Novo Holdings A/S (Denmark)

NEW YORK, Feb. 21, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Novo Nordisk A/S ("Novo" or the "Company") (NYSE: NVO) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Novo investors who were adversely affected by alleged securities fraud between November 2, 2022 and December 19, 2024. Follow the link below to get more information and be contacted by a member of our team: NVO investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500. CASE DETAILS: According to the complaint, on December 20, 2024, Novo issued a press release announcing the below-expected results of their "REDEFINE 1" trial, "a 68-week efficacy and safety trial investigating subcutaneous CagriSema." The trial showed that patients treated with CagriSema exhibited weight loss of 22.7% after 68 weeks, well short of Novo's targeted expectation of at least 25% weight loss. The press release further indicated that participant patients were permitted to modify their own dosage during the trial and, as a result, only 57.3% of patients treated with CagriSema were on the highest dosage contemplated by the study. Following this news, Novo's stock price fell by $18.44 per share to close at $85.00 per share. WHAT'S NEXT? If you suffered a loss in Novo during the relevant time frame, you have until March 25, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. CONTACT: Levi & Korsinsky, LLP Joseph E. Levi, Esq. Ed Korsinsky, Esq. 33 Whitehall Street, 17th Floor New York, NY 10004 [email protected] Tel: (212) 363-7500 Fax: (212) 363-7171 SOURCE Levi & Korsinsky, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The FDA said Friday that the shortage of semaglutide, the main ingredient in Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy, has been resolved after more than two years. The move could hinder compounding pharmacies’ ability to make large amounts of copies of the brand-name obesity and diabetes drugs, which is typically permitted only when there’s a supply shortage. Med spas and telehealth companies such as Hims and Ro have capitalized on the opportunity to provide compounded semaglutide at much lower costs, but the FDA and drugmakers have warned that the shots aren’t tested or approved for safety and efficacy. Hims’ stock dropped by as much as 20% on Friday morning, while Novo Nordisk’s stock was up about 4% on the news. “We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand,” Novo Nordisk’s US operations head Dave Moore said in a news release. “No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients.” The end of the semaglutide shortage comes a couple of months after the FDA declared an end to the shortage of the GLP-1 tirzepatide, sold by Eli Lilly as Mounjaro and Zepbound. That decision is now the subject of a legal battle, after a compounding pharmacy trade group sued the FDA and alleged the agency didn’t follow rulemaking procedure or consider relevant evidence that the drug remains hard for patients to get.

Today, a brief rundown of news involving Novo Nordisk, Acelyrin and Intra-Cellular Therapies, as well as updates from Gilead Sciences and PhRMA that you might have missed.The Food and Drug Administration has declared a two-and-a-half year shortage of Novo Nordisks metabolic drugs Ozempic for diabetes and Wegovy for obesity to be resolved, as of Friday. The decision follows the FDAs declaration of an end to shortages for Eli Lillys competing drugs Mounjaro and Zepbound. The two companies have struggled with capacity as demand for the drugs has soared, particularly in obesity. To ensure supplies of compounded alternatives of the Novo drugs arent disrupted, the FDA said it wont enforce any bans on those products until April 22 if manufactured at a state-licensed pharmacy or May 22 if theyre made at a federally authorized outsourcing facility. Shares in Hims & Hers Health, which has marketed compounded versions of the drugs, fell by more than 20% in Friday morning trading. Jonathan GardnerConcentra Biosciences, an entity controlled by investment firm Tang Capital Partners, has made an unsolicited bid for Acelyrin weeks after the company agreed to merge with fellow immune drug developer Alumis. Through the offer announced Thursday, Concentra intends to acquire Acelyrin for $3 per share in cash as well as the right to 80% of the proceeds if Concentra licenses or sells the companys programs. Acelyrin stockholders would get about 45% of Alumis shares which currently trade around $5 apiece in the planned merger. Acelyrin said its board will act in the best interests of all stockholders and it will make a further announcement in due course. If approved by shareholders, its merger with Alumis would close in the second quarter. Ben FidlerIntra-Cellular Therapies, maker of the mind-stabilizing medicine Caplyta, reported on Friday that net sales of the product totaled almost $681 million last year. That sum is up 47% compared to 2023. Caplyta is already approved in the U.S. as a treatment for schizophrenia and bipolar depression, and could be cleared in major depression before too long. Sensing the drugs blockbuster potential, Johnson & Johnson recently agreed to acquire Intra-Cellular for nearly $15 billion. The deal is expected to close later this year. Jacob BellEuropean regulators have granted conditional authorization to Gilead Sciences seladelpar in primary biliary cholangitis, a rare autoimmune condition of the liver. The European Commissions decision follows by six months the Food and Drug Administrations decision to grant accelerated authorization to the drug, which Gilead sells as Livdelzi in the U.S. Testing showed seladelpar reduced levels of a liver enzyme that is elevated in PBC patients. To gain full approval, Gilead is working on a confirmatory trial designed to show seladelpar can reduce PBC-related complications in people with the condition and compensated cirrhosis. The company gained the drug in its $4.3 billion acquisition of CymaBay Therapeutics. Jonathan GardnerPfizer CEO Albert Bourla has assumed the role of chair of the Pharmaceutical Research and Manufacturers of Americas board. Bourla, who has been Pfizers CEO since 2019, said he wants drugmakers biggest lobbying group to work with policymakers to address the burden of chronic disease and other devastating conditions, improve patients lives, and ensure lifechanging medicines are available and affordable for people who need them. Bourla will take PhRMAs reins from Gilead Sciences CEO Daniel ODay. Sanofi CEO Paul Hudson was elected as PhRMAs chair-elect and Merck & Co.s CEO Robert Davis will serve as treasurer. Jonathan GardnerIncyte and Genesis Therapeutics are teaming up on an AI collaboration the companies said will help them find new small molecule drug candidates more quickly. Announced Thursday, the deal hands Genesis $30 million upfront with the potential for $295 million more upon hitting certain milestones. If successful, Incyte retains the rights to develop and commercialize any drugs that emerge from the partnership. Neither company said which disease area would be pursued first. Gwendolyn Wu '