V6 PRV engine

TransCode Therapeutics CEO Letter to Shareholders

Retrieved on: 
Wednesday, July 5, 2023
Acceleration, Pancreatic cancer, Carcinoma, Priority review, CRISPR, Glioblastoma, Partnership, Optimism, PRV, University, V6 PRV engine, Marketing, ODD, Clinical trial, Fear, Cancer, Osteosarcoma, Transcoding, Breast, Research, Monroe Dunaway Anderson, RNA, Immunotherapy, Trust, Animal, Patent, IRB, Patient, Melanoma, Knowledge, Neoplasm, FDA, Recurrence, IND, MD Anderson Cancer Center, Pancreatic tumor, TTX, Pharmaceutical industry

I am delighted to inform you about the accomplishments and advancements we have attained at TransCode following our initial public offering in July 2021.

Key Points: 
  • I am delighted to inform you about the accomplishments and advancements we have attained at TransCode following our initial public offering in July 2021.
  • In our dedicated pursuit to transform the treatment of cancer, we believe TransCode Therapeutics has made significant strides in research, innovation, and clinical development.
  • We have observed significant tumor regression and durable responses in multiple animal models, which we believe support the therapeutic potential of TTX-MC138.
  • Development stage biotech companies, such as TransCode Therapeutics, play a crucial role as the sources from which these large companies discover their next potential candidates.

bluebird bio Sells Second Priority Review Voucher for $95 Million

Retrieved on: 
Friday, January 6, 2023
General Health, Neurology, FDA, Health, Pharmaceutical, Food, Bluebird, PRV, V6 PRV engine, Patient, Thalassemia, Jefferies Group, US Foods, FDA, Sale, Pharmaceutical industry

bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today announced that it has entered into a definitive agreement to sell its second Rare Pediatric Disease Priority Review Voucher (PRV) for $95 million.

Key Points: 
  • bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today announced that it has entered into a definitive agreement to sell its second Rare Pediatric Disease Priority Review Voucher (PRV) for $95 million.
  • On December 29, 2022, bluebird closed the sale of its first PRV for $102 million.
  • “The sale of our second priority review voucher further bolsters our financial position and provides an important source of non-dilutive funding for the company,” said Chris Krawtschuk, chief financial officer, bluebird bio.
  • Jefferies LLC acted as the exclusive financial advisor to bluebird for this transaction.

Soligenix Announces Distribution of Series D Preferred Stock to Holders of its Common Stock

Retrieved on: 
Friday, December 23, 2022
Project, Psoriasis, BDP, Government, V6 PRV engine, COVID-19, Specialization, Proxy, Public health, Biomedical Advanced Research and Development Authority, Venture round, Research, EMA, NIAID, Severe acute respiratory syndrome coronavirus 2, PRV, BARDA, Form 10-Q, Delaware General Corporation Law, Head, Partnership, Risk, DTRA, National Institute of Allergy and Infectious Diseases, Infection, FDA, Inflammation, Unitary state, Therapy, Development, Defense Threat Reduction Agency, Genta (company), Mucositis, Priority review, IDR, NDA, Congress, Doctor of Philosophy, Health care reform, Security (finance), Bangladesh Securities and Exchange Commission, T-cell lymphoma, Protalix BioTherapeutics, Clinical trial, CTCL, Vaccine, Legislation, Pharmaceutical industry

The shares of Series D Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Standard Time on January 4, 2023.

Key Points: 
  • The shares of Series D Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Standard Time on January 4, 2023.
  • Subject to certain limitations, each outstanding share of Series D Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series D Preferred Stock).
  • The Series D Preferred Stock will be uncertificated, and no shares of Series D Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company's common stock held by such holder.
  • In that case, a number of one one-thousandths of a share of Series D Preferred Stock equal to the number of shares of the Company's common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.

bluebird bio Sells Priority Review Voucher for $102 Million

Retrieved on: 
Wednesday, November 30, 2022
FDA, Health, Genetics, General Health, Pharmaceutical, Biotechnology, US Foods, Bluebird bio, Bird, Food, Risk, Safety, Bluebird, BLA, Patient, Thalassemia, Sumathi Best Television Current Reporting Award, Disease, Security (finance), PDUFA, Sale, Research, China Biologic Products, Sickle cell disease, FDA, V6 PRV engine, PRV, Pharmaceutical industry

bluebird bio, Inc. (NASDAQ: BLUE) (bluebird bio or the Company) today announced that it has entered into a definitive agreement to sell a Rare Pediatric Disease Priority Review Voucher (PRV) for $102 million.

Key Points: 
  • bluebird bio, Inc. (NASDAQ: BLUE) (bluebird bio or the Company) today announced that it has entered into a definitive agreement to sell a Rare Pediatric Disease Priority Review Voucher (PRV) for $102 million.
  • With the sale of our first priority review voucher, we have significantly strengthened our financial outlook, said Andrew Obenshain, chief executive officer, bluebird bio.
  • bluebird will receive a payment of $102 million upon closing of the transaction, which remains subject to customary closing conditions, including anti-trust review.
  • bluebird bio, ZYNTEGLO and SKYSONA are registered trademarks of bluebird bio, Inc. All rights reserved.

Immix Biopharma Receives Institutional Review Board Approval to Enroll Pediatric Patients in Upcoming IMX-110 Clinical Trial, Key Requirement for U.S. Food and Drug Administration Approval of Rare Pediatric Disease Priority Review Voucher

Retrieved on: 
Friday, November 11, 2022
V6 PRV engine, Regulation, U.S. Securities and Exchange Commission, Clinical trial, CEO, Rhabdomyosarcoma, FDA, RMS, Cancer, Priority review, Prevalence, MD, Adolescence, Disease, LOS, Security (finance), Platform, GLOBE, Adult, Institutional review board, Patient, PRV, Drug development, Neoplasm, Forward-looking statement, Government Accountability Office, TME, Industry, Dietary supplement, Pharmaceutical industry

LOS ANGELES, Nov. 11, 2022 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases, today announced that it has received Institutional Review Board (“IRB”) approval to enroll pediatric patients in its upcoming IMX-110 clinical trial. Enrolling pediatric patients in a clinical trial is a key requirement for FDA approval of a Priority Review Voucher (“PRV”). PRV holders can benefit from an expedited six-month review of a new drug application for any disease by the FDA. While their future value is uncertain, PRVs are transferable to other companies and have historically sold for $67 to $350 million according to a January 2020 report on drug development by the Government Accountability Office.

Key Points: 
  • Enrolling pediatric patients in a clinical trial is a key requirement for FDA approval of a Priority Review Voucher (PRV).
  • PRV holders can benefit from an expedited six-month review of a new drug application for any disease by the FDA.
  • Our key opinion leaders at our 5 clinical trial sites are excited to bring IMX-110 to their adult and pediatric cancer patients.
  • Rhabdomyosarcoma (RMS) is a high-grade, malignant cancer in children, the most common soft tissue sarcoma in pediatric and adolescent populations.

Global Pressure Relief Valves Market Analysis/Forecasts Report 2022: U.S. Market is Estimated at $697.3 Million in 2022, While China is Forecast to Reach $727.5 Million by 2026 - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 18, 2022
Construction & Property, Other Construction & Property, Pilot-operated relief valve, Growth, V6 PRV engine, Device file, Safety, CAGR, Temperature, PRV, Pet, Video game, Renewable energy

The "Pressure Relief Valves - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Pressure Relief Valves - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.
  • The U.S. Market is Estimated at $697.3 Million in 2022, While China is Forecast to Reach $727.5 Million by 2026
    The Pressure Relief Valves market in the U.S. is estimated at US$697.3 Million in the year 2022.
  • China, the world's second largest economy, is forecast to reach a projected market size of US$727.5 Million by the year 2026 trailing a CAGR of 4.6% over the analysis period.
  • In the global Pressure & Temperature Actuated segment, USA, Canada, Japan, China and Europe will drive the 3.6% CAGR estimated for this segment.

InPipe Energy Announces the HydroXS Next Generation Technology That Produces Renewable Energy from Water Pipelines

Retrieved on: 
Wednesday, July 13, 2022
Technology, Goal, SCADA, Electricity, Water loss, Solution, Kilowatt-hour, V6 PRV engine, CEO, Climate, Hydrox, Pressure, Water, Carbon, Renewable energy

PORTLAND, Ore., July 13, 2022 /PRNewswire-PRWeb/ -- InPipe Energy, a renewable energy and smart water technology company, today announced the availability of the HydroXS, the latest generation of the company's micro-hydro energy recovery technology that produces renewable energy while managing pressure in municipal water pipelines. Building on the company's successful first-generation product, the new HydroXS product line features a proprietary new design that produces up to 50% more power and includes models suited for municipal, agricultural and industrial water systems. The product is appropriate for pipe sizes from 2" to 110" in diameter and can generate from 20kW to over a megawatt of green energy. HydroXS also includes a more robust set of monitoring and reporting features that help water managers improve water loss control, track renewable energy produced and carbon saved, and report progress on sustainability goals.

Key Points: 
  • PORTLAND, Ore., July 13, 2022 /PRNewswire-PRWeb/ -- InPipe Energy , a renewable energy and smart water technology company, today announced the availability of the HydroXS, the latest generation of the company's micro-hydro energy recovery technology that produces renewable energy while managing pressure in municipal water pipelines.
  • "Our HydroXS technology is centered at the intersection of climate, energy, water, and equity," said Gregg Semler, President, and CEO of InPipe Energy.
  • InPipe Energy is a renewable energy and smart water technology company and the innovator of the In-PRV and the new HydroXS product line that uses safe, clean, micro-hydropower technology to harvest excess water pressure and convert it to clean, low-cost electricity.
  • It is the company's mission to help water managers everywhere leverage their water delivery pipelines to generate renewable energy while precisely managing pressure, reducing carbon, saving water and supporting sustainability and resilience.

US FDA AWARDS RARE PEDIATRIC DISEASE DESIGNATION (RPDD) TO PAXALISIB FOR AT/RT, A RARE FORM OF CHILDHOOD BRAIN CANCER

Retrieved on: 
Wednesday, July 6, 2022
Review, FDA, Annual report, ODD, PNOC, Patient, Brain tumor, PRV, Food and Drug Administration Safety and Innovation Act, ASX, Marketing, PI3K, American Association for Cancer Research, Goal, VEGFR3, V6 PRV engine, DMG Media, AACR, Innovation Act, Glioblastoma, Orphan, Food, AT/RT, American Association, St. Jude Children's Research Hospital, SEC, Incidence, Rinderpest, NASDAQ, Acceleration, Twitter, Brain, Neurodevelopmental disorder, Program, Multimedia, KZIA, GBM, Pharmaceutical industry, Vaccine, Genentech, Kazia Pelka, DIPG

Rare Pediatric Disease Designation (RPDD) is granted to drugs which are under development for rare childhood diseases.

Key Points: 
  • Rare Pediatric Disease Designation (RPDD) is granted to drugs which are under development for rare childhood diseases.
  • Paxalisib was previously granted orphan drug designation (ODD) for AT/RT by FDA on 16 June 2022.
  • Brain cancer is the most common cause of cancer death in children, and outcomes in many forms of childhood brain cancer have not improved in decades.
  • In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020, and for AT/RT in June 2022.

Soligenix to Present at the H.C. Wainwright Global Investment Conference

Retrieved on: 
Wednesday, May 18, 2022
Infection, Severe acute respiratory syndrome coronavirus 2, Biomedical Advanced Research and Development Authority, Inflammation, Form 10-Q, Specialization, Company, U.S. Securities and Exchange Commission, Nasdaq, T-cell lymphoma, Mucositis, National Institute, V6 PRV engine, National Institute of Allergy and Infectious Diseases, Contract, Vaccine, Defense Threat Reduction Agency, Clinical trial, Health care reform, COVID-19, DTRA, Unitary state, Legislation, Research, FDA, Psoriasis, BDP, Time, Priority review, Conference, NIAID, EMA, Congress, Technology, Public health, IDR, Risk, Protalix BioTherapeutics, Head, Therapy, LinkedIn, Twitter, PRV, Government, Development, Project, Security (finance), CTCL, BARDA, Pharmaceutical industry

The conference will be held May 23 through 26, 2022 with presentations, one-on-one meetings, and networking.

Key Points: 
  • The conference will be held May 23 through 26, 2022 with presentations, one-on-one meetings, and networking.
  • For more information about the H.C. Wainwright Global Investment Conference, please refer to the conference website at https://hcwevents.com/globalconference/ .
  • Key members of Soligenix management will hold one-on-one meetings throughout the conference.
  • Registered conference attendees may schedule a meeting with Soligenix via the conference scheduling platform.

Appili Therapeutics Announces New Late-Stage Clinical Program ATI-1801 to Treat Cutaneous Leishmaniasis

Retrieved on: 
Wednesday, April 13, 2022
FDA, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, Drug development, News, CEO, Cutaneous leishmaniasis, Government, Disability, Social stigma, Woman, Index, US Foods, Risk, Ulcer, Intention, Non-governmental organization, Food, Infection, PRV, OTCQX, Program, Patient, Review, Francisella tularensis, Death, Company, Skin, Therapy, V6 PRV engine, TSX, Safety, Scar, Partnership, FDA, Disease, Hospital, Leishmaniasis, Pharmaceutical industry

Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the Company or Appili), a biopharmaceutical company focused on drug development for infectious diseases, today announced the addition of ATI-1801, a clinical stage topical paromomycin product to treat cutaneous leishmaniasis, to its development pipeline.

Key Points: 
  • Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the Company or Appili), a biopharmaceutical company focused on drug development for infectious diseases, today announced the addition of ATI-1801, a clinical stage topical paromomycin product to treat cutaneous leishmaniasis, to its development pipeline.
  • Appili holds the full clinical dossier for ATI-1801, including the results of a randomized, double-blind, vehicle-controlled Phase 3 study which evaluated the safety and efficacy of ATI-1801 for the treatment of cutaneous leishmaniasis in Tunisia.
  • The PRV program was developed to incentivize drug development in US government priority areas including medical countermeasures and tropical diseases such as leishmaniasis.
  • Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections.