Latest news with #GEN
Indianapolis Star
2 days ago
- Health
- Indianapolis Star
GEN and Sulfateq BV Announce Positive Phase 1 Trial Data on Investigational Drug SUL-238 for Alzheimer's and Other Neurodegenerative Diseases
Phase 1 results demonstrate that SUL-238, a first-in-class, orally administered, mitochondria-directed drug candidate, is safe and well-tolerated in healthy elderly volunteers, showing a favourable pharmacokinetic profile and high brain penetration. These findings support the advancement of SUL-238 into further clinical development for Alzheimer's and other neurodegenerative diseases. ANKARA, TR / ACCESS Newswire / July 28, 2025 / GEN Pharmaceuticals ( Türkiye's leading specialty pharmaceutical company, announced positive results from its Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics (PK) of first-in-class and novel orally administered mitochondria-directed drug candidate SUL-238 in healthy elderly volunteers. The findings were presented at the Alzheimer's Association International Conference 2025 (AAIC ®) in Toronto. This single oral ascending dose (SAD) Phase 1, first-in-human, randomized, double-blind, placebo-controlled study was conducted in three parts, involving a total of 53 healthy elderly adults. Part 1 included 6 cohorts (50, 100, 250, 500, 1000, and 2000 mg orally, n=23). In Part 2, the PK of a single 1000 mg oral dose was investigated in 10 healthy elderly adults. In Part 2B, the food effect was assessed using a randomized, single oral 2000 mg dose, two-treatment, two-period, crossover design (n=20). The trial results showed that single oral doses of 50-2000 mg of SUL-238 were safe and well-tolerated, while demonstrating a favourable PK profile and high cerebrospinal fluid (CSF) penetration. These findings make SUL-238 a promising candidate for further clinical development in neurodegenerative diseases, including Alzheimer's disease. No adverse effects (AEs) limited dose escalation, AE rates were comparable between SUL-238 and placebo, and all AEs were mild or moderate. The mean terminal elimination half-life was 0.86-3.80 hours, and the time to maximum plasma concentration was 0.50-1.39 hours. Under fed conditions, maximum plasma concentration (C max) and area under the plasma concentration-time curve (AUC 0-∞) decreased by 50% and 60%, respectively. CSF-to-plasma percentages at 2 and 8 hours post-dose were 21.1% (±6.6%) and 74.2% (±46.0%). Abidin Gülmüş, Chairman of GEN, stated: 'We are very encouraged by these promising first-in-human results, marking an important step forward in our mission to address the underlying biology of Alzheimer's disease.' Nadir Ulu, MD, PhD, Vice President of R&D at GEN, added: 'With its excellent safety and PK profile in this Phase 1 trial, combined with robust preclinical data, SUL-238 represents a strong candidate for further clinical development to meet the critical unmet needs in neurodegenerative diseases, including Alzheimer's disease.' About SUL-238 SUL-238 is a novel, first-in-class, hibernation-derived small molecule that targets mitochondria, the cell's 'powerhouse.' It supports mitochondrial bioenergetics via complex I/IV activation and has improved mitochondrial function in rodent models of neurodegenerative, cardiovascular, and renal diseases, as well as aging. SUL-238 crosses the blood-brain barrier and has undergone extensive safety evaluation in preclinical and Phase 1 studies. GEN licenses SUL-238 from Sulfateq BV for neurodegenerative disease applications. About GEN: Founded in 1998, GEN is Türkiye's leading specialty pharmaceutical company, focused on developing innovative therapies across multiple therapeutic areas. GEN manufactures high-quality, competitive products at its GMP-certified facility and pursues original drug development through two dedicated R&D centers and investments. About Sulfateq: Sulfateq B.V. is an early-stage Dutch biotech company that fosters strategic collaborations with academic and industrial research centers to accelerate the development of innovative new medicines. It has developed a novel class of small molecules, the SUL-compounds, that maintain mitochondrial health. Contact Information Bulutay Güneş Sr. Head of Corporate Brand Ali Ketencioğlu Investor Relations Manager Kees van der Graaf Sulfateq CEO View the original press release on ACCESS Newswire The post GEN and Sulfateq BV Announce Positive Phase 1 Trial Data on Investigational Drug SUL-238 for Alzheimer's and Other Neurodegenerative Diseases appeared first on DA80 Hub.
Yahoo
16-07-2025
- Business
- Yahoo
Will Gen Digital (GEN) Beat Estimates Again in Its Next Earnings Report?
If you are looking for a stock that has a solid history of beating earnings estimates and is in a good position to maintain the trend in its next quarterly report, you should consider Gen Digital (GEN). This company, which is in the Zacks Technology Services industry, shows potential for another earnings beat. When looking at the last two reports, this security software maker has recorded a strong streak of surpassing earnings estimates. The company has topped estimates by 1.77%, on average, in the last two quarters. For the most recent quarter, Gen Digital was expected to post earnings of $0.59 per share, but it reported $0.58 per share instead, representing a surprise of 1.72%. For the previous quarter, the consensus estimate was $0.55 per share, while it actually produced $0.56 per share, a surprise of 1.82%. Price and EPS Surprise For Gen Digital, estimates have been trending higher, thanks in part to this earnings surprise history. And when you look at the stock's positive Zacks Earnings ESP (Expected Surprise Prediction), it's a great indicator of a future earnings beat, especially when combined with its solid Zacks Rank. Our research shows that stocks with the combination of a positive Earnings ESP and a Zacks Rank #3 (Hold) or better produce a positive surprise nearly 70% of the time. In other words, if you have 10 stocks with this combination, the number of stocks that beat the consensus estimate could be as high as seven. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a version of the Zacks Consensus whose definition is related to change. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Gen Digital currently has an Earnings ESP of +1.67%, which suggests that analysts have recently become bullish on the company's earnings prospects. This positive Earnings ESP when combined with the stock's Zacks Rank #2 (Buy) indicates that another beat is possibly around the corner. We expect the company's next earnings report to be released on August 7, 2025. Investors should note, however, that a negative Earnings ESP reading is not indicative of an earnings miss, but a negative value does reduce the predictive power of this metric. Many companies end up beating the consensus EPS estimate, though this is not the only reason why their shares gain. Additionally, some stocks may remain stable even if they end up missing the consensus estimate. Because of this, it's really important to check a company's Earnings ESP ahead of its quarterly release to increase the odds of success. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Gen Digital Inc. (GEN) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
IOL News
12-06-2025
- Business
- IOL News
Only the bold can change the world
African Bank CEO, Kennedy Bungane, receiving the Ecosystem Catalyst Award at the Global Entrepreneurship Congress in Indiana from GEN President, Jonathan Ortmans. Image: Supplied. The Global Entrepreneurship Congress (GEC) returned to the US for the first time in 15 years, where it was first hosted. In 2009, Kansas City welcomed just a few hundred ecosystem stakeholders who banded together with one vision – to build a 'one global entrepreneurial ecosystem''. The movement has now quite literally mushroomed over the years and has seen thousands of ecosystem stakeholders meet annually to discuss better ways to support the development of entrepreneurs across the globe. In 2017, South Africa hosted the GEC, which welcomed over 5000 delegates from 160 countries onto our shores. Last week, the City of Indianapolis greeted 3455 participants from 141 countries, marking the 15th Global Entrepreneurship Congress under the theme, the 'Bold Change the World'. With over 148 sessions and 200 speakers, the congress was over-saturated with rich and impactful content. Some of the key highlights included a keynote fireside chat with one of the world's most renowned entrepreneurs, Mark Cuban, who advised entrepreneurs to explore unchartered territories, saying 'Go where others don't look and just start'. Many other significant highpoints of the GEC include the launch of the GEN Catalyst Index, which is a bold new initiative aimed at developing a standardised framework to assess, benchmark and elevate the performance of Enterprise Support Organisations (ESOs) worldwide. GEN and Startup Genome also launched the Aptitudes and Policies for Exponential Entrepreneurship (APEXE), which is aimed at helping national governments evaluate and enhance the performance of national policy action in growing tech startup ecosystems. The first instalment of the APEXE Nations Ranking offers a balanced scorecard of the performance of each country's past entrepreneurial innovation policies. At the awards evening, African Bank, a local bank in South Africa, was awarded the prestigious Ecosystem Catalyst Award – in recognition reserved for an organisation that demonstrates outstanding commitment to driving long-term, inclusive growth in their local entrepreneurship ecosystem, through programmes and education. From championing township entrepreneurs to pioneering new financial models for underserved communities, the bank continues to demonstrate what it means to not only fund ideas – but to believe in the people behind them. Now here's the kicker. In September 2026, the global community will convene in Cape Town for the 2nd Global Entrepreneurship Congress (GEC+) Africa, which will welcome over 2000 delegates with arms wide open from across the continent onto our shores, in addition to a few other hand-picked international delegates. The GEC+Africa promises to promote inclusive and sustainable growth; accelerate digital transformation; improve access to finance; advocate for supportive policies and strengthen pan-African collaboration. Many participants I met at the congress simply craved stability. Around the world, they urged their government leaders to also prioritise transparency and provide clarity. As an example, Cuban encouraged entrepreneurs to just be entrepreneurs and focus on what they do best. As he said, 'if your business succeeds, politicians will come to you, and you must build a business that outlasts any one politician''. I left GEC feeling totally inspired and echoed the words of Jonathan Ortmans, the GEN president, 'entrepreneurs are the new diplomats of the world'. Kizito Okechukwu is the co-Chair of the Global Entrepreneurship Network (GEN) Africa; and Executive Head of 22 On Sloane, Africa's largest entrepreneurship campus Kizito Okechukwu Kizito Okechukwu is the executive head of 22 On Sloane, Africa's largest entrepreneurship campus and co-chair of the Global Entrepreneurship Network (GEN) Africa. Image: Supplied.
Technical.ly
10-06-2025
- Business
- Technical.ly
Meet the ESHIP Alliance: New name for the national ecosystem building movement
Andy Stoll has one t-shirt, loads of post-it notes and a new job that's a lot like his old job. Stoll is the founding executive director of what is now called the ESHIP Alliance, a nonprofit startup that announced its new name last week in Indianapolis at the Global Entrepreneurship Congress (GEC). The GEC is a global conference organized by the Global Entrepreneurship Network (or GEN, which is lovingly pronounced like the name Jen by its many admirers). Stoll made his announcement alongside GEN founder and CEO Jonathan Ortmans, and right before Right to Start's Victor Hwang, another entrepreneurship booster with his own big announcement. They're just three of a constellation of groups that have spun off from the Kauffman Foundation 's decades-long investment in entrepreneurship. Last year, Kauffman announced plans to narrow its focus to economic opportunity in its hometown of Kansas City, winding down its national programming funding. Stoll joked that his ESHIP Alliance could be the younger sister to GEC, which makes the Kauffman Foundation mom and dad, and Hwang a kind of attentive uncle — with plenty of cousins and lots of folksy Midwestern charm to go around. Catching the ecosystem-building bug Stoll was a local organizer in Iowa first, working on startups and gatherings in the early 2000s and 2010s. Hwang, once an influential Kauffman executive, gave Stoll the language to describe what he and thousands of others were doing. 'Victor told me: What you're doing is the future of place-based economic development,' Stoll said. 'And I said: I'm doing the what of what?' In 2012, Hwang published ' The Rainforest,' a widely cited book on local economic development, and in 2017 hired Stoll. Together they produced Kauffman's Entrepreneurial Ecosystem Building Playbook, which put institutional heft behind rag-tag community efforts flourishing around the country. From 2017-2019, Stoll was emcee and organizer of annual Kauffman-backed ESHIP Summits. Hundreds came from around the country to discuss rebuilding their local economies from the ground up: some were there as part of their jobs, many others were not. But most talk fondly and passionately about being part of something that seemed overlooked then and is now taken more seriously. Stoll and his team would stock up on colorful post-it notes, markers and engagement activities. As a 2023 report on the origins of inclusive entrepreneurship tracked, many grassroots efforts to reshape local economies took hold after the Great Recession and steadily grew during the 2010s. One of the most enduring is the 'entrepreneurial ecosystem building' that is sometimes called ' place-based economic development ' among industry insiders. Their shared and primary push: state and local policymakers and civic leaders should put entrepreneurship at the center of their strategies for economic growth, opportunity and development. Like scripture passages, these believers cite studies showing that new businesses create effectively all net new jobs, and that each 1% increase in entrepreneurship correlates with 2% declines in poverty. The ecosystem metaphor teaches that big institutions are vital, but must prioritize the many differently sized, aged and types of organizations that overlap to make an economy. NRPs: National ecosystem resource providers Stoll is friendly, chatty, and millennial nerd chic enough to be among the movement's leaders, backed by the influence and checkbook of the Kauffman Foundation. Over a decade-plus, from an early Startup Champions summit to SXSW activations and beyond, I've seen Stoll at his most comfortable in a t-shirt, effusing folksy modesty while cracking self-effacing jokes and serving as a community historian of the work, preferably leading an exercise on collaboration with post-it notes. Pushed out of the comfortable confines of the Kauffman Foundation, Stoll is now stitching together a coalition so this on-the-ground change can last. Among his partners is Black-entrepreneurship focused Forward Cities, which also got its start with Kauffman funding and has been long led by Stoll's years-long collaborator Fay Horwitt. Together this week, they introduced the ESHIP Alliance's renewed focus to a network of so-called national ecosystem resource providers (NRPs) — organizations that address needs common to many ecosystems or state and local entrepreneurial communities. 'At its core, this alliance is about strengthening the profession of ecosystem building across the United States,' Stoll said in a GEC session. 'We need entrepreneurship, we need ecosystems, but we need to center equity so anyone, anywhere who wants to be an entrepreneur has the opportunity to participate.' The alliance will gather these resource providers and help advance and formalize 'ecosystem building' as a discipline for state and local governments to embrace. Events, training material and policy positions will help. As part of that work the ESHIP Alliance launched the ESHIP Commons, a social network intended to help ecosystem builders connect, share ideas and find resources. What's next for the ESHIP Alliance Turns out Technically itself is an NRP, so I was at one of Stoll's tables at GEC — years since the last time I saw him in action. On stage, he guided about a hundred NRP leaders through a series of exercises to identify the next set of challenges and potential solutions for ecosystem building. Much to attendee amusement, Stoll's presentation included a photo of him from years ago wearing the same 'Mass Collaboration' t-shirt he wore this week, signaling that while much has changed, many faces haven't. Horrowit was up next with an exercise that cleverly required attendees to never reference funding as a problem. As she said, 'That's a problem for everyone, give us something new.' That let us focus on more specific obstacles to advance the work of centering entrepreneurship in local policymaking and economic development. Good for an exercise, but what's next? Stoll, like this conversation, has graduated from the Kauffman nest (the group was initially called the Ecosystem Builders Leadership Network, so the rebrand gives it a fresh start). Entrepreneurship rates have surged post pandemic, led by women and people of color. That's caught the attention of serious state and local leaders. Stoll, Hwang and so many others have for years advocated for a bigger stage, and now they have it. Stoll donned a dress shirt to get on the GEC main stage and announce his organization's new name. He seemed more at home the next day in his t-shirt, pushing all of us who support local entrepreneurship and innovation efforts across the country. Said Stoll: 'We have who we need in the room.'
Technical.ly
09-06-2025
- Business
- Technical.ly
GEC 2025: What the Global Entrepreneurship Congress says about American entrepreneurial leadership
Among the greatest of American exports, hip-hop and basketball have gone entirely global. Entrepreneurship too. Back to antiquity, the first businesses were in Africa and the Arabian Peninsula. The modern corporation is a European invention, and the longest running company is Japanese. But the Americans made it cool. From the 1980s-era 'greed is good' to post-Great Recession social entrepreneurship, the United States put get-rich businesses on magazine covers and humble small business owners on primetime reality TV. Fitting, then, that the Global Entrepreneurship Congress is an American product that has been mostly held abroad. With origins in the early 2000s, this first-of-its-kind globally-minded pro-startup conference was held in 2009 for 200 attendees in Kansas City, with funding from the entrepreneurship-obsessed Kauffman Foundation. Founded by trained economist and policy wonk Jonathan Ortmans, the conference is organized by what is now called the Global Entrepreneurship Network (or GEN, pronounced like the name Jen), which Ortmans leads. This year boasted more than 3,000 attendees. 'Entrepreneurs are the new diplomats of the world.' Jonathan Ortmans, Global Entrepreneurship Network Over the following 15 years, the Congress was held the world over, including Brazil, Saudi Arabia and Australia. Last week, GEC was held in the United States for the first time since its start — in Indianapolis, a growing city in a Midwestern state with bipartisan support for business growth and a hook into federal research dollars. 'Entrepreneurs are the new diplomats of the world,' Ortmans said on stage. His opening remarks lamented fading enthusiasm for an interconnected global economy. Elsewhere, he spoke optimistically of what remains bipartisan support for business creation. In the conference's keynote conversation with entrepreneur-turned-celebrity investor Mark Cuban, Ortmans boasted that GEC was held in Moscow in the weeks that followed the Russian invasion of Crimea. Back in March 2014, for the conference-attending entrepreneurs and their supporters from around the world, 'nothing was different.' Whether that sounds like a hardworking ethic or aloof indifference, Ortmans argues entrepreneurs crave stability, clarity and transparency, which benefits everyone else. Alongside Ortmans, Cuban presented as even more optimistic, and idealistic, for Entrepreneur The Diplomat. Cuban gushed about the promise of artificial intelligence to unlock the entrepreneurial spirit around the world, leveling the playing field with just an internet connection. Famously, Silicon Valley notables broke toward supporting Donald Trump in the 2024 presidential election, but Cuban was a prominent outlier and frequent MAGA critic. He was less directly critical at nonpolitical-striving GEC, and Ortmans encouraged him to widen his lens to consider a global audience in the convention hall that came from at least 130 countries. Tellingly, there was no formal delegation from the American federal government, nor its DOGE-cost-cutting Small Business Administration. (One member of a GEC advisory group politely declined to comment and sensibly encouraged this reporter to focus on the international presence and bipartisan support among state and local American officials.) 'There are plenty of places to talk about politics. If you're an entrepreneur, be an entrepreneur. If your business succeeds, the politicians will come to you,' Cuban advised. 'You want your business to outlast any one politician.' In some sense, it's a hopeful throwback to a more innocent time when a jet-setting elite believed commerce would lead to peace and prosperity. That's the optimistic worldview that led the American government to welcome the Chinese Community Party into the World Trade Organization, and the same that encouraged the German government to rely on the Russian state for its energy security. In recent years, there's been a reversal: Global citizens of international capitals have been humbled into a choice, say more, or say less. During the pandemic, social justice protests demanded that entrepreneurs speak out on a growing list of political issues. Ortmans, Cuban and the spirit of GEN's GEC seem to say something different. As one GEC collaborator has told me: 'Entrepreneurship is my politics.' Informed by the modest, Midwestern style of the Kauffman Foundation, the conference was filled with practical advice for entrepreneurs and local economic development leaders. Common-sense policy discussions happened alongside meet-and-greets between commerce ministers from dozens of countries. Each GEC features a dedicated 'compass room' with a UN-style circular white table with microphones. Its orientation stands in contrast to the Silicon Valley investor-catwalk startup conferences, Austin's hipper-than-thou SXSW and and the sprawling and showy Las Vegas consumer technology shows. Ortmans hopped between sessions and off-site events. He addressed both the launch of a national campaign to center entrepreneurs in next year's anniversary of the American Revolution and at a working session of 'national ecosystem resource providers' — of which Technically is one. 'This is one way back,' Ortmans said of a more pro-growth time. 'Customers matter. Failure doesn't.' Mark Cuban Cuban, who knows something about hip hop and basketball, embodies a brighter optimism than most American elites of late. A thousand of us overflowed conference chairs, and clapped and chuckled at his folksy charm, embodied by the carefully chosen polo-shirt he wore from his Indiana University alma mater,. As ready-for-TV as Cuban is, he still offers practical advice for founders: 'Raising money isn't an accomplishment. It's an obligation.' And in practiced, self-effacement: 'Customers matter. Failure doesn't.' (In contrast, another main-stage panel of Colorado-bred tech startup notables was a snoozefest of self-congratulation from a bygone era.) Cuban advised policymakers and economic development leaders to invest in community, rule of law and lifestyle to attract and retain entrepreneurs: When he chose where to start his businesses, first Indiana and later Texas, 'not one single time did I look at the tax rate first.' Speaking to a crowd with attendees from countries including Iraq, Nigeria and France, he personified his role as the commonsense sage of American-style center-left techno-optimism. Said Cuban: 'An entrepreneur is always an entrepreneur first.'
