Regenxbio Inc (RGNX) News & EventsRGNXNews & EventsRegenxbio Inc

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 RGX-121 Clinical Hold, FDA Finds Spine MRI Abnormalities

Regenxbio provided an update on its investigational gene therapy, RGX-121, for the treatment of Mucopolysaccharidosis type II, also known as Hunter Syndrome. The U.S. Food and Drug Administration placed a clinical hold on RGX-121 following the discovery of asymptomatic spine MRI findings in five participants in the CAMPSIITE study; REGENXBIO does not expect to resubmit the RGX-121 Biologics License Application in the near term. "All five participants continue to do well clinically and have demonstrated overall stability to improvement on neurocognitive and neurobehavioral assessments. The findings were identified through an expanded MRI monitoring plan, implemented by Regenxbio a few months ago, following the clinical hold related to RGX-111. The enhanced monitoring included both brain and spine MRI and identified asymptomatic findings of either a small nodule or a small cystic mass in spine MRIs of five participants who received intracisternal or intraventricular RGX-121 approximately three to six years ago. Investigators deemed these findings to be nonserious and radiologists believe they are likely benign. There is no clinical or pathological evidence to confirm the nature or causation of the spine MRI findings. No brain nodules or masses were identified on any brain MRIs. Because spine MRI is not normally conducted for MPS in clinical practice or trials, the underlying prevalence and clinical significance of these types of asymptomatic findings in this patient population is unknown. Investigators plan to continue to observe these patients with periodic imaging only," the company stated. "We believe these findings are unique and limited to our Hunter Syndrome program, and require longer-term follow-up and additional data analysis to assess the benefit-risk profile of RGX-121. We remain focused on our Duchenne and retinal disease candidates, which utilize a different capsid and routes of administration, with near-term catalysts that are on track, including the planned submission of the Duchenne BLA this quarter and the wet AMD topline pivotal data announcement in the fourth quarter," said Curran Simpson, President and CEO of Regenxbio.

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.