Breakthrough therapy

Tonix Pharmaceuticals Announces Oral Presentation at the World Vaccine Congress Europe

Retrieved on: 
Wednesday, October 11, 2023
SL, Autoimmunity, Government, Medicine, Headache, DSM-IV codes, CD40L, Research, Risk, Infection, COVID-19, Binge eating disorder, Smallpox, Central nervous system, Upsher-Smith Laboratories, Fibromyalgia, Hydrogen chloride, Annual report, Prader–Willi syndrome, PPAR, Pain, Obesity, Sumatriptan, Breakthrough therapy, Neurology, Cancer, CEST, FDA, Long, Migraine, CNS, MDD, Security (finance), Disease, Congress, Therapy, Failure, Long COVID, Gustav Neuring, Science, Social anxiety disorder, Orphan drug, Psychiatry, Pharmaceutical industry, CD154, Tonix Pharmaceuticals

A copy of the Company’s presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.

Key Points: 
  • A copy of the Company’s presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.
  • Additional meeting information can be found on the World Vaccine Congress website here .
  • Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering.
  • TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases.

New FDA Designations Accelerate Progress in Pancreatic Cancer Treatments: A Year in Review

Retrieved on: 
Friday, October 13, 2023
MBA, NYSE, Colorectal cancer, RET, Safety, US Foods, Therapy, Oncolytics Biotech, Breakthrough therapy, Transfection, News, NRG1, Research, Eli Lilly and Company, Cancer, HIV disease progression rates, Gastrointestinal cancer, JD, MD Anderson Cancer Center, AstraZeneca, LLY, EDB, Spacecraft, TSX, Eye, Pyxis, Liver, Disease, System, FDA, RECIST, University, Pancreatic Cancer Action Network, Thorax, Immunotherapy, FTD, Extracellular matrix, Fusion, Neoplasm, Congress, GI, Incidence, ORR, MD, ONC, Meru Networks, Colon, AZN, Pancreatic cancer, Patient, BTC, Johns Hopkins University, Pharmaceutical industry, Durvalumab, Lancet

VANCOUVER, BC, Oct. 13, 2023 /PRNewswire/ -- USA News Group  -  Since September 2022, the US Food and Drug Administration (FDA) has seen new treatments for pancreatic cancer that are worthy of further investigation or approval. Known as one of the deadliest cancers on earth, analysis published in The Lancet in April 2023 showed a rising incidence of pancreatic cancer among individuals younger than 55 years, further demonstrating a need for more treatments. Among the treatments in development that caught the eye of the FDA over the past year are those that have come from  Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Pyxis Oncology, Inc. (NASDAQ: PYXS), AstraZeneca PLC (NASDAQ: AZN), Eli Lilly and Company (NYSE: LLY), and Merus N.V. (NASDAQ: MRUS).

Key Points: 
  • A lot of the main efforts in fighting this particular cancer are in line with the work of the Pancreatic Cancer Action Network (PanCAN).
  • They've been asking supporters from every state in the US to get in touch with Congress to boost federal funds for pancreatic cancer research.
  • Near the end of 2022, the FDA rewarded pelareorep with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • Out of the 13 patients checked, one had a complete response - something that doesn't happen often when treating pancreatic cancer.

New FDA Designations Accelerate Progress in Pancreatic Cancer Treatments: A Year in Review

Retrieved on: 
Friday, October 13, 2023
MBA, NYSE, Colorectal cancer, RET, Safety, US Foods, Therapy, Oncolytics Biotech, Breakthrough therapy, Transfection, News, NRG1, Research, Eli Lilly and Company, Cancer, HIV disease progression rates, Gastrointestinal cancer, JD, MD Anderson Cancer Center, AstraZeneca, LLY, EDB, Spacecraft, TSX, Eye, Pyxis, Liver, Disease, System, FDA, RECIST, University, Pancreatic Cancer Action Network, Thorax, Immunotherapy, FTD, Extracellular matrix, Fusion, Neoplasm, Congress, GI, Incidence, ORR, MD, ONC, Meru Networks, Colon, AZN, Pancreatic cancer, Patient, BTC, Johns Hopkins University, Pharmaceutical industry, Durvalumab, Lancet

VANCOUVER, BC, Oct. 13, 2023 /PRNewswire/ -- USA News Group  -  Since September 2022, the US Food and Drug Administration (FDA) has seen new treatments for pancreatic cancer that are worthy of further investigation or approval. Known as one of the deadliest cancers on earth, analysis published in The Lancet in April 2023 showed a rising incidence of pancreatic cancer among individuals younger than 55 years, further demonstrating a need for more treatments. Among the treatments in development that caught the eye of the FDA over the past year are those that have come from  Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Pyxis Oncology, Inc. (NASDAQ: PYXS), AstraZeneca PLC (NASDAQ: AZN), Eli Lilly and Company (NYSE: LLY), and Merus N.V. (NASDAQ: MRUS).

Key Points: 
  • A lot of the main efforts in fighting this particular cancer are in line with the work of the Pancreatic Cancer Action Network (PanCAN).
  • They've been asking supporters from every state in the US to get in touch with Congress to boost federal funds for pancreatic cancer research.
  • Near the end of 2022, the FDA rewarded pelareorep with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • Out of the 13 patients checked, one had a complete response - something that doesn't happen often when treating pancreatic cancer.

Tonix Pharmaceuticals Announces Pricing of $4.5 Million Public Offering

Retrieved on: 
Friday, September 29, 2023
Long COVID, Prader–Willi syndrome, Sumatriptan, Failure, Telephone, Drug Master File, Autoimmunity, Pain, Acquisition, Madison Avenue, Psychiatry, Therapy, Capital market, SL, Research, Infection, Risk, Orphan drug, Security (finance), FDA, Health, COVID-19, Cancer, Smallpox, Disease, Government, Breakthrough therapy, Hydrogen chloride, MDD, Annual report, Neurology, Form, CD40L, Central nervous system, CNS, Sale, Prospectus, S-3, DSM-IV codes, Nature, Fibromyalgia, Pharmaceutical industry, CD154, Tonix Pharmaceuticals

The closing of the public offering is expected to take place on or about October 3, 2023, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The closing of the public offering is expected to take place on or about October 3, 2023, subject to the satisfaction of customary closing conditions.
  • The gross proceeds of the offering will be approximately $4.5 million before deducting placement agent fees and other estimated offering expenses payable by the Company.
  • Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-placement agent for the offering.
  • The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC.

Tonix Pharmaceuticals Announces Proposed Public Offering

Retrieved on: 
Thursday, September 28, 2023
Long COVID, Prader–Willi syndrome, Sumatriptan, Failure, Binge eating disorder, Telephone, Drug Master File, PPAR, Upsher-Smith Laboratories, Autoimmunity, Pain, Acquisition, Social anxiety disorder, Madison Avenue, Migraine, Psychiatry, Headache, Therapy, Capital market, SL, Research, Infection, Risk, Orphan drug, Security (finance), FDA, Long, COVID-19, Cancer, Smallpox, Disease, Government, Breakthrough therapy, Hydrogen chloride, MDD, Annual report, Gustav Neuring, Neurology, Form, CD40L, Obesity, Central nervous system, CNS, Sale, Prospectus, S-3, DSM-IV codes, Nature, Fibromyalgia, Pharmaceutical industry, CD154, Tonix Pharmaceuticals

CHATHAM, N.J., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase shares of common stock in a public offering.

Key Points: 
  • CHATHAM, N.J., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase shares of common stock in a public offering.
  • All of the securities to be sold in the offering are to be offered by Tonix.
  • The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
  • Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the public offering, the timing and size of the public offering, the intended use of proceeds from the public offering and other statement that are predictive in nature.

Verastem Presents Avutometinib and Defactinib Combination Program Updates at the 5th Annual RAS-Targeted Drug Development Summit

Retrieved on: 
Thursday, September 28, 2023
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, KRAS, FRCP, Verastem Oncology, MBBS, American Society of Clinical Oncology, Clinical trial, Cancer, Breakthrough therapy, Royal Marsden Hospital, The Institute, DNB, FRAME, Part, Doctor of Philosophy, PFS, ASCO, RAMP, RAS, Patient, Annual general meeting, Drug development, Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, Society, ORR, RAF, Pharmaceutical industry, MD

Verastem Oncology, (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced the presentation of scientific background and clinical trial updates on the avutometinib and defactinib programs at the 5th Annual RAS-Targeted Drug Development Summit in Boston, Massachusetts.

Key Points: 
  • Verastem Oncology, (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced the presentation of scientific background and clinical trial updates on the avutometinib and defactinib programs at the 5th Annual RAS-Targeted Drug Development Summit in Boston, Massachusetts.
  • The updates are part of two oral presentations by Jonathan Pachter, PhD, Chief Scientific Officer and Louis Denis, MD, Chief Medical Officer at Verastem Oncology.
  • The first presentation titled “Vertical Inhibition of RAS, RAF & MEK: Enhancing Antitumor Efficacy of KRAS G12C & G12D Inhibitors with RAF/MEK Clamp Avutometinib”, includes scientific rationale for clinical combinations with avutometinib and defactinib in various RAS pathway-driven cancers.
  • The second presentation titled, “Introducing Rational Combinations of RAF/MEK Clamp Avutometinib: Breakthrough Therapy Designation & Beyond,” discusses novel combination treatment approaches and provides an overview of the avutometinib and defactinib clinical development program.

Pancreatic Cancer Research Gains Momentum Amidst Soaring Young-Onset Cases

Retrieved on: 
Tuesday, September 26, 2023
Gastrointestinal cancer, MDT, Breakthrough therapy, MBA, GH, Congress, Incidence, Helmy Eltoukhy, Patient, JAMA Network Open, Health, NYSE, Polyp, News, Disease, Oncolytics Biotech, Research, Attention, Biologics license application, MRD, ONC, Pancreatic Cancer Action Network, Data, JD, TSX, FDA, Lancet, GI, Pancreatic cancer, Human, CAD, NSCLC, Biomarker, NRG1, Colorectal cancer, CR, United States Congress, ORR, Clinical trial, FOLFIRINOX, ASCO, American Society of Clinical Oncology, Physician, EUS, Annual general meeting, Poster, Recurrence, Society, FTD, Breast cancer, Pharmaceutical industry, Medical imaging, Meru Networks, Nvidia, Medtronic

VANCOUVER, British Columbia, Sept. 26, 2023 /PRNewswire/ -- USA News Group - The seriousness of pancreatic cancer continues to grow, with increasing alarm since The Lancet published an analysis back in April 2023, showing a rising incidence of pancreatic cancer among individuals younger than 55 years. Another study published in JAMA Network Open showed that early-onset cancer in people younger than 50 rose over the last decade, with gastrointestinal cancers seeing the fastest increase. This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now. Among the ongoing efforts that are drawing more attention in the pancreatic cancer space have been the developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Merus N.V. (NASDAQ: MRUS), Guardant Health, Inc. (NASDAQ: GH), Medtronic plc (NYSE: MDT), and even NVIDIA Corporation (NASDAQ: NVDA).

Key Points: 
  • This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now.
  • "By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."
  • Pelareorep delivered the company a big win near the end of 2022, when the FDA rewarded it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options," said Julie Fleshman, JD, MBA, President and CEO of PanCAN.

Pancreatic Cancer Research Gains Momentum Amidst Soaring Young-Onset Cases

Retrieved on: 
Tuesday, September 26, 2023
Gastrointestinal cancer, MDT, Breakthrough therapy, MBA, GH, Congress, Incidence, Helmy Eltoukhy, Patient, JAMA Network Open, Health, NYSE, Polyp, News, Disease, Oncolytics Biotech, Research, Attention, Biologics license application, MRD, ONC, Pancreatic Cancer Action Network, Data, JD, TSX, FDA, Lancet, GI, Pancreatic cancer, Human, CAD, NSCLC, Biomarker, NRG1, Colorectal cancer, CR, United States Congress, ORR, Clinical trial, FOLFIRINOX, ASCO, American Society of Clinical Oncology, Physician, EUS, Annual general meeting, Poster, Recurrence, Society, FTD, Breast cancer, Pharmaceutical industry, Medical imaging, Meru Networks, Nvidia, Medtronic

VANCOUVER, British Columbia, Sept. 26, 2023 /PRNewswire/ -- USA News Group - The seriousness of pancreatic cancer continues to grow, with increasing alarm since The Lancet published an analysis back in April 2023, showing a rising incidence of pancreatic cancer among individuals younger than 55 years. Another study published in JAMA Network Open showed that early-onset cancer in people younger than 50 rose over the last decade, with gastrointestinal cancers seeing the fastest increase. This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now. Among the ongoing efforts that are drawing more attention in the pancreatic cancer space have been the developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Merus N.V. (NASDAQ: MRUS), Guardant Health, Inc. (NASDAQ: GH), Medtronic plc (NYSE: MDT), and even NVIDIA Corporation (NASDAQ: NVDA).

Key Points: 
  • This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now.
  • "By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."
  • Pelareorep delivered the company a big win near the end of 2022, when the FDA rewarded it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options," said Julie Fleshman, JD, MBA, President and CEO of PanCAN.

Press Release: Once-weekly ALTUVIIIO® approved in Japan as a new class of factor VIII therapy for hemophilia A

Retrieved on: 
Monday, September 25, 2023
US Foods, Bleeding, MHLW, Factor VIII, European Medicines Agency, ABR, Quality of life, Haemophilia, Fast Track, Coordinated Specialty Care, Arthralgia, European Commission, Marketing, Breakthrough therapy, Orphan drug, Patient, Physician, Risk, VIII, Sanofi, Joint, MAA, FDA, Haemophilia A, Chronic pain, Headache, Food, Birth control, Pharmaceutical industry, Welfare, Health

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO®[Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein], a first-in-class, high-sustained factor VIII replacement therapy.

Key Points: 
  • The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO®[Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein], a first-in-class, high-sustained factor VIII replacement therapy.
  • ALTUVIIIO is indicated for control of bleeding tendency in patients with hemophilia A (factor VIII deficiency).
  • ALTUVIIIO was also recently approved by the Taiwan Food and Drug Administration for treatment of adults and children with hemophilia A on August 31, 2023.
  • The high-sustained factor activity levels will enable patients and physicians to reimagine living with hemophilia.

89bio Announces U.S. FDA has Granted Breakthrough Therapy Designation for Pegozafermin in Nonalcoholic Steatohepatitis (NASH)

Retrieved on: 
Thursday, September 21, 2023
Cirrhosis, Histology, NASH, Breakthrough therapy, BTD, FGF21, Inflammation, Patient, SAN, Liver, Fatty liver disease, Priority, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, F4, Safety, Pharmaceutical industry

SAN FRANCISCO, Sept. 21, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pegozafermin in patients with nonalcoholic steatohepatitis (NASH).

Key Points: 
  • SAN FRANCISCO, Sept. 21, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pegozafermin in patients with nonalcoholic steatohepatitis (NASH).
  • “We believe pegozafermin is well positioned as a leading FGF21 analog treatment option with demonstrated strong histology data, best-in-class tolerability, and dosing convenience to date.
  • It has the potential to meet the treatment needs for F2/3 patients as well as compensated cirrhotic (F4) patients.
  • BTD is an FDA program designed to expedite the development and review of product candidates intended for serious or life-threatening conditions.