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Avidity Biosciences Receives FDA Breakthrough Therapy Designation for Delpacibart Etedesiran (AOC 1001) for Treatment of Myotonic Dystrophy Type 1

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수요일, 5월 8, 2024

FDA, Food, RNA, QMT, Initiation, Facial muscles, Natural history, AOC, Therapy, Myopathy, European Medicines Agency, EMA, DM1, Avidity, Breakthrough therapy, SAN, Pharmaceutical industry

SAN DIEGO, May 8, 2024 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to delpacibart etedesiran (AOC 1001), the company's lead clinical development program, for the treatment of myotonic dystrophy type 1 (DM1). Delpacibart etedesiran, abbreviated as del-desiran, is an investigational treatment designed to address the root cause of DM1, an underrecognized, progressive and often fatal neuromuscular disease with no approved therapies.

Key Points:

Delpacibart etedesiran, abbreviated as del-desiran, is an investigational treatment designed to address the root cause of DM1, an underrecognized, progressive and often fatal neuromuscular disease with no approved therapies.
"We are pleased that the FDA has granted Breakthrough Therapy designation to del-desiran for myotonic dystrophy type 1, underscoring the potential of del-desiran to be an effective treatment and the urgency of bringing this treatment to people living with DM1," said Sarah Boyce, president and chief executive officer at Avidity.
Avidity is initiating the global pivotal HARBOR™ study of del-desiran this quarter.
In addition to receiving FDA Breakthrough Therapy designation, del-desiran has previously been granted Orphan Drug and Fast Track designations by the FDA and Orphan designation by the European Medicines Agency (EMA) for the treatment of DM1.

Avidity Biosciences Honors Rare Disease Day®

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목요일, 2월 29, 2024

Rare disease, Therapy, SAN, Avidity, Caregiver, DMD, Duchenne muscular dystrophy, Facioscapulohumeral muscular dystrophy, Hope, Learning, DM1, RNA, Rare Disease Day, FSHD, Patient, Disease, AOC, Myopathy, Research

"Today, on Rare Disease Day, we are proud to join the global community in raising awareness for people living with rare diseases," said Sarah Boyce, president and chief executive officer at Avidity.

Key Points:

"Today, on Rare Disease Day, we are proud to join the global community in raising awareness for people living with rare diseases," said Sarah Boyce, president and chief executive officer at Avidity.
"Recently, we had the privilege of hosting individuals affected by rare muscle diseases at Avidity.
Rare Disease Day takes place on the last day of February each year with the goal to raise awareness of the impact of rare diseases worldwide.
EURORDIS established Rare Disease Day in 2008 and coordinates with more than 70 national alliance patient organizations each year to honor those living with rare diseases as well as their families and caregivers.

Avidity Biosciences Receives FDA Rare Pediatric Disease Designation for AOC 1044 for Treatment of Duchenne Muscular Dystrophy in People with Mutations Amenable to Exon 44 Skipping

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화요일, 2월 20, 2024

In addition to receiving Rare Pediatric Disease Designation, AOC 1044 has been granted Orphan Designation by the FDA and the European Medicines Agency (EMA), and Fast Track Designation by the FDA.

Key Points:

In addition to receiving Rare Pediatric Disease Designation, AOC 1044 has been granted Orphan Designation by the FDA and the European Medicines Agency (EMA), and Fast Track Designation by the FDA.
"We are pleased that the FDA has granted Rare Pediatric Disease designation to AOC 1044, adding to the Orphan Drug and Fast Track designations already granted.
Avidity plans to provide a first look at AOC 1044 data in people living with DMD44 in 2H 2024.
The EXPLORE44 trial is a randomized, placebo-controlled, double-blind, Phase 1/2 clinical trial to evaluate AOC 1044 in healthy volunteers and participants with DMD mutations amenable to exon 44 skipping (DMD44).

ATS Reports Third Quarter Fiscal 2024 Results

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수요일, 2월 7, 2024

In the fourth quarter of fiscal 2024, management expects the conversion of Order Backlog to revenues to be in the 36% to 39% range.

Key Points:

In the fourth quarter of fiscal 2024, management expects the conversion of Order Backlog to revenues to be in the 36% to 39% range.
In the third quarter of fiscal 2024, restructuring expenses of $16.2 million were recorded in relation to the reorganization.
The majority of the remaining actions are expected to be completed during the fourth quarter of fiscal 2024.
ATS will host a conference call and webcast at 8:30 a.m. eastern on Wednesday, February 7, 2024 to discuss its quarterly results.

ATS Completes Acquisition Of Avidity Science

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금요일, 11월 17, 2023

General Health, Environment, Health, Other Technology, Technology, Avidity, Acquisition, ATS, NYSE, TSX, Water, Pharmaceutical industry

ATS Corporation (TSX and NYSE: ATS) (“ATS” or the “Company”), today announced the successful completion of its acquisition of Avidity Science, LLC ("Avidity"), a growing designer and manufacturer of automated water purification solutions for biomedical and life science applications.

Key Points:

ATS Corporation (TSX and NYSE: ATS) (“ATS” or the “Company”), today announced the successful completion of its acquisition of Avidity Science, LLC ("Avidity"), a growing designer and manufacturer of automated water purification solutions for biomedical and life science applications.
ATS entered into a definitive agreement and announced its intention to acquire Avidity on September 22, 2023.

This Week in Health News: 10 Stories You Need to See

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금요일, 12월 1, 2023

NEW YORK, Dec. 1, 2023 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help journalists covering the healthcare industry stay on top of the week's most newsworthy and popular releases, here's a roundup of stories from the week that shouldn't be missed.

Key Points:

Together, we're reshaping the narrative around drug costs, setting a new industry standard."
"We are excited to expand our collaboration with Bristol Myers Squibb, who are world leaders in cardiovascular drug discovery and development.
Subject Matter Experts: Access ProfNet , a database of industry experts to connect with as sources or for quotes in your articles.
Related Resources: Read and subscribe to our journalist- and blogger-focused blog, Beyond Bylines , for media news roundups, writing tips, upcoming events, and more.

Avidity Biosciences Announces Expansion of Cardiovascular Collaboration with Bristol Myers Squibb for up to Five Targets Utilizing Avidity's Proprietary AOC™ Platform Technology

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화요일, 11월 28, 2023

SAN DIEGO, Nov. 28, 2023 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), today announced a global licensing and research collaboration with Bristol Myers Squibb (NYSE: BMY) focused on the discovery, development and commercialization of multiple cardiovascular targets with potential cumulative payments of up to $2.3 billion. AOCs are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to target the root cause of diseases previously untreatable with RNA therapeutics. This strategic collaboration broadens the reach of AOCs through the expansion of the existing relationship with Bristol Myers Squibb. Avidity continues to advance its internal research and development programs in rare cardiac indications.

Key Points:

This strategic collaboration broadens the reach of AOCs through the expansion of the existing relationship with Bristol Myers Squibb.
Bristol Myers Squibb will fund all future clinical development, regulatory and commercialization activities coming from this collaboration.
"We are excited to expand our collaboration with Bristol Myers Squibb, who are world leaders in cardiovascular drug discovery and development.
This new collaboration with Bristol Myers Squibb expands on the research conducted in cardiovascular disease and is a testament to the broad utility of the AOC platform technology.

Avidity Biosciences to Participate in Upcoming Investor Conference

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화요일, 11월 21, 2023

Therapy, SAN, Conference, Antibody-oligonucleotide conjugate, RNA, Avidity

SAN DIEGO, Nov. 21, 2023 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that Avidity management will be participating at the following upcoming conference:

Key Points:

SAN DIEGO, Nov. 21, 2023 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that Avidity management will be participating at the following upcoming conference:
6th Annual Evercore ISI HealthCONx Conference on November 28 at 9:30 a.m. PT/12:30 p.m.
ET
A live webcast of the event, up-to-date event details and an archived replay will be available on the "Events and Presentations" page in the "Investors" section of Avidity's website at https://aviditybiosciences.investorroom.com/events-and-presentations .

Avidity Science® launches Solo™ S system, setting a new standard for laboratory water purification sustainability

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화요일, 11월 7, 2023

Laboratory, Reverse osmosis, Water, Science, RO, Carbon, Type 1, Acquisition, Research, Ultrapure water, Near-field communication, LED, NFC, Water quality, Fine chemical, Purified water, Avidity

LONG CRENDON, United Kingdom, Nov. 7, 2023 /PRNewswire/ -- Avidity Science is proud to announce the launch of the world's first laboratory ultrapure water system with reusable plastic cartridges, the Avidity Science Solo™ S. Avidity Science showcased the Solo™ S at The Lab Innovations Trade Show in Birmingham, UK, November 1 -2.

Key Points:

LONG CRENDON, United Kingdom, Nov. 7, 2023 /PRNewswire/ -- Avidity Science is proud to announce the launch of the world's first laboratory ultrapure water system with reusable plastic cartridges, the Avidity Science Solo™ S. Avidity Science showcased the Solo™ S at The Lab Innovations Trade Show in Birmingham, UK, November 1 -2.
The Solo™ S is a benchtop Type 1 water purification system producing Ultrapure water directly from tap water, up to 10 liters per day.
"We believe the Solo™ S sets a new standard for laboratory water system sustainability with its unique reusable cartridge design and AvRecycle™" said Tim McDougle, Executive Vice President, Global Life Sciences for Avidity Science.
"For decades Avidity has focused on driving innovation to match customer needs and the Solo™ S is an excellent example of how we meet both our customers' critical water quality and environmental impact needs."

Avidity Science® launches Solo™ S system, setting a new standard for laboratory water purification sustainability

Retrieved on:

화요일, 11월 7, 2023

Laboratory, Reverse osmosis, Water, Science, RO, Carbon, Type 1, Acquisition, Research, Ultrapure water, Near-field communication, LED, NFC, Water quality, Fine chemical, Purified water, Avidity

LONG CRENDON, United Kingdom, Nov. 7, 2023 /PRNewswire/ -- Avidity Science is proud to announce the launch of the world's first laboratory ultrapure water system with reusable plastic cartridges, the Avidity Science Solo™ S. Avidity Science showcased the Solo™ S at The Lab Innovations Trade Show in Birmingham, UK, November 1 -2.

Key Points:

LONG CRENDON, United Kingdom, Nov. 7, 2023 /PRNewswire/ -- Avidity Science is proud to announce the launch of the world's first laboratory ultrapure water system with reusable plastic cartridges, the Avidity Science Solo™ S. Avidity Science showcased the Solo™ S at The Lab Innovations Trade Show in Birmingham, UK, November 1 -2.
The Solo™ S is a benchtop Type 1 water purification system producing Ultrapure water directly from tap water, up to 10 liters per day.
"We believe the Solo™ S sets a new standard for laboratory water system sustainability with its unique reusable cartridge design and AvRecycle™" said Tim McDougle, Executive Vice President, Global Life Sciences for Avidity Science.
"For decades Avidity has focused on driving innovation to match customer needs and the Solo™ S is an excellent example of how we meet both our customers' critical water quality and environmental impact needs."