Catalyst calendar
Biotech catalysts in the next 90 days
247 catalysts are expected across the biotech companies we cover in the next 90 days, including 10 FDA decisions, 8 of them on a set date. The next is the FDA decision on Bepirovirsen (Ionis Pharmaceuticals) on Oct 26.
Firm dates · a specific day set by the company or regulator
Next 30 days
- Oct 23in 10 daysVMT-NET · Phase 1/2a interim results · SSTR2-positive neuroendocrine tumors
- Oct 23in 10 daysAzer-cel · Phase 1 enrollment complete · Progressive multiple sclerosis
- Oct 24in 11 daysEVX-01 · Phase 2 long-term results · Advanced melanoma
- Oct 26in 13 daysBepirovirsen · FDA decision · Chronic hepatitis B
- Oct 31in 18 daysBHV-1530 · Phase 1 interim results · Advanced solid tumors · FGFR3-altered or overexpressing
- Nov 1in 19 daysMitapivat · FDA decision (supplemental application) · Sickle cell disease
- Nov 1in 19 daysNeflamapimod · Phase 2a interim results · Nonfluent variant primary progressive aphasia
- Nov 8in 26 daysVelinotamig · Phase 1 results · Autoimmune diseases
Next 60 days
- Nov 14in 32 daysAficamten · FDA decision (supplemental application) · Obstructive HCM
- Nov 14in 32 daysIvonescimab · FDA decision · Non-small cell lung cancer · EGFRm+ · second-line or later
- Nov 18in 36 daysAI-Immunology · Results · Autoimmune diseases
- Nov 22in 40 daysDeramiocel · FDA decision · Duchenne muscular dystrophy cardiomyopathy
- Nov 27in 45 daysBBP-418 · NDA accepted for review · LGMD2I/R9
- Nov 28in 46 daysD-PLEX 100 · FDA decision · Surgical site infection prevention · colorectal surgery
Next 90 days
- Dec 27in 75 daysRelutrigine · FDA decision · SCN2A and SCN8A developmental and epileptic encephalopathy
- Jan 6in 85 daysANKTIVA · FDA decision (supplemental application) · NMIBC · BCG-unresponsive, papillary disease without CIS
Estimated timing · a month, quarter, half-year or year-end the company gave
Expected in October 2026
- October 2026Lifileucel · Phase 2 updated results (IOV-COM-202) · Advanced melanoma · frontline
- October 2026Phentolamine Ophthalmic Solution · Phase 3 topline results (LYNX-3) · Visual disturbances · post-keratorefractive surgery · mesopic, low-contrast conditions
- October 2026
- October 2026ORIC-114 · Results · NSCLC · EGFR exon 20 / EGFR atypical
- October 2026SL-325 · IND submission · Hidradenitis suppurativa · moderate to severe
- October 2026Foralumab · Phase 2a results (INFORM-MS) · Multiple sclerosis · non-active secondary progressive
- October 2026ENTR-601-45 · Phase 1/2 results (ELEVATE-45-201) · Duchenne muscular dystrophy · exon 45 skipping amenable
- October 2026VS-7375 · Results · Advanced KRAS G12D-mutant solid tumors
Expected in November 2026
- early November 2026EQ504 · Phase 1 start · Ulcerative colitis
- November 2026CMS final Medicare payment determination for EsoGuard
- November 2026PGN-EDODM1 · Phase 2 results (FREEDOM2) · Myotonic dystrophy type 1
Expected by end of November 2026
- late 2026Sabirnetug · Phase 2 topline results (ALTITUDE-AD) · Alzheimer's disease · early
- late 2026ACI-19764 · Phase 1b interim results · Neuroinflammation
- late 2026VMT01 · Phase 1/2a interim results · Unresectable or metastatic melanoma · MC1R-positive
- late 2026PSV359 · Phase 1/2a interim results · Advanced solid tumors · FAP-positive
- late 2026Omecamtiv mecarbil · Phase 3 enrollment complete (COMET-HF) · HFrEF
- late 2026Tegoprubart · Phase 3 start · Kidney transplant rejection prevention
- late 2026Riboswitch · Trial start · CNS disorders
Expected in December 2026
- December 2026CLN-978 · Results · Rheumatoid arthritis
- December 2026CLN-049 · Phase 1 results · Relapsed/refractory AML · MDS
- December 2026EP-104GI · Phase 2b topline results (RESOLVE) · Eosinophilic esophagitis
- December 2026KSI-101 · Phase 3 topline results (PEAK) · Macular Edema Secondary to Inflammation (MESI)
Expected in Q4 2026
- Q4 2026ABCL575 · Phase 1 results · Atopic dermatitis · moderate to severe
- Q4 2026Cytisinicline · NDA resubmission · Nicotine dependence · smoking cessation
- Q4 2026Bosakitug · Phase 2 topline results · Atopic dermatitis · moderate to severe
- Q4 2026ATI-052 · Phase 2b start · Asthma
- Q4 2026Modzatinib · Phase 2b start · Lichen planus
- Q4 2026ATI-9494 · IND submission
- Q4 2026ACR-368 · Phase 2b enrollment complete (ACR-368-201) · Endometrial cancer · serous all-comer
- Q4 2026ADG138 · Phase 1 start · Advanced solid tumors
- Q4 2026ZYNLONTA · Phase 1b final results (LOTIS-7) · Diffuse large B-cell lymphoma · relapsed/refractory
- Q4 2026vCLAS PMA approval decision
- Q4 2026Vafseo · Phase 4 results (VOCAL) · Anemia in CKD · dialysis
- Q4 2026Envudeucitinib · NDA submission · Moderate-to-severe plaque psoriasis
- Q4 2026ANX007 · Phase 2 topline results (ARCHER) · Dry AMD with geographic atrophy
- Q4 2026Tanruprubart · BLA submission · Guillain-Barr Syndrome
- Q4 2026ABI-6250 · Phase 2 start · Chronic hepatitis delta virus
- Q4 2026ABI-5366 · Phase 2 start · Recurrent genital herpes
- Q4 2026TransCon CNP · EU regulatory decision · Achondroplasia · pediatric 2+ years
- Q4 2026Obe-cel · Phase 1 long-term results (CARLYSLE) · Systemic lupus erythematosus
- Q4 2026Infigratinib · MAA submission · Achondroplasia
- Q4 2026BBO-11818, BBO-10203 · Results · KRAS-mutant cancers
- Q4 2026Silevertinib · Phase 2 start · Glioblastoma · EGFRvIII+ · newly diagnosed
- 4Q 2026Rese-cel · Phase 2 start (RESET-SSc) · Systemic sclerosis · interstitial lung disease
- Q4 2026CAN-2409 · BLA submission · Localized prostate cancer · intermediate-to-high-risk
- Q4 2026CAN-3110 · Phase 1b long-term results · Recurrent glioblastoma
- Q4 2026Redtail · IND submission · NSCLC · ovarian cancer
- Q4 2026Budoprutug · Phase 1b/2a results · Immune thrombocytopenia
- Q4 2026COMP360 · NDA submission · Treatment-resistant depression
- Q4 2026CTX-10726 · Phase 1 results · Solid tumors
- Q4 2026CTX-8371 · Phase 1 results · Solid tumors (NSCLC · TNBC · HL)
- Q4 2026CTIM-76 · Phase 1b results · Platinum-resistant ovarian cancer
- Q4 2026DT-216P2 · Pivotal trial start · Friedreich Ataxia
- Q4 2026ELI-002 7P · Phase 1 start · Metastatic PDAC · mKRAS · first-line
- 4Q 2026Detalimogene · BLA submission · NMIBC with CIS · BCG-unresponsive
- 4Q 2026Detalimogene · Pivotal results (LEGEND) · NMIBC with CIS · BCG-unresponsive
- Q4 2026EDG-7500 · Phase 3 start · Hypertrophic cardiomyopathy
- Q4 2026Rexaceract · Regulatory submission · Parkinson's disease
- Q4 2026MRT-2359 · Phase 1/2 interim results · Advanced CRPC · AR mutations
- Q4 2026ACCG-3535 · Phase 1 start · Obesity or overweight
- Q4 2026Aleniglipron + ACCG-2671 · Phase 1 start (GLP-1) · Obesity or overweight
- Q4 2026Aleniglipron · Phase 2 final results · Obesity or overweight
- early Q4 2026Revita · PMA submission · Obesity · post-GLP-1 discontinuation
- early Q4 2026Revita · Phase 2 topline results (REMAIN-1) · Obesity · post-GLP-1 discontinuation
- Q4 2026HLP003 · Phase 3 topline results (APPROACH) · Major Depressive Disorder
- Q4 2026IHEEZO · Topline results (QUELL) · Intravitreal injection procedure
- Q4 2026NATACYN · Topline results
- Q4 2026OPGx-RDH12 · Trial start · RDH12-related Leber congenital amaurosis (LCA) · inherited retinal degeneration
- Q4 2026Lanifibranor · Phase 3 topline results (NATiV3) · Metabolic dysfunction-associated steatohepatitis (MASH)
- end of Q3 2026VYD2311 · Phase 3 topline results (DECLARATION) · COVID-19
- end of Q3 2026VYD2311 · Phase 3 topline results (DECLARATION) · COVID-19 prevention · adults and adolescents with and without risk factors
- Q4 2026JADE301 · Phase 1 start · Undisclosed autoimmune disease
- Q4 2026KP-104 · Phase 2 interim results · Rare renal disorders
- Q4 2026Zenkuda · BLA submission · Wet Age-Related Macular Degeneration · Diabetic Retinopathy · Retinal Vein Occlusion
- Q4 2026Selinexor · sBLA accepted for review · Myelofibrosis
- Q4 2026Miv-cel · Phase 1 results · Progressive multiple sclerosis
- Q4 2026Miv-cel · BLA submission · Stiff person syndrome
- Q4 2026YUTREPIA · Phase 2a start (RE-WARM) · Raynaud's phenomenon associated with systemic sclerosis (SSc-RP)
- Q4 2026LX2020 · Phase 1/2 interim results (HEROIC-PKP2) · PKP2-associated arrhythmogenic cardiomyopathy
- Q4 2026EscharEx · Trial start · Pressure ulcers
- Q4 2026MGX-001 · IND submission · Hemophilia A
- Q4 2026 interim analysis with results expected Q1 2027Obicetrapib · Phase 3 results (PREVAIL) · Atherosclerotic cardiovascular disease · on maximally tolerated lipid-lowering therapy
- Q4 2026NMRA-215 · Phase 1 start · Obesity
- Q4 2026NMRA-511 · Results · Alzheimer's disease · agitation
- Q4 2026NMRA-511 · Phase 2 start · Alzheimer's disease · agitation
- Q4 2026FDA decision on Optune Lua PMA for NSCLC brain metastases
- Q4 2026Optune Gio · Phase 3 enrollment complete (KEYNOTE) · Newly diagnosed glioblastoma
- 4Q 2026NXP100 · IND submission · Paroxysmal nocturnal hemoglobinuria
- 4Q 2026NXP200 · IND submission · BRAF-mutated solid tumors
- Q4 2026OCU400 · Phase 3 topline results (liMeliGhT) · Retinitis pigmentosa
- Q4 2026AXPAXLI · NDA submission · Wet AMD
- Q4 2026OST-HER2 · MAA submission · Pediatric osteosarcoma · post-resection
- Q4 2026OV329 · Trial start · Tuberous sclerosis complex-associated seizures
- Q4 2026Vormatrigine · Trial start (POWER3) · Epilepsy · standalone agent
- Q4 2026Relutrigine · Enrollment complete (EMERALD) · Developmental and epileptic encephalopathy
- Q4 2026Relutrigine · Pivotal topline results (EMERALD) · Developmental and epileptic encephalopathy · broad DEE
- Q4 2026In-house obesity compound · IND accepted for review · Obesity
- Q4 2026QTORIN rapamycin · Phase 3 start · Cutaneous venous malformations
- Q4 2026MICVO · Phase 1/2 interim results · R/M HNSCC · 1L treatment
- Q4 2026RAD101 · Phase 3 start · Brain metastases · suspected recurrent
- Q4 2026UX701 · Results · Wilson disease
- Q4 2026SAB-142 · Phase 2b enrollment complete (SAFEGUARD) · Autoimmune type 1 diabetes · newly diagnosed
- Q4 2026SLS009 · Phase 2 topline results · Acute myeloid leukemia · newly diagnosed first-line
- Q4 2026TA-ERT · BLA submission · Mucopolysaccharidosis Type IIIB (MPS IIIB)
- Q4 2026TA-ERT · Trial start (TrAnsform) · Mucopolysaccharidosis Type IIIB (MPS IIIB) · severe
- Q4 2026IV Choline Chloride · Phase 2b/3 interim results (THRIVE-3) · Parenteral support dependence
- Q4 2026TARA-002 · Phase 2 enrollment complete (ADVANCED-2) · Non-muscle invasive bladder cancer · BCG-unresponsive
- Q4 2026TSC-101 · Phase 1 interim results (ALLOHA) · Hematologic malignancies · post-HCT
- Q3 2026 + 30 daysTXM · Phase 2a start · Seasonal influenza · prophylaxis
- Q4 2026TSHA-102 · Regulatory submission · Rett syndrome
- Q4 2026
- Q4 2026TSHR · IND submission · Thyroid eye disease
- Q4 2026Tibulizumab · Phase 2 results (TibuSHIELD) · Hidradenitis suppurativa · moderate to severe
- Q4 2026Tibulizumab · Phase 2 start (NEXUS-PMR) · Polymyalgia rheumatica
Expected in H2 2026
- H2 2026ACI-24 · Phase 2 results (ABATE) · Alzheimer's disease
- H2 2026ATI-052 · Phase 1b topline results · Atopic dermatitis
- H2 2026ACR-368 · Phase 2b interim results (ACR-368-201) · Endometrial cancer · serous all-comer
- H2 2026ADG126 · Phase 1 start · Colorectal cancer · MSS · 3L+
- H2 2026AG-181 · Phase 1b results · Phenylketonuria
- H2 2026AG-236 · Phase 2 start · Polycythemia vera
- H2 2026ALX2004 · Phase 1 results · EGFR-expressing solid tumors
- H2 2026AMX0035 · Phase 3 start · Wolfram syndrome
- H2 2026RDX10531 · IND submission · Multiple therapeutic areas
- H2 2026AlloNK · Phase 3 start · Refractory rheumatoid arthritis
- H2 2026TransCon CNP · Phase 3 start · Hypochondroplasia
- H2 2026Tabelecleucel · BLA resubmission · EBV+ PTLD · post-SOT/HCT
- H2 2026Infigratinib · Phase 2 results · Hypochondroplasia
- H2 2026BBO-10203 · Results · HER2+ breast cancer, HR+/HER2- breast cancer · PIK3CA mutant, KRAS mutant colorectal cancer
- H2 2026BHV-7000 · Phase 3 topline results · Major depressive disorder
- H2 2026BHV-7000 · Phase 3 topline results (RISE3) · Focal epilepsy
- H2 2026Taldefgrobep alfa · Phase 2 topline results · Obesity
- H2 2026BHV-1400 · Phase 3 start · IgA nephropathy
- H2 2026BGE-102 · Phase 2 results · Obesity
- H2 2026Casdozokitug · Phase 2 results · NSCLC, HCC
- H2 2026Tagmokitug · Phase 1b interim results · Esophageal squamous cell carcinoma · 1L and 2L
- H2 2026ClearPoint PRISM · EU regulatory decision · Neuro LITT
- H2 2026LD IL-2 · Phase 2 results · Alzheimer's disease
- H2 2026COYA 303 · Results · Inflammatory diseases · preclinical
- H2 2026COYA 302 · Phase 2 start · Frontotemporal Dementia
- H2 2026Neflamapimod · Phase 3 start · DLB
- H2 2026Soquelitinib · Phase 2 start · Asthma
- H2 2026CK-586 · Enrollment complete (AMBER-HFpEF) · HFpEF · LVEF ≥60%
- H2 2026Azer-Cel · Phase 1 interim results · Progressive Multiple Sclerosis
- H2 2026ELI-002 · Phase 3 start · PDAC · post-resection · R0
- H2 2026EDG-15400 · Phase 2 start (EQUINOX-HFpEF) · Heart failure · HFpEF
- H2 2026PIKTOR · Phase 2 topline results (FTH-PIK-201) · Advanced endometrial cancer · second-line
- H2 2026NEK7 (second-gen) · IND submission · CNS inflammatory diseases · IL-1/NLRP3 inflammasome-driven
- H2 2026RJVA-001 · Interim results · Type 2 diabetes · inadequately controlled
- H2 2026RJVA-001 · Phase 1/2 start · Type 2 diabetes · inadequately controlled
- H2 2026RJVA-001 · Phase 1/2 start · Type 2 diabetes · inadequately controlled
- H2 2026IDE892 · Phase 1 start (IDE397) · MTAP-deleted cancer
- H2 2026IDE849 · Phase 1 start · Extensive-stage small cell lung cancer
- H2 2026Darovasertib · NDA submission · Metastatic uveal melanoma · first-line · HLA-A*A2:01-negative
- H2 2026IMC-U120AI · CTA submission · Atopic dermatitis
- H2 2026IMC-P115C · Phase 1 interim results · Multiple solid tumors
- H2 2026Atebimetinib · Phase 2a start · Non-small cell lung cancer · advanced
- H2 2026IMA402 · Phase 1 results · Melanoma · gynecologic cancers
- H2 2026Amtagvi · UK regulatory decision · Advanced melanoma · anti-PD-1 failed
- H2 2026Briquilimab · Phase 2b start · CSU
- H2 2026Selinexor · Phase 3 topline results (XPORT-MM-031) · Multiple myeloma · anti-CD38 pre-treated
- H2 2026Nomlabofusp · BLA submission · Friedreich's ataxia
- H2 2026WP1066 · Phase 2 start · Brain tumor · pediatric
- H2 2026Etripamil · Phase 3 start (ReVeRA-301) · Atrial fibrillation with rapid ventricular rate
- H2 2026NKTR-0165 · Preclinical results · Multiple sclerosis
- H2 2026NMRA-861 · Phase 1 results · Schizophrenia
- H2 2026NMRA-898 · Results · Schizophrenia
- H2 2026NTLA-2001 · Phase 3 enrollment complete (MAGNITUDE-2) · ATTR polyneuropathy
- H2 2026NTLA-2001 · Phase 3 enrollment complete (MAGNITUDE-2) · ATTR with polyneuropathy
- H2 2026LNCB74 · Phase 1 results · Multiple cancers
- H2 2026OV4071 · Trial start · Psychosis · proof-of-mechanism
- H2 2026PM577 · Phase 1 interim results · Wilson's Disease
- H2 2026QTORIN pitavastatin · Phase 2 start · Disseminated superficial actinic porokeratosis
- H2 2026QTORIN rapamycin · NDA submission · Microcystic lymphatic malformations
- H2 2026Topical rapamycin · Trial start · Microcystic Lymphatic Malformations · Venous Malformations
- H2 2026QRX003 · Phase 3 start · Netherton Syndrome
- H2 2026RAD402 · Phase 1 results · Advanced prostate cancer
- H2 2026UX016 · Phase 1/2 start · GNE myopathy
- H2 2026RP-A701 · Phase 1 start · BAG3-associated dilated cardiomyopathy
- 2H 2026Descartes-08 · Phase 1 start · Generalized myasthenia gravis · in vivo delivery
- H2 2026Brepocitinib · Phase 3 topline results · Non-infectious uveitis
- H2 2026IMVT-1402 · Phase 2 topline results · Cutaneous lupus erythematosus
- H2 2026REV102 · Phase 1 start · Hypophosphatasia
- H2 2026REC-7735 · Phase 1 start · PI3K H1047R mutant breast cancer · solid tumors
- H2 2026REC-7735 · REC-102 · Phase 1 start · PI3K H1047R mutant breast cancer · solid tumors · Hypophosphatasia
- H2 2026REC-1245 · Phase 1 results (DAHLIA) · Solid tumors · R/R lymphomas
- H2 2026REC-7735 · Phase 1/2 start (ZINNIA) · PI3K H1047R mutant solid tumors
- H2 2026Denifanstat + Resmetirom · Phase 2 start · MASH cirrhosis · F4
- H2 2026Denifanstat · Phase 3 start (AURORA) · Acne vulgaris · moderate-to-severe
- H2 2026Ivonescimab · Phase 3 results (HARMONi-3) · Non-small cell lung cancer · first-line · squamous
- H2 2026TARA-002 · Pivotal trial start (ADVANCED-3) · NMIBC · BCG-Naïve
- H2 2026Autoimmunity program · Preclinical results · T-cell-driven autoimmune disorders
- H2 2026BRIUMVI · BLA submission · Relapsing forms of multiple sclerosis · initiation dosing optimization
- H2 2026TNG456 · Phase 1/2 interim results · Glioblastoma
- H2 2026ENTR-601-50 · Regulatory submission · Duchenne muscular dystrophy · exon 50 skipping amenable
- H2 2026ENTR-601-50 · Trial start (ELEVATE-50-201) · Duchenne muscular dystrophy · exon 50 skipping amenable
- H2 2026VRDN-008 · Phase 1 results · Autoimmune disease
- H2 2026XP-8121 · Phase 3 start (Cornerstone) · Hypothyroidism
Expected by end of 2026
- end of 2026Obefazimod · NDA submission · Ulcerative colitis · moderate to severe
- by end of 2026Avexitide · NDA submission · Post-bariatric hypoglycemia
- Fall 2026ANX1502 · Enrollment complete · Cold agglutinin disease
- before end of 2026Plozasiran · sNDA submission · Severe hypertriglyceridemia
- year-end 2026ATH434 · Phase 3 start · Multiple System Atrophy
- year-end 2026AUTO8 · Phase 1 interim results (ALARIC) · Light-chain amyloidosis
- year-end 2026VMT-NET · Phase 3 start · SSTR2-positive neuroendocrine tumors
- Year-end 2026Zipalertinib · NDA submission · EGFR ex20ins NSCLC · first-line
- Fall 2026Tagmokitug · Phase 1b start · Metastatic castration-resistant prostate cancer
- end of 2026Varseta-M · Phase 1 results · Advanced colorectal cancer
- year-end 2026Alpha DaRT · Pivotal topline results (ReSTART) · Cutaneous squamous cell carcinoma · recurrent
- by end of 2026PBGENE-DMD · Pivotal trial start · Duchenne Muscular Dystrophy
- before end of 2026EVX-04 · Regulatory submission · Acute myeloid leukemia
- end of 2026IDE849 · Pivotal trial start · DLL3-positive solid tumors
- end 2026 or early 2027IDE034 · Phase 1 results · Solid tumors
- end of 2026CDKN2A inhibitor · IND submission · MTAP-deletion solid tumors
- post-October 2026VYD2311 · BLA submission · COVID-19 prevention · adults and adolescents with and without risk factors
- end of 2026KPL-1161 · Phase 1 start · IL-1-mediated disease
- year-end 2026LIBERTY · EU regulatory decision · Peripheral endovascular procedures
- December 2026 to February 2027Annamycin · Phase 3 results (MIRACLE) · AML · relapsed/refractory
- end of 2026NGN-401 · Trial start · Rett syndrome
- end of 2026NXP900 · Phase 1b interim results · Non-small cell lung cancer · sotorasib-resistant
- year-end 2026OMS527 · Phase 1b results · Cocaine use disorder
- late 2026 or 2027OMS1029 · Phase 2 start · MASP-2-mediated disease (indication under selection)
- year-end 2026Narsoplimab · Trial start · Hyperinflammatory ARDS
- end of 2026PRGN-2009 · Phase 2 start · Newly diagnosed HPV-associated oropharyngeal cancer
- year-end 2026AX-0810 · Phase 1 long-term results · Cholestatic liver disease · NTCP modulation
- before the end of 2026QRX009 · IND submission · Additional indication (unspecified)
- year-end 2026RP2 · Phase 2 results · Hepatocellular carcinoma · anti-PD-1/PD-L1 failed
- end of 2026TVB-3567 · Phase 2 start · Acne vulgaris · moderate-to-severe
- year-end 2026STK-002 · Phase 1 enrollment complete (OSPREY) · Autosomal Dominant Optic Atrophy
- by year-end 2026TX2100 · Phase 2 start · Hereditary hemorrhagic telangiectasia
- year-end 2026 or early 2027Ublituximab (subcutaneous) · Phase 3 topline results · Relapsing forms of multiple sclerosis
- year-end 2026Azenosertib · Topline results (DENALI) · Ovarian cancer · platinum-resistant · Cyclin E1-positive