Pipeline & Launch Brand Alerts — September 2025
In September we tracked 28 significant updates — 4 FDA approvals, 2 new indication approvals and multiple positive Phase 3 readouts, most tied to brands projected to generate $1B+ annually. Top Hot Tips: iberdomide, pegozafermin and Palsonify.
At Athena BDA we publish a monthly newsletter for clients summarising the highest-priority FDA approvals and late-stage pipeline developments across pharma.
In September, we tracked 28 significant updates — including 4 FDA approvals, 2 new indication approvals and multiple positive Phase 3 readouts, most linked to brands projected to generate $1B+ in annual sales. Below are our top-priority selections as Hot Tips.
Hot Tip #1 — Iberdomide | BMS
Peak-sales consensus: ~$3B · Stage: Positive Phase 3 data (multiple myeloma)
BMS’s CELMoD iberdomide achieved a Phase 3 win in relapsed/refractory multiple myeloma, hitting its MRD-negativity endpoint and setting up discussions with regulators for accelerated approval.
Athena BDA insight: Priority Score 1 — major market potential with multiple launch leaders already mapped across BMS’s CELMoD programme.
Hot Tip #2 — Pegozafermin | Roche / 89bio
Peak-sales consensus: ~$4B · Stage: Phase 3 acquisition target (MASH)
Roche’s $3.5B acquisition of 89bio adds pegozafermin, a late-stage FGF21 analog for MASH, alongside newly secured co-commercialisation rights for petrelinitide — a bold expansion in metabolic disease.
Athena BDA insight: Priority Score 1 — watch for a slew of upcoming metabolic hires across Roche.
Hot Tip #3 — Palsonify | Crinetics
Peak-sales consensus: $500M–$1.5B · Stage: FDA approval (acromegaly)
The FDA approved Palsonify, the first oral therapy for acromegaly, marking Crinetics’ commercial debut. Premium pricing (~$290K/year) has driven analysts to raise post-launch revenue forecasts.
Athena BDA insight: Priority Score 1 — large commercial team identified with active hiring still underway.
What else is moving this month?
- 🦉 An oral IL-23 inhibitor that just beat a leading rival in Phase 3 psoriasis trials, showing superior skin clearance and matching safety, with filings now complete in both the US and Europe.
- 🦉 A first-in-class oral PCSK9 inhibitor that hit its third straight Phase 3 success, delivering LDL reductions to rival injectables and potentially redefining cholesterol management.
- 🦉 A complement-blocking RNA combo that impressed in myasthenia gravis and PNH, with clean safety data and quarterly dosing convenience, setting up filings for early 2026.
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