FDA grants orphan drug designation to Soligenix (NASDAQ: SNGX) therapy SGX945

Rhea-AI Filing Summary

Soligenix, Inc. reported that the U.S. Food and Drug Administration’s Office of Orphan Products Development has granted orphan drug designation to dusquetide, the active ingredient in its drug candidate SGX945, for the treatment of Behçet’s Disease. This decision follows review of recent Phase 2a clinical results that showed biological efficacy and safety in patients with Behçet’s Disease.

The company highlighted that this regulatory milestone is based on early-stage clinical data and cautioned that forward-looking statements are subject to significant risks and uncertainties described in its periodic SEC reports.

Positive

• FDA orphan drug designation granted to dusquetide (SGX945) for treatment of Behçet’s Disease, based on Phase 2a clinical results showing biological efficacy and safety.

Negative

• None.

Insights

Biotech regulatory and pipeline analyst

FDA grants orphan drug designation to Soligenix’s SGX945 for Behçet’s Disease.

Soligenix disclosed that the FDA’s Office of Orphan Products Development granted orphan drug designation to dusquetide, the active ingredient in SGX945, for treating Behçet’s Disease. The designation follows Phase 2a clinical results demonstrating biological efficacy and safety in affected patients, signaling that the FDA sees potential in the therapy for this rare condition.

Orphan drug designation typically provides benefits such as regulatory support and, if ultimately approved, potential market exclusivity, although those specific benefits are not detailed here. The disclosure also reiterates that outcomes remain uncertain and subject to risks noted in the company’s Form 10-K for the year ended December 31, 2024 and other periodic reports.

The key next steps will depend on how the company advances SGX945 beyond the Phase 2a data referenced in the disclosure. Future filings may describe later-stage study designs, additional safety and efficacy results, or further regulatory interactions that clarify the development path for dusquetide in Behçet’s Disease.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported):  August 18, 2025

Commission File No. 001-14778

Soligenix, Inc.

(Exact name of small business issuer as specified in its charter)

DELAWARE		41-1505029
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)
29 Emmons Drive, Suite B-10 Princeton, NJ		08540
(Address of principal executive offices)		(Zip Code)

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(609) 538-8200

(Issuer’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $.001 per share		SNGX		The Nasdaq Capital Market

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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Item 8.01. Other Events.

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On August 18, 2025, Soligenix, Inc. (the “Company”) issued a press release announcing that the Office of Orphan Products Development of the United States Food and Drug Administration has granted orphan drug designation to dusquetide, the active ingredient in SGX945, for “treatment of Behçet’s Disease” following review of recent Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet’s Disease. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

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Safe Harbor for Forward-Looking Statements

Certain statements contained in this report may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “predicts,” “plans,” “expects,” “anticipates,” “believes,” “goal,” “target,” “estimate,” “potential,” “may,” “might,” “could,” “see,” “seek,” “forecast,” and similar words. Forward-looking statements are based on the Company’s current plans and expectations and involve risks and uncertainties which are, in many instances, beyond the Company’s control, and which could cause actual results to differ materially from those included in or contemplated or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks, uncertainties and factors detailed in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including in the Company’s Annual Report for the year ended December 31, 2024 on Form 10-K, which was filed with the SEC, and in other periodic reports on Form 10-Q and Form 8-K. As a result of such risks, uncertainties and factors, the Company’s actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this report as of the date hereof and assumes no obligations to update the information included in this report or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Item 9.01. Financial Statements and Exhibits.

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(d)     Exhibits.

Exhibit No.		Description
99.1	​	Press release dated August 18, 2025
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104	​	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURE

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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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	Soligenix, Inc.
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August 18, 2025	By:	/s/ Christopher J. Schaber
		Christopher J. Schaber, Ph.D.
​	​	President and Chief Executive Officer
​	​	(Principal Executive Officer)

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FAQ

What regulatory milestone did Soligenix (SNGX) announce for SGX945?

Soligenix announced that the U.S. FDA’s Office of Orphan Products Development granted orphan drug designation to dusquetide, the active ingredient in SGX945, for the treatment of Behçet’s Disease.

Which condition is Soligenix’s dusquetide (SGX945) targeting under the new FDA designation?

Dusquetide, the active ingredient in SGX945, received FDA orphan drug designation for the treatment of Behçet’s Disease.

What clinical evidence supported the orphan drug designation for Soligenix’s SGX945?

The FDA granted orphan drug designation after reviewing recent Phase 2a clinical results that demonstrated biological efficacy and safety of SGX945 (dusquetide) in patients with Behçet’s Disease.

Does the Soligenix (SNGX) disclosure mention financial results or transactions?

No, the disclosure focuses on the regulatory milestone of FDA orphan drug designation for dusquetide (SGX945) in Behçet’s Disease and does not present financial results or major transactions.

How does Soligenix describe the risks around forward-looking statements in this update?

Soligenix states that forward-looking statements involve risks and uncertainties, and refers readers to the risk factors in its Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports for details.

Where can investors find more detail on Soligenix’s risk factors related to SGX945?

The company directs readers to its filings with the SEC, including its Form 10-K for the year ended December 31, 2024 and other Form 10-Q reports, for a detailed discussion of risks and uncertainties.