the company did not provide guidance for fiscal 2027.

Shares of the identity management provider fell more than 3% in after-hours trading on Tuesday.

Here’s how the company did versus LSEG estimates:

  • Earnings per share: 82 cents adjusted vs. 76 cents expected
  • Revenue: $742 million vs. $730 million expected

Compared to previous third-quarter reports, Okta refrained from offering preliminary guidance for the upcoming fiscal year. Finance chief Brett Tighe cited seasonality in the fourth quarter, and said providing guidance would require “some conservatism.”

Okta released a capability that allows businesses to build AI agents and automate tasks during the third quarter.

CEO Todd McKinnon told CNBC that upside from AI agents haven’t been fully baked into results and could exceed Okta’s core total addressable market over the next five years.

“It’s not in the results yet, but we’re investing, and we’re capitalizing on the opportunity like it will be a big part of the future,” he said in a Tuesday interview.

Revenues increased almost 12% from $665 million in the year-ago period. Net income increased 169% to $43 million, or 24 cents per share, from $16 million, or breakeven, a year ago. Subscription revenues grew 11% to $724 million, ahead of a $715 million estimate.

For the current quarter, the cybersecurity company expects revenues between $748 million and $750 million and adjusted earnings of 84 cents to 85 cents per share. Analysts forecast $738 million in revenues and EPS of 84 cents for the fourth quarter.

Returning performance obligations, or the company’s subscription backlog, rose 17% from a year ago to $4.29 billion and surpassed a $4.17 billion estimate from StreetAccount.

This year has been a blockbuster period for cybersecurity companies, with major acquisition deals from the likes of Palo Alto Networks and Google and a raft of new initial public offerings from the sector.

Okta shares have gained about 4% this year.

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