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Details:
SGX302 (synthetic hypericin) is a novel, first-in-class, photodynamic therapy (PDT) that is expected to avoid many of the long-term risks associated with other PDT treatments. It is under phase 2 clinical development for the treatment of mild-to-moderate psoriasis.
Lead Product(s): Hypericin
Therapeutic Area: Dermatology Product Name: SGX302
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2024
Details:
The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light approximately 24 hours later.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2023
Details:
HyBryte (SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by malignant T-cells.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2022
Details:
BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL).
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: NJEDA
Deal Size: $1.2 million Upfront Cash: Undisclosed
Deal Type: Funding November 15, 2022
Details:
HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: U.S. Food and Drug Administration
Deal Size: $2.6 million Upfront Cash: Undisclosed
Deal Type: Funding September 06, 2022
Details:
HyBryte™ (SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by malignant T-cells.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2022
Details:
HyBryte (SGX301) is novel, photodynamic therapy utilizing safe, visible light for activation, is synthetic hypericin, potent photosensitizer that topically applied to skin lesions that taken up by malignant T-cells, and activated by visible light 16 to 24 hours later.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2022
Details:
Visible light-activated synthetic hypericin (SGX302) is a novel, first-in-class, photodynamic therapy (PDT), a photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells.
Lead Product(s): Hypericin
Therapeutic Area: Dermatology Product Name: SGX302
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2022
Details:
Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes. HyBryte™ continued to be safe and well tolerated.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2021
Details:
HyBryte™ potentially represents the safest available efficacious treatment for CTCL. With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2021
Details:
Visible light-activated synthetic hypericin is novel, first-in-class, photodynamic therapy that is expected to avoid much of the long-term risks associated with other PDT treatments. Company will be expanding this novel therapy under research name SGX302 into psoriasis.
Lead Product(s): Hypericin
Therapeutic Area: Dermatology Product Name: SGX302
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2021
Details:
The PIP waiver of HyBryte™ (SGX301 or hypericin) used in early stage cutaneous T-cell lymphoma, allows us to work towards advancing a marketing authorization application (MAA) with EMA in a more cost-effective manner.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2021
Details:
HyBryte™ potentially represents the safest available efficacious treatment for CTCL. With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2021
Details:
The presented data shows the ability of HyBryte™ (SGX301) to treat both patch and plaque disease, also generating complete disease responses, while being associated with fewer and less severe adverse events than other currently approved skin-directed therapies for CTCL.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2021
Details:
The presentation, which was designated "Top 12 Late-Breaking Research," expanded on data related to the efficacy and safety of HyBryte™ (SGX301) in the treatment of cutaneous T-cell lymphoma (CTCL).
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: HyBryte
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2021
Details:
With the completion of its pivotal Phase 3 FLASH study, Soligenix is preparing to begin submission of the rolling NDA in 2Q 2021 for this first-in-class therapy.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: SGX301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2021
Details:
The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of cutaneous T-cell lymphoma. SGX301, for which positive primary endpoint results in a pivotal Phase 3 study for the treatment of CTCL were recently announced.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: SGX301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2021
Details:
Daavlin will exclusively manufacture the proprietary light device for use with SGX301 for the treatment of CTCL. Upon approval of SGX301 by the U.S FDA, Soligenix will promote SGX301 and the companion light device, and facilitate the direct purchase of the device from Daavlin.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: SGX301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Soligenix
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 07, 2021
Details:
The access to less dilutive capital provided by this facility is designed to increase Soligenix's financial flexibility to advance its rare disease pipeline, and build toward commercialization in the U.S with SGX301 and SGX942.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: SGX301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pontifax Medison Debt Financing
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Financing December 16, 2020
Details:
Nearly half of all patients in Phase 3 trial continue to see sustained and statistically significant improvement in their response rates when treated with SGX301 through 18 weeks (Cycle 3), reinforcing positive SGX301 primary endpoint treatment response.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: SGX301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
In the double-blind, placebo controlled Cycle 1 portion of the study, a statistically significant treatment response was achieved in the primary endpoint after 6 weeks of therapy.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2020
Details:
SGX301 treatment response continues to demonstrate highly statistically significant improvement after 12 weeks of therapy.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2020
Details:
The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of cutaneous T-cell lymphoma (CTCL).
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2020
Details:
The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response.
Lead Product(s): Hypericin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 19, 2020
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