Phase 2 biotech companies
214 listed drug developers whose lead program is in Phase 2, largest first, with the next catalyst each has disclosed.
| Company | Ticker | Lead program | Indication | Next catalyst |
|---|---|---|---|---|
| Spyre Therapeutics, Inc. | SYRE | SKYLINE (SPY001, SPY002, SPY003 and combinations) | Ulcerative colitis | Q4 2026 — SKYWAY PsA and axSpA sub-study topline data expected 4Q 2026; SPY003 SKYLINE Part A UC data September 2026. |
| Kymera Therapeutics, Inc. | KYMR | KT-621 (STAT6 degrader) | Atopic dermatitis (BROADEN2) and asthma (BREADTH) | — |
| Oruka Therapeutics, Inc. | ORKA | ORKA-001 | moderate-to-severe plaque psoriasis (EVERLAST-A Phase 2a, EVERLAST-B Phase 2b) | Q4 2026 — Week 16 data |
| CRISPR Therapeutics AG | CRSP | CASGEVY (exagamglogene autotemcel) | sickle cell disease and transfusion-dependent beta thalassemia | — |
| Edgewise Therapeutics, Inc. | EWTX | EDG-7500 | Obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) | Q4 2026 — Initiation of Phase 3 trial in HCM |
| Tango Therapeutics, Inc. | TNGX | vopimetostat (TNG462) | MTAP-deleted cancers incl. pancreatic (PRMT5 inhibitor) | October 2026 — ESMO combination data |
| AbCellera Biologics Inc. | ABCL | ABCL635 | Moderate-to-severe vasomotor symptoms (VMS) associated with menopause | Q4 2026 — Phase 1 topline data readout |
| Tarsus Pharmaceuticals, Inc. | TARS | XDEMVY (lotilaner ophthalmic solution) 0.25% | Demodex blepharitis | 2026 — Expected close of Alkeus acquisition (adds Phase 3 gildeuretinol program for Stargardt disease) |
| Denali Therapeutics Inc. | DNLI | AVLAYAH (tividenofusp alfa-eknm; DNL310) | neurologic manifestations of Hunter syndrome (MPS II) | — |
| Vicore Pharma Holding AB | VCRE | buloxibutid | idiopathic pulmonary fibrosis (IPF) | H1 2027 — ASPIRE trial remains on track to report 52-week topline results in mid-2027. |
| Beam Therapeutics Inc. | BEAM | risto-cel (BEAM-101) | Sickle cell disease | Q4 2026 — BLA submission |
| Supernus Pharmaceuticals, Inc. | SUPN | Qelbree (viloxazine extended-release) | ADHD in pediatric patients 6+ and adults | H2 2026 — Initiate Phase 1 SAD/MAD study in healthy volunteers |
| MBX Biosciences, Inc. | MBX | canvuparatide (MBX 2109) | Chronic hypoparathyroidism | Q4 2026 — Results from first cohort of 12-week MAD portion of Phase 1 |
| Precigen, Inc. | PGEN | Papzimeos (zopapogene imadenovec-drba; PRGN-2012) | recurrent respiratory papillomatosis (adults) | date not stated — EMA review of Marketing Authorization Application (validated, under review) |
| Recursion Pharmaceuticals, Inc. | RXRX | REC-4881 (MEK1/2 inhibitor) | Familial adenomatous polyposis (TUPELO) | November 2026 — Full Phase 1b/2 trial dataset for REC-4881 will be presented at the CGA-IGC Annual Meeting on November 2, 2026. |
| Lakefront Biotherapeutics | LKFT | Gamgertamig (OM336) | Autoimmune cytopenias (ITP, AIHA) and seropositive autoimmune diseases (myositis, Sjogren's, pemphigus) | 2027 — Expected entry into registrational studies (Gilead-led) |
| Vera Therapeutics, Inc. | VERA | TRUTAKNA (atacicept-vymj) | reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression | Q4 2026 — Supplemental BLA submission for full approval |
| Xeris Biopharma Holdings, Inc. | XERS | Recorlev, Gvoke, Keveyis (commercial portfolio) | Cushing's syndrome (endogenous hypercortisolemia); severe hypoglycemia; primary periodic paralysis | 2026 — Initiate Phase 3 clinical trial |
| First Tracks Biotherapeutics, Inc. | TRAX | Rosnilimab | rheumatoid arthritis | Q1 2027 — Cohort 2 enrollment completing imminently; topline Q1 2027. |
| Maze Therapeutics, Inc. | MAZE | MZE829 | APOL1-mediated kidney disease | H1 2027 — Initiate pivotal trial, subject to regulatory feedback |
| Hemab Therapeutics Holdings, Inc. | COAG | sutacimig (HMB-001) | Glanzmann thrombasthenia (Phase 1/2) and Factor VII deficiency (Phase 2), prophylaxis | H2 2026 — commence Phase 3 trial |
| uniQure N.V. | QURE | AMT-130 | Huntington's disease | — |
| Pacira BioSciences, Inc. | PCRX | EXPAREL (bupivacaine liposome injectable suspension) | postsurgical local and regional analgesia | H2 2026 — LG Chem to file for marketing authorization in Thailand |
| Tyra Biosciences, Inc. | TYRA | Dabogratinib (oral, formerly TYRA-300) | FGFR3-altered urothelial cancers (LG-UTUC, IR NMIBC) and achondroplasia | March 2027 — Safety sentinel cohort results incl. 6-month annualized height velocity |
| Taysha Gene Therapies, Inc. | TSHA | TSHA-102 | Rett syndrome (MECP2 loss-of-function) | H1 2027 — REVEAL pivotal 6-month interim analysis topline data and FDA regulatory feedback toward BLA submission |
| GH Research PLC | GHRS | GH001 | Treatment-resistant depression (TRD) | — |
| Silence Therapeutics plc | SLN | Divesiran (SLN124) | Polycythemia vera | 2027 — Potential IND filing |
| Verastem, Inc. | VSTM | AVMAPKI FAKZYNJA CO-PACK (avutometinib + defactinib) | KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy | 2026 — Company plans to open TARGET-D 301 Phase 3 trial in first-line mPDAC by year-end 2026 following FDA alignment on study design. |
| Avalyn Pharma Inc. | AVLN | AP01 (inhaled pirfenidone) | Progressive pulmonary fibrosis (PPF) | 2026 — Phase 1 study initiation |
| Seaport Therapeutics, Inc. | SPTX | GlyphAllo (SPT-300), oral Glyphed prodrug of allopregnanolone | major depressive disorder (MDD) with or without anxious distress | H2 2026 — Topline data from Phase 1 driving simulation trial |
| MannKind Corporation | MNKD | Afrezza (insulin human) Inhalation Powder | Diabetes mellitus (adults; label expanded to ages 6 and older May 2026) | — |
| Odyssey Therapeutics, Inc. | ODTX | OD-001 | ulcerative colitis | H2 2026 — CTA filing outside the US |
| Jade Biosciences, Inc. | JBIO | JADE101 | IgA nephropathy (IgAN) | H1 2027 — Initiate registrational Phase 3 in IgAN |
| Rigel Pharmaceuticals Inc | RIGL | TAVALISSE (fostamatinib) and other marketed products | chronic immune thrombocytopenia (ITP); R/R AML mIDH1; RET+ NSCLC/thyroid cancer; ESR1m breast cancer | H2 2026 — Complete dose-expansion enrollment and select recommended Phase 2 dose |
| Obsidian Therapeutics, Inc. | OBX | amsoki-cel (OBX-115) | Advanced melanoma (second-line, post-ICI); also NSCLC | Q4 2026 — Updated melanoma RP2D data |
| Alto Neuroscience, Inc. | ANRO | ALTO-207 | Treatment-resistant depression | H1 2027 — Phase 2b topline data |
| Sagimet Biosciences Inc. | SGMT | denifanstat (TVB-2640) | MASH (also acne and select cancers) | 2026 — Sagimet plans to initiate TVB-3567 Phase 2 clinical trial in moderate to severe acne patients before the end of 2026. |
| Immix Biopharma, Inc. | IMMX | NXC-201 (CAR-T) | relapsed/refractory AL amyloidosis | date not stated — NEXICART-2 final readout followed by BLA submission |
| Arbutus Biopharma Corp | ABUS | imdusiran (AB-729) | chronic hepatitis B | date not stated — Phase 2b trial initiation (FDA alignment reached May 2026) |
| Design Therapeutics, Inc. | DSGN | DT-168 | Fuchs endothelial corneal dystrophy (FECD) | Q4 2026 — Update on registrational plans |
| Wave Life Sciences, Inc. | WVE | WVE-007 | obesity (INHBE GalNAc-siRNA) | H2 2026 — Additional INLIGHT data incl. 600 mg SAD cohort |
| Climb Bio, Inc. | CLYM | budoprutug (IV) | primary membranous nephropathy (pMN) | Q4 2026 — Additional ITP data from 500 mg and 1000 mg cohorts |
| Puma Biotechnology, Inc. | PBYI | NERLYNX (neratinib) | HER2-positive breast cancer (extended adjuvant and metastatic) | — |
| Aclaris Therapeutics, Inc. | ACRS | Bosakitug (ATI-045) | Moderate to severe atopic dermatitis | Q4 2026 — Phase 2 atopic dermatitis top-line data |
| Electra Therapeutics, Inc. | ETRA | ipsoprubart (formerly ELA026) | secondary hemophagocytic lymphohistiocytosis (sHLH) | H1 2027 — Phase 1 healthy-volunteer data |
| MapLight Therapeutics, Inc. | MPLT | ML-007C-MA | Schizophrenia | H2 2027 — VISTA Phase 2 topline |
| Bright Minds Biosciences Inc. | DRUG | BMB-101 | drug-resistant epilepsies (absence epilepsy, developmental epileptic encephalopathy); Prader-Willi syndrome | — |
| Entera Bio Ltd. | ENTX | EB613 (oral PTH(1-34) tablet) | Postmenopausal osteoporosis | H2 2026 — Initiation of Phase 3 registrational program (single ~750-patient placebo-controlled trial) |
| Delcath Systems, Inc. | DCTH | HEPZATO KIT (melphalan for Injection/Hepatic Delivery System) | Liver-directed treatment of uveal melanoma with unresectable hepatic metastases | 2027 — Primary endpoint (hPFS) read-out |
| Neurogene Inc. | NGNE | NGN-401 | Rett syndrome | 2026 — Complete process performance qualification (PPQ) runs |
| DiaMedica Therapeutics Inc. | DMAC | DM199 (rinvecalinase alfa; rhKLK1) | acute ischemic stroke (ReMEDy2 Phase 2/3); preeclampsia and fetal growth restriction (Phase 2) | October 2026 — Rat PK/pharmacologic activity study completion, then submission to FDA to support IND |
| Unknown | Unknown | BH-30643 | EGFR-mutant non-small cell lung cancer (NSCLC) | Q4 2026 — End-of-Phase 1 meeting with FDA regarding recommended Phase 2 dose and potential accelerated approval pathway |
| Phathom Pharmaceuticals, Inc. | PHAT | VOQUEZNA (vonoprazan) | Erosive GERD, Non-Erosive GERD heartburn, H. pylori infection | Q4 2026 — Topline results from 12-week blinded treatment portion of Phase 2 EoE trial |
| Eupraxia Pharmaceuticals Inc. | EPRX | EP-104GI | Eosinophilic esophagitis (EoE) | December 2026 — Interim analysis of Phase 2b portion of RESOLVE (first 60 patients at 6 months) |
| AgomAb Therapeutics | AGMB | Ontunisertib (AGMB-129) | Fibrostenosing Crohn's disease | — |
| Faeth Therapeutics, Inc. | FTH | PIKTOR (serabelisib + sapanisertib) | second-line advanced endometrial cancer; HR+/HER2- advanced breast cancer | 2026 — Phase 2 topline data in advanced endometrial cancer |
| Allogene Therapeutics, Inc. | ALLO | cemacabtagene ansegedleucel (cema-cel, ALLO-501A) | 1L consolidation in newly diagnosed large B-cell lymphoma (MRD+ after first-line therapy) | H2 2026 — initial data |
| Ovid Therapeutics Inc. | OVID | OV329 | treatment-resistant focal onset seizures (also TSC-associated seizures, infantile spasms) | Q4 2026 — Initiate proof-of-concept study in TSC-associated seizures |
| Autolus Therapeutics plc | AUTL | AUCATZYL (obecabtagene autoleucel, obe-cel) | Adult relapsed/refractory B-cell precursor acute lymphoblastic leukemia | Q4 2026 — Initial Phase 1 data |
| ARS Pharmaceuticals, Inc. | SPRY | neffy (intranasal epinephrine) | emergency treatment of Type I allergic reactions including anaphylaxis | 2026 — Canadian commercial launch by partner ALK |
| Eikon Therapeutics, Inc. | EIKN | EIK1001 | First-line advanced melanoma (with pembrolizumab); also NSCLC | October 2026 — Initial clinical data at ESMO |
| Tectonic Therapeutic, Inc. | TECX | TX45 | Group 2 pulmonary hypertension in HFpEF (PH-HFpEF) | Q1 2027 — Topline results |
| C4 Therapeutics, Inc. | CCCC | cemsidomide (IKZF1/3 degrader) | relapsed/refractory multiple myeloma | H2 2026 — Dose escalation progress update |
| Avalo Therapeutics, Inc. | AVTX | abdakibart (AVTX-009) | hidradenitis suppurativa | — |
| IRulya Therapeutics Inc. | IRLA | LAM-001 | Pulmonary hypertension associated with ILD (PH-ILD); bronchiolitis obliterans syndrome | Q1 2027 — Phase 2 BOS trial results |
| Relmada Therapeutics, Inc. | RLMD | NDV-01 (sustained-release intravesical gemcitabine/docetaxel) | non-muscle-invasive bladder cancer (high-risk BCG-unresponsive; intermediate-risk adjuvant) | 2026 — US IND filing |
| Enanta Pharmaceuticals, Inc. | ENTA | Zelicapavir (EDP-938) | Respiratory syncytial virus (RSV) | Q4 2026 — Study initiation |
| Galectin Therapeutics Inc | GALT | belapectin (GR-MD-02) | NASH cirrhosis / portal hypertension | — |
| Zura Bio Ltd | ZURA | tibulizumab (ZB-106) | Hidradenitis suppurativa (TibuSHIELD) and early diffuse cutaneous systemic sclerosis (TibuSURE) | Q4 2026 — TibuSHIELD Phase 2 topline results |
| Turn Therapeutics Inc. | TTRX | GX-03 | Atopic dermatitis / moderate-to-severe eczema (topical PHMB-based immunomodulator) | June 2027 — Initiation of Phase 2a study |
| Contineum Therapeutics, Inc. | CTNM | PIPE-791 | idiopathic pulmonary fibrosis (PROPEL-IPF Phase 2); also chronic pain | — |
| Benitec Biopharma Inc. | BNTC | BB-301 (AAV9 'Silence and Replace' ddRNAi gene therapy) | Oculopharyngeal muscular dystrophy (OPMD)-related dysphagia | October 2026 — Late-breaking poster of interim Phase 1b/2a results (12-month Cohort 1, interim Cohort 2) at ESGCT |
| Artiva Biotherapeutics, Inc. | ARTV | AlloNK (AB-101) plus rituximab | Refractory rheumatoid arthritis (lead); also Sjögren’s disease, systemic sclerosis, idiopathic inflammatory myopathies | H2 2026 — Initiation of registrational Phase 3 trial in refractory RA |
| Agenus Inc | AGEN | Botensilimab (BOT) plus balstilimab (BAL) | Refractory MSS/pMMR metastatic colorectal cancer without active liver metastases (also neoadjuvant MSS colon cancer) | H2 2026 — Further study details anticipated to be published |
| Arcturus Therapeutics Holdings Inc. | ARCT | ARCT-032 (LUNAR-CF) | Cystic fibrosis (CFTR mRNA, inhaled) | — |
| Vogenx, Inc. | VOGX | mizagliflozin | Post-bariatric hypoglycemia (PBH) | 2026 — Begin patient screening in Phase 2b EMERGE study |
| SAB Biotherapeutics, Inc. | SABS | SAB-142 (fully human anti-thymocyte globulin, Tc-Bovine derived) | Stage 3 autoimmune type 1 diabetes (new or recent onset) | — |
| Q32 Bio Inc. | QTTB | bempikibart (ADX-914) | Alopecia areata | — |
| Lineage Cell Therapeutics, Inc. | LCTX | OpRegen (RG6501) | Geographic atrophy secondary to dry age-related macular degeneration | — |
| Rocket Pharmaceuticals, Inc. | RCKT | RP-A501 | Danon disease | H1 2027 — Company expects dosing completion of pivotal Phase 2 Cohort 4 for RP-A501 in Danon Disease by mid-2027. |
| Cabaletta Bio, Inc. | CABA | rese-cel (resecabtagene autoleucel, CABA-201) | Autoimmune disease; lead registrational cohort in dermatomyositis / anti-synthetase syndrome (myositis) | June 2027 — BLA-enabling topline data from registrational cohort |
| Bicycle Therapeutics PLC | BCYC | Zelenectide pevedotin (Nectin-4 BDC) | Metastatic urothelial cancer | 2026 — Report certain Phase I/II data in 2026, after which internal development ends and partnering is explored |
| Clinuvel Pharmaceuticals Ltd | CUVL | SCENESSE (afamelanotide 16mg) | Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP); vitiligo (with NB-UVB) under study in CUV105 | December 2026 — Top line results |
| AC Immune SA | ACIU | ACI-7104.056 | early-stage Parkinson's disease | Q1 2027 — FDA meetings on Part 2 (expansion) design of VacSYn |
| Larimar Therapeutics, Inc. | LRMR | nomlabofusp | Friedreich's ataxia | 2027 — Planned commercial launch if approved |
| BioAge Labs, Inc. | BIOA | BGE-102 | Cardiovascular/obesity-related (NLRP3 inhibitor) | H2 2027 — BioAge expects topline results from QUELL-DME Phase 2 trial in second half of 2027. |
| InflaRx N.V. | IFRX | izicopan (oral C5aR inhibitor) | ANCA-associated vasculitis (AAV) and other complement-mediated renal disease; HS and CSU Phase 2a completed | July 1, 2027 — US EUA termination becomes effective |
| Lexeo Therapeutics, Inc. | LXEO | LX2006 (AAVrh10 frataxin gene therapy) | Friedreich ataxia cardiomyopathy | 2027 — Program prioritization update for acquired FA programs expected in early 2027. |
| Keros Therapeutics, Inc. | KROS | rinvatercept (KER-065) | Duchenne muscular dystrophy (DMD); ALS planned | H2 2026 — Engage regulators on design of Phase 2 trial in ALS |
| Protalix BioTherapeutics, Inc. | PLX | Elelyso (taliglucerase alfa) | Gaucher disease | — |
| Eledon Pharmaceuticals, Inc. | ELDN | tegoprubart | Prevention of allograft rejection in kidney transplantation | H2 2026 — Initiation of Phase 3 clinical development |
| Evommune, Inc. | EVMN | EVO756 | Moderate-to-severe atopic dermatitis | Q2 2027 — Phase 2b commencement |
| PepGen Inc. | PEPG | PGN-EDODM1 | Myotonic dystrophy type 1 (DM1) | November 2026 — PepGen expects to report clinical data from the 10 mg/kg multiple-dose cohort of FREEDOM2 in November 2026. |
| Entrada Therapeutics, Inc. | TRDA | ENTR-601-44 | Duchenne muscular dystrophy (exon 44 skipping) | Q1 2027 — Cohort 2 topline |
| Innate Pharma SA | IPHA | lacutamab (anti-KIR3DL2) | cutaneous T-cell lymphoma (Sezary syndrome, mycosis fungoides) | November 18, 2026 — Initial Phase 1 dose-escalation data at ENA 2026 |
| Sionna Therapeutics, Inc. | SION | SION-719 | Cystic fibrosis | — |
| Adagene Inc. | ADAG | ADG126 (muzastotug) | MSS metastatic colorectal cancer (with anti-PD-1) | Q4 2026 — Initiate first-in-human Phase 1 study in China |
| NovaBridge Biosciences | NBP | Givastomig (TJ033721 / ABL111), Claudin 18.2 x 4-1BB bispecific antibody | First-line HER2-negative metastatic gastric / gastroesophageal adenocarcinoma (GEA) | October 25, 2026 — Poster presentation of Phase 1b combination dose expansion data at ESMO 2026 |
| Akebia Therapeutics, Inc. | AKBA | Vafseo (vadadustat) | Anemia due to CKD (dialysis) | — |
| Coherus Oncology, Inc. | CHRS | LOQTORZI (toripalimab-tpzi) | Nasopharyngeal carcinoma (1L with cisplatin/gemcitabine; monotherapy after platinum) | 2026 — Initiation of Phase 1b study with pasritamig (Janssen) in metastatic castration-resistant prostate cancer |
| NervGen Pharma Corp. | NGEN | NVG-291 | Spinal cord injury (chronic and subacute tetraplegia) | — |
| Upstream Bio, Inc. | UPB | verekitug | Severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and COPD (anti-TSLP receptor antibody) | Q1 2027 — Initiate dosing in Phase 3 trials |
| ALX Oncology Holdings Inc. | ALXO | evorpacept | HER2-positive metastatic breast cancer (ASPEN-09-Breast) | — |
| Acumen Pharmaceuticals, Inc. | ABOS | sabirnetug (ACU193) | Early Alzheimer's disease (MCI or mild dementia due to AD) | H2 2026 — Phase 2 top-line results |
| Protara Therapeutics, Inc. | TARA | TARA-002 (intravesical), ADVANCED-2 | BCG-unresponsive / BCG-naive high-grade NMIBC with CIS | Q4 2026 — Interim results from dose-confirmation portion |
| Molecular Partners AG | MOLN | MP0317 | first-line advanced biliary tract carcinoma / cholangiocarcinoma (with durvalumab + gemcitabine-cisplatin) | H2 2026 — First-in-human imaging start |
| Satellos Bioscience Inc. | MSLE | Forazapadin (SAT-3247), oral AAK1 inhibitor | Duchenne muscular dystrophy (DMD) | Q4 2026 — Start of Phase 2 trial in adults with FSHD |
| Cue Biopharma, Inc. | CUE | CUE-221 | allergic diseases (chronic spontaneous urticaria Phase 2; food allergy planned) | 2026 — IND submission and Phase 1 start |
| Armata Pharmaceuticals, Inc. | ARMP | AP-SA02 | Complicated Staphylococcus aureus bacteremia (adjunct to best available antibiotic therapy) | H2 2026 — Initiation of pivotal Phase 3 superiority study in complicated S. aureus bacteremia |
| AN2 Therapeutics, Inc. | ANTX | Epetraborole | Mycobacterium abscessus complex lung disease | Q4 2026 — PV Phase 2 enrollment start |
| Spruce Biosciences, Inc. | SPRB | TA-ERT (tralesinidase alfa) | Mucopolysaccharidosis IIIB (Sanfilippo B) | Q4 2026 — BLA submission for accelerated approval |
| Nkarta, Inc. | NKTX | NKX019 | Autoimmune diseases (lupus nephritis, primary membranous nephropathy, systemic sclerosis, myositis, ANCA-associated vasculitis, rheumatoid arthritis) | — |
| Cumberland Pharmaceuticals Inc | CPIX | ifetroban | cardiomyopathy associated with Duchenne muscular dystrophy (also SSc, IPF, cancer metastasis) | date not stated — Top-line results |
| Kazia Therapeutics Ltd | KZIA | Paxalisib (GDC-0084) | Glioblastoma and other brain cancers (brain metastases, DIPG/DMG, breast cancer) | 2026 — Clinical study report |
| Tiziana Life Sciences Ltd | TLSA | Foralumab (TZLS-401), intranasal anti-CD3 mAb | non-active secondary progressive multiple sclerosis; also Alzheimer's, MSA, ALS | — |
| Retension Pharmaceuticals, Inc. | RTSN | RTN-001 | Uncontrolled hypertension (also resistant hypertension) | H1 2027 — Initial data from Phase 2b dose-ranging trial in uncontrolled hypertension |
| PDS Biotechnology Corp | PDSB | PDS0301 (formerly PDS01ADC / NHS-IL12) | metastatic colorectal cancer with liver metastases (also prostate cancer, Kaposi sarcoma, other liver-associated cancers) | Q4 2026 — Interim readout, biochemically recurrent prostate cancer |
| Black Diamond Therapeutics, Inc. | BDTX | Silevertinib (BDTX-1535) | EGFR-mutant non-small cell lung cancer; EGFRvIII+ newly diagnosed glioblastoma | H1 2028 — Interim PFS analysis of randomized Phase 2 |
| enGene Therapeutics Inc. | ENGN | Detalimogene voraplasmid (EG-70) | BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ | Q4 2026 — Reevaluate additional LEGEND cohorts after FDA discussion |
| Neonc Technologies Holdings, Inc. | NTHI | NEO100 (intranasal perillyl alcohol) | recurrent malignant glioma (IDH1-mutant Grade III/IV astrocytoma); also skull-base meningioma | November 17, 2026 — FDA End-of-Phase 1 Type B meeting for NEO212 scheduled for November 17, 2026 to discuss Phase 2 design and possible accelerated approval path. |
| PMV Pharmaceuticals, Inc. | PMVP | rezatapopt (PC14586) | TP53 Y220C-mutant solid tumors; platinum-resistant/refractory ovarian cancer | Q1 2027 — PMV Pharmaceuticals plans to submit an NDA for accelerated approval of rezatapopt in platinum-resistant/refractory ovarian cancer in first quarter of 2027. |
| Coya Therapeutics, Inc. | COYA | COYA 302 (low-dose IL-2 + CTLA4-Ig) | Amyotrophic lateral sclerosis (ALS) | — |
| Polaryx Therapeutics, Inc. | PLYX | PLX-200 (gemfibrozil) | Lysosomal storage disorders (CLN2, CLN3, Krabbe, Sandhoff) | H2 2026 — Initiation of SOTERIA Phase 2 proof-of-concept basket trial |
| Tonix Pharmaceuticals Holding Corp. | TNXP | TONMYA (cyclobenzaprine sublingual, TNX-102 SL) | fibromyalgia | H1 2027 — OASIS ASD topline |
| Milestone Pharmaceuticals Inc. | MIST | CARDAMYST (etripamil) nasal spray | Paroxysmal supraventricular tachycardia (PSVT) | H2 2026 — Enroll first patient in Phase 3 registrational study |
| Corbus Pharmaceuticals Holdings, Inc. | CRBP | CRB-701 (SYS6002) | Nectin-4-expressing solid tumors (2L oropharyngeal/head and neck SCC, cervical cancer) | Q1 2027 — Data for CRB-701 plus Keytruda in first-line OPSCC |
| Acrivon Therapeutics, Inc. | ACRV | ACR-368 (prexasertib) | endometrial cancer | — |
| Cardiff Oncology, Inc. | CRDF | Onvansertib (PLK1 inhibitor), CRDF-004 | First-line RAS-mutated metastatic colorectal cancer | — |
| Medicinova Inc | MNOV | MN-166 (ibudilast) | ALS (COMBAT-ALS) | — |
| Cognition Therapeutics Inc | CGTX | zervimesine (CT1812) | early Alzheimer's disease; dementia with Lewy bodies | date not stated — START Phase 2 topline results |
| Oncolytics Biotech Inc. | ONCY | Pelareorep | Second-line RAS-mutated MSS metastatic colorectal cancer (randomized Phase 2 REO 033); also anal and pancreatic cancers | — |
| Pelthos Therapeutics Inc. | PTHS | Zelsuvmi (berdazimer) topical gel, 10.3% | molluscum contagiosum | Q1 2027 — Commercial relaunch |
| OS Therapies Inc | OSTX | OST-HER2 (OST31-164) | Recurrent, fully resected pulmonary metastatic osteosarcoma | Q4 2026 — UK MHRA conditional marketing authorization application submission targeted early Q4 2026. |
| Fortress Biotech, Inc. | FBIO | Emrosi (DFD-29) and Journey Medical marketed dermatology portfolio; ZYCUBO (CUTX-101) | inflammatory lesions of rosacea (Emrosi); Menkes disease (ZYCUBO) | H2 2026 — topline data, Phase 2 in adults co-infected with HIV and CMV |
| Apollomics Inc. | APLM | Vebreltinib (APL-101) | c-MET altered NSCLC (METex14 skipping, c-MET amplification), brain tumors and other solid tumors with MET alterations | H1 2027 — Submit US IND for accelerated approval in 2L NSCLC with c-MET amplification |
| XBiotech Inc. | XBIT | Natrunix (anti-IL-1 alpha antibody, formerly bermekimab) | pancreatic cancer and other oncology/inflammatory indications | — |
| Clene Inc. | CLNN | CNM-Au8 | Amyotrophic lateral sclerosis (ALS) | Q4 2026 — NDA submission seeking accelerated approval |
| MiNK Therapeutics, Inc. | INKT | agenT-797 | severe pneumonia / moderate-to-severe hypoxemic acute respiratory failure (critical pulmonary immune failure) | 2026 — First patient dosing in investigator-sponsored GvHD prevention Phase 1 trial |
| Eloxx Pharmaceuticals, Inc. | ELOX | exaluren | Alport syndrome with nonsense mutations (NMAS) | Q3 2027 — First patient dosing in EXPRESS Phase 2 trial of exaluren in ADPKD expected in third quarter 2027. |
| Elicio Therapeutics, Inc. | ELTX | ELI-002 7P | Adjuvant mKRAS-driven pancreatic ductal adenocarcinoma (PDAC) | Q4 2026 — Initiation of Phase 1 study in metastatic PDAC |
| Rein Therapeutics, Inc. | RNTX | LTI-03 (inhaled Cav1-derived peptide) | Idiopathic pulmonary fibrosis (IPF) | H2 2026 — Company may report data from Phase 2 trial of LTI-03 in the second half of 2026. |
| Xilio Therapeutics, Inc. | XLO | efarindodekin alfa (masked IL-12) | advanced solid tumors | H2 2026 — initiate dosing Phase 1/2 |
| Connect Biopharma Holdings Ltd | CNTB | rademikibart | acute exacerbations of asthma and COPD (Type 2 inflammation) | date not stated — FDA meeting to align on Phase 3 program |
| ImageneBio, Inc. | IMA | IMG-007 (olevaprubart) | Moderate-to-severe atopic dermatitis | 2026 — Alopecia areata Phase 2 initiation |
| Biomea Fusion, Inc. | BMEA | icovamenib (BMF-219) | Type 2 diabetes (also type 1 diabetes studied) | — |
| Estrella Immunopharma, Inc. | ESLA | EB103 (CD19-directed ARTEMIS T-cell therapy) | Relapsed/refractory B-cell non-Hodgkin lymphomas | — |
| Nasus Pharma Ltd | NSRX | NS002 (intranasal epinephrine powder, PBI technology) | emergency treatment of allergic reactions / anaphylaxis (emergency medical conditions) | — |
| Veru Inc. | VERU | enobosarm | Preservation of muscle during GLP-1 RA-induced weight loss in older patients with obesity | Q4 2026 — Veru plans a Phase 2b clinical study of sabizabulin in metastatic pancreatic cancer resistant to daraxonrasib, with preIND FDA meeting expected in Q4 2026. |
| Dogwood Therapeutics, Inc. | DWTX | Halneuron (tetrodotoxin, Nav1.7 modulator) | Chemotherapy-induced neuropathic pain (CINP) | H2 2026 — Start of Phase 1b patient dosing in CIPN |
| Alterity Therapeutics Ltd | ATHE | ATH434 | Multiple System Atrophy (MSA) | 2026 — Initiation of Phase 3 trial activities in MSA |
| CervoMed Inc. | CRVO | neflamapimod | Dementia with Lewy bodies (DLB); also nfvPPA, RAS, ALS | H2 2026 — Initiation of planned Phase 3 trial |
| Evaxion A/S | EVAX | EVX-01 (personalized neoantigen cancer vaccine) | advanced melanoma | — |
| Not specified | Not specified | IHL-42X | Obstructive sleep apnea | H1 2027 — DReAMzz Study completion |
| Celularity Inc | CELU | cenplacel-L | Diabetic foot ulcers | — |
| Aligos Therapeutics, Inc. | ALGS | pevifoscorvir sodium (ALG-000184) | chronic hepatitis B virus infection | Q4 2026 — Start of chronic HBV cohort after 150 mg MAD cohort |
| Abvc Biopharma, Inc. | ABVC | ABV-1505 | Adult attention-deficit hyperactivity disorder (ADHD) | Q4 2026 — Phase II start |
| Atossa Therapeutics, Inc. | ATOS | (Z)-endoxifen | ER+/HER2- breast cancer (neoadjuvant), breast density reduction, DCIS; rare disease exploration (DMD, MAS) | H2 2026 — Data from expanded combination arms |
| IGC Pharma, Inc. | IGC | IGC-AD1 | Agitation in Alzheimer's dementia | date not stated — CALMA Phase 2 completion / topline |
| Immutep Limited | IMMP | eftilagimod alfa (efti, IMP321) | head and neck squamous cell carcinoma (HNSCC), 1st line, PD-L1 CPS <1 | — |
| Psyence Biomedical Ltd. | PBM | NPX-5 (nature-derived psilocybin 25 mg) | Adjustment disorder in patients with incurable cancer (palliative care) | November 2026 — Psyence expects to conclude definitive agreement with PsyLabs for exclusive ibogaine supply for the United States on or before November 30, 2026. |
| Quoin Pharmaceuticals Ltd. | QNRX | QRX003 | Netherton Syndrome | Q4 2026 — Quoin expects to complete recruitment of all 20 participants in Phase 2/3 Netherton Syndrome study CL-QRX003-004 by the end of 2026. |
| Neuphoria Therapeutics Inc. | NEUP | BNC210 (alpha7 nicotinic receptor negative allosteric modulator) | Post-traumatic stress disorder | 2026 — Expected close of proposed merger with Scancell Holdings plc |
| Kyntra Bio, Inc. | KYNB | FG-3246 (CD46-targeted ADC) with FG-3180 PET imaging agent | metastatic castration-resistant prostate cancer (mCRPC), post-ARPI pre-chemotherapy | Q4 2026 — Interim analysis of Phase 2 dose optimization study (composite PSA50/ORR) |
| Jasper Therapeutics, Inc. | JSPR | KP-104 (vensobafusp alfa) | PNH and rare renal indications (IgA nephropathy, C3 glomerulopathy; Phase 2 basket trial) | Q4 2026 — Interim data from Stage 1 of Phase 2 basket trial |
| aTyr Pharma, Inc. | ATYR | efzofitimod | systemic sclerosis-associated interstitial lung disease (Phase 2 EFZO-CONNECT); pulmonary sarcoidosis new Phase 3 planned | Q1 2027 — Topline data |
| Radiopharm Theranostics Ltd | RADX | RAD101 (18F-fluoropivalate, FASN-targeting PET imaging agent) | diagnosis of suspected recurrent brain metastases from solid tumors | November 2026 — Phase 2b interim data late-breaking oral at SNO26 |
| Allarity Therapeutics, Inc. | ALLR | stenoparib | platinum-resistant/ineligible ovarian cancer (DRP-guided); also relapsed SCLC with temozolomide | — |
| Vyome Holdings, Inc. | HIND | VT-1953 | signs and symptoms (malodor, pain) of malignant fungating wounds in advanced cancer | date not stated — Type C meeting with FDA on pivotal clinical development program in malignant fungating wounds |
| Cerenome, Inc. | CNSY | rhenium (186Re) obisbemeda (REYOBIQ) | recurrent glioblastoma; leptomeningeal metastases; pediatric brain cancers | H2 2026 — First patient enrolled in Phase 1 pediatric trial |
| Cellectar Biosciences, Inc. | CLRB | iopofosine I 131 | relapsed/refractory Waldenstrom macroglobulinemia | date not stated — Phase 3 randomized confirmatory study in WM launch/first patient (precondition for accelerated-approval NDA) |
| Actuate Therapeutics, Inc. | ACTU | elraglusib (IV injection) | first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) | date not stated — Planned University of Birmingham BEACON2 neuroblastoma dose-confirmation cohort (up to 20 patients) |
| BioVie Inc. | BIVI | Bezisterim (NE3107) | Parkinson's disease | date not stated — Finalize Phase 3 design and endpoints with FDA |
| Lisata Therapeutics, Inc. | LSTA | certepetide (LSTA1) | metastatic pancreatic ductal adenocarcinoma (mPDAC) and other solid tumors | 2026 — Final clinical study report |
| BioLineRx Ltd. | BLRX | motixafortide (solid tumors) | pancreatic ductal adenocarcinoma (PDAC) | — |
| Kiora Pharmaceuticals, Inc. | KPRX | KIO-301 | Retinitis pigmentosa | — |
| Lantern Pharma Inc. | LTRN | LP-300 (Harmonic trial) | never-smoker non-small cell lung cancer (NSCLC), in combination with chemotherapy; focus on EGFR exon 21 L858R | — |
| MetaVia Inc. | MTVA | vanoglipel (DA-1241) | MASH / metabolic disease | Q4 2026 — finalize Phase 2a Clinical Study Report |
| Theriva Biologics, Inc. | TOVX | VCN-01 (zabilugene almadenorepvec) | metastatic pancreatic ductal adenocarcinoma (with gemcitabine/nab-paclitaxel) | January 2027 — First patient enrolled in Phase 2/3 (if protocol agreed) |
| CalciMedica, Inc. | CALC | Auxora (zegocractin) | acute pancreatitis (with SIRS); also AKI with AHRF | 2027 — Phase 1b proof-of-concept data in PAH |
| Chemomab Therapeutics Ltd. | CMMB | nebokitug | primary sclerosing cholangitis (PSC) | 2027 — Chemomab must initiate a Phase 2 trial of CM-101 within 12 months following FDA acceptance of an IND. |
| Soligenix, Inc. | SNGX | SGX302 (synthetic hypericin sodium, photodynamic therapy) | mild-to-moderate psoriasis | — |
| Immuron Ltd | IMRN | Travelan (IMM-124E) | Prevention of travelers' diarrhea (ETEC) | date not stated — End-of-Phase 2 meeting with FDA on pivotal Phase 3 / BLA strategy |
| CNS Pharmaceuticals, Inc. | CNSP | Berubicin (legacy, anthracycline; not under active development, available for out-license) | Recurrent glioblastoma / malignant glioma | date not stated — Acquire or in-license a new clinical-stage oncology or neurology asset |
| Exicure, Inc. | XCUR | GPC-100 (with propranolol) | Hematopoietic stem cell mobilization in blood cancer / multiple myeloma patients eligible for transplant | — |
| Moleculin Biotech, Inc. | MBRX | Annamycin (MIRACLE trial) | Relapsed/refractory acute myeloid leukemia (with cytarabine) | December 2026 — Part A full unblinding |
| Skye Bioscience, Inc. | SKYE | Nimacimab | Obesity | — |
| Acurx Pharmaceuticals, Inc. | ACXP | ibezapolstat (ACX-362E) | Clostridioides difficile infection (CDI) | Q4 2026 — First patient enrollment in open-label pilot trial in multiply recurrent CDI |
| AIM ImmunoTech Inc. | AIM | Ampligen (rintatolimod) + durvalumab (DURIPANC) | late-stage pancreatic cancer | January 2027 — Completion of secondary endpoint data collection |
| Alzamend Neuro, Inc. | ALZN | AL001 | Bipolar disorder (also Alzheimer's, MDD, PTSD) | Q4 2026 — Topline data, Phase II BD 'Lithium in Brain' study |
| Traws Pharma, Inc. | TRAW | ratutrelvir (TRX01) | COVID-19 | 2026 — resolve FDA clinical hold |
| Longeveron Inc. | LGVN | laromestrocel (Lomecel-B; allogeneic mesenchymal stem cell therapy) | Hypoplastic Left Heart Syndrome (ELPIS II) | 2027 — Start single Phase 2 registrational trial (subject to financing) |
| Medicus Pharma Ltd. | MDCX | SkinJect (doxorubicin dissolvable microneedle array, D-MNA) | Basal cell carcinoma (nodular BCC) and Gorlin syndrome | — |
| NeuroSense Therapeutics Ltd. | NRSN | PrimeC (extended-release ciprofloxacin + celecoxib) | Amyotrophic lateral sclerosis (ALS) | — |
| Apimeds Pharmaceuticals US, Inc. | APUS | APITOX | Pain associated with osteoarthritis (and other indications) | 2027 — Contemplated spin-off of the BioBusiness / distribution of 51% of Lokahi equity (approx. twelve months from 2026-04-24) |
| NuCana plc | NCNA | NUC-7738 | PD-1 inhibitor-resistant melanoma (in combination with pembrolizumab); advanced solid tumors (Phase 1 monotherapy) | 2026 — Report data from Phase 2 expansion study in PD-1 inhibitor-resistant melanoma |
| Jupiter Neurosciences, Inc. | JUNS | JOTROL (enhanced oral resveratrol formulation) | Parkinson's disease | Q2 2027 — Phase IIa Parkinson's disease results |
| RedHill Biopharma Ltd. | RDHL | Talicia (omeprazole, amoxicillin, rifabutin) | H. pylori infection | — |
| Enlivex Ltd. | ENLV | Allocetra | Moderate-to-severe age-related primary knee osteoarthritis | Q2 2027 — Three-month topline data |
| Cadrenal Therapeutics, Inc. | CVKD | CAD-1005 | heparin-induced thrombocytopenia (HIT); also cardiac surgery-associated acute kidney injury | 2029 — NDA submission, contingent on obtaining funding to run the pivotal Phase 3 |
| GRI Bio, Inc. | GRI | GRI-0621 | Idiopathic pulmonary fibrosis (IPF) | H1 2027 — Complete IND-enabling studies, file IND, and begin Phase 1a/1b trial in healthy volunteers |
| Galmed Pharmaceuticals Ltd. | EOCN | Aramchol | Oncology (GI cancers, development being advanced); historically NASH/MASH and fibrosis | 2026 — Submit real-world data to FDA to support US pivotal study; first device revenue |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | Arakoda (tafenoquine) | Malaria prophylaxis/prevention | January 2027 — Company will request a pre-sNDA meeting with FDA in January 2027 to discuss data requirements, patient population, regulatory pathway, and post-marketing requirements for tafenoquine in babesiosis. |
| Silexion Therapeutics Corp | SLXN | SIL204 | locally advanced pancreatic cancer (KRAS-mutated) | Q1 2027 — submit IND to the FDA |
| GeoVax Labs, Inc. | GOVX | Gedeptin (GDEPT) | advanced head and neck squamous cell carcinoma | H2 2026 — Initiation of pivotal Phase 3 trial |
| Kairos Pharma, LTD. | KAPA | ENV 105 (carotuximab) | Androgen-therapy-resistant castrate-resistant prostate cancer (with apalutamide) | Q4 2027 — Kairos Pharma targets completion of the modified Phase 2 trial of ENV-105 in or before the fourth quarter of 2027. |
| Oragenics Inc | OGEN | ONP-002 | Mild traumatic brain injury (concussion) | Q4 2026 — Submit US IND (FDA Type B meeting requested July 2026) |
| Purple Biotech LTD. | PPBT | NT219 | Recurrent/metastatic squamous cell carcinoma of the head and neck | — |
| XORTX Therapeutics Inc. | XRTX | XRx-026 (XORLO, proprietary oxypurinol formulation) | Gout (hyperuricemia-associated) | date not stated — File Clinical Trial Application with Health Canada for XRX-OXY-102 (part one in Canada) |
| Matinas BioPharma Holdings, Inc. | MTNB | MAT2203 (oral amphotericin B, LNC platform) | invasive aspergillosis in patients with limited treatment options (cryptococcal meningitis Phase 2 EnACT completed) | — |
| Curis, Inc. | CRIS | emavusertib (CA-4948) | R/R primary CNS lymphoma; CLL | December 2026 — First CLL Phase 2 patient expected late Q4 2025 or early Q1 2026, with data expected at ASH in December 2026. |
| Genprex, Inc. | GNPX | REQORSA (quaratusugene ozeplasmid; GPX-001) | Non-small cell lung cancer (EGFR-mutant, post-Tagrisso) and extensive-stage small cell lung cancer | 2026 — Complete enrollment of first 25 patients for interim analysis |
| Artelo Biosciences, Inc. | ARTL | ART27.13 | cancer-related anorexia/cachexia | — |
| Lakewood-Amedex Biotherapeutics Inc. | LABT | Nu-3 (Bisphosphocin) gel | Mildly infected diabetic foot ulcers (iDFU) | — |
| SciSparc Ltd. | SPRC | SCI-110 (THC + PEA/CannAmide) | Tourette syndrome; Alzheimer's disease agitation | — |
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.