ELOX: FDA Orphan Drug Grant for Cystinosis Drug & Naz Bell
Apr 27, 2018 16:51:05 GMT
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Post by icemandios on Apr 27, 2018 16:51:05 GMT
Eloxx Pharmaceuticals Announces FDA Grant of Orphan-Drug Designation for Investigational Drug ELX-02 for Treatment of Cystinosis
Company to ring NASDAQ Closing Bell on Monday April 30
WALTHAM, Mass., April 27, 2018 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (“Eloxx”), (NASDAQ:ELOX), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat cystic fibrosis, cystinosis and other diseases caused by nonsense mutations limiting production of functional proteins, today announced that it has received orphan-drug designation from the Food and Drug Administration (FDA) for ELX-02 for treatment of cystinosis from the FDA and that it will ring the Nasdaq Closing Bell on Monday, April 30, 2018.
“We are pleased to have received an orphan-drug designation for ELX-02 for treatment of cystinosis and for the opportunity to ring the NASDAQ Closing Bell in celebration of our recent listing on the Nasdaq coincident with our successful $50 million public offering,” said Robert E. Ward, Chairman and CEO of Eloxx Pharmaceuticals. “As we ring the closing bell, I would like to acknowledge and thank the employees, investors, patients, and partners who have supported Eloxx in our journey thus far. Given the clinical progress in 2017 for our lead product candidate, ELX-02, we are poised to seek regulatory clearance to initiate Phase 2 clinical trials in cystic fibrosis and cystinosis this year in Belgium and the United States, respectively. Our listing on the Nasdaq and capital raise position us well to advance these and other future clinical programs and pursue our mission, which is to transform the lives of patients with rare and ultra rare diseases.”
Eloxx’s common stock trades on the Nasdaq Global Market and began trading under the symbol “ELOX” on Thursday, April 26, 2018.
A live webcast of the honorary opening bell ceremony, courtesy of Nasdaq, will begin at 3:45 am ET on Monday, April 30, 2018, and will be available at new.livestream.com/nasdaq/live and also on the Investor Relations portion of Eloxx’s website at www.eloxxpharma.com.
About Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc. (NASDAQ:ELOX) is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates that are designed to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA. As a consequence, patients with premature stop codon diseases have reduced or eliminated protein production from the mutation bearing allele accounting for some of the most severe phenotypes in these genetic diseases. These premature stop codons have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is focused on extending mRNA half-life and increasing protein synthesis by enabling the cytoplasmic ribosome to read through premature stop codons to produce full-length proteins. Eloxx’s lead product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis and cystinosis. ELX-02 is an investigational drug that has not been approved by any global regulatory body. Eloxx is headquartered in Waltham, MA, with R&D operations in Rehovot, Israel.
Company to ring NASDAQ Closing Bell on Monday April 30
WALTHAM, Mass., April 27, 2018 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (“Eloxx”), (NASDAQ:ELOX), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat cystic fibrosis, cystinosis and other diseases caused by nonsense mutations limiting production of functional proteins, today announced that it has received orphan-drug designation from the Food and Drug Administration (FDA) for ELX-02 for treatment of cystinosis from the FDA and that it will ring the Nasdaq Closing Bell on Monday, April 30, 2018.
“We are pleased to have received an orphan-drug designation for ELX-02 for treatment of cystinosis and for the opportunity to ring the NASDAQ Closing Bell in celebration of our recent listing on the Nasdaq coincident with our successful $50 million public offering,” said Robert E. Ward, Chairman and CEO of Eloxx Pharmaceuticals. “As we ring the closing bell, I would like to acknowledge and thank the employees, investors, patients, and partners who have supported Eloxx in our journey thus far. Given the clinical progress in 2017 for our lead product candidate, ELX-02, we are poised to seek regulatory clearance to initiate Phase 2 clinical trials in cystic fibrosis and cystinosis this year in Belgium and the United States, respectively. Our listing on the Nasdaq and capital raise position us well to advance these and other future clinical programs and pursue our mission, which is to transform the lives of patients with rare and ultra rare diseases.”
Eloxx’s common stock trades on the Nasdaq Global Market and began trading under the symbol “ELOX” on Thursday, April 26, 2018.
A live webcast of the honorary opening bell ceremony, courtesy of Nasdaq, will begin at 3:45 am ET on Monday, April 30, 2018, and will be available at new.livestream.com/nasdaq/live and also on the Investor Relations portion of Eloxx’s website at www.eloxxpharma.com.
About Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc. (NASDAQ:ELOX) is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates that are designed to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA. As a consequence, patients with premature stop codon diseases have reduced or eliminated protein production from the mutation bearing allele accounting for some of the most severe phenotypes in these genetic diseases. These premature stop codons have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is focused on extending mRNA half-life and increasing protein synthesis by enabling the cytoplasmic ribosome to read through premature stop codons to produce full-length proteins. Eloxx’s lead product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis and cystinosis. ELX-02 is an investigational drug that has not been approved by any global regulatory body. Eloxx is headquartered in Waltham, MA, with R&D operations in Rehovot, Israel.