The U.S. Food and Drug Administration on Monday approved the first-ever GLP-1 pill for obesity from Wegovy maker Novo Nordisk, a landmark decision that health experts say could open up treatment access to more patients.

Novo Nordisk said it expects to launch the pill in early 2026. The Danish drugmaker said starting in early January, the starting dose of 1.5 milligrams will be available in pharmacies and via select telehealth providers with savings offers for $149 per month.

That’s the same price that cash-paying patients can access the starting dose of the pill on President Donald Trump’s direct-to-consumer website, TrumpRx, under a deal Novo Nordisk struck with his administration last month. Trump’s site also launches in January.

Novo Nordisk did not say how much higher doses of the drug would cost, but said additional information on coverage and savings options for eligible patients will be available at that time as well.

Shares of Novo Nordisk gained roughly 9% in extended trading Monday.

The FDA’s approval also clears the pill for use to reduce the risk of major cardiovascular events, such as death, heart attack or stroke, in adults with obesity and established cardiovascular disease, according to Novo Nordisk. That’s consistent with the approval label of the company’s blockbuster weight loss drug Wegovy, which shares the same active ingredient, semaglutide.

The move gives Novo Nordisk a head start over chief rival Eli Lilly, which is currently the dominant player in the market and is racing to launch its own obesity pill. Pills are the next battleground for the two drugmakers, which established the booming GLP-1 space that some analysts say could be worth roughly $100 billion by the 2030s.

Wall Street thinks there’s plenty of room for pills in the market, with Goldman Sachs analyst saying in August that pills could capture a 24% share — or around $22 billion — of the 2030 global weight loss drug market.

“What we’ve learned through years of research is that having an oral option really kind of opens up, activates and motivates different segments to seek treatment,” Dave Moore, Novo Nordisk’s executive vice president of U.S. operations, told CNBC ahead of the approval. “To have that conversation with their doctor to see if this is something that might be right for them.”

“That’s what we’re excited about — to be able to give people an option and make sure we have access and ease of access like we have been doing with our injections,” he continued.

The approval is based on a phase three trial that followed more than 300 adults with obesity but not diabetes.

In that study, a 25-milligram dose of Novo Nordisk’s oral semaglutide helped patients lose up to 16.6% of their weight on average after 64 weeks, according to results from the trial presented at a medical conference in 2024. That weight loss was 13.6% when the company analyzed all patients regardless of whether they stopped the drug.

The pill appears to be slightly more effective than an experimental oral drug from Eli Lilly, which is still waiting for FDA approval.

But unlike Novo Nordisk’s pill, Eli Lilly’s treatment is not a peptide medication. That means it is absorbed more easily by the body and does not require dietary restrictions. People who take Novo Nordisk’s pill have to wait 30 minutes before eating or drinking each day.

Moore said the prices of the pill get costs closer to what some people are paying for unapproved, compounded versions of branded GLP-1s, some of which are still being illegally mass marketed and sold in the U.S.

Patients flocked to the cheaper copycats when Ozempic and Wegovy were in short supply over the last two years due to skyrocketing demand, or if they didn’t have insurance coverage for the costly treatments. During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. But the agency earlier this year determined that the shortage of semaglutide is over, barring the practice in most cases.

“It continues to be alarming and disturbing for us,” Moore told CNBC, referring to illegitimate ingredients that are imported into the U.S. illegally and used by some compounding pharmacies to create copycat versions of GLP-1s.

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Paramount Skydance on Monday guaranteed the backing of billionaire Larry Ellison in an amended offer for Warner Bros. Discovery — a clear response to questions raised by the WBD board of directors.

“Larry Ellison has agreed to provide an irrevocable personal guarantee of $40.4 billion of the equity financing for the offer and any damages claims against Paramount,” the company said in a news release.

Paramount said Ellison, the father of Paramount CEO David Ellison, has also agreed not to revoke the Ellison family trust or adversely transfer its assets during a pending transaction. The guarantee does not replace committed funds from RedBird Capital and sovereign wealth funds, but constitutes a new layer of security for the commitments.

Paramount Skydance is offering $30 per share, all cash, for Warner Bros. Discovery in a hostile attempt that’s meant to rival an agreement with Netflix.

Last week, Warner Bros. Discovery Chairman Samuel Di Piazza told CNBC’s David Faber the board had concerns about the supposed backing of Oracle co-founder Larry Ellison in the bid.

“We were not confident that one of the richest people in the world would be there at closing,” Di Piazza said at the time. “Doing a deal is great; closing a deal is better.”

WBD earlier this month agreed to sell its studio and streaming assets to Netflix in a transaction valued at roughly $83 billion on an enterprise basis. Paramount wants to buy the entirety of WBD, including its portfolio of TV networks, and says its offer comes with an enterprise value of $108.4 billion.

Paramount notably did not increase its bid on Monday, reiterating that it believes the deal is superior, though Paramount did hike its proposed reverse breakup fee to match that of Netflix’s offer.

WBD confirmed receipt of the amended offer on Monday and said in a release it would “carefully review and consider Paramount Skydance’s offer in accordance with the terms of Warner Bros. Discovery’s agreement with Netflix.”

“What we’ve done in this amended filing is we’ve cleared the brush of obfuscation around the offer,” said Gerry Cardinale, founder and managing partner of RedBird Capital Partners, on CNBC’s “Squawk Box” on Monday.

RedBird is an investor in Paramount Skydance and has also committed to financing the proposed Paramount acquisition of WBD.

Cardinale said Monday that as part of the amended filing Larry Ellison would back the bid through an irrevocable trust, which is anchored by 1.2 billion Oracle shares.

“Like we’ve done through the six bids that we’ve made, we are being responsive to what their concerns are,” Cardinale said.

Shares of Warner Bros. Discovery rose 3% in early trading Monday, while Paramount gained more than 7%. Netflix’s stock was down nearly 1%.

Paramount made three offers for WBD in the fall, which were all rejected by the company. WBD then launched a formal sale process that brought in offers from other bidders, including Netflix.

Cardinale said Paramount’s unsolicited offers likely spurred WBD to open up to a sale, putting Paramount “a little bit on the back foot.”

During Monday’s CNBC interview Cardinale, like Ellison on CNBC last week, appealed directly to WBD shareholders.

“At the end of the day … the shareholders own this company. The board doesn’t own it. [CEO] David Zaslav doesn’t own this company,” said Cardinale. “This should be a lot more simple than it is. It’s very simple.”

Besides the question of value between the two bids, the question of regulatory approval has also been raised by Paramount as well as industry onlookers.

“The Netflix deal kills competition,” Cardinale said, adding that a combination of streaming platforms Netflix and HBO Max would create 420 million subscribers under one roof. “No wonder the constituents in the ecosystem — talent, creators, theatrical exhibitors — are losing their minds on this because they see the pricing power that they will create.”

Netflix co-CEOs Ted Sarandos and Greg Peters have said they are confident their deal would pass regulatory muster. Sarandos has also issued reassurances about the future of the theatrical slate for WBD under Netflix’s ownership.

At a conference earlier in December, Sarandos argued the Netflix offer for WBD’s assets would preserve jobs at a time of mounting layoffs across the industry.