Soligenix

Soligenix, Inc. is a late-stage biopharmaceutical company, which engages in the development and commercialization of products to treat rare diseases. It operates through the Specialized BioTherapeutics and Public Health Solutions segments. The Specialized BioTherapeutics segment focuses on the development of a novel photodynamic therapy (SGX301) utilizing topical synthetic hypericin activated with safe visible fluorescent light for the treatment of cutaneous T-cell lymphoma. The Public Health Solutions segment consists of active development programs for RiVax, a ricin toxin vaccine candidate, and SGX943, a therapeutic candidate for antibiotic resistant and emerging infectious disease. The company was founded in 1987 and is headquartered Princeton, NJ.

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Meeting expected to occur approximately 30 days from the FDA's receipt of meeting request PRINCETON, N.J. , March 9, 2023 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company has submitted a Type A Meeting Request to the United States (U.S.) Food and Drug Administration (FDA) to discuss the contents of a refusal to file (RTF) letter previously issued by the FDA regarding the Company's new drug application (NDA) for HyBryte™ (synthetic hypericin) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer, where it has successfully demonstrated statistically significant results in a Phase 3 clinical trial.

Soligenix Submits Type A Meeting Request to U.S. FDA for HyBryte™ New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma

Soligenix (NASDAQ: SNGX ) stock is falling hard on Tuesday after the company's HyBryte cancer drug was rejected by the FDA. The FDA is refusing to review an application for Soligenix covering a rare type of cancer drug.

Why Is Soligenix (SNGX) Stock Down 35% Today?

Soligenix (NASDAQ: SNGX ) stock is falling hard on Tuesday after the company's HyBryte cancer drug was declined for review by the U.S. Food and Drug Administration (FDA). The FDA is refusing to review an application for Soligenix's drug treatment for a rare type of cancer.

Why Is Soligenix (SNGX) Stock Down 27% Today?

Soligenix (NASDAQ:SNGX) slumped in Tuesday's early deals after revealing its cancer drug has been knocked back by the US Food and Drug Administration. The company, in a statement, told investors that it has received a Refusal to File (RTF) letter from the FDA for its HyBryte new drug application (NDA).

Soligenix stock slumps as cancer drug application is knocked back

Soligenix intends to seek guidance from the FDA on how to further advance HyBryte ™  towards potential approval PRINCETON, N.J. , Feb. 14, 2023 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the United States (U.S.) Food and Drug Administration (FDA) has provided the Company with a Refusal to File (RTF) letter for its HyBryte™ (synthetic hypericin) new drug application (NDA) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer and area of unmet medical need affecting over 25,000 patients in the U.S.  Upon preliminary review, the FDA determined that the NDA, submitted on December 14, 2022, was not sufficiently complete to permit substantive review.

Soligenix Receives Refusal to File Letter from U.S. FDA for HyBryte™ New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma

Focusing on 25 micro-cap companies with key catalysts and/or strong performance in the current market PRINCETON, N.J. , Jan. 19, 2023 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it will be presenting at the upcoming Virtual Investor Summit on January 26, 2023.

Soligenix Invited to Present at the Virtual Investor Summit Event

PRINCETON, N.J. , Dec. 23, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series D Preferred Stock, par value $0.001 per share, for each outstanding share of the Company's common stock held of record as of 5:00 p.m.

Soligenix Announces Distribution of Series D Preferred Stock to Holders of its Common Stock

RiVax ® - Vaccinated NHP survival was statistically significantly correlated with an epitope-specific serum assay ("EPICC") prior to challenge Correlates of protection are essential to support approval via the FDA "Animal Rule" PRINCETON, N.J. , Dec. 20, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of preclinical immunogenicity challenge studies for RiVax® (heat stable ricin toxin vaccine) demonstrating statistically significant correlates of protection predicting survival after lethal aerosolized ricin challenge in non-human primates (NHPs).

Soligenix Announces Publication Demonstrating Positive Correlates of Protection with RiVax® in Non-Human Primate Survival after Ricin Challenge

Study HPN-PSR-01 opens patient enrollment PRINCETON, N.J. , Dec. 19, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that patient enrollment has been opened for its Phase 2a study (protocol number HPN-PSR-01) evaluating SGX302 (synthetic hypericin) in the treatment of mild-to-moderate psoriasis.

Soligenix Initiates Phase 2 Clinical Trial of SGX302 (synthetic hypericin) for the Treatment of Mild-to-Moderate Psoriasis

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PRINCETON, N.J. , Dec. 15, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it submitted a new drug application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for HyBryte™ (synthetic hypericin) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer and area of unmet medical need affecting over 25,000 patients in the U.S.  The Company estimates the potential worldwide market for HyBryte™ to be in excess of $250 million for the treatment of CTCL.

Soligenix Announces Submission of New Drug Application to the FDA for HyBryte™ in the Treatment of Cutaneous T-cell Lymphoma

PRINCETON, N.J. , Nov. 15, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received preliminary approval for a tax credit from the New Jersey Economic Development Authority's (NJEDA) New Jersey Technology Business Tax Certificate Transfer program.

Soligenix to Receive $1.2 M in Non-Dilutive Funding Through New Jersey Technology Business Tax Certificate Transfer Program

Princeton, New Jersey--(Newsfile Corp. - November 11, 2022) - Investor Summit Group, today announced that Soligenix, Inc. (NASDAQ: SNGX) (Soligenix or the Company) will attend the Q4 Investor Summit live in NYC at the Sheraton Times Square. Jonathan Guarino, the Company's Senior Vice President and Chief Financial Officer, will be presenting a Company update and attend 1x1 meetings. During the presentation Mr.

Investor Summit Group Announces Soligenix, Inc. To Present at Q4 Conference

PRINCETON, N.J. , Nov. 10, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended September 30, 2022.

Soligenix Announces Recent Accomplishments And Third Quarter 2022 Financial Results

Emerging infectious diseases where n o protective vaccines are currently available SuVax™ targets Sudan ebolavirus, origin of a current disease outbreak in Uganda PRINCETON, N.J. , Oct. 27, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company has been invited by the Biomedical Advanced Research and Development Authority (BARDA) Division of Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures to submit a full contract proposal for the development of single-vial, adjuvanted, heat stable subunit vaccines to prevent filovirus infection.

Soligenix Invited to Submit BARDA Contract Proposal for Development of Thermostabilized Subunit Vaccines for Sudan Ebola and Marburg Viruses

Phase 2a clinical study in mild-to-moderate psoriasis initiating  in December 2022 PRINCETON, N.J. , Oct. 25, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it advances the Phase 2a clinical development of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis.

Soligenix Announces Formation of Psoriasis Medical Advisory Board

Meeting adjourned to November 17, 2022, at 9:00 a.m., Eastern Time Soligenix encourages all stockholders as of record July 25, 2022, who have not yet voted, to vote by 11:59 p.m.

Soligenix Announces Adjournment of Annual Meeting and Information for Reconvened Meeting

New York, New York--(Newsfile Corp. - October 13, 2022) - PCG Digital -- Late-stage biopharmaceutical company, Soligenix, Inc. (NASDAQ: SNGX) is anticipating significant catalysts in Q4 and a potentially transformational year in 2023.Following its successful Phase 3 clinical trial evaluating HyBryte (synthetic hypericin) as a treatment for cutaneous T-cell lymphoma (CTCL), Soligenix is preparing to file a New Drug Application (NDA) with the FDA.

Soligenix Enters Q4 With Multiple Catalysts in Play

Soligenix is an underfollowed biotech company trading at a $20 million market cap. The company is about to file an NDA for HyBryte, which I expect to become a first-in-class treatment in cutaneous T-cell lymphoma.

Soligenix: A Biotech Bargain Ready To File For Approval In Cutaneous T-Cell Lymphoma

- Meeting adjourned to October 19, 2022, at 9:00 a.m., Eastern Time - Soligenix encourages all stockholders of record at the close of business on July 25, 2022 who have not yet voted, to vote by 11:59 p.m.

Soligenix Announces Partial Adjournment of Annual Meeting and Information for Reconvened Annual Meeting

New York, New York--(Newsfile Corp. - September 12, 2022) - PCG Digital -- Late-stage biopharmaceutical company Soligenix, Inc. (NASDAQ: SNGX) has announced the award of a $2.6 million grant from the FDA to support a study of expanded HyBryte™ treatment, including at-home usage. The FDA's support will give patients an opportunity to access Soligenix's HyBryte™ therapy in an open-label setting.

FDA Awards $2.6 Million Grant for Expanded Study of Soligenix's Hybryte(TM) for CTCL

PRINCETON, N.J. , Sept. 8, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company will deliver a corporate presentation at the upcoming H.C.

Soligenix to Present at the H.C. Wainwright 24th Annual Global Investment Conference

Grant supports study of expanded HyBryte™ treatment, including in the Home Use Setting PRINCETON, N.J. , Sept. 6, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has awarded an Orphan Products Development grant to support the evaluation of HyBryte™ (synthetic hypericin) for expanded treatment in patients with early-stage CTCL.

U.S. Food and Drug Administration Awards $2.6 Million Orphan Products Development Grant for Expanded Study of HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma

PRINCETON, N.J. , Aug. 12, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended June 30, 2022.

Soligenix Announces Recent Accomplishments And Second Quarter 2022 Financial Results

PRINCETON, N.J. , July 27, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received agreement from the US Food & Drug Administration (FDA) on an initial pediatric study plan (iPSP) for HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL).

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