Polen Thomas E Jr sold (to issuer) $7.2M of BDX

BD (BDX) announced its STANCE clinical trial for GalaFLEX LITE™ Scaffold in breast revision surgery has treated 274 patients, surpassing a key milestone. The trial, comparing the scaffold to conventional surgery, aims to support a future FDA application for a new breast indication. BD's P4HB technology has over a decade of clinical use in soft tissue support.

Becton, Dickinson and Company (BDX) medical technology shares have outperformed the S&P 500 and the iShares U.S. Medical Devices ETF over the past year and YTD. After Q3 results on Aug. 6, BDX reported adjusted EPS of $3.23 vs $3.14 expected, revenue of $5.0B vs $4.9B, and full-year adjusted EPS guidance of $12.62 to $12.72. Analysts rate it a “Moderate Buy” with a mean target of $187.33 and a Citigroup target of $208.

Medline said regulatory guidance followed its corrective actions for surgical convenience kits whose components were affected by a Becton Dickinson recall. The alert cites BD lot 4032183 ChloraPrep Clear 1 mL and lot 4073005 FREPP Clear 1.5 mL applicators, with compromised sterile seals and possible Aspergillus contamination. Medline reported no severe injuries or deaths as of Aug 3. MDLN shares were $35.71, up 0.61%.

BD reported Q3 fiscal 2026 results for “New BD” after its Life Sciences spin-off. Revenue was $4.98B, up 4.4% FX-neutral; adjusted diluted EPS was $3.23, up 4.9%. Adjusted operating margin was 24.9% after 110 bps tariff impact. Full-year adjusted EPS guidance raised to $12.62-$12.72 midpoint; revenue growth guided toward high end of low-single-digit FX-neutral range.

BD (NYSE: BDX) said enrollment is complete for the PREVENT randomized trial of Phasix Mesh to prevent incisional hernias after elective open midline abdominal surgery. The study enrolled 477 patients at 32 US and European sites. Patients will be followed to a 24-month primary endpoint, with longer follow-up to five years and planned FDA submission after results.

FDA updates cover inspection reorganization plans, proposed IND reforms for early-stage biologics research, and accelerated approval of Replimune’s Tudriqev (vusolimogene oderparepvec-wtpg) with Bristol Myers Squibb’s Opdivo for melanoma after PD-1 regimens. Other items include FDA workshops, Seegene EUA for an assay, and multiple drug/device recalls.