MIRA

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

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화요일, 5월 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.

Virtual Incision Announces Publication of Data from its U.S. Investigational Device Exemption Study in the Clinical Journal, Diseases of Colon and Rectum

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화요일, 4월 30, 2024
Medical Devices, Health, Surgery, Health Technology, Clinical Trials, General Health, Colorectal surgery, FDA, Lankenau Medical Center, Learning, Safety, Food, IDE, Surgeon, MD, Trial of the century, Doctor of Philosophy, FACS, MIRA, Incidence, Patient, De novo, Aes, Investigational device exemption, Quality of life

Virtual Incision Corporation , the developer of the MIRA™ Surgical System (MIRA), today announced data from its Investigational Device Exemption (IDE) clinical study has been published in Diseases of Colon and Rectum .

Key Points: 
  • Virtual Incision Corporation , the developer of the MIRA™ Surgical System (MIRA), today announced data from its Investigational Device Exemption (IDE) clinical study has been published in Diseases of Colon and Rectum .
  • The study was designed to assess the safety and efficacy of MIRA, the world’s first miniaturized robotic-assisted surgery device, in adults undergoing colectomy procedures.
  • Results were provided to the Food and Drug Administration (FDA) as part of the submission to support the de novo marketing authorization of the device.
  • The data demonstrated the following results:
    The primary efficacy endpoint, the successful completion of pre-defined procedural steps without conversion to open surgery, was met.

Virtual Incision to Showcase Miniaturized Robotic-Assisted Surgery at SAGES 2024

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수요일, 4월 10, 2024
Robotics, Medical Devices, Health, Technology, Surgery, Health Technology, FDA, Cancer, Miniaturization, International Space Station, Trial of the century, MIRA, Marketing

Virtual Incision Corporation , the developer of the MIRA Surgical System (MIRA), today announced its participation at the 2024 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conference taking place April 17-20 in Cleveland.

Key Points: 
  • Virtual Incision Corporation , the developer of the MIRA Surgical System (MIRA), today announced its participation at the 2024 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conference taking place April 17-20 in Cleveland.
  • Attendees are invited to “Meet MIRA” in the exhibit hall at Virtual Incision booth #736.
  • They will be able to gain hands-on experience with the world’s first miniaturized robotic-assisted surgery (miniRAS) system, which recently received FDA marketing authorization .
  • “It is a significant milestone as we embark on the commercialization of a brand-new category of miniaturized robotic-assisted surgery.

Virtual Incision’s MIRA Surgical System to be Featured Among Elite AI-Enabled Innovations at NVIDIA GTC

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월요일, 3월 18, 2024
Technology, Manufacturing, Health, General Health, Robotics, Health Technology, Other Technology, Medical Devices, Artificial Intelligence, Surgery, Engineering, Nvidia Jetson, Computer graphics, GTC, MIRA, Data science, Patient, International Space Station, Artificial intelligence, General surgery, Surgeon, Gynaecology, ISS, Safety, Machine learning, Expo Hall, NVIDIA, FDA

Virtual Incision Corporation , the developer of the MIRA Surgical System (MIRA), today announced the company will showcase MIRA at NVIDIA GTC .

Key Points: 
  • Virtual Incision Corporation , the developer of the MIRA Surgical System (MIRA), today announced the company will showcase MIRA at NVIDIA GTC .
  • Virtual Incision will be featured in booth 1332 at the Healthcare Pavilion located inside the Expo Hall.
  • The system utilizes the NVIDIA Jetson platform to collect, convert, and enhance visual data from MIRA’s integrated articulating camera.
  • “The MIRA Surgical System leverages key computing elements from the NVIDIA accelerated computing and AI platform.

MIRA Pharmaceuticals Welcomes Dr. Itzchak Angel, former Head of Pharmacology at Synthelabo, as Chief Scientific Advisor

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목요일, 3월 21, 2024
Discovery, Research, Depression, Epilepsy, MIRA, Development, Shire (pharmaceutical company), Stroke, Litoxetine, IND, VPA, Sanofi, Clinical trial, Research and development, Investigational New Drug, Drug development, Marketing, Pharmaceutical industry

MIAMI, March 21, 2024 /PRNewswire/ -- MIRA Pharmaceuticals Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on the development of novel treatments for neurologic and neuropsychiatric disorders, proudly announces the appointment of distinguished pharmaceutical executive Dr. Itzchak Angel as its new Chief Scientific Advisor.

Key Points: 
  • Dr. Angel brings over 40 years of preclinical, clinical and regulatory acumen to MIRA.
  • He has significantly contributed to the research, development and regulatory approval of groundbreaking medications over his remarkable career.
  • Additionally, his activities contributed to the development and marketing of Mizollen (mizolastine), Xatral (alfuzosin) and Ambien (zolpidem).
  • "We are truly honored to have Dr. Angel on our team," stated Erez Aminov, Chairman & CEO of MIRA.

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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일요일, 3월 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 to present MIRA trial data of Nanobody® sonelokimab in hidradenitis suppurativa as a late breaker at the AAD Annual Meeting 2024

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월요일, 3월 4, 2024
MIRA, University College Dublin, Doctor of Philosophy, MD, Teaching hospital, Single-domain antibody, EST, Hidradenitis suppurativa, Inflammation, AAD, Safety, Patient, PST, Moonlake, Venereology, HS, American Academy, Pharmaceutical industry

Kristian Reich, MD, PhD, Chief Scientific Officer at MoonLake commented: “We are pleased that the 24-week data from our Phase 2 MIRA trial has been selected by the American Academy of Dermatology as an oral late-breaking presentation.

Key Points: 
  • Kristian Reich, MD, PhD, Chief Scientific Officer at MoonLake commented: “We are pleased that the 24-week data from our Phase 2 MIRA trial has been selected by the American Academy of Dermatology as an oral late-breaking presentation.
  • The presentation will be held on Sunday 10 March at 14:00 PST / 17:00 EST / 23:00 CET during the late breaking research session 2 (S050) in room 20B.
  • Key members of the MoonLake team, including the executive leadership team, will attend AAD.
  • This was followed by an announcement in October 2023, reporting from the trial at 24 weeks, further establishing sonelokimab as a highly promising and differentiated therapeutic solution for HS.

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

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목요일, 2월 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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월요일, 2월 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.

Virtual Incision Receives FDA Authorization for the MIRA Surgical System as the First Miniaturized Robotic-Assisted Surgery Device

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토요일, 2월 24, 2024
Technology, Surgery, Medical Devices, FDA, Hospitals, Health Technology, Health, Robotics, Artificial Intelligence, MIRA, Miniaturization, Food, Surgeon, IDE, General surgery, MIS, Gynaecology, Colectomy, Patient, Operating, Trial of the century, 3D printing

Virtual Incision Corporation announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization of the MIRA™ Surgical System (MIRA), the world’s first miniaturized robotic-assisted surgery (miniRAS) device, for use in adults undergoing colectomy procedures.

Key Points: 
  • Virtual Incision Corporation announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization of the MIRA™ Surgical System (MIRA), the world’s first miniaturized robotic-assisted surgery (miniRAS) device, for use in adults undergoing colectomy procedures.
  • FDA authorization was based in part on findings from the company’s U.S. Investigational Device Exemption (IDE) clinical study.
  • The announcement was made by Virtual Incision’s president and chief executive officer, John Murphy, at the SAGES 5th Annual Next Big Thing Innovation Weekend in Houston.
  • “Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturized robotic surgery a reality,” said John Murphy.