Değerli konuklar, mutlu bir sabah, mutlu bir gün, mutlu bir gelecek dileyerek konuşmama başlıyorum. Mutlu olma sanatı, mutluluğun tanımıyla başlamaya çalışıyorum. Bütün her şeyde olduğu gibi mutluluğun da bir tanımı var.Bütün özlemler eksiksiz ve sürekli ulaşmaktan duyulan saadet bahtiyarlık diye geçer. Daha kolay bir tanım. Elin erişebileceği çiçeklerden bir demet yapma sanatıdır.Başarı istediğini elde etmek. Bir otor yine bunu güzel özetlemiş. Mutluluk ise elde ettiğini sevmektir.Daha güzel bir özet. Mutl ...

Eee, ben Gizem Girişmen. Türkiye'nin Paralimpik Oyunlar Tarihinde altın madalya kazanan ilk kadın sporcusuyum. Dünya şampiyonu Okçuyum.Eee, bugün karşınızda, eee, bulunma amacım, şunu başardım, bunu yaptım, böyle bir hayat hikayem var gibi bir eee, anlatı yapmak değil aslında. E, aksine, eee, dört kere düştüysem beş kere kalkma mücadelem, eee, hatalarımdan ders çıkartma, eee, vazgeçmeme deneyimlerimle sizlerle paylaşmak için buradayım. Eee, biraz önce de söyledim.E şampiyon bir okçu olarak karşınızda bulunu ...

Summary of Capricor Therapeutics (CAPR) Update Call Company Overview - **Company**: Capricor Therapeutics - **Focus**: Development of Daramyacel, a cell therapy candidate for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) Key Points Regulatory Update - Capricor received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for Daramyacel, indicating that the application does not meet the requirements for substantial evidence of effectiveness and requires more clinical data [4][5] - The review clock has been stopped until a complete response is submitted, and Capricor does not believe a new BLA will be required [5][41] - Capricor is preparing a written response to the CRL and has initiated engagement with the FDA for further discussions [5][10] Clinical Data and Efficacy - The BLA was supported by data from the HOPE-two trial, which demonstrated statistically significant benefits in cardiac function [7][8] - The HOPE-two open label extension study showed significant results in left ventricular ejection fraction with a p-value of 0.0079 [9] - Ongoing Phase III HOPE-three clinical trial is seen as a key opportunity to address the FDA's request for additional clinical data [10] - HOPE-three has completed a twelve-month evaluation of 104 DMD patients, with data expected in Q3 2025 [10] Manufacturing and Quality Control - Capricor is committed to resolving outstanding issues in the chemistry, manufacturing, and controls (CMC) section of the application [11] - The company believes that the issues raised by the FDA are resolvable in a timely manner [11] Industry Context - The FDA's decision is viewed as concerning, especially given the high unmet medical need in DMD and the innovative nature of the therapy [6][12] - Capricor emphasizes the importance of using long-term extension data and real-world evidence in evaluating therapies for rare diseases like DMD [12] Support from Medical Community - A group of leading DMD physician scientists submitted a letter to the FDA expressing support for the Daramyacel clinical program [13] - The letter highlighted their extensive experience in treating DMD and their belief in the efficacy and safety of Daramyacel [13] Future Outlook - Capricor remains committed to working collaboratively with the FDA and is optimistic about the potential for Daramyacel to receive approval [14][15] - The company aims to provide updates as they achieve clarity with the FDA regarding the path forward [69] Financial and Strategic Considerations - Capricor maintains its priority review status and is focused on addressing the FDA's concerns without needing a new BLA [48] - The partnership with NS Pharma remains strong, with continued commitment to commercialization in the U.S. despite the CRL setback [58] Additional Insights - The FDA's cancellation of the Public Advisory Committee meeting without explanation raised concerns about the review process [6] - Capricor's approach to statistical analysis in clinical trials has been a point of contention with the FDA, particularly regarding the use of parametric versus nonparametric models [30][36] This summary encapsulates the critical updates and insights from the Capricor Therapeutics conference call, highlighting the company's current challenges and future strategies in the context of regulatory approval for Daramyacel.

BOCA RATON, FL, July 11, 2025 (GLOBE NEWSWIRE) -- DeFi Development Corp. (Nasdaq: DFDV) (the “Company”) the first public company with a treasury strategy built to accumulate and compound Solana (“SOL”), today announced the signing of a non-binding Letter of Intent (LOI) with Switchboard Technology Labs Inc., a core contributor to the Switchboard Protocol, a leading decentralized oracle network on Solana. Under the agreement, DeFi Dev Corp. and Switchboard intend to explore a strategic collaboration focused ...

BOCA RATON, FL, July 11, 2025 (GLOBE NEWSWIRE) -- DeFi Development Corp. (Nasdaq: DFDV) (the “Company”) the first public company with a treasury strategy built to accumulate and compound Solana (“SOL”), today announced the signing of a non-binding Letter of Intent (LOI) with Switchboard Technology Labs Inc., a core contributor to the Switchboard Protocol, a leading decentralized oracle network on Solana. Under the agreement, DeFi Dev Corp. and Switchboard intend to explore a strategic collaboration focused ...

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Core Insights - Kitron reported solid quarterly sales and profits, particularly driven by the Defence & Aerospace market sector [1][3] - The company raised its outlook for 2025 due to sustained momentum in key sectors [3][4] Financial Performance - Revenue for Q2 2025 was EUR 172.2 million, an increase from EUR 164.6 million in Q1 2025 and EUR 167.6 million in Q2 2024 [1] - Operating profit (EBIT) for Q2 2025 was EUR 15.0 million, compared to EUR 12.5 million in Q1 2025 and EUR 15.0 million in Q2 2024, with an EBIT margin of 8.7% [2] - Profit after tax for Q2 2025 was EUR 10.0 million, slightly down from EUR 10.4 million in the same quarter last year, resulting in earnings per share of EUR 0.05 [3] Order Backlog and Growth - The order backlog at the end of Q2 2025 was EUR 509.3 million, reflecting a 12% increase compared to the previous year, with strong growth in the Defence/Aerospace and Industry sectors [3] - The company secured five strategically important contracts during the second quarter [3] Outlook for 2025 - Kitron expects full-year revenue for 2025 to be between EUR 675 million and EUR 725 million, and operating profit (EBIT) to be between EUR 55 million and EUR 65 million, an increase from the previous outlook [4]

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