Trial of the century

LIFESTANCE HEALTH GROUP, INC. (NASDAQ: LFST) SHAREHOLDER CLASS ACTION ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against LifeStance Health Group, Inc. (NASDAQ: LFST)

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Tuesday, September 27, 2022
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NEW YORK, Sept. 27, 2022 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a securities class action lawsuit that has been filed on behalf of investors who purchased or otherwise acquired the common stock of LifeStance Health Group, Inc. (“LifeStance” or the “Company”) (NASDAQ: LFST) pursuant and/or traceable to the Registration Statement and Prospectus (collectively, the “Registration Statement”) issued in connection with LifeStance’s June 10, 2021 initial public stock offering (the “IPO”). The lawsuit was filed in the United States District Court for the Southern District of New York and alleges violations of the Securities Exchange Act of 1933.

Key Points: 
  • Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or [email protected] to discuss your rights.
  • The lawsuit was filed in the United States District Court for the Southern District of New York and alleges violations of the Securities Exchange Act of 1933.
  • LifeStance is one of the nations largest providers of virtual and in-person outpatient mental health care.
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

Sorrento Therapeutics Completes Enrollment of Phase 2 Clinical Trial of Resiniferatoxin (RTX) for Treatment of Knee Pain in Moderate to Severe Osteoarthritis of the Knee (OAK) Patients

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Monday, September 26, 2022
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Given the durability of OAK pain relief response to RTX demonstrated in earlier phase 1/2 trials, Sorrento has decided to include an active comparator (injectable corticosteroid) in the current trial protocol.

Key Points: 
  • Given the durability of OAK pain relief response to RTX demonstrated in earlier phase 1/2 trials, Sorrento has decided to include an active comparator (injectable corticosteroid) in the current trial protocol.
  • The primary objective of the study was to evaluate the safety of RTX and identify the recommended Phase 3 dose.
  • The second arthritis pain phase 2 clinical trial in humans completed enrollment in September 2022.
  • RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients.

Dystrogen Therapeutics Investigational Chimeric Cell Therapy DT-DEC01 for Duchenne Muscular Dystrophy Demonstrates Clinically Significant Functional and Biomarker Improvements

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Monday, September 26, 2022
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Patient #2. (15-year-old non-ambulatory with deletion of Exon 48-50).  Improved duration and amplitude of motor unit potentials (up to 287% of baseline) on EMG when compared to pretreatment baseline. Improved grip strength (8kg-->9.7kg); improved PUL (20-->23). Statistically and clinically significant increase in activity via activity tracker.

Key Points: 
  • Results include 6-month safety, functional, and biomarker data from three clinical trial participants in the first, low-dose cohort.
  • All patients, independent of their genetic mutation, demonstrated both clinical and biomarker improvements when compared to baseline.
  • Dystrogen Therapeutics is a clinical-stage life sciences company committed to developing therapies for rare genetic diseases and disorders associated with aging.
  • Dystrogen has developed a patented cell engineering technology platform, which has been shown to improve function in both clinical and pre-clinical trials.

Windtree Therapeutics Announces Istaroxime Late Breaker Abstract from its Positive Phase 2 Study in Early Cardiogenic Shock (SEISMiC) to be Presented at Heart Failure Society of America

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Monday, September 26, 2022
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The SEISMiC study met its primary endpoint of significantly improved systolic blood pressure over the first 6 hours of study drug infusion.

Key Points: 
  • The SEISMiC study met its primary endpoint of significantly improved systolic blood pressure over the first 6 hours of study drug infusion.
  • This is an important clinical objective in treating patients with cardiogenic shock.
  • Windtree Therapeutics, Inc. is advancing multiple late-stage interventions for acute cardiovascular disorders to treat patients in moments of crisis.
  • Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release.

MoonLake Immunotherapeutics to initiate global Phase 2 study of the Nanobody® sonelokimab in patients with active psoriatic arthritis

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Monday, September 26, 2022
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Sonelokimab (M1095) is an investigational Nanobody designed to treat inflammatory disease by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation.

Key Points: 
  • Sonelokimab (M1095) is an investigational Nanobody designed to treat inflammatory disease by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation.
  • The ARGO study (M1095-PSA-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the Nanobody sonelokimab, administered subcutaneously, in the treatment of adult patients with active psoriatic arthritis.
  • The study will comprise approximately 200 patients, and will evaluate different doses of sonelokimab, with placebo control and adalimumab as an active reference arm.
  • MoonLake Immunotherapeutics AG is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory disease, to revolutionize outcomes for patients.

Atea Pharmaceuticals Announces U.S. FDA Fast Track Designation Granted to AT-752 for Treatment of Dengue

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Monday, September 26, 2022
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BOSTON, Sept. 26, 2022 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AT-752, a novel, orally administered, direct-acting antiviral for the treatment of dengue virus infection.

Key Points: 
  • AT-752, a novel, orally administered direct-acting antiviral derived from Ateas purine nucleotide prodrug platform was designed for the treatment and prophylaxis of dengue.
  • Dengue is the most prevalent mosquito-borne virus affecting up to 400 million people annually and is a substantial public health and economic burden worldwide.
  • Dengue causes a severe generalized illness with fever which may require hospitalization and is associated with mortality.
  • The FDA, together with other governmental and non-governmental agencies, recognize dengue as a substantial and growing global public health burden.

Allarity Therapeutics Appoints Seasoned Biotechnology Executive Jerry McLaughlin to Board of Directors

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Monday, September 26, 2022
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Mr. McLaughlin is a highly accomplished biotechnology executive with extensive experience in financing, drug development, licensing, commercialization, and product lifecycle management.

Key Points: 
  • Mr. McLaughlin is a highly accomplished biotechnology executive with extensive experience in financing, drug development, licensing, commercialization, and product lifecycle management.
  • I am delighted that Jerry has chosen to join Allaritys board at this crucial time in our evolution, said Dr. Duncan Moore, Allaritys Chairman of the Board.
  • Prior to serving in this role, he was President, CEO, and Member of the Board of Directors at Neos Therapeutics (acquired by Aytu BioScience.)
  • Before joining Neos Therapeutics, he served as President, CEO, and Member of the Board of Directors at AgeneBio, Inc.

Atamyo Therapeutics Announces First Patient Dosed with ATA-100 Gene Therapy in LGMD-R9 Clinical Trial

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Monday, September 26, 2022
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John Vissing, Director of the Copenhagen Neuromuscular Center at the National Hospital, Rigshospitalet, in Copenhagen, where the first patient was dosed, and principal investigator of this trial.

Key Points: 
  • John Vissing, Director of the Copenhagen Neuromuscular Center at the National Hospital, Rigshospitalet, in Copenhagen, where the first patient was dosed, and principal investigator of this trial.
  • Atamyo Therapeutics is a clinical-stage biopharma focused on the development of a new generation of effective and safe gene therapies for neuromuscular diseases.
  • A spin-off of gene therapy pioneer Genethon, Atamyo leverages unique expertise in AAV-based gene therapy and muscular dystrophies from the Progressive Muscular Dystrophies Laboratory at Genethon.
  • Atamyo conveys the spirit of its commitment to improve the life of patients affected by neuromuscular diseases with life-long efficient treatments.

Sensorion to Participate in Various Upcoming Investor Conferences

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Monday, September 26, 2022
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Sensorion (FR0012596468 ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, announces the participation of Sensorions management in various upcoming investor conferences.

Key Points: 
  • Sensorion (FR0012596468 ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, announces the participation of Sensorions management in various upcoming investor conferences.
  • CEO Nawal Ouzren will attend, in-person, the Jefferies Cell and Genetic Medicine Summit on September 30, 2022, in New-York, USA.
  • On this occasion, she will participate in a fireside chat and will be available for one-on-one meetings throughout the event.
  • CEO Nawal Ouzren will participate, in-person, in the HealthTech Innovation Days (HTID) meeting on October 13, 2022, in Paris, France.

AAHRPP Accredits Five More Research Organizations, Including First in Japan

Retrieved on: 
Friday, September 23, 2022
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WASHINGTON, Sept. 23, 2022 /PRNewswire/ -- The Association for the Accreditation of Human Research Protection Programs has accredited five more research organizations, including its first organization in Japan, two public research universities, a children's hospital and an acute-care hospital.

Key Points: 
  • WASHINGTON, Sept. 23, 2022 /PRNewswire/ -- The Association for the Accreditation of Human Research Protection Programs has accredited five more research organizations, including its first organization in Japan, two public research universities, a children's hospital and an acute-care hospital.
  • Review Board of Human Rights and Ethics for Clinical Studies (HURECS), Tokyo, Japan, a nonprofit provider of research review services.
  • AAHRPP has accredited research entities across the U.S. and in Australia, Belgium, Brazil, Canada, China, India, Japan, Jordan, Mexico, Republic of Korea, Saudi Arabia, Singapore, Taiwan and Thailand.
  • Research institutes, clinical research centers and community hospitals also are among those that have attained accreditation.