COPENHAGEN, Denmark, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S ASND today announced that the U.S. Food & Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) in adult growth hormone deficiency (GHD) for TransCon hGH (lonapegsomatropin-tcgd; marketed as SKYTROFA ® for pediatric GHD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025. "This marks another step towards achieving our objective to expand SKYTROFA's label beyond pediatric GHD and expand its reach to address new groups of patients," said Jan Mikkelsen, Ascendis Pharma's President and Chief Executive Officer. "Adult GHD is an undertreated condition associated with significant comorbidities and higher annual healthcare costs compared to the 5-10% of patients who receive treatment, indicative of the high unmet need." The sBLA submission is based on results from foresiGHt, a Phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial that compared the efficacy and safety of weekly TransCon hGH with weekly placebo and daily human growth hormone (hGH) in adults with GHD. The trial evaluated 259 adults with GHD aged 23 to 80 years old, randomized 1:1:1, titrated to receive a target fixed dose of TransCon hGH, placebo, or daily hGH based on age and oral estrogen intake with approximately equivalent hGH mg/week for TransCon hGH and daily hGH. TransCon hGH demonstrated superiority on its primary efficacy and key secondary efficacy endpoints at Week 38, with TransCon hGH-treated participants showing a statistically significant reduction from baseline in trunk fat and increase in total body lean mass at Week 38 compared to placebo. In the trial, TransCon hGH was generally safe and well tolerated, with no discontinuations related to study drug and with comparable safety and tolerability to daily hGH treatment. About Adult Growth Hormone Deficiency Growth hormone plays an essential role in the health of children and adults, promoting normal growth in children and maintenance of normal body composition and cardiometabolic health throughout adulthood. In adults, growth hormone boosts protein production, promotes fat utilization, enhances muscle mass, and helps regulate blood sugar levels. Adult GHD is a condition in which an individual's body does not produce enough growth hormone. Symptoms and morbidity can include central obesity, metabolic syndrome, decreased bone density, alterations in lipid profile and markers of cardiovascular risk, fatigue, general weakness, lack of muscle tone, and psychological symptoms such as cognitive impairment, social isolation, lack of motivation, and depression. 1 About Ascendis Pharma A/S Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients' lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis' future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the PDUFA goal date for SKYTROFA, (ii) Ascendis' objective to expand SKYTROFA's label and reach to address new groups of patients, (iii) Ascendis' ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (iv) Ascendis' use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis' products and product candidates; unforeseen safety or efficacy results in Ascendis' development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis' development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis' business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis' ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis' business in general, see Ascendis' prospectus supplement filed on September 20, 2024 and Ascendis' current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 20-F filed with the SEC on February 7, 2024. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, and SKYTROFA ® , are trademarks owned by the Ascendis Pharma group. © December 2024 Ascendis Pharma A/S. Investor Contacts: Media Contact: Scott Smith Melinda Baker Ascendis Pharma Ascendis Pharma ir@ascendispharma.com +1 (650) 709-8875 media@ascendispharma.com Patti Bank ICR Westwicke +1 (415) 513-1284 patti.bank@icrhealthcare.com 1 . Hoffman AR, Mathison T, Andrews D, Murray K, Kelepouris N, Fleseriu M. Adult Growth Hormone Deficiency: Diagnostic and Treatment Journeys From the Patients' Perspective. J Endocr Soc. 2022;6(7):bvac077. Published 2022 May 12. doi:10.1210/jendso/bvac077 © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

My older brother is a New York Jets fan, and we talk after every Miami Dolphins and Jets game. He couldn’t see the game on Sunday, so he just saw the score and how it went to overtime. He said it looked like a typical Dolphins vs. Jets game. I said, “Yes, it was. The Dolphins should have lost the game on Sunday because the Jets were the better team, but the Jets have stupid coaches, and they bailed the Dolphins out.” I was very disappointed in the Dolphins’ defense on Sunday. They were bad, and yes, they had a 5-yard loss and a sack on back-to-back plays on the final possession. Kendall Fuller was able to get Devante Adams out of bounds to keep time on the clock, but for the most part, the Jets’ offense had its way with the Dolphins. It started up front where the Jets don’t have a very good offensive line, but they ran the ball decently against the Dolphins with two rookie running backs drafted late in the draft. The Dolphins were giving up 4 yards a carry, making you wonder why the Jets didn’t keep running it. The Dolphins were missing a tackle and not getting much push up front. Aaron Rodgers picked apart the Dolphins all day long, throwing his first 300-yard game in over two years. Adams and Garrett Wilson looked like the duo the Jets had been looking for all season. The Dolphins had no answers for them. I feel like the Dolphins have more holes than ever on defense, and they are getting labeled as being soft , and it’s more than justified. The Dolphins don’t set the tone up front and get pushed, especially against good teams, but the Jets aren’t even an average team. Our defensive line lacks physicality as a whole and can’t dominate up front. I knew it would be different this year after losing Christian Wilkins , but the Dolphins banked on 38-year-old Calais Campbell and many guys on one-year contracts. Campbell and Zach Seiler have played well, but the other guys don’t give the effort those guys offer. The Dolphins have to find some younger, bigger, and more physical players to compliment Seiler on the defensive line next year, or we are going to see the same issues upfront. The Dolphins also need better linebackers. Yes, Jordan Brooks has played well but missed some tackles on Sunday. Anthony Walker has provided a little spark after moving on from David Long but has durability issues. The Dolphins need to find an inside linebacker who can run sideline to sideline and make tackles—one who doesn’t take bad angles, over-pursue, and miss the ball carrier. It’s been a while since the Dolphins have had that type of linebacker. Instead, they have had undersized guys who aren’t physical enough against the better teams. How many games this year have we seen the Dolphins miss over ten tackles? Too many. That’s why they were overmatched by the Green Bay Packers, and it cost them the game against the Arizona Cardinals on their final drive to win earlier this year. And the safeties are horrible as a group. Jordan Poyer needs to retire because he can’t play anymore, and it is so clear every time you watch him play. He’s not as fast as he used to be, and he is a liability. Jevon Holland is supposed to be our blue-chip safety for years to come, and his contract is up after the season. Well, I would tell him to take a walk after the season because his play has been uninspiring to say the least. He takes bad angle,s and he and Poyer are constantly having communication issues in the secondary. The Dolphins have to tear down that position as well and more physical ball-hawking safeties. I’m not going to place the blame on defensive coordinator Anthony Weaver because it’s an easy cop-out. I blame the person who put this team together, and that’s general manager Chris Grier. I don’t know why he thought this defense would be good signing older players and a bunch of scrap-free agents to one-year deals. He should have done a better job last offseason. If he returns next year, this team currently has ten draft pick,s and he needs to use at least half of them to rebuild this defense. It needs to get younger, and it needs players that are tough-minded and physical. This group as a whole doesn’t have it. They also need to get faster. I understand the Dolphins went into the season without their top pass rushers from a season ago coming off season-ending injuries, but that’s on Grier for not stocking up the defense better. This side of the ball went through change with free-agent losses, and it needs more change next year. If they don’t, then it’s going to be the same soft defense. You can change the defensive coordinator, but that would be lazy putting lipstick on the pig. If the Dolphins want to shed the soft label on defense, go find more tough-minded players. This article first appeared on Dolphins Talk and was syndicated with permission.Promotion Affirms Company's Commitment to Galvanize New Era of Tech-Driven Real Estate Investment NEW YORK , Dec. 12, 2024 /PRNewswire/ -- Underscoring its commitment to revolutionize investment strategies by leveraging advanced technologies to drive investor value, real estate investment firm AWH Partners announces the promotion of Devashish (Dev) Sharma to director of analytics. Sharma, who has been with the New York -based firm since July 2023 , has played a pivotal role in enhancing returns for investors by strengthening the integration of technology and data analytics in his previous role in asset management. In this new position, he will leverage the firm's data assets to create insights that sharpen acquisition strategies, improve asset performance, and strengthen overall decision-making and corporate governance, ultimately driving superior outcomes for stakeholders. In leading this newly created role, Sharma will focus on enhancing AWH Partners' cross-functional data ecosystem and optimizing technology-enabled processes to deliver actionable investment insights, streamline analysis, automate recurring tasks, and identify market opportunities ahead of industry trends. By developing business intelligence tools and mechanisms, he will ensure the firm's leadership and continuity in hospitality real estate, delivering enhanced transparency and scalability of tech-driven initiatives to foster sustainable growth and maximize investor returns. With dual master's degrees in business administration and hospitality management from Cornell University , Sharma has 13 years' experience across investment banking, real estate financing, hotel acquisition and hotel asset management. Before relocating to the U.S. for his graduate studies, Sharma was the investment manager at SAMHI Hotels, which specializes in hotel investments in India , and an associate investment manager at Piramal Fund Management, one of the first firms to enter real estate fund management in India . His global expertise in real estate financing and operational excellence has directly contributed to the success of the firm's high-value investment portfolios. "Dev brings a truly exceptional background to this new role with his experience in real estate financing and data analytics, as well as earning advanced degrees in business and hospitality from one of this country's premier Ivy League universities. Since joining AWH, he has demonstrated dedication and passion for helping the firm realize the next level of data-driven decision-making," said Chad Cooley , co-founder and managing partner of AWH Partners. "His work has strengthened our ability to deliver consistent value to our investors, helping us stand out in an increasingly competitive market." AWH Partners has made substantial investments in technology to identify and acquire differentiated investment opportunities in a highly competitive marketplace. This position underscores the firm's strategic focus on combining innovation and expertise to generate superior investor outcomes. By empowering its team with leadership opportunities, AWH Partners fosters an environment where talent thrives, furthering its goal of shaping the future of real estate investment. Sharma's leadership will continue to advance the firm's mission to deliver sustainable growth and performance across its portfolio. A native of India , Sharma is a chartered accountant and earned his bachelor's degree in finance from Sri Venkateswara College at the University of Delhi in 2009. Sharma's global perspective and track record of integrating analytics into investment strategies position him as a key player in advancing AWH Partners' investor-centric vision. "My goal is to further integrate analytics into every aspect of our investment process to ensure we are at the forefront of data and technology use in real estate investment worldwide," he said. About AWH Partners: AWH Partners (AWH) is a leading national platform for hotel real estate investment, management and development. Privately held, it was founded in 2010 by alumni of The Blackstone Group and The Related Companies. The firm partners with marquee institutional investors, family offices, and high-net-worth individuals around the world. Its portfolio includes properties from renowned brands, including the Marriott and Hilton corporations, as well as independently branded assets. View original content to download multimedia: https://www.prnewswire.com/news-releases/awh-partners-promotes-dev-sharma-as-director-of-analytics-302330763.html SOURCE AWH Partners

THE Political Leader of the Saint Labour Party, and Prime Minister of Saint Lucia, received a unanimous vote of confidence at the closed session of the Annual General Meeting of the party, held in the constituency of Dennery North, on Sunday, November 24. Now, what does a unanimous vote for a political leader of a party means? Very simply, it means that all the voting delegates at the conference, and there were 261 such votes cast to express confidence in the political leader and Prime Minister. In the Westminster model of parliamentary governance, which Saint Lucia follows, this process is quite legal. It means that the delegates at the conference agree on the political and social policies and activities of the Leader and his government. The delegates at the conference are representatives from all the 17 constituencies represented by the Saint Lucia Labour Party. The Political leader and Prime Minister has been pointedly consistent in improving the economic and social environments in Saint Lucia for the people. And the delegates of the SLP Annual Conference have recognised that and acknowledged that effort with their unanimous vote. Indeed, Saint Lucians have continually applauded the PJP administration for its forthright approach in dealing with their bread and butter and other economic matters. What is the present economic situation in Saint Lucia? Tourism, the island’s biggest industry and main source of jobs, income and foreign exchange, accounts for 65-70% of the country’s Gros Domestic Product, GDP. Agriculture, which was once the mainstay of the economy, now contributes to about 5% of GDP, but continues to account for about 25% of jobs. Manufacturing has been providing strong support to bolstering the economic situation. Indeed, the Minister of Agriculture, Fisheries, Food Security and Rural Development, Honourable Alfred Prospere, is exerting a lot of energy in trying to improve banana production and the fisheries sector. The Honourable Emma Hippolyte, Minister for Commerce, Manufacturing, Business development, Cooperatives and Consumer Affairs is moving briskly with that sector. Very recently, I heard her saying that her consumer officers will be monitoring prices on the shelves of supermarkets in particular to ensure that prices of items are correct. I have highlighted Tourism, the money earner; Agriculture, Manufacturing and Commerce for obvious reasons. The country needs finance, and the people need food to meet their basic needs that Abraham Maslow emphasises. I have noted, in several places in this article, the Gross Domestic Product (GDP). What is GDP? A simple definition is a monetary measure of the market value of all the final goods and services produced and rendered in a specific time period by a country. It is important to investigate the current economic performance of our country. Saint Lucia’s Economic Freedom score is about 65%, making its economy the 64th freest in the 2024 Index of Economic Freedom. What is economic freedom? Economic freedom is the fundamental right of every human to control his or her own labour and property. Now the SLP Political leader and Prime Minister is an economist by profession. So, it is not strange that he conceptualised the Youth Economy Programme which has given scores of young people economic freedom. And that programme is doing extremely well. Now, the more income the Minister of Tourism, Honourable Ernest Hilaire can generate for our country, the more our citizens will enjoy economic freedom. In conclusion, I wish to say that the more our country improves economically, the more the Prime Minister will make the benefits available to the people of Saint Lucia.Intel's leadership hinted at a possible sale of its manufacturing operations amid uncertainties surrounding a new chip technology, 18A, slated for next year. As co-CEOs Michelle Johnston Holthaus and David Zinsner took the helm following Pat Gelsinger's ouster, they face the challenge of revitalizing the company's manufacturing edge against competitors like Nvidia. During a Barclays conference in San Francisco, Holthaus discussed Intel's unique dual role in chip design and manufacturing, noting the potential need to separate these functions if the new technology does not deliver results. Intel aims to bring its flagship PC chip manufacturing back in-house, a move crucial for regaining momentum in the chip industry. Chief Financial Officer Zinsner highlighted the separation of Intel Foundry, its manufacturing division, into a standalone subsidiary. While its finances and operations are already distinct, a complete separation remains uncertain. Intel's shares climbed 2.3% after the executives' remarks, reflecting cautious optimism. (With inputs from agencies.)