RGNX News & Events

Regenxbio announced the successful completion of dosing in the confirmatory study of RGX-202, a potential best-in-class gene therapy for Duchenne muscular dystrophy. This milestone positions Regenxbio to initiate a Biologics License Application under the accelerated approval pathway in Q3 2026 for a potential approval by the U.S. FDA in the second half of 2027. The BLA submission will include a substantial safety dataset from the AFFINITY DUCHENNE study of RGX-202 pivotal and confirmatory studies and efficacy data from the pivotal portion. The BLA is expected to include 12-month functional data for at least half of the total participants in the pivotal study.

The major averages had a mixed finish, with the Nasdaq the loser amid weakness in technology stocks, most notably SpaceX. Peace negotiations between the U.S. and Iran have reportedly shown progress, helping push oil prices lower and reducing some of the inflation pressure that had worried investors in recent weeks. Of note, U.S. Treasury Secretary Scott Bessent said in a social media post that the Treasury Department has issued a temporary 60-day license to allow Iran to sell oil.At the same time, attention is shifting back toward the Federal Reserve and the possibility that rates stay elevated for longer. Markets this week are closely watching upcoming inflation data, particularly the PCE reading, as recent commentary has reinforced expectations that policymakers remain focused on controlling inflation rather than supporting asset prices.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Chevronwith Microsoftto power a data center in West TexasCRHArcosafor $150 per share in cashAbbVieApogee Therapeuticsfor $135.11 per share in cash, or $10.9BSpaceXhas signed a computing power deal with Reflection worth up to $6.3B,Texas AG Ken Paxtoninto Carnivalfollowing the company's April data breach2. WALL STREET CALLS:SpaceXwith a Sector Weight at KeyBancVisteonat JPMorgan and BarclaysRoth Capitala handful of exploration and production names, saying oil prices are close to a near-term bottomAccentureto Hold at TD CowenTE Connectivityto In Line at Evercore ISI3. AROUND THE WEB:Metais planning a $900M investment in Indian fintech startup Cred for a roughly 20% stake, alongside plans to appoint Cred founder Kunal Shah as the new leader of WhatsApp, Bloomberg' reportsBaldwin Groupis exploring a take-private transaction, Insurance Insider reportsRegenxbioChief Executive Curran Simpson said the Food and Drug Administration has agreed to reverse its rejection of an experimental gene therapy for a rare and fatal brain disease, WSJ saysCharles Schwabis working with Cboe Global Marketsto roll out prediction market contracts that allow customers to place yes-or-no wagers on the performance of the S&P 500, WSJ reportsJohn Jumper is leaving GoogleDeepMind to join Anthropic, Reuters says4. MOVERS:Gettyincreases after entering aDefinium Therapeuticsgains after announcing its Emerge studyMoonLakehigher in New York after announcingfrom its Phase 3 VELA-1 and VELA-2 trialsSable Offshorelower after entering into aVirgin Galacticfalls after filing to exchange $52.5M in5. EARNINGS/GUIDANCE:Ennis, with EPS and revenue higher year-over-yearHawkEye, with EPS missing consensusFervo Energy, with EPS lower year-over-yearMicron Technologytoon June 24FedExtoon June 23INDEXES:The Dow rose 148.01, or 0.29%, to 51,712.71, the Nasdaq lost 351.33, or 1.32%, to 26,166.60, and the S&P 500 declined 27.79, or 0.37%, to 7,472.79.