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Transformative Evidence

  Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information

CS-003

  • Patients with high-risk, non-muscle invasive bladder cancer now have greater access to the first and only FDA-approved intravesical gene therapy
  • With full supply of ADSTILADRIN ahead of schedule, Ferring ends the temporary ADSTILADRIN Early Experience Program
  • Enrollment in ABLE-41 U.S. Real-World Evidence Study is ongoing

ARAMIS Trial

Context: Randomized controlled trials (RCTs) have shown that addition of docetaxel or androgen receptor axis–targeted therapy (ARAT) to androgen deprivation therapy (ADT) or addition of ARAT to ADT and docetaxel improves overall survival (OS) in metastatic hormone-sensitive prostate cancer (mHSPC). However, it is unknown whether docetaxel, when given as part of triplet therapy, has an independent OS benefit.

Trials in Progress

  Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information

Oral EPI 7386 Trial

  • Combination of masofaniten plus enzalutamide continues to be well tolerated with deep and durable reductions in PSA in patients with mCRPC
  • Phase 2 dose expansion currently underway at the RP2CDs of masofaniten 600 mg BID in combination with enzalutamide 160 mg QD
  • Across all dosing cohorts, 81% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 63% of patients achieved PSA <0.2ng/mL. While the data are still maturing, median time to PSA progression is currently at 16.6 months.

Pivot-006 Trial

Reno, Nevada (UroToday.com) -- CG Oncology, Inc. (Nasdaq: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, announced the pricing of its upsized initial public offering of 20,000,000 shares of its common stock at an initial public offering price of $19.00 per share. All of the shares are being offered by CG Oncology. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $380.0 million. CG Oncology’s common stock is expected to begin trading on the Nasdaq Global Select Market on January 25, 2024 under the ticker symbol “CGON.” The offering is expected to close on January 29, 2024, subject to the satisfaction of customary closing conditions. In addition, CG Oncology has granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.