HERG

PurMinds NeuroPharma Announces PUR501 as Lead Candidate Novel Non-Hallucinogenic Neuroplastogen

Retrieved on: 
Donnerstag, Mai 30, 2024
HERG, Hallucination, IND, Neuron, Psilocybin, Mouse, Pharmaceutical industry

PurMinds NeuroPharma to initiate preclinical development of lead candidate PUR501 in 2024 in preparation for IND submission

Key Points: 
  • PUR501 is a novel, orally bioavailable, serotonin 2A (5-HT2A) receptor partial agonist that has been selected as the Company's lead candidate following comprehensive screening.
  • Together, these findings indicate that PUR501 is a cardiac safe, orally bioavailable, non-hallucinogenic neuroplastogen that offers promise as a novel therapeutic for treating neurological and neurodegenerative disease.
  • "Selecting PUR501 as the lead development candidate marks a significant milestone for PurMinds.
  • These data emphasize PUR501's potential as a novel neuroplastogen molecule with key pharmacological properties indicating favourable tolerability and efficacy in relevant models," said Janet Qi, CEO and co-founder of PurMinds NeuroPharma.

Inhibikase Therapeutics Reports First Quarter Financial Results and Highlights Recent Period Activity

Retrieved on: 
Donnerstag, Mai 16, 2024
Patient, PD, Pulmonary hypertension, Parkinson's disease, PAH, NDA, FDA, IND, Therapy, Orthostatic hypertension, HERG, Blood, Malignancy, Research, Pathology, Minutes, Division, International, Nephrology, Pharmaceutical industry

On the regulatory front, we had positive interactions with the FDA for IkT-001Pro in gastrointestinal and hematological cancers and cardiopulmonary disease.

Key Points: 
  • On the regulatory front, we had positive interactions with the FDA for IkT-001Pro in gastrointestinal and hematological cancers and cardiopulmonary disease.
  • Following completion of the double-blinded phase of the 201 trial, Inhibikase will request an end of Phase 2 meeting with the FDA.
  • R&D Expenses: Research and development expenses were $2.8 million for the quarter ended March 31, 2024 compared to $2.9 million in the quarter ended March 31, 2023.
  • After the live webcast, the event will be archived on Inhibikase's website for approximately 90 days after the call.

Inhibikase Therapeutics Announces Final Pre-IND Meeting Outcomes for IkT-001Pro as a Treatment for Pulmonary Arterial Hypertension

Retrieved on: 
Donnerstag, Mai 9, 2024
HIV/AIDS, Nephrology, FDA, Parkinson's disease, New chemical entity, CTD, Woman, Pulmonary hypertension, Blood, Food, Imatinib, NME, Connective tissue disease, PAH, Partnership, IND, Cardiology, Disease, Therapy, Patent, Ventricular septal defect, HIV, Clinical trial, HERG, Division, Investigational New Drug, Pharmaceutical industry

BOSTON and ATLANTA, May 09, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced that the Company has received final meeting minutes from its recent pre-IND meeting with the Division of Cardiology and Nephrology of the U.S. Food and Drug Administration (FDA) for IkT-001Pro (“Pro”) as a candidate treatment for Pulmonary Arterial Hypertension (PAH). Following review of the final meeting minutes, Inhibikase is preparing the Investigational New Drug (IND) application.

Key Points: 
  • Following review of the final meeting minutes, Inhibikase is preparing the Investigational New Drug (IND) application.
  • If approved, IkT-001Pro could be a branded product with all the value drivers of a novel treatment for an indication of high unmet medical need.
  • In parallel, the Company has initiated discussions with potential strategic partners in order to advance the development of Pro for Pulmonary Arterial Hypertension.
  • Pulmonary Arterial Hypertension is a rare disease of the pulmonary microvasculature.

Schrödinger Reports First Quarter 2024 Financial Results

Retrieved on: 
Mittwoch, Mai 1, 2024
Science, Software, Biotechnology, Research, Pharmaceutical, Health, Health Technology, Technology, Table, FDA, CDC7, Protein, Investment, Myelodysplastic syndrome, American Chemical Society, Food, NLRP3, AML, MALT1, IND, Patient, SOS1, Acute myeloid leukemia, Drug discovery, BMS, Disulfiram-like drug, Bristol Myers Squibb, HERG, GAAP, Pharmaceutical industry

For the second quarter of 2024, software revenue is expected to range from $31 million to $33 million.

Key Points: 
  • For the second quarter of 2024, software revenue is expected to range from $31 million to $33 million.
  • In March, Schrödinger presented the discovery of SGR-1505, its MALT1 inhibitor, during the First Time Disclosure Session at the American Chemical Society Spring 2024 Meeting.
  • Schrödinger expects to initiate a Phase 1 dose-escalation trial of SGR-3515 in patients with solid tumors in the third quarter of 2024.
  • Schrödinger will host a conference call to discuss its first quarter 2024 financial results on Wednesday, May 1, 2024, at 4:30 p.m.

Aprea Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update

Retrieved on: 
Dienstag, März 26, 2024
Ovarian cancer, Cyclin, IND, Therapy, Anemia, Research, University, Cell cycle, MD Anderson Cancer Center, PLK1, DDR, Investigational New Drug, Safety, Pharmacokinetics, Synthetic lethality, WEE1, U.S. FDA, Mutation, Acceleration, Part, HERG, ATR, KOL, Acquisition, Cancer, AACR, Research and development, Poster, FDA, Cyclin E, Toxicity, Aplastic anemia, Administration, Conference, APRE, PLK3, PLK2, Division, Data, Cardiotoxicity, Pharmaceutical industry

DOYLESTOWN, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • “Aprea had a very productive 2023 with significant progress across our diversified pipeline of synthetic lethality-based cancer therapeutics.
  • An update from Part 1 of the trial was featured in a poster presentation at the AACR-NCI-EORTC International Conference in October 2023.
  • Select Financial Results for the Fourth Quarter ended December 31, 2023
    As of December 31, 2023, Aprea reported cash and cash equivalents of $21.6 million.
  • Research and Development (R&D) expenses were $2.0 million for the quarter ended December 31, 2023, compared to $0.5 million for the fourth quarter of 2022.

Enveric Biosciences Reports Financial Results and Provides Corporate Update for Fourth Quarter and Fiscal Year Ended 2023

Retrieved on: 
Dienstag, März 26, 2024
Biotechnology, Pharmaceutical, Health, Mental Health, Depression, Conference, American Chemical Society, Patent, Acceleration, Partnership, HERG, Patient, CNS, Journal, Anxiety, IND, Chemical substance, Addiction, Safety, Therapy, Arthropathy, Medicinal chemistry, Pharmaceutical industry

Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today provided a corporate update and reported financial results for the fourth quarter of 2023 and fiscal year ended December 31, 2023.

Key Points: 
  • Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today provided a corporate update and reported financial results for the fourth quarter of 2023 and fiscal year ended December 31, 2023.
  • “The fourth quarter of 2023 and early 2024 was a significant period for Enveric, highlighted by the selection of EB-003 as our lead development candidate.
  • Continued to strengthen our intellectual property portfolio, receiving ten patent issuances from the United States Patent and Trademark Office.
  • The gross proceeds to the Company from the two warrant exercises totaled approximately $4.5 million.

Schrödinger Reports Strong Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Mittwoch, Februar 28, 2024
Apps, Applications, Technology, Medical Devices, Other Technology, Health Technology, Software, Biotechnology, Health, Pharmaceutical, AML, G protein-coupled receptor, ASH, Investment, FEP, CDC7, Growth, Table, AbbVie, NLRP3, MALT1, Society, GAAP, Myelodysplastic syndrome, GPCR, Lymphoid leukemia, Solubility, Patient, Drug discovery, HERG, Acute myeloid leukemia, MBBS, IND, Research, Pharmaceutical industry

Cash used for operating activities in 2024 is expected to be above cash used for operating activities in 2023.

Key Points: 
  • Cash used for operating activities in 2024 is expected to be above cash used for operating activities in 2023.
  • For the first quarter of 2024, software revenue is expected to range from $33 million to $35 million.
  • “We had a very strong year in 2023, with significant growth in our software and drug discovery revenue and substantial progress in our proprietary pipeline and at our co-founded companies.
  • Schrödinger will host a conference call to discuss its fourth quarter and full year 2023 financial results on Wednesday, February 28, 2024, at 4:30 p.m.

Aprea Therapeutics Provides Corporate Update and Announces Development Plans for 2024

Retrieved on: 
Donnerstag, Januar 4, 2024
ATR, Aplastic anemia, IND, DDR, Principal, FDA, Spacecraft, Breast, WEE1, Data, APRE, PLK1, PLK, PLK2, Complex conjugate, HERG, Therapy, Pharmacokinetics, PLK3, Cancer, PARP, Prostate, Toxicity, Patient, Safety, Non-Euclidean geometry, ADC, NSCLC, History, Pharmaceutical industry

DOYLESTOWN, Pa., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today provided a corporate update highlighting recent developments and plans for advancement of its pipeline of DNA Damage Response (DDR) anti-cancer agents in 2024.

Key Points: 
  • DOYLESTOWN, Pa., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today provided a corporate update highlighting recent developments and plans for advancement of its pipeline of DNA Damage Response (DDR) anti-cancer agents in 2024.
  • The most recent analysis of the data cut (January 2, 2024) shows that two patients have achieved stable disease – one each in the 50 mg and 200 mg cohorts.
  • Upon the addition of the higher dose cohorts, Aprea expects to determine the recommended Phase 2 dose (RP2D) in the second half of 2024.
  • Aprea will be hosting institutional investor and business development meetings at the Annual Corporate Access Event in San Francisco, hosted by our investor relations firm LifeSci Partners.

Enveric Biosciences Reports Year End Progress for Preclinical Development of Lead Prodrug Candidate EB-373

Retrieved on: 
Mittwoch, Dezember 27, 2023
Biotechnology, Natural Resources, Pharmaceutical, General Health, Health, Mental Health, Cannabis, Clinical Trials, Toxicology, DRF, Metabolism, Research, Depression, Absorption, Psilocybin, HERG, Human, Addiction, Clinical trial, Disulfiram-like drug, Rat, ADR, Dog, Anxiety, Mental health, Animal, Cardiotoxicity, CNS, Safety, Therapy, Vomiting, Pharmaceutical industry

In addition, cardiac, respiratory, CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies have been completed and are undergoing analyses.

Key Points: 
  • In addition, cardiac, respiratory, CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies have been completed and are undergoing analyses.
  • Enveric expects to finalize all preclinical activities involving EB-373 in the first quarter of 2024 in preparation for a first-in-human clinical trial.
  • “Our research team has continued to diligently advance the preclinical program for our lead novel psilocin prodrug, EB-373, as we anticipate initiating first in human trials in 2024,” said Joseph Tucker, Ph.D., Director and CEO of Enveric.
  • Results from this study also demonstrated rapid conversion of EB-373 to the active metabolite psilocin, consistent with previously reported pharmacokinetic (PK) studies.

Aprea Therapeutics Reports Third Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Donnerstag, November 9, 2023
HERG, Synthetic lethality, DDR, Acquisition, Safety, MD Anderson Cancer Center, WEE1, Therapy, University, PLK3, Gynecologic oncology, IND, ATR, PLK, Patient, PLK1, Division, FDA, Conference, Cardiotoxicity, Cell death, Ovarian cancer, APRE, Anemia, Poster, KOL, PLK2, AACR, Pharmaceutical industry, Aprea-Cuccaro clan

DOYLESTOWN, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today reported financial results for the three and nine months ended September 30, 2023, and provided a business update.

Key Points: 
  • DOYLESTOWN, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today reported financial results for the three and nine months ended September 30, 2023, and provided a business update.
  • “We are very pleased by the progress of our diversified programs this past quarter.
  • “We are continuing with patients in the dose escalation portion of the study, and the dose expansion cohort is on track to be initiated in 2Q 2024.
  • The first poster included initial data from the Company’s first-in-human Phase 1/2a dose escalation trial of ATRN-119 in solid tumors.