NEW YORK, NY / ACCESSWIRE / March 3, 2017 / The Biotech's Post-Election rally gained some steam this week after President Trump labeled the U.S. Food and Drug Administration's drug approval process as "slow and burdensome" in his speech to Congress on Tuesday, February 28th. The iShares NASDAQ Biotechnology Index ETF and the SPDR S&P Biotech ETF have posted year-to-date gains of 12.97 percent and 19.28 percent, respectively. President Trump has previously vowed to slash current FDA regulations by "75% to 80%".
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In his first address to Congress, President Trump specifically talked about Megan Crowley, who was diagnosed with a rare genetic disorder Pompe disease, and is also the daughter of John F. Crowley, Chairman and CEO of Amicus Therapeutics. Megan's life was saved by a treatment created by a company that John started, Novazyme Pharmaceuticals.
"Our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan's life, from reaching those in need," President Trump in his speech to Congress on February 28th. "If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles just like Megan."
Let's Take a Closer Look at Today's Trending Tickers
Aurinia Pharmaceuticals' shares soared 22.10 percent to close at $4.53 a share on Thursday. The stock traded between $4.35 and $6.00 on volume of 47.96 million shares traded. On March 1st, the company announced top-line results from its Phase IIb AURA-LV (AURA) study in lupus nephritis (LN). Voclosporin met its 48-week remission endpoints and achieved the highest complete remission rate of any global LN study. Shares of Aurinia Pharmaceuticals have gained approximately 115.7 percent.
"The AURA trial's long-term results convincingly demonstrate that the addition of voclosporin to standard of care treatment is superior to standard of care alone. These data are not only statistically significant, but clinically important. Twice as many patients given 23.7 mg voclosporin twice daily achieved a complete renal response compared to those treated with placebo. This is an impressive renal response rate and these results may shift the treatment paradigm of LN. Based on these encouraging data, I am looking forward to the Phase III trial of voclosporin in LN," said Brad Rovin, MD, FASN, Director of Nephrology and Vice Chairman of Research for the Department of Internal Medicine at the Ohio State University Wexner Medical Center.
Nektar Therapeutics' shares gained 13.68 percent to close at $14.79 a share on Thursday. The stock traded between $12.50 and $15.61 on volume 6.38 million shares traded. The company reported revenues were $37.5 million for the fourth quarter of 2016, compared to revenue of $39.4 million reported in the fourth quarter of 2015. The company has reported loss of $42.2 million or $0.28 a share in the fourth quarter of 2016 as compared to loss of $54.1 million or $0.40 a share reported in the fourth quarter of 2015. Cash and investments in marketable securities at December 31, 2016 were $389.1 million as compared to $308.9 million at December 31, 2015.
In February 2017, Nektar submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NKTR-358, a new biologic designed to treat autoimmune disease. Clinical trials are planned for NKTR-358 in patients with systemic lupus erythematous (SLE) and other indications.
Today's Features Includes:
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH)
Nektar Therapeutics (NASDAQ: NKTR)
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