Pipeline & Launch Brand Alerts — June 2025
In June we tracked 24 significant updates: 8 FDA approvals, 2 new indication approvals and 14 pipeline news catalysts. Top Hot Tips: orforglipron and efsitora alfa, enlicitide decanoate and ziftomenib.
At Athena BDA we publish a monthly newsletter for clients summarising the highest-priority FDA approvals and pipeline developments.
In June, we tracked 24 significant updates: 8 FDA approvals, 2 new indication approvals and 14 pipeline news catalysts. Below are our top-priority selections as Hot Tips.
Hot Tip #1 — Orforglipron + Efsitora Alfa | Lilly
Peak-sales consensus: ~$30B combined · Stage: Positive Phase 3 data, filings expected by late 2025
Lilly’s metabolic franchise is surging. Oral GLP-1 orforglipron showed strong A1C reduction and up to 8% weight loss, while once-weekly insulin efsitora matched or outperformed daily options, cutting over 300 injections per year. A commercial showdown with Novo’s Awiqli is on the horizon.
Athena BDA database insight: we’ve mapped launch leaders and a deep pool of metabolic-focused contacts across both diabetes and obesity roles.
Hot Tip #2 — Enlicitide Decanoate | Merck
Peak-sales consensus: ~$2B · Stage: Positive Phase 3 data, filing expected 2026
Merck’s oral PCSK9 therapy demonstrated a 60% LDL reduction, differentiating it from injectable competitors. With strong data, commercial buildout already underway and filing plans in motion, this could be a game-changer in cholesterol management.
Athena BDA database insight: 16 commercial stakeholders already mapped to the brand, providing a highly targeted pool for outreach.
Hot Tip #3 — Ziftomenib | Kura
Peak-sales consensus: TBD · Stage: NDA accepted, under FDA Priority Review with a November PDUFA date
Ziftomenib is on track to become the first targeted therapy for NPM1-mutant AML. A rapidly expanding commercial team suggests Kura is gearing up for a meaningful launch in a tightly defined but high-need patient population.
Athena BDA database insight: multiple new commercial hires directly supporting this asset identified, all tagged and ready for prioritised outreach.
What else is moving this month?
- 🦉 A $4–5B HIV prevention launch from a top-5 biopharma player.
- 🦉 A hemophilia blockbuster with peak sales estimated at $1B just announced positive Phase 3 results.
- 🦉 A lung cancer approval from a biotech already competing with Roche and BMS in a $1B+ segment.
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