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Soligenix, Inc. (SNGX)
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SNGX Q3 results 11/12/2021. $29mm on hand + Gvt Funding.
"Nov. 12, 2021 -- Soligenix, 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, 2021.
Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "There continues to be a great deal of activity across our Specialized BioTherapeutics and Public Health Solutions business segments. We continue to work diligently to prepare the new drug application (NDA) for HyBryte(TM) (SGX301 or synthetic hypericin) following the positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL). The Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) granted orphan drug designation to the active ingredient hypericin for the treatment of T-cell lymphoma, expanding the treatment population beyond CTCL. Additionally, we announced expansion of synthetic hypericin development into psoriasis, under the research name SGX302, where we plan to initiate a Phase 2a clinical study in the second half of 2022. This decision follows validation of synthetic hypericin's biologic activity in the FLASH study, as well as positive proof-of-concept (PoC) demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, a large and underserved market with a significant unmet medical need. Under our Public Health Solutions business segment, we remain focused on developing heat-stable vaccines for global use. Most notably, we announced publication of compelling pre-clinical immunogenicity studies for CiVax(TM) (heat stable COVID-19 vaccine program) demonstrating durable broad-spectrum neutralizing antibody responses in non-human primates (NHPs), including against the Beta, Gamma and Delta variants."
Dr. Schaber continued, "With approximately $29 million in cash, not including our non-dilutive government funding, we anticipate having the necessary capital to achieve our upcoming milestones, including NDA filing and expansion into psoriasis with the conduct of the Phase 2a clinical trial. We are also continuing to actively assess various strategic options, including but not limited to, partnership and merger and acquisition opportunities."
Soligenix Recent Accomplishments
-- On November 8, 2021, the Company announced it had been granted a
Pediatric Investigation Plan (PIP) product-specific waiver in the United
Kingdom from the Medicines and Healthcare products Regulatory Agency for
HyBryte(TM) in the treatment of CTCL. To view this press release, please
-- On November 4, 2021, the Company announced the publication of
pre-clinical immunogenicity studies for RiVax(R) (heat stable ricin toxin
vaccine) demonstrating enduring protection for at least 12 months
post-vaccination. The article titled "Durable Immunity to Ricin Toxin
Elicited by a Thermostable, Lyophilized Subunit Vaccine" has been
accepted for publication in the journal mSphere. To read the publication,
please click here. To view this press release, please click here.
-- On September 28, 2021, the Company announced the publication of
pre-clinical immunogenicity studies for CiVax(TM) demonstrating durable
broad-spectrum neutralizing antibody responses, including against the
Beta, Gamma and Delta variants of concern. The article, titled "Protein
Vaccine Induces a Durable, More Broadly Neutralizing Antibody Response in
Macaques than Natural Infection with SARS-CoV-2 P.1", has been posted as
an accelerated preprint on bioRxiv. To view the publication, please click
here. To view this press release, please click here.
-- On September 16, 2021, the Company announced that following the
validation of synthetic hypericin's biologic activity in the positive
pivotal Phase 3 FLASH study in CTCL, as well as 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 affecting between
60-125 million people worldwide. To view this press release, please click
-- On September 9, 2021, the Company announced that the Office of Orphan
Products Development of the U.S. FDA had granted orphan drug designation
to the active ingredient hypericin for the treatment of T-cell lymphoma,
extending the target population beyond CTCL as previously granted. To
view this press release, please click here.
-- On August 23, 2021, the Company announced a publication describing the
formulation of single-vial platform presentations of monovalent (single
antigen), bivalent (two antigens) and trivalent (three antigens)
combinations of filovirus vaccine candidates. In collaboration with
University of Hawai
If you want to make some money here buy the warrant very cheap been watching this thing for years since on the otc and finally decide to get in holding 50 k on warrants at 02
Someone has some knowledge that we don't.
so sngx has 29 million in cash and operates on 3 million a year on average. They have a lot of things in the pipeline. We just need fda approval on something!
SNGX: Double immunity for Rivax.
I am a bull here but I would have to say it's real shady they are not pursuing European or US approvals for hybryte. From the may pr they said the fda suggested additional supportive data for inclusion in the NDA filing. Wish the company would tell us what the fda is looking for. Hopefully its long term follow up data. But if additional data is needed wouldn't that require another phase 3? Anyone have any information on what's really happening here?
something bullish is going to happen this week
Folks the CEO is a known conman. But let’s take that out of it. Just study thier past 20 years. It’s nothing but a giant pile of delayed diluted scam scrap heap tech. Now let’s look just at 301 as a microcosm even though everyone of thier programs are poster child’s for fraud. So they were extremely selective in who could join trial and it was delayed 9 different times and an interim data added mid trial that was never in the pre trial design. Then they not the patient selected 3 lesions to treat. They never gave data for full body treatment and they never gave the results if they did 3 rd party verification of the photos. They delayed the NDA now 3 times with the last time being a few weeks after emptying the atm conviently while gullible shareholders lined up for the potential catalyst. Then they admit the fda told them to not bother and Schaber claims he need a little more data that he’s not even collecting and oh yeah now that’s because of supply chain issues with the global pandemic. Please it’s called Decieve Delay and Dilute
SNGX 11/8 granted IP waiver for HyBryte in UK.
Soligenix Granted Pediatric Investigational Plan Waiver for HyBryte in CTCL in the United Kingdom November 08 2021 - 07:30AM
PRINCETON, N.J., Nov. 8, 2021 /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 been granted a Pediatric Investigation Plan (PIP) product-specific waiver from the Medicines and Healthcare products Regulatory Agency (MHRA) for HyBryte™ (SGX301 or synthetic hypericin), which has successfully concluded a Phase 3 pivotal clinical study for the treatment of early stage cutaneous T-cell lymphoma (CTCL).
The waiver was provided for all subsets of the pediatric population from birth to less than 18 years of age on the grounds that clinical studies in this rare population are not feasible. Earlier this year the European Medicines Agency (EMA) also granted a waiver to the Pediatric Investigational Plan requirements for the European Union (EU). With the withdrawal of the United Kingdom (UK) from the EU effective January 1, 2021, the MHRA became the UK's standalone medicines and medical devices regulator.
"This achievement is an important regulatory milestone as we move forward with marketing applications worldwide," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The PIP waiver allows us to work towards advancing a marketing authorization application (MAA) in the UK in a more cost-effective manner since we will not need to expend resources to conduct a pediatric clinical study."
***"The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II Small Business Innovation Research (SBIR) grant (#1R44CA210848-01A1) awarded to Soligenix, Inc."***
Noone can answer the question of potential for rivax. Ricin could be used somewhere in the world tomorrow and open the eyes of everyone. Then I would imagine it would be pushed out kinda like the current covid vaccines that a being given to everyone with little testing. The program is further than I thought already human efficacy talked about. There is potential for a good chunk of revenue weather it is more grant money for more testing or approval
Latest SEC filing says,
"Due to disruptions caused by the global COVID-19 pandemic resulting in delays by the commercial active pharmaceutical ingredient contract manufacturer, Soligenix, Inc. (the “Company”) is unable to provide the pre-requisite amount of accrued stability data required to file its HyBryte™ (SGX301) new drug application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) by the first half of 2022. Therefore, the timeline for anticipated NDA filing with the FDA is being adjusted to the second half of 2022 with corresponding potential FDA approval adjusted to the second half of 2023."
After all the pumping and pimping of Hybryte, Shabby is now blaming covid for not being able to provide the FDA required Hybryte stability data.
Sounds like the kid who told the teacher that he did his homework but the dog ate it.
CEO has to be asking himself, imo: "Am I really worth $810K/year when the value of my company's stock is floundering to a new 52 week low? Maybe I should take some of that excessive compensation and buy some on the open market, rather than plan for yet another reverse split."
I have been in and out of this stock multiple times over the last 10 years or so. Sometimes I made money, sometimes I lost - I suspect I am probably about even in total. One thing has always been consistent - the next great thing has always been right there on the horizon - that is how I got sucked in a few times. Year after year this is the case and yet in all of this time nothing - no approved products - no revenue - just an occasional grant. At this point, after a decade+ of this it seems to me management credibility should be ZERO. I am surprised they are still around - but I guess that plan of always being close is just enough, to keep at least some new money coming in for management to burn...
Soligenix Announces Publication Demonstrating Enduring Protection of its Thermostable RiVax® Vaccine
• Vaccinated mice remained protected against lethal ricin poisoning for at least 12 months post-vaccination
• Strong protection mounted within 1 month of vaccination and complete protection occurred by 2 months post-vaccination
• Study facilitated continued development of correlates of immune protection, required for potential approval under the FDA “Animal Rule”
Princeton, NJ – November 4, 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 publication of pre-clinical immunogenicity studies for RiVax® (heat stable ricin toxin vaccine) demonstrating enduring protection for at least 12 months post-vaccination. The article titled “Durable Immunity to Ricin Toxin Elicited by a Thermostable, Lyophilized Subunit Vaccine” has been accepted for publication in the journal mSphere (available here). The article results from collaborative work with the Wadsworth Center of the New York State Department of Health. Coupled with previous demonstration of efficacy in mice and non-human primates (NHPs) as well as long-term thermostability (at least 1 year at 40°C or 104°F), these results reinforce the practicality of stockpiling and potentially utilizing the RiVax® vaccine in warfighters and civilian first responders without the complexities that arise for vaccines that require stringent cold chain handling. This same thermostabilization approach is also being advanced in the development of Soligenix’s CiVax™ vaccine for COVID-19.
Wow. This could be a huge added revenue stream. About to load some more
#SNGX $SNGX 8k filing
"the timeline for anticipated NDA filing with the FDA is being adjusted to the second half of 2022 with corresponding potential FDA approval ADJUSTED TO THE SECOND HALF OF 2023"
2023 not 2022
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What happened for the big jump AFH ?
here's yhy he keeps the printing press busy. not a bad paycheck:
Dr. Christopher J. Schaber Ph.D.Chairman, CEO & Pres $810.3k
Mr. Jonathan L. Guarino CPA, CGMASr. VP, CFO & Corp. Sec. $294.08k
Dr. Oreola Donini Ph.D.Sr. VP & Chief Scientific Officer $380.46k
What is the potential annual revenue for Rivax ? Why do they waste money on advertising this product ? Any and all info would be appreciated . Thanks
any news? trying to find reason for $0.01 rally
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