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• Two Different Approval Routes: Tenon Medical (NASDAQ: TNON) and Establishment Labs (NASDAQ: ESTA) illustrate the contrast between the FDA's 510(k) and PMA pathways.
• Well-Capitalized New Entrant: Elicio Therapeutics' (NASDAQ: ELTX) $15 million raise adds fresh capital to a therapeutic area with historically poor outcomes.
• Phase 3 OLE Safety Data Presented at ASCO GI: Open-Label Extension data demonstrated a manageable safety and tolerability profile for daraxonrasib in combination with standard chemotherapy.
• Phase 1/2 Trial Initiated July 1, 2026: AstraZeneca initiated a Phase 1/2 trial combining lumipodlin (ABSK043) with TAGRISSO (osimertinib) in non-small cell lung cancer.
• Late-Breaking Data Coming: Tenax Therapeutics (NASDAQ: TENX) will present Phase 3 LEVEL trial results at ESC Congress 2026 in Munich.
• 1-for-3 Split Announced: NewGenIvf Group (NASDAQ: NIVF) will consolidate its Class A ordinary shares at a 1-for-3 ratio.
• 1-for-3 Reverse Split Effective July 6: The reverse stock split of Class A ordinary shares becomes effective at 12:01 a.m. ET on July 6, 2026.
• 50% Improvement in ANT1: PMGC Holdings (NASDAQ: ELAB) reported that AI-identified molecules improved ANT1 expression by up to 50% in primary skeletal muscle cells.
• FDA 510(k) Clearance Received: Tenon Medical received regulatory clearance for its Catamaran SI Joint Fusion System for treating sacro-pelvic disorders.
• Formal Deficiency Notice Received June 30: Nasdaq's Listing Qualifications Department notified Mdxhealth on June 30, 2026, that it failed to satisfy minimum bid price criteria.
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