<div>
  <ul>
    <li>
      <p>
        The FDA has rejected Lykos Therapeutics' application for MDMA-assisted therapy for post-traumatic stress disorder. The FDA requested that Lykos conduct another Phase III trial to study the safety and efficacy of MDMA further.
      </p>
    </li>
    <li>
      <p>
        Lykos Therapeutics plans to request a meeting with the FDA to discuss the decision and explore regulatory pathways. The company believes existing data can address many of the FDA's concerns and is committed to finding an expeditious path forward for patients.
      </p>
    </li>
    <li>
      <p>
        <b>Analyst QuickTake:</b>
         The rejection reflects concerns raised during the FDA advisory committee meeting in 
        <a href="https://sp-edge.com/updates/30125">
          June 2024
        </a>
        , including issues related to the durability of the treatment's effects, potential expectancy bias from participants with prior MDMA use, and questions about the role of psychotherapy in the treatment.
      </p>
    </li>
  </ul>
  <p>
  </p>
</div>


<div>
  <p>
    <a href="https://news.lykospbc.com/2024-08-09-Lykos-Therapeutics-Announces-Complete-Response-Letter-for-Midomafetamine-Capsules-for-PTSD">
      Press release
    </a>
  </p>
  <p>
    <a href="https://psychedelicalpha.com/news/breaking-fda-rejects-lykos-therapeutics-mdma-assisted-therapy-for-ptsd">
      Psychedelic Alpha
    </a>
  </p>
</div>


Psychedelic Medicine

ANALYST_QUICK_TAKE

INCUMBENTS_PRESENT

<div>
 <p>The FDA has not approved Lykos Therapeutics' proposal to use MDMA-assisted therapy for post-traumatic stress disorder, citing the need for an additional Phase III trial to further examine the drug's safety and efficacy.</p>
 <p>Responding to the decision, Lykos Therapeutics intends to arrange a meeting with the FDA to reconsider the ruling, based on the belief that existing data can satisfy many of the agency's concerns. The company is determined to swiftly find a solution for patient benefit.</p>
 
</div> <p><b>Analyst QuickTake:<br>
</b> The rejection reflects concerns raised during the FDA advisory committee meeting in <a href="https:<br>
//sp-edge.com/updates/30125"> June 2024 </a> , including issues related to the durability of the treatment's effects, potential expectancy bias from participants with prior MDMA use, and questions about the role of psychotherapy in the treatment.</p>

FDA rejects Lykos Therapeutics' MDMA-assisted therapy for PTSD

Additive manufacturing makes objects by systematically adding material via a CAD program

Additive Manufacturing

<div>
 
 <p>6K Additive, a supplier of additive manufacturing materials, has been chosen by America Makes, an institution that collaborates on 3D printing projects in the US, to participate in the "Powder Alloy Development for Additive Manufacturing (PADAM)" project.</p>
 <p>The project, endowed with six million dollars from the Air Force Research Laboratory, aims to enhance the cost-efficiency and effectiveness of the production of niobium C-103 powder for laser powder bed fusion and directed energy deposition (DED) 3D printing processes. Additionally, it aims to extend the source pool and utilize a wider range of particle sizes for C-103, a niobium alloy utilized in high-temperature applications. The project will also include collaboration with Castheon, NASA Glenn Research Center, NSL Analytical, Lockheed Martin, and Firefly Aerospace.</p>
 <p>&nbsp;6K Additive plans to use its proprietary UniMelt microwave plasma process to generate C-103 powders from revert sources, reportedly enhancing efficiency in high-temperature and space applications.</p>
 
</div> <p><b>Analyst Quicktake:<br>
 </b> This news marks the second time that American Makes has selected the company to participate in one of its projects. Last month, the company <a href="https:<br>
//sp-edge.com/updates/32452"> partnered with RTX Technology Research Center and the University of Arizona </a> as part of the EARTH project under America Makes and the National Center for Defense Manufacturing and Machining to make aerospace and defense product manufacturing more sustainable.</p>

6K Additive awarded project to develop C-103 powder for additive manufacturing

PROMINENT_CATEGORY

<div>

<p>Innovative Space Carrier (ISC), a company in Tokyo specializing in space transportation systems, has entered into a partnership with WAAM3D, Cranfield University, and Aichi Sangyo. All these organizations bring different specialties to the table - WAAM3D is a metal AM solutions provider, while Aichi Sangyo is known for their metal 3D printers. The collaboration aims to develop reusable space transportation vehicles.</p>
<p>The partnership will allow ISC to procure 3D printers from WAAM3D in Japan for the purpose of creating propellant tanks and other necessary components for space transport. This should contribute to the flexibility and efficiency of the development process.&nbsp;</p>

</div>

WAAM3D partners with Innovative Space Carrier, Cranfield University, and Aichi Sangyo for space transport development

Using real-time data to create dynamic virtual representations of the real world

Digital Twin

<div>
 <p>Akselos, a provider of digital twin technology, has launched a new software called Structural Performance Management for FPSO 4.0. The software is designed for Floating Production Storage and Offloading (FPSO) vessels and aims to enhance their operations and longevity.</p>
 <p>The software offers several benefits including a reduction in operating costs, optimal planning for inspections and maintenance, minimal downtime, and faster resolution of structural issues. Utilizing RB-FEA technology, the software produces millimeter-level precision for monitoring structural integrity. It develops a digital twin of the FPSO and has the capability to integrate various data such as inspection, metocean, tank fills, and unloading.</p>
 
</div> <p><b>Analyst QuickTake:<br>
 </b> Akselos has entered partnerships to offer digital twin solutions for FPSOs in the past. Last September, the company partnered with <a href="https:<br>
//sp-edge.com/updates/21998"> Yinson Production and Enauta </a> to deploy Akselos' digital twin technology on the floating vessel Atlanta FPSO in Brazil's Santos Basin.</p>

Akselos introduces software for FPSO monitoring

AI-based solutions for evolving digital threats

Next-gen Cybersecurity

<div>
 
 <p>Operant AI, a runtime protection startup, has successfully raised USD 10 million in a Series A funding round. The round was led by SineWave Ventures and had contributions from Felicis, Alumni Ventures, Massive, Calm Ventures, and Gaingels. The startup has raised a total of USD 13.5 million since launching publicly in April 2023.</p>
 <p>The new funds will be used to expand the company's staff and product offerings. Operant AI plans to provide a runtime application platform that can protect all layers of live applications from potential attacks.</p>
 <p>The solution from Operant AI purports to block over 80% of common runtime attacks, which include those in the OWASP Top 10. This level of protection is achievable without making substantial changes to the code or instrumentation. The company sees a substantial market for runtime application protection tools as replacements for traditional static security approaches.</p>
 
</div>

Operant AI raises USD 10 million in Series A funding to boost runtime protection

Ensuring the right people access the right resources at the right time

Identity & Access Management

<div>
 
 <p>Aembit, a company that specializes in nonhuman identity and access management (IAM), recently raised USD 25 million in a Series A funding round. The round was spearheaded by Acrew Capital and saw participation from Ballistic Ventures, Ten Eleven Ventures, Okta Ventures, and CrowdStrike Falcon Fund.</p>
 <p>The capital raised will be channeled into improving Aembit's nonhuman IAM solutions. These services perform the crucial role of securing access between workloads, such as clouds, SaaS, and data centres.</p>
 <p>Aembit conducted a survey that shed light on the state of nonhuman identity credentials in organizations. It found that 30% of the organizations store these credentials as code, while 23% communicate them through email and chat. Interestingly, over 60% of the respondents expressed a desire for a comprehensive solution for managing nonhuman identities throughout their organizations.</p>
 
</div>

Aembit raises USD 25 million in Series A funding to advance IAM solutions

<div>
 
 <p>Saviynt, a cloud-native identity and governance platform provider, has unveiled its Intelligence Suite, including Intelligent Recommendations. This advanced feature set is now open for general use, intending to transform identity security.</p>
 <p>The Intelligence Suite comprises several key elements: Access Recommendations, an advanced engine detecting various aspects; Copilot, an AI-assistant for end users task streamlining; and Trust Scoring, a feature merging risk signals into a single trust score for better decision-making.</p>
 <p>The company asserts that the Intelligence Suite can reduce access request and provisioning times by over 50%, cut role development and management efforts by over 80%, and lessen access certification workloads by up to 80%. Early adopters signal a 70% rise in access revocations for sensitive and critical access, efficiency gains over 60% in access recommendations, and a six-time increase in identifying and cleaning up outlier access.</p>
 
</div>

Saviynt launches Intelligence Suite for identity security

Sustainably solving the food shortages of the future

Smart Farming

<div>
 
 <p>FarmWise, a company based in California which provides precision agriculture solutions via robots, has formed a partnership with RDO Equipment Co., a seller of agricultural equipment. This collaboration is to sell and provide support for FarmWise's Vulcan precision weeding technology.</p>
 <p>The objective of the partnership is to supply Vulcan solutions to vegetable farmers in the Southwest US. RDO will perform the roles of sales and field support for FarmWise, utilizing its service network to widen Vulcan's offerings for existing and newly introduced specialty crops.</p>
 <p>They believe that this partnership will also help in overcoming labor problems faced in the agriculture sector of the region. They plan to do this by giving farmers access to non-chemical weed removal alternatives.</p>
 
</div>

FarmWise partners with RDO Equipment Co. to expand AI-powered weeding technology for vegetable growers

Bringing fresh produce closer to consumers with efficient, advanced technology.

Vertical Farming

<div>
 
 <p>Alberta Food Security Inc. (AFSI), a TrustBIX Inc. subsidiary, was awarded a USD 5 million contract to construct several indoor vertical farms in Ontario, Canada.</p>
 <p>AFSI stipulates that they have received 50% of the cost upfront before delivery, and will acquire the remaining balance within 30 days. They predict roughly a 15% gross margin on the order.</p>
 <p>AFSI plans to levy a yearly 5% fee of the purchase price for maintenance and management services, driven by artificial intelligence and machine learning, once the indoor farms become fully functional.</p>
 
</div>

Alberta Food Security Inc. receives USD 5 million order for indoor farming technology

AI, robotics, and IoT to streamline the flow of goods and information

Logistics Tech

<div>
<p>AutoStore, an automated storage and retrieval systems provider, has announced an enhancement of its micro-fulfillment offerings. This includes a new Multi-Temperature Solution, expanded 18-level Grid, and a Motorized Service Vehicle. </p>

<p>The Multi-Temperature Solution integrates multiple temperature zones in a single AutoStore cube, accommodating frozen and chilled environments within a range of -25°C to +6°C. It is currently in use at Haugaland Storhusholdning and will soon be installed at La Réserve des Saveurs by Swisslog. The solution will be available for order from Q1 2025.</p> 

<p>With the new 18-level Grid, the company increases storage density by up to 12.5% and reduces Grid floor space by up to 11%. Alongside this, AutoStore introduced the Motorized Service Vehicle to enhance safety during maintenance tasks on large systems, and improve cube control software functionality. </p>
</div>

AutoStore enhances microfulfilment offering with new grid capabilities and multi-temperature solution

Exploring the limitless possibilities of AI

Generative AI Applications

<div>
 
 <p>OpenAI introduces o1, a new series of AI models for fact-checking and code generation purposes.</p>
 <p>The o1 preview employs a "chain of reasoning" system, which assesses all facets of a query before responding. The model's capability to plan and execute a series of tasks over a longer period makes it ideal for undertaking tasks that demand the integration of multiple subtasks. The price for using o1-preview in API is set at USD 15 per 1 million input tokens and USD 60 per 1 million output tokens.</p>
 <p>The service also includes a more affordable modeling option called o1-mini designed for coding, which is priced 80% less than the cost of o1-preview.</p>
 
</div> <p><b>Analyst </b> <b>QuickTake:<br>
 </b> This news comes as the company reportedly seeks to <a href="https:<br>
//sp-edge.com/updates/33517"> raise USD 6.5 billion </a> in funding while considering <a href="https:<br>
//sp-edge.com/updates/33264"> restructuring </a> to attract investors. Notably, the new <a href="https:<br>
//sp-edge.com/updates/32995"> o1 model </a> was code-named "Strawberry" and planned to be launched in the fall of 2024 (September–December). The company claims that the model outperforms previous data analysis, science, and coding models. However, o1 can be slower than other models, sometimes taking over 10 seconds to answer questions, and may still produce errors and hallucinations.</p>

All Updates

FDA rejects Lykos Therapeutics' MDMA-assisted therapy for PTSD

6K Additive awarded project to develop C-103 powder for additive manufacturing

WAAM3D partners with Innovative Space Carrier, Cranfield University, and Aichi Sangyo for space transport development

Akselos introduces software for FPSO monitoring

Operant AI raises USD 10 million in Series A funding to boost runtime protection

Aembit raises USD 25 million in Series A funding to advance IAM solutions

Saviynt launches Intelligence Suite for identity security

FarmWise partners with RDO Equipment Co. to expand AI-powered weeding technology for vegetable growers

Alberta Food Security Inc. receives USD 5 million order for indoor farming technology

AutoStore enhances microfulfilment offering with new grid capabilities and multi-temperature solution

OpenAI launches o1, a self-fact-checking AI model

Psychedelic Medicine

FDA rejects Lykos Therapeutics' MDMA-assisted therapy for PTSD

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