• Powered by Crown Equity Holdings Inc.
      • crown-logo

        Crown Equity Holdings Inc. is publicly traded with the symbol CRWE. The Company primarily provides and offers advertising, branding, marketing solutions and services to boost customer awareness, as well as merchant visibility as a worldwide online multi-media publisher. For list of services offered click here

Post on CRWE World Login
logo Fairfield, UNITED STATES
header-img
  • Home
  • News
  • World
      • World News
      • Español
  • Politics
      • U.S. Legislators
      • Political News
  • Sports
  • Business
      • Markets
      • Hottest Stocks Today
      • CRWEWorld Stocks
      • Blockchain
      • Regulatory
      • Accounting
      • Fundraising Campaigns
      • IPOs
      • Money
      • Career
  • Tech
      • Tech
      • Science
  • Living
      • Arts & Entertainment
      • Family
      • Food
      • Pets
      • Seniors
      • Fashion/Fitness
      • Home & Garden
  • Health
      • Health
      • Pharma & Biotech
  • Opinion
      • Finance
      • Law
      • Healthcare
      • Cannabidiol (CBD)
      • Fashion
      • Podcasts
      • Tech
      • Music
  • Travel
  • Local
      • News
      • Trending Now
      • Real Estate
      • Coupons & Deals
      • Business Directory
  • Jobs
  • More
      • Business 2 Business
      • Press Releases
      • Press Releases Pricing
      • News from GlobeNewswire
      • News from PR Newswire
      • News from Business Wire
      • News from Accesswire
      • Video Channels
      • Beauty
      • Business
      • Comedy
      • Entertainment
      • Fashion
      • Featured
      • Health
      • Instructional
      • News
      • Politics
      • Sports
      • Technology
      • Entertainment
      • Horoscope
      • Sudoku
      • Crossword
      • Games
      • Chat
      • Affiliate | How It Works
      • Join CRWE WORLD Affiliate Program
      • CRWE WORLD Advertising Services Rate
      • Crown Equity Holdings' Overview
      • CRWEWorld Real-Time Global Visitors
      • Content Delivery Solution
        • Contact Us
  • More

Change City


-- OR --
load
load
/assets/img/hottest3.png
/assets/img/hottest2.png

/assets/img/reef2.png
/assets/img/red-line.jpg
/assets/img/reef.png
  • Home
  • Articles
  • News Provided by GlobeNewswire
21ьз╕ Cweather-icon
/assets/img/hottest3.png
/assets/img/hottest2.png

/assets/img/reef2.png
/assets/img/red-line.jpg
/assets/img/reef.png

BioCryst Reports Agreement with PMDA on Phase 3 Clinical Trial and Regulatory Requirements for Marketing Authorization of BCX7353 in Japan

News Provided by GlobeNewswire2018-06-25
13 Views

BCX7353 continues development under Sakigake designation

RESEARCH TRIANGLE PARK, N.C., June 25, 2018 (GLOBE NEWSWIRE) --  BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, today announced that the Company has reached agreement on the design of a Phase 3 trial and regulatory requirements for marketing authorization of BCX7353 for Hereditary Angioedema (“HAE”) with the Pharmaceuticals and Medical Devices Agency (“PMDA”) in Japan.

The Phase 3 trial design agreed upon for Japan, APeX-J, is a randomized, placebo-controlled double-blind trial of 24 weeks duration with a 28-week safety extension. Approximately 24 Japanese subjects with HAE will be enrolled. The APeX-J trial design closely follows the design of APeX-2, a Phase 3 clinical trial being conducted in the U.S., Canada and European countries. APeX-J tests the same dose levels of BCX7353 as in APeX-2, 110 mg daily and 150 mg daily, and the endpoints are identical to those in APeX-2. Data from the APeX-J and APeX-2 trials will be combined for regulatory submission in Japan.

“Japanese HAE patients would welcome an oral prophylactic drug as another treatment alternative, which provides HAE patients ease in daily life as well as relief from travelling outside their home town for treatment to receive on-demand therapy of HAE attacks in a hospital,” said Professor Michihiro Hide, M.D., Ph.D, Dean of the School of Medicine and Professor and Chairman, Department of Dermatology, Hiroshima University, and a leading expert in HAE in Japan.

BCX7353 was one of the first products granted Sakigake designation by the Japanese PMDA in October 2015. Sakigake designation is awarded to innovative products addressing an unmet medical need in Japan or providing improved efficacy compared to available treatment.  Sakigake designation is associated with accelerated review of a Japanese NDA as well as pricing and other corporate benefits for the holder.

"Now that we have agreement on the regulatory requirements for marketing authorization of BCX7353 in Japan, we can move forward with executing APeX-J and selecting a commercialization partner for this region," said Jon P. Stonehouse, President & Chief Executive Officer. "A once-a-day oral treatment for this rare disease represents a high unmet medical need in Japan and an excellent partnering opportunity."

About BCX7353

Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with HAE. BCX7353 has been generally safe and well tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is currently conducting the Phase 3 APeX-2 clinical trial and the long-term safety APeX-S clinical trial, both evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. BioCryst is also conducting the ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing an oral liquid formulation of BCX7353 for the treatment of acute angioedema attacks.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule medicines that address both common and rare conditions. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, galidesivir, a potential treatment for filoviruses, and a preclinical program to develop oral Alk-2 inhibitors for the treatment of fibrodysplasia ossificans progressive (“FOP”). RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of HAE second generation drug candidates (including ZENITH-1, APeX-2, APeX-S and APeX-J) may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the Company may not advance human clinical trials with product candidates as expected; that the FDA, EMA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, or may not provide regulatory clearances which may result in delay of planned clinical trials, or may impose a clinical hold with respect to such product candidate, or withhold market approval for product candidates. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements.

BCRXW

CONTACT:    Thomas Staab, BioCryst Pharmaceuticals, +1-919-859-7910

 



© 2018 GlobeNewswire, Inc. All Rights Reserved.

Read More..
The news, reports, views and opinions of authors (or source) expressed are their own and do not necessarily represent the views of CRWE World.


XPeng (NYSE: XPEV) Unveils Beta Version Navigation Guided Pilot Function





/assets/img/cw-stocks.png

/assets/img/wysh-jewels.png

/assets/img/hjli.png

/assets/img/Mars-Parachute-2.png

/assets/img/crweworld-podcast.jpg
Sponsored
Also read
European Energy A/S adjusts expectations for 2020 and foresees a strong 2021
Agios Presents Final Data from Phase 3 ClarIDHy Study of TIBSOVO® (ivosidenib tablets) in Patients with Previously Treated IDH1-Mutant Cholangiocarcinoma
Putin critic Alexei Navalny to return to Russia amid threat of arrest
Airline industry needs up to another $80bn to survive pandemic
Indonesia earthquake: Heavy rain hampers search for survivors
Russia Navalny: Poisoned opposition leader flying home
La Ertzaintza ha abierto 735 actas por el incumplimiento de las medidas preventivas contra la Covid-19
Wonder Woman 1984: las legendarias guerreras de la antigüedad que inspiraron el personaje de la Mujer Maravilla


Post on CRWE WorldSign Up for Free E-mail Updates
  • Real Estate Eagle Firm, Real Estate
Signup for free email updates
/assets/img/wall-street-rect2.png
/assets/img/wall-street-sq.png



Join with us
Live Traffic Feed
About CrweWorld
  • About Us
  • Privacy Policy
  • Terms & Conditions
  • Finance Disclaimer
  • Jobs
Subscribe for newsletter
3+2
Contact Info
  • contact@crweworld.com

  • P: (702) 683-8946

  • P: (702) 810-0178

  • 11226 Pentland Downs St, Las Vegas, NV 89141

Tweets by CrweWorld
Tweets by @CrweWorld
  • © 2021 crweworld.com
ad1

/assets/images/ad/crwe_tech.jpg

Your Technology Source, Your Technology Team

Server Maintenance, Web Development, Mobile Application Solutions, SEO Services and more

Contact Us: contact@crwetech.com

www.CRWETech.com

ad2

/assets/images/ad/content-delivery-solution.jpg

 

Our content delivery solution through CRWE WORLD, CRWE Press Release and CRWE Tube gives corporations and businesses a vehicle to expand their exposure

CLICK HERE FOR MORE INFORMATION

ad3

/assets/img/crwe_info.png

CRWE Info ( CRWE.Info ) provides news and updates about Crown Equity Holdings Inc. and the CRWE World platform

www.crwe.info

ad4

/assets/images/ad/crwetube.png

Share your videos. Upload your videos for free on CRWETube

www.CRWETube.com

ad5

/assets/images/ad/ad4.png

 

Place Your Ad Here! Advertise your business online on CRWE WORLD. Your Company, product, or service in front of the world!

Contact Us: contact@crweworld.com

www.CRWEWorld.com

Advertisements

/assets/images/ad/crwe_tech.jpg

Your Technology Source, Your Technology Team

Server Maintenance, Web Development, Mobile Application Solutions, SEO Services and more

Contact Us: contact@crwetech.com

www.CRWETech.com

/assets/images/ad/content-delivery-solution.jpg

 

Our content delivery solution through CRWE WORLD, CRWE Press Release and CRWE Tube gives corporations and businesses a vehicle to expand their exposure

CLICK HERE FOR MORE INFORMATION

/assets/img/crwe_info.png

CRWE Info ( CRWE.Info ) provides news and updates about Crown Equity Holdings Inc. and the CRWE World platform

www.crwe.info

/assets/images/ad/crwetube.png

Share your videos. Upload your videos for free on CRWETube

www.CRWETube.com

/assets/images/ad/ad4.png

 

Place Your Ad Here! Advertise your business online on CRWE WORLD. Your Company, product, or service in front of the world!

Contact Us: contact@crweworld.com

www.CRWEWorld.com

CRWE WORLD Advertising Services RateJoin CRWE WORLD Affiliate Program