KalVista Pharmaceuticals, Inc. expects to complete enrollment for the KVD900 Phase 2 clinical trial before year-end 2019 and to provide data in 2020. “We are pleased with the rate of enrollment of our Phase 2 clinical trial of KVD900 in HAE patients,” said Andrew Crockett, CEO of KalVista. “Our plan to recruit patients primarily in [...]
Takeda Pharmaceutical Company Limited announces new data that further investigate the long-term safety and efficacy of TAKHZYRO® (lanadelumab-flyo) injection in patients with HAE 12 years of age and older studied in the ongoing Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study™ Open-label Extension (OLE). The analyses, being presented at the 2019 American College of Allergy, Asthma [...]
BioCryst Pharmaceuticals, Inc. announces the 48-week results from its APeX-S and APeX-2 trials and comprehensive market research which support the significant commercial opportunity for oral, once daily BCX7353 in HAE. “The 48-week clinical trial data we now have from APeX-S and APeX-2 highlight the control patients are having over their attacks with oral, once daily [...]
Announcing the financial results for the third quarter ended 30 September 2019 BioCryst Pharmaceuticals, Inc., President and CEO Jon Stonehouse says: “BioCryst is positioned for a transformational 2020, with the potential approval and launch of BCX7353 in the U.S. and regulatory filings for BCX7353 in Japan and Europ. We are also actively evaluating multiple approaches to add capital [...]
BioCryst Pharmaceuticals, Inc. has licensed commercialization rights in Japan to Torii Pharmaceutical, Co. for BCX7353, an oral, once-daily treatment for the prevention of HAE attacks. “We are excited to partner with Torii to accelerate access for Japanese patients to BCX7353,” said Jon Stonehouse, president and CEO of BioCryst. “Torii has a strong and recent history [...]
The third 2019 issue of the HAE International magazine Global Perspectives is out now. This time you can among many other things read about: The 2020 HAE Global Conference – “Creating the Path for Better Health” Highlights from the 2019 US HAEA National Patient Summit The 2019 Global HAE youth advocacy workshop in Atlanta: Understand it, plan it and do it Marco [...]
The National Institute for Health and Clinical Excellence (NICE), the health technology appraisal body in England and Wales, has issued its Final Appraisal Determination (FAD) recommending Takhzyro (lanadelumab) subcutaneous injection as an option for preventing recurrent attacks of HAE in patients aged 12 years and older only if: (1) they are eligible for preventive C1-esterase [...]
The clinical-stage company Pharvaris B.V. which is focused on the discovery and development of novel oral B2-receptor antagonists for the treatment of HAE, has completed a 66 million USD Series B financing. In addition, the company announces its entry into clinical development with the initiation of a Phase 1 study of its lead compound, PHA121, in [...]
At the presentation of the financial results for the quarter ended 30 June 2019, Kenneth T. Mills, President and CEO of the clinical-stage biotechnology company REGENXBIO Inc., said: "We recently announced the expansion of our pipeline using NAV Vectors to deliver therapeutic antibodies, beginning with novel treatments for HAE. This approach has enormous potential for patients [...]
BioCryst Pharmaceuticals, Inc. has announced the financial results for the second quarter ended 30 June 2019 and provided a corporate update. “We have just returned from the 2019 HAEA National Patient Summit with more than 1,000 attendees from the U.S. and around the world. Patients’ excitement about BCX7353 was resounding as they told us an oral [...]