Regenxbio Inc（RGNX）のニュースとイベントRGNXRegenxbio Inc

REGENXBIO Announces Positive Data from Diabetic Retinopathy Study

REGENXBIO "announced positive long-term follow-up data from the Phase II ALTITUDE(R) study of investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) in diabetic retinopathy using suprachoroidal delivery. These new data were presented at the Retina Society 59th Annual Scientific Meeting in Los Angeles. In long-term follow-up from the Phase II ALTITUDE(R) trial, a single in-office administration of sura-vec using suprachoroidal delivery in participants with non-proliferative DR at Dose Level 3 (1.010 GC/eye) with short-course prophylactic topical steroids demonstrated a durable efficacy profile at three years with no new sura-vec-related safety signals observed during long-term follow up. 60% of all Dose Level 3 participants with three-year visits (n=6/10) achieved greater than2-step improvement on the Diabetic Retinopathy Severity Scale without additional treatment for diabetic retinopathy.1 These participants did not experience any vision-threatening events. Additionally, the majority of participants who achieved a 1-step DRSS improvement at one year without supplemental anti-VEGF injections went on to achieve a greater than2-step DRSS improvement by three years without additional treatment for diabetic retinopathy."

U.S. Stock Futures Weaker, Nasdaq Down 0.63%

Stock futures are pointing to a weaker open as the market comes off a losing week for all three major indexes, with technology stocks particularly pressured by the recent rise in Treasury yields.A catalyst this week is Nvidia's earnings on Wednesday. Nvidia shares have already declined for five consecutive sessions, while some of its customers have reportedly been told that AI server prices could rise by more than 15% because of higher memory costs.The Federal Reserve is another major focus, with Fed Chair Kevin Warsh scheduled to speak Friday at the Jackson Hole symposium. Investors will be looking for clues about the Fed's rate path after recent inflation data came in relatively benign, but the labor market has weakened. At the same time, the bond market has become a source of concern. The 30-year Treasury yield reached roughly 5.34% last week, its highest level in about 19 years, putting additional pressure on growth stocks. The week's economic calendar also includes July PCE inflation data on Wednesday.The U.S. is preparing new economic sanctions targeting Iran's trade partners, with Treasury Secretary Scott Bessent expected to provide details. Oil prices have pulled back despite the escalating tensions. There is also a new U.S.-Canada trade dispute to watch after trade negotiations broke down, adding another source of uncertainty for companies with significant North American supply chains and sales exposure.In pre-market trading, S&P 500 futures fell 0.20%, Nasdaq futures fell 0.63% and Dow futures fell 0.11%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Erascaup 3% after reporting the FDA has granted Fast Track Designation to ERAS-0015UP AFTER EARNINGS -Napco Securityup 19%PDD Holdingsup 3%DOWN AFTER EARNINGS -Gogorodown 10%XPengdown 4%LOWER -Regenxbiodown 20% after the FDA placed a clinical hold on RGX-121 following the discovery of asymptomatic spine MRI findings in five participants in the CAMPSIITE studyCanada Goosedown 5% after Wells Fargo double downgraded the stock to Underweight from Overweight with a price target of C$10, down from C$16Alibabadown 1% after announcing the pricing of its HK$80B placing of 710,000,000 newly issued ordinary shares of the company to non-U.S. persons outside the United States, at a placing price of HK$112.70 per placement share

Regenxbio Shares Halted Due to FDA Clinical Hold

Regenxbio is scheduled to resume quoting at 7:20 am ET and to resume trading at 7:25 am ET, according to Nasdaq. Shares were halted, pending news, ahead of the company announcing that the FDA placed a clinical hold on RGX-121 following the discovery of asymptomatic spine MRI findings in five participants in the CAMPSIITE study.