(RTTNews) - argenx (ARGX) said that it agreed to acquire a U.S. Food and Drug Administration Priority Review Voucher or PRV from Bayer Healthcare Pharmaceuticals Inc for $98 million.
A Priority Review Voucher entitles the holder to FDA priority review of a single New Drug Application or Biologics License Application, which reduces the target...
(RTTNews) - The week ending November 20 saw some more good news on the COVID-19 front, with Pfizer (PFE) and German biotechnology company BioNTech (BNTX) making emergency use approval request to the FDA for their vaccine candidate on Friday. AstraZeneca PLC's (AZN) Covid-19 vaccine candidate, AZD1222, licensed from the Oxford University, is better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups, revealed preliminary findings of a phase II study reported in the Lancet Journal on November 18.
Meanwhile, the number of coronavirus cases continues to rise in the U.S. - with a record daily high of 185,759 new infections registered on November 19, according to Johns Hopkins University. As of this writing, the case count in the U.S. has crossed 12 million while the number of deaths has risen to 255,800.
Three healthcare firms went public in the week - Sotera Health (SHC), Maravai Life Sciences (MRVI), and Olema Pharmaceuticals (OLMA).
Olema, which priced its IPO at $19, made its debut on the Nasdaq market on Thursday, November 19, opening at a price of $45. The stock closed Friday's trading at $48.90.
Let's take a look at some of the pharma stocks that merit attention in the holiday-shortened week ahead.
1. Eiger BioPharmaceuticals Inc. (EIGR)
The FDA has approved Eiger BioPharma's Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies. The news was announced after the bell Friday and the company is scheduled to host a conference call November 23 at 8:30 AM ET to discuss the Zokinvy approval.
Progeria and Progeroid Laminopathies are serious, ultra-rare diseases characterized by premature and accelerated aging in children. It is estimated that globally, there are 400 children with Progeria and 400 children with Progeroid Laminopathies. The average life expectancy for the untreated children is around 14 years.
Zokinvy, known generically as Lonafarnib, is the first-ever treatment for Progeria and Progeroid Laminopathies.
EIGR closed Friday's trading at $10.03, down 3.46%.
2. Sonoma Pharmaceuticals Inc. (SNOA)
Sonoma Pharma reported second fiscal quarter results after the bell Friday and also restated its first quarter financial statements for the quarter ended June 30, 2020 due to material errors.
Sonoma is a healthcare company developing and producing stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, animal health care, eye care, nasal care, oral care and dermatological conditions.
Net income from continuing operations for the quarter ended September 30, 2020, was $151,000 or $0.07 per share compared to a net loss of $1.29 million or $0.98 per share in the year-earlier quarter. Revenue was $5.77 million for the second fiscal 2020 quarter, up from $4.73 million in the comparable prior-year quarter.
As for the restatement of the first quarter results, the net income has been corrected from $992,000 to $240,000, with earnings per share corrected from $0.54 to $0.13.
SNOA closed Friday's trading at $6.63, down 0.30%.
3. Liquidia Technologies Inc. (LQDA)
Liquidia Technologies' product candidate LIQ861, proposed for the treatment of pulmonary arterial hypertension, is at the FDA altar, awaiting a decision on November 24.
LIQ861 is a dry powder inhalation of Treprostinil. A sterile formulation of Treprostinil as an inhalation solution, developed by United Therapeutics Corp. (UTHR) is already approved by the FDA and has been marketed as Tyvaso since 2009.
Liquidia and United Therapeutics are locked in a patent dispute over Tyvaso. In a patent suit filed in June this year, United Therapeutics had alleged that Liquidia Infringed on two patents for Tyvaso, which are set to expire in December 2028.
LQDA closed Friday's trading at $3.14, down 7.65%.
4. Rhythm Pharmaceuticals Inc. (RYTM)
The FDA decision on Rhythm Pharma's investigational drug Setmelanotide is expected to be announced on November 27.
Setmelanotide is proposed for the treatment of two ultra-rare types of genetic obesity - pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.
It is estimated that in the U.S., there are approximately 100 to 500 patients with POMC deficiency obesity and about 500 to 2,000 patients with LEPR deficiency obesity.
RYTM closed Friday's trading at $21.37, down 2.11%.
DUBAI, U.A.E, Nov. 25, 2020 /PRNewswire/ -- HBKiCare a pioneering developer of IoT (Internet of Things) software for remote health monitoring, announced today that it will sponsor the leading Middle East Telehealth Technologies Forum. HBKiCare was launched recently by Hamad Bin Khalifa Department of Projects (HBK DOP) from the United Arab Emirates (UAE) together with its partner, SURE Universal Ltd, a leading software developer from Israel specializing in remote patient monitoring.
With the COVID-19 driven tsunami in the telehealth sector, the Middle East Telehealth Technologies Forum brings together leading healthcare companies in the Middle East to share their experiences, lessons learned, and to discuss opportunities and digital health challenges.
Anwar Hussein, CEO of HBK DOP, stated: " We are proud to sponsor this Middle East Telehealth Technology forum and demonstrate a solution for COVID-19 that can benefit the health and well-being of the entire Middle East region."
SURE's CEO, Viktor Ariel, will give a keynote presentation about HBKiCare's remote outpatient IOT monitoring solution for COVID-19.
"We are excited to participate in this prestigious event and to speak about the importance of remote health monitoring during COVID-19 pandemic in our region," stated SURE's CEO, Dr. Ariel. "I am proud of our HBKiCare product and our partnership with HBK DOP, which is bringing together new solutions and forging new relationships between Israel and our regional neighbours in the Middle East."
HBKiCare, was the first joint product launch between an Israeli health-tech company and UAE firm following signing of the historic peace deal. The innovative product, powered by SURE's technology, provides a Universal Remote Healthcare IOT platform and home care kit enabling continuous outpatient monitoring of wellness with maximum flexibility and affordability.
Due to the COVID-19 pandemic, the number of patients that currently need care outnumbers the number of healthcare professionals. In addition, there is a threat of hospital acquired infections, which is a threat to both patients and medical practitioners. Telehealth addresses these challenges by enabling medical professionals to use early outpatient COVID-19 detection and monitoring with the help of new technology.
The HBKiCare platform uses inexpensive off-the-shelf wearable devices and SURE Universal's software IoT platform to monitor patients at home both before and after treatment for COVID-19. It provides continuous monitoring of vital signs, such as, body temperature, blood oxygen, respiratory rate, heart rate, and even ECG, which comprise an essential COVID-19 monitoring protocol. All the devices have FDA or CE Medical certification and the software delivers routine as well as smart AI-based recommendations to doctors regarding patients' medical conditions.
About HBK DOP
Sheikh Hamad bin Khalifa bin Mohammed Al Nahyan Department of Projects (HBK DOP) was founded by its Chairman, His Highness Sheikh Hamad bin Khalifa bin Mohammed Al Nahyan a member of the UAE ruling family to handle project investments and enter into JV partnerships with partners presenting viable and interesting projects with sustainability and job creation. His Highness Sheikh Hamad bin Khalifa bin Mohammed Al Nahyan is a seasoned business leader with a proven track record of success over the past two decades, across regions and including most segments of business. His leadership style is often described as visionary, innovative and inspirational.
For more information visit www.hbkdop.org
About Sure Universal
SURE Universal Ltd is a pioneering developer of IoT software for remote patient monitoring, addressing the critical and growing need for accessible healthcare services worldwide. SURE Universal Care is a complete solution suitable for inpatient hospital care, outpatient treatment by clinics and old age homes, as well as wellness and fitness tracking and family care at home. SURE Universal Care platform is based on international standards for IoT and medical care to guarantee device interoperability, data security, and user privacy. SURE Universal works closely with international partners in the US, China, UAE, Hong Kong, Singapore and other regions. The company was co-founded by seasoned technology entrepreneurs, Mr. Ray Stata and Dr. Viktor Ariel, and is headquartered in Ramat Gan, Israel.
For more information visit www.sureuniversal.com
Anwar HusseinGroup CEO,HBK Department of ProjectsTel: +email@example.com
Viktor ArielCEO,SURE UniversalTel: +firstname.lastname@example.org
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SOURCE SURE Universal and HBK Department of Projects