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

Retrieved on: 
Sunday, March 10, 2024

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

Retrieved on: 
Monday, March 4, 2024

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

Retrieved on: 
Thursday, February 29, 2024

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)

Retrieved on: 
Monday, February 26, 2024

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

Retrieved on: 
Saturday, February 24, 2024

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.

Virtual Incision Receives FDA Authorization for the First Miniaturized Robotic-Assisted Surgery Device

Retrieved on: 
Tuesday, February 27, 2024

GRAND RAPIDS, Mich., Feb. 27, 2024 /PRNewswire/ -- Virtual Incision , a cultivate(MD) portfolio company , has been granted marketing authorization of the MIRA™ Surgical System (MIRA) from the FDA.

Key Points: 
  • GRAND RAPIDS, Mich., Feb. 27, 2024 /PRNewswire/ -- Virtual Incision , a cultivate(MD) portfolio company , has been granted marketing authorization of the MIRA™ Surgical System (MIRA) from the FDA.
  • This marks a significant milestone as MIRA becomes the first miniaturized robotic-assisted surgery device in the world approved for adult colectomy procedures.
  • FDA authorization was based in part on findings from the company's U.S. Investigational Device Exemption (IDE) clinical study.
  • With FDA authorization in hand, Virtual Incision is set to initiate MIRA's commercial rollout in select centers in the United States.

Virtual Incision’s Miniaturized Surgical Robot En Route to the International Space Station for Testing of Long-Range Remote Capabilities

Retrieved on: 
Tuesday, January 30, 2024

Virtual Incision Corporation, the developer of the MIRA Surgical System (MIRA), today announced that spaceMIRA is currently in transit to the International Space Station.

Key Points: 
  • Virtual Incision Corporation, the developer of the MIRA Surgical System (MIRA), today announced that spaceMIRA is currently in transit to the International Space Station.
  • Testing with spaceMIRA on the International Space Station will assess the impact of zero gravity when performing simulated surgical tasks.
  • Learnings about remote surgery could potentially impact healthcare in space and across the globe.
  • The testing with spaceMIRA will tell us more about the future potential of miniRAS as it might be applied to remote surgery applications.”

[INVNT GROUP]™, the Global Brand Storytelling and Marketing Agency Portfolio, Marks a New Era in Global Expansion with Significant Advances in United Arab Emirates (UAE)

Retrieved on: 
Wednesday, December 20, 2023

The Stella McCartney Marketplace: An experience spotlighting product displays and information on the LVMH brand's unwavering commitment to sustainability and conscious luxury movement.

Key Points: 
  • The Stella McCartney Marketplace: An experience spotlighting product displays and information on the LVMH brand's unwavering commitment to sustainability and conscious luxury movement.
  • One World One Humanity: A large-scale interactive entertainment performance using human-driven, larger-than-life characters to deliver a narrative inspired by COP28's central message: "UNITE.
  • “In today's rapidly evolving global landscape, our focus across the group is squarely on engaging both global and local audiences through immersive brand storytelling.
  • Our team blends global vision with local insights and tactics, ensuring our initiatives resonate meaningfully in the region.

MoonLake Immunotherapeutics Reports Third Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, November 14, 2023

During the quarter and post period, MoonLake announced significant new positive clinical data from two global Phase 2 trials of sonelokimab: “MIRA”, in moderate-to-severe hidradenitis suppurativa (HS) and “ARGO”, in active psoriatic arthritis (PsA).

Key Points: 
  • During the quarter and post period, MoonLake announced significant new positive clinical data from two global Phase 2 trials of sonelokimab: “MIRA”, in moderate-to-severe hidradenitis suppurativa (HS) and “ARGO”, in active psoriatic arthritis (PsA).
  • The Nanobody’s® smaller size versus traditional antibodies and its albumin-binding domain provide an opportunity for further efficacy.
  • Research and development expenses for the quarter ended September 30, 2023, were $7.6 million, compared to $8.7 million in the previous quarter.
  • General and administrative expenses for the quarter ended September 30, 2023, were $5.4 million, compared to $4.5 million in the previous quarter.

Metrohm Presents Tools for Fentanyl Identification On the Street and In the Lab

Retrieved on: 
Monday, December 11, 2023

PLAINSBORO, N.J., Dec. 11, 2023 /PRNewswire-PRWeb/ -- Finding a problem is the first step to solving it.

Key Points: 
  • Metrohm is pleased to announce that it has released a new website dedicated to the identification of fentanyl.
  • idfentanyl.com is an overview of Metrohm's capability to detect and identify fentanyl using Raman spectroscopy.
  • Metrohm's Raman tools identify fentanyl in a field or laboratory setting, aiding law enforcement in establishing cause and clearing forensic backlogs.
  • Raman products from Metrohm can work in either a field or laboratory setting to identify fentanyl.