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FDA accepts resubmission of Camurus' CAM2029 NDA for acromegaly with decision due Dec 18, 2026

Market News
17 Jul 2026
PRNewsWire
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Bullish
pluang ai news

Camurus announced that the US FDA has accepted the resubmission of the New Drug Application (NDA) for CAM2029, an extended-release octreotide injection for treating acromegaly. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of December 18, 2026. This follows a previous Complete Response Letter related to manufacturing inspection issues, which have since been resolved without concerns about the drug's safety or efficacy. CAM2029 is already approved in the EU and UK and offers once-monthly self-administration via an autoinjector pen, with clinical trials showing superior biochemical control and improved patient outcomes compared to existing treatments. The FDA review outcome will determine its availability in the US market.

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Realkredit Danmark posts DKK 2,388 million net profit in H1 2026 amid strong lending and housing market.

Realkredit Danmark posts DKK 2,388 million net profit in H1 2026 amid strong lending and housing market.

Realkredit Danmark reported a net profit of DKK 2,388 million for the first half of 2026, slightly down from the previous year due to margin pressure and lower loan impairment reversals. Lending growth remained positive, driven by business and person...

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Telia Lietuva reports strong H1 2026 growth with revenue up 7.2% and record dividends paid.

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Telia Lietuva announced a 7.2% revenue increase to EUR 259.1 million in the first half of 2026, with profit rising 14.7% to EUR 51.3 million. The company invested heavily in expanding its 5G network, acquiring new frequency bands and committing EUR 7...

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Aduro and ECOCE advance to HCT testing for recycling Mexico's flexible plastic waste streams.

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Aduro Clean Technologies and ECOCE have completed phase 1 of mapping flexible plastic waste streams in Mexico, estimated at 1.5 million tonnes annually. They are now moving selected post-consumer flexible packaging materials into Hydrochemolytic™ (HC...

Market News
Bullish
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Aduro and ECOCE complete Phase 1 of mapping flexible plastic waste in Mexico, starting HCT testing for circular recycling.

Aduro and ECOCE complete Phase 1 of mapping flexible plastic waste in Mexico, starting HCT testing for circular recycling.

Aduro Clean Technologies and ECOCE have successfully completed Phase 1 of mapping flexible and multilayer plastic waste streams in Mexico, estimated at 1.5 million tons annually. The project now moves into testing these materials using Aduro's Hydroc...

Market News
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