New Drug Application

Appili Therapeutics Reports Financial and Operational Results for First Quarter of Fiscal Year 2024

Retrieved on: 
Friday, August 11, 2023
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Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the first quarter of its fiscal year 2024, which ended on June 30, 2023.

Key Points: 
  • Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the first quarter of its fiscal year 2024, which ended on June 30, 2023.
  • These achievements are expected to position us with the required resources to continue to make progress in advancing our infectious disease assets."
  • On May 5, 2023, Appili executed an initial cooperative agreement with USAFA the previously announced funding of the ATI-1701 program.
  • This initial funding, in the amount of US$7.3 million, will be used to kick-off ATI-1701 early-stage development and regulatory activities.

CASI PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2023 BUSINESS AND FINANCIAL UPDATES

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Friday, August 11, 2023
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BEIJING, Aug. 11, 2023 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported financial results for the quarter ended June 30, 2023.

Key Points: 
  • BEIJING, Aug. 11, 2023 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported financial results for the quarter ended June 30, 2023.
  • Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, commented, "We are pleased to report $9.8 million sales revenue for the second quarter of 2023.
  • This is a 15% increase compared to the same period last year and an 18% of increase from the first quarter of 2023."
  • As of June 30, 2023, CASI had cash, cash equivalents and short-term investments of $36.8 million.

Subsequent to the Release of Positive Phase 3 Trial Results, Vistagen Provides Corporate Update and Reports Fiscal 2024 First Quarter Financial Results

Retrieved on: 
Thursday, August 10, 2023
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Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years,” said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • Positive Phase 3 PALISADE-2 study of fasedienol yields statistically significant top-line results for the acute treatment of anxiety in adults with SAD.
  • Based on the positive top-line results of the Phase 3 PALISADE-2 study, we are currently preparing for our Phase 3 PALISADE-3 trial, with potential to initiate the trial during the first half of calendar 2024.
  • Vistagen will host a conference call and live audio webcast this afternoon at 4:30 p.m. Eastern Time to provide a corporate update.

ARS Reports Second Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, August 10, 2023
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SAN DIEGO, Aug. 10, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the second quarter of 2023.

Key Points: 
  • Topline data from the company’s ongoing Phase 2 randomized, placebo-controlled study of neffy in urticaria patients are expected by the fourth quarter of 2023.
  • R&D Expenses: Research and development (R&D) expenses were $7.3 million for the quarter ended June 30, 2023.
  • G&A Expenses: General and administrative (G&A) expenses were $13.3 million for the quarter ended June 30, 2023.
  • Net Loss: Net loss was $17.4 million for the quarter ended June 30, 2023.

Defender Pharmaceuticals Phase 3 Motion Sickness Trial Results Selected for Presentation at 2023 Military Health System Research Symposium (MHSRS)

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Thursday, August 10, 2023
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ST. LOUIS, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced that the previously reported, positive results from its Phase 3 clinical trial with DPI-386 Nasal Gel for prevention of nausea and vomiting induced by motion in adults has been selected for presentation at the upcoming 2023 Military Health System Research Symposium (MHSRS) to be held August 14 -17, 2023 in Kissimmee, FL.

Key Points: 
  • ST. LOUIS, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced that the previously reported, positive results from its Phase 3 clinical trial with DPI-386 Nasal Gel for prevention of nausea and vomiting induced by motion in adults has been selected for presentation at the upcoming 2023 Military Health System Research Symposium (MHSRS) to be held August 14 -17, 2023 in Kissimmee, FL.
  • “The selection of our Phase 3 clinical trial results for presentation at this premiere event underscores both the strength of the data and the heavy impact that motion sickness has on the ability to ensure effective military operations,” said Barry I. Feinberg, M.D., President & CEO of Defender Pharmaceuticals.
  • Abstract title: Efficacy of Intranasal Scopolamine HBr (INSCOP, DPI-386) for the prevention of vomiting or the need for rescue medication associated with motion.
  • The poster will be available on the Company’s website at https://defenderpharma.com/ shortly after the event.

U.S. FDA Accepts Astellas' sNDA for CRESEMBA® (isavuconazonium sulfate) in Children

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Thursday, August 10, 2023
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NORTHBROOK, Ill., Aug. 10, 2023 /PRNewswire/ -- Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for CRESEMBA® (isavuconazonium sulfate), a prodrug of isavuconazole, an azole antifungal drug, seeking approval for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in pediatric patients aged one to 17 years old. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 9, 2023.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 9, 2023.
  • CRESEMBA is already approved by the FDA for the treatment of IA and IM in adults.
  • If approved for pediatric use, it may offer children significant advances in treatment or may provide a treatment where no adequate therapy exists.
  • "This sNDA acceptance by the FDA brings Astellas one step closer to helping pediatric patients by potentially having a new treatment option available for IA and IM for a younger patient population, if approved."

Phathom Pharmaceuticals Reports Second Quarter 2023 Results

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Thursday, August 10, 2023
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Second Quarter 2023 Financial Results:

Key Points: 
  • Second Quarter 2023 Financial Results:
    Net loss for the second quarter ended June 30, 2023, was $41.0 million, compared to $50.9 million for second quarter 2022.
  • Second quarter 2023 net loss included a non-cash charge related to stock-based compensation of $7.3 million compared to $5.9 million for second quarter 2022.
  • Research and development expenses for the second quarter 2023 were $12.8 million, a decrease of $6.0 million compared to $18.8 million for second quarter 2022.
  • General and administrative expenses for the second quarter 2023 were $18.9 million, a decrease of $7.6 million compared to $26.5 million for second quarter 2022.

Applied Therapeutics Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 10, 2023
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NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • “In the second quarter we continued to advance our programs across Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy,” said Shoshana Shendelman, PhD, Founder, Chief Executive Officer, and Chair of the Board.
  • In June 2023, the Company presented baseline data at the 2023 Annual Meeting of the ADA from the ongoing Phase 3 ARISE-HF study of AT-001 (caficrestat) in Diabetic Cardiomyopathy (DbCM).
  • The Company expects topline data from the study in the fourth quarter of 2023.
  • Net loss for the second quarter of 2023 was $29.6 million, or $0.37 per basic and diluted common share, compared to a net loss of $25.9 million, or $0.96 per basic and diluted common share, for the second quarter 2022.

Aldeyra Therapeutics, Inc. investors: Please contact the Portnoy Law Firm to recover your losses; September 29, 2023 deadline

Retrieved on: 
Wednesday, August 9, 2023
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LOS ANGELES, Aug. 09, 2023 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Aldeyra Therapeutics, Inc. (“Aldeyra” or the “Company”) (NASDAQ: ALDX) investors that a lawsuit filed on behalf of investors that purchased Aldeyra securities between March 17, 2022 and June 20, 2023, inclusive (the “Class Period”)

Key Points: 
  • The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
  • On June 21, 2023, Aldeyra made public that it had received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) in relation to its New Drug Application (NDA) for ADX-2191, a treatment for vitreoretinal lymphoma.
  • The Portnoy Law Firm represents investors in pursuing claims against caused by corporate wrongdoing.
  • The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors.

Mirati Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Tuesday, August 8, 2023
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SAN DIEGO, Aug. 8, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the second quarter 2023 along with recent pipeline and corporate updates.

Key Points: 
  • ET / 2:30 p.m. PT
    SAN DIEGO, Aug. 8, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the second quarter 2023 along with recent pipeline and corporate updates.
  • Based on these results, the Company plans to discuss a tumor agnostic Accelerated Approval approach with FDA by year-end 2023.
  • Net reduction in cash, cash equivalents and short-term investments for the second quarter of 2023 was $122.9 million.
  • ET / 2:30 p.m. PT during which company executives will review financial information for the second quarter and provide corporate updates.