Latest news with #Toledano
Daily Mail
2 days ago
- Business
- Daily Mail
Expert: How to fix the condo crisis sweeping the South
With the turbulent real estate scene in Florida being described as the 'epicenter of housing market weakness', one developer is going against the grain. Billionaire real estate developer Isaac Toledano plans to completely alter the Miami skyline. While some developers have hit pause on Florida for the foreseeable future, Toledano is taking full advantage of the state's widespread 'condo crisis' and the ensuing buyout frenzy. He's got his eye on the thousands of older buildings along Florida's coastline and wants to turn them into luxury housing that is better equipped to withstand the area's natural disasters. Not everyone is happy with his plans. As Toledano bulldozes the prized coastline, the buyouts have become one of the few ways to secure prime real estate in the area. For some owners in these aging buildings, selling to a developer can be a welcome relief from finding a buyer in a sluggish market, especially when the cost of bringing the property up to code outweighs its current value. But some residents refuse to sell - no matter the price. It's an uphill battle as a once-necessary measure of unanimous resident approval becoming a thing of the past. These sales can leave many people displaced. Some are being forced onto families or into assisted living, while others have nowhere to go. Meanwhile, Florida's controversial Live Local Act - passed in 2023 and amended in May 2024 - is only assisting developers in their takeover, offering them the right to build at maximum capacity if 40 percent of the units are set aside as 'affordable,' but it's usually still more than retirees on a budget can afford. Still, with all the problems the older condos are having, Toledano's bet is paying off. His company has broken ground on a new build called The Residences on Six Fisher Island in Miami, which has already sold $650 million-worth of homes inside the $1 billion property. His other ultra luxury branded projects include The Ritz-Carlton West Palm Beach, W Pompano Beach and Viceroy Residences Aventura. Toledano, who owns BH Group - a major Miami-based real estate investment and development firm working exclusively in Florida - currently has over 1,100 residential units in his portfolio, with over 10,000 residential units in progress. 'We're seeing a very, very healthy demand and we still see buyers relocating here across our portfolio,' Toledano told the Daily Mail. 'We own office buildings, we own retail, and we're involved in a lot of residential projects, so we have the opportunity to speak to a lot of buyers.' He said more South Americans are flocking to South Florida now that the dollar is weaker, adding that more Europeans are also looking for properties. 'We see more foreign nationals coming and we think that will continue. 'We still see a lot of US based buyers - especially New Yorkers - in our Ritz-Carlton Residence up in West Palm Beach, at the Ritz-Carlton Residence in Palm Coast, the W in Pompano Beach and our project down in Miami or Fisher Island.' Toledano had been a quiet figure in the South Florida real estate scene until he founded BH Group in 2009. He runs the company with his wife, Liat Toledano. Florida saw a huge influx of new residents during the Covid-19 pandemic due to its affordability, weather and the possibility for Americans to work remotely. But the Sunshine State has since turned into a housing market nightmare - especially for sellers looking to get out. The area has been hit by a mix of high home prices, soaring insurance premiums, rising property taxes, natural disasters and the need for remote workers to return to offices. Still, Toledano says he's 'doubling down' on the state. He's betting on the luxury market for single family homes, too. He says he will buy outdated properties, tear them down and build new. He's currently developing an entire gated community of high-end homes for those who don't want to live in condos. 'You have people that are trying to sell their older homes - either they want to upgrade to a newer place, or families are growing and want to move from a smaller apartment or condo to a bigger unit. 'Then you see couples whose kids have left the house, and they don't have a reason to keep a big condo, so they want to downsize to a single-family home. This happens all the time.' The Greenview at Presidential Estates will total 103 luxury single-family homes. 'We're already under construction, and we see healthy demand as well,' he said. As for the area's natural disaster rate, Toledano said he predicts the high insurance rates will eventually come down with all the new builds because they are built to withstand hurricanes and storms much better than older condos. 'Obviously natural disasters is not something that we can predict,' he said. 'Look at the terrible fires in California; the huge storm that took place in Texas. 'I would say that Florida is still a great place, a safe place, and you cannot predict where the next natural disaster is coming. 'The good news is that we see insurance rates are going down with the luxury buildings. And I think this will continue.' Toledano said branded residences are also the future of South Florida. This is when a residential building will have its name attached to a brand, such as The Ritz-Carlton West Palm Beach, and the building will feature the same amenities as the brand's hotels - down to the saunas, gym and valet. The brand affiliation will attract buyers, and the brand will get a cut of sales. 'We have lot of new product coming, new projects, great architecture, a lot of buildings offering great services, great amenities and a great lifestyle, all tied to brands' he said. 'I think this momentum will get better and better, and stronger and stronger.' And the shock of the Champlain Towers South tragedy in 2021 still lingers. When the Surfside condo collapsed, killing 98 people, it exposed shocking design flaws, rotting concrete and decades of neglected maintenance. In its wake, Florida passed a tough new law requiring all condos over 30 years old to pass a structural inspection, with owners footing the bill for repairs. Developers began circling like vultures, eyeing buildings on the beach with surface-level parking lots and fewer than 100 units - translation: easy to demolish. Realtors will come knocking when a developer is interested, Toledano explained. The 80 percent ownership mark required by Florida law to dissolve a condo association and take over completely can be easily hit with the right dollar amount. As Toledano continues to snap up the aging condo buildings, he's offering big money to preexisting residents. But where are older Florida residents going? With skyrocketing costs, mandatory repairs, expensive HOAs and aggressive buyouts, these longtime residents who are being priced out of their homes are, in many cases, also being priced out of Florida entirely. After selling their condo, m any retirees are being forced to move out of the state unless they can find housing in another part of Florida with lower living costs. States like North Carolina, South Carolina and Tennessee also attract retirees due to lower costs and similar climates. Joseph M. Hernandez, partner at Bilzin Sumberg, which specializes in condo terminations and sales to developers, said the dramatic increase in assessments for a large number of unit owners across the state will incentivize them to sell their property to developers. 'They'll avoid the costly repair and retrofitting work that's now mandatory for older buildings,' Hernandez said. According to a report by Florida Realtors, which releases real estate data in South Florida, Gerard Yetming, executive manager of Colliers, said condo buyouts are a 'growing trend,' but that sellers need to consider one thing. 'The only time this makes sense is when the value of the underlying land is significantly more than what the collective units are currently selling for,' Yetming said. 'Why else would somebody want to sell their property unless they can make a significant profit?' As for Toledano, he's got a vision for a skyline that's entirely remade and that he says is 'going to get nicer and nicer'. He's now leading a demolition that's underway in Boca Raton for 500 residential units, 45,000 square feet of retail space, and 400,000 square feet of office space, much of it already pre-leased. 'I can tell you that overall we really believe in the growth of South Florida,' he told the Daily Mail. 'This market is going nowhere... There is really no crash,' he added.
Business Upturn
3 days ago
- Business
- Business Upturn
Entera Bio Receives FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study in Post-Menopausal Women with Osteoporosis
JERUSALEM, July 28, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and protein replacement therapies, announced today that in a written response to a Type A meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company's proposal that the NDA marketing application filing for EB613 would be supported by a single multinational, randomized, double-blind, placebo-controlled, 24 month phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint. This marks a shift from precedent placebo-controlled phase 3 studies of new osteoporosis drugs which required incidence of fracture as the primary endpoint. 'This regulatory update is a major milestone for Entera and the entire osteoporosis community,' said Miranda Toledano, CEO of Entera. 'Our alignment with the FDA reflects the strength of our data and collaborative discussions. Importantly, it allows us to advance our clinical development program without having to wait for FDA's qualification of the Study to Advance Bone Mineral Density as a Regulatory Endpoint (SABRE), which is still expected this year. We thank the FDA and the Review Team at the Division of Endocrinology for their constructive approach. We also thank the SABRE team for paving the path to innovation for osteoporosis treatment,' said Toledano. 'Osteoporosis afflicts more women than heart attack, stroke and breast cancer combined. Over 200 million women globally are estimated to have osteoporosis and remain vastly undertreated, despite efficacious injectable anabolic (bone forming) treatments. One in two women over the age of 50 will suffer a fracture due to osteoporosis. No new drug for osteoporosis has been approved by FDA since 2019; and innovation has stalled for close to a decade due to the size, duration, cost and ethical constraints associated with fracture endpoint studies. In a silent disease, patient and clinician access to novel and alternative forms of validated mechanisms of action is important. We are developing EB613 as the first oral, once-daily anabolic tablet treatment to potentially serve this unmet medical need. EB613 is intended to increase skeletal mass, improve bone microarchitecture and reduce the risk of fracture,' said Miranda Toledano, CEO of Entera. About EB613 Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. EB613 completed a phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D-DXA showed increases with EB613 compared with placebo in a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening, and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with those of published subcutaneous teriparatide at the 6-month time point. Further abstracts have been submitted to ASBMR and NAMS 2025 conferences. About Entera Bio Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. The Company's most advanced product candidate, EB613 (oral PTH(1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP-2 peptide as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit or follow us on LinkedIn , Twitter , Facebook , Instagram . About SABRE The Study to Advance BMD as a Regulatory Endpoint (SABRE) initiative, which started as a public private partnership sponsored by the FNIH in 2013, has amassed the strongest evidence to date that treatment-related gains in Bone Mineral Density (BMD) reliably and quantitatively predict fracture-risk reduction. In November 2023, the SABRE team submitted a full qualification package to FDA's Biomarker Division as part of the Drug Development Tool Biomarker Qualification Pathway to potentially qualify BMD as a surrogate endpoint to fracture; in March 2024, the FDA Biomarker Division indicated to the SABRE project team that a decision would be issued within 10 months. The single most important predictor of osteoporotic fractures in postmenopausal women without a previous fracture is BMD. Treatment guidelines in the U.S. strongly recommend pharmacologic therapy for patients with a BMD T-score of -2.5 or lower in the spine, femoral neck, total hip. SABRE final FQP meta-analysis included data from 22 randomized, placebo-controlled trials (63,000 participants across seven drug classes) and showed that treatment-related gains in total-hip BMD explain 72% of the observed fracture-risk reduction. The R2 for this correlation was 0.73—double the correlation between blood pressure and stroke (R² = 0.37), which is the well accepted basis for the value of antihypertensive therapy. Cautionary Statement Regarding Forward Looking Statements Various statements in this presentation are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, 'anticipate,' 'believe,' 'can,' 'could,' 'expect,' 'estimate,' 'design,' 'goal,' 'intend,' 'may,' 'might,' 'objective,' 'plan,' 'predict,' 'project,' 'target,' 'likely,' 'should,' 'will,' and 'would,' or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera's forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's ability to establish and maintain development and commercialization collaborations; Entera's operation as a development stage company with limited operating history; Entera's competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the 'Cautionary Statement Regarding Forward-Looking Statements,' 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of Entera's most recent Annual Report on Form 10-K filed with the SEC, as well as Entera's subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
The Star
18-07-2025
- Business
- The Star
Vietnam outlines new financial reforms in bid for emerging market status
HANOI: Vietnam is set to officially launch a central counterparty mechanism in early 2027 as part of its push to be reclassified as an emerging market as early as this year and attract more foreign investors, the State Securities Commission said. Vietnam has been on global index provider FTSE Russell's watchlist for an upgrade since 2018. It is currently classed as a frontier market, limiting the investment it can attract from funds, investors, and family offices in the nation's listed companies. An upgrade to emerging market status could rapidly channel US$5 billion into Vietnam's financial markets, according to World Bank estimates. The government released a four-phase plan running through 2027 to secure the upgrade during a visit to Hanoi by FTSE Russell's global head of equity and multi-asset, Gerald Toledano. The roadmap includes finalising the legal framework and establishing a Central Counterparty-operating subsidiary under the Vietnam Securities Depository and Clearing Corporation. In a meeting with Toledano late on Thursday, Prime Minister Pham Minh Chinh (pic) expressed his hope FTSE would support a classification upgrade for Vietnam, state-broadcaster Voice of Vietnam reported. Toledano highlighted Vietnam's strong liquidity, which he said surpassed regional peers Thailand and Singapore, VOV added. Vietnam's financial markets are small in comparison with regional peers. As of Thursday's close, the main benchmark stock index had a market valuation of around $245 billion, compared to around $455 billion for the main Thai index and around $490 billion for Singapore's STI Index, LSEG data showed. The CCP will act as an intermediary between buyers and sellers in the equity market, ensuring trades are honoured even if one party defaults. The country has already introduced other measures, such as a new transaction settlement system and the removal of a requirement for overseas investors to fully pre-fund equity trades, to address obstacles to its potential reclassification. Foreign investors have increased purchases of Vietnamese stocks following the announcement of a trade agreement between the United States and Vietnam. The benchmark VN-Index has risen 7.22% so far this month. FTSE Russell is set to release a review in September. If Vietnam secures the upgrade to secondary emerging market status, the reclassification process could take six to 12 months, consistent with the agency's procedural guidelines. Vietnam had previously targeted 2025 for achieving the upgrade. - Reuters
Bangkok Post
18-07-2025
- Business
- Bangkok Post
Vietnam outlines new financial reforms in bid for emerging market status
HANOI - Vietnam is set to officially launch a central counterparty mechanism in early 2027 as part of its push to be reclassified as an emerging market as early as this year and attract more foreign investors, the State Securities Commission said. Vietnam has been on global index provider FTSE Russell's watchlist for an upgrade since 2018. It is currently classed as a frontier market, limiting the investment it can attract from funds, investors, and family offices in the nation's listed companies. An upgrade to emerging market status could rapidly channel $5 billion into Vietnam's financial markets, according to World Bank estimates. The government released a four-phase plan running through 2027 to secure the upgrade during a visit to Hanoi by FTSE Russell's global head of equity and multi-asset, Gerald Toledano. The roadmap includes finalising the legal framework and establishing a Central Counterparty-operating subsidiary under the Vietnam Securities Depository and Clearing Corporation. In a meeting with Toledano late on Thursday, Prime Minister Pham Minh Chinh expressed his hope FTSE would support a classification upgrade for Vietnam, state-broadcaster Voice of Vietnam reported. Toledano highlighted Vietnam's strong liquidity, which he said surpassed regional peers Thailand and Singapore, VOV added. Vietnam's financial markets are small in comparison with regional peers. As of Thursday's close, the main benchmark stock index had a market valuation of around $245 billion, compared to around $455 billion for the main Thai index and around $490 billion for Singapore's STI Index, LSEG data showed. The CCP will act as an intermediary between buyers and sellers in the equity market, ensuring trades are honoured even if one party defaults. The country has already introduced other measures, such as a new transaction settlement system and the removal of a requirement for overseas investors to fully pre-fund equity trades, to address obstacles to its potential reclassification. Foreign investors have increased purchases of Vietnamese stocks following the announcement of a trade agreement between the United States and Vietnam. The benchmark VN-Index has risen 7.22% so far this month. FTSE Russell is set to release a review in September. If Vietnam secures the upgrade to secondary emerging market status, the reclassification process could take six to 12 months, consistent with the agency's procedural guidelines. Vietnam had previously targeted 2025 for achieving the upgrade.
Fashion Network
30-06-2025
- Business
- Fashion Network
Zalando names Laura Toledano MD Western Europe
Laura Toledano, who was already overseeing Zalando 's business in France, the UK and Ireland, has been named managing director Western Europe by the German fashion e-tailer, taking charge of its operations in the entire region. From July 1, Toledano will also lead Zalando in Belgium, Luxembourg and the Netherlands. She took charge of Zalando France in 2021, and two years later the UK and Ireland were added to her remit. Her mission is to apply Zalando's commercial strategy locally, adapting the e-tailer's offering to each country's demand. 'Zalando is a profoundly European company possessing a genuine knowledge of local specificities, and this is what enables us to inspire our customers with increasingly relevant experiences,' said Toledano. In fiscal 2024, Zalando generated revenue of €10.5 billion, up 4.2%. It meant a return to modest growth after two weak years which had led Zalando to cut several hundred jobs. Zalando is currently present in 25 European markets, and recently further extended its footprint on the continent by launching in Portugal, Greece and Bulgaria. The group is relying on generative AI to boost its business, notably to produce images more quickly for its app and website, by using solutions like the generation of virtual models.
