Pre-clinical biotech companies
52 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 |
|---|---|---|---|---|
| Regencell Bioscience Holdings Limited | RGC | Standardized TCM Formula for ADHD and ASD | Attention Deficit Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD) | — |
| Legend Biotech Corp | LEGN | CARVYKTI (ciltacabtagene autoleucel, cilta-cel) | relapsed/refractory multiple myeloma | — |
| Adma Biologics, Inc. | ADMA | ASCENIV (Immune Globulin Intravenous, Human - slra 10% Liquid) | Primary humoral immunodeficiency (PI/PIDD) | 2026 — Submission of pre-IND package to FDA |
| Korsana Biosciences, Inc. | KRSA | CYC-126 | treatment-resistant depression (propofol + dexmedetomidine with personalized delivery/monitoring system) | — |
| Opko Health, Inc. | OPK | Rayaldee (calcifediol ER) | secondary hyperparathyroidism in CKD stage 3-4 with vitamin D insufficiency | — |
| Sana Biotechnology, Inc. | SANA | SC451 | type 1 diabetes | 2026 — IND filing and begin Phase 1/2 clinical trial |
| 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 |
| Indaptus Therapeutics, Inc. | INDP | Decoy20 | advanced solid tumors (anti-cancer/anti-viral immunotherapy; clinical development discontinued) | — |
| Surrozen, Inc. | SRZN | SZN-8141 | diabetic macular edema; neovascular AMD | 2026 — Initiation of Phase 1b/2a DUET study in DME |
| 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 | — | — | — |
| Alector, Inc. | ALEC | AL137 | Alzheimer's disease | January 2, 2027 — Termination effective |
| Abeona Therapeutics Inc. | ABEO | ZEVASKYN (prademagene zamikeracel) | Wounds in recessive dystrophic epidermolysis bullosa (RDEB) | — |
| SIGA Technologies, Inc. | SIGA | TPOXX (tecovirimat) - smallpox PEP indication (supplemental NDA) | Smallpox post-exposure prophylaxis | H1 2027 — Supplemental NDA submission for smallpox post-exposure prophylaxis indication |
| Camp4 Therapeutics Corp | CAMP | CMP-002 | SYNGAP1-related disorder (developmental and epileptic encephalopathy) | Q4 2026 — Initiation of Phase 1/2 clinical trial in SYNGAP1 |
| Niagen Bioscience, Inc. | Unknown | NB4168 | Ataxia-Telangiectasia (A-T) | — |
| Alpha Cognition Inc. | ACOG | ZUNVEYL (benzgalantamine) | Mild to moderate dementia of the Alzheimer's type | — |
| Korro Bio, Inc. | KRRO | KRRO-121 | hyperammonemia in urea cycle disorders and hepatic encephalopathy | H2 2026 — Commence first-in-human trial |
| Atrium Therapeutics, Inc. | RNA | ATR 1072 | PRKAG2 syndrome | Q4 2026 — First participant enrolled in Corventis Phase 1/2 trial |
| OnKure Therapeutics, Inc. | OKUR | OKI-345 | PI3Kalpha-mutant breast cancer (pan-mutant PI3Kalpha inhibitor) | 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) |
| Equillium, Inc. | EQ | EQ504 | ulcerative colitis and other GI diseases (inflammatory lung diseases as expansion) | Q4 2026 — Initiate Phase 1 placebo-controlled proof-of-mechanism study |
| Telomir Pharmaceuticals, Inc. | TELO | Telomir-Zn (previously referred to as Telomir-1) | Advanced or metastatic triple-negative breast cancer (TNBC); also preclinical work in multiple disease areas | — |
| Heron Therapeutics, Inc. | HRTX | ZYNRELEF (bupivacaine and meloxicam) | Postsurgical analgesia for up to 72 hours after soft tissue and orthopedic surgery | — |
| Boundless Bio, Inc. | BOLD | none active (BBI-940 clinical development halted Jun 2026) | — | — |
| Instil Bio, Inc. | TIL (delisted) | — | — | — |
| Filana Therapeutics, Inc. | FLNA | simufilam | Tuberous sclerosis complex-related epilepsy | date not stated — Resolution of FDA clinical hold on proposed TSC trial |
| 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. |
| 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) |
| 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) | H2 2026 — Written feedback from BPD Type 2b meeting with FDA |
| Pluri Inc. | PLUR | PLX cell therapy (placental-derived adherent stromal cells) | — | — |
| Adial Pharmaceuticals, Inc. | ADIL | AT177 | ulcerative colitis | Q2 2027 — IND filing |
| 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. |
| Palatin Technologies, Inc. | PTN | MC4R selective long-acting peptide agonist | Rare obesity disorders (hypothalamic obesity, Prader-Willi syndrome, Bardet-Biedl syndrome) | — |
| InMed Pharmaceuticals Inc. | INM | INM-901 | Alzheimer's disease | Q1 2027 — Pre-IND meeting |
| Curanex Pharmaceuticals Inc | CURX | Phyto-N | Ulcerative colitis (lead); also atopic dermatitis, rheumatoid arthritis, gout, diabetic foot, cancer cachexia | October 2026 — Pre-IND meeting with FDA |
| 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 | — |
| 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) |
| 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. |
| Liminatus Pharma, Inc. | LIMN | IBA101 (Hu3A5 anti-CD47 monoclonal antibody) | advanced solid cancers including NSCLC | 2026 — Phase 1 clinical trial start (scheduled) |
| 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 |
| Ernexa Therapeutics Inc. | ERNA | ERNA-101 | platinum-resistant ovarian cancer | Q4 2026 — First-in-human Phase 1 trial start (investigator-sponsored) |
| 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 |
| 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 |
| Scinai Immunotherapeutics Ltd. | SCNI | NanoAbs (VHH antibody fragment) pipeline; PC111 (option to acquire) | inflammation and immunology; severe dermatological conditions | — |
| Nexentis Technologies Ltd. | NXTS | MitoCareX SLC25A inhibitors | cancer | — |
| Lunai Bioworks Inc. | LNAI | RENB-DC11 (allogeneic dendritic cell vaccine) | solid tumors, initially pancreatic cancer | — |
| CDT Equity Inc. | CDT | AZD1656 co-crystal (HK-4 glucokinase activator) | inflammatory/autoimmune disorders (repurposing, AI-guided) | — |
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.