DOR

Updated Data from TRIDENT-1 Trial Show Durable Efficacy Benefits with Repotrectinib for Patients with Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

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Mercredi, août 16, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Priority review, Progression-free survival, DOR, New Drug Application, International Association, Lung cancer, Prescription Drug User Fee Act, Hope, TKI, NSCLC, Brain, Immunotherapy, EDT, PFS, BMY, Yonsei University, Phase 1, Patient, NTRK, ROS1, Corr, Therapy, Abstract, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Conference, NYSE, ORR, Food, Pharmaceutical industry, Medical imaging

In this updated analysis, repotrectinib continued to demonstrate durable efficacy in patients with ROS1-positive NSCLC, including intracranial activity, in patients who were TKI-naïve or previously treated with one TKI and no chemotherapy.

Key Points: 
  • In this updated analysis, repotrectinib continued to demonstrate durable efficacy in patients with ROS1-positive NSCLC, including intracranial activity, in patients who were TKI-naïve or previously treated with one TKI and no chemotherapy.
  • In patients with measurable brain metastases at baseline (n=9), intracranial ORR per BICR was 89% and responses were prolonged.
  • At the recommended dose for Phase 2, the safety profile of repotrectinib was manageable and remained consistent with previous reports.
  • Furthermore, the data offer hope for the patients with ROS1-positive non-small cell lung cancer who still face high remaining unmet needs,” said Joseph Fiore, executive director, global program lead, repotrectinib, Bristol Myers Squibb.

Celcuity Inc. Reports Second Quarter 2023 Financial Results and Provides Corporate Updates

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Jeudi, août 10, 2023
AACR, DOR, ESMO, Fulvestrant, American Association for Cancer Research, Woman, G&A, GAAP, Oncology, Research, PFS, PIK3CA, PI3K, Patient, AKT, PTEN, Breast cancer, Investment, CELC, Webcast, Entrepreneurship, Poster, R, European Society of Gynaecological Oncology, European Society for Medical Oncology, ORR, Letrozole, Pharmaceutical industry, Medical imaging, Birth control, Cryptocurrency, Video game

ET

Key Points: 
  • ET
    MINNEAPOLIS, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today reported financial results for the second quarter ended June 30, 2023 and provided other recent corporate updates.
  • Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2023, compared to the second quarter ended June 30, 2022.
  • Total operating expenses were $15.1 million for the second quarter of 2023, compared to $9.6 million for the second quarter of 2022.
  • General and administrative (G&A) expenses were $1.3 million for the second quarter of 2023, compared to $1.2 million for the second quarter of 2022.

Zymeworks Provides Corporate Update and Reports Second Quarter 2023 Financial Results

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Jeudi, août 10, 2023
Docetaxel, GEA, Abstract, Partnership, Therapy, Senior, BeiGene, DOR, ESMO, Calendar, Quality of life, GAAP, Research, EDT, PFS, Public expenditure, Congress, Patient, Cancer, Corr, Item, ADC, Spacecraft, BTC, Ovarian cancer, IND, Regulation S-K, Regulation, Sodium-dependent phosphate transport protein 2B, Tislelizumab, Pharmaceutical industry, Medical imaging, Management, Cryptocurrency, Life insurance, Zymeworks, Jazz, The Lancet

“During the second quarter of 2023, we made excellent progress in advancing several of our key planned corporate goals for the year,” said Kenneth Galbraith, Chair, President and Chief Executive Officer of Zymeworks.

Key Points: 
  • “During the second quarter of 2023, we made excellent progress in advancing several of our key planned corporate goals for the year,” said Kenneth Galbraith, Chair, President and Chief Executive Officer of Zymeworks.
  • In partnership with Jazz and BeiGene, multiple abstracts for zanidatamab were presented at the ASCO Annual Meeting in Chicago in June 2023.
  • Financial Results for the Six Months Ended June 30, 2023
    Revenue for the six months ended June 30, 2023 was $42.6 million compared to $7.4 million for the same period of 2022.
  • Reconciliations between historical GAAP and non-GAAP information are contained at the end of this press release following the accompanying financial data.

Ecogensus Announces Groundbreaking Reinforced Sustainable Composite Material

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Jeudi, août 10, 2023
Science, DOR, United States Patent and Trademark Office, Research, Recycling

U.S. Patent Office Granted the Composition Patent on July 4th, 2023

Key Points: 
  • U.S. Patent Office Granted the Composition Patent on July 4th, 2023
    HOUSTON, Aug. 10, 2023 /PRNewswire/ -- Ecogensus today unveiled its new structurally reinforced, waste-derived lumber innovation, a significant development towards liberating waste-derived substances for use in a broader set of sustainable building material applications.
  • The structurally reinforced composite adds secondary strength-enhancing polymers, such as in the form of rods.
  • Ecogensus is conducting further research in methods of cross-linking polymers, such that the EGS-6™ composite material becomes bonded to embedded polymer matrices or other solid structures.
  • "With this new development, we believe Ecogensus is placing itself at the intersection of materials science and sustainable resources," said the inventor and CEO/CTO Bjørnulf Østvik.

Ecogensus Announces Groundbreaking Reinforced Sustainable Composite Material

Retrieved on: 
Jeudi, août 10, 2023
Science, DOR, United States Patent and Trademark Office, Research, Recycling

U.S. Patent Office Granted the Composition Patent on July 4th, 2023

Key Points: 
  • U.S. Patent Office Granted the Composition Patent on July 4th, 2023
    HOUSTON, Aug. 10, 2023 /PRNewswire/ -- Ecogensus today unveiled its new structurally reinforced, waste-derived lumber innovation, a significant development towards liberating waste-derived substances for use in a broader set of sustainable building material applications.
  • The structurally reinforced composite adds secondary strength-enhancing polymers, such as in the form of rods.
  • Ecogensus is conducting further research in methods of cross-linking polymers, such that the EGS-6™ composite material becomes bonded to embedded polymer matrices or other solid structures.
  • "With this new development, we believe Ecogensus is placing itself at the intersection of materials science and sustainable resources," said the inventor and CEO/CTO Bjørnulf Østvik.

Sparian Biosciences Awarded $19 Million Five-Year NIH/ NIDA Grant to Fund Development of SBS-518 for Stimulant Use Disorder Through Phase 1 Clinical Development

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Mardi, août 8, 2023
University of Florida College of Pharmacy, Stud, Substance abuse, SR, Florida College, University, Therapy, Methamphetamine, Public, DOR, Opioid use disorder, The Help, OUD, Brain, Dopamine, Harvard Medical School, CNS, Government, Pain, Entrepreneurship, Cocaine, Central nervous system disease, DAT, National Institute on Drug Abuse, NIDA, MOR, HEAL, IND, Drug, Pharmaceutical industry, Pharmacy

SBS-518 is a first-in-class dual sigma receptor (SR) antagonist/dopamine transporter (DAT) inhibitor in development for the treatment of stimulant use disorder (StUD).

Key Points: 
  • SBS-518 is a first-in-class dual sigma receptor (SR) antagonist/dopamine transporter (DAT) inhibitor in development for the treatment of stimulant use disorder (StUD).
  • StUD is a subset of substance use disorders that includes cocaine and methamphetamine use disorders.
  • The grant was awarded by NIH/NIDA under the Help End Addiction Long-Term (HEAL) initiative.
  • Since its founding, Sparian has been awarded a total of $41 million in government grants to support three programs.

Day One Reports Second Quarter 2023 Financial Results and Corporate Progress

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Lundi, août 7, 2023
Exercise, IRC, Hypophosphatemia, Human, Arm, DOR, Clinical trial, NDA, MAPK, MEK, CPK, CSR, ASCO, Vomiting, Wild Arms 2, Independent Review Committee, Patient, Investment, Maculopapular rash, Anemia, Ageing, FDA, Headache, Research, AST, Society, Conference, Safety, Fatigue, D, Pharmaceutical industry, Nursing, Cryptocurrency, Pediatrics

BRISBANE, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its second quarter 2023 financial results and highlighted recent corporate achievements.

Key Points: 
  • R&D Expenses: Research and development expenses were $32.2 million for the second quarter of 2023 compared to $22.6 million for the second quarter of 2022.
  • G&A Expenses: General and administrative expenses were $17.1 million for the second quarter of 2023 compared to $14.2 million for the second quarter of 2022.
  • Net Loss: Net loss totaled $45.9 million for the second quarter of 2023 with non-cash stock compensation expense of $9.5 million, compared to $36.5 million for the second quarter of 2022 with non-cash stock compensation expense of $5.6 million.
  • 2023 Wedbush PacGrow Healthcare Conference, August 8-9, 2023
    Morgan Stanley 21st Annual Global Healthcare Conference, September 11-13, 2023

BeiGene Announces FDA Acceptance of sNDA for Fifth BRUKINSA® Indication

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Mercredi, juillet 12, 2023
Biotechnology, FDA, Pharmaceutical, Health, Obinutuzumab, Prescription Drug User Fee Act, BGNE, Arm, Diarrhea, Follicular lymphoma, DOR, Safety, Initiative, Multimedia, SSE, Shanda, HIV disease progression rates, Patient, Risk, European, United Kingdom, Fever, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ORR, Food, Fatigue, Pharmaceutical industry, Medical device, Hematology, BeiGene

BRUKINSA was previously granted Fast Track and Orphan designation for this indication.

Key Points: 
  • BRUKINSA was previously granted Fast Track and Orphan designation for this indication.
  • The FDA has assigned a target action date in the first quarter of 2024, under the Prescription Drug User Fee Act.
  • Safety results from the ROSEWOOD study were consistent with previous studies of both medicines.
  • The global BRUKINSA development program includes more than 4,900 subjects enrolled to-date in 29 countries and regions.

Iovance Biotherapeutics Announces Regulatory and Clinical Updates for TIL Therapy in Advanced Non-Small Cell Lung Cancer

Retrieved on: 
Lundi, juillet 10, 2023
IOV, Prescription Drug User Fee Act, TIL, DOR, RECIST, Cancer, NSCLC, ROS, Patient, SAN, EGFR, Interleukin, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, ORR, Food, Disease, ALK, Pharmaceutical industry, Iovance Biotherapeutics

SAN CARLOS, Calif., July 10, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced positive regulatory and clinical updates related to its registrational single-arm Phase 2 IOV-LUN-202 trial in post-anti-PD-1 NSCLC.

Key Points: 
  • Based on this FDA feedback, Iovance completed a preliminary analysis of the IOV-LUN-202 trial.
  • Based on the regulatory discussions, Iovance plans to enroll a total of approximately 120 patients into the registrational IOV-LUN-202 trial.
  • As previously announced , Iovance is also preparing to meet with the FDA this year to discuss a randomized confirmatory trial of LN-145 in frontline advanced NSCLC patients.
  • This confirmatory trial in frontline advanced NSCLC is expected to be well underway at the time of a potential approval in advanced post-anti-PD-1 NSCLC.

Sorrento Announces Positive Phase IIa Study Results of Abivertinib for the Treatment of Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL) and Its Plan for a Pivotal Phase III Study

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Mercredi, juillet 5, 2023
DOR, DCR, IC50, Lung cancer, BTK, PFS, Hypertension, Patient, EGFR, SAN, OTC, National Medical Products Administration, CR, Estonia, Arrhythmia, Therapy, III, NMPA, ORR, Safety, Pharmaceutical industry, Medical device

Sorrento has communicated with the China Health Authority (National Medical Products Administration or NMPA) regarding the design of a pivotal phase III registration study of R/R MZL in China.

Key Points: 
  • Sorrento has communicated with the China Health Authority (National Medical Products Administration or NMPA) regarding the design of a pivotal phase III registration study of R/R MZL in China.
  • SAN DIEGO, July 05, 2023 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (OTC: SRNEQ) today announced positive results from a China phase IIa study of Abivertinib on R/R MZL and its plan for a pivotal study.
  • (3) Sorrento has communicated with the NMPA, and a consensus has been reached for a pivotal phase III registration study for the treatment of R/R MZL.
  • The pivotal study will be a multicenter phase III study to assess the efficacy and safety of Abivertinib for treatment of relapsed/refractory marginal zone lymphoma.