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GRAY float so low 21m this can fly in a day as done in past. $52m in cash and value $5 pps makes it EXTREMELY under valued even after this minor pop today.
GLTA
DWAC is best spac of past 2 years.
IMO
Nice time to add DWAC !
GLTA
GRAY on the move today 8/9 !
50x volume and +30% so far on no news!
It’s about time. This low float can EXPLODE as seen so many times before…
GLTA
This just popped up in my Twitter alert, and actually said 8/3.
Not sure why it alerted today?
Obviously didn't help the pps...
SNGX 8/2: "Study Reveals Successful Results for Treatment of Cutaneous T-Cell Lymphoma."
"August 2, 2022 Soligenix announces positive phase 3 results from FLASH study for the use of synthetic hypericin to reduce cutaneous T-cell lymphoma lesions.
Phase 3 results of the Fluorescent Light Activated Synthetic Hypericin (FLASH) study1 demonstrated significant reductions in cutaneous T-Cell lymphoma (CTCL) lesion sizes with synthetic hypericin (HyBryte; Soligenix) treatment. These findings provide hope for a new treatment to patients diagnosed with the life-altering disease. As a chronic type of cancer that severely impacts patients’ quality of life, there is an unmet need for a well-tolerated and safe treatment option. The FLASH study is the largest double-blind, randomized, placebo-controlled clinical trial for CTCL to date.
The study data also showed that the treatment response continued to improve over 6-week treatment cycles. The main end point of the study evaluated the Composite Assessment of Index Lesion Severity (CAILS) of three specific lesions and the success was determined as ≥50% reduction in CAILS score relative to baseline. Patients reported that their lesions continued to reduce throughout the treatment cycle. After the first 6-week treatment cycle, 16% of patients had a response (p=0.04 versus patients with 6 weeks of placebo treatment). The response rate continued to increase to 49% through 18 weeks of treatment (p<0.0001 versus patients with 6-week hypericin or placebo treatment).
Synthetic hypericin is a novel photodynamic therapy that uses safe, visible light for activation. The drug is topically applied to skin lesions and activated with visible light 16-24 hours after. The US Food and Drug Administration has granted orphan drug and fast track designations for the groundbreaking treatment.2.
Data throughout the study indicated that synthetic hypericin was safe and well-tolerated, while current treatment options for CTCL have significant safety concerns and black-box warnings. Synthetic hypericin will offer safer long-term options to patients. CTCL is a class of non-Hodgkin's lymphoma (NHL), a cancer of the white blood cells. Unlike other NIHLs, CTCL is caused by an expansion of malignant T-cell lymphocytes which normally migrate to the skin. There is currently no cure for CTCL.".
https://www.dermatologytimes.com/view/study-reveals-successful-results-for-treatment-of-cutaneous-t-cell-lymphoma
GLTA
...
GRAY is a current HOLD with potential $5 pps...
"SVB Securities Reaffirms Their Hold Rating on Graybug Vision (GRAY)
July 22 2022 - 05:39AM
SVB Securities analyst Marc Goodman maintained a Hold rating on Graybug Vision (GRAY – Research Report) on July 11 and set a price target of $5.00. The company's shares closed last Thursday at $1.00, close to its 52-week low of $0.72. According to TipRanks.com, Goodman is a 3-star analyst with an average return of 1.1% and a 47.8% success rate. Goodman covers the Healthcare sector, focusing on stocks such as Biohaven Pharmaceutical Holding Co, Opthea Limited Sponsored ADR, and Amylyx Pharmaceuticals Inc. Graybug Vision has an analyst consensus of Hold, with a price target consensus of $2.50.
https://www.tipranks.com/news/blurbs/svb-securities-reaffirms-their-hold-rating-on-graybug-vision-gray?utm_source=advfn.com&utm_medium=referral . "
GLTA
Saudi Arabia has been a critical US “partner” with trade (much more than oil) going back 80 years+.
To condemn a Nation based on its individual terrorist groups would put we the US in question…
DWAC is on a roll UP and political banter won’t stop it.
GLTA
Me too? Could it be IMPP dilution ???
SNGX 7/27/2022: "Soligenix Receives Agreement from FDA on Initial Pediatric Study Plan for HyBryte(TM) for the Treatment of Cutaneous T-Cell Lymphoma.
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(TM) (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). The agreed iPSP stipulates that Soligenix intends on requesting a full waiver of pediatric studies upon submission of a new drug application (NDA). Agreement with FDA on an iPSP is one of the regulatory requirements that must be met prior to submitting a NDA.
https://mma.prnewswire.com/media/1514137/HyBryte_High_Resolution_Logo.jpg
"We are pleased to have FDA's agreement on our proposal to request a full waiver of pediatric studies at the time of our HyBryte(TM) NDA filing later this year," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix. "This is consistent with decisions by the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom which have previously granted product-specific waivers from the requirement for pediatric studies in applications for marketing authorization of HyBryte(TM) in the UK and Europe."
About HyBryte(TM)
HyBryte(TM) (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte(TM) 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 16 to 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte(TM) has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).
The recently published Phase 3 FLASH trial trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received HyBryte(TM) treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte(TM) achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte(TM) treatment in the first cycle was safe and well tolerated.
In the second open-label treatment cycle (Cycle 2), all patients received HyBryte(TM) treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte(TM) treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte(TM) treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). 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(TM) continued to be safe and well tolerated. Additional analyses also indicated that HyBryte(TM) is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.
The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte(TM) treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte(TM) throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte(TM) is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte(TM) continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.
Overall safety of HyBryte(TM) is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte's(TM) mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte(TM) 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.
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, Inc.
About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.
CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually."
GLTA
IMPP after-hours delight !
Tomorrow should be magnificent !
GLTA
IMPP green is beautiful ! Keep it UP !
GLTA
SNGX new 7/26 proxy statement looks very positive as well.
Increase in Authorized shares is outlined “for potential mergers”. SNGX has been very good with their current Authorized shares 75m, and only 43m confirmed Outstanding as of 7/25/2022.
I’m usually not for increasing Authorized but this case seems best for near-term mergers, and ensures against threat of near-term reverse? IMO??
GLTA
SNGX 7/25/2022 announces Strategic Partnership with SERB Pharmaceuticals to Supply its Novel Ricin Antigen.
SERB Pharmaceuticals pursuing therapeutic treatment against ricin poisoning using Soligenix ricin antigen
"PRINCETON, N.J., July 25, 2022 -- 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 signed a worldwide exclusive license to supply its ricin antigen to SERB Pharmaceuticals (SERB), for development of a novel therapeutic treatment against ricin toxin poisoning. There is an unmet need for protection against this highly potent toxin for which there is no vaccine or therapeutic intervention available.
"We are pleased to be partnering with Soligenix on the use of their antigen to accelerate our ricin therapeutic program. With no current therapeutic options, the threat of ricin represents a significant unmet need in the field of biodefense and medical countermeasures," said Anthony Higham, CEO of SERB Pharmaceuticals. "Our expertise in antibody development and the commercial scale manufacturing capabilities acquired with BTG together with SERB's track record of reliably providing a portfolio of high-quality Chemical, Biological, Radiological, and Nuclear (CBRN) antidotes, uniquely positions us to successfully deliver a solution."
"Beyond our own development of a heat stable ricin vaccine (RiVax®) to protect against lethal ricin poisoning, which has been supported with more than $30 million dollars to date by the U.S. government, we felt it important to also partner with SERB in the development of its ricin therapeutic drug candidate," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "SERB is a leader in the field of medical countermeasures to protect the public and military forces. By supplying our novel ricin antigen as an important component of their formulation, we are hopeful that it will assist in accelerating development of this early-stage program."
In pursuit of a ricin antidote, SERB will leverage its unique broad-spectrum polyclonal antibody platform, gained in its acquisition of BTG Specialty Pharmaceuticals. This specialized manufacturing process generates binding fragments from antibodies that are specific to a given antigen, helping to ensure potency and purity. This platform is currently used to manufacture two of the company's currently marketed products, CroFab® and DigiFab®.
The antibodies will be generated using a modified form of the ricin toxin, developed by Soligenix. The modifications have removed the biological activity of the protein so that it is not toxic, while still retaining its shape to trigger an effective antibody response.
The specific licensing terms have not been disclosed at this time, but consist of a manufacturing supply agreement and small royalty percentage upon commercialization.
The Ricin Threat
Ricin is a source of concern because it is a relatively easy to obtain, easy to weaponize and highly potent toxin. Ricin can be extracted from the seeds of the castor oil plant, Ricinus communis. Ricin is one of the most toxic biological agents known—a Category B bioterrorism agent and a Schedule number 1 chemical warfare agent.
Ricin has been a threat since governments began experimenting with it during World War I. Most famously used in the assassination of Bulgarian writer Georgi Markov in 1978, ricin has been developed and deployed with alarming frequency. Several ricin attacks have been prevented in Europe and the United States in recent years, ranging from a militant group in Germany prevented from launching a ricin attack by police in 2017 to the 2020 delivery of letters laced with ricin to the White House.
About SERB Pharmaceuticals
SERB is a growing pharmaceutical company and a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain. SERB acquired BTG Specialty Pharmaceuticals in March of 2021."
GLTA
Ha same! In 1 of my 3 trade accounts
Yeah been that way for so long now not fazed.
They are more active than ever before.
Soon.
Maybe soon...
GLTA
DWAC back above $80 soon enough...
GLTA
6/28 - GRAY $53m investment + retaining Piper Sandler is all UP from here..
“Graybug Announces Review Of Strategic Alternatives.
Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of ocular diseases, today announced that its Board of Directors will conduct a comprehensive review of strategic alternatives focused on maximizing shareholder value.
As part of this process, the Company will explore the potential for an acquisition, company sale, merger, divestiture of assets, private placement of equity securities, or other strategic transactions. As of March 31, 2022, the company's cash, cash equivalents, and short-term investments totaled $55.3 million. Graybug has retained Piper Sandler Companies to act as its financial advisor to assist with this review process.
'The goal of this strategic evaluation process is to ensure that we are exploring a range of possible options to maximize value for our shareholders while leveraging our diversified pipeline and experienced team. Pending the outcome of this review, cost-containment measures are being put in place to maximize our cash resources available,' said Frederic Guerard, PharmD, Chief Executive Officer of Graybug.”
GLTA
SNGX float so low only 43m can definitely blow UP short squeeze!
Been heavily manipulated past 12-18 Months with extremely low volume so it’s about time !
GLTA
SNGX +25% pre-market 6/28 with:
Soligenix Receives FDA IND Clearance for Phase 2 Clinical Trial of Synthetic Hypericin in the Treatment of Psoriasis
Mentioned: SNGX
Enrollment on Track to Begin in 4th Quarter of 2022
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 cleared the Investigational New Drug (IND) application for a Phase 2a clinical trial titled, "Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis." The study is designed to evaluate the safety and efficacy of topically-applied SGX302 (synthetic hypericin) and is expected to begin patient enrollment in the fourth quarter of 2022.
"We are pleased to have received FDA clearance on our SGX302 Phase 2a clinical trial in mild-to-moderate psoriasis," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "During the last year, we have made announcements of important development milestones that we have achieved with HyBryte(TM) (synthetic hypericin) in the treatment of early stage cutaneous T-cell lymphoma (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 second half of 2022. We are excited to expand synthetic hypericin'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. 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 proof of concept 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."
Under this IND, the Phase 2a clinical trial of SGX302 will be a randomized, double-blind, placebo-controlled study that will enroll up to 32 patients age 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body. Patients will receive placebo or SGX302 (randomized 1:1) as a twice weekly treatment for up to 18 weeks. Each treatment will consist of the application of SGX302 followed approximately 24 hours later with visible light activation. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices.
About Synthetic Hypericin
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 safety concerns. 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 (Fluorescent Light Activated Synthetic Hypericin) 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 in this orphan disease caused by malignant T-cells. In a published Phase 1/2 proof of concept clinical study using synthetic hypericin, efficacy was demonstrated in patients with CTCL (58.3% response, p=0.04) as well as psoriasis (80% response, p<0.02).
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.
The Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly in 6-week cycles. In the first double-blind treatment cycle, 116 patients received HyBryte(TM) treatment and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte(TM) achieved at least a 50% reduction in their lesions (using the standard Composite Assessment of Index Lesions Severity [CAILS] score) compared to only 4% of patients in the placebo group after just 6 weeks of treatment (p=0.04). Further treatment with HyBryte(TM) increased the number of treatment successes to 40% and 49% after 12 and 18 weeks, respectively (p<0.0001 for both). Additional analyses also indicated that HyBryte(TM) is equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment in Cycle 1) and patch (37%, p=0.0009) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions. This is also relevant to psoriasis where the lesions can be thicker than the patches observed in CTCL.
In a subset of patients evaluated during their third treatment cycle, it was demonstrated that HyBryte(TM) is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte(TM) continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.
GLTA!
I’m so happy with DWAC investment.
GLTA
Part of the problem.
Not DWAC.
GLTA
And that is why I love DWAC.
GLTA
Yeah everybody liked Pence. IMPP back over $1 within 3-4 trade days?
GLTA
Great post. DWAC keep the Faith !
GLTA
DWAC low volume. Not concerned. yet
SNGX it's time... Money out of Big market flows to us...
GLTA
IMPP over $1 in pre-market, and now .70? We knew about these Warrants in MARCH !!!
GLTA
Hopefully the start back to UP trend
Yes. IMPP just hitting the 10:30am dip followed by the 11:30am return back UP.
GLTA
Agreed relative, but IMPP value based on Capacity & Demand to haul it when it's on a high...
GLTA
It's about INTEGRITY.
REPUTATION.
TLSS towers above SalSon who abuses customers, employees, partners, and also likely this deal they should have taken...
GLTA
Too many relate IMPP direct to oil.
IMPP is transport of oil which will increase demand no matter price of oil…
GLTA
I know SalSon & they are a SHIT Company.
Most shippers won’t do business with SalSon unless they are just as desperate themselves…
Better days & acquisitions ahead now that TLSS $30m debt taken care of…
GLTA
SNGX pipeline will prove to be the one that should’ve been owned
What’s with IMPP after hours volume & RISE ???!!!
SNGX soon to run UP with a pipeline like this & hitting a market over $20b!
"The U.S. home medical equipment market, which helps patients adhere to treatment and stay on track with their health,is expected to exceed $20.4 billion by 2027".
Soligenix 6/7/2022: Moves Forward with Treatments for Cutaneous T-Cell Lymphoma and Psoriasis
https://finance.yahoo.com/news/soligenix-moves-forward-treatments-cutaneous-123000857.html
GLTA
Definitely looks like GRAY manipulation has slowed.
GRAY such low float moves FAST even on low volume...
Any further confirmations of progress & won't be able to catch the run UP...
GLTA
Oh it’ll happen…
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MULN
“RE-SALE”… Wait till we hear what it’s for!
DWAC
GLTA