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Soligenix, Inc. (SNGX)

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1.0400+0.0150 (+1.46%)
At close: 4:00PM EDT
1.0500 +0.01 (0.96%)
Pre-Market: 08:02AM EDT
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  • N
    SNGX 9/16: Soligenix to Advance Synthetic Hypericin Development in Psoriasis.
    "8:23 am ET September 16, 2021: 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 following the validation of synthetic hypericin's biologic activity in the positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL), as well as positive proof-of-concept (PoC) demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, the Company will be expanding this novel therapy under the research name SGX302 into psoriasis, a large and underserved market with a significant unmet medical need.

    Visible light-activated synthetic hypericin is a novel, first-in-class, photodynamic therapy (PDT) that is expected to avoid much of the long-term risks associated with other PDT treatments. Synthetic hypericin is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the root cause of psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using ultraviolet (UV) light associated with more severe potential long-term toxicities. The use of visible light in the red-yellow spectrum has the advantage of deeper penetration into the skin (much more than UV light) potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in the positive Phase 3 FLASH study in CTCL. Synthetic hypericin or HyBryte(TM) (tradename used in CTCL) was demonstrated in this study to be equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment) and patch (37%, p=0.0009) lesions of this orphan disease caused by malignant T-cells. Further, this treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-damaging drugs and other phototherapies that are dependent on UV A or B exposure. The use of synthetic hypericin coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in psoriasis.

    "Similar to CTCL, psoriasis is a chronic disease where the management of side effects and toxicities is as important as the management of the disease itself. Having treated both CTCL and psoriasis patients for over 20 years and having seen first-hand how they struggle to find good treatment options, access to an additional effective and safe therapy would add significantly to patient care and quality of life," stated Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego and an investigator in the Phase 3 FLASH study. "The success of synthetic hypericin in targeting malignant T-cells during CTCL clinical trials is a promising indicator of the ability of SGX302 to provide a much-needed approach for the treatment of mild-to-moderate psoriasis, also caused by dysregulated T-cells. This success is further supported by both the previous synthetic hypericin PoC study in psoriasis and by the success, albeit confounded by potentially severe toxicity, of other photodynamic therapies in psoriasis."

    "During the last year, we have made announcements of several important development milestones that we have achieved with HyBryte(TM) (synthetic hypericin) in the treatment of early stage CTCL. We have clearly validated synthetic hypericin's biologic activity with the Phase 3 FLASH study in this orphan disease, where we expect to file a New Drug Application (NDA) in the first half of next year. We believe it is now appropriate to expand synthetic hypericin's or SGX302's development into different cutaneous T-cell diseases such as psoriasis, as a component of our long-term strategy to enhance the value of this unique compound," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Psoriasis is an ongoing unmet medical need, with as many as 7.5 million people in the U.S. and 60-125 million people worldwide affected by this incurable disease. Given our promising results with hypericin to date, including a small Phase 1/2 PoC clinical trial in mild-to-moderate psoriasis, we are hopeful synthetic hypericin will have a role to play in helping patients suffering from this difficult to treat and chronic disease."

    Dr. Schaber continued, "As we get closer to initiating a follow-on Phase 2a clinical trial in mild-to-moderate psoriasis, we will provide further details regarding trial design and timeline; however, our high level plan in the interim is to evaluate different topical formulations of synthetic hypericin to ensure optimal
  • N
    SNGX Sept. 9, 2021 "Soligenix, Inc., 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 Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient hypericin for the treatment of T-cell lymphoma, extending the target population beyond cutaneous T-cell lymphoma (CTCL) as previously granted.

    The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application (NDA), and certain tax credits.

    "The FDA's decision to grant and expand our hypericin orphan drug designation beyond CTCL signifies an important step for Soligenix as we continue to advance the program toward NDA filing in the first half of 2022," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix. "HyBryte™'s biologic activity was clearly demonstrated in the positive Phase 3, pivotal FLASH (Fluorescent Light Activated Synthetic Hypericin) study in patients suffering with early stage CTCL. The marketing exclusivity that this broadened orphan drug designation imparts adds significantly to the existing patent estate surrounding hypericin."
    The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix."
  • r
    I have to laugh when there are posts on here trying to say that market down turns are not the reason that SNGX is down but there is something wrong with the stock.
  • T
    Very logical to understand the importance of this advancement and approval by the FDA and
    totally understandable that everyone would want to get in on this at an early stage and
    hold for major gains. I bought 5,000 shares this morning when I saw the news and looked
    in to how few shares are outstanding. There are currently only 40.1 million shares to be purchased
    today and have a look at how many have already sold. That's right 39,900,000 as I type.
    Think about that... GO LONGS..!
  • J
    The vaccine study is in collaboration with the universities of Hawaii and Colorado.
  • J
    the only reason this did not pop yesterday like i n d p did this morning is that it's below $5 and many mutual funds and institutions are not allowed to touch stocks below $5
  • d
    The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
  • T
    We are now at a stage that I like the most. When the hype fades out and the
    real value of the stock is shown by the new level of volume now 4 times the average.
    As you could see from the volume today people still want in on this stock but now
    there's a difference. I believe the vast majority of those at this stage who are holding now
    are dedicated long.
    I'll hold for at least 6 months and at that point make my move when the price
    is twice what it is now. Cheers to all longs and I'll let you know if a chart shows
    me something worth posting.
  • s
    I see 3 dollars
  • N
    SNGX 9/3: Hypericin Designated "orphan Drug" for Treatment of T-cell lymphoma.

    Incentives of Orphan Drug Designation
    - 7-year marketing exclusivity to sponsors of approved orphan products.
    - 25% federal tax credit for expenses incurred in conducting clinical research within the United States. ...
    - Waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs.

    SNGX volume afterhours 9/3 was +20% & 1,800,000 or 4x daily average volume.

    GLTA !!!
    Search Orphan Drug Designations and Approvals
  • G
    Unless these guys get a proven partnership with a big pharma we will never go beyond this penny land.

    Hope the BOD understand and get into a partnership so that some recognition will be there.

    Otherwise it is all smoke and mirrors.

  • S
    1.25? why? any news?
  • J
    At 20 a share big pharma gets the company for less than one billion
  • J
    This could easily be a 1 to 50 dollar stock. Not saying it will happen but is possible.
  • T
    My prediction on this stock is a move of over 40% to even 100% or higher from the
    ring of the closing bell to the open tomorrow.
  • N
    8/24/2021 - Soligenix: Developing Tools to Tackle the Next Potential Pandemic.
    SNGX Vaccines are known for the stringent cold chain storage requirements necessary to maintain their integrity. In the U.S., maintaining refrigerated or frozen conditions is a simple logistical hurdle. In developing nations, however, vaccine storage is a considerable challenge for the nearly three billion people who live in regions lacking temperature-controlled storage. As new vaccines are engineered, the development of thermally stable vaccines has lagged.

    Late-stage biopharmaceutical company, Soligenix (Nasdaq:SNGX), has shared preclinical data demonstrating that its thermostable vaccine platform may be an important contributor to addressing the next potential pandemic and future health emergencies.

    Key findings include:

    -- Demonstrated successful formulation and heat stabilization of filovirus vaccine platform published in Vaccine

    -- Potent efficacy data in monovalent (single antigen) and bivalent (two antigens) formulations demonstrated in non-human primates (NHPs) published in Frontiers in Immunology

    -- Efficacy of thermostabilized vaccine formulations in NHPs in single-vial presentation
  • O
    Here we go again. Another PR as usual. Never saw a small biotech desperately pump out so many press releases. Most are a lot about nothing. Shabby should be worried if his p3 Hybryte clinical trial has enough accurate and robust data to be able to successful file an acceptable NDA without having it rejected or without ending up with a CLR. Have they yet shown the pictures of ALL the lesions in the p3 clinical trial?
  • H
    Easy $2.00 by tomorrow, with only 40M shares floating, will see how far it will go, let's hope goes up like SAVA!
  • J
    After hours and pre market don't mean a lot but it's nice to see anyway great volume also.
  • i
    Good one as believed. NHP study positive results