Primate

CRL INVESTIGATION ALERT: Johnson Fistel LLP Investigates Charles River Laboratories’ Directors and Officers for Breach of Fiduciary Duties

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木曜日, 6月 6, 2024
Primate, SAN, LLP, Exchange, CRL

SAN DIEGO, June 06, 2024 (GLOBE NEWSWIRE) -- Johnson Fistel, LLP ( www.johnsonfistel.com ), a shareholder rights law firm, announces its continuing investigation of whether certain directors and officers of Charles River Laboratories International, Inc. (NYSE: CRL) breached their fiduciary duties to CRL and its shareholders.

Key Points: 
  • SAN DIEGO, June 06, 2024 (GLOBE NEWSWIRE) -- Johnson Fistel, LLP ( www.johnsonfistel.com ), a shareholder rights law firm, announces its continuing investigation of whether certain directors and officers of Charles River Laboratories International, Inc. (NYSE: CRL) breached their fiduciary duties to CRL and its shareholders.
  • If you are a current Charles River shareholder, you may have legal claims that may be brought on behalf of the company, against CRL’s directors and officers.
  • In February 2023, Charles River was informed by the Department of Justice that in conjunction with the U.S.
  • Johnson Fistel LLP’s investigation seeks to determine whether Charles River’s senior officers or members of its board of directors harmed the company by breaching their fiduciary duties or otherwise violating securities laws in connection with the foregoing alleged conduct.

Tonix Pharmaceuticals Announces Two Oral Presentations and One Poster Presentation Involving TNX-1500 (Fc-modified humanized anti-CD40L mAb) at the American Transplant Congress 2024

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木曜日, 6月 6, 2024
Research, FC, Ischemia, Faculty, CD28, CD2, Safety, CD154, Science, Primate, Pennsylvania Convention Center, Survival, Tonix Pharmaceuticals, Massachusetts General Hospital, Pharmacokinetics, Kinoshita, Pharmaceutical industry

CHATHAM, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announces two oral presentations and a poster presentation at the American Transplant Congress 2024, held June 1-5, 2024 at the Pennsylvania Convention Center, Philadelphia, Pa. A copy of the oral and poster presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

Key Points: 
  • “We remain encouraged by the potential of our TNX-1500, Fc-modified humanized anti-CD40L monoclonal antibody therapy for the prevention of rejection in solid organ transplantation,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • “Despite advancements in the field of solid organ transplantation, there remains a significant need for new treatments with improved activity and tolerability.
  • In February 2024, Tonix announced completion of the clinical stage of its Phase 1 single ascending dose study of TNX-1500 in healthy volunteers.
  • This first-in-human study is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients.

Precision BioSciences Presents New Preclinical Safety Data for PBGENE-HBV Clinical Candidate at the European Association for the Study of the Liver Congress

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水曜日, 6月 5, 2024
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Genome, Gene editing, Hepatocyte, New Drug Application, Doctor of Philosophy, IND, EASL, Safety, HBV, CccDNA, Poster, Primate, CTA, Precision BioSciences, Vaccine

The poster will also showcase non-human primate data demonstrating good tolerability of a multi-dosing approach for the treatment of chronic hepatitis B.

Key Points: 
  • The poster will also showcase non-human primate data demonstrating good tolerability of a multi-dosing approach for the treatment of chronic hepatitis B.
  • “We are pleased to present new safety data at EASL for our lead PBGENE-HBV program.
  • Preclinical safety data supports the advancement of PBGENE-HBV to clinical trials as a potentially curative treatment for chronic hepatitis B.
  • Full poster details are included below:
    Presenter: Emily Harrison, PhD, Senior Scientist - Hepatitis Research Leader, Precision BioSciences

NewAmsterdam Pharma to Present New Clinical and Preclinical Data Highlighting Obicetrapib’s Impact on Key Risk Factors for Cardiovascular Disease at Upcoming Medical Meetings

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火曜日, 5月 21, 2024
Patient, Cardiovascular disease, Primate, EAS, Hypercholesterolemia, Risk, NLA, NAMS, Congress, Biomarker, Adipose tissue, National Lipid Association

NAARDEN, the Netherlands and MIAMI, May 21, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that it will present new clinical and preclinical data highlighting the potential for obicetrapib as a novel, oral, low-dose therapy for hypercholesterolemia, at the European Atherosclerosis Society (EAS) 92nd Congress and the National Lipid Association (NLA) 2024 Scientific Sessions, taking place on May 26 – 29 in Lyon, France and May 30 – June 2 in Las Vegas, Nevada, respectively.

Key Points: 
  • -- Presentations include new data from OCEAN, ROSE, and ROSE2 Phase 2 clinical trials, demonstrating obicetrapib’s impact on key lipid and lipoprotein biomarkers --
    NAARDEN, the Netherlands and MIAMI, May 21, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that it will present new clinical and preclinical data highlighting the potential for obicetrapib as a novel, oral, low-dose therapy for hypercholesterolemia, at the European Atherosclerosis Society (EAS) 92nd Congress and the National Lipid Association (NLA) 2024 Scientific Sessions, taking place on May 26 – 29 in Lyon, France and May 30 – June 2 in Las Vegas, Nevada, respectively.
  • Presentation details are as follows:
    Oral Presentation Session Date and Time: Monday, May 27, 2024, 2:42 PM- 2:49 PM CET (8:42 AM-8:49 AM ET)
    Oral Presentation Session Date and Time: Tuesday, May 28, 2024, 2:12 PM- 2:19 PM CET (8:12 AM-8:19 AM ET)
    Oral Presentation Session Date and Time: Tuesday, May 28, 2024, 3:17-3:24 CET (9:17 AM-9:24 AM ET)
    Oral Presentation Session Date and Time: Tuesday, May 28, 2024, 3:24-3:31 CET (9:24 AM-9:31 AM ET)
    Title: Obicetrapib does not Accumulate in Adipose Tissue: Results from Studies in Man and Non-Human Primates
    Title: Obicetrapib Does Not Accumulate in Adipose Tissue: Results from Studies in Man and Non-human Primates Abstract/Poster #: 127

Rezolute Reports Third Quarter Fiscal 2024 Financial Results and Provides Business Update

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水曜日, 5月 15, 2024
Update, Chi, Patient, Pharmacokinetics, Human, Investment, FDA, Trial of the century, Disease, Safety, Transaminase, DME, Primate, Rat, Diabetic retinopathy, Research, Congenital hyperinsulinism, Insulinoma, Pharmaceutical industry

REDWOOD CITY, Calif., May 15, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today reported financial results and provided a business update for the three months ended March 31, 2024.

Key Points: 
  • Additionally, at the 40 mg/kg dose in this study, SD rats had liver abnormalities consistent with previous in-vivo studies.
  • Cash, cash equivalents and investments in marketable securities were $81.6 million as of March 31, 2024, compared with $118.4 million as of June 30, 2023.
  • General and administrative expenses were $3.8 million for the third quarter of fiscal 2024, compared with $2.9 million for the same period a year ago, with the increase primarily attributable to personnel-related expenses due to increased headcount.
  • Net loss was $17.1 million for the third quarter of fiscal 2024 compared with a net loss of $15.7 million for the same period a year ago.

Dyadic Announces First Quarter 2024 Financial Results and Highlights Recent Company Progress

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火曜日, 5月 14, 2024
Cygnus, Partnership, Infection, Analysis, Food, Vaccine, Poultry, Senior, Primate, Note, Hospital, Research, Therapy, Biofuel, RBD, Massachusetts General Hospital, Human, Rabies, Sale, Rabbit, Trial of the century, Pithing, AVATAR, Cattle, SAHPRA, European, Enzyme, Negotiation, Host cell protein, COVID-19, Protein, Safety, Animal, Immortalised cell line, SME, A-DNA, Melamaravakkadu, Insurance, Antigen, Nature Communications, Innovation, Health, Livestock, C1, Convertible, Manuscript, Virology, Transferrin, Webcast, Clinical study report, Phibro Animal Health

JUPITER, Fla., May 14, 2024 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a biotechnology company focused on the efficient large-scale manufacture of proteins for use in human and animal vaccines and therapeutics, as well as non-pharmaceutical applications including food, nutrition, and wellness, today announced its financial results for the first quarter of 2024 and highlighted recent Company progress.

Key Points: 
  • ET today
    JUPITER, Fla., May 14, 2024 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a biotechnology company focused on the efficient large-scale manufacture of proteins for use in human and animal vaccines and therapeutics, as well as non-pharmaceutical applications including food, nutrition, and wellness, today announced its financial results for the first quarter of 2024 and highlighted recent Company progress.
  • In March 2024, the Company entered into a co-promotion agreement with Biftek Co. for the promotion of growth media supplement for cell culture.
  • The Company is undergoing a beta-lactoglobulin animal-free recombinant whey protein project, expected to begin sampling in the late third quarter.
  • The Company is undergoing a recombinant lactoferrin project, expected to begin sampling the product in the late second or early third quarter.

Liberate Bio Announces Presentation to Update on Advancements on their RAPTOR LNP Platform

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木曜日, 5月 16, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, Patient, Intelligence, Risk, Liver, Disease, Bone marrow, Lipid, Primate, Liberation, Oligonucleotide, RNA, Therapy, Spleen, Vaccine

“We are excited to demonstrate both the establishment of our Rapid Particle Optimizer (RAPTOR™) platform and the first results from our high-throughput screening in the platform at TIDES,” said Walter R. Strapps, Ph.D., Chief Scientific Officer of Liberate.

Key Points: 
  • “We are excited to demonstrate both the establishment of our Rapid Particle Optimizer (RAPTOR™) platform and the first results from our high-throughput screening in the platform at TIDES,” said Walter R. Strapps, Ph.D., Chief Scientific Officer of Liberate.
  • “The presentation demonstrates our ability to rapidly screen a diverse lipid library, designed rationally and by generative artificial intelligence, directly in non-human primates to the genetic medicines community.
  • RAPTOR™ combines the power of high throughput screening with artificial intelligence to efficiently explore vast design spaces covering lipid chemistry, formulation characteristics, and targeting approaches.
  • Our vision at Liberate Bio is to achieve the extraordinary—delivering genetic medicines that transcend liver-based limitations, liberating patients from disease.

Precision BioSciences Reports First Quarter 2024 Financial Results and Provides Business Update

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月曜日, 5月 13, 2024
Science, Biometrics, Research, Pharmaceutical, Health, FDA, Genetics, Clinical Trials, Janus, CTA, Novartis, Autoimmune disease, Sickle cell disease, IND, Hemoglobinopathy, OTC, Primate, Neuron, Fast Track, Vivo, RNA, CRISPR, Therapy, TRAC, Gene editing, Cell, Patent, NHP, Hepatitis B virus, HBV, Mitochondrion, ATM, Administration, CccDNA, PMM, Infant, Economics, Precision BioSciences, Rachel Haurwitz, Food, AAV, Duchenne muscular dystrophy, Cancer, Mitochondrial disease, Nature Metabolism, Precision, Patient, DNA, University, Gene, Cash, Development, Central nervous system, Pharmaceutical industry

Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, announced financial results for the first quarter ended March 31, 2024, and provided a business update.

Key Points: 
  • Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, announced financial results for the first quarter ended March 31, 2024, and provided a business update.
  • PBGENE-HBV is advancing through final toxicology studies and Precision expects to submit an IND and/or CTA for this program in 2024.
  • Cash and Cash Equivalents: As of March 31, 2024, Precision had approximately $137.8 million in cash and cash equivalents.
  • Shares: Basic weighted-average common shares outstanding for the first quarter of 2024 were 5,060,978 compared to 3,709,894 for the same period in 2023.

Kate Therapeutics Unveils Platform and Pipeline Progress at American Society of Gene & Cell Therapy 2024 Annual Meeting

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木曜日, 5月 9, 2024
Mortality, FDA, University, Facioscapulohumeral muscular dystrophy, Mouse, RNA interference, Safety, Tissue, Heart, Animal, Death, MD, Primate, Cell, Duchenne, Science, Disease, Rockefeller University, Patient, Liver, Society, Gene, X-linked myotubular myopathy, Pediatrics, Gene expression, Judgement, Duchenne muscular dystrophy, Capsid, Annual general meeting, SAN, Muscular dystrophy, Vaccine

SAN DIEGO, May 9, 2024 /PRNewswire/ -- Kate Therapeutics Inc. ("KateTx"), a next-generation gene therapy company, will present detailed preclinical efficacy and safety results on its pipeline and platform at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting being held May 7-11, 2024, in Baltimore, MD and virtually. The results support the best-in-class potential of KateTx's newest generation of skeletal muscle- and heart-targeted, liver de-targeted engineered MyoAAV capsids and gene regulation technology to treat Duchenne muscular dystrophy (DMD), facioscapulohumeral muscular dystrophy (FSHD), and other devastating genetic skeletal muscle and heart diseases.

Key Points: 
  • KateTx remains on track to select development candidates for additional muscle and cardiac programs in the near term.
  • "KateTx has made significant advances over the past 12 months," said Kevin Forrest, Ph.D., co-founder, president and CEO of KateTx.
  • KateTx's results show the potential to give a one-time gene therapy that potently suppresses DUX4 whenever it is expressed in skeletal muscles.
  • In vitro, the company's MyoAAV-LD mediated RNAi gene therapy candidate showed potent knockdown of DUX4 in FSHD patient myotubes with no off-target effects.

Myeloid Therapeutics Presents Multiple Posters at the American Society of Gene & Cell Therapy (ASGCT) 2024 Annual Meeting

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火曜日, 5月 7, 2024
CRISPR, Safety, CREATE, Gene editing, Vivo, MD, RNA, Canadian Aviation Regulations, Cell, Trial of the century, Primate, DNA, Patient, Gene, Society, Antigen, Messenger, Drug development, Annual general meeting, Therapy, Vaccine

CAMBRIDGE, Mass., May 7, 2024 /PRNewswire/ -- Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage immunology company, today announced multiple poster presentations at the American Society of Gene & Cell Therapy (ASGCT) 2024 Annual Meeting, taking place May 7 – 11, 2024, in Baltimore, MD and virtually. 

Key Points: 
  • "The data presented at ASGCT showcase that Myeloid continues to lead the field of in vivo immune cell engineering and RNA-enabled gene editing and delivery.
  • The data presented today underlies our in vivo mRNA CAR, MT-302, that continues to progress well in the ongoing clinical study.
  • We are expanding plans for MT-302's clinical use, given several inherent product advantages for patients," said Daniel Getts, Ph.D., Chief Executive Officer of Myeloid.
  • Poster presentation details and abstract highlights include:
    Myeloid has designed novel CARs that achieve expression and function in targeted immune cell populations.