Fintech PR
How Psychedelic-Based Therapeutics Are Advancing in Treating Generalized Anxiety Disorder (GAD) Condition
FN Media Group News Commentary
PALM BEACH, Fla., Jan. 24, 2024 /PRNewswire/ — The coming years could see a massive shift in the U.S. government’s approach to regulating hallucinogenic drugs. Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD). GAD is a prevalent mental health condition characterized by excessive and persistent worry, often extending beyond specific triggers. Individuals with GAD experience heightened levels of anxiety, anticipating future events and exhibiting physical symptoms such as muscle tension and restlessness. The disorder significantly impairs daily functioning and quality of life. A report from Delveinsight said that the total market size of the Generalized Anxiety Disorder (GAD) treatment market is anticipated to experience growth during the forecast period (2032) due to the emergence of new and effective treatments, especially numerous trials developing new and innovative next-generation psychedelic treatment options. The report added: “The diagnosis of Generalized Anxiety Disorder (GAD) involves a comprehensive assessment of an individual’s mental health, considering the presence of excessive and uncontrollable worry across various aspects of life for a minimum of six months. Clinicians utilize standardized psychiatric interviews and validated screening tools to evaluate the severity of anxiety symptoms, along with a thorough exploration of associated physical and psychological manifestations. Differential diagnosis is crucial to rule out other psychiatric conditions, medical disorders, or substance-related issues that may mimic GAD symptoms. The diagnostic process also entails considering the impact of anxiety on daily functioning and its persistence in the absence of identifiable stressors. A multidimensional approach aids in ensuring an accurate diagnosis and facilitates the development of an effective treatment plan tailored to the individual’s needs.” Active Companies active today in markets include: Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), Seelos Therapeutics, Inc. (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI).
It continued: “DelveInsight’s analyst projects that among the total diagnosed prevalent cases of Generalized Anxiety Disorder (GAD) in 7MM approximately 53% of cases were from the US. As per our estimations, in 2022, the EU4 and the UK accounted for nearly 6,007,995 diagnosed prevalent cases of GAD. In the 7MM, the market mainly consisted of standard treatments like SSRIs/SNRIs, Benzodiazepines, Tricyclic Antidepressants/Azapirone (Buspirone), and others (Antiepileptics, antipsychotics, etc.) which generated nearly USD 1,500 million in 2022. The Generalized Anxiety Disorder (GAD) market is projected to witness consistent growth throughout the forecast period (2023–2032). The market size of Generalized Anxiety Disorder (GAD) in the 7MM is expected to increase, driven by better diagnosis and the launch of emerging therapies.”
Cybin Inc. (NYSE AMERICAN: CYBN) (NEO: CYBN) Announces FDA Clearance to Initiate a Phase 2a Study of CYB004 in Generalized Anxiety Disorder
– Recently announced positive Phase 1 topline safety, pharmacokinetic (“PK”) and pharmacodynamic (“PD”) data show that intravenous (“IV”) CYB004 demonstrated robust and rapid-onset psychedelic effects at lower doses compared to native DMT –
– U.S. composition of matter patent granted with protection expected through 2041 –
– Company to initiate a randomized, double-blind, active controlled Phase 2a study in Q1 2024 –
Cybin Inc. (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic treatment options, announced that the U.S. Food and Drug Administration (“FDA”) has cleared its investigational new drug (“IND”) application for CYB004, its proprietary deuterated dimethyltryptamine (“DMT”) molecule in development for the treatment of Generalized Anxiety Disorder (“GAD”). This clearance allows the Company to proceed with its plans to initiate a Phase 2a study of CYB004 in Q1 2024. The Phase 2a study will be a randomized, double-blind, active-controlled trial to assess the preliminary clinical efficacy, safety, tolerability, PK and PD of CYB004 in participants with GAD. This trial will be conducted at study sites in the United States.
“With the recent positive topline results from two Phase 1 studies of our proprietary deuterated DMT molecules, CYB004 and SPL028, we are well-positioned to initiate a Phase 2a study of CYB004 in GAD this quarter,” said Doug Drysdale, Chief Executive Officer of Cybin. “From our extensive portfolio of DMT and deuterated DMT datasets across five completed clinical studies, we have gathered important insights on dosing and preliminary efficacy signals in both depression and anxiety that will inform our next steps. Exploratory data from our completed Phase 2a study of SPL026 (IV DMT) have shown that SPL026 reduced symptoms of anxiety in patients with major depressive disorder, which further serves to de-risk the development of deuterated DMT in anxiety disorders as we continue to evaluate the efficacy and safety of CYB004.”
“Although anxiety disorders are one of the most prevalent mental health disorders, current treatment options remain limited, with suboptimal response and remission rates. We are committed to developing improved treatment options with the goal of improving the quality of life for people suffering from anxiety disorders worldwide. We look forward to exploring the potential of CYB004 to offer more convenient and patient-friendly dose forms and treatment duration,” concluded Drysdale. CONTINUED… Read the full Press Release for Cybin at: https://www.cybin.com/news
In other active company biotech news in the markets this week:
atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, recently announced a strategic investment in Beckley Psytech Limited (“Beckley Psytech”), a private clinical-stage biotechnology company dedicated to transforming short-duration psychedelics into effective and rapid-acting medicines for neuropsychiatric conditions.
This strategic investment and collaboration aims to accelerate the development of Beckley Psytech’s two clinical-stage, patent-protected, short-duration psychedelic candidates, BPL-003 and ELE-101, by adding them to atai’s mental health innovation platform. BPL-003 is a novel, short-duration, intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT also known as Mebufotenin), and ELE-101 is a novel intravenous formulation of psilocin, the primary moiety of psilocybin.
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, recently provided a corporate update and outlook for 2024.
“Our strong progress in 2023 culminated in the delivery of statistically and clinically significant topline results for our lead program (MM-120) in our Phase 2b study of GAD. These positive results reinforce our scientific understanding of the mechanism of action for MM-120 and emphasize the critical role we believe the perceptual effects of MM-120 play in driving clinical outcomes,” said Rob Barrow, Chief Executive Officer and Director of MindMed. “We are excited to enter 2024 with an enhanced focus on our lead program. In 2024, we plan to continue working diligently and efficiently to advance our MM-120 program into Phase 3, bringing us one step closer to potentially providing a new treatment option to the millions of patients suffering from GAD. We anticipate several key data milestones for our MM-120 program in 2024, including full 12-week results for MM-120 in GAD, results from our Phase 1 pharmacokinetics bridging study to support advancement of our MM-120 ODT formulation into pivotal clinical trials and additional results from our collaborator University Hospital Basel’s one-year follow-up study of lysergide in anxiety disorders. We will be working closely with the FDA to finalize our Phase 3 development program for MM-120 in GAD and expect to hold our End-of-Phase 2 meeting with FDA in the first half of the year with initiation of our Phase 3 clinical program in the second half of the year.”
Seelos Therapeutics, Inc. (NASDAQ: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, recently announced the receipt of minutes from its End of Phase II Meeting with the FDA.
In the meeting minutes, the FDA agreed that the primary endpoint in a Phase III trial could be the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 16, rather than the 24-hour timepoint that was selected in the Phase II SLS-002-201 study. The key secondary endpoint could be the change from baseline at 24 hours on the suicidality scale. This agreement with the FDA gives Seelos further confidence for its Phase III development of SLS-002 as data in the Phase II study showed clinically significant treatment differences from placebo on both the Day 16 MADRS (p-value: 0.012) and the 24-hour Sheehan- Suicidality Tracking Scale (S-STS) (p-value: 0.008).
“We are very excited about the potential that SLS-002 has to address the unmet need of acute suicidality. We are working to design one robust Phase III trial that has the potential to demonstrate a statistically persuasive effect utilizing agreed FDA endpoints,” said Raj Mehra, Ph.D., Chairman and Chief Executive Officer of Seelos.
Compass Pathways plc (NASDAQ: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Hackensack Meridian Health (“HMH”), a leading not-for-profit health care organization and the largest, most comprehensive and truly integrated network in New Jersey, recently announced that that they have entered into a research collaboration agreement to inform the delivery model design of investigational COMP360 psilocybin treatment, if FDA-approved.
The collaboration between Compass and HMH aims to improve health outcomes and improve patient and provider experiences for mental health conditions such as treatment-resistant depression. Together they will work to understand the real-world challenges and opportunities of delivering care to those living with depression, to inform how future clinical trials of COMP360 psilocybin treatment are designed, and to understand how it will be delivered to patients, if approved. COMP360 is Compass’s investigational proprietary formulation of synthetic psilocybin, administered in conjunction with psychological support.
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Fintech PR
Omada Announces Investment from GRO and Kirk Kapital to Drive Next Phase of Growth and Innovation in Identity Governance
COPENHAGEN, Denmark, April 29, 2025 /PRNewswire/ — Omada A/S (“Omada”), a global leader of Identity Governance and Administration (IGA) software, announced a new phase in its partnership with existing investor GRO, which, together with Kirk Kapital, will take a majority ownership position to support Omada’s continued expansion and innovation.
Omada offers a scalable, AI-driven identity governance solution that enables enterprises to manage who has access to which systems and applications with confidence. Omada’s cloud-native, multi-tenant platform simplifies identity management, enhances security, and facilitates compliance – empowering organizations to manage complex identity workflows with greater efficiency and precision.
Enhanced cybersecurity through scalable identity governance
As digital ecosystems grow in complexity and regulatory requirements increase, identity governance plays a critical role in protecting sensitive data and achieve compliance. Omada’s AI-powered solution helps organizations reduce their attack surfaces and maintain real-time visibility into user access, strengthening both enterprise security and operational resilience.
Today, Omada supports enterprise customers across Europe and North America, providing the foundation for identity lifecycle management, enabling organizations to advance their cybersecurity, compliance, automation and business transformation goals. Focused on simplifying IGA, Omada delivers a streamlined, cost-effective approach built on code-free configuration, future-ready cloud architecture, and intuitive workflows. As a result, customers typically realize value in just 90 days, reduce provisioning time by 80%, and cut help desk tickets by 60%.
The investment, led by GRO Fund III as lead investor together with Kirk Kapital and other co-investors, including the Private Equity Group of J.P. Morgan Asset Management and P+, provides a full exit to CVC Growth Funds and GRO Fund II, and will accelerate Omada’s global growth strategy. The company will continue to scale through AI-driven product innovation and go-to-market expansion, building on its momentum as a globally recognized category leader, as acknowledged by leading industry analysts.
Michael Garrett, CEO of Omada, said: “This marks an exciting new chapter for Omada. With the continued backing of GRO and the addition of Kirk Kapital, we’re positioned to accelerate our global growth, double down on innovation in AI, machine identity and other focus areas, and explore strategic M&A opportunities. We’re thrilled to strengthen our partnership with GRO as we scale our vision for the future of identity governance.”
Lars Dybkjær, Managing Partner at GRO, said: “Omada is a true category leader in identity governance and a standout asset within our core thematic focus on cybersecurity software, exemplifying the kind of innovation and ambition we’re proud to back. With AI becoming critical to enterprise security, Omada is poised to take a leading role in shaping the industry’s future. We’re excited to deepen our partnership and support the company’s continued growth, innovation, and strategic expansion.”
Kim Gulstad, CEO of Kirk Kapital, said: “We’re delighted to join Omada and support its continued growth alongside GRO. Omada’s leadership in identity governance, strong European roots, and global ambitions align well with our long- term investment approach. We see tremendous potential in the company’s continued innovation in AI and are excited to be part of this next chapter.”
Sebastian Kuenne, Partner at CVC, said: “Omada has grown into a category leader in IGA, with a robust cloud – native platform and a differentiated approach to managing identity at scale for the most complex of enterprises. We are grateful to have been part of this journey and look forward to Omada’s continued success.”
The transaction remains subject to customary regulatory approvals.
About Omada
Omada, a global market leader in Identity Governance and Administration (IGA), offers a full-featured, cloud-native IGA solution that enables organizations to achieve compliance, reduce risk, and maximize operational efficiency. Founded in 2000, Omada specializes in simplifying IGA, delivering innovative identity management solutions for complex hybrid environments, based on a proven best practice process framework and a streamlined deployment approach.
For more information about Omada, please visit omadaidentity.com and www.linkedin.com/company/omada-as/.
About GRO
GRO is a leading Northern European private equity firm with an exclusive focus on B2B software companies with strong growth prospects. GRO serves as an active owner developing portfolio companies with a view to creating long-term value. The partners behind GRO have been investors in more than 25 technology and software related companies and GRO has approximately EUR 1.2bn in AUM.
For more information about GRO, please visit www.grocapital.dk and www.linkedin.com/company/gro-capital.
About Kirk Kapital
Kirk Kapital is a family-owned investment company that manages capital with a long-term focus on strategic minority investments in market-leading companies in Scandinavia, along with a diversified portfolio of financial investments. The company has its headquarters in Vejle and was established by the Kirk Johansen family, descendants of LEGO founder Ole Kirk Christiansen. Kirk Kapital has 17 active strategic investments and manages approximately EUR 3.5bn in AUM.
For more information about Kirk Kapital, please visit www.kirkkapital.dk and www.linkedin.com/company/kirkkapital/.
About CVC
CVC is a leading global private markets manager with a network of 30 office locations throughout EMEA, the Americas, and Asia, with approximately EUR 200bn of assets under management. CVC has seven complementary strategies across private equity, secondaries, credit and infrastructure, for which CVC funds have secured commitments of over EUR 260bn from some of the world’s leading pension funds and other institutional investors. Funds managed or advised by CVC’s private equity strategy are invested in approximately 140 companies worldwide, which have combined annual sales of over EUR 168bn and employ over 600,000 people.
For further information about CVC, please visit: https://www.cvc.com/ and https://www.linkedin.com/company/cvc-capital-partners/.
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Anyone is not a listing site. It is the first digital transaction facilitator for real estate.
NEW YORK, April 29, 2025 /PRNewswire/ — Real estate remains one of the last multi-trillion-dollar industries still dependent on outdated tools, fragmented workflows, and manual coordination. Today, that changes.
Anyone.com launches in the United States, the Netherlands, the United Kingdom, and several other international markets — introducing a fully digital, end-to-end transaction platform that empowers buyers, sellers, and agents alike.
With access to over 31 million properties for sale worldwide and a database of 4.6 million realtors, Anyone.com brings together every stakeholder in the real estate process — all within one seamless interface.
From first viewing to final signature all in one platform
While traditional platforms focus only on listings, Anyone.com connects the full transaction journey: buyers, sellers, agents, home inspectors, mortgage advisors, and notaries can now collaborate digitally in a single, integrated space.
“We’ve basically built the Uber of real estate.” says Reza Sardeha, founder of Anyone.com. “The entire transaction — from finding the right home and agent to submitting offers and signing is now handled in one digital workflow.”
What Anyone.com offers:
- Fully digital transactions — From scheduling viewings to making offers and closing deals online.
- AI-powered agent matchmaking — Buyers and sellers are matched with the most relevant agents using 12+ billion data points.
- Centralized communication — All conversations, documents, and updates are managed in one place. No more juggling tools.
- Access to over 300 million property data points — Make data-driven decisions with real-time insights into homes and neighborhoods.
- Truly international platform — With listings from across the globe and local agent expertise, Anyone supports both domestic and cross-border buyers and sellers.
Trusted by real estate agents worldwide
Real estate agents from around the world are already using Anyone.com to streamline their workflows and better serve clients — including professionals from Germany, France, Canada, Australia, India, Sweden, the United Arab Emirates, Netherlands, Italy, Belgium, Spain, Finland, Switzerland, Poland, Portugal, Ireland, and Austria.
Global property access
Buyers can already find homes for sale in the United States, Canada, United Kingdom, Portugal, Greece, Netherlands, Switzerland, Poland, Belgium, Ireland, and more. Over the coming weeks, Anyone will expand its listings coverage in each of these markets, aiming to grow from 84% to near-complete coverage (99.99%) of all active listings.
A new take on home financing
Anyone is also developing an innovative mortgage product called the Anyone Mortgage for over two years now, launching in 2026. Designed for first-time buyers and underserved segments, the model aims to make homeownership more accessible by lowering the financial barrier to entry by almost 50%.
About Anyone.com
Anyone.com was founded by the team behind Dan.com — a digital asset marketplace acquired by GoDaddy in 2022. Leveraging deep expertise in simplifying complex digital transactions, the Anyone team has now turned its focus to one of the most important and antiquated industries: real estate.
By building the world’s first truly integrated transaction platform for buying and selling homes, Anyone is reshaping the way people access property — making real estate faster, smarter, and more inclusive for everyone.
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Fintech PR
Nucleus Synapse 2025 Ignites the Human-AI Alliance as the Middle East Leads the Charge in AI-Powered Banking
DUBAI, UAE, April 29, 2025 /PRNewswire/ — The Middle East isn’t just adopting digital transformation—it’s engineering the future of banking with bold leadership, smart regulation, and rapid AI investment. It is in this spirit of transformation that Nucleus Software convened Synapse 2025 – Middle East, held at the iconic Taj Exotic Resorts, The Palm, Dubai, uniting visionary banking leaders, technologists, and innovators to shape the Human-AI Alliance. More than just a gathering, Synapse 2025 was a catalyst for dialogue, strategy, and co-creation—anchored in the belief that the fusion of human insight and AI is the foundation of next-generation finance.
Mr. Vishnu R. Dusad, Managing Director & Co-founder of Nucleus Software, opened the event with an inspiring address that beautifully captured the spirit of the gathering—a celebration of enduring partnerships, innovation, and shared aspirations. With heartfelt reflections on Nucleus Software’s journey and a forward-looking vision rooted in technological purpose and human-centric progress, his words set a thoughtful and energizing tone for the day, reminding everyone of the power of collaboration in shaping the future of banking. “At Nucleus, we are committed to building solutions that are not just future-ready but future-defining,” he shared. “The Middle East is leading this transformation—bold, visionary, and driven by clear ambition. We are honoured to contribute to this journey.”
A compelling keynote was delivered by Mr. Jamal Saleh, Director General of the UAE Banks Federation (UBF), whose address illuminated the UAE’s transformative journey in digital finance. Highlighting the expansion of UBF from 46 to 62 member banks—now representing nearly the entire balance sheet of the UAE banking sector—Mr. Saleh reaffirmed the Federation’s leadership in driving regulatory innovation and AI adoption. Citing over 40 nationwide banking transformation initiatives inspired by His Highness Sheikh Mohammed bin Rashid Al Maktoum’s mobile-first government vision, Mr. Saleh underscored that “AI is no longer a buzzword—it is becoming the bloodstream of modern banking.” He emphasized the essential role of cybersecurity, trusted regulations, and human oversight in this evolution, and projected with confidence that the UAE would exceed its goal of doubling the digital economy’s GDP contribution by 2030—with partners like Nucleus Software playing a crucial role.
The day’s dialogue was further enriched by two dynamic panel discussions. In the business-focused session, thought leaders Shoaib Rizvi (SVP, Group Head of Digital Products, Emirates NBD), Sudarshan Seshadri (Head of Retail Banking, National Bank of Umm Al Qaiwain), Ahmed Mourad (COO, Astratech), and Suvo Sarkar (Banking Industry Leader & Host of Money Majlis) explored how human insight, powered by AI, is transforming the very fabric of banking. “Customer centricity is no longer optional—it’s programmable,” said Rizvi, while Seshadri noted that “AI is our co-pilot, not our competitor.” Moderated by Anshul Khare, Director, Products & Business Solutions at Nucleus Software, the panel emphasized that trust, agility, and hyper-personalization are central to next-generation growth.
In the technology dialogue, leaders Nitin Bhargava (COO, Al Masraf Bank), Fozi Sultan (Head of IT & Projects, Deem Finance), and Shino Thomas (Head of Technology Operations, mBank), offered deep insights into how AI-native infrastructure is being engineered today to enable scale and speed. From real-time intelligence to modular, cloud-first platforms, the panel, steered by Mohamed Roshdy (CIO, Reem Finance), affirmed that the early-mover advantage in AI development lies in bold execution and a clear architectural vision.
One of the most anticipated moments of the event was the fireside chat with Chris Taylor, CEO of Deem Finance. In a rare and personal conversation, Taylor revealed how his passion for endurance sports has shaped his leadership philosophy—one rooted in discipline, clarity, and sustained execution. Moderated by Mr. Ashwani Arora, Global Head – Customer Success at Nucleus Software, the discussion highlighted Deem’s transformation journey, including its $400M securitization achievement and the remarkable shift from 80% manual to 60% automated interactions. “The biggest barrier to doing the right thing with AI is resistance born out of fear,” Taylor stated, while applauding Nucleus Software’s seamless platform implementation of FinnOne Neo® Collections as a benchmark ‘green-to-green’ transformation.
As the event drew to a close, Mr. Parag Bhise, CEO & Executive Director of Nucleus Software, delivered a powerful closing note, thanking the distinguished participants and reaffirming the company’s commitment to co-creating the future of finance. “We leave here with stronger bonds, sharper perspectives, and a shared determination to lead this Human-AI era with integrity, intelligence, and impact,” he said.
The Middle East is rapidly emerging as a global epicenter for AI-driven banking innovation. Guided by visionary leadership, progressive regulation, and strategic investments in digital infrastructure, the region is redefining the future of financial services. It is against this dynamic backdrop that Nucleus Software hosted Synapse 2025 – Middle East, bringing together stalwarts from across the banking and fintech ecosystem to shape the future of responsible, AI-powered finance. The event was a powerful declaration of what lies ahead. A bold leap into a future where human potential and artificial intelligence work in harmony, not in competition, as collaborative engines of progress.
To know more, please visit https://www.nucleussoftware.com/
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