NDA

Zai Lab Partner Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or Metastatic...

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Monday, April 1, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Lung cancer, BMY, NMPA, Development, NSCLC, Cetuximab, Progression-free survival, New Drug Application, Patient, Neoplasm, Shanda, NDA, Cancer, Bristol Myers Squibb, Pancreatic cancer, CRC, Safety, PFS, FDA, PDUFA, Pharmaceutical industry

The study remains ongoing to assess the additional key secondary endpoint of overall survival.

Key Points: 
  • The study remains ongoing to assess the additional key secondary endpoint of overall survival.
  • Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients.
  • KRAZATI had no new safety signals and the safety data was consistent with the known safety profile.
  • Zai Lab thanks the patients and investigators involved in the KRYSTAL-12 clinical trial.

Quince Therapeutics Provides Business Update and Reports Fourth Quarter and Fiscal 2023 Financial Results

Retrieved on: 
Monday, April 1, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, A-T, DSP, Disease, SPA, Half-life, Hematology, Patient, NDA, EU4, Acquisition, Standard of care, Pivotal, Cancer, Quality of life, Biology, AIDE, Investment, Clinical trial, Therapy, NEAT, FDA, Pharmaceutical industry

Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today provided an update on the company’s development pipeline and reported financial results for the fourth quarter and fiscal year ended December 31, 2023.

Key Points: 
  • Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today provided an update on the company’s development pipeline and reported financial results for the fourth quarter and fiscal year ended December 31, 2023.
  • Pivotal Phase 3 NEAT clinical trial will be conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food & Drug Administration (FDA).
  • Expect to report Phase 3 NEAT topline results in the second half of 2025 with a potential NDA submission in 2026, assuming positive study results.
  • Quince estimates there are an aggregate of approximately 10,000 patients with A-T in the U.S., U.K., and EU4 countries.

Immunome Reports Full Year 2023 Financial Results and Provides Update on Recently Acquired Assets

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Thursday, March 28, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Research, RLT, FAP, Ayala, NDA, Acquisition, Executive Committee, Spacecraft, PIPE, Phase 3, Pharmacology, ADC, Pharmaceutical industry

We expect to add novel antibody-drug conjugates (ADCs) and radioligand therapies (RLTs) to the pipeline through internal discovery efforts while continuing to evaluate opportunities to acquire high-quality assets on favorable financial terms.

Key Points: 
  • We expect to add novel antibody-drug conjugates (ADCs) and radioligand therapies (RLTs) to the pipeline through internal discovery efforts while continuing to evaluate opportunities to acquire high-quality assets on favorable financial terms.
  • Immunome expects to report topline data for the ongoing Phase 3 RINGSIDE Part B trial of AL102 in the first quarter of 2025.
  • In parallel, Immunome is evaluating and performing additional manufacturing and pharmacology work required to support an NDA submission of AL102.
  • Immunome reported a net loss of $106.8 million, or basic and diluted net loss per share attributable to common stockholders of $5.38, for the year ended December 31, 2023.

InnoCare Releases 2023 Results and Business Highlights

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Thursday, March 28, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, QD, Tafasitamab, Patient, B-cell lymphoma, NDA, SLE, POC, IND, Clinical trial, Bone marrow, IKZF1, Phase, Therapy, IGA, MCD, Dexamethasone, MCL, Neuromyelitis optica spectrum disorder, IKZF3, AML, NMOSD, Outline of health sciences, DLT, Cancer, Autoimmune disease, Safety, TYK2, HSA, NRDL, BLA, Follicular lymphoma, Food, GC, Development, Multiple sclerosis, PD, CRBN, Public, Gordon Ramsay's Bank Balance, Multiple myeloma, ITP, BCL2, Leukemia, Cmax, Gadolinium, HKEX, SRI, AAD, Proteinuria, DLBCL, Glucocorticoid, IVIG, Loss, European Hematology Association, American Academy, EHA, Lenalidomide, NHL, Non-Hodgkin lymphoma, CCR8, US FDA, BTK, NRS, Pharmaceutical industry

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.
  • In 2023, InnoCare has continued to advance its robust pipeline across various clinical stages, continuously unleashing the power of innovation to meet unmet medical needs.
  • In June 2023, the ITP Phase II result was orally presented at the European Hematology Association (EHA) 2023 Hybrid Congress.
  • InnoCare was approved by the Hong Kong Stock Exchange to remove "B" from the stock code from May 12, 2023.

GlycoMimetics Reports Highlights and Financial Results for Fourth Quarter and Full Year 2023

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Wednesday, March 27, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Research, NCI, Sickle cell disease, Plasma, ASH, Disease, AML, Patient, National Cancer Institute, NDA, Inflammation, Volunteering, Cancer, VOE, Pharmacokinetics, SCD, Therapy, Data, FDA, Engineering, Pharmaceutical industry

GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today reported its financial results and highlights for the quarter and year ended December 31, 2023.

Key Points: 
  • GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today reported its financial results and highlights for the quarter and year ended December 31, 2023.
  • In August 2023, GlycoMimetics initiated a Phase 1a single-center, double-blind, randomized, placebo-controlled, sequential, single ascending dose trial in healthy adult volunteers.
  • R&D Expenses: The company’s research and development expenses decreased to $5.3 million for the quarter ended December 31, 2023, compared to $5.9 million for the fourth quarter of 2022.
  • G&A Expenses: The company’s general and administrative expenses decreased to $4.3 million for the quarter ended December 31, 2023, compared to $4.7 million for the fourth quarter of 2022.

SilverBow Resources Highlights Successful Implementation of Strategy and Positive Business Momentum

Retrieved on: 
Thursday, March 28, 2024
Oil, Gas, Energy, Inclusion, Letter, Growth, Shirin David, Partnership, ALL, History, NDA, Acquisition, Interview, ROCE, Investment, System, KTG, NOT, Chevron Corporation, Annual general meeting, Audit committee, Management

SilverBow has been successfully implementing our strategy of building a scalable and durable portfolio, driving efficiencies and enhancing margins, protecting the balance sheet, and delivering profitable growth.

Key Points: 
  • SilverBow has been successfully implementing our strategy of building a scalable and durable portfolio, driving efficiencies and enhancing margins, protecting the balance sheet, and delivering profitable growth.
  • From 2020 to 2023, we have more than doubled our portfolio to approximately 1,000 gross locations across 220,000 acres.
  • Our strategy has proven to be resilient through market cycles and has delivered significant shareholder value, with total shareholder returns of more than 550% since 2021.
  • Our results are telling a clear story of the positive momentum in our business.

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

Retrieved on: 
Wednesday, March 27, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Research, Aplastic anemia, Pfizer, AML, Webcast, Patient, Venetoclax, NDA, G&A, Azacitidine, ID, MDS, Bone marrow, RARA, Pharmaceutical industry

Gross proceeds to Syros were approximately $45.0 million, before underwriting discounts and commissions and offering expenses payable by Syros.

Key Points: 
  • Gross proceeds to Syros were approximately $45.0 million, before underwriting discounts and commissions and offering expenses payable by Syros.
  • Cash, cash equivalents and marketable securities as of December 31, 2023, were $139.5 million, as compared with $202.3 million on December 31, 2022.
  • ET to discuss the fourth quarter and full-year 2023 financial results and provide a corporate update.
  • A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com .

Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye Disease

Retrieved on: 
Thursday, March 28, 2024
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, RASP, Environment, Patient, NDA, University, Quality of life, Clinical trial, Therapy, University of California, Telecanthus, FDA, Food, DSM-IV codes, Pharmaceutical industry

Following discussions with the FDA, Aldeyra intends to initiate a dry eye chamber clinical trial in the first half of 2024.

Key Points: 
  • Following discussions with the FDA, Aldeyra intends to initiate a dry eye chamber clinical trial in the first half of 2024.
  • In the proposed dry eye chamber trial, patients will be administered vehicle (the drug product without the active ingredient) before and during exposure to a dry eye chamber.
  • The design and statistical powering for the proposed trial are derived from four previously completed dry eye chamber clinical trials with reproxalap.
  • ET today, March 28, 2024, to discuss the clinical development plan for resubmission of the new drug application for reproxalap in dry eye disease.

Peer-Reviewed Scientific Publication Proposes Unifying Single Toxin Theory of Brain Neurodegeneration that Identifies New Drug Targets and Treatments for Alzheimer’s Disease and Other Neurodegenerative Disorders

Retrieved on: 
Tuesday, March 26, 2024
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Toxicity, Brain, DSM-IV codes, APOE4, Patient, Biomarker, NDA, Standard of care, Prion, Doctor of Philosophy, MD, Protein, Neurotoxicity, Genotype, Treatment, Safety, ALS, Canadian International Council, Amyloid

In addition, our single toxin theory of brain neurodegeneration identifies new targets and approaches for the development of disease-modifying treatments,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.

Key Points: 
  • In addition, our single toxin theory of brain neurodegeneration identifies new targets and approaches for the development of disease-modifying treatments,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.
  • The application of biomarkers, in particular p-tau, synaptic markers, and brain volumetrics for the evaluation of disease course and therapeutic efficacy in AD trials.
  • Other neurodegenerative disorders follow the same pattern of protein dysregulation, impaired clearance, and increased aggregation, leading to neurotoxicity and loss of function.
  • In these diseases, a normal essential protein starts accumulating in the brain, misfolding and aggregating into soluble oligomers.

Tvardi Therapeutics Appoints Sujal Shah as Chairman and Adds Shaheen Wirk to the Board of Directors

Retrieved on: 
Tuesday, March 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Citigroup, Rabin Medical Center, Biomedicine, Biomedical engineering, Partnership, Tiger Management, Business, Duke University, Duke University Hospital, NDA, Acquisition, Credit Suisse, University, MD Anderson Cancer Center, Therapy, Bangladesh Technical Education Board, STAT3, Pharmaceutical industry

Tvardi Therapeutics, Inc. (“Tvardi”), a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, announced that current Board of Directors member Sujal Shah has been appointed Chairman, and experienced healthcare investor Shaheen Wirk, M.D.

Key Points: 
  • Tvardi Therapeutics, Inc. (“Tvardi”), a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, announced that current Board of Directors member Sujal Shah has been appointed Chairman, and experienced healthcare investor Shaheen Wirk, M.D.
  • Formerly, Mr. Shah was a healthcare investment banker for global investment banks Citigroup and Credit Suisse.
  • Newly appointed board member Dr. Wirk has more than 20 years of investment experience in public and private life science companies.
  • “The appointment of Sujal as Chairman and the addition of Shaheen to Tvardi’s Board of Directors are instrumental to the success of Tvardi,” said Imran Alibhai, Ph.D., CEO of Tvardi.