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Independent Data Safety Monitoring Board unanimously recommends continuation of the global Phase 2/3 study of orally-administered opaganib in severe COVID-19 pneumonia based on review of unblinded safety data from the first 255 treated patients
The 464-patient global Phase 2/3 COVID-19 study is over 75% enrolled, with completion of enrollment expected in the coming weeks
Opaganib potentially minimizes likelihood of resistance due to viral mutations by targeting a human cell component involved in viral replication
TEL AVIV, Israel and RALEIGH, N.C., April 9, 2021 /PRNewswire/ RedHill Biopharma Ltd. (Nasdaq: RDHL) ( RedHill or the Company ), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva
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STOCKHOLM, SWEDEN - April 9, 2021. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Aprea Therapeutics drug candidate eprenetapopt for the treatment of acute myeloid leukemia (AML). KDev Investments, a company jointly owned by Karolinska Development and Rosetta Capital, holds 8 percent of the shares in Aprea Therapeutics, which is listed on Nasdaq Global Select Market in the USA.
Eprenetapopt is a small molecule targeting the tumor suppressor protein p53. Mutations of the p53 gene occur in around 50% of all human tumors and are associated with poor overall survival.
RedHill Biopharma s Phase 2/3 COVID-19 Study of Opaganib Passes Fourth DSMB Review with Unanimous Recommendation to Continue prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Aprea Therapeutics Receives FDA Orphan Drug Designation for Eprenetapopt for the Treatment of .
Aprea TherapeuticsApril 8, 2021 GMT
BOSTON, April 08, 2021 (GLOBE NEWSWIRE) Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to eprenetapopt for treatment of AML.
“We are pleased to have been granted Orphan Drug designation by FDA for eprenetapopt in AML, building on the Fast Track designation in AML that was granted in November 2020,” said Christian S. Schade, Chairman and Chief Executive Officer of Aprea. “We look forward to continued productive dialogue with FDA and bringing eprenetapopt to patients as soon as possible.”
RedHill Biopharma Announces Compassionate Use Treatment with Opaganib of first COVID-19 Patients in Switzerland prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.