It appears, the second one did no good.
I guess I'm glad I sold some yesterday after all. I could buy some back much cheaper this morning (I think), but not putting any more money here.
SNGX always 2x PRs: 12/01/203: "December 01 2023 - 07:30AM PR Newswire
"HyBryte™ has potential to address a critical gap in treatment of early-stage CTCL
PRINCETON, N.J., Dec. 1, 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 an article describing the potential use of HyBryte™ in the treatment of cutaneous T-cell lymphoma (CTCL) has been published in Frontiers in Drug Discovery. The mini-review summarizes findings about the use, mechanism and effectiveness of HyBryte™ in the treatment of CTCL with a particular emphasis on the ability of HyBryte™ to address the unmet medical need in patients with early-stage disease.
"With its chronic course and major impact on patient quality of life, CTCL is an orphan disease in urgent need of additional treatment options that are well-tolerated and safe over the long term," stated Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY. "Clinical studies with HyBryte™ have demonstrated its safety and effectiveness, with broad applicability across different lesion types, different skin tones and different disease stages. I know I can speak for my colleagues that have been involved with these studies when I say that the data generated to date has been extremely compelling."
"In treating CTCL, which is a chronic cancer with no cure, long-term safety is a strong driver of treatment choice. Most current treatment options for CTCL are associated with significant safety concerns, including black-box warnings. HyBryte™ treatment has demonstrated strong and rapid efficacy with a very benign safety profile," stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. "Studies to date have indicated a substantial increase in efficacy with longer treatment with similar performance against both patch and plaque lesions. These results are derived from one of the largest studies ever conducted in CTCL and we believe HyBryte™ will be of significant benefit to patients living with this difficult disease."
12 halts so far,the sma200 has climbed to 1.11 now for support from here,in other words,ave number of ppl who bought in last 200 days are at break even and profit taking should end if news is hopeful enough and if new ppl start buying it will go up now,most tickers don’t exceed the first run up tho because of new profit takers/flippers
Yeah I'm around $7 cost-basis as wouldn't throw any more at it...
(because of r/s)
Figures. They shut it down right at my cost basis. Dang it!
Does this re-open at $2.50 or .53?
What the heck?? I mention $1.93 on here and suddenly a ton of dumping at $1.93.
I don't see a halt.
The stock typically trades under 300k shares per day. Today so far its at 37.5 MILLION!
Nice move today,dang halts,can’t sell,ZERO BORROW,42%fee is promising,profit taking now,sma200 is .80 support bounce
The cost basis on most of my shares is $1.93. I'm hoping to dump when it gets there.
Admittedly I don't have a full grasp on approval for small pharma companies (most still seem worthless). I don't understand how this news means a whole lot to the company as, it's not a phase III approval, but apparently someone does. And they've been loading up all morning.
I don't own enough of this to care much. Stupidly, I bought into it based on Jim Cramer back in November 2020.
I am always on here telling people not to throw out money on stupid stock plays. Occasionally I do it myself and almost without fail, I am reminded not to do it again.
Please do the after lunch BIG run !
The moment market makers realized this is for realz!
Geez, I'll be curious to see if all those shares picked up first thing this morning at .56 get dumped later today.
11/30/23 09:51:15 AM D O 2 0.9800 I
11/30/23 09:51:15 AM D O 600 0.9800
11/30/23 09:51:15 AM D O 160 1.0000
11/30/23 09:51:15 AM P 50 1.0000 I
11/30/23 09:51:15 AM D O 941 1.0000
11/30/23 09:51:15 AM P 10 1.0000 I
11/30/23 09:51:15 AM P 46 1.0000 I
11/30/23 09:51:15 AM P 70 1.0000 I
11/30/23 09:51:15 AM P 50 1.0000 I
11/30/23 09:51:15 AM P 1 1.0000 I
11/30/23 09:51:15 AM P 82 1.0000 I
11/30/23 09:51:15 AM D O 100 0.9900
11/30/23 09:51:15 AM O 0.9800 O 1.0000 28 X 465 BBO
11/30/23 09:51:15 AM P 200 0.9800 Y F
11/30/23 09:51:15 AM P 100 0.9800 Y F
11/30/23 09:51:15 AM O 100 0.9800 Y F
11/30/23 09:51:15 AM O 0.9800 O 1.0000 27 X 465 BBO
11/30/23 09:51:15 AM P 200 0.9800 Y F
11/30/23 09:51:15 AM O 37 0.9800 Y F I
Trading a MASSIVE amount of shares today. This may be real. There has been no pre-loading for a pump and dump.
Not sure I trust any of it but....
SNGX 11/30 confirmation news the real deal?
Or another run up to dilute, r/s, and fail another 2-3 years?
One can only hope..
“7:30a ET 11/30/2023 - PR Newswire
Soligenix Receives FDA IND Clearance for Phase 2 Clinical Trial of Dusquetide in the Treatment of Aphthous Ulcers in Beh?et's Disease”
I saw no mention of r/s.
Read the details of annual meeting,see what is on vote agenda,usually reverse split or other bad dilution when meeting
SNGX low volume sell off? WTH?
The biotech sector is draconian
95 per cent losers
5 per cent long term winners
100% same here!
SNGX Volume very low so fat lady hasn’t sung but definitely warming up…
I've got to quit buying garbage stocks in my IRA. Can't even take the tax loss.
SNGX 50 cent after hours must be leak of ANOTHER reverse split?…
SNGX 7/11/2023: Phase 2a Study in Mild-to-Moderate Psoriasis
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 the expansion of its Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis after demonstration of biological effect in the initial five subjects. The study is expected to enroll at least an additional five subjects, exploring the use of SGX302 in the standard of care psoriasis setting, prior to undertaking the larger phase of the study.
Evaluation of the initial five subjects enrolled demonstrated a clear biological signal, with the majority of patients recording an improvement in the PASI (psoriasis area and severity index) score. Enrolling additional patients will enable Soligenix to evaluate the use of SGX302 in the context of accelerated light treatment and additional adjunct treatment.
"Patients with mild-to-moderate disease do not qualify for the use of biologics and have fewer treatment options. The patients enrolled in this study all demonstrated clinical improvement and, with the experience gained in this first portion of the study, we anticipate being able to further improve responses as we move forward," stated Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego and Chair of the Company's Psoriasis MAB. "Having previously participated in the positive Phase 3 clinical trial of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL), I have had a clinical interest in this novel therapy and am pleased that the Soligenix team is advancing synthetic hypericin in psoriasis where there remains an unmet medical need. 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. Psoriasis affects more than 7.5 million patients in the U.S. alone, and 60-125 million people worldwide. Having treated psoriasis patients for over 20 years and 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 for many people that are living with this disease. I look forward to working with my esteemed colleagues to support Soligenix in advancing this important development program forward."
"We are pleased with the initial results from our Phase 2a trial," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The expansion of this psoriasis study continues our evaluation of synthetic hypericin into other disease indications, including non-orphan indications, where there remains an unmet medical need. Current estimates show as many as 60-125 million people worldwide living with the condition, with a global treatment market valued at approximately $15 billion in 2020 and projected to reach as much as $40 billion by 2027. The success of HyBryte™ 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. We anticipate being in a position to report additional SGX302 study data before year-end, as well as the outcome of our ongoing discussions with the FDA regarding a feasible and executable trial design for a confirmatory Phase 3 study with HyBryte™ in the treatment of early stage CTCL."
SNGX sell off 6/20 must be MORE bad news
Wow SNGX now .05 "pre-split"... Schaber trying to kill people or save lives???
To think SNGX over $4 few days ago…
Soligenix Announces Positive Clinical Results from Compatibility Study of HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma
Results Confirm and Extend Response Results from Phase 3 FLASH Study
PRINCETON, N.J., May 4, 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 positive clinical results from a compatibility study evaluating HyBryte™ (synthetic hypericin sodium) in the treatment of cutaneous T-cell lymphoma (CTCL) using the commercially ready Daavlin Series 7 visible light device, which recently received 510(k) clearance from U.S. Food and Drug Administration (FDA). The open-label study (protocol HPN-CTCL-02) enrolled 9 patients to receive 8 weeks of HyBryte™ treatment of their cancerous lesions, with an assessment of treatment response conducted at week 10 using the Composite Assessment of Index Lesion Severity (CAILS) score. All subjects were enrolled by Brian Poligone, MD, PhD, at the Rochester Skin Lymphoma Medical Group.
The purpose of the study was to establish that any light device capable of producing visible light of an appropriate and consistent wavelength (500 to 650 nm) was suitable for use with HyBryte™ and extend the pharmacokinetic profile using a recently developed, more sensitive hypericin assay. In addition to meeting these objectives, the efficacy demonstrated strongly substantiates the results of the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study. The treatment response data of 22% following 8 weeks of twice weekly HyBryte™ therapy recapitulates the results of the FLASH trial, despite the fact that patients in the current study were specifically selected to have more extensive disease consistent with its potential commercial use. Additionally, in this study all patients had improvements in their cumulative CAILS score (average improvement of 36.4%, range 8 to 100%). Results in individual lesions showed that 7 of the 27 index lesions (25.9%) had at least a 50% improvement in their CAILS score and 4 of the 27 index lesions (14.8%) were completely resolved after as little as 8 weeks of treatment. Other key evaluations included measurements of systemic exposure and cardiac output, which yielded extremely low and limited levels of systemic hypericin (plateau concentration of approximately 0.00013 µg/mL) detected in the blood and no observable impact to normal sinus rhythm, reinforcing the safety of HyBryte™.
"We were excited for the opportunity to work with Soligenix and make HyBryte™ available to our patients," stated Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, and Principal Investigator for the compatibility study and Leading Enrolling Investigator in the FLASH study. "Since the completion of the Phase 3 FLASH study, I have had a number of patients asking about possible access to this promising therapy. Fortunately, we were chosen to conduct this study and the patients' enthusiasm for the product was evident by their willingness to participate in the trial, allowing for its rapid completion. I look forward to continuing to work with Soligenix to further advance the HyBryte™ program so my patients can have this much needed treatment option available to them."
"These results reinforce the positive HyBryte™ data from the FLASH study. Important corporate objectives for the study were to replicate results previously observed in the FLASH study, while using finished drug product manufactured by our proposed commercial contract manufacturer and activated using a commercially viable light device," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We look forward to continuing to work with Dr. Poligone and all of our committed clinical investigators to make HyBryte™ available to this underserved orphan patient population."
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 that is taken up by the malignant T-cells, and then activated by visible light approximately 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™ 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 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™ treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ 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