Ep. 5: Biotech Trends and Insights: Rare Diseases, Patent Expirations, ESMO25 and Sheff's Watchlist | Biotech Bulls & Breakthroughs Podcast

What It Covers

Biotech trader "Chef" and BioPharm Catalyst's John Galliano cover three macro themes — FDA rare disease policy shifts, Keytruda's August 2026 patent expiration, and ESMO 2025 previews — then walk through 20+ specific small-cap biotech catalysts spanning September through December 2025.

Key Questions Answered

• •Rare Disease FDA Transparency: The FDA's newly published five-year archive of Complete Response Letters lets investors identify exactly why drugs failed approval. Combined with the Rare Disease Innovation Hub and orphan drug designation vouchers, small companies now have a clearer regulatory roadmap, reducing the blind-spot risk that previously derailed late-stage rare disease programs.
• •Keytruda Patent Expiration Strategy: Merck projects a revenue drop from $33B in 2028 to $27B in 2029 — roughly 19% — as biosimilars capture 30–40% market share within 12 months of the August 2026 loss of exclusivity. Merck's counter-move is launching a subcutaneous Keytruda formulation, since biosimilar entrants will initially be intravenous only, preserving near-term market share.
• •Conference Catalyst Trading Edge: Presenting data at a named conference — ESMO October 12–19, ASN Kidney Week November 5–9 — gives traders a precise date to position around, unlike vague "Q3/Q4" company guidance. Specific presentation dates allow defined entry and exit planning, reducing the timing uncertainty that makes binary biotech events difficult to trade systematically.
• •Regulatory Communication as Investment Signal: Before taking a position on a company's FDA meeting catalyst, review the prior press release history. Companies like OSTX that have issued consistent FDA communication updates since April signal lower surprise risk. Companies announcing FDA meetings without prior preparatory disclosures carry higher binary risk and warrant smaller or no positions.
• •Trading Stocks Over Options for Catalyst Events: For retail investors trading biotech binary events, equity positions carry fewer variables than options — no expiration date misalignment, no strike price selection, no implied volatility decay. Options add three to four additional decision layers on top of the core catalyst bet, compounding execution errors for investors unfamiliar with derivatives mechanics.