Top Biotech Gainers: CODX, NRXP, NVAX - Clinical Trials Update
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This article covers the recent advancements of CODX in Ebola assays, NRXP's nearing FDA decision, and NVAX's watch status in clinical trials. Stay informed on key biotech gainers.
Three Nasdaq names on biotech watch lists in mid-2026 — CODX, NRXP, and NVAX — are moving on verifiable regulatory and clinical catalysts, not rumor. Co-Diagnostics is advancing Ebola PCR assay work with CoSara, NRx Pharmaceuticals has FDA clearance to run MIND1 for NRX-101 plus TMS, and Novavax is executing a large Phase 4 postmarketing study after U.S. approval of its 2025-2026 Nuvaxovid formula.
Contents10 sections
Key Takeaways
- On June 2, 2026, Co-Diagnostics (CODX) said it is advancing pan-Ebola and multiplex ebolavirus PCR assays with CoSara for the Co-Dx PCR platform, which remains subject to FDA review and is not for sale.
- On May 7, 2026, FDA cleared NRx Pharmaceuticals (NRXP) to initiate MIND1, a Phase 2/3 trial of NRX-101 versus placebo with robotic-assisted or sham TMS.
- FDA approved Novavax’s Nuvaxovid 2025-2026 Formula on August 27, 2025; Phase 4 NCT07086222 continues through an estimated November 18, 2026 completion.
- Investors should separate trial clearance and postmarketing commitments from marketing approval — only Nuvaxovid among these three catalysts is an approved product update.
Why is CODX in focus for Ebola PCR assays?
Co-Diagnostics, Inc. (Nasdaq: CODX) is a molecular diagnostics company, not Codexis. In a June 2, 2026 wire release, the company and joint venture CoSara Diagnostics announced continued progress on a dual Ebola PCR program: a pan-Ebola assay intended to detect multiple ebolavirus species quickly, and a multiplex assay designed to differentiate Sudan, Taï Forest, Zaire, and Bundibugyo ebolaviruses linked to Central African outbreaks.
The company also described blood-based workflow configurations for the Co-Dx PCR Pro point-of-care instrument. Critically, Co-Diagnostics states the Co-Dx PCR platform and associated tests remain subject to FDA or other regulatory review and are not yet available for sale. Earlier, on May 19, 2026, the company said it had completed an assay development strategy for Bundibugyo virus (BDBV) after WHO’s May 17, 2026 public health emergency declaration tied to outbreaks in the Democratic Republic of the Congo and Uganda.
Primary detail is in the company’s June 2, 2026 PR Newswire release and the May 19, 2026 PR Newswire BDBV strategy update.
What FDA action did NRXP actually receive in 2026?
NRx Pharmaceuticals (Nasdaq: NRXP) did not receive marketing approval for NRX-101 in the May 2026 catalyst that moved shares into “gainers” chatter. On May 7, 2026, FDA cleared the company to initiate MIND1: a randomized, double-blind, three-arm Phase 2/3 study of NRX-101 (D-cycloserine/lurasidone fixed-dose combination) versus placebo as adjunctive therapy to active or sham robotic-assisted transcranial magnetic stimulation in adults with treatment-resistant major depressive disorder.
NRX-101 already carries Breakthrough Therapy Designation for suicidal bipolar depression. Separately, NRx has described initiating an NDA manufacturing module and requesting rolling review for that indication, plus Fast Track Designation for NRX-100 (preservative-free intravenous ketamine) for suicidal ideation in depression, including bipolar depression. Those filings are not the same as an FDA approval decision date.
See the May 7, 2026 GlobeNewswire FDA clearance announcement.
How does NVAX’s 2025-2026 vaccine status differ from a watch-list rumor?
Novavax (Nasdaq: NVAX) already has a U.S.-approved COVID-19 vaccine franchise. On August 27, 2025, FDA approved the Nuvaxovid 2025-2026 Formula for people 65 and older, or ages 12 through 64 with at least one underlying condition that raises risk of severe COVID-19. FDA’s public strain guidance for the 2025-2026 season recommended monovalent JN.1-lineage composition, preferentially using LP.8.1.
What remains “on watch” is postmarketing evidence generation. ClinicalTrials.gov lists NCT07086222 as a Phase 4, randomized, double-blind, placebo-controlled study of a single dose of NVX-CoV2705 (Omicron JN.1 recombinant spike with Matrix-M) in approximately 6,500 healthy adults aged 50 to under 65 who are not considered high risk for severe COVID-19. The registry lists a November 20, 2025 start and an estimated primary completion of November 18, 2026.
- Product: Nuvaxovid 2025-2026 Formula (protein-based, non-mRNA)
- Regulator page: FDA 2025-2026 COVID-19 vaccine formula guidance
- Trial ID: NCT07086222 (Phase 4; ~6,500 participants)
Sources: Novavax August 27, 2025 PR Newswire approval release, FDA 2025-2026 COVID-19 vaccine formula page, and ClinicalTrials.gov NCT07086222.
What BD and investor teams should track next
For CODX, the near-term diligence questions are assay validation timelines, any emergency-use or 510(k)-style path for outbreak assays, and whether NGO or government partners fund deployment. The platform disclaimer — not for sale pending review — is material for valuation narratives that treat CODX as a commercial diagnostics name today.
For NRXP, separate MIND1 enrollment and interim readouts from the suicidal bipolar depression NDA path and from NRX-100 ANDA/NDA activity. A May 2026 trial clearance does not set a PDUFA date for NRX-101.
For NVAX, commercial execution with Sanofi on the approved 2025-2026 formula matters alongside NCT07086222 safety and efficacy outcomes that could shape label or recommendation debates for lower-risk adults aged 50–64.
Data points that separate these three catalysts
Concrete, sourced markers for mid-2026 screening:
- CODX dual assay design named four ebolavirus species on June 2, 2026
- WHO PHEIC timing cited by CODX as May 17, 2026 for BDBV-linked outbreak reporting
- NRXP MIND1 cleared May 7, 2026 as Phase 2/3 three-arm TMS adjunct study
- NVAX Nuvaxovid 2025-2026 U.S. approval dated August 27, 2025
- NCT07086222 targets ~6,500 participants with estimated completion November 18, 2026
What remains unproven
No public primary source confirms that CODX’s Ebola assays are cleared for U.S. sale, that NRX-101 has received marketing approval, or that NCT07086222 has reported primary efficacy results. Stock moves around “gainers” lists often conflate strategy announcements and IND/trial clearances with approvals. This article sticks to company wires, FDA pages, and ClinicalTrials.gov and drops unverified revenue or efficacy percentages from the prior draft.
Related NovaPharma coverage
- New Ebola Outbreak in Congo: Implications for Pharma
- NRx Pharmaceuticals FDA Feedback on Preservative-Free Ketamine Generic
- America's Innovation Engine: Small and Mid-Sized Biotechs Drive U.S. Clinical Trials
Frequently Asked Questions
What is driving CODX interest around Ebola diagnostics?
Co-Diagnostics (Nasdaq: CODX) and joint venture CoSara are advancing pan-Ebola and multiplex PCR assays for Sudan, Taï Forest, Zaire, and Bundibugyo species on the Co-Dx PCR platform, which is not yet available for sale pending FDA or other regulatory review.
Did FDA approve NRX-101 for NRXP, or clear a trial?
On May 7, 2026, FDA cleared NRx Pharmaceuticals to start the MIND1 Phase 2/3 trial of NRX-101 versus placebo as adjunctive therapy with active or sham robotic-assisted TMS in treatment-resistant major depressive disorder. That is trial clearance, not marketing approval of NRX-101.
What Novavax clinical work remains after Nuvaxovid approval?
After FDA approved the Nuvaxovid 2025-2026 Formula, Novavax is running Phase 4 study NCT07086222 of NVX-CoV2705 versus placebo in about 6,500 adults aged 50 to under 65 without high-risk conditions, with estimated completion November 18, 2026.
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