Phase 3 readouts still due in 2026
14 Phase 3 or registrational readouts that listed companies still guide to before the end of 2026, as of Oct 28, 2026. Each line is the most recent timing statement in the company's own filings or releases, with a link to it. Companies can and do move these dates.
- First half of December 2026Biogen Inc. BIIB
TOPAZ-1 and TOPAZ-2 — litifilimab in systemic lupus erythematosusThe Company expects to announce top line data from both TOPAZ-1 and TOPAZ-2 Phase 3 studies, evaluating litifilimab in SLE, in the first half of December 2026.
Source: 8-K, Oct 28, 2026 - December 2026Argenx SE ARGX
EMPASSION — empasiprubart in multifocal motor neuropathyTopline results from the Phase 3 EMPASSION study (MMN) expected in December 2026
Source: 6-K, Oct 22, 2026 - December 2026Kodiak Sciences Inc. KOD
PEAK, Pivotal Analysis 1 — KSI-101 in macular edema secondary to inflammationEnrollment of the first 300-patient cohort in the PEAK trial supporting Pivotal Analysis 1 has completed and topline results remain on track for a December 2026 release.
Source: S-3, Oct 20, 2026 - Q4 2026Annexon, Inc. ANNX
ARCHER II — vonaprument (ANX007) in geographic atrophyThe Month 15 primary endpoint remains on track for the fourth quarter of 2026.
Source: 10-Q, Aug 12, 2026 - Q4 2026Helus Pharma Inc. HELP
APPROACH — HLP003 in adjunctive treatment of major depressive disorderThe Company continues to anticipate reporting topline data from its Phase 3 APPROACH pivotal study of HLP003 in major depressive disorder in Q4 2026.
Source: 6-K, Oct 27, 2026 - Q4 2026Incyte Corp INCY
STOP-PN1 and STOP-PN2 — povorcitinib in prurigo nodularisData from the Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with moderate to severe prurigo nodularis (PN) are anticipated in the fourth quarter of 2026.
Source: 8-K, Jul 28, 2026 - Q4 2026Incyte Corp INCY
TRuE-HS1 and TRuE-HS2 — ruxolitinib cream (Opzelura) in hidradenitis suppurativaTopline results from the Phase 3 studies (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) are anticipated in the fourth quarter of 2026.
Source: 8-K, Jul 28, 2026 - Q4 2026Krystal Biotech, Inc. KRYS
IOLITE (registrational) — KB803 in corneal abrasions in dystrophic epidermolysis bullosaThe Company’s registrational, intra-patient, double-blind, de-centralized, placebo-controlled study (IOLITE) with crossover design evaluating KB803 for the treatment and prevention of corneal abrasions in DEB patients was fully enrolled in April and is on track for a top-line data readout in 4Q 2026.
Source: 8-K, Aug 3, 2026 - Q4 2026Regeneron Pharmaceuticals, Inc. REGN
Phase 3 vs pembrolizumab — fianlimab with Libtayo in adjuvant melanomaReport results from Phase 3 study versus pembrolizumab in adjuvant melanoma (fourth quarter 2026)
Source: 10-Q, Jul 30, 2026 - Q4 2026REGENXBIO Inc. RGNX · with AbbVie
ATMOSPHERE and ASCENT — sura-vec (ABBV-RGX-314) in wet age-related macular degenerationREGENXBIO expects to announce topline data with AbbVie from the ATMOSPHERE® and ASCENT® pivotal trials of sura-vec using subretinal delivery in Q4 2026.
Source: 8-K, Aug 6, 2026 - By year-end 2026NewAmsterdam Pharma Company N.V. NAMS
RUBENS — obicetrapib in type 2 diabetes or metabolic syndromeThe trial is expected to enroll approximately 300 patients, with topline data expected by year end 2026.
Source: 10-Q, Aug 5, 2026 - Around year-end 2026Oculis Holding AG OCS
PREDICT-1 (registrational Phase 2/3) — licaminlimab (OCS-02) in dry eye diseaseOculis expects to report topline results around year-end 2026.
Source: press release, Oct 19, 2026 - As early as the end of 2026Immunocore Holdings plc IMCR
TEBE-AM — tebentafusp (KIMMTRAK) in previously treated advanced melanomaThe Company expects to be able to share topline data as early as the end of 2026.
Source: 8-K, Sep 14, 2026 - Second half of 2026Karyopharm Therapeutics Inc. KPTI · with European Myeloma Network
XPORT-MM-031 / EMN29 — selinexor with pomalidomide and dexamethasone in previously treated multiple myelomaWe expect to report topline data from this event-driven trial in the second half of 2026.
Source: 10-Q, Aug 13, 2026
Guided for 2026, already out or moved
- Reported Aug 10, 2026Tenax Therapeutics, Inc. TENX
LEVEL — Did not meet its primary endpoint (6-minute walk distance vs placebo) or key secondary endpoint. - Reported Jul 9, 2026Astrazeneca PLC AZN
CARDIO-TTRansform (Wainua, with Ionis) — Did not meet its primary endpoint (cardiovascular mortality and recurrent cardiovascular events vs placebo). - MovedInnate Pharma SA IPHA
PACIFIC-9 (AstraZeneca-led, monalizumab) — now expected in the first half of 2027 - Reported Aug 19, 2026Moderna, Inc. MRNA
INTerpath-001 (intismeran autogene, with Merck) — Met its primary endpoint (recurrence-free survival) and key secondary endpoint (distant metastasis-free survival).
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.