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Intellectia

IRD News

Opus Genetics Aligns with FDA on Phase 3 Study for LCA5 Treatment

1d agoNewsfilter

Opus Genetics Aligns with FDA on Phase 3 Trial Design

1d agoNASDAQ.COM

Opus Genetics Added to Russell Indexes, Enhancing Market Visibility

Jun 26 2026Newsfilter

Opus Genetics Updates on Gene Therapy Developments

Jun 17 2026NASDAQ.COM

Wall Street's Latest Ratings and Price Target Adjustments

Jun 04 2026CNBC

Opus Genetics Reports Q1 Losses and Revenue Decline

May 12 2026seekingalpha

Opus Genetics Reports Vision Restoration Data in Pediatric Patients

May 07 2026Newsfilter

Opus Genetics Receives FDA RDEP Designation for LCA5 Gene Therapy

May 05 2026NASDAQ.COM

IRD Events

07/06 09:00
Nasdaq and S&P 500 Futures Rise as Chip Stocks Rebound
Nasdaq and S&P 500 futures are higher as chip stocks rebound after recent weakness. The Dow also enters the week near record territory. Markets are returning from the holiday weekend with a constructive tone, as investors look to extend last week's rally and begin the new week.Last week's weaker-than-expected labor report reduced some fears of additional near-term Federal Reserve tightening, which has helped improve risk appetite. Investors are now turning attention to Wednesday's Fed meeting minutes for clues on how policymakers view inflation and economic growth going into the second half of the year.Earnings season also begins to move into focus this week. Investors are looking for confirmation that corporate earnings can continue justifying elevated valuations after a strong first half of 2026. Analysts are expecting more than 20% year-over-year earnings growth for S&P 500 companies.In pre-market trading, S&P 500 futures rose 0.41%, Nasdaq futures rose 1.17% and Dow futures fell 0.07%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Seerup 37% after receiving an unsolicited, non-binding proposal from Omid Farokhzad, Seer's chair and CEO, to acquire all of the outstanding shares of Seer's Class A common stock for $2.45 per share in cash plus two separate contingent value rightsTeraWulfup 17% after executing a 20-year lease agreement with Anthropic at its Justified Data campus in Hawesville, KentuckyOrthofixup 6% after disclosing that CMS had reversed itself on its very recent 10% reimbursement cut within traditional Medicare for non-invasive bone growth stimulatorsBroadcomup 4% after disclosing an agreement with Appleto expand their long-standing technology collaboration through 2031 by entering into new multi-year long-term agreements for Broadcom to develop and supply a range of custom ASIC silicon products for use in multiple generations of Apple productsKosmosup 3% after providing a portfolio updateOpus Geneticsup 3% after reaching alignment with the FDA in a Type B Rare Disease Evidence Principles meeting on the design of its registrational Phase 3 clinical trial evaluating OPGx-LCA5Comcastup 1% after announcing Sky has agreed terms to acquire ITV Media & Entertainment from ITV plc for a total consideration of up to GBP 1.6BAlibabaup 1% after BloombergU.S. District Judge Eumi Lee has ordered the Pentagon to give Alibaba reprieve from a law that led to many lobbyists dropping it as a client while she considers the constitutionality of the measureLOWER -Datadogdown 4% after Bernstein downgraded the stock to Market PerformJ.B. Huntdown 1% after Morgan Stanley downgraded shares to Underweight
07/06 07:30
Opus Genetics Aligns with FDA to Advance LCA5 Clinical Trial
Opus Genetics announced that it has reached alignment with the FDA in a Type B Rare Disease Evidence Principles, or RDEP, meeting on the design of its registrational Phase 3 clinical trial evaluating OPGx-LCA5 for LCA5-associated IRD, an early-onset severe inherited retinal dystrophy. Opus Genetics has received the meeting minutes from the Type B meeting confirming several key elements of the trial. The Phase 3 study is expected to enroll eight participants who are able to complete microperimetry testing with both eyes treated. The study is also expected to include a six-month run-in period, allowing each participant to serve as their own natural history control prior to receiving treatment. Seven of the eight planned participants have already been enrolled and are currently completing the run-in period, and the company expects to initiate dosing in the fourth quarter of 2026. The primary efficacy endpoint is a mean improvement of at least 7 decibels in retinal sensitivity across the central 16 test loci, a clinically meaningful measure of visual function. The Phase 3 study is designed with greater than 90% statistical power to detect a treatment effect of at least seven decibels. The Phase 1/2 trial supports this outcome measure as those participants able to complete microperimetry demonstrated an average improvement of approximately 10.5 dB. Importantly, the FDA indicated that Opus Genetics may submit a Biologics License Application based on compelling efficacy at the six-month primary endpoint, with 12-month durability data submitted during the BLA review process.

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