Phase

Supernus Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024

ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

Key Points: 
  • Fourth quarter 2023 net sales of Qelbree® increased 97% to $46.4 million compared to fourth quarter 2022; Full year 2023 net sales of Qelbree increased 129% to $140.2 million compared to full year 2022.
  • Fourth quarter 2023 net sales of GOCOVRI® increased 10% to $32.0 million compared to fourth quarter 2022; Full year 2023 net sales of GOCOVRI increased 15% to $119.6 million compared to full year 2022.
  • Full year 2023 operating loss (GAAP) was $(5.3) million; Full year 2023 operating earnings (non-GAAP)(2), were $125.1 million.
  • ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

Recce Pharmaceuticals Announces Expansion of Phase I/II Trial of RECCE® 327 for the Treatment of Diabetic Foot Infections

Retrieved on: 
Tuesday, February 27, 2024

The objective of this trial is to evaluate R327’s potential as a topical broad-spectrum anti-infective treatment.

Key Points: 
  • The objective of this trial is to evaluate R327’s potential as a topical broad-spectrum anti-infective treatment.
  • In the coming months, additional study sites both locally and overseas will become active and include the broader patient population in the study.
  • Of the estimated 537 million people worldwide who have diabetes, 19–34% will develop a DFU in their lifetime.
  • “A non-invasive method to treat the burdensome challenges of diabetic foot ulcer infections gives hope to better patient outcomes and avoid limb amputation, as is so commonly the case with these complicated patients.

Philogen provides update on pre-planned interim analysis of the Phase III FIBROSARC trial investigating Onfekafusp alfa (L19TNF) in patients with first-line advanced or metastatic Soft Tissue Sarcoma

Retrieved on: 
Tuesday, February 20, 2024

SIENA, Italy, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Philogen S.p.A. (BIT:PHIL) is pleased to announce that the Phase III FIBROSARC trial (NCT04650984) will continue as planned by the protocol. The decision was made by an Independent Data and Safety Monitoring Board (DSMB) following the review of efficacy and safety data in the pre-planned interim analysis.

Key Points: 
  • The decision was made by an Independent Data and Safety Monitoring Board (DSMB) following the review of efficacy and safety data in the pre-planned interim analysis.
  • FIBROSARC is a Phase III 1:1 randomized trial (NCT04650984) which studies L19TNF in combination with doxorubicin (Experimental Arm) versus doxorubicin alone (Control Arm) in 118 patients as first-line therapy for advanced or metastatic Soft Tissue Sarcoma (STS).
  • The Phase III FIBROSARC trial was designed to demonstrate a significant clinical benefit of L19TNF plus doxorubicin compared to doxorubicin alone.
  • For more information about Onfekafusp alfa (also known as Fibromun), FIBROSARC Phase III study (NCT04650984), Soft Tissue Sarcoma, and Philogen, please visit https://www.philogen.com/investors/press-releases/ .

RenovoRx Highlights Key Leadership Promotions

Retrieved on: 
Friday, March 8, 2024

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlighted the recent key leadership promotions of Leesa Gentry to Chief Clinical Officer and Ronald B. Kocak, CPA to Principal Accounting Officer.

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlighted the recent key leadership promotions of Leesa Gentry to Chief Clinical Officer and Ronald B. Kocak, CPA to Principal Accounting Officer.
  • Since joining RenovoRx, Ms. Gentry has demonstrated exemplary leadership and commitment to advancing the Company’s clinical pipeline.
  • Mr. Kocak has been promoted to the position of Principal Accounting Officer and will retain his roles as Vice President and Controller of RenovoRx.
  • In this new leadership role, Mr. Kocak will oversee all financial management, reporting and strategic planning initiatives crucial to furthering the Company’s research and development efforts.

MediPrint® Ophthalmics Announces Successful Completion of Its Phase 2b Glaucoma Clinical Study with Positive Results.

Retrieved on: 
Wednesday, March 6, 2024

MediPrint® Ophthalmics , a clinical-stage ocular drug delivery platform technology focused on transforming ocular drug delivery, announces the completion of its Glaucoma SIGHT-2, Phase 2b study.

Key Points: 
  • MediPrint® Ophthalmics , a clinical-stage ocular drug delivery platform technology focused on transforming ocular drug delivery, announces the completion of its Glaucoma SIGHT-2, Phase 2b study.
  • The Phase IIb trial was an active-controlled, randomized, dose-finding, multi-center study, evaluating the Company’s lead candidate (LL-BMT1) versus a control group on bimatoprost 0.01% ophthalmic solution.
  • SIGHT-2 study evaluated safety and efficacy of LL-BMT-1 in 28 patients diagnosed with open-angle Glaucoma for three weeks.
  • “The successful completion of the study is an important milestone as it validates our company’s technology and will help address significant unmet need for patients suffering from Glaucoma or Ocular Hypertension.

Oragenics, Inc. Prepares Drug for Phase II Clinical Trials to Treat Concussion

Retrieved on: 
Tuesday, March 5, 2024

The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion.

Key Points: 
  • The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion.
  • A 40-patient Phase I human study showed ONP-002 to be safe and well-tolerated.
  • Phase II patients will be recruited between the ages of 18-55 in the acute phase following concussion.
  • “Preclinical intranasal targeting of the brain has been shown to improve outcomes in animals and safety margin following concussion.

SolasCure Publishes Phase IIa Clinical Trial Report in Leading Wound Care Journal

Retrieved on: 
Monday, March 4, 2024

SOLASCURE Ltd (SolasCure), a biotechnology company developing a novel treatment to transform chronic wound care, has today announced the publication of its CLEANVLU Phase IIa clinical trial report in the International Wound Journal, a leading wound care journal.1 SolasCure’s first investigational product, Aurase Wound Gel, is a hydrogel releasing tarumase (provisional INN), a recombinant enzyme derived from medical maggots, which aims to promote wound healing through debridement and wound bed preparation.

Key Points: 
  • SOLASCURE Ltd (SolasCure), a biotechnology company developing a novel treatment to transform chronic wound care, has today announced the publication of its CLEANVLU Phase IIa clinical trial report in the International Wound Journal, a leading wound care journal.1 SolasCure’s first investigational product, Aurase Wound Gel, is a hydrogel releasing tarumase (provisional INN), a recombinant enzyme derived from medical maggots, which aims to promote wound healing through debridement and wound bed preparation.
  • The Phase IIa data, which demonstrates proof-of-concept and safety of Aurase Wound Gel in humans, has now been peer-reviewed and published, providing strong validation as SolasCure progresses into further clinical studies, and marks a significant milestone for the Company.
  • SolasCure’s CLEANVLU Phase IIa trial was performed in venous leg ulcer (VLU) patients across centers in the US, UK, and Hungary.
  • The trial compared five escalating dose concentrations to baseline the use of tarumase for enzymatic debridement and wound bed preparation.

Exonate first-in-class eye drop Phase Ib/IIa trial data demonstrate safety and biological activity in treatment of diabetic retinopathy and diabetic macular oedema

Retrieved on: 
Tuesday, March 5, 2024

These data demonstrate the safety and tolerability of EXN407, as well as clear indications of biological activity, positioning it well for further development as the first topical treatment for retinal vascular diseases such as diabetic retinopathy and diabetic macular oedema.

Key Points: 
  • These data demonstrate the safety and tolerability of EXN407, as well as clear indications of biological activity, positioning it well for further development as the first topical treatment for retinal vascular diseases such as diabetic retinopathy and diabetic macular oedema.
  • Exonate is now planning to progress EXN407 to the CLEAR-DM (Clinical Evaluation of a New Eyedrop for Alleviating Retinopathy in Diabetic Macular Oedema) Phase IIb clinical trial.
  • The mild NPDR/DME (NCT04565756) clinical study assessed the safety, tolerability and signals of biological response to EXN407 monotherapy in a double-masked, placebo-controlled Phase Ib/IIa dose-ranging clinical trial in treatment-naïve patients with mild/moderate non-proliferative diabetic retinopathy (NPDR) and mild diabetic macular oedema.
  • “The results suggest that topical ocular EXN407 may provide clinical benefit and substantially reduce the injection burden for patients with diabetic eye disease.

Antibe Announces Unfavorable Decision in Arbitration With Nuance Pharma

Retrieved on: 
Monday, March 4, 2024

“We strongly disagree with this decision,” commented Dan Legault, Antibe’s CEO. “Nonetheless, we acknowledge the fact that we agreed to binding arbitration in a foreign jurisdiction. Antibe respects the confidentiality and final nature of the arbitration proceedings and will accept the decision in good faith. We continue to believe that the comprehensive data package shared with Nuance for the previous chronic pain formulation fully reflected the drug’s safety and efficacy characteristics. Although this ruling presents a significant short-term challenge, we remain committed to developing otenaproxesul -- particularly due to the strength of recent clinical results for acute pain that have significantly de-risked its final trials.”

Key Points: 
  • The confidential ruling from the Singapore International Arbitration Centre rescinds the license agreement and requires Antibe to refund the US$20 million upfront payment and pay interest and costs of approximately US$4 million.
  • Antibe views this unexpected result as highly unusual based on best practices for licensing deals in the biotech industry.
  • “Nonetheless, we acknowledge the fact that we agreed to binding arbitration in a foreign jurisdiction.
  • Antibe respects the confidentiality and final nature of the arbitration proceedings and will accept the decision in good faith.

Therapeutic Solutions International Announces Landmark Finding Regarding Mechanism of Action of its JadiCell Stem Cell Product

Retrieved on: 
Thursday, February 29, 2024

Depletion of either of these cells significantly reduced therapeutic effects of JadiCells.

Key Points: 
  • Depletion of either of these cells significantly reduced therapeutic effects of JadiCells.
  • Additionally, transfer of monocytes and T cells from JadiCell treated mice was able to protect naïve mice from lung injury.
  • The therapeutic effect of JadiCells was amplified by administration of Leukine (GM-CSF), which is known to increase circulating monocytes.
  • We are dedicated to curing this terrible disease1 and making our cells the new standard of care.”