Cambiar Aggressive Value ETF

CAMX

Valor de mercado US$ 66,7 mi

PDUFA target action date set to 10 June 2026 LUND, Sweden, Jan. 9, 2026 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's resubmission of the New Drug Application (NDA) for Oclaiz™ (CAM2029), octreotide extended-release injection, for the treatment of patients with acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 10 June 2026.

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Treatment well tolerated with a safety profile consistent with standard-of-care (SoC) Increased biochemical response rates (IGF-1 ≤ 1xULN) vs SoC at baseline Continuous improvement of acromegaly symptom and quality of life scores vs baseline Study results reinforce previously reported interim results from ACROINNOVA 21 LUND, Sweden , July 15, 2024 /PRNewswire/ -- Camurus (NASDAQ: CAMX) (STO: CAMX) today announced positive, final, topline results from the 52-week Phase 3 open-label ACROINNOVA 2 (NCT04125836) study, which evaluated safety and efficacy of the company's once-monthly octreotide subcutaneous (SC) depot (CAM2029). The study included a total of 135 patients with acromegaly who were biochemically controlled (IGF-1≤1xULN) or uncontrolled on stable doses of standard-of-care (SoC) with first generation somatostatin ligands (SRL) at screening; of these, 81 were new to study patients and 54 were roll-over patients from 24-week randomized treatment with octreotide SC depot or placebo (ACROINNOVA 1).