Phase 1 biotech companies
95 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 |
|---|---|---|---|---|
| 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 |
| 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 |
| Arcutis Biotherapeutics, Inc. | ARQT | ARQ-234 | moderate-to-severe atopic dermatitis | February 23, 2027 — FDA PDUFA action on sNDA |
| Xencor Inc | XNCR | XmAb819 (ENPP3 x CD3) | Clear cell renal cell carcinoma (ccRCC) | — |
| Septerna, Inc. | SEPN | SEP-479 | Not specified in reviewed text | Q1 2027 — SEP-479 Phase 1 SAD/MAD data anticipated in Q1 2027. |
| Schrodinger, Inc. | SDGR | SGR-1505 | relapsed or refractory B-cell malignancies | 2026 — Full commercial version release |
| Aurinia Pharmaceuticals Inc. | AUPH | aritinercept | autoimmune diseases | date not stated — Primary endpoint: proportion of patients achieving complete renal response at 6 months |
| Vir Biotechnology, Inc. | VIR | VIR-5500/ASP6958 | metastatic castration-resistant prostate cancer (mCRPC) | November 2026 — Presentation of expanded Phase 2 SOLSTICE results at AASLD |
| Zymeworks Inc. | ZYME | ZW191 | Folate receptor-alpha expressing solid tumors | — |
| Absci Corp | ABSI | ABS-201 | Androgenetic alopecia (persistent hair loss) | Q4 2026 — Start Phase 2 in endometriosis |
| Lycia Therapeutics, Inc. | LYCA | LCA-0061 | Food allergy and other allergic diseases | H2 2027 — Phase 1 clinical trial initiation and initial data |
| Damora Therapeutics, Inc. | DMRA | DMR-001 | Essential thrombocythemia (ET) and myelofibrosis (MF) | Q4 2026 — First regulatory submission |
| Omeros Corp | OMER | YARTEMLEA (narsoplimab-wuug) | hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) | 2026 — Start enrollment in in-patient clinical trial in cocaine use disorder |
| Janux Therapeutics, Inc. | JANX | JANX007 | metastatic castration-resistant prostate cancer (mCRPC) | — |
| 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 |
| 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 |
| Prime Medicine, Inc. | PRME | PM577a | Wilson disease | H1 2027 — BLA submission |
| Rigel Pharmaceuticals Inc | RIGL | R289 | relapsed/refractory lower-risk myelodysplastic syndromes | 2026 — Recommended Phase 2 dose selection; completion of enrollment in Phase 1b study |
| 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 |
| Adlai Nortye Group Ltd. | ANL | AN4035 | CEACAM5-enriched, RAS-addicted solid tumors (colorectal, pancreatic, lung) | H2 2027 — Report full Phase Ia data |
| Bambusa Therapeutics, Inc. | BBTX | BBT001 | Atopic Dermatitis (moderate-to-severe) | 2026 — Phase 2b AD Study initiation |
| Crescent Biopharma, Inc. | CBIO | CR-001 (SKB118) | Solid tumors incl. NSCLC (PD-1 x VEGF bispecific antibody) | Q4 2026 — Crescent is on track to initiate the global Phase 1/2 APOLLO trial of CR-002 in the fourth quarter of 2026. |
| 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 |
| CytomX Therapeutics, Inc. | CTMX | Varsetatug Masetecan (Varseta-M) | metastatic colorectal cancer (mCRC), later expanding to other EpCAM-expressing tumors | Q4 2026 — Phase 1/2 combination study initiation |
| Arvinas, Inc. | ARVN | ARV-6723 | advanced solid tumors | — |
| Assembly Biosciences, Inc. | ASMB | ABI-6250 | chronic hepatitis delta virus (HDV) infection; planned PBC/PSC | Q4 2026 — initiate Phase 2 study in HDV |
| Prothena Corp Public Ltd Co | PRTA | PRX012 | Alzheimer's disease | — |
| Tevogen Inc. | TVGN | TVGN 489 (ExacTcell allogeneic, off-the-shelf CTL therapy) | COVID-19 in high-risk and immunocompromised patients; Long COVID | — |
| 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 |
| Alector, Inc. | ALEC | AL137 | Alzheimer's disease | April 2027 — First-in-human subcutaneous dosing in Australia |
| 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 |
| Scribe Therapeutics, Inc. | SCTX | STX-1150 | elevated LDL-C and increased risk of ASCVD | — |
| Precision BioSciences, Inc. | DTIL | PBGENE-HBV | chronic hepatitis B | Q1 2027 — PBGENE-HBV Phase 2 ELIMINATE-B2 study initiation expected in Q1 2027. |
| Prelude Therapeutics Inc | PRLD | PRT12396 | polycythemia vera and myelofibrosis (JAK2V617F-mutant MPN) | Q4 2026 — Phase 1 study of PRT13722 in HR+/HER2- breast cancer anticipated to begin enrolling in Q4 2026. |
| Camp4 Therapeutics Corp | CAMP | CMP-002 | SYNGAP1-related disorder (developmental and epileptic encephalopathy) | Q4 2026 — First patient dosed |
| Korro Bio, Inc. | KRRO | KRRO-121 | hyperammonemia in patients with urea cycle disorders (UCDs) and hepatic encephalopathy (HE) | February 2027 — Collaboration termination effective |
| Palisade Bio, Inc. | PALI | PALI-2108 | ulcerative colitis (UC) and Crohn's disease (incl. fibrostenotic Crohn's, FSCD) | H2 2026 — Submit IND for Phase 2 trial |
| ProQR Therapeutics N.V. | PRQR | AX-0810 | cholestatic diseases (NTCP target) | — |
| Compugen Ltd | CGEN | COM701 | Relapsed platinum-sensitive ovarian cancer (maintenance, single agent; MAIA-ovarian trial) | Q1 2027 — Interim analysis of MAIA-ovarian trial |
| Whitehawk Therapeutics, Inc. | WHWK | HWK-007 | Solid tumors incl. NSCLC and ovarian cancer (PTK7 ADC) | 2026 — FDA clearance of IND |
| BridgeBio Oncology Therapeutics, Inc. | BBOT | BBO-8520 | KRAS G12C-mutated non-small cell lung cancer | H2 2026 — Updated Phase 1 clinical data |
| 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 |
| 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 |
| Veraxa Biotech AG - Post de-SPAC | VRXA | VX-A901 (FLYSIN) | acute myeloid leukemia (AML) | — |
| Voyager Therapeutics, Inc. | VYGR | VY1706 | Alzheimer's disease (early stage with tau pathology) | Q4 2026 — VY7523 tau PET imaging efficacy data from MAD trial expected in Q4 2026. |
| Foghorn Therapeutics Inc. | FHTX | FHD-909 (LY4050784), selective SMARCA2 inhibitor | SMARCA4-mutated cancers, primarily NSCLC | date not stated — Potential IND filings (up to four) |
| Anixa Biosciences Inc | ANIX | lira-cel (liraltagene autoleucel) | Recurrent epithelial ovarian cancer | date not stated — Completion of Phase 1 dose-escalation study |
| Anavex Life Sciences Corp. | AVXL | ANAVEX 2-73 (blarcamesine) | Early Alzheimer's disease; Rett syndrome; Fragile X syndrome | — |
| Perspective Therapeutics, Inc. | CATX | VMT-alpha-NET | Neuroendocrine tumors (Pb-212 alpha therapy) | H2 2026 — Further VMT01 melanoma data expected in late 2026. |
| 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. |
| Rallybio Corporation | RLYB | RLYB116 | Complement dysregulation diseases | — |
| 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 |
| Spero Therapeutics, Inc. | SPRO | SP001 | IgG4-related disease | Q2 2027 — Advance into Phase 2 trial in IgG4-RD patients (subject to FDA IND clearance) |
| Kalaris Therapeutics, Inc. | KLRS | TH103 | Neovascular age-related macular degeneration (nAMD) | H1 2027 — Preliminary data from Phase 1b/2 trial |
| Telomir Pharmaceuticals, Inc. | TELO | Telomir-Zn | advanced or metastatic triple-negative breast cancer (TNBC) | date not stated — Phase 1/2 clinical trial commencement in advanced or metastatic TNBC |
| 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 |
| 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 |
| Caribou Biosciences, Inc. | CRBU | vispacabtagene regedleucel (vispa-cel) | — | — |
| iBio, Inc. | IBIO | IBIO-600 | Obesity (long-acting myostatin antibody) | H1 2027 — Commence first-in-human clinical trial |
| Genenta Science S.p.A. | GNTA | Temferon | Newly diagnosed unmethylated MGMT glioblastoma multiforme (TEM-GBM) | — |
| Gain Therapeutics, Inc. | GANX | Rexaceract (GT-02287) | Parkinson's disease with or without GBA1 mutation | Q1 2027 — Company expects to submit Phase 2 protocol to FDA in coming weeks and initiate Phase 2 trial in Q1 2027. |
| 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 |
| ProMIS Neurosciences Inc. | PMN | PMN310 | Early Alzheimer's disease | Q1 2027 — Unblinded 12-month topline data from PRECISE-AD |
| 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 — Phase 2 proof-of-concept study initiation |
| 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 |
| Adicet Bio, Inc. | ACET | prula-cel | systemic lupus erythematosus (SLE), including lupus nephritis (LN) and extra-renal SLE | Q4 2026 — FDA engagement regarding potential expansion of pivotal development program to include lupus patients without nephritis |
| 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 |
| Cocrystal Pharma, Inc. | COCP | CDI-988 | Norovirus (prevention and treatment) | H2 2026 — Cocrystal expects preliminary efficacy results from Phase 1b norovirus challenge study in late 2026 or early 2027. |
| 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 |
| Quantum BioPharma Ltd. | QNTM | Lucid-MS (Lucid-21-302) | Multiple sclerosis | — |
| 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 |
| Marker Therapeutics, Inc. | MRKR | MT-601 | Relapsed lymphoma (post anti-CD19 CAR-T or ineligible) | 2026 — Commence larger pivotal trial in lymphoma |
| Tvardi Therapeutics, Inc. | TVRD | TTI-109 | ulcerative colitis | Q4 2026 — Topline data across three cohorts of REVERT LIVER CANCER Phase 1b/2 trial |
| Bolt Biotherapeutics, Inc. | BOLT | BDC-4182 | claudin 18.2-positive gastric/gastroesophageal junction cancer | — |
| CytoMed Therapeutics Ltd | GDTC | CTM-N2D | cancer (ANGELICA safety trial; specific tumor type not stated in extract) | — |
| Lexaria Bioscience Corp. | LEXX | DehydraTECH-GLP-1 (GLP-1-H24-4) | Obesity/GLP-1 oral delivery | Q4 2026 — Animal study results |
| GT Biopharma, Inc. | GTBP | GTB-3650 | relapsed/refractory CD33+ AML and high-risk MDS | — |
| 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 | PPP2R1A-mutated endometrial cancer (uterine serous carcinoma) and cyclin E-overexpressing platinum-resistant ovarian cancer | November 2026 — Clinical data update at 38th EORTC-NCI-AACR Symposium |
| 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) | October 2033 — Senti announces CVR milestones for SENTI-202: BLA filing, FDA approval, and $200M net sales by October 2033. |
| Processa Pharmaceuticals, Inc. | PCSA | VT-7208 | Food allergy, chronic spontaneous urticaria, relapsing multiple sclerosis | — |
| Pulmatrix, Inc. | PULM | PUR3100 (inhaled dihydroergotamine, iSPERSE) | Acute migraine | 2026 — Licensee Cipla expected to commence Phase 3 (ex-US; not sponsored by Pulmatrix) |
| Azitra, Inc. | AZTR | ATR-04 | EGFR-inhibitor-associated papulopustular rash in cancer patients | H2 2026 — Cosmetic study in human participants |
| Medicus Pharma Ltd. | MDCX | CD228V (PF-08046031) | melanoma, particularly relapsed or refractory disease | date not stated — clinical proof-of-concept in melanoma, supported by existing U.S. IND and first-in-human Phase 1 clinical study (NCT06799533) |
| Aptevo Therapeutics Inc. | APVO | mipletamig (APVO436) | frontline acute myeloid leukemia (AML), in combination with venetoclax + azacitidine | Q4 2026 — Aptevo expects to complete the current RAINIER study by year-end 2026. |
| PRF Technologies Ltd. | PRFX | OcuRing-K (ketorolac sustained-release intraocular ring; LayerBio) | Post-cataract-surgery inflammation and pain | Q4 2026 — LayerBio expects to start patient enrollment in U.S. multi-center Phase 2 trial of OcuRing-K before year-end 2026. |
| Mustang Bio, Inc. | MBIO | MB-109 (combination of MB-101 CAR T and MB-108 oncolytic virus) | IL13Rα2+ relapsed or refractory glioblastoma and high-grade astrocytoma | Q1 2027 — Potential initiation of investigator-sponsored single-institution trial at COH |
| Clearmind Medicine Inc. | CMND | Psychedelic-derived candidates (e.g. MEAI-based) | Alcohol use disorder and other CNS indications | — |
| 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) |
| HCW Biologics Inc. | HCWB | HCW9302 | Alopecia areata (autoimmune) | Q4 2026 — Full Phase 1 human data readout |
| 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.