Phase 1 biotech companies
97 listed drug developers whose lead program is in Phase 1, largest first, with the next catalyst each has disclosed.
| Company | Ticker | Lead program | Indication | Next catalyst |
|---|---|---|---|---|
| Protagonist Therapeutics, Inc | PTGX | PN-881 | Immune-mediated skin diseases, plaque psoriasis (oral IL-17 antagonist peptide) | Q1 2027 — Initiation of Phase 2b psoriasis program |
| Erasca, Inc. | ERAS | ERAS-0015 | RAS-mutant solid tumors (KRAS G12X NSCLC, pancreatic adenocarcinoma, colorectal cancer) | H2 2026 — Preliminary Phase 1 monotherapy safety, PK and initial efficacy data from BOREALIS-1 |
| Arcutis Biotherapeutics, Inc. | ARQT | ZORYVE (roflumilast) topical | Plaque psoriasis, seborrheic dermatitis, atopic dermatitis | February 23, 2027 — FDA PDUFA action on sNDA |
| Enliven Therapeutics, Inc. | ELVN | ELVN-001 | chronic myeloid leukemia (CML), heavily pretreated and 2L+ | — |
| Parabilis Medicines, Inc. | PBLS | Zolucatetide | Desmoid tumors (also FAP, HCC, other Wnt/b-catenin-driven tumors, CRC) | H1 2027 — Initiation of global registrational Phase 3 trial in desmoid tumors |
| Aurinia Pharmaceuticals Inc. | AUPH | LUPKYNIS (voclosporin) | active lupus nephritis (adults) | — |
| Zymeworks Inc. | ZYME | ZW191 | Folate receptor-alpha expressing solid tumors | — |
| Septerna, Inc. | SEPN | SEP-479 | Not specified in reviewed text | Q1 2027 — Phase 1 SAD and MAD data |
| Absci Corp | ABSI | ABS-201 | Androgenetic alopecia (persistent hair loss) | Q4 2026 — Start Phase 2 in endometriosis |
| Eton Pharmaceuticals, Inc. | ETON | INCRELEX (mecasermin) | severe primary IGF-1 deficiency | March 29, 2027 — Type 9 NDA for LIBERVANT ages 6-11 expansion has PDUFA target action date of March 29, 2027. |
| Damora Therapeutics, Inc. | DMRA | DMR-001 | Essential thrombocythemia / myelofibrosis (mutCALR) | H2 2026 — Additional regulatory submissions to expand Phase 1/1b globally |
| Omeros Corp | OMER | YARTEMLEA (narsoplimab-wuug) | hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) | 2026 — Enrollment to begin in two investigator-sponsored studies (hyperinflammatory ARDS; prophylactic pediatric TA-TMA) |
| City Therapeutics, Inc. | CTY | CITY-FXI | thromboembolic disease (secondary stroke prevention, DOAC-ineligible AFib, VTE prophylaxis, cancer-associated thrombosis) | H2 2026 — Report additional Phase 1 data |
| Janux Therapeutics, Inc. | JANX | JANX007 | metastatic castration-resistant prostate cancer (PSMA) | H2 2026 — Enter clinical development |
| Monte Rosa Therapeutics, Inc. | GLUE | MRT-8102 (NEK7 molecular glue degrader) | Inflammatory diseases (NEK7/NLRP3-driven) | — |
| Aktis Oncology, Inc. | AKTS | [225Ac]Ac-AKY-1189 | Locally advanced or metastatic urothelial cancer (Nectin-4 expressing solid tumors) | Q1 2027 — Preliminary results from Part-1 dose escalation portion of Phase 1b trial |
| Adlai Nortye Group Ltd. | ANL | AN4035 | CEACAM5-enriched, RAS-addicted solid tumors (colorectal, pancreatic, lung) | H2 2027 — Report full Phase Ia data |
| Iambic Therapeutics, Inc. | IAM | IAM1363 | HER2-altered advanced solid tumors (HER2-positive breast, GEA, HER2-amplified/mutant NSCLC) | Q4 2026 — IND submission, then Phase 1/2 initiation |
| Prime Medicine, Inc. | PRME | PM577a | Wilson disease | H1 2027 — BLA submission |
| Attovia Therapeutics, Inc. | ATTO | ATTO-1310 | Chronic pruritus / high-itch atopic dermatitis (also CPUO, cholestatic pruritus, CKD-aP planned) | H1 2027 — Initiate Phase 2 clinical trial |
| Shattuck Labs, Inc. | STTK | SL-325 | Inflammatory bowel disease (Crohn's disease Phase 2b planned) | H2 2026 — Additional preclinical data including NHP toxicology |
| CytomX Therapeutics, Inc. | CTMX | Varsetatug masetecan (Varseta-M, CTMX-2051) | EpCAM-expressing solid tumors; late-line metastatic colorectal cancer | Q4 2026 — Phase 1/2 study start |
| Arvinas, Inc. | ARVN | ARV-393 | Relapsed/refractory lymphoma (BCL6 PROTAC) | H2 2026 — Monotherapy data |
| Crescent Biopharma, Inc. | CBIO | CR-001 (SKB118) | Solid tumors incl. NSCLC (PD-1 x VEGF bispecific antibody) | Q4 2026 — Global Phase 1/2 APOLLO trial of CR-002 expected to initiate in fourth quarter of 2026. |
| Prothena Corp Public Ltd Co | PRTA | PRX012 | Alzheimer's disease | — |
| Assembly Biosciences, Inc. | ASMB | ABI-6250 | chronic hepatitis delta virus (HDV) infection; planned PBC/PSC | Q4 2026 — initiate Phase 2 study in HDV |
| TRex Bio, Inc. | TRXB | TRB-061 | Moderate-to-severe atopic dermatitis (also exploring alopecia areata and other autoimmune and inflammatory diseases) | H2 2026 — Lilly intends to start Phase 2a trial in lupus with cutaneous involvement |
| Seismic Therapeutic, Inc. | Unknown | STX-1150 | Elevated LDL-C and increased risk of atherosclerotic cardiovascular disease (ASCVD) | date not stated — Phase 1 clinical trial ongoing to evaluate safety, tolerability, and LDL-C lowering activity |
| Prelude Therapeutics Inc | PRLD | PRT12396 | polycythemia vera and myelofibrosis (JAK2V617F-mutant MPN) | Q4 2026 — Prelude expects to initiate a Phase 1 trial of PRT13722 in patients with HR+/HER2- breast cancer in the fourth quarter of 2026. |
| Century Therapeutics, Inc. | IPSC | CNTY-101 (iPSC-derived allogeneic CD19 CAR-iNK) | B-cell malignancies / autoimmune (CARAMEL investigator-sponsored Phase 1/2) | Q4 2026 — IND submission |
| Fate Therapeutics Inc | FATE | FT819 (iPSC-derived CAR T-cell) | systemic lupus erythematosus (with and without lupus nephritis) | — |
| Palisade Bio, Inc. | PALI | PALI-2108 | ulcerative colitis (UC) and Crohn's disease (incl. fibrostenotic Crohn's, FSCD) | H2 2026 — Initiate patient enrollment (first patient) |
| BridgeBio Oncology Therapeutics, Inc. | BBOT | BBO-8520 | KRAS G12C-mutated non-small cell lung cancer | H2 2026 — Updated Phase 1 clinical data |
| Pyxis Oncology, Inc. | PYXS | micvotabart pelidotin (MICVO, formerly PYX-201) | Recurrent/metastatic head and neck squamous cell carcinoma (2L+ monotherapy; 1L/2L+ with pembrolizumab) and other solid tumors | Q4 2026 — Updated clinical data from Phase 1/2 dose escalation, focused on 1L R/M HNSCC |
| Perspective Therapeutics, Inc. | CATX | VMT-alpha-NET | Neuroendocrine tumors (Pb-212 alpha therapy) | October 2026 — ESMO data update |
| Compugen Ltd | CGEN | COM701 | Relapsed platinum-sensitive ovarian cancer (maintenance, single agent; MAIA-ovarian trial) | Q1 2027 — Interim analysis of MAIA-ovarian trial |
| Precision BioSciences, Inc. | DTIL | PBGENE-HBV | chronic hepatitis B | 2026 — FUNCTION-DMD initial safety data |
| Whitehawk Therapeutics, Inc. | WHWK | HWK-007 | Solid tumors incl. NSCLC and ovarian cancer (PTK7 ADC) | 2026 — FDA clearance of IND |
| ProQR Therapeutics N.V. | PRQR | AX-0810 | cholestatic diseases (NTCP target) | — |
| Yarrow Bioscience, Inc. | YARW | YB-101 (GenSci098) | Graves' disease; thyroid eye disease planned | Q4 2026 — Final report of repeat non-clinical toxicology study in male dogs |
| Sutro Biopharma, Inc. | STRO | STRO-004 (tissue factor-directed ADC) | advanced TF-expressing solid tumors | Q4 2026 — IND submission |
| Macrogenics Inc | MGNX | MGC026 (B7-H3 TOP1i ADC) / MGC028 (ADAM9 TOP1i ADC) | advanced solid tumors | H2 2026 — Initial clinical data report |
| Veraxa Biotech AG - Post de-SPAC | VRXA | VX-A901 (FLYSIN) | acute myeloid leukemia (AML) | — |
| Anavex Life Sciences Corp. | AVXL | ANAVEX 2-73 (blarcamesine) | Early Alzheimer's disease; Rett syndrome; Fragile X syndrome | November 2026 — Anavex has an FDA meeting scheduled for November to discuss adding pediatric participants to the Phase 3 Rett syndrome study. |
| Foghorn Therapeutics Inc. | FHTX | FHD-909 (LY4050784), selective SMARCA2 inhibitor | SMARCA4-mutated cancers, primarily NSCLC | date not stated — Potential IND filings (up to four) |
| Voyager Therapeutics, Inc. | VYGR | VY7523 | Alzheimer's disease (anti-tau antibody) | H2 2026 — Initial tau PET imaging data |
| Anixa Biosciences Inc | ANIX | lira-cel (liraltagene autoleucel) | Recurrent epithelial ovarian cancer | date not stated — Completion of Phase 1 dose-escalation study |
| Tevogen Inc. | TVGN | TVGN 489 (ExacTcell allogeneic, off-the-shelf CTL therapy) | COVID-19 in high-risk and immunocompromised patients; Long COVID | — |
| Tenaya Therapeutics, Inc. | TNYA | TN-201 | MYBPC3-associated hypertrophic cardiomyopathy (MyPEAK-1) | Q4 2026 — One-year Cohort 2 and two-year Cohort 1 data |
| Rallybio Corp | RLYB | RLYB116 | complement-mediated diseases (C5 inhibitor, once-weekly subcutaneous) | 2026 — Reverse merger closing and concurrent $215.0M financing (corporate event) |
| Rani Therapeutics Holdings, Inc. | RANI | RT-114 (RaniPill HC with PG-102 bispecific GLP-1/GLP-2 agonist) | Obesity | 2026 — Start of Phase 1b repeat-dose study in patients with obesity |
| ProMIS Neurosciences Inc. | PMN | PMN310 | Early Alzheimer's disease | Q1 2027 — Unblinded 12-month topline data from PRECISE-AD |
| Neumora Therapeutics, Inc. | NMRA | NMRA-511 | Agitation in Alzheimer's disease (V1aR antagonist) | H2 2026 — NMRA-898 Phase 1 MAD data expected in the second half of 2026. |
| Spero Therapeutics, Inc. | SPRO | SP001 | IgG4-related disease | Q2 2027 — Advance into Phase 2 trial in IgG4-RD patients (subject to FDA IND clearance) |
| Caribou Biosciences, Inc. | CRBU | vispacabtagene regedleucel (vispa-cel, CB-010) | relapsed/refractory B cell non-Hodgkin lymphoma (2L LBCL) | — |
| Gain Therapeutics, Inc. | GANX | Rexaceract (GT-02287) | Parkinson's disease with or without GBA1 mutation | — |
| Pliant Therapeutics, Inc. | PLRX | PLN-101095 | solid tumors resistant to immune checkpoint inhibitors (NSCLC, ccRCC, high-TMB tumors) in combination with pembrolizumab | H2 2026 — Additional platform detail and initial treatment indications |
| Actinium Pharmaceuticals, Inc. | ATNM | Iomab-ACT | CD45-targeted conditioning before CAR-T / cell and gene therapy (R/R NHL, B-cell malignancies, sickle cell disease BMT) | Q4 2026 — Data from ongoing clinical studies |
| Werewolf Therapeutics, Inc. | HOWL | WTX-124 | Immunotherapy-sensitive advanced or metastatic solid tumors (incl. cutaneous melanoma), monotherapy and with pembrolizumab | Q4 2026 — Completion of Phase 1/1b clinical trial |
| iBio, Inc. | IBIO | IBIO-600 | Obesity (long-acting myostatin antibody) | H1 2027 — Commence first-in-human clinical trial |
| Kalaris Therapeutics, Inc. | KLRS | TH103 | Neovascular age-related macular degeneration (nAMD) | H1 2027 — Preliminary data from Phase 1b/2 trial |
| Serina Therapeutics, Inc. | SER | SER-252 (POZ-apomorphine) | advanced Parkinson's disease | — |
| Scynexis Inc | SCYX | SCY-770 | Autosomal dominant polycystic kidney disease (ADPKD) | Q4 2026 — Initiate Phase 2 proof-of-concept study in ADPKD |
| Adicet Bio, Inc. | ACET | prula-cel (prulacabtagene leucel, ADI-001) | autoimmune diseases (lupus nephritis, SLE, SSc, AAV, IIM, SPS) | H2 2026 — Potential pivotal program start in LN, subject to regulatory clearance |
| Nanoviricides, Inc. | NNVC | NV-387 | viral infections: Mpox, Ebola, COVID-19, viral acute respiratory infections (RSV, influenza, coronaviruses, hMPV) | date not stated — Initiation of Phase II trial |
| Genenta Science S.p.A. | GNTA | Temferon | Newly diagnosed unmethylated MGMT glioblastoma multiforme (TEM-GBM) | — |
| Transcode Therapeutics, Inc. | RNAZ | TTX-MC138 | advanced solid tumors / metastatic cancers (miR-10b overexpressing); Phase 2a in ctDNA-positive MRD colorectal cancer | — |
| Mira Pharmaceuticals, Inc. | MIRA | Ketamir-2 | chemotherapy-induced peripheral neuropathy (CIPN) | Q1 2027 — Initiation of Phase 2a trial in CIPN |
| Context Therapeutics Inc. | CNTX | CTIM-76 | CLDN6-positive gynecologic and testicular cancers; platinum-resistant ovarian cancer | Q1 2027 — Initiation of Phase 1b dose expansion trial |
| Seres Therapeutics, Inc. | MCRB | SER-155 | Bloodstream infection prevention in allo-HCT patients; immune checkpoint-related enterocolitis (irEC) | 2026 — IND-readiness |
| Quantum BioPharma Ltd. | QNTM | Lucid-MS (Lucid-21-302) | Multiple sclerosis | — |
| Cocrystal Pharma, Inc. | COCP | CDI-988 | Norovirus (prevention and treatment) | H2 2026 — Cocrystal expects preliminary efficacy results from CDI-988 Phase 1b study in late 2026 or early 2027. |
| Marker Therapeutics, Inc. | MRKR | MT-601 | Relapsed lymphoma (post anti-CD19 CAR-T or ineligible) | 2026 — Commence larger pivotal trial in lymphoma |
| Pasithea Therapeutics Corp. | KTTA | PAS-004 | neurofibromatosis type 1 plexiform neurofibromas (NF1-PN) and MAPK pathway-driven advanced tumors | 2028 — Complete first-in-human Phase 1 advanced cancer study |
| Tvardi Therapeutics, Inc. | TVRD | TTI-109 | Ulcerative colitis | Q4 2026 — Topline data from REVERT LIVER CANCER Phase 1b/2 clinical trial |
| Bolt Biotherapeutics, Inc. | BOLT | BDC-4182 | claudin 18.2-positive gastric/gastroesophageal junction cancer | — |
| GT Biopharma, Inc. | GTBP | GTB-3650 | relapsed/refractory CD33+ AML and high-risk MDS | — |
| CytoMed Therapeutics Ltd | GDTC | CTM-N2D | cancer (ANGELICA safety trial; specific tumor type not stated in extract) | 2026 — Recruit additional patients |
| IN8BIO, Inc. | INAB | INB-100 | high-risk leukemias (AML) undergoing haploidentical stem cell transplantation | H2 2026 — Complete treatment of all expansion-cohort patients and present clinical update |
| Phio Pharmaceuticals Corp. | PHIO | PH-762 | Cutaneous squamous cell carcinoma (PD-1 siRNA, INTASYL) | — |
| Tempest Therapeutics, Inc. | TPST | TPST-2003 | Relapsed/refractory multiple myeloma; POEMS syndrome | Q4 2026 — First patient dosing in China IIT |
| Aprea Therapeutics, Inc. | APRE | APR-1051 | biomarker-defined solid tumors (uterine serous carcinoma, cyclin E-overexpressing platinum-resistant ovarian cancer) | Q4 2026 — Next clinical data update from ACESOT-1051 at a medical meeting |
| Lexaria Bioscience Corp. | LEXX | DehydraTECH-GLP-1 (GLP-1-H24-4) | Obesity/GLP-1 oral delivery | Q4 2026 — Animal study results |
| FibroBiologics, Inc. | FBLG | CYWC628 | Diabetic foot ulcers (wound healing) | H2 2026 — Six-week interim safety and primary efficacy data once 28 patients per arm complete 6 weeks |
| Senti Biosciences Holdings, Inc. | SNTI | SENTI-202 | Relapsed/refractory hematologic malignancies including acute myeloid leukemia (CD33/FLT3 Logic Gated CAR-NK) | — |
| Creative Medical Technology Holdings, Inc. | CELZ | Olastrocel (CELZ-201, ADAPT trial) | chronic lower back pain due to degenerative disc disease | — |
| Pulmatrix, Inc. | PULM | PUR3100 (inhaled dihydroergotamine, iSPERSE) | Acute migraine | 2026 — Licensee Cipla expected to commence Phase 3 (ex-US; not sponsored by Pulmatrix) |
| Processa Pharmaceuticals, Inc. | PCSA | VT-7208 | Food allergy, chronic spontaneous urticaria, relapsing multiple sclerosis | H2 2026 — Initiate Phase 2 studies in food allergy and CSU |
| Azitra, Inc. | AZTR | ATR-04 | EGFR-inhibitor-associated papulopustular rash in cancer patients | Q4 2026 — Initial data from Cohort 1 of Phase 1/2 trial |
| Clearmind Medicine Inc. | CMND | Psychedelic-derived candidates (e.g. MEAI-based) | Alcohol use disorder and other CNS indications | — |
| Aptevo Therapeutics Inc. | APVO | mipletamig (APVO436) | frontline acute myeloid leukemia (AML), in combination with venetoclax + azacitidine | — |
| Mustang Bio, Inc. | MBIO | MB-101 (IL13Ra2-targeted CAR T) / MB-109 (MB-101 + MB-108 oncolytic HSV-1) | IL13Ra2+ recurrent glioblastoma and high-grade astrocytoma | Q4 2026 — Potential initiation of investigator-sponsored single-institution Phase 1 trial at City of Hope |
| HCW Biologics Inc. | HCWB | HCW9302 | Alopecia areata (autoimmune) | Q4 2026 — Full Phase 1 human data readout |
| PRF Technologies Ltd. | PRFX | OcuRing-K (ketorolac sustained-release intraocular ring; LayerBio) | Post-cataract-surgery inflammation and pain | 2026 — LayerBio expects to start patient enrollment in the planned U.S. multi-center Phase 2 trial of OcuRing-K before year-end 2026. |
| Calidi Biotherapeutics, Inc. | CLDI | NeuroNova (stem-cell-based oncolytic virus) | oncology (investigator-initiated Phase 1 run by City of Hope) | Q1 2027 — Enter the clinic (first-in-human) |
| Revelation Biosciences, Inc. | REVB | Gemini (PHAD formulation), GEM-AKI | Acute kidney injury | — |
| Valion Bio, Inc. | VBIO | Entolimod | Acute radiation syndrome | — |
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.