Regulation of food and dietary supplements by the U.S. Food and Drug Administration

Protara Therapeutics Announces Third Quarter 2023 Financial Results and Business Update

Retrieved on: 
Friday, November 3, 2023
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The Company remains on track to report preliminary results in the first half of 2024.

Key Points: 
  • The Company remains on track to report preliminary results in the first half of 2024.
  • General and administrative expenses for both the third quarter of 2023 and 2022 were $4.5 million.
  • For the third quarter of 2023, Protara reported a net loss of $9.9 million, or $0.87 per share, compared with a net loss of $7.7 million, or $0.68 per share, for the same period in 2022.
  • Net loss for the third quarter of 2023 included approximately $1.4 million of stock-based compensation expenses.

Angiex Announces FDA Clearance of IND Application for AGX101, a novel, First-in-Class TM4SF1-Directed Antibody-Drug Conjugate for the Treatment of Solid Cancers

Retrieved on: 
Thursday, November 2, 2023
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CAMBRIDGE, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Angiex, a developer of Nuclear-Delivered Antibody-Drug Conjugate™ (ND-ADC) therapies for solid cancers, announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for AGX101, a novel TM4SF1-directed antibody-drug conjugate being developed for the treatment of solid cancers.

Key Points: 
  • CAMBRIDGE, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Angiex, a developer of Nuclear-Delivered Antibody-Drug Conjugate™ (ND-ADC) therapies for solid cancers, announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for AGX101, a novel TM4SF1-directed antibody-drug conjugate being developed for the treatment of solid cancers.
  • “Angiex also is pioneering a novel ability to release ADC payloads in the nucleus of target cells in the tumor.
  • The dose escalation portion of the study is designed to assess doses up to 10 mg/kg in an all-comers, solid tumor patient population.
  • The dose expansion portion of the study will evaluate treatment at the Recommended Phase 2 Dose in multiple indications.

ROSEN, TRUSTED INVESTOR COUNSEL, Encourages Integra LifeSciences Holdings Corporation Investors to Secure Counsel Before Important Deadline in Securities Class Action – IART

Retrieved on: 
Thursday, November 2, 2023
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WHAT TO DO NEXT: To join the Integra class action, go to https://rosenlegal.com/submit-form/?case_id=19078 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the Integra class action, go to https://rosenlegal.com/submit-form/?case_id=19078 or call Phillip Kim, Esq.
  • WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

SHAREHOLDER ALERT: Morris Kandinov Investigating ARDX, LESL, ENVX, and FATE; Shareholders are Encouraged to Contact the Firm

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Thursday, November 2, 2023
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Morris Kandinov is investigating Ardelyx, Inc. regarding possible breaches of fiduciary duties and other violations of law, including securities claims on behalf of shareholders.

Key Points: 
  • Morris Kandinov is investigating Ardelyx, Inc. regarding possible breaches of fiduciary duties and other violations of law, including securities claims on behalf of shareholders.
  • Morris Kandinov is investigating Leslie’s, Inc. regarding possible breaches of fiduciary duties and other violations of law, including securities claims on behalf of shareholders.
  • Morris Kandinov is investigating Enovix Corporation regarding possible breaches of fiduciary duties and other violations of law, including securities claims on behalf of shareholders.
  • Morris Kandinov is investigating Fate Therapeutics, Inc. regarding possible breaches of fiduciary duties and other violations of law, including securities claims on behalf of shareholders.

Cytokinetics Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023
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SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2023. Net loss for the third quarter was $129.4 million, or $1.35 per share, compared to net loss for the third quarter of 2022 of $142.3 million, or $1.52 per share. Cash, cash equivalents and investments totaled $554.7 million on September 30, 2023.

Key Points: 
  • On Track for Topline Results from SEQUOIA-HCM,
    a Pivotal Phase 3 Clinical Trial of Aficamten in Obstructive HCM,
    the Open-Label Extension Study of Aficamten,
    SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2023.
  • Net loss for the third quarter was $129.4 million, or $1.35 per share, compared to net loss for the third quarter of 2022 of $142.3 million, or $1.52 per share.
  • “During the third quarter we made considerable progress across our specialty cardiology franchise, with aficamten remaining our top priority.
  • During the quarter we also started ACACIA-HCM, a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM.

Pharvaris Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 2, 2023
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Results of nonclinical toxicology study on-track to be submitted to the FDA by the end of 2023.

Key Points: 
  • Results of nonclinical toxicology study on-track to be submitted to the FDA by the end of 2023.
  • R&D expenses were €18.5 million for the quarter ended September 30, 2023, compared to €14.1 million for the quarter ended September 30, 2022.
  • G&A expenses were €7.7 million for the quarter ended September 30, 2023, compared to €8.3 million for the quarter ended September 30, 2022.
  • Details are as follows:
    Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board.

Ocuphire Pharma Announces Successful End-of-Phase 2 Meeting with FDA for Oral APX3330 in Diabetic Retinopathy

Retrieved on: 
Thursday, November 2, 2023
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FARMINGTON HILLS, Mich., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of oral APX3330 for the treatment of diabetic retinopathy (DR) into Phase 3 studies based on the recently completed Phase 2 ZETA-1 trial.

Key Points: 
  • “We are pleased to have FDA agreement on the primary endpoint for Phase 3 pivotal trials of APX3330 which we believe is the most advanced oral therapy currently in development for diabetic retinopathy,” said George Magrath, M.D, MBA., M.S., Chief Executive Officer of Ocuphire.
  • “Results from our Phase 2 ZETA-1 results demonstrate that oral APX3330 has the potential to slow or prevent clinically meaningful progression of diabetic retinopathy, as measured by the percentage of subjects with ≥ 3-step worsening on a binocular diabetic retinopathy severity scale (DRSS), which will be the Phase 3 primary endpoint.
  • The randomized, double-masked, placebo-controlled Phase 2 trial was designed to evaluate the efficacy and safety of oral APX3330 in diabetic retinopathy patients.
  • A safe convenient oral medication that could slow or prevent diabetic retinopathy would be a major advance in our fight against diabetic blindness.”

Cellectar to Release Top-line Data from WM Pivotal Trial During the JP Morgan Healthcare Conference the Week of January 8, 2024

Retrieved on: 
Thursday, November 2, 2023
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FLORHAM PARK, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced that top-line data from the pivotal trial in Waldenstrom’s macroglobulinemia (WM) will be released during the JP Morgan Healthcare conference the week of January 8, 2024.

Key Points: 
  • The PRIME designation was awarded based upon data from a pre-planned interim assessment in the pivotal study and six patients from the Phase 2a.
  • “We continue to collect and evaluate patient data from our pivotal trial and expect to announce top-line data the week of January 8, 2024.
  • We view this data announcement as a potentially transformational event for Cellectar and as such merits optimal market and industry awareness, which the JP Morgan conference provides.
  • Stockholders and other interested parties may participate in the conference call by dialing 1-888-886-7786 (in the U.S.) or 1-416-764-8658 (outside the U.S.).

Scilex Holding Company Announces Positive Type C Meeting with the FDA and Reaches Agreement on Path Forward to File an NDA for SP-102 (SEMDEXATM) in Lumbosacral Radicular Pain (Sciatica)

Retrieved on: 
Thursday, November 2, 2023
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The Company has reached agreement with the FDA on the path forward to advance the clinical development of SP-102 and on the requirements to file a New Drug Application (“NDA”).

Key Points: 
  • The Company has reached agreement with the FDA on the path forward to advance the clinical development of SP-102 and on the requirements to file a New Drug Application (“NDA”).
  • Recently, during the Type C meeting with the FDA, the Company received an advisement on expectations and requirements to file the NDA, including clinical and preclinical data.
  • Scilex intends to file the SP-102 NDA utilizing the 505(b)(2) regulatory pathway to reference the currently approved drug, Dexamethasone sodium phosphate injection.
  • SP-102 (SEMDEXATM) is expected to be administered in up to 3 injections during a 6-month observation period.

Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA

Retrieved on: 
Thursday, November 2, 2023
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ROCKVILLE, Md., Nov. 02, 2023 (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 that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).

Key Points: 
  • ROCKVILLE, Md., Nov. 02, 2023 (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 that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).
  • The resubmission is now considered filed, with a user fee goal date (PDUFA date) of April 5, 2024.
  • “We are pleased with the FDA’s acceptance of our NDA resubmission for SPN-830 and look forward to continuing to work with them during their review,” said Jack Khattar, President and CEO of Supernus.
  • “SPN-830 is an important product candidate which, if approved by the FDA, represents a novel and less invasive treatment option for PD patients.”