Arm

Celcuity Inc. Announces Plan to Initiate a Phase 3 Clinical Trial for Gedatolisib as First-Line Treatment for HR+/HER2- Advanced Breast Cancer and Secures Approximately $62 Million Debt Financing

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четверг, мая 30, 2024

“We are very encouraged by the preliminary clinical data for gedatolisib as first-line treatment in patients with advanced breast cancer.

Key Points: 
  • “We are very encouraged by the preliminary clinical data for gedatolisib as first-line treatment in patients with advanced breast cancer.
  • In our Phase 1b trial that evaluated gedatolisib in combination with palbociclib and letrozole, median progression free survival was 48.6 months, and the ORR was 79%.
  • Therefore, a safety run-in of approximately 12-36 subjects will evaluate the safety profile of gedatolisib combined with ribociclib and fulvestrant.
  • At the closing of this amendment to the debt financing agreement, Celcuity will receive $61.7 million and will have $100 million of total debt outstanding.

Immunocore converts Phase 2/3 TEBE-AM clinical trial into registrational Phase 3 trial evaluating KIMMTRAK for previously treated advanced cutaneous melanoma

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среда, мая 29, 2024

The Phase 2/3 TEBE-AM trial was designed to evaluate KIMMTRAK® (tebentafusp-tebn), as monotherapy and in combination with pembrolizumab, versus a control arm, for the treatment of patients with previously treated advanced cutaneous melanoma.

Key Points: 
  • The Phase 2/3 TEBE-AM trial was designed to evaluate KIMMTRAK® (tebentafusp-tebn), as monotherapy and in combination with pembrolizumab, versus a control arm, for the treatment of patients with previously treated advanced cutaneous melanoma.
  • The trial was originally designed as an adaptive Phase 2/3 trial with the optionality to review Phase 2 data and drop an arm.
  • Following consultation with the FDA, the Company has decided to conduct the trial solely as a Phase 3 with the primary endpoint of overall survival.
  • Mark Moyer, SVP, Regulatory Affairs, Immunocore said: “The decision to launch a registrational trial in cutaneous melanoma was based on KIMMTRAK’s overall survival benefit in uveal melanoma, and promising clinical activity as monotherapy and in combination with immune checkpoint therapy in Phase 1 cutaneous melanoma trials.

World First at Maria Middelares Hospital in Belgium Thanks to da Vinci SP’s Innovative Technology

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среда, мая 29, 2024

The new da Vinci SP (single port) surgical system has now been in use since May 21, making complex surgery even less invasive, via a single incision.

Key Points: 
  • The new da Vinci SP (single port) surgical system has now been in use since May 21, making complex surgery even less invasive, via a single incision.
  • It was on May 27 that a world first took place at the hospital: a kidney autotransplantation assisted by the da Vinci SP surgical system.
  • The arrival of Intuitive’s new da Vinci SP system aligns perfectly with Maria Middelares' vision of developing a patient-oriented robotics platform.
  • The da Vinci SP offers incredible value on a daily basis for Maria Middelares and its patients.

A Growing Gap: As Recognition Spend Increases, The Unrecognized Nearly Double

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среда, мая 29, 2024

The State of Recognition is an annual survey AWI conducts to examine trends, best practices, and priorities in employee recognition programs.

Key Points: 
  • The State of Recognition is an annual survey AWI conducts to examine trends, best practices, and priorities in employee recognition programs.
  • Many organizations are highly focused on retaining top performers, focusing resources and recognition on the 20% or so who consistently outperform.
  • However, there is considerable opportunity in increasing recognition across the board, likely improving outcomes for both average and low performers.
  • While managers establish a foundation for recognition, top programs also include peer recognition to foster employee connections and accelerate results.

Mad Max: Fury Road was a pioneering portrayal of disability. Furiosa is a letdown

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вторник, мая 28, 2024

Furiosa in Fury Road, played by Charlize Theron, represented a more inclusive form of heroism – a postfeminist celebration of teamwork.

Key Points: 
  • Furiosa in Fury Road, played by Charlize Theron, represented a more inclusive form of heroism – a postfeminist celebration of teamwork.
  • Furiosa promised to give us the impairment origin story and explain the experiences that shaped Furiosa to become the strong, disabled female leader in Fury Road.

Haunted by the past

  • In the 1979 first film, Max recognises his emerging, vengeful mania, saying spending too much time on the road will make him “a terminal crazy”.
  • As Max further withdraws from society, the films chronicle patriarchy at its extremes, and the breakdown of post-apocalyptic society.
  • By Fury Road, Max (Tom Hardy) is artfully shown suffering from post-traumatic stress disorder, repeatedly haunted by guilt and experiencing hallucinations.
  • Powerfully, also in Fury Road, the cause of Furiosa’s disability is neither revealed nor spoken of.

A narrative prosthesis

  • When disability is used as a narrative prosthesis, the story focuses on disability as a tragedy, or on overcoming the tragedy of an impaired body.
  • This focus comes at the expense of representations of disability and trauma explored throughout the previous films’ subtexts.
  • The characters with disabled and ageing bodies hold the promise for a new beginning, suggesting alternatives to violent, despotic overlords.
  • Such arresting imagery only serves to emphasise the former film’s potency and resonance at the expense of the latter.

Kymera Therapeutics to Present New Clinical Data from Ongoing Phase 1 Trial of MDM2 Degrader KT-253 at ASCO Annual Meeting

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четверг, мая 23, 2024

WATERTOWN, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced new clinical data for KT-253, a first-in-class MDM2 degrader, from its ongoing Phase 1 dose escalation trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 – June 4, 2024, in Chicago, Illinois. Results released in an ASCO abstract today include a data cut-off of January 26, 2024.

Key Points: 
  • Results released in an ASCO abstract today include a data cut-off of January 26, 2024.
  • “We continue to see encouraging data from the trial’s dose escalation phase demonstrating potent upregulation of p53 biomarkers and signs of antitumor activity in patients.
  • The Company expects to complete the study and share additional clinical data to inform the program’s next development steps in 2024 at an upcoming medical meeting.
  • Kymera is also developing a biomarker-based patient selection strategy for subsequent development beyond Phase 1a and is expected to present data at a medical meeting this year.

Nature Medicine Highlights Significant Improvement in Hand and Arm Function After Spinal Cord Injury with Use of ONWARD® ARC-EX® Therapy

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понедельник, мая 20, 2024

EINDHOVEN, the Netherlands, May 20, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces the publication of global Up-LIFT pivotal trial results in Nature Medicine. The study achieved all primary safety and effectiveness endpoints, and ARC-EX Therapy demonstrated significant improvements in upper limb strength, function, and sensation among people with chronic tetraplegia due to cervical SCI.

Key Points: 
  • The study achieved all primary safety and effectiveness endpoints, and ARC-EX Therapy demonstrated significant improvements in upper limb strength, function, and sensation among people with chronic tetraplegia due to cervical SCI.
  • Notably, the number of responders increased to 90% when the definition included participants with improvements in at least one strength or functional outcome*.
  • 87% of participants reported that ARC-EX Therapy delivered improvements in overall quality of life*.
  • “Improvement in arm and hand function is among the highest priorities for people with tetraplegia3 who have endured far too long without effective therapies for functional recovery,” said Dave Marver, CEO, ONWARD Medical.

Broadcom Announces Accelerate Program to Deliver Enhanced Customer Experience

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пятница, мая 17, 2024

An expansion of the Broadcom Global Cybersecurity Aggregator Program , the Accelerate Program is aimed at providing enhanced service levels for more Broadcom software solutions delivered to a broader range of Broadcom customers across multiple geographies.

Key Points: 
  • An expansion of the Broadcom Global Cybersecurity Aggregator Program , the Accelerate Program is aimed at providing enhanced service levels for more Broadcom software solutions delivered to a broader range of Broadcom customers across multiple geographies.
  • Through the Broadcom Accelerate Program, partners will act as an extension of the Broadcom team, helping customers receive the most value from their Broadcom software investment.
  • “Our goal is to deliver best-in-class experiences for customers of all sizes, and we continue to deliver on that with our partners through innovative models, like the Broadcom Accelerate Program,” said Cynthia Loyd, vice president of Global Commercial & Partner Sales, Broadcom.
  • With the Broadcom Accelerate Program, partners can differentiate themselves and create closer relationships with customers through their extensive knowledge of Broadcom solutions, in-region expertise and ability to deliver value-added services.

Flash News: OKX Fosters Growth in Notcoin Ecosystem with Trading Campaign Featuring 300 Million NOT Prize Pool

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четверг, мая 16, 2024

OKX today announced the launch of its 'NOT Trade and Earn' campaign featuring a 300 million NOT prize pool.

Key Points: 
  • OKX today announced the launch of its 'NOT Trade and Earn' campaign featuring a 300 million NOT prize pool.
  • This campaign, coupled with the recent addition of Notcoin on OKX's Jumpstart and spot market, aims to offer more ways for eligible users to interact with the Notcoin ecosystem, which already boasts 35 million members.
  • OKX also partnered with Notcoin to launch a 'NOT Learn and Earn' campaign earlier this week.
  • Far from being your typical GameFi project, Notcoin is TON's clicker game that has achieved viral status within the Telegram ecosystem.

LeddarTech Reports F2Q24 Results

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среда, мая 15, 2024

QUEBEC CITY, Canada, May 15, 2024 (GLOBE NEWSWIRE) -- LeddarTech Holdings Inc. (“LeddarTech”) (Nasdaq: LDTC), an automotive software company that provides patented disruptive AI-based low-level sensor fusion and perception software technology, LeddarVision ™, for ADAS, AD and parking applications, is pleased today to announce financial results for its fiscal second quarter 2024, which ended on March 31, 2024.

Key Points: 
  • QUEBEC CITY, Canada, May 15, 2024 (GLOBE NEWSWIRE) -- LeddarTech Holdings Inc. (“LeddarTech”) (Nasdaq: LDTC), an automotive software company that provides patented disruptive AI-based low-level sensor fusion and perception software technology, LeddarVision ™, for ADAS, AD and parking applications, is pleased today to announce financial results for its fiscal second quarter 2024, which ended on March 31, 2024.
  • Together, we eagerly anticipate achieving new milestones and driving the widespread adoption of our groundbreaking technology,” said Frantz Saintellemy, President and CEO of LeddarTech.
  • Product and Industry Collaboration Announcements:
    January 9, 2024: LeddarTech supports accelerated L2/L2+ ADAS development by releasing the LeddarVision Surround-View premium highway assist software stack on an embedded platform.
  • March 13, 2024: LeddarTech collaborates with Arm on future-ready software-defined vehicles.