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Fulcrum Therapeutics Provides Business Update and 2023 Outlook

Retrieved on: 
Wednesday, January 4, 2023
Anemia, Food, Therapy, EST, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Sickle cell disease, Patient, FDA, Losmapimod, Hemolysis, Conference, Cohort, REACH, Management, Pharmaceutical industry, SCD, FSHD, HBF, Fulcrum

CAMBRIDGE, Mass., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today outlined its recent accomplishments and expected 2023 milestones.

Key Points: 
  • “We are entering 2023 with a tremendous amount of momentum and expect it to be a productive year for our two clinical programs: FTX-6058 for SCD, and losmapimod for FSHD,” said Robert J. Gould, Ph.D., Fulcrum’s interim president and chief executive officer.
  • “FTX-6058 is a potential best-in-class oral HbF inducer candidate that could address critical gaps in the SCD treatment landscape.
  • We are excited by the levels of HbF induction in our initial doses and look forward to further broadening our understanding of its effect at a higher dose.
  • An archived replay will be available on Fulcrum’s website for 30 days.

Editas Medicine Announces Positive Safety and Efficacy Data from the First Two Patients Treated in the RUBY Trial of EDIT-301 for the Treatment of Severe Sickle Cell Disease

Retrieved on: 
Tuesday, December 6, 2022
Life, Event, Broad Institute, Clinical trial, Annual report, HBG1, TDT, HBF, HBS, Editas Medicine, Safety, Fetal hemoglobin, Busulfan, Manifest and latent functions and dysfunctions, NCT, Gene editing, CD34, Polymerization, SCD, MD, Harvard University, Sickle cell disease, Mutation, Patent, CRISPR, Senior, Patient, Anemia, Pharmaceutical industry, Vaccine, HBG2

CAMBRIDGE, Mass., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a clinical stage genome editing company, today announced positive, initial clinical data from the first two patients with sickle cell disease (SCD) treated with EDIT-301 in the Phase 1/2 RUBY trial. EDIT-301 is under development for the treatment of severe sickle cell disease. The clinical data includes safety data from the first two patients and efficacy data from the first patient treated.

Key Points: 
  • The clinical data includes safety data from the first two patients and efficacy data from the first patient treated.
  • Additionally, neither patient has experienced any vaso-occlusive events since treatment with EDIT-301, at five and 1.5 months follow up, respectively.
  • EDIT-301 is an experimental cell therapy medicine under investigation for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
  • The RUBY trial is a single-arm, open-label, multi-center Phase 1/2 study designed to assess the safety and efficacy of EDIT-301 in patients with severe sickle cell disease.

Editas Medicine to Host Virtual Event to Highlight Initial Clinical Data from the RUBY Trial of EDIT-301 for Severe Sickle Cell Disease

Retrieved on: 
Thursday, December 1, 2022
TDT, Polymerization, Anemia, HBF, CD34, Event, Mutation, HBG1, Fetal hemoglobin, Patient, SCD, Broad Institute, Harvard University, Sickle cell disease, Patent, HBS, Editas Medicine, NCT, CRISPR, Safety, Manifest and latent functions and dysfunctions, Pharmaceutical industry, Vaccine, HBG2

The clinical data will include safety data from the first two patients and efficacy data from the first patient treated with EDIT-301.

Key Points: 
  • The clinical data will include safety data from the first two patients and efficacy data from the first patient treated with EDIT-301.
  • In sickle cell disease, the red blood cells are misshapen in a sickle shape instead of a typical disc shape.
  • EDIT-301 is an experimental cell therapy medicine under investigation for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
  • The RUBY trial is a single-arm, open-label, multi-center Phase 1/2 study designed to assess the safety and efficacy of EDIT-301 in patients with severe sickle cell disease.

Pivotal Commware Lights Up mmWave Fixed Wireless Coverage in Houston

Retrieved on: 
Wednesday, November 30, 2022
Data Management, Technology, Mobile, Wireless, Telecommunications, Software, Networks, FWA, MNOS, MNO, Pivotal, IBMS, Total cost, Deutsch, HBF, High-pass filter, Ecosystem, Hertz, TCO, Tier 1, Mobile phone operator, Mobile phone, Turnkey

Turnkey delivers potential fixed wireless access (FWA) subscribers to MNOs at lower Total Cost of Ownership (TCO) – 25% to 35% the cost of fiber – and lower time-to-revenue. WaveScape® network planning optimizes the placement of network elements -- Pivot 5G® and Echo 5G® -- for a given coverage objective. Pivots navigate mmWave signals around obstacles. Echos penetrate them indoors through window glass to deliver gigabit broadband speed. Intelligent Beam Management System (IBMS) manages and optimizes the repeater network layer.

Key Points: 
  • Pivotal Commware, global leader in 5G mmWave infrastructure products for the wireless edge, announces that Pivotal Turnkey is expanding 5G mmWave coverage for a Tier 1 mobile network operator (MNO) in Houston.
  • Pivotal Turnkey provides an end-to-end solution using Pivotals mmWave product ecosystem.
  • Turnkey delivers potential fixed wireless access (FWA) subscribers to MNOs at lower Total Cost of Ownership (TCO) 25% to 35% the cost of fiber and lower time-to-revenue.
  • WaveScape network planning optimizes the placement of network elements -- Pivot 5G and Echo 5G -- for a given coverage objective.

Beam Therapeutics Enrolls First Patient in BEACON Clinical Trial of BEAM-101 Base Editing Therapy Candidate for the Treatment of Sickle Cell Disease

Retrieved on: 
Monday, November 14, 2022
Allele, Clinical trial, Gene editing, SCD, Cell, Biotechnology, Protocol, HBF, Patent, DNA, Chromosome, CRISPR, Safety, Polymerization, Security (finance), Failure, Annual report, Fetal hemoglobin, HSC, COVID-19, HBS, Sickle cell disease, Patient, Pharmaceutical industry, Beam

BEACON is an open-label, single-arm, multicenter, Phase 1/2 clinical trial designed to evaluate the safety and efficacy of BEAM-101 in adult patients with severe sickle cell disease (SCD).

Key Points: 
  • BEACON is an open-label, single-arm, multicenter, Phase 1/2 clinical trial designed to evaluate the safety and efficacy of BEAM-101 in adult patients with severe sickle cell disease (SCD).
  • Following enrollment in the BEACON trial, each patient will undergo a transfusion and mobilization process for HSC retrieval.
  • The enrollment of the first patient in our BEACON trial is a significant step forward for Beam and for the field of base editing, said John Evans, chief executive officer of Beam.
  • Beam Therapeutics (Nasdaq: BEAM) is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines.

Fulcrum Therapeutics Announces Recent Business Highlights and Third Quarter 2022 Financial Results

Retrieved on: 
Tuesday, November 8, 2022
GLOBE, OLE, Losmapimod, Investigational New Drug, IND, REACH, Merck & Co., Nasdaq, Webcast, HBF, Merck, Investor relations, Conference call, G&A, Therapy, SCD, RWS, HIV disease progression rates, WMS, Maintenance, Conference, Patient, Growth, Pharmaceutical industry, FSHD, Fulcrum

ET today

Key Points: 
  • ET today
    CAMBRIDGE, Mass., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today reported financial results for the third quarter of 2022.
  • Collaboration Revenue: Collaboration revenue was $1.2 million for the third quarter of 2022, as compared to $4.9 million for the third quarter of 2021.
  • Net Loss: Net loss was $23.7 million for the third quarter of 2022, as compared to a net loss of $20.7 million for the third quarter of 2021.
  • ET to discuss its third quarter 2022 recent business highlights and financial results.

Beam Therapeutics Announces Portfolio Progress and Reports Third Quarter 2022 Financial Results

Retrieved on: 
Monday, November 7, 2022
Patient, Piz, HBF, G6PC, LNP, Research, DNA, Science, Glucose, Investment, ASH, Seizure, Sickle cell disease, Wave 1, AATD, Biotechnology, Society, Genetic disorder, Pizzicato, Lung, Security (finance), GLOBE, FDA, Cell, Safety, Adult, IND, Mutation, Quality of life, Nasdaq, Genetic distance, HSC, ESCAPE, Fetal hemoglobin, Clinical trial, Medicine, Liver, AAT, Disease, Gene editing, HBS, Survival, Treatment, Address, SCD, Program, Degenerative disease, Health, Pharmaceutical industry, Medical imaging, Vaccine, Third wave, Second wave, Beam

Beam continues to expect enrollment of the first patient in the BEACON trial by the end of 2022.

Key Points: 
  • Beam continues to expect enrollment of the first patient in the BEACON trial by the end of 2022.
  • Research & Development (R&D) Expenses: R&D expenses were $85.3 million for the third quarter of 2022, compared to $54.6 million for the third quarter of 2021.
  • General & Administrative (G&A) Expenses: G&A expenses were $21.8 million for the third quarter of 2022, compared to $15.8 million for the third quarter of 2021.
  • Beam Therapeutics (Nasdaq: BEAM) is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines.

Pivotal Commware Announces Commercial Launch of Pivotal Turnkey Services

Retrieved on: 
Thursday, September 22, 2022
5G, Telecommunications, Networks, Internet, Hardware, Technology, Mobile, Wireless, Security, Pivotal, GNB, Echos, Rest, City, Product management, Las Vegas Convention Center, High-pass filter, Pivot, FWA, NFL, IBMS, Technology, Ecosystem, Mobile World Congress, Mobile, GIS, HBF, Television

Pivotal Commware, global leader in 5G mmWave infrastructure products, announces the launch of Pivotal Turnkey Services to accelerate deployment of fixed wireless access (FWA) networks using mmWave.

Key Points: 
  • Pivotal Commware, global leader in 5G mmWave infrastructure products, announces the launch of Pivotal Turnkey Services to accelerate deployment of fixed wireless access (FWA) networks using mmWave.
  • Pivotal will showcase Turnkey Services and its mmWave ecosystem at Mobile World Congress Las Vegas in its booth W1.726, West Hall at the Las Vegas Convention Center.
  • Pivotal Turnkey uses Pivotals own product ecosystem to deliver potential FWA subscribers so network operators can focus on other growth vectors.
  • With Pivotal Turnkey, network operators target buildings with prospective subscribers and the locations of their pre-existing network elements, if any, like gNBs.

Northern Illinois Community Initiatives Awards Impact Grants Totaling $300,000

Retrieved on: 
Thursday, August 18, 2022
People, Cooke Township, Cumberland County, Pennsylvania, Woman, Association, HBF, NYSE, Nicor Gas, Poverty, Thought, NICI, Workforce, SMC, Motivation, Quality of life, Southern Company, Education, Program, Community, Economic development, Culture, Southern Company Gas, Leduc-Nisku Economic Development Association, Student, Renewable energy

NAPERVILLE, Ill., Aug. 18, 2022 /PRNewswire/ -- Micro-transit solutions, a K–12 enrichment program and disadvantaged business owners will benefit from the latest round of grant funding from Northern Illinois Community Initiatives. NICI, the nonprofit founded by natural gas distributor Nicor Gas, announces three Impact Grant awards worth $100,000 each to nonprofit organizations serving Rockford, Harvey, south and west suburban Cook County and Will County. The grants, created to provide bridge funding for economic and workforce development, and community revitalization programs, builds upon NICI's mission to attract investment, mobilize partners, and connect vital resources to underserved communities in Nicor Gas' service areas.

Key Points: 
  • Funding will support micro-transit strategy, educational enrichment and diverse entrepreneurs
    NAPERVILLE, Ill., Aug. 18, 2022 /PRNewswire/ -- Micro-transit solutions, a K12 enrichment program and disadvantaged business owners will benefit from the latest round of grant funding from Northern Illinois Community Initiatives.
  • The data shows that poverty has steadily moved outside the city of Chicago into other parts of northern Illinois, but services and resources have not followed.
  • Northern Illinois Community Initiatives (NICI) builds a more vibrant and equitable region by investing in bold economic development initiatives that help communities thrive.For more information, visit www.nici-il.org .
  • Nicor Gas serves more than 2.2 million customers in a service territory that encompasses most of the northern third of Illinois, excluding the city of Chicago.

Fulcrum Therapeutics Announces Second Quarter 2022 Financial Results and Business Update

Retrieved on: 
Thursday, August 11, 2022
Fulcrum, GlaxoSmithKline, Patient registration, Services General Administration and Coordination Department, Government of Sindh, Investor relations, GLOBE, Growth, Conference call, IND, Research, Merck, General counsel, Patient, Therapy, D, HBF, Merck & Co., G&A, Â, Webcast, Nasdaq, Thalassemia, Conference, Investigational New Drug, REACH, Pharmaceutical industry, Cryptocurrency, Management, Video game, SCD, FSHD

In the second quarter, we achieved major milestones in both of our clinical programs, said Bryan Stuart, Chief Executive Officer of Fulcrum Therapeutics.

Key Points: 
  • In the second quarter, we achieved major milestones in both of our clinical programs, said Bryan Stuart, Chief Executive Officer of Fulcrum Therapeutics.
  • Collaboration Revenue: Collaboration revenue was $1.9 million for the second quarter of 2022, as compared to $4.4 million for the second quarter of 2021.
  • G&A Expenses: G&A expenses were $11.1 million for the second quarter of 2022, as compared to $6.7 million for the second quarter of 2021.
  • ET to discuss its second quarter 2022 recent business highlights and financial results.