Fast track (FDA)

Pancreatic Cancer Battle Boosted by $200M VC Firm

Retrieved on: 
Tuesday, September 19, 2023
MACK, Rockefeller University, Stanford University, Pancreatic Cancer Action Network, MBA, Congress, Emerson Collective, MD, Patient, BNTX, Fast track (FDA), News, The New York Times, Interview, Ipsen, BioNTech, Mirati Therapeutics, Incyte, ONC, JD, Memorial Sloan Kettering Cancer Center, TSX, Metastasis, FDA, Roche, Pancreatic cancer, Oncolytics Biotech, Cancer, Lung cancer, MIT, Messenger, Mirati, MSK, Partnership, Pelareorep, Irinotecan, Merrimack Pharmaceuticals, American Cancer Society, FTD, Pharmaceutical industry, Genentech, Apple, Yosemite National Park, Research

VANCOUVER, BC, Sept. 19, 2023 /PRNewswire/ -- USA News Group  -  A new cancer-focused venture capital firm is making headlines, having debuted with $200 million in funding from prominent individuals and institutions such as MIT,  Memorial Sloan Kettering Cancer Center and The Rockefeller University. Led by 31-year old Reed Jobs, the new firm dubbed 'Yosemite' appears to be an extension of the legacy left by the founder's father, Steve Jobs, the co-founder of Apple, who died in 2011 from a rare form of pancreatic cancer at the age of only 56. From an investment standpoint, the Global Pancreatic Cancer Market is expected to surpass US$7.4 billion by 2032, growing at a health CAGR of 13.7% along the way. Among the biotech sector's most promising developers of treatments for pancreatic cancer are Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK), Incyte Corporation (NASDAQ:INCY), Mirati Therapeutics, Inc. (NASDAQ:MRTX), and BioNTech SE (NASDAQ:BNTX).

Key Points: 
  • According to the American Cancer Society in its Cancer Facts & Figures 2023 report, the five-year survival rate for pancreatic cancer increased by 1% from the previous year to 12%.
  • In terms of targeting pancreatic cancer, the efforts align with the Pancreatic Cancer Action Network (PanCAN), which has been urging advocates from all 50 US states to call on Congress to increase federal funding for pancreatic cancer research.
  • These tests will be for people who have certain kinds of lung cancer, bowel cancer, pancreatic cancer, and other solid tumors, with Mirati providing Incyte with a drug called Adagrasib to use in the study.
  • The tailored neoantigen pancreatic cancer vaccine from BioNTech invoked an immune response in 50% of patients and prevented relapse.

Pancreatic Cancer Battle Boosted by $200M VC Firm

Retrieved on: 
Tuesday, September 19, 2023
MACK, Rockefeller University, Stanford University, Pancreatic Cancer Action Network, MBA, Congress, Emerson Collective, MD, Patient, BNTX, Fast track (FDA), News, The New York Times, Interview, Ipsen, BioNTech, Mirati Therapeutics, Incyte, ONC, JD, Memorial Sloan Kettering Cancer Center, TSX, Metastasis, FDA, Roche, Pancreatic cancer, Oncolytics Biotech, Cancer, Lung cancer, MIT, Messenger, Mirati, MSK, Partnership, Pelareorep, Irinotecan, Merrimack Pharmaceuticals, American Cancer Society, FTD, Pharmaceutical industry, Genentech, Apple, Yosemite National Park, Research

VANCOUVER, BC, Sept. 19, 2023 /PRNewswire/ -- USA News Group  -  A new cancer-focused venture capital firm is making headlines, having debuted with $200 million in funding from prominent individuals and institutions such as MIT,  Memorial Sloan Kettering Cancer Center and The Rockefeller University. Led by 31-year old Reed Jobs, the new firm dubbed 'Yosemite' appears to be an extension of the legacy left by the founder's father, Steve Jobs, the co-founder of Apple, who died in 2011 from a rare form of pancreatic cancer at the age of only 56. From an investment standpoint, the Global Pancreatic Cancer Market is expected to surpass US$7.4 billion by 2032, growing at a health CAGR of 13.7% along the way. Among the biotech sector's most promising developers of treatments for pancreatic cancer are Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK), Incyte Corporation (NASDAQ:INCY), Mirati Therapeutics, Inc. (NASDAQ:MRTX), and BioNTech SE (NASDAQ:BNTX).

Key Points: 
  • According to the American Cancer Society in its Cancer Facts & Figures 2023 report, the five-year survival rate for pancreatic cancer increased by 1% from the previous year to 12%.
  • In terms of targeting pancreatic cancer, the efforts align with the Pancreatic Cancer Action Network (PanCAN), which has been urging advocates from all 50 US states to call on Congress to increase federal funding for pancreatic cancer research.
  • These tests will be for people who have certain kinds of lung cancer, bowel cancer, pancreatic cancer, and other solid tumors, with Mirati providing Incyte with a drug called Adagrasib to use in the study.
  • The tailored neoantigen pancreatic cancer vaccine from BioNTech invoked an immune response in 50% of patients and prevented relapse.

Health Canada Accepts Valneva’s Chikungunya Vaccine License Application for Review

Retrieved on: 
Tuesday, August 29, 2023
Epidemic, Priority review, NDS, Biologics license application, Pan American Health Organization, Saint-Herblain, Priority, Marketing, Coalition, European Medicines Agency, Valneva SE, CEPI, PAHO, Coalition for Epidemic Preparedness Innovations, Licensure, Chikungunya, Person, Trial of the century, Fast track (FDA), EMA, Euronext Paris, VLA, MD, Instituto Butantan, Ageing, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry, Vaccine, Lancet

Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.

Key Points: 
  • Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.
  • This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023.
  • A Biologic License Application (BLA) is currently under priority review1 by the U.S. Food and Drug Administration (FDA)2.
  • VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need.

Comanche Biopharma Drug Receives FDA Fast Track Designation

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Wednesday, August 23, 2023
Pregnancy, Drug development, Public, Woman, Fast Track, Comanche, Fast track (FDA), Small RNA, Pre-eclampsia, Death, HIV disease progression rates, Patient, Premature, Entrepreneurship, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

CONCORD, Mass., Aug. 23, 2023 /PRNewswire/ -- Comanche Biopharma Corp. today announced that they have received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the investigation of Comanche's asset CBP-4888 as a novel siRNA therapy for preeclampsia.

Key Points: 
  • CONCORD, Mass., Aug. 23, 2023 /PRNewswire/ -- Comanche Biopharma Corp. today announced that they have received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the investigation of Comanche's asset CBP-4888 as a novel siRNA therapy for preeclampsia.
  • The FDA's Fast Track designation expedites the development and review of potential treatments for serious conditions where current therapeutic options are limited or absent.
  • A Fast Track designation for a drug meant to treat preeclampsia signifies the urgent need to address this gap in medical care.
  • Today's FDA Fast Track designation brings us one step closer to our shared goal of advancing a safe and effective treatment option for patients with preeclampsia."

VBI Vaccines Reports Second Quarter 2023 Financial Results

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Monday, August 14, 2023
Research, Infectious Diseases, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Shekel, Vaccine, Impairment, Prison, Medicaid, Partnership, SG, GBM, CPT, Marketing, NRC, SARS-CoV-2, Bank statement, COVID-19, Net, SARS, Hepatitis B, Hepatitis B vaccine, GAAP, MERS-related coronavirus, VBI, Israeli new shekel, Government, Fast track (FDA), CDC, High-net-worth individual, Medicare, Research and development, MERS, ...Continued, Anthrax Vaccine Immunization Program, ISED, Patient, Administration, Recombinant, InSight, Growth, Internationalized domain name, R, Syneos Health, HBV, National Research Council, Disease, Pharmaceutical industry, Video game, Bank, Adsorption

Cost of Revenues: Cost of revenues was $3.5 million in the second quarter of 2023 as compared to $2.5 million in the second quarter of 2022.

Key Points: 
  • Cost of Revenues: Cost of revenues was $3.5 million in the second quarter of 2023 as compared to $2.5 million in the second quarter of 2022.
  • Research and Development (R&D): R&D expenses for the second quarter of 2023 were $3.3 million as compared to $5.6 million for the second quarter of 2022.
  • Impairment for the second quarter of 2023 was $20.0 million as compared to $0 for the second quarter of 2022.
  • Foreign exchange loss for the second quarter of 2023 was $5.9 million as compared to $21.9 million for the second quarter of 2022.

Erasca Reports Second Quarter 2023 Financial Results and Business Updates

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Thursday, August 10, 2023
Lead, AACR, Probability, CRC, GBM, American Journal of Clinical Oncology, ODD, Karachi School of Business & Leadership, American Association for Cancer Research, BRAF, MEK, Cetuximab, CNS, Glioblastoma, SHP2, Fast track (FDA), Food and Drug Administration, Journal, Patient, Colorectal cancer, SAN, EGFR, ERK, Administration, HNSCC, HPV, Depreciation, Research and development, Outsourcing, R, Research, FDA, EC, Resuscitation, FTD, Food, Glioma, Pharmaceutical industry, Cryptocurrency, Management

 SAN DIEGO, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today reported financial results for the fiscal quarter ended June 30, 2023, and provided business updates.

Key Points: 
  • Strengthened Business Leadership: In May 2023, Erasca promoted David Chacko, M.D., previously Erasca’s chief financial officer, to the dual position of chief financial officer and chief business officer, and Nik Chetwyn, Ph.D., previously Erasca’s senior vice president of operations, to chief operating officer.
  • Erasca expects its current cash, cash equivalents, and marketable securities balance to fund operations into the second half of 2025.
  • Research and Development (R&D) Expenses: R&D expenses were $26.2 million for the quarter ended June 30, 2023, compared to $27.5 million for the quarter ended June 30, 2022.
  • General and Administrative (G&A) Expenses: G&A expenses were $9.8 million for the quarter ended June 30, 2023, compared to $8.4 million for the quarter ended June 30, 2022.

Genprex Granted FDA Orphan Drug Designation (ODD) for REQORSA® Immunogene Therapy for the Treatment of Small Cell Lung Cancer

Retrieved on: 
Thursday, August 10, 2023
MedImmune, Inc. v. Genentech, Inc., Carcinoma, Maintenance, Diabetes, ODD, Clinical trial, Cancer, TUSC2, NSCLC, Lung cancer, PFS, Lung, Fast track (FDA), SCLC, Non-small-cell lung cancer, Patient, Mouse, Orphan, FDA, FTD, Pharmaceutical industry, Pembrolizumab

AUSTIN, Texas, Aug. 10, 2023 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the Company's lead drug candidate, REQORSA® Immunogene Therapy (quratusugene ozeplasmid), for the treatment of small cell lung cancer (SCLC). 

Key Points: 
  • AUSTIN, Texas, Aug. 10, 2023 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the Company's lead drug candidate, REQORSA® Immunogene Therapy (quratusugene ozeplasmid), for the treatment of small cell lung cancer (SCLC).
  • With ES-SCLC, the cancer has spread from one lung to the other, or to other parts of the body.
  • "We are excited to receive Orphan Drug Designation from the FDA for REQORSA for patients with SCLC," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex.
  • "This FDA Orphan Drug Designation in combination with our recently received FDA Fast Track designation underscores the great need for better treatment options for patients with SCLC,ES-SCLC and NSCLC.

Rocket Pharmaceuticals Reports Second Quarter 2023 Financial Results and Highlights Recent Progress

Retrieved on: 
Thursday, August 10, 2023
Health, Genetics, Research, Pharmaceutical, Science, Biotechnology, University of California, San Diego Performance-Based Skills Assessment, Communication, Advanced Therapy Medicinal Product, LV, University, PKP2, Marketing, European Medicines Agency, Survival, Clinical trial, Bone marrow, UCSD, Arrhythmia, AAV, Disorder, Medication, Fast track (FDA), EMA, ATMP, MMC, BAG3, Investigational New Drug, Invitae, Patient, IRB, Investment, CGMP, LAMP2, Genetic testing, Cardiomyopathy, FDA, Death, BLA, IND, Gene, Safety, Pharmaceutical industry, Vaccine, Fine chemical, Cryptocurrency, G&A, Danon disease

“The second quarter of 2023 marked a period of strong forward momentum across our cardiovascular AAV and hematology LV portfolios highlighted by the BLA submission for our LAD-I program, Rocket’s first product filing.

Key Points: 
  • “The second quarter of 2023 marked a period of strong forward momentum across our cardiovascular AAV and hematology LV portfolios highlighted by the BLA submission for our LAD-I program, Rocket’s first product filing.
  • ATMP designation is intended for medicines that offer groundbreaking new opportunities and allows for a single evaluation and authorization procedure.
  • Initiating two-patient pediatric safety run-in for RP-A501 pivotal study; approaching final alignment with FDA on primary composite endpoint to support accelerated approval.
  • As of June 30, 2023, Rocket had cash, cash equivalents and investments of $307.0 million.

Aura Biosciences Reports Second Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights

Retrieved on: 
Wednesday, August 9, 2023
Research, FDA, Clinical Trials, Biotechnology, Pharmaceutical, Health, Optical, Science, Oncology, Other Science, Senior, SC, NMIBC, Drug, Vanderbilt University Medical Center, Bladder cancer, DRS, Melanoma, Quality, Incidence, CM, Patient, Division, Roivant Sciences, VDC, Growth, Regulatory affairs, SVP, Visual acuity, Fast track (FDA), Safety, Pharmaceutical industry, Nursing, Medical imaging, Medical device, Cryptocurrency

Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today reported financial results for the second quarter ended June 30, 2023, and provided clinical development and operational highlights.

Key Points: 
  • Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today reported financial results for the second quarter ended June 30, 2023, and provided clinical development and operational highlights.
  • The first patient is expected to be dosed in the second half of 2023.
  • Strengthened the clinical leadership team with the following key appointments:
    Dr. Bruce Brown joined Aura as Therapeutic Area Head Urologic Oncology.
  • As of June 30, 2023, Aura had cash and cash equivalents and marketable securities totaling $162.0 million.

Sangamo Therapeutics Reports Recent Business Highlights and Second Quarter 2023 Financial Results

Retrieved on: 
Tuesday, August 8, 2023
Biotechnology, Pharmaceutical, Genetics, Health, Pfizer, Central nervous system, Therapy, Gene, Haemophilia A, BLA, Biogen, Safety, Fabry disease, Phytoene synthase, Research, Brain, AAV, Science, Fast track (FDA), U.S. FDA, Sodium, Phase 3, Nav1.7, Novartis, Patient, Prion, Primate, Annual general meeting, Cell, American Society for Cell Biology, Eli Lilly and Company, MAA, FDA, STAAR, Enzyme replacement therapy, IND, Neurology, Haemophilia, Society, Pharmaceutical industry, Medical device, Vaccine, Fabry, Chroma, Sanofi, Sangamo Therapeutics

Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, today reported recent business highlights and second quarter 2023 financial results.

Key Points: 
  • Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, today reported recent business highlights and second quarter 2023 financial results.
  • We are pleased to have executed several business development deals, demonstrating the excitement in Sangamo’s science and platform,” said Sandy Macrae, Chief Executive Officer of Sangamo.
  • Revenues for the second quarter ended June 30, 2023 were $6.8 million, compared to $29.4 million for the same period in 2022.
  • Additionally, revenues relating to our collaboration agreement with Kite decreased by $5.1 million, reflecting a reduction in collaboration activities during the quarter.