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Wednesday, August 20, 2025

NovaBay New CEO, Rocket FDA Lifts Clinical Hold, Celldex Plunges, Soligenix On Watch

 NovaBay Pharmaceuticals, Inc. (NBY) has entered into a $6 million securities purchase agreement with private investor David E. Lazar for the purchase of the company's non-voting convertible preferred stock. As part of the agreement, the company has received $3.85 million in the first of two closings. Lazar has assumed the role of the CEO and director of the company. Former Chief Executive Officer Justin Hall has assumed the newly created position of Vice President of Business Development. A special cash dividend to its stockholders is expected to be declared during this quarter.

In premarket trading, NBY is up 62% at $0.97.

Propanc Biopharma, Inc. (PPCB) closed an underwritten public offering of 1 million shares of its common stock, par value $0.001 per share, at a price of $4.00 per share yesterday. The gross proceeds from the offering were $4 million. The company's shares were uplisted to the Nasdaq from the OTC Markets, Pink Tier, on August 15, 2025. Propanc is developing a novel approach to prevent recurrence and metastasis of solid tumors by using pancreatic proenzymes that target and eradicate cancer stem cells in patients suffering from pancreatic, ovarian, and colorectal cancers. Its lead investigational asset is PRP, which is all set to advance to a Phase 1b, first-in-human clinical study.

PPCB is up 32% at $4.85.

Rocket Pharmaceuticals, Inc. (RCKT), today announced that the FDA has lifted the clinical hold on its pivotal Phase 2 trial of investigational gene therapy RP-A501 for the treatment of Danon disease. A clinical hold was imposed on the study by the U.S. regulatory agency on May 23, 2025, after a patient participating in the study experienced an unexpected Serious Adverse Event. The patient passed away after an acute systemic infection. The clinical hold has been lifted after Rocket satisfactorily addressed the issues outlined in the clinical hold. Danon disease is a rare, inherited disorder linked to the X chromosome that affects multiple organs.

RCKT is up 24% at $3.60.

Soligenix Inc. (SNGX) recently completed its Phase 2a proof of concept study evaluating SGX945 in the treatment of Behçet's Disease and achieved the study objective of demonstrating biological efficacy. Dusquetide, the active ingredient in SGX945, was granted Orphan Drug Designation for the treatment of Behçet's Disease as recently as Aug.19, 2025. Before the end of this year, the company plans to share top-line results from its Phase 2a clinical trial with SGX302 in mild-to-moderate psoriasis and a continued clinical update for the ongoing investigator-initiated study (IIS) evaluating extended HyBryte treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (CTCL). A confirmatory Phase 3 study of HyBryte for early-stage CTCL is ongoing, with top-line results anticipated in 2026.

SNGX is up nearly 5% at $3.87.

Celldex Therapeutics Inc. (CLDX) has decided not to advance the development of Barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus, based on its phase II study results. The study met the primary endpoint, demonstrating Barzolvolimab's ability to effectively deplete mast cells in the gastrointestinal tract. However, this profound mast cell depletion did not translate into improved clinical outcomes, providing direct evidence that mast cells are not a primary driver in EoE. Barzolvolimab is being tested in two Phase 3 studies in chronic spontaneous urticaria and Phase 2 studies in atopic dermatitis and prurigo nodularis.

CLDX is down 12% at $21.21.

HCW Biologics Inc. (HCWB), while reporting Q2, 2025 results earlier this week, revealed that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of the audited financial statements, without additional funding or financial support. This clinical-stage biopharmaceutical company focuses on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases.

HCWB is down 13% at $3.10.

https://www.rttnews.com/3567702/novabay-names-new-ceo-rocket-soars-as-fda-lifts-clinical-hold-celldex-plunges-soligenix-on-watch.aspx

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