Pre-clinical biotech companies
47 listed drug developers whose lead program is in Pre-clinical, largest first, with the next catalyst each has disclosed.
| Company | Ticker | Lead program | Indication | Next catalyst |
|---|---|---|---|---|
| Glaukos Corporation | GKOS | RevOpsis multi-specific biologic molecule | retinal disease (neovascular AMD, diabetic macular edema, retinal vein occlusion) | 2027 — Company is preparing to commence Phase 3 clinical program for third-generation customized tomography-guided iLink therapy in 2027. |
| Legend Biotech Corp | LEGN | CARVYKTI (ciltacabtagene autoleucel, cilta-cel) | relapsed/refractory multiple myeloma | December 2026 — Legend to present CITADEL study results on preemptive steroid strategy to mitigate immune effector cell-associated parkinsonism following CARVYKTI at ASH 2026. |
| ADMA Biologics, Inc. | ADMA | SG-001 | Treatment and prevention of S. pneumoniae infection | date not stated — IND submission |
| Regencell Bioscience Holdings Limited | RGC | Standardized TCM Formula for ADHD and ASD | Attention-Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD) | — |
| Novavax, Inc. | NVAX | Clostridioides difficile colitis vaccine | Clostridioides difficile colitis | H1 2027 — Completion of tech transfer (triggers $75M milestone) |
| Korsana Biosciences, Inc. | KRSA | KRSA-028 | Alzheimer's disease | Q4 2026 — CTN (Australia) or CTA (New Zealand) submission |
| Sana Biotechnology, Inc. | SANA | SC451 | Type 1 diabetes | 2026 — IND filing and Phase 1/2 trial initiation |
| Surrozen, Inc. | SRZN | SZN-8141 | diabetic macular edema; neovascular AMD | 2026 — Initiation of Phase 1b/2a DUET study in DME |
| Indaptus Therapeutics, Inc. | INDP | Decoy20 | advanced solid tumors (anti-cancer/anti-viral immunotherapy; clinical development discontinued) | — |
| SL Science Holding Ltd | SLBT | CD-19 Armed-T Therapy | CD19+ blood cancers (Armed-T bispecific-antibody-conjugated immune cells) | Q1 2027 — Pre-IND meeting request |
| Editas Medicine, Inc. | EDIT | EDIT-401 | Heterozygous familial hypercholesterolemia / elevated LDL-C | Q1 2027 — Editas expects to report initial safety and tolerability data from EDIT-401 Phase 1/2 trial in the first quarter of 2027. |
| Fulcrum Therapeutics, Inc. | FULC | — | — | — |
| Abeona Therapeutics Inc. | ABEO | ZEVASKYN (prademagene zamikeracel) | Wounds in recessive dystrophic epidermolysis bullosa (RDEB) | — |
| Alpha Cognition Inc. | ACOG | ZUNVEYL (benzgalantamine) | Mild to moderate dementia of the Alzheimer's type | — |
| Atrium Therapeutics, Inc. | RNA | ATR 1072 | PRKAG2 syndrome | H2 2027 — Atrium expects initial proof of concept data from the Phase 1/2 Corventis trial in the second half of 2027. |
| Equillium, Inc. | EQ | EQ504 | ulcerative colitis and other GI diseases (inflammatory lung diseases as expansion) | — |
| OnKure Therapeutics, Inc. | OKUR | OKI-345 | breast cancer | H1 2027 — IND submission |
| Cellectis S.A. | CLLS | .HEAL-101 | severe hypertriglyceridemia (in vivo APOC3 base editing) | H2 2027 — Preliminary Phase 1 IIT data (China) |
| Boundless Bio, Inc. | BOLD | none active (BBI-940 clinical development halted Jun 2026) | — | — |
| Heron Therapeutics, Inc. | HRTX | ZYNRELEF (bupivacaine and meloxicam) | Postsurgical analgesia for up to 72 hours after soft tissue and orthopedic surgery | — |
| Instil Bio, Inc. | TIL | — | — | — |
| Metagenomi Therapeutics, Inc. | MGX | MGX-001 | Hemophilia A (site-specific Factor VIII gene integration, AAV + LNP) | Q4 2026 — Metagenomi plans to submit IND for MGX-001 in hemophilia A in Q4 2026. |
| CDT Equity Inc. | CDT | AZD1656 co-crystal (HK-4 glucokinase activator) | inflammatory/autoimmune disorders (repurposing, AI-guided) | — |
| NextCure, Inc. | NXTC | — | — | — |
| Akari Therapeutics Plc | AKTX | AKTX-101 | Solid tumors (Trop-2 expressing; first-in-human planned in bladder cancer) | 2027 — Advance into clinical trials (Phase 1 first-in-human) |
| Pluri Inc. | PLUR | PLX cell therapy (placental-derived adherent stromal cells) | — | — |
| aTyr Pharma, Inc. | ATYR | ATYR0101 | fibrotic diseases (pulmonary fibrosis, systemic sclerosis, liver fibrosis, kidney fibrosis) | Q4 2026 — Study-related activities for Proposed Phase 3 Study |
| NewcelX Ltd. | NCEL | NCEL-101 | Type 1 diabetes (and potentially insulin-dependent type 2 diabetes) | date not stated — IND submission for NCEL-101 plus tegoprubart Phase 1/2a trial |
| AEON Biopharma, Inc. | AEON | ABP-450 | Botulinum toxin (351(k) biosimilar to Botox; neurology/aesthetic indications) | 2026 — Complete majority of analytical comparability program |
| Adial Pharmaceuticals, Inc. | AZR | AT177 | ulcerative colitis | Q2 2027 — IND filing |
| Curanex Pharmaceuticals Inc | CURX | Phyto-N | Ulcerative colitis (lead); also atopic dermatitis, rheumatoid arthritis, gout, diabetic foot, cancer cachexia | Q4 2026 — IND submission for ulcerative colitis |
| IN8BIO, Inc. | INAB | INB-619 | B cell-driven autoimmune diseases (systemic lupus erythematosus) | November 2026 — Additional mOS data at Society for Neuro-Oncology Annual Meeting |
| InMed Pharmaceuticals Inc. | INM | INM-901 | Alzheimer's disease | — |
| Alaunos Therapeutics, Inc. | TCRT | ALN1003 | obesity and metabolic disorders (MASLD, insulin resistance) | 2028 — Alaunos, after acquiring Velaris and a $350M private placement, expects clinical proof-of-concept data for VLR199 (ActRIIA-Fc ligand trap, PAH) in 2028. |
| Enveric Biosciences, Inc. | ENVB | EB-003 | depression or other neuropsychiatric disorders | date not stated — IND Filing |
| Addex Therapeutics Ltd. | ADXN | Dipraglurant (mGlu5 NAM) | Post-stroke / traumatic brain injury recovery | — |
| Xenetic Biosciences, Inc. | XBIO | systemic DNase (IV rhDNase I) | adjunctive therapy for pancreatic ductal adenocarcinoma, colorectal and other locally advanced or metastatic solid tumors | Q4 2026 — Pivotal study in SLE expected to start Q4 2026. |
| PharmaCyte Biotech, Inc. | PMCB | CypCaps (Cell-in-a-Box encapsulated cells with prodrug) | locally advanced, inoperable, non-metastatic pancreatic cancer (LAPC) | November 30, 2026 — Nasdaq minimum bid price compliance deadline; reverse split authorized if needed |
| XTL Biopharmaceuticals Ltd | XTLB | Psyga Bio psilocybin-derived candidates (Phase 2a trials approved, not yet enrolling) | Treatment-resistant depression, PTSD, anorexia, addiction and other CNS/mental health disorders | H1 2027 — Commencement of at least three human clinical trials (milestone for earn-out shares) |
| Liminatus Pharma, Inc. | LIMN | IBA101 (Hu3A5 anti-CD47 monoclonal antibody) | advanced solid cancers including NSCLC | 2026 — Phase 1 clinical trial start (scheduled) |
| Ernexa Therapeutics Inc. | ERNA | ERNA-101 | platinum-resistant ovarian cancer | Q4 2026 — IND submission |
| Decoy Therapeutics Inc. | DCOY | IMP3ACT Designable Multi-Antivirals (D-MAV) peptide conjugates | respiratory viruses | H1 2027 — File IND (FDA) or CTA (EU equivalent) |
| Silo Pharma, Inc. | SILO | SPC-15 | PTSD and stress-induced anxiety disorders (intranasal prophylactic) | 2026 — IND submission |
| Propanc Biopharma, Inc. | PPCB | PRP (proenzyme therapy: trypsinogen and chymotrypsinogen) | recurrence/metastasis prevention in pancreatic, ovarian and colorectal cancers (solid tumors) | Q4 2026 — Submit clinical trial application (CTA) for First-In-Human study |
| Nexentis Technologies Ltd. | NXTS | MitoCareX SLC25A inhibitors | cancer | — |
| Scinai Immunotherapeutics Ltd. | SCNI | NanoAbs (VHH antibody fragment) pipeline; PC111 (option to acquire) | inflammation and immunology; severe dermatological conditions | — |
| Lunai Bioworks Inc. | LNAI | RENB-DC11 (allogeneic dendritic cell vaccine) | solid tumors, initially pancreatic cancer | — |
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.