Novo’s Wegovy Inches Closer to Becoming First FDA-Approved GLP-1 Weight-Loss Pill

 

The FDA accepted Novo Nordisk’s NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the drug in the fourth quarter of this year.

The FDA on Friday accepted Novo Nordisk’s New Drug Application for an oral formulation of its widely popular obesity drug Wegovy for chronic weight management, bringing the Danish drugmaker one step closer to winning the first regulatory approval for a GLP-1 pill specifically for weight-loss.

Novo did not provide a specific target action date for oral Wegovy, only announcing in its news release that the FDA’s verdict is expected in the fourth quarter. If approved, Wegovy’s pill form will carry a 25-mg dose of the drug, scheduled for once-daily dosing in adults who are overweight or obese and who have at least one comorbid condition.

Supporting Wegovy’s oral bid are results from the Phase III OASIS 4 study. A November 2024 readout showed that daily oral Wegovy could match the weekly injectable in lowering bodyweight, Healio reported at the time. Novo did not provide additional data comparing oral versus injectable Wegovy in its Friday release.

OASIS 4 also found that oral Wegovy significantly outperformed placebo, cutting an average of 13.6% of participants’ weight, as opposed to 2.4% in the control group. The oral drug also had a safety profile consistent with its injectable formulation. Wegovy can cause adverse effects like nausea, diarrhea, constipation and abdominal pain.

Last month, a Novo spokesperson confirmed to BioSpace that the pharma had filed for approval for oral Wegovy. The spokesperson also clarified that Novo already has an oral GLP-1 on the market. Rybelsus, an early brand of semaglutide, was given the FDA’s go-ahead in September 2019 for oral dosing. But instead of being indicated for chronic weight management, Rybelsus is approved to treat type 2 diabetes.

Novo is locked in a close race with Eli Lilly to bring the first weight-loss pill to the market. Last month, Lilly announced that orforglipron, an orally available GLP-1 treatment, significantly lowered blood glucose levels in patients with type 2 diabetes. Analysts at the time were bullish about these findings, with BMO Capital Markets noting that orforglipron achieved “injectable like efficacy.”

Study participants also lost 7.9% body weight after orforglipron treatment, as compared with 1.6% in placebo.

A few days after the late-stage win, Lilly CEO David Ricks told Fox Business that while the study was primarily in diabetes, the pharma’s first drug application for orforglipron will be for chronic weight management later this year. Lilly will subsequently file for approval for type 2 diabetes in 2026. The company also promised to manufacture the drug in the U.S.

https://www.biospace.com/fda/novos-wegovy-inches-closer-to-becoming-first-fda-approved-glp-1-weight-loss-pill

Vertex Abandons AAV as Gene Therapy Space Weathers Difficulties

 

The cell and gene therapy space in recent months has hit several speedbumps, including layoffs, dropped drugs and discontinued partnerships.

Vertex Pharmaceuticals will no longer work on the adeno-associated virus vector technology commonly used to package and deliver gene therapies, according to a Friday report from Endpoints News.

BioSpace has reached out to Vertex for independent confirmation of the news and will update this article accordingly.

The AAV pullback comes after Vertex in February turned its back on a deal it had signed with Verve Therapeutics, handing back the rights to an in vivo liver disease gene editing program. The 2022 deal cost Vertex $60 million upfront, though the partners never unveiled their specific disease target. In late March, Vertex also discontinued its pancreatic islet cell therapy, packaged in a proprietary immunoprotective device, which it was proposing as a therapy for type 1 diabetes.

Terminating work on the AAV platform could also imperil other Vertex partnerships, including its 2020 contract with Affinia Therapeutics to develop novel AAVs for gene therapies—though Vertex has yet to confirm whether that deal would indeed be affected. According to its press announcement at the time, Vertex is using Affinia’s AAV vector technology to package and deliver its gene therapies for a variety of indications, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

Vertex’s decision to do away with its AAV work continues what has been a rough few months for the cell and gene therapy space.

Several notable players have reduced their workforces in recent months, including Encoded Therapeutics, Intellia Therapeutics and Editas. Editas, in particular, was also forced to can its sickle cell disease gene therapy renizgamglogene autogedtemcel after a fruitless search for a development sponsor.

Pfizer, one of the heaviest hitters in the arena, announced in February that it would abandon its FDA-approved hemophilia B gene therapy Beqvez across all global markets, pointing to “the limited interest patients and their doctors have demonstrated in hemophilia gene therapies.” A month earlier, Pfizer turned its back on development partner Sangamo Therapeutics, with which it was advancing another hemophilia gene therapy.

Still, there are some positive signs on the horizon for gene therapies, not least of which is the apparent openness of new FDA Commissioner Marty Makary to some regulatory flexibility for gene therapies, particularly for rare diseases. In an interview last month with Megyn Kelly, Makary said the FDA could consider drug approvals based on a “plausible mechanism,” particularly for diseases that affect “a small number of people.”

https://www.biospace.com/business/vertex-abandons-aav-as-gene-therapy-space-weathers-difficulties

Mizuho Adjusts Price Target on Incyte to $70 From $77, Maintains Neutral Rating

 Incyte has an average rating of overweight and mean price target of $73.42, according to analysts polled by FactSet.

https://www.marketscreener.com/quote/stock/INCYTE-CORPORATION-9675/news/Mizuho-Adjusts-Price-Target-on-Incyte-to-70-From-77-Maintains-Neutral-Rating-49827614/

'US media stocks fall as Trump threatens 100% tariff on foreign-made films'

 American media stocks tumbled on Monday after President Donald Trump unveiled a 100% tariff on all movies produced outside the U.S., in his latest levies that could sharply raise costs for Hollywood studios and roil the global entertainment industry.

Trump's announcement was light on details. It did not say whether the duties will target films on streaming platforms and those shown in theaters, nor did it specify if the tariffs will be calculated based on production costs or box office revenue.

Streaming pioneer Netflix could particularly be at risk, as it relies on its global production network to produce content for international audiences. Its shares slumped 4.9% in premarket trading, leading a slide in media stocks.

Disney, Warner Bros Discovery and Universal-owner Comcast were down between 0.8% and 2.7%. Stocks of theater operators such as Cinemark and IMAX fell 3.5% and 5.9%, respectively. AMC Entertainment slipped 0.4%.

Despite Los Angeles' historic reputation as the hub of cinema, studios have over the years shifted production overseas to locations such as the UK, Canada and Australia to take advantage of generous tax credits and lower labor costs.

Most of this year's Oscar best picture nominees were shot outside the U.S. and a survey among studio executives over their preferred production locations for 2025 to 2026 by ProdPro showed that the top five choices were all overseas.

A forced move back to the U.S. would likely drive up production budgets and disrupt a global supply chain that now includes shooting in Europe, post-production in Canada and visual effects work in Southeast Asia.

"The problem is that pretty much all the studios are moving tons of production overseas to reduce production costs," said Rosenblatt Securities analyst Barton Crockett. 

"Raising the cost to produce movies could lead studios to make less content. There's also a risk of retaliatory tariffs against American content overseas." 

Films are a huge U.S. export. American movies generated $22.6 billion in exports and a trade surplus of $15.3 billion in 2023, according to data from trade body Motion Picture Association.

Any higher costs or levies will add pressure on an industry grappling with cord-cutting by subscribers leaving cable TV for streaming.

The industry is already in the crosshairs of China, which last month vowed to curb imports of Hollywood movies after Trump's aggressive tariffs. But analysts said the financial fallout of that move may be limited, as box office revenues from China have waned in recent years.

STOKING CONCERNS

Trump's latest decision undermines hopes that he was starting to back away from the heavy tariffs on imported goods imposed in recent months that have shaken confidence among consumers and businesses and sapped economic growth.

The White House has been forced to backtrack on levies as investors started to doubt the safety of U.S. assets - but Trump has often paired his retreat in one area with additional threats elsewhere.

The global film industry responded to his latest threats - which Trump claimed were meant to address national security concern - with a mix of shock and concern.

Leaders in Australia and New Zealand said they would advocate for their local industries. Some Marvel superhero movies have been filmed in Australia, while New Zealand was the backdrop for "The Lord of the Rings" films.

British media and entertainment union Bectu called on the government to move swiftly to protect the country's "vital" film industry, warning the tariffs would threaten tens of thousands jobs of freelancers who make films in the UK.

Matthew Stillman, CEO of Prague-based Stillking Films, one of the biggest producers of U.S.-financed international content in Central and Eastern Europe, said the tariff threat risked derailing global production pipelines.

"We are awaiting clarity about how the tariff is calculated and whether its on international rebated production, film financing or U.S. distribution - all of which have implications and complications," he said.

https://www.msn.com/en-gb/money/other/us-media-stocks-fall-as-trump-threatens-100-tariff-on-foreign-made-films/ar-AA1EbTIW

Integra LifeSciences posts mixed Q1, cuts EPS guidance for tariff impact

 Integra LifeSciences (Nasdaq: IART)

 shares took a hit before hours today on first-quarter results that came in mixed compared to the consensus forecast.

Shares of IART fell 11% to $14.99 apiece in pre-market trading today. The investor response was potentially related to slashed adjusted EPS guidance in response to the expected impact of tariffs.

Integra LifeSciences reaffirmed its 2025 revenue guidance range for between $1.65 billion and $1.715 billion. That represents growth between 2.4% and 6.5%. However, the company reduced its adjusted EPS guidance to a range between $2.19 and $2.29. This accounts for an estimated 22¢ per share impact from tariffs imposed by the Trump Administration.

For the quarter, the Princeton, New Jersey-based medtech company reported losses of $25.3 million. That equals 33¢ per share on sales of $382.65 million for the three months ended March 31, 2025.

Integra recorded a more than $20 million bottom-line slide on a sales increase of 3.7%.

Adjusted to exclude one-time items, earnings per share came in at 41¢. That fell 2¢ shy of expectations on Wall Street. Sales managed to top estimates, though, as experts forecast $381.2 million in revenue.

The company continues to grapple with an FDA warning letter outlining quality systems issues at three locations.

“We remain laser-focused on strengthening our quality systems, improving supply reliability, and driving operational excellence. There remains significant work ahead, but we are continuing to put the processes and people in place to execute on our comprehensive compliance master plan and build a foundation for sustainable performance,” said Mojdeh Poul, president and CEO. “As I reflect on my first quarter at Integra and continue spending time across our operations and with employees, I remain inspired by the deep commitment of our teams to our customers and patients. I am also encouraged by the positive feedback I consistently receive from customers about the impact of our solutions and the value of our portfolio. I’m equally optimistic about the long-term growth and earnings potential of our differentiated offerings.”

https://www.massdevice.com/integra-mixed-q1-2025-guidance-tariff/

Ascendis Pharma (ASND) Sees Analyst Upgrade and Price Target Increase

 Ascendis Pharma (ASND) received an analyst rating upgrade from Morgan Stanley's Vikram Purohit, shifting from an "Equal-Weight" to an "Overweight" status. This upgrade reflects a positive outlook on the company's future performance.

In addition to the rating change, Morgan Stanley has significantly raised the price target for Ascendis Pharma (ASND, Financial) from $180.00 to $250.00. This adjustment represents a substantial 38.89% increase in the price target. The revision underscores growing confidence in the firm's growth prospects.

https://www.gurufocus.com/news/2827480/ascendis-pharma-asnd-sees-analyst-upgrade-and-price-target-increase-asnd-stock-news

BioCryst Upbeat Q1 Earnings, Improved Full Year Guidance

 Shares of BioCryst Pharmaceuticals, Inc. (BCRX) soared 10% in pre-market trading on Monday after the company raised its full-year guidance and reported first quarter (Q1) earnings above Wall Street expectations.

The firm reported total revenue of $145.5 million, compared to $92.8 million in the first quarter of 2024, owing to an increase in revenue from Orladeyo. The Q1 revenue beat an analyst estimate of $127.79 million, as per Finchat data.

Orladeyo is a prescription medicine used to prevent attacks of hereditary angioedema (HAE), a rare, genetic condition causing recurrent episodes of swelling in various parts of the body, in adults and children 12 years of age and older.

Orladeyo's net revenue in the first quarter of 2025 was $134.2 million, a 51% jump from the previous year.

Net income for the first quarter was $32,000 or $0 per share, compared to a net loss of $35.4 million, or $0.17 per share, for the first quarter of 2024. Analysts expected the company to report a loss of $0.05 per share.

The company has already submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) to expand the Orladeyo label to children with HAE aged 2 to 11 using an oral granule formulation.

The company also increased its full-year outlook. It now expects global net Orladeyo revenue to be between $580 million and $600 million for the full year, up from its previous guidance of between $535 million and $550 million.

The company also expects to deliver net income and positive cash flows for the full year 2025, earlier than its previous outlook for achieving it in 2026.

https://www.msn.com/en-us/money/topstocks/biocryst-pharma-stock-soars-10-pre-market-on-upbeat-q1-earnings-improved-full-year-guidance-retail-s-pleased/ar-AA1EbYEj?ocid=finance-verthp-feeds