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 immunogenicity studies for RiVax® (heat stable ricin toxin vaccine) identifying novel correlates of immune protection to facilitate potential approval under the United States Food and Drug Administration (FDA) "Animal Rule." The article, titled "A Multivariate Model Combining Endpoint and Epitope-specific Antibody Responses as a Correlate of Protection to Ricin Toxin," has been submitted to the peer-reviewed medical journal Vaccine and a preprint is available here.
By David Bautz, PhD NASDAQ:SNGX READ THE FULL SNGX RESEARCH REPORT Business Update Positive Topline Results for SGX301 Phase 3 Trial in CTCL On March 19, 2020, Soligenix, Inc. (NASDAQ:SNGX) announced positive topline results for the Phase 3 clinical trial of SGX301 in patients with cutaneous T cell lymphoma (CTCL). The FLASH (Fluorescent Light Activated Synthetic Hypericin) trial is a randomized,
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 its ongoing collaboration with the University of Hawaiʻi at Mānoa (UH Mānoa) is being expanded to assess potential coronavirus vaccines (including COVID-19).
By David Bautz, PhD NASDAQ:SNGX READ THE FULL SNGX RESEARCH REPORT Business Update Developing Coronavirus Vaccines On March 23, 2020, Soligenix, Inc. (NASDAQ:SNGX) announced an expansion of the ongoing collaboration with the University of Hawaii at Manoa to develop potential coronavirus vaccines, including one against SARS-CoV-2 to prevent COVID-19. Soligenix has performed extensive work on
Miami Beach, Florida--(Newsfile Corp. - February 20, 2020) - Soligenix may be nearing a transformative point in its history as data from its Phase 3 SGX301 (FLASH) trial to treat cutaneous T-cell lymphoma (CTCL) nears its release. The topline data from this late-stage study is expected in less than 40 days. And, if that release can validate data known from a recent case study performed by Dr. Brian Poligone, MD, Ph.D., then Soligenix ...
By David Bautz, PhD NASDAQ:SNGX READ THE FULL SNGX RESEARCH REPORT Business Update Increased Efficacy with Continued Treatment in Phase 3 Trial of SGX301 On April 30, 2020, Soligenix, Inc. (NASDAQ:SNGX) announced positive results for Cycle 2 of the Phase 3 FLASH clinical trial of SGX301 in patients with cutaneous T cell lymphoma (CTCL) showing that continued treatment out to 12 weeks results in
Anyone researching Soligenix, Inc. (NASDAQ:SNGX) might want to consider the historical volatility of the share price...
A week ago, Soligenix, Inc. (NASDAQ:SNGX) came out with a strong set of yearly numbers that could potentially lead to...
New York, New York--(Newsfile Corp. - March 24, 2020) - Soligenix Inc. (NasdaqGS: SNGX), through its Public Health Solutions business segment, announced on Monday that the company is expanding its ongoing collaboration with the University of Hawai'i at Manoa to assess potential coronavirus vaccines, including COVID-19. More specifically, the study is evaluating the application of the company's heat-stabilization technology that has the potential to substantially alleviate the strains of cold-storage and distribution challenges ...
By David Bautz, PhD NASDAQ:SNGX READ THE FULL SNGX RESEARCH REPORT Business Update New Publication on RiVax® On May 11, 2020, Soligenix announced a publication on immunogenicity studies for RiVax®, the company’s heat stable ricin vaccine, that showed correlates between immune protection and survival in mice. RiVax® is one of the company’s vaccine candidates being developed to protect against
Soligenix, Inc. (Nasdaq: SNGX) ("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 that it has executed an agreement for the exclusive worldwide license of CoVaccine HT™, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals ("BTG"), a division of Boston Scientific Corporation (NYSE: BSX), for the fields of SARS-CoV-2, the cause of COVID-19 and pandemic flu.
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 its recent accomplishments and financial results for the year ended December 31, 2019.
Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks that hit 52-week highs April 15.) * Bio-Rad Laboratories, Inc. Class B Common Stock (NYSE: BIO) * Calithera Biosciences Inc (NASDAQ: CALA) (provided an update on the impact of COVID-19 on its ongoing clinical trials) * Eli Lilly And Co (NYSE: LLY) * Keros Therapeutics Inc (NASDAQ: KROS) (went public April 8) * Masimo Corporation (NASDAQ: MASI) * Moderna Inc (NASDAQ: MRNA (analysts hiked price targets for the shares following the company's Virtual Vaccines Day) * Pluristem Therapeutics Inc. (NASDAQ: PSTI) * Regeneron Pharmaceuticals Inc (NASDAQ: REGN)Down In The Dumps (Biotech stocks that hit 52-week lows April 15.) * Akorn, Inc. (NASDAQ: AKRX) * AxoGen, Inc Common Stock (NASDAQ: AXGN) * TherapeuticsMD Inc (NASDAQ: TXMD) * Vaccinex Inc (NASDAQ: VCNX) * Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.Stocks In Focus UroGen's Kidney Cancer Drug Gets FDA Approval Urogen Pharma Ltd (NASDAQ: URGN) said the FDA granted expedited approval for its Jelmyto for pyelocaliceal solution, indicated to treat adults with low-grade upper tract urothelial cancer. The company said the approval was granted based on positive results from a Phase 3 Olympus trial that demonstrated Jelmyto's effectiveness in this rare and difficult-to-treat cancer.Jelmyto consists of mitomycin, an established chemotherapy and sterile hydrogel, using Urogen's proprietary sustained release RTGel technology.The stock was trading more than 14% higher at $24 in Thursday's premarket session. Accelerate Diagnostics Pre-Announces In-Line Q1 Revenue Accelerate Diagnostics Inc (NASDAQ: AXDX) said it expects first-quarter net sales of $2.3 million, higher than $1.8 million in the year-ago period and in line with the consensus estimate.Citing the uncertainty surrounding the duration of the COVID-19 pandemic, the company withdrew its guidance.The stock rallied 7.89% to $9.02 in after-hours trading.Vanda To Study Impact Of Human Genetic Variations On Coronavirus Infection, Progression Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced the initiation of the CALYPSO program to study the role that human genetic variations play in SARS-CoV-2 infection and disease progression. The company said it will collaborate with the University of Washington School of Medicine and its Virology Lab on a pharmacogenetics study in COVID-19 patients."The study will focus on the sequencing of the genome of individual patients, as well as the COVID-19 virus, and the identification of genetic factors that correlate with disease progression and outcomes," according to Vanda. Separately, Vanda said it has enrolled the first patient in its ODYSSEY trial at Lenox Hill Hospital in New York City with Northwell Health's research arm. The ODYSSEY trial is a Phase 3 study investigating the efficacy and safety of tradipitant, a neurokinin-1 receptor antagonist, in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 infection.The stock was trading 8.45% higher at $11.30 in Thursday's premarket session. See also: The Week Ahead In Biotech: Urogen FDA Decision, Amarin, J&J Earnings And More COVID-19 Updates Vir Presents Positive Data For Hepatitis B Virus Drug Vir Biotechnology Inc (NASDAQ: VIR) announced additional interim data from the ongoing Phase 2 study and results from the Phase 1 trial in healthy volunteers of VIR-2218, an investigational small interfering ribonucleic acid that mediates RNA interference for the treatment of chronic hepatitis B virus infection.The company said interim results from the Phase 2 study showed VIR-2218 resulted in a significant dose-dependent and durable reduction in hepatitis B surface antigen through week 24 in patients who received two doses ranging from 20 mg to 200 mg.Vir had licensed the investigational asset from Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY). Vir said it will initiate combination trials of VIR-2218 with a shortened course of pegylated interferon, with dosing likely to begin in the second half of 2020.Vir shares were trading 0.79% higher at $29.50 in the premarket session. Co-Diagnostics Says COVID-19 Tests Validated For Use With Saliva Samples Co-Diagnostics Inc (NASDAQ: CODX) said OralDNA Labs, a CLIA-certified laboratory, recently validated a COVID-19 PCR test based on the its patented CoPrimer technology for use with saline oral rinse samples, and has notified the FDA of their intent to use the validated test in their CAP accredited high-complexity laboratory.The stock was adding 7.16% to $10.18 in premarket trading. Soligenix Licenses COVID-19 Vaccine Adjuvant From Boston Scientific Unit Soligenix, Inc. Common Stock (NASDAQ: SNGX) announced an agreement for exclusive worldwide licensing of CoVaccine HT, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation (NYSE: BSX), for SARS-CoV-2.View more earnings on IBBThe stock was ripping higher by 60% to $2.24 in premarket trading. Eagle Pharma Submits IND For Coronavirus Treatment Candidate Eagle Pharmaceuticals Inc (NASDAQ: EGRX) said its Ryanodex for injectable suspension inhibited the growth of SARS-CoV-2 in lab tests. The company said it submitted an IND to the FDA for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of Ryanodex in patients infected with the virus.Inovio Nets $6.9M In Funding To Initiate South Korean Clinical Trial Of Coronavirus Vaccine Candidate Inovio Pharmaceuticals Inc (NASDAQ: INO) has been granted $6.9 million in funding by the Coalition for Epidemic Preparedness Innovations to work with the International Vaccine Institute and the Korea National Institute of Health for a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine candidate INO-4800 in South Korea, according to the IVI. The organization said it will conduct the trial in South Korea.In premarket trading Thursday, Inovio shares were advancing 7.84% to $7.70.Ascendis' Growth Hormone Deficiency Drug Granted Orphan Drug Designation Ascendis Pharma A/S (NASDAQ: ASND) said the FDA has granted Orphan Drug Designation to its TransCon hGH as a treatment for growth hormone deficiency.AEterna Warned On Nasdaq Listing Standards, Has 180-Day Grace Period To Regain Compliance AEterna Zentaris Inc. (NASDAQ: AEZS) said it has received notice from Nasdaq indicating the company is not in compliance with the minimum $1-per-share bid price requirement, having closed below $1 per share for the prior 30 consecutive business days. The company said it has been provided a grace period of 180 calendar days through Oct. 5 to regain compliance.Novavax Coronavirus Vaccine To Enter Clinics In Australia Novavax, Inc.'s (NASDAQ: NVAX) Australian development partner Nucleus Network said it is due to commence Phase 1 testing of the former's NVX-CoV2372, a SARS-CoV-2 recombinant spike protein nanoparticle vaccine, at its Melbourne and Brisbane clinics in the coming weeks.In premarket trading Thursday, Novavax shares were adding 2.51% to $17.97. Offerings Calithera said it has priced its underwritten public offering of 5 million shares at $6.25 per share. The company expects to raise gross proceeds of $31.25 million from the offering. The offering is expected to close April 20.The stock was down 1.18% to $7.51 in the premarket session. Arcturus Therapeutics Ltd (NASDAQ: ARCT), which recently issued an update on its COVID-19 vaccine development program, said it intends to sell shares of its common stock in an underwritten public offering. All the shares are to be offered by the company.The company said it intends to use the net proceeds for working capital and general corporate purposes, including capex and R&D expenses related to the advancement of its LUNAR-OTC, LUNAR-COV19 and its other product candidates and clinical trial expenditures.The stock was down 3.06% at $17.45 in the premarket session. Athersys Inc (NASDAQ: ATHX) said it intends to offer $50 million of its common stock for sale in an underwritten public offering. The company said it will use the net proceeds for working capital and general corporate purposes, including funding its acute respiratory distress syndrome clinical program, which includes initiation of a Phase 2/3 pivotal study for COVID-19-induced ARDS patients, and its process development and manufacturing projects.The stock was down 25.81% at $2.30 in the premarket session. On The Radar Clinical Readouts Moleculin Biotech Inc (NASDAQ: MBRX) is hosting a web-based investor conference call at 4:30 p.m. ET Thursday to explain the significance of the recent discovery that the active compound in its WP1122 drug candidate, which it has licensed to WPD Pharmaceuticals Inc (OTC: WCOTF), has been shown to reduce replication of SARS-CoV-2 by 100%.Earnings Thursday Abbott Laboratories (NYSE: ABT) (before the market open)Intuitive Surgical, Inc. (NASDAQ: ISRG) (after the close)Related Link:Gilead Analysts Break Down Remdesivir Data Readout From Compassionate Use See more from Benzinga * 3 Frontrunners In COVID-19 Vaccine Development: What You Need To Know * The Daily Biotech Pulse: Applied DNA Ships Vaccine Constructs For Animal Testing, Herceptin Biosimilar Now Available In US * The Daily Biotech Pulse: Amarin Reports Strong Q1 Vascepa Sales, BeiGene Aces Late-Stage Lung Cancer Study, Glaxo, Sanofi Strike COVID-19 Vaccine Partnership(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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 European patent office has granted the divisional patent application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 2932973). The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of cutaneous T-cell lymphoma (CTCL). Synthetic hypericin is the active pharmaceutical ingredient in SGX301, the Company's photodynamic therapy, for which positive primary endpoint results in a pivotal Phase 3 study for the treatment of CTCL were recently announced (available here). This new patent expands on Soligenix's comprehensive patent estate, which includes protection on the composition of the purified synthetic hypericin, methods of synthesis and therapeutic methods of use in both CTCL and psoriasis, and is being pursued worldwide.
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 continued treatment with SGX301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment) in the open-label treatment cycle (referred to as Cycle 2) of its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage cutaneous T-cell lymphoma (CTCL). These highly statistically significant results confirm the benefit of continued SGX301 treatment in CTCL patients.
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 approximately $840,000, net of transaction costs, in non-dilutive financing via the state of New Jersey's Technology Business Tax Certificate Transfer Program.
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 preliminary top-line results for its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial evaluating SGX301 (Synthetic Hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. In addition, preliminary assessment of the open-label Cycle 2 results suggest a significantly more robust response rate after 12 weeks of SGX301 treatment. These data are expected to be announced in June 2020.
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 its recent accomplishments and financial results for the quarter ended March 31, 2020.
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 its ongoing collaboration with the University of Hawai'i at Manoa (UHM) and Hawaii Biotech Inc. (HBI) has resulted in what the Company believes is a significant milestone in the development of heat stable filovirus vaccines, in which the platform has demonstrated feasible thermostable formulations and protection in non-human primate models with both monovalent and bivalent vaccine candidates in the three most deadly human pathogenic filoviruses (Ebola virus, Sudan virus and Marburg virus).
New York, New York--(Newsfile Corp. - March 20, 2020) - Soligenix, on Thursday, announced positive topline data for its lead CTCL drug candidate, SGX301. The published data demonstrated statistically significant efficacy results in treating this challenging and often debilitating chronic cancer. Additionally, this potentially transformative milestone for Soligenix (NASDAQ: SNGX) positions the company to explore strategic partnership and commercialization opportunities to take advantage of what is an expected $250 million drug market opportunity. The ...