Pipeline & Launch Brand Alerts — August 2025
In August we tracked 21 significant updates: 9 FDA approvals, 2 new indication approvals and 10 pipeline news catalysts. Top Hot Tips: gedatolisib, ianalumab and Wegovy in MASH.
At Athena BDA we publish a monthly newsletter for clients summarising the highest-priority FDA approvals and pipeline developments.
In August, we tracked 21 significant updates: 9 FDA approvals, 2 new indication approvals and 10 pipeline news catalysts. Below are our top-priority selections as Hot Tips.
Hot Tip #1 — Gedatolisib | Celcuity
Peak-sales consensus: ~$2B · Stage: Positive Phase 3 data, NDA filing by Q4 2025
Celcuity’s PI3K/mTOR inhibitor met its primary endpoints in breast cancer Phase 3 trials, outperforming Faslodex-based regimens. A rolling NDA is set to begin in September.
Athena BDA database insight: launch leaders identified and 17 commercial stakeholders mapped, with more hiring currently taking place.
Hot Tip #2 — Ianalumab | Novartis
Peak-sales consensus: ~$5B · Stage: Positive Phase 3 data in Sjögren’s disease and ITP
Ianalumab hit primary endpoints in two pivotal trials, showing reductions in disease activity in Sjögren’s and improved durability in ITP. Fast Track designation positions filings ahead.
Athena BDA database insight: 10 asset-focused commercial leads identified, with a large group of immunology contacts to also engage.
Hot Tip #3 — Wegovy | Novo Nordisk
Peak-sales consensus (MASH): ~$2B · Stage: FDA accelerated approval
Wegovy won accelerated approval for MASH with fibrosis, extending the GLP-1 franchise beyond obesity and cardiovascular outcomes. Positioned against Rezdiffra while expanding Novo’s reach into liver disease.
Athena BDA database insight: over 40 MASH/liver-focused contacts mapped for outreach in this new indication.
What else is moving this month?
- 🦉 A first-in-class oncology approval offering a targeted oral therapy in a space previously dominated by IV competitors.
- 🦉 An RNA-based rare disease therapy just approved, positioned against an entrenched market leader but with a more convenient dosing profile.
- 🦉 A long-awaited neurology approval — the first new treatment in its indication in over 15 years — supported by strong Phase 3 efficacy and favourable tolerability.
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