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FDA accepts Replimune's RP1 melanoma treatment BLA resubmission, advisory meeting set for July

Company Fundamentals
29 Jun 2026
GlobeNewsWire
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Bullish
pluang ai news

Replimune announced the FDA has accepted the resubmission of its Biologics License Application (BLA) for RP1 combined with nivolumab to treat advanced melanoma, with a target decision date of August 2, 2026, and an advisory committee meeting expected in late July. The company reported strong clinical trial progress, including positive survival data from the IGNYTE trial and promising results from the RP2 trial in solid tumors. Financially, Replimune ended fiscal 2026 with $268.9 million in cash, sufficient to fund operations into early 2027, despite a net loss of $313.9 million for the year. The FDA review milestone is critical for potential commercialization of RP1, which aims to offer a new durable treatment option for melanoma patients.

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Shirofune launches Walmart Connect to automate and unify retail media campaign management.

Shirofune launches Walmart Connect to automate and unify retail media campaign management.

Shirofune has introduced Walmart Connect, an integration that allows advertisers and agencies to manage Walmart retail media campaigns alongside other digital channels within a single platform. This automation reduces manual bid adjustments and repor...

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Purecore signs LOI to option 100% of Yurchison uranium property in Canada's Athabasca Basin

Purecore signs LOI to option 100% of Yurchison uranium property in Canada's Athabasca Basin

Purecore Metals Inc. has signed a non-binding letter of intent with Skyharbour Resources to acquire an option to earn up to 100% interest in the Yurchison uranium property in Saskatchewan's Athabasca Basin. The property covers over 35,000 hectares an...

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Point closes $508.6M HEI securitization, largest ever in home equity investment class

Point closes $508.6M HEI securitization, largest ever in home equity investment class

Point completed a $508.6 million rated asset-backed securitization of its Home Equity Investment (HEI) assets, marking the largest transaction ever in the HEI asset class. The deal attracted over 30 institutional investors and priced at significantly...

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Reactive hot melt adhesives market to reach $4.29B by 2035, driven by automotive and furniture demand.

Reactive hot melt adhesives market to reach $4.29B by 2035, driven by automotive and furniture demand.

The global reactive hot melt adhesives market is projected to grow from $2.02 billion in 2025 to $4.29 billion by 2035, at a CAGR of 7.72%. Growth is driven by regulations limiting solvent-based adhesives, increased use of polyurethane adhesives in a...

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$1.7B invested to deploy Bloom Energy fuel cells powering AI cloud infrastructure for Nebius.

$1.7B invested to deploy Bloom Energy fuel cells powering AI cloud infrastructure for Nebius.

Industrial Development Funding (IDF) and Oaktree have committed $1.7 billion to support Bloom Energy's fuel cell technology for building AI cloud infrastructure for Nebius. This project will provide dedicated behind-the-meter power to meet the high c...

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