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MaaT Pharma Announces 2023 Annual Results and Provides a Business Overview

Retrieved on: 
Thursday, March 28, 2024
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MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.

Key Points: 
  • MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.
  • In December 2023 , the Company presented positive results from the Early Access Program (EAP) in Europe involving 111 patients with aGvHD treated with MaaT013, at the 2023 American Society of Hematology (ASH) Annual Meeting.
  • In April 2023 , data from the Phase 1b study (CIMON) with MaaT033, previously communicated during the 64th annual ASH meeting, were also presented at the EBMT 2023 conference.
  • During 2023 and Q1 2024, MaaT Pharma reinforced its board of directors, executive team, and key functions:
    Karim Dabbagh as Chairman and Nadia Kamal as Director, both independent.

Vivani Medical Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 26, 2024
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Research and development expenses: Research and development expenses during the fourth quarter of 2023 were $4.7 million, compared to $4.4 million during the fourth quarter of 2022.

Key Points: 
  • Research and development expenses: Research and development expenses during the fourth quarter of 2023 were $4.7 million, compared to $4.4 million during the fourth quarter of 2022.
  • General and administrative expenses: General and administrative expenses during the fourth quarter of 2023 were $1.5 million, compared to $3.4 million during the fourth quarter of 2022.
  • Other income (expense): Other income (expense), net during the fourth quarter of 2023 was $0.2 million, compared to $0.5 million during the fourth quarter of 2022.
  • Net Loss: The net loss during the fourth quarter of 2023 was $6.0 million, compared to $7.3 million during the fourth quarter of 2022.

Citius Pharmaceuticals Announces FDA Acceptance of the BLA Resubmission of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

Retrieved on: 
Monday, March 18, 2024
T-cell lymphoma, PDUFA, Symantec Endpoint Protection, Letter, Disease, Patient, CRL, CTCL, Drug development, Safety, FDA, BLA, Food, Pharmaceutical industry

CRANFORD, N.J., March 18, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The FDA has assigned a PDUFA goal date of August 13, 2024.

Key Points: 
  • "The acceptance of the BLA resubmission reflects the completeness of our response to the enhanced product testing and additional controls highlighted by the FDA in their July 2023 CRL.
  • "We believe there remains a critical unmet need for an additional viable treatment option for patients with relapsed or refractory CTCL as current therapies are non-curative.
  • We look forward to the FDA's decision and the potential benefit LYMPHIR may provide patients with relapsed or refractory CTCL," added Mazur.
  • The resubmission follows dialog with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023.

ARS Pharmaceuticals Reviews Recent Clinical Updates and Commercial Opportunity at neffy® Investor Day

Retrieved on: 
Thursday, March 7, 2024
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The event included presentations by members of the ARS Pharma management team and by two distinguished allergists, Dr. Jonathan Spergel, M.D., Ph.D. and Dr. Thomas B. Casale, M.D.

Key Points: 
  • The event included presentations by members of the ARS Pharma management team and by two distinguished allergists, Dr. Jonathan Spergel, M.D., Ph.D. and Dr. Thomas B. Casale, M.D.
  • Of the patients that do fill their prescription, 80-90% either do not carry or use their treatment as indicated.
  • In late-February, the Company announced positive clinical data from a Phase 2 trial evaluating neffy in adults with chronic spontaneous urticaria.
  • The webcast replay and accompanying slides from today’s investor event may be accessed through the Events & Presentations page in the Investors & Media section of the Company's website.

Molecular Templates, Inc. Provides Interim Update

Retrieved on: 
Monday, March 4, 2024
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Unique pharmacodynamic effects demonstrating potent Treg clearance and IL-2 increases were observed at the first dose level.

Key Points: 
  • Unique pharmacodynamic effects demonstrating potent Treg clearance and IL-2 increases were observed at the first dose level.
  • MTEM intends to initiate a study of MT-0169 in CD38+ acute leukemias in collaboration with MD Anderson Cancer Center.
  • Additional details on each of these participant’s clinical profile and response to the investigational treatment are provided below.
  • MTEM plans on initiating an investigator sponsored trial with MD Anderson Cancer Center to evaluate MT-0169 in relapsed or refractory CD38+ AML patients.

Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

Retrieved on: 
Tuesday, February 27, 2024
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The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.

Key Points: 
  • The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.
  • The submitted safety database included an inadequate number of subjects exposed to roluperidone at the proposed dose (64 mg) for at least 12 months.
  • To address these deficiencies, the FDA stated that Minerva must submit at least one additional positive, adequate, and well-controlled study to support the safety and effectiveness of roluperidone for the treatment of negative symptoms.
  • “There is a critical need for a treatment for the negative symptoms of schizophrenia.

Theratechnologies Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2023 and Provides 2024 Guidance

Retrieved on: 
Wednesday, February 21, 2024
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For the fourth quarter of Fiscal 2023, sales of EGRIFTA SV® reached $16,958,000 compared to $14,458,000 in the fourth quarter of the prior year, representing an increase of 17.3%.

Key Points: 
  • For the fourth quarter of Fiscal 2023, sales of EGRIFTA SV® reached $16,958,000 compared to $14,458,000 in the fourth quarter of the prior year, representing an increase of 17.3%.
  • In the fourth quarter of Fiscal 2023, Trogarzo® sales amounted to $6,494,000 compared to $6,963,000 for the same quarter of Fiscal 2022, representing a decrease of 6.7%.
  • Lower unit sales in the fourth quarter of Fiscal 2023, were also a result of higher inventory buildup in Fiscal 2022, a situation which has resolved itself in Fiscal 2023.
  • Net finance costs in the fourth quarter of Fiscal 2022 included interest on the Convertible Notes, whereas this amount was nil in the fourth quarter of Fiscal 2023.

ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy® (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

Retrieved on: 
Tuesday, February 20, 2024
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SAN DIEGO, Feb. 20, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions.

Key Points: 
  • “The study objective was to compare twice dosing with epinephrine injection and twice dosing with neffy under normal conditions and after nasal allergen challenge.
  • With these results, we are completing the necessary work to submit our response to FDA in the next couple of months.
  • The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023.
  • In addition, multiple PADAC members highlighted the favorable profile of neffy in our single dose NAC study.

VERRICA PHARMACEUTICALS INVESTIGATION INITIATED by Former Louisiana Attorney General: Kahn Swick & Foti, LLC Investigates the Officers and Directors of Verrica Pharmaceuticals Inc. - VRCA

Retrieved on: 
Friday, March 8, 2024
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Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Verrica Pharmaceuticals Inc. (NasdaqGM: VRCA).

Key Points: 
  • Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Verrica Pharmaceuticals Inc. (NasdaqGM: VRCA).
  • On September 20, 2021, the Company disclosed the receipt of a Complete Response Letter (“CRL”) resulting from deficiencies at its contract manufacturer’s facility.
  • KSF’s investigation is focusing on whether Verrica’s officers and/or directors breached their fiduciary duties to its shareholders or otherwise violated state or federal laws.
  • About Kahn Swick & Foti, LLC
    KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation’s premier boutique securities litigation law firms.

Agendia Presents Data at Miami Breast 2024 Demonstrating MammaPrint® + BluePrint®’s Ability to Further Stratify Tumor Categories in Hormone-Positive Breast Cancer, Highlighting Response to Different Chemotherapy Regimens

Retrieved on: 
Friday, March 8, 2024
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The first poster, titled MammaPrint® and BluePrint® predict anthracycline chemosensitivity in patients with HR+HER2-early-stage breast cancer enrolled in FLEX, (Audeh, W., et al.

Key Points: 
  • The first poster, titled MammaPrint® and BluePrint® predict anthracycline chemosensitivity in patients with HR+HER2-early-stage breast cancer enrolled in FLEX, (Audeh, W., et al.
  • ), investigates the associations between MammaPrint and BluePrint classifications, therapy regimen, and the likelihood of achieving a pathologic Complete Response (pCR).
  • The second poster, titled Prediction of chemotherapy benefit by MammaPrint® in patients with HR+HER2-early-stage breast cancer from real-world evidence studies (Audeh, W., et al.
  • Taken together, these findings indicate the utility of MammaPrint to predict neoadjuvant and adjuvant chemotherapy benefit in this patient population.