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Biotech catalyst calendar — November 2026

Company-stated PDUFA, topline/data and conference timing from existing public SEC records. Statements retain their filing dates and wording.

Open the calendar · Qualified periods

Dates and months below come from company statements. A conference range does not identify a presentation day. Qualified periods can overlap November 2026; they do not establish a November event.

Page presentation updated . This is not a new source check.

Dates, ranges and months stated for November 2026

Full company statements and SEC source links:

AGIOS PHARMACEUTICALS, INC. (AGIO) · mitapivat

PDUFA · Stated timing: November 1, 2026

The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA’s accelerated approval pathway, is November 1, 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Cullinan Therapeutics, Inc. (CGEM) · velinotamig

Conference/data · Stated timing: November 2026

in a poster session at American College of Rheumatology Convergence 2026 in November.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

REGENERON PHARMACEUTICALS, INC. (REGN) · cemdisiran

PDUFA · Stated timing: November 2026

The FDA will review the New Drug Application (NDA) under priority review with a target action date in November 2026, following use of a Priority Review Voucher.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Editas Medicine, Inc. (EDIT) · EDIT-401

Conference/data · Stated timing: November 6-9, 2026

The Company also announced that new preclinical data, demonstrating durability of LDL-C reduction with EDIT-401, will be released via an oral presentation at the American Heart Association (AHA) Scientific Sessions 2026, taking place November 6-9, 2026, in Chicago, Illinois.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Corbus Pharmaceuticals Holdings, Inc. (CRBP) · CRB-913

Conference/data · Stated timing: November 14 – 17, 2026

will be detailed in a late-breaking presentation at ObesityWeek® 2026, to be held November 14 – 17, 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

CYTOKINETICS INC (CYTK) · aficamten

PDUFA · Stated timing: November 14, 2026

The FDA assigned a standard review classification to the sNDA with a PDUFA date of November 14, 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ACADIA PHARMACEUTICALS INC (ACAD) · remlifanserin

Conference/data · Stated timing: November 16-19, 2026

The Company plans to present detailed safety and efficacy results from the RADIANT Phase 2 study in an oral presentation at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) conference, taking place November 16-19, 2026 in Boston.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

CAPRICOR THERAPEUTICS, INC. (CAPR) · Deramiocel

PDUFA · Stated timing: November 22, 2026

New PDUFA target action date of November 22, 2026 follows submission of additional Phase 3 HOPE-3 data and analyses supporting a refined proposed indication

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Savara Inc (SVRA) · molgramostim

PDUFA · Stated timing: November 22, 2026

Prescription Drug User Fee Act ("PDUFA") target action date to November 22, 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

BridgeBio Pharma, Inc. (BBIO) · BBP-418

PDUFA · Stated timing: November 27, 2026

BBP-418 for limb-girdle muscular dystrophy type 2I/R9, or LGMD2I/R9 (PDUFA date with Priority Review: November 27, 2026)

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Cogent Biosciences, Inc. (COGT) · bezuclastinib and sunitinib

PDUFA · Stated timing: November 30, 2026

PDUFA target action date of November 30, 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Qualified periods overlapping November 2026

Broader periods retain their exact wording. No particular day or November occurrence is assigned.

Autolus Therapeutics plc (AUTL) · AUTO8

Topline/data · Stated timing: end of 2026

The Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis is ongoing and initial data are expected to be reported at the end of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

BIOCRYST PHARMACEUTICALS INC (BCRX) · BCX17725

Topline/data · Stated timing: end of 2026

expects to report data from this part by the end of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Beam Therapeutics Inc. (BEAM) · BEAM-301

Topline/data · Stated timing: 2026

initial data from the trial in 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Beam Therapeutics Inc. (BEAM) · BEAM-302

Conference/data · Stated timing: 2026

updated BEAM-302 data at a medical congress in 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Beam Therapeutics Inc. (BEAM) · risto-cel

Topline/data · Stated timing: year-end 2026

We expect to report updated data for the BEACON clinical trial by year-end 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

BIOGEN INC. (BIIB) · litifilimab

Topline/data · Stated timing: end of 2026

Registrational data for litifilimab in SLE expected by end of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Cogent Biosciences, Inc. (COGT) · bezuclastinib

Topline/data · Stated timing: end of 2026

SUMMIT extension trial with preliminary results expected by end of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

PRECISION BIOSCIENCES INC (DTIL) · PBGENE-DMD

Topline/data · Stated timing: year-end 2026

The study is actively recruiting patients at specialized Duchenne care centers with initial safety data expected by year-end 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Immunome Inc. (IMNM) · IM-1021

Topline/data · Stated timing: 2026

initial lymphoma data for IM-1021 in 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

IONIS PHARMACEUTICALS INC (IONS) · pelacarsen

Topline/data · Stated timing: 2026

Pelacarsen Lp(a)-CVD Lp(a) HORIZON data •

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Century Therapeutics, Inc. (IPSC) · CNTY-101 (CARAMEL IST)

Topline/data · Stated timing: in 2026

CNTY-101 preliminary clinical data from Phase 1/2 CARAMEL IST expected in 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Kymera Therapeutics, Inc. (KYMR) · KT-621

Topline/data · Stated timing: year-end 2026

its expected topline data readout by six months to year-end 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Lineage Cell Therapeutics, Inc. (LCTX) · COR1

Topline/data · Stated timing: 2026

Lineage has also elected to advance the COR1 program into in-vivo animal testing with initial preclinical data expected to be generated in 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Moderna, Inc. (MRNA) · intismeran autogene

Topline/data · Stated timing: 2026

Phase 3 adjuvant melanoma data potentially in 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Moderna, Inc. (MRNA) · mRNA-1403

Topline/data · Stated timing: 2026

data expected in 2026, subject to case accruals

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Moderna, Inc. (MRNA) · mRNA-3927

Topline/data · Stated timing: 2026

We expect potential data in 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Moderna, Inc. (MRNA) · mRNA-4359

Topline/data · Stated timing: 2026

we expect a potential Phase 2 data readout in 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Nkarta, Inc. (NKTX) · NKX019

Conference/data · Stated timing: 2026

Initial clinical data from Ntrust-1 and Ntrust-2 are planned for presentation at a medical conference in 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ONCOLYTICS BIOTECH INC (ONCY) · pelareorep

Topline/data · Stated timing: year-end 2026

Company expects to have sufficient Part A data to provide an interim clinical update by year-end 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

PALISADE BIO, INC. (PALI) · PALI-2108

Topline/data · Stated timing: 2026

Additional PALI-2108 data to be presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting and United European Gastroenterology (UEG) Week 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Arcus Biosciences, Inc. (RCUS) · casdatifan

Topline/data · Stated timing: 2026

In second-line IO-experienced ccRCC, more mature overall response rate data and initial PFS data, including Kaplan-Meier curve(s), for approximately 45 patients treated in the ARC-20 cohort evaluating casdatifan plus cabozantinib. All patients will have had at least 18 months of follow-up.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Arcus Biosciences, Inc. (RCUS) · casdatifan

Topline/data · Stated timing: 2026

early efficacy data for the cohort evaluating casdatifan plus zimberelimab

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Arcus Biosciences, Inc. (RCUS) · casdatifan

Topline/data · Stated timing: 2026

early safety data for the cohort evaluating casdatifan plus zimberelimab plus ipilimumab

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Arcus Biosciences, Inc. (RCUS) · casdatifan

Topline/data · Stated timing: 2026

In late-line ccRCC, updated data from the ARC-20 monotherapy cohorts, including overall survival data.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Replimune Group, Inc. (REPL) · RP2

Topline/data · Stated timing: end of 2026

The protocol has been amended to include RP2 as monotherapy and we plan to release preliminary HCC data by the end of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Replimune Group, Inc. (REPL) · TUDRIQEV (RP1)

Topline/data · Stated timing: 2026

We have closed enrollment in the ARTACUS trial and are planning a publication of the data in 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Silence Therapeutics plc (SLN) · SLN312

Topline/data · Stated timing: 2026

Phase 1 data presentations are planned for medical and research congresses in 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Tango Therapeutics, Inc. (TNGX) · vopimetostat

Topline/data · Stated timing: 2026

disclose clinical data in the lung cancer cohort of the vopimetostat monotherapy clinical trial in 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Vanda Pharmaceuticals Inc. (VNDA) · HETLIOZ

Topline/data · Stated timing: in 2026

The Phase III study of HETLIOZ® in the treatment of delayed sleep phase disorder (DSPD) with results expected in 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Vanda Pharmaceuticals Inc. (VNDA) · NEREUS

Topline/data · Stated timing: in 2026

The Thetis Phase III study of NEREUSTM for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Vanda Pharmaceuticals Inc. (VNDA) · VQW-765

Topline/data · Stated timing: in 2026

The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder, with results expected in 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Zenas BioPharma, Inc. (ZBIO) · ZB021

Topline/data · Stated timing: year-end 2026

These data are expected by year-end 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Aclaris Therapeutics, Inc. (ACRS) · ATI-052

Topline/data · Stated timing: second half of 2026

We initiated a Phase 1b proof-of-concept trial with ATI-052 in atopic dermatitis in January 2026 and a Phase 1b proof-of-concept trial in asthma in February 2026, with top-line data from both studies expected in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

AGIOS PHARMACEUTICALS, INC. (AGIO) · AG-181

Topline/data · Stated timing: second half of 2026

Data from this trial are expected in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ALUMIS INC. (ALMS) · envudeucitinib

Topline/data · Stated timing: 2H 2026

Envudeucitinib in Moderate-to-Severe Plaque Psoriasis o Long-term data: Phase 2, two-year safety data (2H 2026)

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ALNYLAM PHARMACEUTICALS, INC. (ALNY) · ALN-6400

Topline/data · Stated timing: second half of 2026

additional data from the Phase 1 clinical trial as well as initial results in the Phase 2 clinical trial in HHT the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ALNYLAM PHARMACEUTICALS, INC. (ALNY) · ALN-6400

Topline/data · Stated timing: second half of 2026

initial results in the Phase 2 clinical trial in HHT the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ALNYLAM PHARMACEUTICALS, INC. (ALNY) · ALN-2232

Topline/data · Stated timing: second half of 2026

In the second half of 2026, Alnylam expects to announce clinical data from additional pipeline programs, including: • Results from Phase 1 and Phase 2 clinical trials of ALN-6400 in healthy volunteers and patients with hereditary hemorrhagic telangiectasia (HHT), respectively. • Results from a Phase 1 clinical trial of ALN-2232 in obesity and weight management.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ALNYLAM PHARMACEUTICALS, INC. (ALNY) · ALN-HTT02

Topline/data · Stated timing: second half of 2026

initiated a Phase 1b clinical trial of ALN-HTT02 in adult patients with HD and expect to present initial data from this trial in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ARVINAS, INC. (ARVN) · ARV-393

Conference/data · Stated timing: second half of 2026

clinical data from the early monotherapy cohorts in the ongoing Phase 1 dose escalation clinical trial of ARV-393 in patients with relapsed/refractory NHL at a medical congress in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ARVINAS, INC. (ARVN) · ARV-806

Topline/data · Stated timing: second half of 2026

KRAS G12D mutations. ◦ Reiterated plan to share initial data from the Phase 1 monotherapy dose escalation clinical trial in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Actinium Pharmaceuticals, Inc. (ATNM) · Actimab-A + PD-1 inhibitor

Topline/data · Stated timing: 2H:2026 or 1H:2027

We expect to report initial data from this trial in 2H:2026 or 1H:2027.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ArriVent BioPharma, Inc. (AVBP) · firmonertinib

Topline/data · Stated timing: 2H 2026

EGFR exon 20 insertion mutant NSCLC is anticipated in 2H 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Biohaven Ltd. (BHVN) · Opakalim (BHV-7000)

Topline/data · Stated timing: the second half of 2026

Dosing remains ongoing in BHV7000-303 and topline data continues to be on timelines for the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Biohaven Ltd. (BHVN) · Taldefgrobep alfa

Topline/data · Stated timing: 2H 2026

Topline data expected during 2H 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Coherus Oncology, Inc. (CHRS) · tagmokitug + toripalimab

Topline/data · Stated timing: 2H 2026

The Phase 1b dose-optimization studies evaluating tagmokitug in combination with toripalimab in second-line head and neck squamous cell carcinoma (HNSCC) and upper gastrointestinal adenocarcinomas remain ongoing, with initial data readouts expected in 2H 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Coherus Oncology, Inc. (CHRS) · tagmokitug + toripalimab

Topline/data · Stated timing: 2H 2026

The Phase 1b/2a study evaluating the tagmokitug and toripalimab combination in fourth-line and beyond colorectal cancer with no liver metastasis, is fully enrolled, with initial data expected in 2H 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Coherus Oncology, Inc. (CHRS) · tagmokitug + toripalimab +/− chemotherapy

Topline/data · Stated timing: 2H 2026

esophageal squamous cell carcinoma (ESCC), continues to enroll patients, with initial data expected in 2H 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Caribou Biosciences, Inc. (CRBU) · CB-011

Topline/data · Stated timing: second half of 2026

In the second half of 2026, Caribou expects to report initial safety and efficacy from dose expansion on more than 15 patients with a minimum of three months follow up, as well as longer follow-up data on the 12-patient, BCMA-naïve RDE cohort from dose escalation.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Caribou Biosciences, Inc. (CRBU) · CB-011

Topline/data · Stated timing: second half of 2026

In the second half of 2026, Caribou expects to report initial safety and efficacy from dose expansion on more than 15 patients with a minimum of three months follow up

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Erasca, Inc. (ERAS) · ERAS-4001

Topline/data · Stated timing: second half of 2026

We anticipate a Phase 1 monotherapy data readout from the BOREALIS-1 trial in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

EXELIXIS, INC. (EXEL) · zanzalintinib

Topline/data · Stated timing: Second Half of 2026

Topline Results for Phase 3 STELLAR-304 Pivotal Trial Expected in Second Half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

IN8BIO, INC. (INAB) · INB-619

Topline/data · Stated timing: second half of 2026

We expect to report initial in vivo data for INB-619 in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

INCYTE CORP (INCY) · INCA033989

Topline/data · Stated timing: second half of 2026

Data from the Phase 1 cohort evaluating INCA033989 as a monotherapy and in combination with ruxolitinib in treatment naïve MF patients are anticipated in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

INCYTE CORP (INCY) · INCA33890

Topline/data · Stated timing: second half of 2026

Additional data from the ongoing Phase 1 study evaluating INCA33890 in combination with bevacizumab and/or chemotherapy in patients with solid tumors is anticipated in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

INCYTE CORP (INCY) · INCB160058

Topline/data · Stated timing: second half of 2026

Results from the Phase 1 trial evaluating INCB160058 in MPN patients with a JAK2V617F mutation are anticipated in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

INCYTE CORP (INCY) · axatilimab + ruxolitinib

Topline/data · Stated timing: second half of 2026

ruxolitinib in patients with newly diagnosed chronic GVHD is ongoing, with results anticipated in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

INCYTE CORP (INCY) · povorcitinib

Topline/data · Stated timing: second half of 2026

Topline data from the Phase 2 proof-of-concept trial for povorcitinib in asthma are anticipated in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

INCYTE CORP (INCY) · povorcitinib

Topline/data · Stated timing: second half of 2026

additional data from STOP-V1 and STOP-V2 in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

INCYTE CORP (INCY) · INCB161734 + chemotherapy

Topline/data · Stated timing: second half of 2026

treatment in patients with metastatic PDAC is anticipated in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Janux Therapeutics, Inc. (JANX) · JANX011

Topline/data · Stated timing: second half of 2026

Initial clinical data from the Phase 1 healthy volunteer study of JANX011 expected to be announced in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Kura Oncology, Inc. (KURA) · darlifarnib + cabozantinib

Topline/data · Stated timing: second half of 2026

updated Phase 1a dose-escalation data from the combination of darlifarnib and cabozantinib in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Kura Oncology, Inc. (KURA) · ziftomenib + gilteritinib

Topline/data · Stated timing: second half of 2026

anticipate presenting preliminary data in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Kura Oncology, Inc. (KURA) · ziftomenib + quizartinib + 7+3

Topline/data · Stated timing: second half of 2026

anticipate presenting preliminary data in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Kura Oncology, Inc. (KURA) · ziftomenib + venetoclax + azacitidine

Topline/data · Stated timing: 2H 2026

Updated long-term KOMET-007 Phase 1b data evaluating ziftomenib with venetoclax and azacitidine in newly diagnosed, intensive chemotherapy-ineligible NPM1 -m AML patients, including durability, survival, and MRD outcomes – 2H 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Veradermics, Inc (MANE) · VDPHL01 Study 302

Topline/data · Stated timing: in the second half of 2026

Twelve-month data from Study ‘302’ are anticipated in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Veradermics, Inc (MANE) · VDPHL01 Study 304

Topline/data · Stated timing: in the second half of 2026

Phase 3 Study ‘304’; Topline Data Anticipated in 2H26: Topline data from Study ‘304’, a confirmatory Phase 3 trial evaluating the safety and efficacy of VDPHL01 in the treatment of male pattern hair loss, are expected in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Oric Pharmaceuticals, Inc. (ORIC) · enozertinib / ORIC-114

Topline/data · Stated timing: second half of 2026

We expect to report data in the second half of 2026 in 1L NSCLC patients with EGFR exon 20 insertion mutations as a monotherapy and in combination with SC amivantamab, as well as in 1L NSCLC patients with EGFR atypical mutations as a monotherapy.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Q32 Bio Inc. (QTTB) · bempikibart

Conference/data · Stated timing: second half of 2026

additional details from 36-week results and initial findings from 52-week results to be presented at a medical conference in the second half of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Resolution filing held: 2026-09-30. The original statement is retained.

Roivant Sciences Ltd. (ROIV) · IMVT-1402

Topline/data · Stated timing: 2H 2026

Further updates from difficult-to-treat rheumatoid arthritis program 2H 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Roivant Sciences Ltd. (ROIV) · IMVT-1402

Topline/data · Stated timing: 2H 2026

Topline data from Phase 2 trial in cutaneous lupus erythematosus 2H 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Roivant Sciences Ltd. (ROIV) · mosliciguat

Topline/data · Stated timing: 2H 2026

Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease 2H 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Resolution filing held: 2026-09-08. The original statement is retained.

RECURSION PHARMACEUTICALS, INC. (RXRX) · REC-1245

Topline/data · Stated timing: 2H26

REC-1245 (RBM39): Additional Phase 1 dose escalation data expected in 2H26

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Sarepta Therapeutics, Inc. (SRPT) · SRP-1001

Topline/data · Stated timing: 2H 2026

Readouts from our MAD cohorts of our ongoing phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Sarepta Therapeutics, Inc. (SRPT) · SRP-1003

Topline/data · Stated timing: 2H 2026

Readouts from our MAD cohorts of our ongoing phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Scholar Rock Holding Corp (SRRK) · SRK-439

Topline/data · Stated timing: second half of 2026

A Phase 1 study of SRK-439 in healthy volunteers is currently underway, with topline data anticipated in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Tango Therapeutics, Inc. (TNGX) · TNG456

Topline/data · Stated timing: second half of 2026

We anticipate providing initial clinical data from this trial in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Vir Biotechnology, Inc. (VIR) · VIR-5818

Topline/data · Stated timing: second half of 2026

The Company expects to report updated dose-escalation data from its Phase 1 trial evaluating VIR-5818, a HER2-targeted PRO-XTEN ® dual-masked TCE, as a monotherapy and in combination with pembrolizumab, in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

VERTEX PHARMACEUTICALS INC / MA (VRTX) · VX-670

Topline/data · Stated timing: second half of 2026

Vertex is on track to complete dosing in the trial and share results in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

VERTEX PHARMACEUTICALS INC / MA (VRTX) · VX-828

Topline/data · Stated timing: second half of 2026

Vertex completed dosing in this study and is on track to share results in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Wave Life Sciences, Inc. (WVE) · WVE-006

Topline/data · Stated timing: the second half of 2026

We expect to share data from the 600 mg monthly multidose cohort of RestorAATion-2 in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Wave Life Sciences, Inc. (WVE) · WVE-007

Topline/data · Stated timing: the second half of 2026

Additional data from the INLIGHT trial, including data from the 600 mg Phase 1 SAD cohort, are expected in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Zai Lab Ltd (ZLAB) · ZL-1503 SAD

Topline/data · Stated timing: in the second half of 2026

ZL-1503 (IL-13/IL-31Rα): Completed enrollment in the single ascending dose (SAD) portion of the Phase 1/1b study of ZL-1503 in healthy volunteers, with initial PK, PD, safety and immunogenicity data expected in the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Zymeworks Inc. (ZYME) · pasritamig + JNJ-9401

Topline/data · Stated timing: second half of 2026

in combination with JNJ-9401 in patients with advanced prostate cancer who have progressed after multiple lines of therapy, during the second half of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ACADIA PHARMACEUTICALS INC (ACAD) · trofinetide

Topline/data · Stated timing: September to November 2026

trofinetide clinical trial in Japan, with topline results now anticipated in the September to November 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

AbCellera Biologics Inc. (ABCL) · ABCL575

Topline/data · Stated timing: Q4 2026

Completed dosing for the Phase 1 study of ABCL575, with top-line data readout expected in Q4 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ANAPTYSBIO, INC (ANAB) · dostarlimab

Topline/data · Stated timing: Q4 2026

Data expected in Q4 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Annexon, Inc. (ANNX) · vonaprument

Topline/data · Stated timing: fourth quarter of 2026

The Month 15 primary endpoint remains on track for the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Aprea Therapeutics, Inc. (APRE) · APR-1051

Topline/data · Stated timing: fourth quarter of 2026

We expect to report the next clinical data update from ACESOT-1051 at a medical meeting in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ARGENX SE (ARGX) · empasiprubart

Topline/data · Stated timing: fourth quarter of 2026

Topline results from registrational EMPASSION study (MMN) expected in fourth quarter of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Arcutis Biotherapeutics, Inc. (ARQT) · roflumilast foam 0.3%

Topline/data · Stated timing: Q4 of 2026

Phase 2 trial of ZORYVE foam 0.3% in individuals with vitiligo with disclosure of topline results and decision on program advancement anticipated in Q4 of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ARVINAS, INC. (ARVN) · ARV-102

Conference/data · Stated timing: fourth quarter of 2026

additional biomarker data from the Phase 1 clinical trial in patients with PD at the International Congress on Parkinson’s Disease and Movement Disorders in the fourth quarter of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ATOSSA THERAPEUTICS, INC. (ATOS) · (Z)-endoxifen + abemaciclib

Topline/data · Stated timing: 4Q26

Enrollment completed, top line data anticipated in 4Q26

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Axsome Therapeutics, Inc. (AXSM) · solriamfetol

Topline/data · Stated timing: 4Q 2026

Clinical Trial Topline Results: o Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (4Q 2026)

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

BridgeBio Oncology Therapeutics, Inc. (BBOT) · BBO-11818 / BBO-10203

Topline/data · Stated timing: in the fourth quarter of 2026

BBO-11818 and BBO-10203 monotherapy data update in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Candel Therapeutics, Inc. (CADL) · linoserpaturev

Topline/data · Stated timing: fourth quarter of 2026

We expect to present data on potential long-term survivors in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Celcuity Inc. (CELC) · gedatolisib + darolutamide

Topline/data · Stated timing: fourth quarter of 2026

We expect to provide updated clinical data and additional visibility into its mCRPC development strategy during the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Climb Bio, Inc. (CLYM) · budoprutug

Topline/data · Stated timing: in the fourth quarter of 2026

Anticipate additional data from the 500 mg and 1000 mg cohorts in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Climb Bio, Inc. (CLYM) · budoprutug

Topline/data · Stated timing: in the fourth quarter of 2026

Enrollment is now ongoing in the second cohort (600 mg) and anticipate initial data, including preliminary B cell and anti-PLA2R data from low dose cohort (200mg at 12-24 weeks), at a medical meeting in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Climb Bio, Inc. (CLYM) · budoprutug

Topline/data · Stated timing: in the fourth quarter of 2026

Anticipate data, including safety and biomarker data from the Global study in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Climb Bio, Inc. (CLYM) · CLYM116

Topline/data · Stated timing: in the fourth quarter of 2026

Additional data from the ongoing Phase 1 study and initial reporting of Beijing Mabworks Biotech Co., Ltd. (Mabworks) Phase 1 healthy volunteer study in China to be presented at an upcoming medical meeting in the fourth quarter of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

ENANTA PHARMACEUTICALS INC (ENTA) · EDP-978

Topline/data · Stated timing: 4Q 2026

On Track to Report Topline Data from a Phase 1 Trial of EDP-978, an Oral, Once-Daily KIT Inhibitor in Development for the Treatment of Urticaria, in 4Q 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Edgewise Therapeutics, Inc. (EWTX) · sevasemten

Topline/data · Stated timing: fourth quarter of 2026

top-line data expected in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Harmony Biosciences Holdings, Inc. (HRMY) · BP-205

Topline/data · Stated timing: in Q4 2026

The Company today reiterated its full-year 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion and is on track to report MAD study data for BP-205 in Q4 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

HARROW, INC. (HROW) · IHEEZO (QUELL)

Topline/data · Stated timing: in the fourth quarter of 2026

IHEEZO (QUELL): Topline data from QUELL, a prospective, randomized, multi-center clinical trial evaluating IHEEZO in patients undergoing intravitreal injections, are expected in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

HARROW, INC. (HROW) · NATACYN

Topline/data · Stated timing: in the fourth quarter of 2026

NATACYN®: The first patients were enrolled in an investigator-initiated clinical study during the second quarter, with topline data expected in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

INCYTE CORP (INCY) · povorcitinib

Topline/data · Stated timing: fourth quarter of 2026

Data 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

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

INCYTE CORP (INCY) · ruxolitinib cream

Topline/data · Stated timing: fourth quarter of 2026

Topline 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

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

IOVANCE BIOTHERAPEUTICS, INC. (IOVA) · lifileucel (AMTAGVI)

Topline/data · Stated timing: 4Q26

Enrollment is nearly complete in the pivotal cohorts and program updates are expected in 4Q26.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Jasper Therapeutics, Inc. (JSPR) · KP-104 (vensobafusp alfa)

Topline/data · Stated timing: fourth quarter of 2026

KP-104 is currently being evaluated in a Phase 2 basket trial in rare renal indications and interim data from Stage 1 of the trial is expected in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Kymera Therapeutics, Inc. (KYMR) · KT-579

Topline/data · Stated timing: fourth quarter of 2026

Phase 1 clinical trial in healthy volunteers , with data expected in the fourth quarter of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Mirum Pharmaceuticals, Inc. (MIRM) · brelovitug

Topline/data · Stated timing: fourth quarter of 2026

Topline results from the Phase 3 AZURE-4 study, the second of the two pivotal studies supporting the U.S. registration package, are expected in the fourth quarter of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Mirum Pharmaceuticals, Inc. (MIRM) · maralixibat

Topline/data · Stated timing: Q4 2026

EXPAND Phase 3 study in cholestatic pruritus due to additional rare cholestatic conditions topline results expected in Q4 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

OCULAR THERAPEUTIX, INC (OCUL) · AXPAXLI (OTX-TKI)

Topline/data · Stated timing: fourth quarter of 2026

we plan to conduct an interim safety analysis of the SOL-R trial in the fourth quarter of 2026 to provide Week 52 safety data on subjects dosed with AXPAXLI in the trial in support of our NDA for AXPAXLI for the treatment of wet AMD.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Phathom Pharmaceuticals, Inc. (PHAT) · vonoprazan (VOQUEZNA)

Topline/data · Stated timing: fourth quarter of 2026

Topline results from the 12-week blinded treatment portion of the trial are expected during the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

PMV Pharmaceuticals, Inc. (PMVP) · rezatapopt (PC14586)

Conference/data · Stated timing: fourth quarter of 2026

The Company plans to provide an update on all PYNNACLE Phase 2 pivotal trial cohorts at a medical conference in the fourth quarter of 2026, including the primary analysis data from the ovarian cancer cohort.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Rapport Therapeutics, Inc. (RAPP) · RAP-219

Topline/data · Stated timing: the fourth quarter of 2026

Data from the open-label trial is expected in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Ultragenyx Pharmaceutical Inc. (RARE) · UX701

Topline/data · Stated timing: fourth quarter of 2026

Data from this stage are expected in the fourth quarter of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Revolution Medicines, Inc. (RVMD) · RAS(ON) inhibitor combinations

Topline/data · Stated timing: fourth quarter of 2026

We currently expect to provide updated combination data in CRC in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

SELLAS Life Sciences Group, Inc. (SLS) · SLS009

Topline/data · Stated timing: fourth quarter of 2026

with topline data expected in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Syndax Pharmaceuticals Inc (SNDX) · axatilimab

Topline/data · Stated timing: fourth quarter of 2026

topline data from MAXPIRe, a Phase 2, 26-week randomized, double-blinded, placebo-controlled trial of axatilimab on top of standard of care in patients with IPF in the fourth quarter of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Syndax Pharmaceuticals Inc (SNDX) · revumenib

Topline/data · Stated timing: fourth quarter of 2026

safety and efficacy data from R/R NUP98r acute leukemia patients treated with revumenib in the fourth quarter of 2026

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Spyre Therapeutics, Inc. (SYRE) · SPY072

Topline/data · Stated timing: fourth quarter of 2026

axSpA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 at Week 16 with open-label follow-up through Week 40. Topline proof-of-concept data are expected in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Spyre Therapeutics, Inc. (SYRE) · SPY072

Topline/data · Stated timing: fourth quarter of 2026

PsA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 at Week 16 with open-label follow-up through Week 40. Topline proof-of-concept data are expected in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

TG THERAPEUTICS, INC. (TGTX) · ublituximab subcutaneous

Topline/data · Stated timing: year-end 2026 or early 2027

Top-line Phase 3 data is expected year-end 2026 or early 2027

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Tenaya Therapeutics, Inc. (TNYA) · TN-201

Topline/data · Stated timing: fourth quarter of 2026

Tenaya plans to report additional interim data from the MyPEAK-1 clinical trial in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Tenaya Therapeutics, Inc. (TNYA) · TN-401

Topline/data · Stated timing: fourth quarter of 2026

Tenaya expects to report additional interim data from the RIDGE-1 clinical trial in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Vir Biotechnology, Inc. (VIR) · elebsiran + tobevibart

Topline/data · Stated timing: fourth quarter of 2026

Topline data from the Phase 3 ECLIPSE 1 trial are expected in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Voyager Therapeutics, Inc. (VYGR) · VY7523

Topline/data · Stated timing: Q4 2026

Voyager expects tau positron emission tomography (PET) imaging efficacy data in Q4 2026 from the ongoing multiple ascending dose (MAD) clinical trial in participants with Alzheimer’s disease (AD).

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Zenas BioPharma, Inc. (ZBIO) · obexelimab

Topline/data · Stated timing: fourth quarter of 2026

Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) topline results expected in 4Q 2026: Zenas anticipates reporting topline overall and biomarker population results in the fourth quarter of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

CytomX Therapeutics, Inc. (CTMX) · varsetatug masetecan / CX-2051

Topline/data · Stated timing: by the end of 2026

Additional Phase 1 Varseta-M data, including data from ongoing dose optimization, is anticipated to be presented by the end of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Rani Therapeutics Holdings, Inc. (RANI) · RT-114 / PG-102 via RaniPill HC

Topline/data · Stated timing: by the end of 2026

We have continued to advance the program in the clinic, with additional data from the dose expansion cohort expected by the end of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

RIGEL PHARMACEUTICALS INC (RIGL) · R289

Topline/data · Stated timing: by the end of 2026

We anticipate sharing preliminary data from the dose expansion phase of the study by the end of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Rezolute, Inc. (RZLT) · ersodetug

Topline/data · Stated timing: before the end of 2026

We anticipate completing enrollment and announcing topline results from the study before the end of 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Entrada Therapeutics, Inc. (TRDA) · ENTR-601-44

Topline/data · Stated timing: by year-end 2026

The Company is on track to report data from the Cohort 1 (6 mg/kg) open-label period of the study by year-end 2026.

SEC filing · Filed · Quote matched to filing; not yet reviewed by founder

Earlier wording remains on the linked company pages. This page repeats source statements and does not forecast an outcome.