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FDA accepts Opus Genetics' OPGx-LCA5 gene therapy into Rare Disease Evidence Principles program

Market News
04 May 2026
GlobeNewsWire
View Source
Bullish
pluang ai news

Opus Genetics announced that its gene therapy candidate OPGx-LCA5 for Leber congenital amaurosis type 5 (LCA5), a rare inherited retinal disease causing early blindness, has been accepted into the FDA's Rare Disease Evidence Principles (RDEP) program. This acceptance supports early collaboration with the FDA on regulatory strategy and clinical trial design, aiming to streamline development and approval for this ultra-rare condition with no current treatments. OPGx-LCA5 is in Phase 1/2 trials showing promising vision improvements and has multiple FDA designations including RMAT. The company will work closely with the FDA to advance the therapy toward potential approval.

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Autonomize boosts leadership to drive AI adoption across healthcare at enterprise scale

Autonomize boosts leadership to drive AI adoption across healthcare at enterprise scale

Autonomize, a healthcare AI platform, has strengthened its leadership by appointing three industry veterans to its Advisory Board and hiring Mike Longacre as Head of Transformation. These moves aim to help healthcare organizations move beyond AI pilo...

Market News
Bullish
1 hour ago
Fairfax completes $10.90/share Kennedy Wilson buyout, gaining majority economic interest.

Fairfax completes $10.90/share Kennedy Wilson buyout, gaining majority economic interest.

Fairfax Financial Holdings has finalized its acquisition of Kennedy-Wilson Holdings at $10.90 per share in cash, led by a consortium including Kennedy Wilson's CEO William McMorrow and affiliates of Fairfax. The Kennedy Wilson management team retains...

Company Fundamentals
Bullish
1 hour ago
Aya Gold & Silver to join VanEck Gold Miners ETF, boosting visibility and liquidity.

Aya Gold & Silver to join VanEck Gold Miners ETF, boosting visibility and liquidity.

Aya Gold & Silver Inc., a Canadian precious metals mining company operating in Morocco, will be added to the VanEck Gold Miners ETF (GDX) effective June 19, 2026. This inclusion marks a significant milestone reflecting the company's growth in product...

Company Fundamentals
Bullish
2 hours ago
Nephros highlights ultrafiltration tech to tackle microplastic risks in drinking water after EPA prioritizes contaminants.

Nephros highlights ultrafiltration tech to tackle microplastic risks in drinking water after EPA prioritizes contaminants.

Nephros, Inc. emphasizes its ultrafiltration technology's ability to capture microplastics and nanoplastics in water, following the U.S. EPA's April 2026 decision to list microplastics as a priority contaminant under the Safe Drinking Water Act. The ...

Market News
Bullish
2 hours ago
Shipping traffic through Strait of Hormuz may take weeks to normalize despite US-Iran deal

Shipping traffic through Strait of Hormuz may take weeks to normalize despite US-Iran deal

After the US and Iran reached a deal expected to reopen the Strait of Hormuz, the world's largest tanker owner, Mitsui OSK Lines, cautions that shipping companies will wait for proof the agreement works before resuming normal traffic. The strait is c...

Market News
Neutral
2 hours ago
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