Interim analysis

AEON Biopharma Reports First Quarter 2024 Financial Results

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星期二, 五月 14, 2024
AEON, Patient, Headache, Food, Migraine, Safety, Alembic Pharmaceuticals, Interim analysis, LTD, U.S. FDA, Pharmaceutical industry

IRVINE, Calif., May 14, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced financial results for the first quarter ended March 31, 2024, and provided a business update.

Key Points: 
  • – Ongoing analysis of interim data from the Phase 2 study of ABP-450 in chronic migraine, which did not achieve its primary or secondary endpoints –
    IRVINE, Calif., May 14, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced financial results for the first quarter ended March 31, 2024, and provided a business update.
  • Several of the late-stage clinical programs are candidates to advance into the next phase of clinical development,” commented Marc Forth, AEON’s President and Chief Executive Officer.
  • The study has enrolled a total of 492 patients across approximately 50 sites in the United States, Canada and Australia.
  • The meeting resulted in a preliminary alignment on the design and endpoints for the proposed pivotal Phase 3 trial.

PolyPid Provides Corporate Update and Reports First Quarter 2024 Financial Results

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星期三, 五月 8, 2024
SHIELD, Patient, Cancer, Research, New Drug Application, Marketing, Interim analysis, PIPE, Conference, Completeness, G&A

PETACH TIKVA, Israel, May 08, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three months ended March 31, 2024.

Key Points: 
  • Unblinded Interim Analysis to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up; Top-line Results Expected in Second Half of 2024
    PETACH TIKVA, Israel, May 08, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three months ended March 31, 2024.
  • Top-line results are anticipated in the second half of 2024.
  • The Company’s cash runway now extends into the fourth quarter of 2024 and beyond the expected timing of the planned unblinded interim analysis.
  • PolyPid expects that its pro forma cash balance will be sufficient to fund operations into the fourth quarter of 2024.

Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results

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星期三, 三月 6, 2024
Janus, Sorbitol, Marketing, EMA, Doctor of Philosophy, New Drug Application, MAA, Interim analysis, P-value, FDA, Food, Growth, Treatment, INSPIRE, Priority review, PDUFA, Chairperson, Therapy, CHMP, European Medicines Agency, Patient, Private placement, PRV, NDA, Ageing, Pharmaceutical industry

The FDA also noted that it is planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • The FDA also noted that it is planning to hold an advisory committee meeting to discuss the application.
  • Govorestat was previously granted Pediatric Rare Disease designation and will qualify for a Priority Review Voucher (PRV) upon approval.
  • The Company expects a decision by the EMA in the fourth quarter of 2024.
  • Full study results will be presented at an upcoming medical conference, along with results of the Diabetic Peripheral Neuropathy sub-study, which are still being analyzed.

Mitsubishi Tanabe Pharma America to Showcase Presentations on ALS Research at 2024 MDA Clinical & Scientific Conference

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星期五, 三月 1, 2024
Real-World Evidence, Massachusetts General Hospital, Spirometry, Data mart, ALS, Doctor of Philosophy, Interim analysis, Edaravone, M.S, Hospital, Conference, Natural history, State university system, Abstract, CDM, SVC, MDA, Phase 4, Episcopal conference, MTPA, Pharmaceutical industry

JERSEY CITY, N.J., March 1, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of five abstracts in amyotrophic lateral sclerosis (ALS) at the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, being held in Orlando, Fla., March 3-6.

Key Points: 
  • JERSEY CITY, N.J., March 1, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of five abstracts in amyotrophic lateral sclerosis (ALS) at the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, being held in Orlando, Fla., March 3-6.
  • "These presentations reinforce our commitment to making a positive impact on the ALS community by better understanding disease markers and outcomes and providing important information on our treatment options for clinical practice."
  • Interim Analysis of the Radicava/Edaravone Findings in Biomarkers from ALS (REFINE-ALS) Study (James Berry, M.D., M.P.H.
  • Real-World Evidence on Treatment Retention, Safety, and Tolerability of Edaravone in Canadian Patients With Amyotrophic Lateral Sclerosis (Dung Pham, PhD; MTPA-CA)

PolyPid Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

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星期三, 二月 14, 2024
SHIELD, Marketing, Research, New Drug Application, Interim analysis, Completeness, PLEX, Conference, Monoclonal antibody, Dicarboxylic acid, Patient, Survival, PIPE, G&A, Pharmaceutical industry

Financial results for the full year ended December 31, 2023

Key Points: 
  • Financial results for the full year ended December 31, 2023
    R&D expenses, net for the year ended December 31, 2023, were $16.1 million, compared to $28 million in 2022.
  • G&A expenses for the year ended December 31, 2023, were $5.5 million, compared to $8.0 million for 2022.
  • Marketing and business development expenses for the year ended December 31, 2023, were $1.2 million, compared to $2.9 million for 2022.
  • PolyPid expects that its pro forma cash balance will be sufficient to fund operations into late third quarter 2024.

PolyPid Announces Enrollment of the 100th Patient in the Ongoing SHIELD II Phase 3 Trial

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星期一, 二月 12, 2024
SHIELD, Late, Infection, New Drug Application, Interim analysis, Completeness, Patient, PIPE, Pharmaceutical industry

PETACH TIKVA, Israel, Feb. 12, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has enrolled and randomized the 100th patient in its ongoing SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. There are currently approximately 40 centers open.

Key Points: 
  • There are currently approximately 40 centers open.
  • The Company intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up, which is expected to occur in mid-2024.
  • “As anticipated, since last November, we have doubled the number of open centers, and enrollment into SHIELD II has recently begun to ramp-up,” said Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer.
  • The PIPE syndicate was comprised of new and existing investors, including participation from new U.S. life sciences-focused investors, DAFNA Capital Management and Rosalind Advisors.

Denali Therapeutics Announces Presentations on Its Investigational Blood-Brain Barrier (BBB)-Crossing Enzyme Replacement Therapies at the Upcoming 2024 WORLDSymposium™

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星期四, 二月 1, 2024
Traffic barrier, SAN, BBB, Biomarker, Poster, Degeneracy, CNS, MPS II, Therapy, MPS, Interim analysis, SGSH, ETV, Glycogen storage disease

SOUTH SAN FRANCISCO, Calif., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today announced upcoming presentations from its Enzyme Transport Vehicle (ETV) development programs, tividenofusp alfa (DNL310) and DNL126 (ETV:SGSH), to be given at the 20th Annual WORLDSymposium™, which will be held February 4-9, 2024, in San Diego, California.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today announced upcoming presentations from its Enzyme Transport Vehicle (ETV) development programs, tividenofusp alfa (DNL310) and DNL126 (ETV:SGSH), to be given at the 20th Annual WORLDSymposium™, which will be held February 4-9, 2024, in San Diego, California.
  • Presentations on DNL310 will include new two-year data on clinical outcomes and previously presented data on biomarkers from the ongoing Phase 1/2 study in MPS II.
  • In addition, an oral presentation will highlight data from preclinical studies of DNL126 in an MPS IIIA mouse model.
  • The presentation schedule at WORLDSymposium™ is as follows:
    Title: DNL310 Phase 1/2 Case Study Demonstrates Properties of Raw, Standard and Growth Scale Scores for Adaptive Behavior Scales (Poster #80)
    Title: DNL310 Normalizes Primary Storage Substrates, Corrects Biomarkers of Lysosomal Dysfunction and Reduces Biomarkers of Neuronal Injury (Neurofilament Light Chain) in MPS II: 2-Year Interim Analysis of a Phase 1/2 Study (Poster #34)
    Title: ETV:SGSH, a Brain-Penetrant Enzyme Transport Vehicle for SGSH, Improves Lysosomal and Microglial Morphology, Degeneration and Cognitive Behavior in MPS IIIA Mice
    Title: 3rd Annual Robert J. Gorlin Symposium – Beyond the Blood Brain barrier: Strategies for Treating the CNS

Bio-Path Holdings Reports Third Quarter 2023 Financial Results

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星期三, 十一月 15, 2023
Acute myeloid leukemia, Clinical trial, Patient, Research, MD Anderson Cancer Center, D.O, Division, AML, Holding, Interim analysis, KOL, Pharmaceutical industry, Cryptocurrency, Decitabine

HOUSTON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the third quarter ended September 30, 2023 and provided an update on recent corporate developments.

Key Points: 
  • HOUSTON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the third quarter ended September 30, 2023 and provided an update on recent corporate developments.
  • Announced Positive Results from Interim Analysis of Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid Leukemia.
  • As of September 30, 2023, the Company had cash of $2.4 million, compared to $10.4 million as of December 31, 2022.
  • ET to review these third quarter 2023 financial results and to provide a general update on the Company.

ORYZON Announces Last Patient Last Visit in its Phase IIb PORTICO Study for Borderline Personality Disorder (BPD)

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星期二, 十一月 7, 2023
ORY, Genomics, Aggression, DMC, ISIN, CNS, Data monitoring committee, EudraCT, Disease, ECNP, Safety, Agitation, BPD, Interim analysis, Patient, Borderline personality disorder, Pharmaceutical industry, Medical device

: 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double-blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.

Key Points: 
  • : 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double-blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.
  • The trial has two primary endpoints: reduction of agitation and aggression and overall disease improvement in BPD severity.
  • The independent Data Monitoring Committee (DMC) has met routinely and reviewed unblinded safety data throughout the PORTICO trial.
  • Our quest on the primary endpoints is replicated in a rich set of secondary endpoints, making PORTICO a very informative trial.

Annovis Bio Showcases Promising Progress in Novel Drug Development at the 2023 Clinical Trials on Alzheimer's Disease Conference

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星期二, 十月 24, 2023
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, FDA, AD, PD, NYSE, Bio, III, II, Human, Axonal transport, Neuroprotection, Mutation, Inflammation, Research, Protein, Clinical trial, Mouse, Parkinson's disease, Animal, New Drug Application, Brain, Buntanetap, NDA, Movement, Interim analysis, Neurotoxicity, Cognition, Pharmaceutical industry, Vaccine, Dietary supplement, Alzheimer's disease, Disease

Annovis Bio, Inc. (NYSE: ANVS), a late-stage clinical drug platform company developing transformative therapies to treat neurodegenerative diseases, including Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), is presenting two posters at the Clinical Trials on Alzheimer's Disease (CTAD) 2023 annual conference held in Boston, Massachusetts, from October 24-27.

Key Points: 
  • Annovis Bio, Inc. (NYSE: ANVS), a late-stage clinical drug platform company developing transformative therapies to treat neurodegenerative diseases, including Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), is presenting two posters at the Clinical Trials on Alzheimer's Disease (CTAD) 2023 annual conference held in Boston, Massachusetts, from October 24-27.
  • This novel mechanism of action makes Annovis' drug a potentially effective treatment option for AD and also for PD.
  • The posters' collective findings highlight a highly promising treatment for neurodegenerative conditions like Alzheimer's disease and Parkinson's disease.
  • Cheng Fang , Ph.D., senior vice president of research and development at Annovis Bio, is presenting two posters at CTAD.