Fast Track

Precision BioSciences Announces Receipt of FDA Fast Track Designation for ECUR-506, iECURE’s Program for the Treatment of Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency

Retrieved on: 
Tuesday, May 7, 2024
Research, Medical Devices, FDA, Genetics, Health Technology, Biotechnology, Health, Other Science, Science, CTA, Fast Track, Safety, Pharmacokinetics, Food, European Commission, OTC, Gene editing, Communication, Collection, IND, Therapy, Precision BioSciences, Patient, Civil service commission, Standard of care, Precision, Vaccine

ECUR-506 is iECURE’s in vivo gene insertion program designed to treat neonatal onset Ornithine Transcarbamylase (OTC) deficiency utilizing a PCSK9-specific ARCUS nuclease, licensed from Precision, that enables insertion of a functional copy of the OTC gene.

Key Points: 
  • ECUR-506 is iECURE’s in vivo gene insertion program designed to treat neonatal onset Ornithine Transcarbamylase (OTC) deficiency utilizing a PCSK9-specific ARCUS nuclease, licensed from Precision, that enables insertion of a functional copy of the OTC gene.
  • The Fast Track designation is designed to facilitate the development and expedite the review of therapeutics to treat serious conditions that fill an unmet medical need.
  • Provided relevant criteria are met, programs with Fast Track designation are eligible for accelerated approval and priority review as well.
  • “Congratulations to iECURE for this significant regulatory designation and for what it can potentially mean to patients with neonatal onset OTC deficiency.

Phanes Therapeutics, Inc. Announces Clinical Supply Agreement with Roche to Evaluate PT217 in Combination with an anti-PD-L1 Therapy

Retrieved on: 
Wednesday, May 8, 2024
FDA, Cancer, CMO, Fast Track, CD47, Safety, Pharmacokinetics, MD, Doctor of Philosophy, Carcinoma, DLL3, Patient, Lung, ODD, Therapy, SAN, Platinum, Pharmaceutical industry

Phanes is currently enrolling patients in a multi-center Phase I clinical trial of PT217.

Key Points: 
  • Phanes is currently enrolling patients in a multi-center Phase I clinical trial of PT217.
  • The next phase of Phanes' study is investigating the therapeutic potential of PT217 as a combination therapy in SCLC, LCNEC and EP-NECs.
  • The clinical collaboration with Roche will evaluate PT217 in combination with atezolizumab in these patients.
  • We believe the mechanisms of PT217 and atezolizumab are complementary and the combination has the potential to improve outcomes for patients.

Lexeo Therapeutics Announces License Agreement to Accelerate Development of LX2006 for the Treatment of Friedreich Ataxia Cardiomyopathy

Retrieved on: 
Monday, April 22, 2024
FDA, Weill Cornell Medicine, Patient, Fast Track, Phenotype, Death, Cardiomyopathy, Research, Natural history, IND, Cornell University, Senior, Friedreich's ataxia, Cardiovascular disease, Therapy, Orphan drug, Pharmaceutical industry

NEW YORK, April 22, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company, today announced an in-license agreement with Cornell University to expedite development of the investigational gene therapy candidate LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy.

Key Points: 
  • Under the license agreement, Lexeo has acquired certain rights1 including rights to current and future data generated in an ongoing investigator-initiated Phase 1A trial of AAVrh.10hFXN to treat FA cardiomyopathy ( NCT05302271 ).
  • The agreement will support Lexeo’s efforts to develop a potentially life-changing therapy for this unmet need.
  • Lexeo previously licensed know-how relating to AAVrh.10hFXN from Weill Cornell Medicine and collaborated with researchers there to further study the candidate, which Lexeo refers to as LX2006.
  • “This agreement with Lexeo Therapeutics builds upon years of collaboration between Weill Cornell Medicine and Lexeo to benefit patients with FA cardiomyopathy.

Q1 2024 Revenue and Business Update

Retrieved on: 
Wednesday, April 17, 2024
FDA, Drug discovery, Fast Track, Physics, TLX, NDA, Food, ASX, Research, Biologics license application, IND, Prostate cancer, Science, Chemistry, Acquisition, BLA, Breakthrough therapy, Growth, Radiochemistry, Medical imaging

MELBOURNE, Australia, April 17, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today provides an update on its revenue and operational performance for the quarter ended 31 March 2024 (Q1 2024).

Key Points: 
  • MELBOURNE, Australia, April 17, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today provides an update on its revenue and operational performance for the quarter ended 31 March 2024 (Q1 2024).
  • U.S. revenue grew by 18% to US$111.8M (US$95.1M in Q4 2023), compared to 11% growth between Q3 2023 and Q4 2023.
  • Dr Christian Behrenbruch, Managing Director and Group CEO of Telix, commented, “The continued, consistent growth of our precision diagnostics business is further evidence of an effective market growth strategy for our prostate cancer franchise.
  • Telix reaffirms guidance provided on 22 February 2024 for full year revenue expected to be in the range of US$445M to $465M (AU$675M to $705M at current exchange rates), representing an approximate 35-40% increase versus 2023.

Lexeo Therapeutics Granted FDA Fast Track Designation for LX2006, an AAV-Based Gene Therapy Candidate for the Treatment of Friedreich’s Ataxia Cardiomyopathy

Retrieved on: 
Tuesday, April 16, 2024
FDA, Fast Track, Safety, Food, Death, Cardiomyopathy, Patient, FA, Therapy, Pharmaceutical industry

LX2006 is designed to deliver a functional frataxin gene to promote frataxin protein expression and restore mitochondrial function in myocardial cells.

Key Points: 
  • LX2006 is designed to deliver a functional frataxin gene to promote frataxin protein expression and restore mitochondrial function in myocardial cells.
  • Fast Track is a process designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and address unmet medical need.
  • “FA cardiomyopathy is the leading cause of death among FA patients, and there are currently no approved treatment options.
  • The FDA’s Fast Track designation for LX2006 underscores the significant unmet need for effective treatment options to address the cardiac impact of this debilitating disease,” said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics.

TLX101-CDx (Pixclara™) Granted FDA Fast Track Designation

Retrieved on: 
Monday, April 15, 2024
FDA, University, Fast Track, Pharmacy, Food and Drug Administration, TLX, NDA, Food, Radiology, MD, ASX, PET, Partnership, Research, Glioma, UCSF, Patient, FET, Radiopharmaceutical, 18F-FET, Diagnosis

MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).

Key Points: 
  • MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).
  • The granted Fast Track designation is for the characterisation of progressive or recurrent glioma using positron emission tomography (PET).
  • Concurrently, Telix is in the final stages of preparing its U.S. New Drug Application (NDA) for TLX101-CDx in this initial indication, in both adult and paediatric patients.
  • This designation enables expedited review and closer consultation with the FDA during the review process.

Aqua-Tots Swims Upstream Into Edina, Minnesota

Retrieved on: 
Monday, April 15, 2024
Fast Track, Social media, Parent, Life, Curriculum, Swimming

Edina, Minnesota, April 15, 2024 (GLOBE NEWSWIRE) -- Aqua-Tots Swim School , the largest international swim school franchise, is excited to announce that its second Minnesota location is coming soon to the city of Edina.

Key Points: 
  • Edina, Minnesota, April 15, 2024 (GLOBE NEWSWIRE) -- Aqua-Tots Swim School , the largest international swim school franchise, is excited to announce that its second Minnesota location is coming soon to the city of Edina.
  • Aqua-Tots Swim School’s world-renowned curriculum has been trusted by parents since 1991 and is used in 14 countries to create safe and confident swimmers for life.
  • “Minnesota is known as ‘The Land of 10,000 Lakes’ and has the most shoreline compared to any other state,” says General Manager Alex Brumley.
  • To learn more about swim lessons at Aqua-Tots Edina or to enroll, please visit aqua-tots.com/edina or call (952) 300-6227.

Global Anti-Venom Market Analysis Report 2024-2032: Increasing Investments in Developing New Drugs and Technological Innovation Fueling Growth - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 1, 2024
Health, Pharmaceutical, USD, Mortality, System, Fast Track, WHO, Fish, World Health Organization, Molecular Modeling Database, ANAVIP, Poisoning, Vaccine, Growth, Instituto Butantan, Incidence, Patient, Biting, Death, Snakebite, Therapy, Snake, NCBI, Overalls, Prevalence, Disease

The "Global Anti-Venom Market Report by Type, Animal Type, End User, Region and Company Analysis 2024-2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Anti-Venom Market Report by Type, Animal Type, End User, Region and Company Analysis 2024-2032" report has been added to ResearchAndMarkets.com's offering.
  • The growing prevalence of snake and other animal bites, such as fish stings, drives the anti-venom market.
  • The global market for anti-venom is expected to grow due to increasing investment in developing new drugs and technological innovation in treating venomous bites.
  • The anti venom market in the U.S. is expected to have significant growth due to the country's high occurrence of snake bites.

Ole Smoky Distillery Earns Seven ‘Growth Brand’ Awards From Beverage Information Group

Retrieved on: 
Monday, April 29, 2024
Retail, Restaurant, Bar, Food, Beverage, Wine & Spirits, Cream, Fast Track, Wine, Distillation, Ole Smoky Distillery, Hall, White chocolate, Rising Star Award, Multimedia, Television

Ole Smoky Distillery , one of the nation’s fastest growing spirits companies, has been nationally recognized with seven prestigious 2024 Growth Brand Awards from the Beverage Information Group, leaders in the beverage alcohol data collection, reporting and analysis, and publishers of Beverage Dynamics , Cheers , StateWays , Beverage Wholesaler .

Key Points: 
  • Ole Smoky Distillery , one of the nation’s fastest growing spirits companies, has been nationally recognized with seven prestigious 2024 Growth Brand Awards from the Beverage Information Group, leaders in the beverage alcohol data collection, reporting and analysis, and publishers of Beverage Dynamics , Cheers , StateWays , Beverage Wholesaler .
  • View the full release here: https://www.businesswire.com/news/home/20240429690493/en/
    Ole Smoky Distillery has earned four Rising Star Awards, for Ole Smoky Peanut Butter Whiskey, Ole Smoky Orange Shinesicle Cream Moonshine, Ole Smoky Banana Pudding Cream Moonshine, and Ole Smoky White Chocolate Strawberry Cream Moonshine, as well as three Fast Track Awards, for the Ole Smoky Moonshine product line, Ole Smoky Whiskey product line, and Ole Smoky Salty Caramel Whiskey.
  • “The team at Ole Smoky is extremely honored to earn seven Growth Brand Awards for 2024, after being recognized with Growth Brand Awards in each of the prior five years,” says Robert Hall, CEO of Ole Smoky Distillery.
  • For more information on Ole Smoky and its products, visit www.olesmoky.com .

AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock

Retrieved on: 
Wednesday, April 10, 2024
Septic, Infection, Mortality, FDA, Public, CMO, Fast Track, Organ dysfunction, Priority review, Food, Adrenomedullin, Septic shock, Communication, Collection, DPP3, Intensive care medicine, Accelerated approval (FDA), Patient, Death, Biomarker, RCI, Medicine, Sepsis, Pharmaceutical industry

AdrenoMed is now preparing a confirmatory Phase IIb/III clinical trial to confirm the reduced septic shock mortality under enibarcimab treatment employing a precision medicine approach.

Key Points: 
  • AdrenoMed is now preparing a confirmatory Phase IIb/III clinical trial to confirm the reduced septic shock mortality under enibarcimab treatment employing a precision medicine approach.
  • AdrenoMed’s CEO Dr. Richard Jones commented: “We are very pleased that enibarcimab has received Fast Track designation from the FDA, recognizing its potential as an innovative biomarker-guided treatment against septic shock to fill the unmet medical need in this very serious condition with a high death toll.
  • With a mortality rate of 20-30% for sepsis1 and 30%-50% for septic shock in developed countries,2 sepsis represents an enormous public health burden and is responsible for almost 20% of all deaths worldwide.
  • Dr. Stephan Witte, CMO of AdrenoMed, said: “We are very confident that the use of enibarcimab in combination with two biomarkers, Adrenomedullin (bio-ADM) and circulating dipeptidyl peptidase 3 (cDPP3), holds the promise to become the first effective targeted treatment against septic shock.