Phase 3 biotech companies
249 listed drug developers whose lead program is in Phase 3, largest first, with the next catalyst each has disclosed.
| Company | Ticker | Lead program | Indication | Next catalyst |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | retatrutide | obesity and type 2 diabetes | — |
| Novartis AG | NVS | Entresto (sacubitril/valsartan) | Heart failure (HFrEF, HFpEF, pediatric) | date not stated — Planned FDA meeting on next steps in FSHD |
| Astrazeneca PLC | AZN | Marketed portfolio (e.g., Farxiga, Tagrisso, Imfinzi, Enhertu) | oncology, CVRM, respiratory & immunology, rare disease | 2027 — Phase III data readout |
| Amgen Inc. | AMGN | MariTide | obesity/metabolic | H1 2027 — Regulatory submissions following positive Phase 3 CROSSING trial results |
| Gilead Sciences, Inc. | GILD | anito-cel (anitocabtagene autoleucel) | relapsed or refractory multiple myeloma (4L+) | — |
| Novo Nordisk A/S | NVO | Semaglutide franchise (Ozempic, Wegovy, Rybelsus) and GLP-1/insulin portfolio | Type 2 diabetes and obesity | Q4 2026 — US decision expected for Ozempic® pill 25 mg in Q4 2026. |
| Pfizer Inc. | PFE | — | — | — |
| Vertex Pharmaceuticals Incorporated | VRTX | Povetacicept | IgA nephropathy | November 30, 2026 — FDA PDUFA action date for accelerated approval in IgAN |
| Bristol Myers Squibb Co | BMY | admilparant | Idiopathic pulmonary fibrosis (IPF) | — |
| Sanofi | SNY | Dupixent (dupilumab; marketed portfolio) | Atopic dermatitis and other type 2 inflammatory diseases | November 25, 2026 — FDA target action date for venglustat NDA in Gaucher disease type 3 (priority review) |
| GSK plc | GSK | Hibsago (bepirovirsen) | chronic hepatitis B virus infection | date not stated — Start PAH and PH-HFpEF studies |
| Moderna, Inc. | MRNA | intismeran autogene (mRNA-4157) | melanoma (adjuvant) | December 2026 — Oral presentation at ASH Annual Meeting |
| Takeda Pharmaceutical Co Ltd | TAK | ENTYVIO (vedolizumab) | Ulcerative colitis and Crohn's disease (IBD) | Q1 2027 — FDA PDUFA target action date (NDA under Priority Review) |
| Argenx SE | ARGX | VYVGART | generalized myasthenia gravis, CIDP, ITP | December 2026 — Phase 3 MMN data for empasiprubart are expected in December 2026. |
| Teva Pharmaceutical Industries Limited | TEVA | BXCL-501 (dexmedetomidine sublingual film) | At-home use for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults | November 2026 — Commercial launch in U.S. |
| BeOne Medicines Ltd. | ONC | zanubrutinib (BRUKINSA) | Chronic lymphocytic leukemia, Waldenström macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, follicular lymphoma | — |
| Revolution Medicines, Inc. | RVMD | RASONQUE (daraxonrasib) | metastatic pancreatic adenocarcinoma (PDAC) | November 2026 — Complete enrollment |
| Biogen Inc. | BIIB | diranersen (BIIB080) | early Alzheimer's disease | — |
| Genmab A/S | GMAB | Epcoritamab (EPKINLY/TEPKINLY) | relapsed/refractory DLBCL and follicular lymphoma; frontline DLBCL combination in Phase 3 | — |
| Roivant Sciences Ltd. | ROIV | brepocitinib | dermatomyositis | H2 2026 — Phase 2 data |
| INSMED Inc | INSM | BRINSUPRI (brensocatib) | non-cystic fibrosis bronchiectasis (NCFB) | January 28, 2027 — US sNDA for MAC lung disease - priority review target action date |
| Incyte Corp | INCY | INCA033989 | Essential Thrombocythemia (mutCALR-positive) | Q4 2026 — Phase 3 EXCALIBUR-MF2 trial initiation |
| UNITED THERAPEUTICS Corp | UTHR | Ralinepag extended-release tablets | Pulmonary arterial hypertension (PAH) | April 26, 2027 — FDA action date (sNDA) |
| BioNTech SE | BNTX | pumitamig | Multiple solid tumors incl. ES-SCLC, NSCLC, TNBC (Phase 3 ROSETTA trials) | 2026 — Start of global pivotal trial in first-line HNSCC |
| Alnylam Pharmaceuticals, Inc. | ALNY | nucresiran | ATTR amyloidosis (polyneuropathy and cardiomyopathy) | November 2026 — FDA action date |
| Exelixis, Inc. | EXEL | zanzalintinib | metastatic colorectal cancer (CRC) | Q1 2027 — Top-line results in nccRCC |
| Ascendis Pharma A/S | ASND | TransCon CNP (navepegritide) | achondroplasia in children | Q4 2026 — Final European Commission decision on TransCon CNP MAA expected during Q4 2026. |
| Neurocrine Biosciences | NBIX | direclidine in schizophrenia | schizophrenia | — |
| BridgeBio Pharma, Inc. | BBIO | Attruby (acoramidis) | Transthyretin amyloidosis (ATTR-CM) | November 27, 2026 — PDUFA target action date |
| Summit Therapeutics Inc. | SMMT | ivonescimab (HARMONi-3) | first-line metastatic non-small cell lung cancer (squamous and non-squamous) | November 14, 2026 — FDA PDUFA goal action date for BLA |
| Halozyme Therapeutics, Inc. | HALO | ENHANZE drug delivery technology platform | Platform: enabling SC delivery across multiple partnered programs | date not stated — FDA decision on sBLA for head and neck squamous cell carcinoma |
| BioMarin Pharmaceutical Inc. | BMRN | VOXZOGO sNDA for hypochondroplasia (HCH) | Hypochondroplasia | February 2027 — PDUFA target action date for full approval in achondroplasia |
| Insulet Corporation | PODD | Omnipod 5 | Type 1 and Type 2 Diabetes | 2026 — Completion of STRIVE 2 study enrollment |
| Vaxcyte, Inc. | PCVX | VAX-31 | Prevention of invasive pneumococcal disease (IPD) and pneumonia in adults | H1 2027 — Safety, tolerability and immunogenicity data from OPUS-2 and OPUS-3 studies |
| Madrigal Pharmaceuticals, Inc. | MDGL | Rezdiffra (resmetirom) | MASH (metabolic dysfunction-associated steatohepatitis) | H1 2027 — Trial initiation |
| TG Therapeutics, Inc. | TGTX | BRIUMVI (ublituximab-xiiy) | relapsing forms of multiple sclerosis (adults) | Q4 2026 — Topline data from Phase 3 in RMS |
| ImmunityBio, Inc. | IBRX | ANKTIVA (nogapendekin alfa inbakicept-pmln) plus BCG | BCG-unresponsive non-muscle invasive bladder cancer (CIS with or without Ta/T1) | 2026 — Planned sBLA submission, BCG-naive NMIBC |
| Krystal Biotech, Inc. | KRYS | VYJUVEK (beremagene geperpavec-svdt) | Dystrophic epidermolysis bullosa (DEB) | February 2027 — Last patient visit for IOLITE Phase 3 study with top-line results |
| Arrowhead Pharmaceuticals, Inc. | ARWR | REDEMPLO (plozasiran) | familial chylomicronemia syndrome (FCS); sHTG in Phase 3 | 2027 — YOSEMITE Phase 3 completion |
| Corcept Therapeutics Inc | CORT | Lifyorli (relacorilant) + nab-paclitaxel | Platinum-resistant ovarian cancer | Q4 2026 — EC approval decision |
| Rhythm Pharmaceuticals, Inc. | RYTM | bivamelagon | acquired hypothalamic obesity | H2 2026 — Complete enrollment in Phase 1/2 Part D trial in PWS |
| Praxis Precision Medicines, Inc. | PRAX | relutrigine | SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) | December 27, 2026 — PDUFA action date (NDA, priority review, extended three months) |
| Alkermes plc. | ALKS | Alixorexton | Narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia | — |
| Abivax S.A. | ABVX | obefazimod | moderately to severely active ulcerative colitis | 2026 — selection of follow-on compound |
| Cytokinetics Inc | CYTK | aficamten (MYQORZO) | symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) | November 14, 2026 — PDUFA date for sNDA adding MAPLE-HCM results to label |
| Kiniksa Pharmaceuticals | KNSA | KPL-387 | recurrent pericarditis | 2026 — Kiniksa expects to initiate a Phase 1 first-in-human trial of KPL-1161 by the end of 2026. |
| Axsome Therapeutics, Inc. | AXSM | AXS-12 (reboxetine) | cataplexy in narcolepsy | May 2027 — PDUFA target action date |
| CG Oncology, Inc. | CGON | Cretostimogene grenadenorepvec (cretostimogene) | BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease | Q4 2026 — BLA submission completion |
| Lantheus Holdings, Inc. | LNTH | PYLARIFY TruVu (piflufolastat F-18) | Prostate cancer imaging (PSMA-positive lesions) | Q4 2026 — Commercial availability beginning |
| Ionis Pharmaceuticals Inc | IONS | TRYNGOLZA (olezarsen) | severe hypertriglyceridemia (sHTG) and familial chylomicronemia syndrome (FCS) | — |
| Immunovant, Inc. | IMVT | IMVT-1402 (imeroprubart) | Graves' disease; D2T rheumatoid arthritis; myasthenia gravis; CIDP; Sjogren's disease | H2 2026 — Further program updates |
| Kodiak Sciences Inc. | KOD | tarcocimab tedromer (Zenkuda, KSI-301) | wet AMD, diabetic retinopathy, retinal vein occlusion | Q4 2026 — Completion of enrollment, second pivotal cohort (PEAK/PINNACLE) |
| Belite Bio, Inc | BLTE | Tinlarebant (LBS-008), oral RBP4 antagonist | Stargardt disease type 1 (STGD1) | February 12, 2027 — FDA PDUFA target action date (NDA with Priority Review) |
| Mirum Pharmaceuticals, Inc. | MIRM | zilurgisertib (Atebrioz) | fibrodysplasia ossificans progressiva (FOP) | Q4 2026 — AZURE-4 Phase 3 topline results |
| Veradermics, Inc | MANE | VDPHL01 | Pattern hair loss (male and female) | H2 2026 — Veradermics anticipates announcing data from Part B of Study '302' later this year. |
| Grifols SA | GRFS | Fibrinogen concentrate (BT524) | Congenital fibrinogen deficiency (US BLA approved 2025); acquired fibrinogen deficiency (EU approved, US Phase III to start 2026) | Q4 2026 — Grifols expects topline results from its Phase 3 SPARTA study evaluating Alpha-1 antitrypsin in patients with emphysema by the end of the fourth quarter of 2026. |
| Scholar Rock Holding Corp | SRRK | apitegromab | Spinal muscular atrophy (SMA), non-ambulatory Type 2/3 | H2 2026 — Topline data from Phase 1 healthy-volunteer study |
| Cogent Biosciences, Inc. | COGT | bezuclastinib (CGT9486) | Non-Advanced Systemic Mastocytosis (NonAdvSM) | November 30, 2026 — PDUFA target action date |
| PTC Therapeutics, Inc. | PTCT | ST-920 (isaralgagene civaparvovec) | Fabry disease | Q4 2026 — BLA submission completion |
| Edgewise Therapeutics, Inc. | EWTX | EDG-7500 | obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) | Q4 2026 — Phase 3 trial initiation |
| Dianthus Therapeutics, Inc. | DNTH | claseprubart | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | December 2026 — Top-line results from Phase 2 MoMeNtum trial |
| Travere Therapeutics, Inc. | TVTX | Pegtibatinase | Classical homocystinuria (HCU) | H2 2027 — Topline data from Phase 3 HARMONY Study |
| Definium Therapeutics, Inc. | DFTX | DT120 ODT (lysergide D-tartrate; formerly MM120) | Generalized anxiety disorder (also MDD and PTSD) | 2026 — Initial Phase 2a data in adult ASD |
| Relay Therapeutics | RLAY | zovegalisib (RLY-2608) | PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer | date not stated — ReDiscover-2 Trial Phase 3 registrational study ongoing |
| Liquidia Corp | LQDA | L606 (liposomal treprostinil, inhaled via next-generation nebulizer) | pulmonary hypertension associated with interstitial lung disease (PH-ILD); also PAH (open-label) | — |
| Pulse Biosciences, Inc. | PLSE | nPulse Cardiac Catheter System | Paroxysmal atrial fibrillation | date not stated — Pivotal study data readout and PMA submission |
| Xenon Pharmaceuticals Inc. | XENE | azetukalner (XEN1101) | focal onset seizures (epilepsy) | H2 2026 — Complete Phase 1 SAD/MAD to support Phase 2 in acute pain |
| Amylyx Pharmaceuticals, Inc. | AMLX | avexitide | post-bariatric hypoglycemia (PBH) | Q4 2026 — NDA submission to FDA |
| ACADIA Pharmaceuticals Inc. | ACAD | NUPLAZID (pimavanserin) | Hallucinations and delusions associated with Parkinson's disease psychosis | Q4 2027 — Phase 2 data readout |
| Iovance Biotherapeutics, Inc. | IOVA | Lifileucel (Amtagvi) | Previously treated advanced melanoma | 2027 — Iovance plans an additional supplemental BLA submission in 2027 for lifileucel in biomarker-enriched NSCLC. |
| Enliven Therapeutics, Inc. | ELVN | relcobatinib (ELVN-001) | BCR-ABL-positive leukemia | date not stated — ENABLE-2 Phase 3 pivotal trial initiation |
| Disc Medicine, Inc. | IRON | bitopertin | erythropoietic porphyrias (EPP and XLP) | Q4 2026 — NDA resubmission |
| Viking Therapeutics, Inc. | VKTX | VK2735 (subcutaneous formulation) | obesity | date not stated — VANQUISH-1 and VANQUISH-2 data readouts |
| Dyne Therapeutics, Inc. | DYN | zeleciment rostudirsen (z-rostudirsen / DYNE-251) | Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping | January 2027 — PDUFA target action date |
| Celcuity Inc. | CELC | REVTORPYK (gedatolisib) | HR+/HER2- advanced breast cancer | 2026 — Further updates from PIK3CA WT and MT cohorts of VIKTORIA-1 at San Antonio Breast Cancer Symposium |
| Telix Pharmaceuticals Ltd | TLX | TLX591-Tx (177Lu-rosopatamab tetraxetan) | Metastatic castration-resistant prostate cancer (ProstACT Global) | 2026 — IND and CTA submissions (US/EU) |
| Viridian Therapeutics, Inc. | VRDN | elegrobart | Thyroid Eye Disease (TED) | Q4 2026 — Communication of development plans |
| Bausch Health Companies Inc. | BHC | Larsucosterol | severe alcohol-associated hepatitis | 2026 — registrational Phase 3 program ongoing for severe alcohol-associated hepatitis |
| IDEAYA Biosciences, Inc. | IDYA | Darovasertib | Metastatic uveal melanoma | Q4 2026 — Phase 3 registrational trial initiation in ES-SCLC and NEC |
| Zai Lab Limited | ZLAB | Zocilurtatug Pelitecan (Zoci, DLL3-Targeting ADC) | First-line extensive-stage small cell lung cancer (1L ES-SCLC) | November 30, 2026 — FDA PDUFA action date for accelerated approval BLA in IgAN |
| Vericel Corporation | VCEL | MASCOT (MACI for ankle) | Osteochondral lesions of the talus | 2027 — MHRA approval and UK commercialization |
| Palvella Therapeutics, Inc. | PVLA | QTORIN 3.9% rapamycin anhydrous gel | microcystic lymphatic malformations | Q4 2026 — Phase 3 pivotal study commencement |
| Xeris Biopharma Holdings, Inc. | XERS | XP-8121 | hypothyroidism | date not stated — Initiation of Phase 3 clinical trial |
| Beam Therapeutics Inc. | BEAM | risto-cel | sickle cell disease | 2026 — Updated data from BEACON trial |
| HUTCHMED (China) Ltd | HCM | Savolitinib (ORPATHYS) + osimertinib (TAGRISSO) | EGFR-mutated NSCLC with MET overexpression/amplification after EGFR-TKI progression | — |
| Arcus Biosciences, Inc. | RCUS | casdatifan | clear cell renal cell carcinoma (ccRCC) | date not stated — PEAK-1 Phase 3 registrational study ongoing |
| Pharvaris N.V. | PHVS | Deucrictibant IR capsule (on-demand) | On-demand treatment of hereditary angioedema (HAE) attacks | Q1 2027 — Topline data from Part 1 of CREAATE in AAE-C1INH |
| Celldex Therapeutics, Inc. | CLDX | Barzolvolimab (CDX-0159) | Chronic Spontaneous Urticaria (CSU) | H2 2026 — Topline data from Phase 2 atopic dermatitis study expected in late 2026. |
| NewAmsterdam Pharma Co N.V. | NAMS | obicetrapib | hypercholesterolemia / elevated LDL-C in patients with ASCVD and/or HeFH | Q4 2026 — Launch in Germany by Menarini |
| Immunome Inc. | IMNM | varegacestat (AL102) | progressing desmoid tumors | Q4 2026 — IND submission |
| Biohaven Ltd. | BHVN | BHV-1300 (MoDE pan-IgG degrader) | Graves' disease | Q4 2026 — SK Biopharmaceuticals license closing (final closing conditions) |
| Trevi Therapeutics, Inc. | TRVI | Haduvio (oral nalbuphine ER) | Chronic cough in idiopathic pulmonary fibrosis (IPF) | Q4 2026 — Phase 2b LAKE sample size re-estimation |
| BioCryst Pharmaceuticals, Inc. | BCRX | navenibart (STAR-0215) | Hereditary angioedema (HAE) prophylaxis | — |
| Harmony Biosciences Holdings, Inc. | HRMY | Pitolisant GR | Narcolepsy (EDS and cataplexy) | Q1 2027 — Phase 1b topline data |
| Sarepta Therapeutics, Inc. | SRPT | SRP-9003 (bidridistrogene xeboparvovec) | LGMD2E (beta-sarcoglycanopathy) | Q4 2026 — Multiple ascending dose data |
| Mesoblast Ltd | MESO | rexlemestrocel-L | chronic low back pain associated with degenerative disc disease | — |
| Zenas BioPharma | ZBIO | obexelimab | IgG4-related disease (IgG4-RD) | Q4 2026 — Topline results including biomarker data |
| Agios Pharmaceuticals, Inc. | AGIO | mitapivat (PYRUKYND®/AQVESME®) | hemolytic anemias (PKR deficiency, thalassemia, sickle cell disease) | H2 2026 — Initiation of phase 2 portion of phase 2/3 trial in polycythemia vera |
| Stoke Therapeutics, Inc. | STOK | zorevunersen (STK-001) | Dravet syndrome | 2026 — Completion of cohort 3 dosing |
| Sellas Life Sciences Group, Inc. | SLS | Galinpepimut-S (GPS) | Acute myeloid leukemia (AML) maintenance, second complete remission (CR2) | Q4 2026 — Topline data for SLS009 Phase 2 trial in newly diagnosed first-line AML expected in Q4 2026. |
| Kailera Therapeutics, Inc. | KLRA | ribupatide injection (KAI-9531) | obesity and overweight | H1 2027 — global Phase 3 program initiation |
| Generate Biomedicines, Inc. | GENB | GB-0895 | Severe asthma (long-acting anti-TSLP, Q26W dosing) | 2026 — Phase 1b data readout |
| Braveheart Bio, Inc. | BRVE | BHB-1893 | Obstructive hypertrophic cardiomyopathy (oHCM) and non-obstructive HCM (nHCM) | H1 2027 — Initiate global Phase 3 trial in nHCM |
| Nurix Therapeutics, Inc. | NRIX | bexobrutideg (NX-5948) | Relapsed/refractory CLL | — |
| Immunocore Holdings plc | IMCR | KIMMTRAK (tebentafusp) | unresectable or metastatic uveal melanoma | H2 2026 — CTA or IND submission |
| Intellia Therapeutics, Inc. | NTLA | lonvoguran ziclumeran (lonvo-z) | hereditary angioedema (HAE) | Q1 2027 — Planned commercial launch |
| Ultragenyx Pharmaceutical Inc. | RARE | DTX301 | Ornithine transcarbamylase (OTC) deficiency | Q4 2026 — FAYUVI PRV sale closure |
| Nanobiotix S.A. | NBTX | JNJ-1900 (NBTXR3) | Locally advanced platinum-ineligible head and neck squamous cell cancer (NANORAY-312); also Stage III unresectable NSCLC and recurrent NSCLC | — |
| NovoCure Ltd | NVCR | METIS (Optune Mya) | brain metastases from non-small cell lung cancer | date not stated — PMA application decision (FDA) |
| uniQure N.V. | QURE | ifezuntirgene inilparvovec (AMT-130) | Huntington's disease | December 2026 — Confirmatory study initiation |
| Nuvation Bio Inc. | NUVB | Safusidenib | IDH1-mutant astrocytoma and grade 2 IDH1-mutant glioma | date not stated — European Medicines Agency MAA decision |
| Kardigan, Inc. | KARD | Danicamtiv | Genetic dilated cardiomyopathy (MYH7 and TTN variants) | H2 2027 — Kardigan expects topline data from Phase 2b KATALYST-AV trial in second half of 2027. |
| Structure Therapeutics Inc. | GPCR | aleniglipron (GSBR-1290) | Chronic weight management (obesity/overweight with and without T2DM) | Q4 2026 — Body composition trial topline |
| Rapport Therapeutics, Inc. | RAPP | RAP-219 | drug-resistant focal onset seizures | Q4 2026 — initial data |
| Ocular Therapeutix, Inc. | OCUL | AXPAXLI (axitinib intravitreal implant) | neovascular (wet) age-related macular degeneration | Q4 2026 — Submit NDA for wet AMD |
| Ascentage Pharma Group International | AAPG | Olverembatinib (HQP1351) | Ph+ ALL (POLARIS-1), previously treated CML-CP (POLARIS-2), SDH-deficient GIST (POLARIS-3) | 2026 — Pursue inclusion in China NRDL |
| ADARx Pharmaceuticals, Inc. | ADRX | onvuzosiran | Prevention of hereditary angioedema (HAE) attacks | Q4 2027 — STOP-HAE Phase 3 topline data |
| Mineralys Therapeutics, Inc. | MLYS | lorundrostat | hypertension (uncontrolled/resistant) | December 2026 — FDA PDUFA action date for NDA |
| LB Pharmaceuticals | LBRX | LB-102 | Schizophrenia | Q1 2027 — Update on potential trial design |
| OPKO Health, Inc. | OPK | ModeX Phase 3 multispecific antibody program | Oncology and infectious diseases | — |
| Nektar Therapeutics | NKTR | rezpegaldesleukin (REZPEG) | moderate-to-severe atopic dermatitis | Q1 2027 — Initiate global registrational ZENITH-AA-1 trial in alopecia areata |
| Inhibrx Biosciences, Inc. | INBX | ozekibart (INBRX-109) | conventional chondrosarcoma (BLA); also colorectal cancer, Ewing sarcoma | Q4 2026 — FDA meeting on first-line registrational CRC trial and potential accelerated pathway in 4L CRC |
| SpyGlass Pharma, Inc. | SGP | Bimatoprost Drug Pad-IOL System (BIM-IOL System) | Open-angle glaucoma and ocular hypertension (IOP reduction at time of cataract surgery) | 2027 — Complete enrollment in two registrational Phase 3 trials |
| Vor Bio | VOR | telitacicept (UPSTREAM MG) | generalized myasthenia gravis (gMG) | H1 2027 — Topline data |
| Compass Pathways plc | CMPS | COMP360 psilocybin | Treatment-resistant depression (TRD) | 2027 — Potential commercial launch if approved |
| UroGen Pharma Ltd. | URGN | UGN-103 (mitomycin) for intravesical solution | recurrent low-grade intermediate risk non-muscle invasive bladder cancer (NMIBC) | Q4 2026 — Phase 3 trial initiation in high-risk NMIBC |
| Tandem Diabetes Care | TNDM | Mobi tubeless capability | Type 1 and Type 2 diabetes (insulin delivery) | date not stated — 510(k) FDA decision (application submitted Q2 2026) |
| Verastem Oncology | VSTM | VS-7375 | KRAS G12D-mutated solid tumors (pancreatic, lung, colorectal cancers) | Q4 2026 — VS-7375 combinations in mCRC expect to open by end of 2026. |
| Savara Inc | SVRA | MOLBREEVI (molgramostim inhalation solution) | autoimmune pulmonary alveolar proteinosis (autoimmune PAP) | November 22, 2026 — FDA PDUFA target action date for BLA (extended after a major amendment) |
| MoonLake Immunotherapeutics | MLTX | Sonelokimab (SLK) | Hidradenitis suppurativa (HS) | November 2026 — FDA acceptance decision on BLA submission |
| Immatics N.V. | IMTX | anzu-cel (anzutresgene autoleucel, IMA203) | second-or-later-line advanced cutaneous melanoma (PRAME-positive); also metastatic uveal melanoma (Phase 2) | 2027 — IMA402 and IMA401 combination cohort in squamous NSCLC is enrolling with first data expected in 2027. |
| Oric Pharmaceuticals, Inc. | ORIC | rinzimetostat (ORIC-944) | metastatic castration-resistant prostate cancer (post-abiraterone), in combination with darolutamide | H1 2027 — The Company plans to initiate Redwood-1, a global Phase 3 registrational trial in EGFR atypical NSCLC in 1H 2027. |
| Inventiva S.A. | IVA | lanifibranor | MASH (metabolic dysfunction-associated steatohepatitis) | — |
| Corvus Pharmaceuticals, Inc. | CRVS | soquelitinib (CPI-818) | relapsed/refractory peripheral T cell lymphoma (PTCL) | Q1 2027 — Initial results from cohort 1 |
| Pharming Group N.V. | PHAR | Joenja (leniolisib) | Activated PI3K delta syndrome (APDS) | November 2026 — Pharming expects to report Phase II topline results for leniolisib in CVID patients in November 2026. |
| MeiraGTx Holdings plc | MGTX | Botaretigene sparoparvovec (bota-vec) | X-linked retinitis pigmentosa (RPGR) | Q2 2027 — Pivotal Phase 2 AQUAx2 12-month data readout |
| Syndax Pharmaceuticals Inc | SNDX | Revuforj (revumenib) | R/R acute leukemia with KMT2A translocation; R/R AML with NPM1 mutation | — |
| Latigo Therapeutics, Inc. | LTGO | onzotrigine | moderate to severe acute pain (postoperative) | H2 2027 — Phase 3 bunionectomy trial topline results |
| Annexon, Inc. | ANNX | tanruprubart (ANX005) | Guillain-Barre Syndrome (GBS) | Q4 2026 — ARCHER II Phase 3 Month 15 primary endpoint readout |
| Lexicon Pharmaceuticals, Inc. | LXRX | sotagliflozin for hypertrophic cardiomyopathy | hypertrophic cardiomyopathy (HCM) | June 2027 — Minimum cash covenant begins |
| Alumis Inc. | ALMS | envudeucitinib (envu, formerly ESK-001) | moderate-to-severe plaque psoriasis | H1 2027 — Initiate Phase 2 biomarker trial in Parkinson's disease |
| Solid Biosciences Inc. | SLDB | SGT-003 | Duchenne muscular dystrophy | Q4 2026 — Type C meeting with FDA to discuss potential accelerated approval pathway and preliminary INSPIRE DUCHENNE data package |
| Cullinan Therapeutics, Inc. | CGEM | zipalertinib (CLN-081/TAS6417) | EGFR exon 20 insertion NSCLC, previously treated | Q4 2026 — Initiate Phase 1/2 combination with venetoclax and azacitidine |
| Ironwood Pharmaceuticals, Inc. | IRWD | Apraglutide | Short bowel syndrome with intestinal failure (SBS-IF), parenteral support dependency | 2029 — NDA filing for SBS-IF |
| Ardelyx, Inc. | ARDX | ACCEL | Chronic idiopathic constipation (CIC) | H2 2027 — Topline data |
| Nuvectis Pharma, Inc. | NVCT | NXP100 (ciprocopan) | complement-related conditions (PNH, IgAN, C3G, LN, MG, d-AMD) | date not stated — Marketing application decision for previously treated PNH in China |
| Achieve Life Sciences, Inc. | ACHV | cytisinicline | smoking cessation (nicotine dependence); also vaping cessation | H1 2027 — Potential FDA approval |
| Zevra Therapeutics, Inc. | ZVRA | MIPLYFFA (arimoclomol) | Niemann-Pick disease type C (NPC) | Q4 2026 — FDA Type C follow-up meeting to discuss regulatory options to potentially accelerate development program |
| Aura Biosciences, Inc. | AURA | bel-sar (belzupacap sarotalocan) | Early choroidal melanoma | — |
| 4D Molecular Therapeutics, Inc. | FDMT | 4D-150 | Wet age-related macular degeneration (wet AMD); DME in preparation | Q2 2027 — 4FRONT-1 Phase 3 topline data |
| ArriVent BioPharma, Inc. | AVBP | firmonertinib | first-line EGFR exon 20 insertion NSCLC (FURVENT) and PACC-mutant NSCLC (ALPACCA) | — |
| Candel Therapeutics, Inc. | CADL | aglatimagene besadenovec (CAN-2409) plus valacyclovir | Localized intermediate/high-risk prostate cancer (completed Phase 3, positive topline); metastatic non-squamous NSCLC (Phase 3 AURORA enrolling) | Q4 2026 — Presentation of data on potential long-term survivors |
| DBV Technologies S.A. | DBVT | Viaskin Peanut | peanut allergy (children aged 4-7 years) | November 2026 — FDA determination of BLA sufficiency for substantive review and Priority Review decision |
| Helus Pharma Inc. | HELP | HLP003 (deuterated psilocin, oral) | Adjunctive treatment of major depressive disorder (MDD) | Q4 2026 — Helus Pharma continues to anticipate reporting topline data from Phase 3 APPROACH pivotal study of HLP003 in major depressive disorder in Q4 2026. |
| Kura Oncology, Inc. | KURA | KOMZIFTI (ziftomenib) | relapsed/refractory NPM1-mutated AML | H2 2026 — KOMET-007 data |
| Sinovac Biotech Ltd | SVA | Bivalent enterovirus vaccine (HFMD2) | hand, foot and mouth disease (EV71/CA16) | date not stated — WHO prequalification application submission |
| Olema Pharmaceuticals, Inc. | OLMA | Palazestrant (OP-1250) | ER+/HER2- metastatic breast cancer | Q4 2026 — Initiate combination arm with darolutamide in mCRPC (Bayer collaboration) |
| Apnimed, Inc. | APMD | AD109 (Oxnimbi) | Obstructive sleep apnea (OSA) | February 28, 2027 — FDA PDUFA goal action date for NDA |
| Bicara Therapeutics Inc. | BCAX | ficerafusp alfa | 1L recurrent/metastatic HPV-negative head and neck squamous cell carcinoma (FORTIFI-HN01) | H2 2026 — Data presentation from cohorts |
| Gyre Therapeutics, Inc. | GYRE | F351 (hydronidone) | CHB-associated liver fibrosis | 2026 — IND application submission to NMPA for COPD |
| Capricor Therapeutics, Inc. | CAPR | deramiocel | Duchenne muscular dystrophy cardiomyopathy | November 22, 2026 — FDA PDUFA target action date for BLA (extended from Aug 22) |
| Valneva SE | VALN | LB6V (VLA15) | Prevention of Lyme disease | 2026 — VLA1553-303 five-year seroresponse data |
| REGENXBIO Inc. | RGNX | ABBV-RGX-314 (sura-vec, surabgene lomparvovec) | Wet age-related macular degeneration | Q4 2026 — Topline data from ATMOSPHERE and ASCENT pivotal trials |
| Monopar Therapeutics | MNPR | ALXN1840 (tiomolybdate choline) | Wilson disease | 2026 — Complete rolling NDA submission (FDA filing acceptance decision to follow) |
| Oculis Holding AG | OCS | OCS-01 (OPTIREACH dexamethasone eye drop) | Diabetic macular edema (DME) | Q4 2026 — PREDICT-1 registrational Phase 2/3 topline results |
| Aquestive Therapeutics, Inc. | AQST | Anaphylm (dibutepinephrine) sublingual film | Type 1 allergic reactions, including anaphylaxis | Q4 2026 — Regulatory application submission to Health Canada |
| Kamada Ltd | KMDA | KEDRAB (rabies immune globulin) | rabies post-exposure prophylaxis | H2 2026 — start of NSP sales |
| CorMedix Inc. | CRMD | DefenCath (taurolidine and heparin) | Reduction of catheter-related bloodstream infections in adult hemodialysis patients with a central venous catheter | H2 2027 — CorMedix targets beginning promotional efforts for REZZAYO prophylaxis indication in H2 2027 if approved. |
| Cerus Corporation | CERS | INTERCEPT Blood System for red blood cells | Pathogen reduction in red blood cells to prevent transfusion-transmitted infections | 2028 — Phase III clinical study completion under DoD contract |
| Altimmune, Inc. | ALT | pemvidutide | MASH | 2029 — 52-week PERFORMA Phase 3 readout |
| Rezolute, Inc. | RZLT | Ersodetug | Tumor hyperinsulinism (insulinoma and non-islet cell tumor hypoglycemia) | December 2026 — Topline data from registrational Phase 3 upLIFT study |
| Avalo Therapeutics, Inc. | AVTX | abdakibart | hidradenitis suppurativa | — |
| Lyell Immunopharma, Inc. | LYEL | rondecabtagene autoleucel (ronde-cel) | relapsed/refractory large B-cell lymphoma (LBCL) | H2 2026 — progress update |
| Allogene Therapeutics, Inc. | ALLO | cema-cel (cemacabtagene ansegedleucel, previously ALLO-501A) | first-line consolidation treatment for patients newly diagnosed with large B-cell lymphoma (LBCL) with minimal residual disease (MRD) following 1L chemoimmunotherapy | November 9, 2026 — clinical and translational data presentation at ACR Convergence |
| Opus Genetics, Inc. | IRD | Phentolamine Ophthalmic Solution 0.75% (PS) - presbyopia sNDA and LYNX-3 (mesopic vision); OPGx-LCA5 is co-lead registrational gene therapy | Presbyopia (sNDA under FDA review, PDUFA 2026-10-17); decreased mesopic vision after keratorefractive surgery (LYNX-3 Phase 3) | Q4 2026 — Enter the clinic |
| Atea Pharmaceuticals, Inc. | AVIR | bemnifosbuvir/ruzasvir (BEM/RZR) | Chronic hepatitis C | Q1 2027 — C-FORWARD Phase 3 topline results |
| Prokidney Corp. | PROK | rilparencel (autologous Selected Renal Cells) | advanced chronic kidney disease with type 2 diabetes | Q2 2027 — PROACT 1 topline readout of surrogate endpoint (eGFR slope) supporting potential accelerated approval |
| Fennec Pharmaceuticals Inc. | FENC | PEDMARK (sodium thiosulfate injection) | reduce risk of cisplatin-induced ototoxicity in pediatric patients with localized, non-metastatic solid tumors | 2026 — Norgine launches in additional European markets |
| X4 Pharmaceuticals, Inc. | XFOR | mavorixafor (X4P-001) | primary chronic neutropenia (PCN) | 2026 — Complete enrollment |
| Agenus Inc. | AGEN | botensilimab (BOT) + balstilimab (BAL) | neoadjuvant high-risk Stage II and Stage III MSS colon cancer | Q1 2027 — First patient dosed |
| Ocugen, Inc. | OCGN | OCU400 | Retinitis pigmentosa (RP) | Q1 2027 — Topline Phase 3 data |
| Kyverna Therapeutics, Inc. | KYTX | miv-cel (KYV-101) | Stiff person syndrome | Q4 2026 — Complete rolling BLA submission |
| Clinuvel Pharmaceuticals Ltd | CUVL | SCENESSE (afamelanotide) | Erythropoietic protoporphyria (EPP) | H2 2026 — EMA regulatory re-submission |
| Immuneering Corp | IMRX | atebimetinib (IMM-1-104) | first-line metastatic pancreatic ductal adenocarcinoma (PDAC) | Q4 2026 — Dose first patient in clinical trial (NSCLC) |
| Vanda Pharmaceuticals Inc. | VNDA | Quimilza (imsidolimab) | Generalized Pustular Psoriasis (GPP) | December 2026 — PDUFA target action date |
| Cartesian Therapeutics, Inc. | RNAC | Descartes-08 | myasthenia gravis (MG) | — |
| SIGA Technologies, Inc. | SIGA | TPOXX® (tecovirimat) smallpox post-exposure prophylaxis | Smallpox post-exposure prophylaxis (PEP) | H1 2027 — Supplemental NDA submission for smallpox post-exposure prophylaxis indication |
| Greenwich LifeSciences, Inc. | GLSI | GLSI-100 | Prevention of breast cancer recurrences in HER2/neu positive patients with residual disease or high-risk pathologic complete response | — |
| Cabaletta Bio, Inc. | CABA | Resecabtagene autoleucel (rese-cel) | Myositis (dermatomyositis and antisynthetase syndrome) | H1 2027 — Go-forward clinical development plan update |
| Inhibikase Therapeutics, Inc. | IKT | IKT-001 (imatinib prodrug), IMPROVE-PAH | Pulmonary arterial hypertension | date not stated — Topline data readout in Part B of IMPROVE-PAH Phase 3 |
| ADC Therapeutics SA | ADCT | ZYNLONTA (loncastuximab tesirine-lpyl) | relapsed/refractory DLBCL after two or more lines of systemic therapy | 2026 — Presentation of updated MZL data |
| Sol-Gel Technologies Ltd. | SLGL | SGT-610 (patidegib gel 2%) | chronic use and prevention of new basal cell carcinomas in Gorlin syndrome | — |
| Anika Therapeutics, Inc. | ANIK | Cingal | Osteoarthritis pain management | December 2027 — NDA submission to FDA |
| MediWound Ltd. | MDWD | NexoBrid | enzymatic eschar removal in deep partial- and full-thickness thermal burns | H2 2026 — Initiate Phase II study in diabetic foot ulcers |
| Invivyd, Inc. | IVVD | VYD2311 | COVID-19 prevention/treatment (DECLARATION and LIBERTY Phase 3) | — |
| Zentalis Pharmaceuticals, Inc. | ZNTL | Azenosertib (ZN-c3) | Cyclin E1-positive platinum-resistant ovarian cancer | H1 2027 — DENALI Part 2 topline readout |
| Jyong Biotech Ltd. | MENS | Botreso® | urinary system diseases | — |
| Compass Therapeutics, Inc. | CMPX | Tovecimig (CTX-009) | Biliary tract cancer (second-line) | Q4 2026 — Clinical data |
| Inovio Pharmaceuticals, Inc. | INO | INO-3107 | recurrent respiratory papillomatosis (RRP) in adults | Q1 2027 — Potential commercial launch following approval |
| PolyPid Ltd. | PYPD | D-PLEX100 | Prevention of surgical site infections (colorectal and abdominal surgery) | November 28, 2026 — D-PLEX100 NDA under FDA Priority Review with November 28, 2026 PDUFA goal date. |
| Humacyte, Inc. | HUMA | Symvess (acellular tissue engineered vessel, ATEV) | vascular trauma; AV access for hemodialysis (supplemental BLA planned) | — |
| Cardiol Therapeutics Inc. | CRDL | CardiolRx (MAVERIC) | recurrent pericarditis | — |
| Minerva Neurosciences, Inc. | NERV | roluperidone | negative symptoms in schizophrenia | H2 2027 — topline efficacy results from C19 trial |
| Immunic, Inc. | IMUX | vidofludimus calcium (IMU-838) | relapsing multiple sclerosis | 2026 — ENSURE-1 and ENSURE-2 topline data |
| Organogenesis Holdings Inc. | ORGO | Amnuvx | wound healing (exact indication not specified) | April 24, 2027 — PDUFA target action date |
| TuHURA Biosciences, Inc. | HURA | IFx-2.0 | first-line advanced/metastatic Merkel cell carcinoma, with pembrolizumab | date not stated — Phase 1b/2 trial with menin inhibitor in mutNPM1 AML (planned) |
| NRx Pharmaceuticals, Inc. | NRXP | NRX-100 (preservative-free IV ketamine) / NRX-101 (D-cycloserine + lurasidone) | Suicidal ideation in depression incl. bipolar depression (NRX-100); suicidal bipolar depression (NRX-101) | Q4 2026 — Commercial launch following ANDA approval |
| Unicycive Therapeutics, Inc. | UNCY | Oxylanthanum carbonate (OLC) | Hyperphosphatemia in chronic kidney disease patients on dialysis | — |
| Genelux Corp | GNLX | Olvi-Vec (olvimulogene nanivacirepvec) | platinum-resistant/refractory ovarian cancer (OnPrime/GOG-3076) | — |
| vTv Therapeutics Inc. | VTVT | Cadisegliatin (TTP399) | Type 1 diabetes (as adjunctive therapy to insulin) | H1 2027 — Topline results from Phase 3 CATT1 study |
| Atara Biotherapeutics, Inc. | ATRA | Tabelecleucel (tab-cel, Ebvallo) | EBV+ post-transplant lymphoproliferative disease (EBV+ PTLD) after rituximab +/- chemotherapy | — |
| OKYO Pharma Ltd | OKYO | urcosimod | Neuropathic corneal pain | — |
| MAIA Biotechnology, Inc. | MAIA | ateganosine (THIO) | third-line non-small cell lung cancer (NSCLC), CPI- and chemotherapy-resistant | 2026 — Filing for accelerated approval in advanced NSCLC |
| Tenax Therapeutics, Inc. | TENX | TNX-103 (oral levosimendan) | Pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) | Q1 2027 — Type C meeting with FDA to discuss overall development and pathway to regulatory approval |
| Cingulate Inc. | CING | CTx-1301 (dexmethylphenidate, PTR platform) | ADHD | date not stated — NDA resubmission following completion of requested CMC work |
| Gossamer Bio, Inc. | GOSS | seralutinib | pulmonary arterial hypertension (PAH); PH-ILD | Q3 2027 — Potential FDA approval decision if NDA accepted |
| Clene Inc. | CLNN | CNM-Au8 | Amyotrophic Lateral Sclerosis (ALS) | 2026 — FDA response on NDA acceptance for review |
| Verrica Pharmaceuticals Inc. | VRCA | YCANTH (VP-102, cantharidin) | Molluscum contagiosum | 2027 — Phase 3 top-line data |
| Talphera, Inc. | TLPH | Niyad | regional anticoagulant for the dialysis circuit (CRRT) | 2026 — enrollment completion |
| Rafael Holdings, Inc. | RFL | Trappsol Cyclo (remibetadex) | Niemann-Pick Disease Type C (NPC) | December 2026 — FDA filing decision on NDA |
| RenovoRx, Inc. | RNXT | Intra-arterial gemcitabine (IAG) delivered via RenovoCath | Locally advanced pancreatic cancer (LAPC) | H2 2027 — Initial top-line data from Phase III TIGeR-PaC trial |
| Mereo BioPharma Group plc | MREO | setrusumab (BPS-804/UX143) | osteogenesis imperfecta (OI) | — |
| LeonaBio, Inc. | LONA | Lasofoxifene | ER+/HER2- metastatic breast cancer with ESR1 mutations | date not stated — Topline results of the ELAINE-3 trial |
| Elicio Therapeutics, Inc. | ELTX | camupepimut (ELI-002 7P) | mKRAS-positive pancreatic ductal adenocarcinoma (PDAC) | Q4 2026 — Phase 1 study initiation in combination with daraxonrasib with or without nivolumab in metastatic mKRAS pancreatic cancer |
| Grace Therapeutics, Inc. | GRCE | GTx-104 (IV nimodipine) | Aneurysmal subarachnoid hemorrhage (aSAH) | date not stated — NDA resubmission following CRL |
| Aldeyra Therapeutics, Inc. | ALDX | reproxalap | dry eye disease and allergic conjunctivitis | Q4 2026 — FDRR meeting with FDA Office of New Drugs |
| Annovis Bio, Inc. | ANVS | Buntanetap | Early Alzheimer's disease | date not stated — Pivotal Phase 3 AD readout |
| INmune Bio | INMB | CORDStrom | Recessive Dystrophic Epidermolysis Bullosa (RDEB) | February 2027 — MAA filing in United Kingdom |
| BriaCell Therapeutics Corp. | BCTX | Bria-IMT™ in combination with Retifanlimab® | Metastatic breast cancer | — |
| Edesa Biotech, Inc. | EDSA | EB05 (paridiprubart) | Acute Respiratory Distress Syndrome (ARDS) | date not stated — Start of Phase 2 proof-of-concept enrollment in vitiligo (Health Canada approved; FDA IND CMC information being provided) |
| BeyondSpring Inc. | BYSI | Plinabulin | 2L/3L EGFR wild-type non-squamous NSCLC after progression on immune checkpoint inhibitors (with docetaxel) | date not stated — Launch of confirmatory global Phase 3 study DUBLIN-4 (plinabulin + docetaxel vs docetaxel) |
| Aardvark Therapeutics, Inc. | AARD | ARD-101 | Hyperphagia associated with Prader-Willi Syndrome | — |
| CEL-SCI Corp | CVM | Multikine (Leukocyte Interleukin, Injection) | newly diagnosed resectable locally advanced primary squamous cell carcinoma of the head and neck (no lymph node involvement, low PD-L1) | date not stated — Start of 212-patient confirmatory registration study, contingent on raising capital; full enrollment 18-24 months after start |
| Quoin Pharmaceuticals Ltd. | QNRX | QRX003 | Netherton Syndrome | November 2026 — Shareholder meeting to amend beneficial ownership limitation |
| Citius Pharmaceuticals, Inc. | CTXR | LYMPHIR (denileukin diftitox-cdxl) | Persistent or recurrent cutaneous T-cell lymphoma (CTCL) | December 2026 — Citius Oncology expects to report complete fiscal fourth quarter and fiscal year 2026 results in December 2026 with Form 10-K filing. |
| Scilex Holding Co | SCLX | ZTlido (lidocaine topical system) 1.8% | neuropathic pain associated with postherpetic neuralgia | — |
| Lipocine Inc. | LPCN | LPCN 1154 (Brlizio) | Postpartum depression (PPD) | date not stated — BLOOM Phase 3 study completion |
| BioCardia, Inc. | BCDA | CardiAMP Cell Therapy (BCDA-01) | Ischemic heart failure with reduced ejection fraction (HFrEF) | 2028 — BioCardia targets treatment of first patients in Japan and realization of commercial revenues in 2028. |
| Dare Bioscience, Inc. | DARE | Ovaprene | hormone-free monthly intravaginal contraception | 2027 — Top-line data from pivotal Phase 3 study |
| Biofrontera Inc. | BFRI | Ameluz (aminolevulinic acid gel) with RhodoLED lamps, photodynamic therapy | Actinic keratosis (face and scalp); label-expansion programs in superficial basal cell carcinoma, AK trunk/extremities, acne | Q4 2026 — Biofrontera plans to launch the sBCC indication of Ameluz late in the fourth quarter of 2026 through the first quarter of 2027. |
| TScan Therapeutics, Inc. | TCRX | TSC-101 | AML and MDS patients undergoing allogeneic HCT (prevention of relapse; HLA-A*02:01) | — |
| Intensity Therapeutics, Inc. | INTS | INT230-6 | soft tissue sarcoma (second- and third-line treatment) | Q1 2027 — IDMB review update on skin irritation resolution |
| Vistagen Therapeutics, Inc. | VTGN | fasedienol (PH94B) nasal spray | acute treatment of anxiety in adults with social anxiety disorder | — |
| Ensysce Biosciences, Inc. | ENSC | PF614 | Severe/chronic pain (abuse-resistant TAAP oxycodone prodrug) | — |
| Jaguar Health, Inc. | JAGX | Mytesi (crofelemer 125 mg delayed-release tablets) | Symptomatic relief of non-infectious diarrhea in adults with HIV/AIDS on antiretroviral therapy | H2 2026 — Submit final clinical study report to FDA |
| Can-Fite BioPharma Ltd. | CANF | Namodenoson (CF102) | Advanced hepatocellular carcinoma (Child-Pugh B7) | Q4 2026 — Initiation of Lowe syndrome Phase 2 |
| Imunon, Inc. | IMNN | IMNN-001 (TheraPlas IL-12 DNA immunotherapy) | Newly diagnosed advanced (stage III/IV) ovarian cancer, with neoadjuvant/adjuvant chemotherapy | H1 2029 — Complete ITT enrollment in Phase 3 OVATION 3 |
| Biodexa Pharmaceuticals Plc | BDRX | eRapa | Familial adenomatous polyposis (FAP) | Q1 2027 — Pre-specified futility analysis for eRapa Phase 3 trial in FAP could occur early next year. |
| Karyopharm Therapeutics Inc. | KPTI | XPOVIO (selinexor) | Multiple myeloma (approved); myelofibrosis in development | — |
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.