Loading…
Loading…
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.
While many market sectors are being troubled by macroeconomic uncertainty, the travel sector may very well have it the worst. Given the rise in inflationary pressures and recession risks, it could be difficult to justify travel expenditures at the moment.
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).
Bull vs. Bear is a weekly feature where the VettaFi writers' room takes opposite sides for a debate on controversial stocks, strategies, or market ideas — with plenty of discussion of ETF ideas to play either angle. For this edition of Bull vs.
SEC filings for CAMX aren't indexed yet — common for recently launched funds. Browse the issuer's filings on SEC EDGAR directly.