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FDA rejects Achieve Life Sciences' smoking cessation drug over manufacturing issues; resubmission planned for Q4 2026

Market News
22 Jun 2026
Benzinga
View Source
Bearish
pluang ai news

Achieve Life Sciences received a Complete Response Letter from the FDA rejecting its smoking cessation drug cytisinicline due to manufacturing problems at a former third-party site and incomplete product labeling. No safety or efficacy issues were found with the drug itself. The company has switched manufacturing to Adare Pharma Solutions and plans to resubmit the New Drug Application in Q4 2026, aiming for FDA approval and U.S. launch in the first half of 2027. The drug showed strong clinical results in Phase 3 trials with over 1,500 participants.

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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...

Market News
Bullish
28 minutes ago
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...

Company Fundamentals
Bullish
28 minutes ago
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...

Company Fundamentals
Bullish
28 minutes ago
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...

Market News
Bullish
1 hour ago
LithiumBank appoints Logan R. Harris as VP to advance Boardwalk lithium project development.

LithiumBank appoints Logan R. Harris as VP to advance Boardwalk lithium project development.

LithiumBank Resources Corp. has appointed Logan R. Harris as Vice President of Project Development to lead the advancement of its Boardwalk Lithium Brine Project in Alberta. Harris brings over 15 years of experience in engineering and project develop...

Company Fundamentals
Bullish
4 hours ago
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