VELA

MoonLake Immunotherapeutics starts Phase 3 VELA program of the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa

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星期四, 五月 16, 2024
IL-17A, Patient, University of Miami, Food, European Medicines Agency, Clinical trial, University, Depression, FDA, Associate professor, Moonlake, Single-domain antibody, Inflammation, MIRA, EMA, Tissue, Scar, HS, Pain, VELA, MAS, Pharmaceutical industry

Sonelokimab is designed to directly target sites of inflammation by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers and to penetrate difficult-to-reach inflamed tissues.

Key Points: 
  • Sonelokimab is designed to directly target sites of inflammation by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers and to penetrate difficult-to-reach inflamed tissues.
  • Following the positive results from the landmark Phase 2 MIRA trial, the Phase 3 VELA program is expected to enroll 800 patients across VELA-1 and VELA-2.
  • The Phase 3 program will use a protocol design consistent with the Phase 2 MIRA trial, which identified the optimal dose of sonelokimab for HS.
  • The topline primary endpoint readout (week 16) from the VELA program is expected as of mid-2025.

MoonLake Immunotherapeutics Reports First Quarter 2024 Financial Results and Provides a Business Update

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星期二, 五月 7, 2024
Komodo, Psoriatic arthritis, VELA, FDA, American Academy, Porokeratosis, Psoriasis, HS, Skin, Rheumatology, MDA, Research, Partnership, Conference, PPP, MIRA, Joint, Bimekizumab, Patient, EMA, AAD, Inflammation, PASI, Moonlake, Dermatology, ARGO, Pharmaceutical industry

Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “2024 is shaping up to be a strong year for MoonLake.

Key Points: 
  • Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “2024 is shaping up to be a strong year for MoonLake.
  • Research and development expenses for the quarter ended March 31, 2024, were $13.0 million, compared to $8.1 million in the previous quarter.
  • The increase was primarily due to expenses incurred to initiate the new clinical trials.
  • General and administrative expenses for the quarter ended March 31, 2024 were $6.8 million, similar to the $6.9 million incurred in the previous quarter.

MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day

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星期日, 三月 10, 2024
Psoriatic arthritis, ACR, Doctor of Philosophy, Adalimumab, Skin, American College, Webcast, Moonlake, HS, Patient, Psoriasis, VELA, MMSc, ARGO, MIRA, EDT, Physician, Inflammation, Safety, Prognosis, Clinical trial, Ankylosing spondylitis, TNF, IL-17A, MDA, American Academy, EMA, Medical college, FDA, Food, Steroid, Prevalence, AAD, Event, Joint, PASI, Hidradenitis suppurativa, PSA, PPP, Disease, Porokeratosis, Medicine, Pharmaceutical industry

In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.

Key Points: 
  • In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.
  • Treatment with sonelokimab resulted in unprecedented improvements in composite scores that reflect responses in different domains simultaneously.
  • In all composite scores, sonelokimab showed 16-29 percentage point differences to the reference adalimumab arm, comparatively higher to competitors using the same reference arm.
  • The discontinuation rate of the second part of ARGO remained low at 5%, in line with other sonelokimab trials.

MoonLake Immunotherapeutics Reports Full Year 2023 Financial Results, Recent Business Highlights and Announces an R&D Day on March 10

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星期四, 二月 29, 2024
MIRA, Psoriatic arthritis, EMA, Research, VELA, Medical college, Inflammation, FDA, Investment, Assessment, Conference, AAD, Rheumatology, Event, ARGO, Hidradenitis suppurativa, Webcast, Patient, Science, American Academy, Pharmaceutical industry

Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “2023 was another momentous year for MoonLake in the inflammation and immunology field.

Key Points: 
  • Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “2023 was another momentous year for MoonLake in the inflammation and immunology field.
  • On top of this, support from world-renowned experts, clinicians, and patient organizations for our data, science and methodologies continues to mount.
  • Matthias Bodenstedt, Chief Financial Officer at MoonLake Immunotherapeutics, said: “MoonLake has added considerable shareholder value over the past year, and we are driven to continue building on this.
  • Other non-operating income increased from $0.6 million in the prior year to $10.1 million for the year ended December 31, 2023.

MoonLake Immunotherapeutics Announces Positive Feedback from both FDA and EMA on Regulatory Path for the Phase 3 Program of the Nanobody® sonelokimab (SLK) in Hidradenitis Suppurativa (HS)

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星期一, 二月 26, 2024
MIRA, Psoriatic arthritis, EMA, VELA, Physician, FDA, Food, SLK, BLA, Inflammation, Hidradenitis suppurativa, Patient, OLE, Moonlake, Biologics license application, Medical imaging

European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake’s proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab (SLK) in hidradenitis suppurativa (HS).

Key Points: 
  • European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake’s proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab (SLK) in hidradenitis suppurativa (HS).
  • The Phase 3 program, named VELA, is expected to enroll 800 patients and in combination with the data from Phase 2 MIRA trial will support both a Biologics License Application (BLA) and E.U.
  • We deeply appreciate the support from both agencies and continue to work swiftly to ramp up the Phase 3 program in HS, named VELA.
  • Moonlake will provide more information relating to the plans for both the HS and PsA programs during an upcoming R&D Day.

Long-time Tampa Private Company Enable Me LLC® Acquired by Danish Manufacturing Company VELA

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星期二, 十月 3, 2023
Manufacturing, Other Health, Health, General Health, Women, Radiology, Health Technology, Medical Devices, Other Manufacturing, Hospitals, Consumer, VELA, Incidence, Mammography, Patient, Falls, Vertigo, Safety, Health insurance, Rolling (metalworking), Furniture

Danish healthcare manufacturing company VELA Chairs has acquired longtime Tampa private company Enable Me LLC® and named it the exclusive North American distributor for its VELA Mammography Chair , which provides safety, security, and wellbeing for mammography patients.

Key Points: 
  • Danish healthcare manufacturing company VELA Chairs has acquired longtime Tampa private company Enable Me LLC® and named it the exclusive North American distributor for its VELA Mammography Chair , which provides safety, security, and wellbeing for mammography patients.
  • “Seated mammography is growing in popularity for its many benefits to the patient, including reducing the stress of standing during the procedure and the incidence of unsteadiness and even falls,” said Mike Laky, founder and CEO of Enable Me.
  • “The electric height-adjustable chair, with a push bar and lockable wheels, is also crafted to provide the most optimal working conditions for the mammographer while contributing to higher image quality.”

Vela Diagnostics Collaborates with SRL Inc. for Product Distribution in Japan

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星期一, 十月 2, 2023
RCA, Information Holdings Inc., Partnership, HIV, HIV-1, NGS, Research and development, Drug resistance, Patient, VELA, FDA, Massive parallel sequencing, Medical device, Nursing, Research

This partnership aims to facilitate the distribution of Vela Diagnostics' cutting-edge molecular diagnostic solutions in Japan.

Key Points: 
  • This partnership aims to facilitate the distribution of Vela Diagnostics' cutting-edge molecular diagnostic solutions in Japan.
  • The research collaboration agreement (RCA) between Vela Diagnostics and SRL Inc was signed in June 2023, marking a significant milestone in their shared commitments to advancing healthcare solutions in Japan.
  • Vela Diagnostics aims to capitalize on SRL Inc's comprehensive distribution network and market understanding, enabling the company to introduce its Sentosa® SQ HIV-1 Genotyping Assay Kit to Japanese healthcare and diagnostic institutions.
  • Dr Tony Zhang, Head of Research and Development at Vela Diagnostics, states that SRL Inc has begun feasibility studies for the Sentosa® SQ HIV-1 Genotyping Assay Kit.

Vela Diagnostics Collaborates with SRL Inc. for Product Distribution in Japan

Retrieved on: 
星期一, 十月 2, 2023
RCA, Information Holdings Inc., Partnership, HIV, HIV-1, NGS, Research and development, Drug resistance, Patient, VELA, FDA, Massive parallel sequencing, Medical device, Nursing, Research

This partnership aims to facilitate the distribution of Vela Diagnostics' cutting-edge molecular diagnostic solutions in Japan.

Key Points: 
  • This partnership aims to facilitate the distribution of Vela Diagnostics' cutting-edge molecular diagnostic solutions in Japan.
  • The research collaboration agreement (RCA) between Vela Diagnostics and SRL Inc was signed in June 2023, marking a significant milestone in their shared commitments to advancing healthcare solutions in Japan.
  • Vela Diagnostics aims to capitalize on SRL Inc's comprehensive distribution network and market understanding, enabling the company to introduce its Sentosa® SQ HIV-1 Genotyping Assay Kit to Japanese healthcare and diagnostic institutions.
  • Dr Tony Zhang, Head of Research and Development at Vela Diagnostics, states that SRL Inc has begun feasibility studies for the Sentosa® SQ HIV-1 Genotyping Assay Kit.

This Week in Transportation News: 11 Stories You Need to See

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星期五, 六月 16, 2023
Database, Horacio Estol, TD, Aluminium, Unique, Related, Transport, Ship, VELA, PR Newswire, News, Subject-matter expert, Geography, Road, Mobile phone, Publishing

NEW YORK, June 16, 2023 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help journalists covering the auto and transportation industries stay on top of the week's most newsworthy and popular releases, here's a roundup of stories from the week that shouldn't be missed.

Key Points: 
  • Electra's proprietary blown lift technology uses eight motors to provide additional wing lift, and hybrid-electric power that provides internal recharging capabilities for aircraft batteries, eliminating the need for new ground infrastructure.
  • All components of the ship have also been designed to be dismantled for reuse on other VELA ships or for other purposes.
  • Subject Matter Experts: Access ProfNet , a database of industry experts to connect with as sources or for quotes in your articles.
  • Related Resources: Read and subscribe to our journalist- and blogger-focused blog, Beyond Bylines , for media news roundups, writing tips, upcoming events, and more.

VELA UNVEILS ITS UNIQUE SAILING CARGO TRIMARAN: AN INNOVATIVE SHIP FOR 100% WIND POWERED TRANSPORTATION

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星期二, 六月 13, 2023
TEU, Organizational founder, Aluminium, Wind, Ship, Atlantic Ocean, VELA, Weather, Transport, Safety, Renewable energy, EU

Departing from the conventional single-hulled approach, and inspired by the modern technologies used for ocean racing, VELA's sailing cargo vessel will have three hulls and is anticipated to be launched in 2025.

Key Points: 
  • Departing from the conventional single-hulled approach, and inspired by the modern technologies used for ocean racing, VELA's sailing cargo vessel will have three hulls and is anticipated to be launched in 2025.
  • All components of the ship have also been designed to be dismantled for reuse on other VELA ships or for other purposes.
  • The first VELA trimaran cargo vessel is expected to make its maiden voyage mid-2025, sailing the transatlantic route between Europe and the United States.
  • The exceptional maneuverability of the VELA Trimaran Cargo vessel allows access to secondary ports, facilitating closer proximity to customers' factories and warehouses.