Infectious disease companies
41 listed infectious disease companies, largest first, with lead program and the next catalyst each has disclosed.
| Company | Ticker | Lead program | Indication | Next catalyst |
|---|---|---|---|---|
| Gilead Sciences, Inc. | GILD | Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) | HIV-1 infection | December 23, 2026 — FDA action on BLA (PDUFA) |
| GSK plc | GSK | Hibsago (bepirovirsen) | chronic hepatitis B virus infection | H2 2026 — GSK continues regulatory submissions for bepirovirsen across multiple geographies with key decisions anticipated in the coming months. |
| Moderna, Inc. | MRNA | Spikevax (mRNA-1273) | COVID-19 | 2026 — Phase 3 melanoma data |
| Vaxcyte, Inc. | PCVX | VAX-31 (adult 31-valent pneumococcal conjugate vaccine) | prevention of invasive pneumococcal disease and pneumonia in adults 50+ | H1 2027 — OPUS-2 and OPUS-3 Phase 3 data |
| Vir Biotechnology, Inc. | VIR | tobevibart + elebsiran (ECLIPSE program) | chronic hepatitis delta (CHD) | H2 2026 — Updated Phase 1 dose-escalation data |
| Novavax Inc | NVAX | COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates (Matrix-M adjuvanted) | COVID-19 and influenza prevention in adults 65 and older | 2027 — Manufacturing technology transfer to Sanofi complete ($75M milestone) |
| Innoviva, Inc. | INVA | Giapreza / Xacduro / Xerava / Zevtera / Nuzolvence (marketed anti-infective and critical-care portfolio) | Serious infections; vasodilatory shock | — |
| Sinovac Biotech Ltd | SVA | Bivalent enterovirus vaccine (HFMD2) | hand, foot and mouth disease (EV71/CA16) | date not stated — WHO prequalification application submission |
| Arbutus Biopharma Corp | ABUS | imdusiran (AB-729) | chronic hepatitis B | date not stated — Phase 2b trial initiation (FDA alignment reached May 2026) |
| CorMedix Inc. | CRMD | DefenCath (taurolidine and heparin) | Reduction of catheter-related bloodstream infections in adult hemodialysis patients with a central venous catheter | H2 2027 — CorMedix is targeting to begin promotional efforts for REZZAYO in the new indication in H2 2027. |
| Valneva SE | VALN | LB6V (VLA15) | Prevention of Lyme disease | 2026 — VLA1553-303 five-year seroresponse data |
| Kamada Ltd | KMDA | KEDRAB (rabies immune globulin) | rabies post-exposure prophylaxis | H2 2026 — start of NSP sales |
| Assembly Biosciences, Inc. | ASMB | ABI-6250 | chronic hepatitis delta virus (HDV) infection; planned PBC/PSC | Q4 2026 — initiate Phase 2 study in HDV |
| Enanta Pharmaceuticals, Inc. | ENTA | Zelicapavir (EDP-938) | Respiratory syncytial virus (RSV) | Q4 2026 — Study initiation |
| Atea Pharmaceuticals, Inc. | AVIR | bemnifosbuvir/ruzasvir (BEM/RZR) | Chronic hepatitis C | Q1 2027 — C-FORWARD Phase 3 topline results |
| Emergent BioSolutions Inc. | EBS | Marketed MCM and naloxone portfolio (BioThrax, CYFENDUS, ACAM2000, ANTHRASIL, raxibacumab, CNJ-016, NARCAN, KLOXXADO) | Anthrax, smallpox/mpox, opioid overdose, other public health threats | — |
| Orasure Technologies Inc | OSUR | OraQuick rapid point-of-care and self-tests (HIV, HCV, Syphilis, Ebola) and sample management solutions | Infectious disease diagnostics and specimen collection | — |
| 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 |
| Precision BioSciences, Inc. | DTIL | PBGENE-HBV | chronic hepatitis B | 2026 — FUNCTION-DMD initial safety data |
| Invivyd, Inc. | IVVD | VYD2311 | COVID-19 prevention/treatment (DECLARATION and LIBERTY Phase 3) | — |
| 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 |
| PolyPid Ltd. | PYPD | D-PLEX100 | Prevention of surgical site infections (colorectal and abdominal surgery) | November 2026 — D-PLEX100 NDA under FDA Priority Review with November 28, 2026 PDUFA goal date. |
| Tevogen Inc. | TVGN | TVGN 489 (ExacTcell allogeneic, off-the-shelf CTL therapy) | COVID-19 in high-risk and immunocompromised patients; Long COVID | — |
| Immucell Corp | ICCC | First Defense (Dual-Force, Tri-Shield) hyperimmune bovine colostrum scours preventives | neonatal calf scours prevention (cattle) | — |
| Inovio Pharmaceuticals, Inc. | INO | INO-3107 | recurrent respiratory papillomatosis (RRP) in adults | October 30, 2026 — FDA PDUFA action date for BLA (accelerated approval review) |
| Zhengye Biotechnology Holding Ltd | ZYBT | Veterinary vaccine portfolio (50 products, e.g., swine, poultry, bovine, canine rabies) | Livestock and companion animal disease prevention | — |
| 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 |
| 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 |
| Seres Therapeutics, Inc. | MCRB | SER-155 | Bloodstream infection prevention in allo-HCT patients; immune checkpoint-related enterocolitis (irEC) | 2026 — IND-readiness |
| 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. |
| 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 |
| 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 |
| Traws Pharma, Inc. | TRAW | ratutrelvir (TRX01) | COVID-19 | 2026 — resolve FDA clinical hold |
| Co-Diagnostics, Inc. | CODX | Co-Dx PCR platform (Co-Dx PCR Pro instrument with Flu A/B and RSV multiplex test) | point-of-care and at-home PCR testing for upper respiratory infections | — |
| 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. |
| Bluejay Diagnostics, Inc. | BJDX | Symphony IL-6 test (Symphony platform) | Aid in assessing 28-day all-cause mortality risk in ICU patients with sepsis or septic shock | 2026 — Complete analytical and clinical testing of SYMON-II samples |
| Decoy Therapeutics Inc. | DCOY | IMP3ACT Designable Multi-Antivirals (D-MAV) peptide conjugates | respiratory viruses | H1 2027 — File IND (FDA) or CTA (EU equivalent) |
| 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) | — |
| Virax Biolabs Group Ltd | VRAX | ViraxImmune (T cell immune profiling IVD platform) | post-acute infection syndromes (Long COVID, ME/CFS, post-treatment Lyme disease) | — |
| Lakewood-Amedex Biotherapeutics Inc. | LABT | Nu-3 (Bisphosphocin) gel | Mildly infected diabetic foot ulcers (iDFU) | — |
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.