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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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Kohl's Q2 EPS beats estimates on tariff refunds despite 18th straight quarter of sales decline

Kohl's Q2 EPS beats estimates on tariff refunds despite 18th straight quarter of sales decline

Kohl's reported a strong adjusted EPS of $1.28 for Q2, more than doubling analyst expectations due to a 43% gross margin boosted by one-time tariff refunds. However, the retailer's total revenue and comparable sales fell by 0.9%, marking the 18th con...

Company Fundamentals
Neutral
50 minutes ago
Royal Bank of Canada beats Q3 earnings and revenue estimates, showing strong financial health.

Royal Bank of Canada beats Q3 earnings and revenue estimates, showing strong financial health.

Royal Bank of Canada reported strong Q3 2026 results, surpassing earnings per share estimates with $3.07 versus $2.89 expected, marking a 6.23% positive surprise and continuing a streak of four quarters beating expectations. Revenue also exceeded for...

Company Fundamentals
Bullish
56 minutes ago
Evercore ISI raises Williams-Sonoma price target after strong Q2 revenue and sales growth.

Evercore ISI raises Williams-Sonoma price target after strong Q2 revenue and sales growth.

Evercore ISI increased its price target for Williams-Sonoma to $245 following a strong Q2 performance, with revenue up 6.7% to $1.96 billion and comparable sales rising 6.2%, beating expectations. The gross margin improved to 51.6%, partly due to one...

Analyst Insights
Bullish
1 hour ago
RBC Capital holds FactSet at 'Sector Perform' with a raised price target amid cautious market sentiment.

RBC Capital holds FactSet at 'Sector Perform' with a raised price target amid cautious market sentiment.

RBC Capital reaffirmed its 'Sector Perform' (hold) rating on FactSet, increasing the price target from $240 to $304 as of August 27, 2026. Despite this optimistic price target adjustment, the broader market remains cautious, with an average 'Reduce' ...

Analyst Insights
Neutral
1 hour ago
Burlington Stores beats EPS estimates with $2.96, grows sales 11%, and raises full-year EPS guidance.

Burlington Stores beats EPS estimates with $2.96, grows sales 11%, and raises full-year EPS guidance.

Burlington Stores reported an EPS of $2.96, significantly beating analyst estimates of $2.19, driven by strong profitability improvements and an 11% growth in total sales. Comparable store sales rose 2%, continuing positive momentum from the prior ye...

Company Fundamentals
Bullish
1 hour ago
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