LUNA

Adverum Biotechnologies Announces New Executive Leadership Roles

Retrieved on: 
Thursday, May 25, 2023
Gilead Sciences, Adverum Biotechnologies, Drug development, AMD, Pharming, Pharmacovigilance, European Medicines Agency, Lead, Novartis Institute for Tropical Diseases, Biomedical Research, LUNA, PRIME, IVT, Patient, Ophthalmology, Johnson & Johnson, United, Medicines and Healthcare products Regulatory Agency, Pharmaceutical industry, Pittosporum tobira

REDWOOD CITY, Calif., May 25, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced new executive leadership roles that support the ongoing development of the investigational gene therapy ixoberogene soroparvovec (Ixo-vec). Ixo-vec is currently being evaluated in the Phase 2 LUNA trial as a one-time intravitreal (IVT) injection for patients in the treatment of neovascular or wet age-related macular degeneration (wet AMD).

Key Points: 
  • Dr. Beckman will continue to advise on Adverum’s pipeline, including Ixo-vec, and support our external engagement with key stakeholders.
  • Star Seyedkazemi, Pharm.D., chief development officer, is expanding her responsibilities to lead Adverum’s clinical development, medical affairs and pharmacovigilance teams.
  • Dr. Beckman and Dr. Seyedkazemi will continue to report to Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies.
  • “I am pleased that he will continue to work with Adverum in his role as senior medical advisor.

Luna Announces First-Quarter 2023 Financial Release Date of May 9, 2023

Retrieved on: 
Friday, April 28, 2023
Telephone, Luna, Webcast, LUNA, Cryptocurrency

Roanoke, VA, April 28, 2023 (GLOBE NEWSWIRE) -- Luna Innovations Incorporated (NASDAQ: LUNA) announced today it will report its first-quarter financial results for the period ended March 31, 2023, before the open of the stock market on Tuesday, May 9, 2023.

Key Points: 
  • Roanoke, VA, April 28, 2023 (GLOBE NEWSWIRE) -- Luna Innovations Incorporated (NASDAQ: LUNA) announced today it will report its first-quarter financial results for the period ended March 31, 2023, before the open of the stock market on Tuesday, May 9, 2023.
  • Following the release, Scott Graeff, President and Chief Executive Officer; Gene Nestro, Chief Financial Officer; and Brian Soller, Chief Technology Officer will host a conference call at 8:00 a.m. Eastern to discuss the first-quarter 2023 earnings results.
  • Participants should ask to join the Luna Innovations Incorporated conference call and are advised to dial in at least fifteen minutes prior to the call.
  • The webcast will be archived on the company’s website under “Webcasts and Presentations” for 30 days following the conference call.

Adverum Biotechnologies Presents Nonclinical Data at the 2023 ARVO Annual Meeting Supporting Potential for Staggered Bilateral Administration of Ixo-vec

Retrieved on: 
Sunday, April 23, 2023
Consensus, McKibbin, ARVO, Adverum Biotechnologies, NOAEL, AMD, Eye, LUNA, Inflammation, Publication, George Loewenstein, Burak Eldem, Administration, Incidence, JAMA Ophthalmology, Patient, Vance DeGeneres, Association for Research in Vision and Ophthalmology, Research, No-observed-adverse-effect level, Visual acuity, New Orleans, Pharmaceutical industry, Vaccine, Publishing, Ophthalmology, NHP

REDWOOD CITY, Calif., April 23, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced nonclinical data supporting the two doses of ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) being evaluated in the Phase 2 LUNA trial and the potential for staggered, bilateral administration in the treatment of wet AMD. The data were featured in an oral presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting in New Orleans, Louisiana.

Key Points: 
  • The data were featured in an oral presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting in New Orleans, Louisiana.
  • Administration of a single intravitreal dose of Ixo-vec in the second eye resulted in peak aflibercept levels that are within the targeted therapeutic range.
  • Despite elevated systemic humoral response after first eye injection, second eye total antibodies were undetectable prior to injection of Ixo-vec dose in the second eye.
  • The presentation will be made available on the Publications page of the Adverum website.

Adverum Biotechnologies Granted Innovative Licensing and Access Pathway Designation in the United Kingdom for Ixo-vec for the Treatment of Wet AMD

Retrieved on: 
Tuesday, April 18, 2023
Ministry of National Health Services, Regulation and Coordination, Adverum Biotechnologies, Doctor of Pharmacy, Anti-VEGF, National Health Service, AMD, OPTIC, Eye, LUNA, PRIME, EMA, Patient, United Kingdom, European Medicines Agency, United, National Institute for Health and Care Excellence, Medicines and Healthcare products Regulatory Agency, Innovation, NHS, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Safety, Fast track (FDA), NICE, Food, Caregiver, MHRA, Pharmaceutical industry

REDWOOD CITY, Calif., April 18, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Ixo-vec (ixoberogene soroparvovec), an investigational gene therapy for the treatment of wet AMD, an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP). The Innovation Passport is the first step in the ILAP process, triggering the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE) and the National Health Service (NHS) England, to partner with Adverum to charter a roadmap for regulatory and development milestones with the goal of early patient access in the United Kingdom (U.K.)

Key Points: 
  • The OPTIC data indicates a greater than 80% reduction in annualized anti-VEGF injections with more than 50% of the trial subjects being supplemental injection-free at two years post-treatment with Ixo-vec, which data is suggestive of a functional cure,” commented Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies.
  • “The current standard of care in wet AMD, requires frequent anti-VEGF injections in the eye that can be a lifelong burden for many patients and their caregivers.
  • We believe Ixo-vec has the potential to provide an in-office treatment option that is durable and safe, provides cost-savings, and addresses the needs of wet AMD patients and their families, retina specialists and health systems worldwide.
  • We look forward to leveraging the benefits of ILAP designation, as we continue our development of Ixo-vec.”
    “The ILAP designation grants us enhanced regulatory and market access interactions and a potentially faster path towards approval in the U.K. Ixo-vec has already received Fast Track Designation by the FDA and PRIME designation by the EMA,” said Star Seyedkazemi, PharmD, chief development officer of Adverum Biotechnologies.

Adverum Biotechnologies Announces Upcoming Nonclinical Data Presentation Supporting Staggered Bilateral Administration of Ixoberogene Soroparvovec (Ixo-vec) at the 2023 ARVO Annual Meeting

Retrieved on: 
Monday, April 17, 2023
ARVO, Association for Research in Vision and Ophthalmology, Adverum Biotechnologies, Research, Neovascularization, LUNA, Annual general meeting, Pharmaceutical industry, Publishing, Ophthalmology

REDWOOD CITY, Calif., April 17, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that the company will present an abstract featuring nonclinical data of Ixoberogene soroparvovec (Ixo-vec) for the treatment of neovascular age-related macular degeneration at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting.

Key Points: 
  • REDWOOD CITY, Calif., April 17, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that the company will present an abstract featuring nonclinical data of Ixoberogene soroparvovec (Ixo-vec) for the treatment of neovascular age-related macular degeneration at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting.
  • Adverum will present data on the human equivalent dose of 6x10^10 (6E10) vg/eye that is being evaluated in Adverum’s Phase 2 LUNA study of Ixo-vec.
  • In addition, data will be presented outlining aflibercept protein levels, as well as durability and tolerability following staggered bilateral administration of Ixo-vec.
  • Presentation Title: Ixoberogene soroparvovec (Ixo-vec) for the treatment of neovascular age-related macular degeneration: Nonclinical data in support of human equivalent dose of 6E10 vg/eye and staggered bilateral dosing

Adverum Biotechnologies Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Phase 2 LUNA Trial Update

Retrieved on: 
Thursday, March 30, 2023
Maintenance, Adverum Biotechnologies, Anti-VEGF, AMD, Clinical trial, Research, LUNA, Inflammation, Dexamethasone, IVT, Investment, Risk, CST, M.A, R, Three Months, Safety, Pharmaceutical industry, Cryptocurrency, OPTIC

REDWOOD CITY, Calif., March 30, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided an update on its ongoing Phase 2 LUNA trial evaluating ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) for the treatment of wet age-related macular degeneration (wet AMD).

Key Points: 
  • I am excited to have enrolled my first subject in the Phase 2 LUNA trial.
  • The Phase 2 LUNA trial evaluating Ixo-vec in subjects with wet AMD continues to enroll.
  • Stock-based compensation expense included in research and development expenses was $1.9 million for the fourth quarter of 2022.
  • Stock-based compensation expense included in general and administrative expenses was $3.3 million for the fourth quarter of 2022.

Verichains Discloses Blockchain security Vulnerabilities,urges action

Retrieved on: 
Saturday, March 11, 2023
Cosmos, IBC, Policy, Research, BSC, BNB, LUNA, Cryptocurrency, Terra

Verichains Discloses Blockchain Security Vulnerabilities, Urges Action

Key Points: 
  • Verichains Discloses Blockchain Security Vulnerabilities, Urges Action
    Leading blockchain security firm Verichains has urged projects using IAVL proof verification in Tendermint Core to secure their assets and mitigate exploitation risks after identifying several significant vulnerabilities.
  • Verichains made these discoveries while carrying out work last October after the BNB Chain bridge was hacked.
  • Verichains has urged affected Web3 projects, still using Tendermint's IAVL proof verification, to upgrade their security before suffering a catastrophic loss.
  • Security flaws and vulnerabilities identified by the Verichains team during its research and testing are regularly posted on the company's website.

Asensus Surgical, Inc. Reports Operating and Financial Results for the Fourth Quarter and Full Year 2022

Retrieved on: 
Thursday, March 2, 2023
Cloud, NYSE, 3D, Image, Robotics, Cholecystectomy, Investment, Growth, Regulation, Safety, GAAP, CE marking, File, Karl Storz SE, Gynaecology, Freedom, Anatomy, Bank statement, Collection, MDR, KARL, Annual report, PARK, Surgeon, U.S. FDA, Urology, European, Digital, Hospital, Cloud computing, Software, FDA, General surgery, Machine learning, LUNA, Health, Active Intelligence Pte Ltd, Security (finance), Google Cloud, CIS, ISU, PGS, RESEARCH, Pharmaceutical industry, Cryptocurrency, Dentistry, Rare-earth element, Video game, Medical device

“As we look to the future, we are incredibly excited about the opportunity we have to revolutionize patient care through Performance-Guided Surgery.

Key Points: 
  • “As we look to the future, we are incredibly excited about the opportunity we have to revolutionize patient care through Performance-Guided Surgery.
  • These instruments were commercially launched in the U.S., Japan and Europe, in the fourth quarter of 2022.
  • The Company submitted its U.S. FDA 510(k) application for pediatric clearance in the U.S. during the third quarter of 2022.
  • The Company had cash, cash equivalents, short-term and long-term investments, excluding restricted cash of approximately $74.4 million as of December 31, 2022.

SEC Charges Terraform and CEO Do Kwon with Defrauding Investors in Crypto Schemes

Retrieved on: 
Thursday, February 16, 2023
Crypto, District court, Cryptocurrency, Clinical trials unit, LUNA, Complaint, Security (finance), PTE, UST, Joint Sigint Cyber Unit, Terraform, Complex, Douglas v. U.S. District Court ex rel Talk America, Terra

According to the SEC’s complaint, from April 2018 until the scheme’s collapse in May 2022, Terraform and Kwon raised billions of dollars from investors by offering and selling an inter-connected suite of crypto asset securities, many in unregistered transactions.

Key Points: 
  • According to the SEC’s complaint, from April 2018 until the scheme’s collapse in May 2022, Terraform and Kwon raised billions of dollars from investors by offering and selling an inter-connected suite of crypto asset securities, many in unregistered transactions.
  • The complaint further alleges that Terraform and Kwon offered and sold investors other means to invest in their crypto empire, including the crypto asset security tokens MIR—or “mirror” tokens—and LUNA itself.
  • The SEC’s complaint alleges that Terraform and Kwon marketed crypto asset securities to investors seeking to earn a profit, repeatedly claiming that the tokens would increase in value.
  • Meanwhile, Terraform and Kwon also allegedly misled investors about the stability of UST.

Luna Announces Fourth-Quarter and Full-Year 2022 Financial Release Date of March 14, 2023

Retrieved on: 
Tuesday, February 21, 2023
Luna, Telephone, Webcast, LUNA, Cryptocurrency

Roanoke, VA, Feb. 21, 2023 (GLOBE NEWSWIRE) -- ROANOKE, VA, February 21, 2023 -- Luna Innovations Incorporated (NASDAQ: LUNA) announced today it will report its fourth-quarter and full-year financial results for the period ended December 31, 2022, after the close of the stock market on Tuesday, March 14, 2023.

Key Points: 
  • Roanoke, VA, Feb. 21, 2023 (GLOBE NEWSWIRE) -- ROANOKE, VA, February 21, 2023 -- Luna Innovations Incorporated (NASDAQ: LUNA) announced today it will report its fourth-quarter and full-year financial results for the period ended December 31, 2022, after the close of the stock market on Tuesday, March 14, 2023.
  • Following the release, Scott Graeff, President and Chief Executive Officer; Gene Nestro, Chief Financial Officer; and Brian Soller, Chief Technology Officer will host a conference call at 5:00 p.m. Eastern to discuss the fourth-quarter and full year 2022 earnings results and provide a business update.
  • Participants should ask to join the Luna Innovations Incorporated conference call and are advised to dial in at least fifteen minutes prior to the call.
  • The webcast will be archived on the company’s website under “Webcasts and Presentations” for 30 days following the conference call.