Claim 50% Off TipRanks Premium
- Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions
- Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential
Camurus AB ( (SE:CAMX) ) has issued an announcement.
Camurus has announced that the US Food and Drug Administration has accepted for review the resubmitted New Drug Application for Oclaiz (CAM2029), a once-monthly, subcutaneous, extended-release octreotide injection for treating acromegaly, and has set a Prescription Drug User Fee Act target action date of 10 June 2026. The filing, which follows an earlier Complete Response Letter tied to cGMP issues at a third-party manufacturer rather than clinical concerns, is backed by seven clinical studies including two Phase 3 trials demonstrating improved biochemical control, symptom reduction and quality-of-life benefits versus standard of care, and follows the product’s 2025 approval and ongoing launch in the EU and UK under the name Oczyesa, underscoring Camurus’ bid to expand its endocrine portfolio and US presence while advancing CAM2029 in additional indications such as GEP-NET and polycystic liver disease.
The most recent analyst rating on (SE:CAMX) stock is a Buy with a SEK691.00 price target. To see the full list of analyst forecasts on Camurus AB stock, see the SE:CAMX Stock Forecast page.
More about Camurus AB
Camurus AB is an international, science-led biopharmaceutical company focused on developing and commercializing innovative, long-acting medicines for severe and chronic diseases, using its proprietary FluidCrystal technology. The company’s R&D pipeline spans treatments for dependence, pain, cancer and endocrine disorders, and it operates across Europe, the US and Australia, with shares listed on Nasdaq Stockholm under the ticker CAMX.
Average Trading Volume: 118,198
Technical Sentiment Signal: Strong Buy
Current Market Cap: SEK37.96B
Find detailed analytics on CAMX stock on TipRanks’ Stock Analysis page.