CSCC

Replimune Reports Third Fiscal Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 3, 2022
Large-cell lung carcinoma, Breast, Progression-free survival, NMSC, Coronavirus, RP3, Goal, Securities Act of 1933, Skin cancer, Antigen, CR, GLOBE, Skin, RPX, U.S. Securities and Exchange Commission, Review, RP1, Annual general meeting, CSCC, Marketing, Neoplasm, Company, Herpes simplex virus, TME, Investment, Securities Exchange Act of 1934, Security (finance), Research, Bristol Myers Squibb, Toxicity, NASDAQ, Clinical trial, D, Tumor microenvironment, Nivolumab, Immunogenic cell death, Immunotherapy, NSCLC, MOA, Melanoma, FDA, Protein, Safety, Forward-looking statement, Patient, RP2, Lung, Gastrointestinal cancer, Lymph, SITC, PFS, ORR, CD40L, Head, Drug Quality and Security Act, Liver disease, Pharmaceutical industry, Medical imaging, Airline, Vaccine, Sanofi, Regeneron Pharmaceuticals

WOBURN, Mass., Feb. 03, 2022 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2021 and provided a business update.

Key Points: 
  • The Company will also provide a detailed overview of its RP2/3 program including the Phase 2 development plan.
  • The Company expects to present initial data from this clinical trial in the first quarter of 2022.
  • G&A Expenses: General and administrative expenses were$10.3 millionfor the third quarter endedDecember 31, 2021, as compared to$6.0 millionfor the third quarter endedDecember 31, 2020.
  • Our actual results could differ materially from the results described in or implied by such forward-looking statements.

Checkpoint Therapeutics to Participate in the B. Riley Securities’ Virtual Oncology Conference

Retrieved on: 
Tuesday, January 25, 2022
Calendar, Baozou Big News Events, CSCC, News, Fortress Biotech, Investor, EST, Biologics license application, Secondary research, Conference, Platinum, CKPT, NASDAQ, Biotechnology, EGFR, Patient, Marketing, GLOBE, Dana–Farber Cancer Institute, Acquisition, Pemetrexed, Pharmaceutical industry

WALTHAM, Mass., Jan. 25, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that James Oliviero, President and Chief Executive Officer, will participate in a fireside chat hosted by Justin Walsh, Equity Research Analyst (Biotechnology), at the B. Riley Securities Virtual Oncology Conference, taking place on Thursday, January 27, 2022, at 11:00 a.m. EST.

Key Points: 
  • WALTHAM, Mass., Jan. 25, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that James Oliviero, President and Chief Executive Officer, will participate in a fireside chat hosted by Justin Walsh, Equity Research Analyst (Biotechnology), at the B. Riley Securities Virtual Oncology Conference, taking place on Thursday, January 27, 2022, at 11:00 a.m. EST.
  • Checkpoint management will also participate in one-on-one meetings during the conference.
  • Checkpoint Therapeutics, Inc. (Checkpoint) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers.
  • Following positive topline results in metastatic cSCC announced earlier today, Checkpoint intends to submit a Biologics License Application for this indication later this year.

Replimune Provides 2021 Year End Review and Overview of Expected 2022 Milestones

Retrieved on: 
Monday, January 10, 2022
Drug Quality and Security Act, Neoplasm, Protein, Securities Exchange Act of 1934, RP3, Securities Act of 1933, U.S. Securities and Exchange Commission, Lung, Toxicity, Nivolumab, Large-cell lung carcinoma, REPL, TME, Melanoma, Security (finance), Goal, RPX, Skin, MOA, Company, ORR, CSCC, Herpes simplex virus, Progression-free survival, Head, Clinical trial, Safety, RP2, PFS, Antigen, Investor, Liver, Patient, Immunogenic cell death, RP1, Skin cancer, CD40L, Nasdaq, Gastrointestinal cancer, GLOBE, Liver disease, NMSC, NSCLC, Tumor microenvironment, Coronavirus, Conference, Cancer, CR, Bristol Myers Squibb, Forward-looking statement, Lymph, Review, Breast, Pharmaceutical industry, Medical imaging, Vaccine, Regeneron Pharmaceuticals, Sanofi

WOBURN, Mass., Jan. 10, 2022 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today provided a corporate update, highlighting the progress of key programs.

Key Points: 
  • Data with RP1 in various high-value skin cancer indications has continued to mature in 2021, said Philip Astley-Sparke, Chief Executive Officer of Replimune.
  • The Company expects to complete enrollment such that the trigger for the primary data analysis is expected in late 2022.
  • The company expects to release interim data from this cohort in late 2022.
  • The Company remains on track to present initial data from this clinical trial in the first quarter of 2022.

InflaRx Initiates Phase III Clinical Program with Vilobelimab in Hidradenitis Suppurativa

Retrieved on: 
Wednesday, January 5, 2022
Blood, CSCC, COVID-19, Agency, Inflammation, Review, Therapy, Company, Patient, Abscess, III, Phase, End organ damage, C5a, Hidradenitis suppurativa, Pyoderma, Moisture sensitivity level, Complement, FDA, Squamous cell carcinoma, Autoimmunity, GLOBE, Nasdaq, ANCA, Anti-neutrophil cytoplasmic antibody, Pharmaceutical industry, Medical device, HS

We have incorporated the FDAs feedback into the trial design and can now move forward with initiating the Phase III trial.

Key Points: 
  • We have incorporated the FDAs feedback into the trial design and can now move forward with initiating the Phase III trial.
  • InflaRx completed a Type A meeting with the U.S. Food & Drug Administration (FDA) in September 2021 to align on the Phase III HS study design.
  • InflaRx incorporated the FDAs input and submitted the Phase III protocol to the Agency in late November 2021.
  • The Company will provide an update on vilobelimab development in HS, including details on the Phase III program.

2021 Global Merkel Cell Carcinoma Pipeline Insight Report - ResearchAndMarkets.com

Retrieved on: 
Tuesday, December 21, 2021
Pharmaceutical, Health, Oncology, News, Clinical trial, TLR9, MCC, FDA, Route of administration, CSCC, Phase, HDAC, Neoplasm, Merck, Merkel cell, Discovery, ROA, Safety, Therapy, Injection, Pharmacokinetics, Tumor microenvironment, Route, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, II, Limited partnership, Patient, Administration, Pharmaceutical industry, Merkel-cell carcinoma, Angela Merkel

The "Merkel Cell Carcinoma - Pipeline Insight, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Merkel Cell Carcinoma - Pipeline Insight, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about 14+ companies and 14+ pipeline drugs in Merkel Cell Carcinoma pipeline landscape.
  • This segment of the Merkel Cell Carcinoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery.
  • Merkel Cell Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Checkmate Pharmaceuticals Announces Initiation of Patient Dosing in Phase 2 Multi-Indication Trial Using Vidutolimod

Retrieved on: 
Monday, December 20, 2021
Forward-looking statement, U.S. Securities and Exchange Commission, LinkedIn, TLR9, Securities Act of 1933, Financial condition report, CpG, Private Securities Litigation Reform Act, Social media, COVID-19, Annual report, NASDAQ, Review, File, CSCC, Safety, Patient, Security (finance), Immune system, GLOBE, Twitter, Analysis, Result, Pharmaceutical industry, Checkmate

Vidutolimod is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component.

Key Points: 
  • Vidutolimod is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component.
  • This multi-indication trial is an important element of our plan to expand on the indications that can be potentially treated using vidutolimod.
  • Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer.
  • The information that Checkmate Pharmaceuticals posts on these channels and websites could be deemed to be material information.

Exicure, Inc. Reports Third Quarter 2021 Financial Results and Corporate Progress

Retrieved on: 
Friday, November 19, 2021
Research, Genetics, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Tissue, FA, Private Securities Litigation Reform Act, Patient, State Administrative Expenses, Research and development, Research, MCC, Review, Safety, Security (finance), Cell, Audit committee, Technology, Audit, Industry, FXN, CSCC, Time, Income, Company, Inflammation, Forward-looking statement, Partnership, HD, Mission statement, Clinical trial, Spherical nucleic acid, AbbVie, U.S. Securities and Exchange Commission, Therapy, COVID-19, Lists of diseases, Intellectual property, Angelman syndrome, DNA, SNA, R, Patent, Neurology, RNA, Board, Architecture, Administration, ORR, NASDAQ, Growth, Pharmaceutical industry, Cryptocurrency

Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, today reported financial results for the quarter ended September 30, 2021 and provided an update on corporate progress.

Key Points: 
  • Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, today reported financial results for the quarter ended September 30, 2021 and provided an update on corporate progress.
  • Research and Development (R&D) Expenses: R&D expenses were $16.5 million for the quarter ended September 30, 2021, compared to $9.1 million for the quarter ended September 30, 2020.
  • General and Administrative Expenses: General and administrative expenses were $2.9 million for the quarter ended September 30, 2021, compared to $2.4 million for the quarter ended September 30, 2020.
  • For further financial information for the period ending September 30, 2021, please refer to the financial statements appearing at the end of this release.

Instil Bio Reports Third Quarter 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 15, 2021
Ipilimumab, SITC, Cohort, Cancer, CD19, HNSCC, Costar, Novartis, Fast track (FDA), TILS, MAA, NASDAQ, Initiate, IMPACT, EMA, Food, BLA, European Medicines Agency, Investment, CA, ESMO, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PD-1, HIV disease progression rates, Program, Head, National, Human, Patient, National Cancer Institute, Company, GLOBE, Large-cell lung carcinoma, CD40, NSCLC, CSCC, Toxicity, Cervical cancer, TIL, Survival, FDA, CD28, IND, Pharmaceutical industry, Lithium

DALLAS, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or (TIL), therapies for the treatment of patients with cancer, today reported its third quarter 2021 financial results and provided a corporate update.

Key Points: 
  • DALLAS, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (Instil) (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or (TIL), therapies for the treatment of patients with cancer, today reported its third quarter 2021 financial results and provided a corporate update.
  • Initiated enrollment in DELTA-1: Instil reported that patients have been enrolled and recruitment is ongoing into the pivotal study.
  • Enrollment for Cohort 1 is expected to be completed within 12 months, with Cohorts 2 and 3 finishing enrollment thereafter.
  • Instil expects top-line data and BLA filing submission in 2023 and a European Medicines Agency (EMA) marketing authorization application (MAA) filing in 2024.

Replimune Reports Fiscal Second Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 4, 2021
Safety, NMSC, Head, Neoplasm, U.S. Securities and Exchange Commission, Interim, Clinical trial, PFS, Drug Quality and Security Act, D, GLOBE, RP3, SITC, Securities Exchange Act of 1934, Liver, Lung, CSCC, Colorectal cancer, Security (finance), Skin, Company, Investment, Herpes simplex virus, Nivolumab, Liver disease, Toxicity, Biotechnology, Skin cancer, Goal, RP2, Immunotherapy, Bristol Myers Squibb, Large-cell lung carcinoma, CD40L, Breast, ORR, Protein, CEO, CR, Melanoma, Annual general meeting, Squamous cell carcinoma, Cancer, Securities Act of 1933, NSCLC, Poster, Gastrointestinal cancer, Patient, NASDAQ, FDA, Review, Lymph, Forward-looking statement, Research, Therapy, Coronavirus, Progression-free survival, Pharmaceutical industry, Medical imaging, Vaccine

WOBURN, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic® platform, today announced financial results for the fiscal second quarter ended September 30, 2021 and provided a business update.

Key Points: 
  • R&D Expenses: Research and development expenses were$19.9 millionfor the second quarter ended September 30, 2021, as compared to$14.1 millionfor the second quarter ended September 30, 2020.
  • G&A Expenses: General and administrative expenses were$9.3 millionfor the second quarter endedSeptember 30, 2021, as compared to$5.6 millionfor the second quarter endedSeptember 30, 2020.
  • Net Loss: Net loss was$29.4 millionfor the second quarter endedSeptember 30, 2021, as compared to a net loss of$20.1 millionfor the second quarter endedSeptember 30, 2020.
  • Our actual results could differ materially from the results described in or implied by such forward-looking statements.

InflaRx Completes Enrollment of Vilobelimab Phase III Study in Severe COVID-19

Retrieved on: 
Tuesday, October 12, 2021
Patient, Kidney, Autoimmunity, Database, ANCA, Death, Phase, COVID-19, Jean-Louis Vincent, Moisture sensitivity level, End organ damage, Standard of care, Blood, GLOBE, Mortality, Complement, Anti-neutrophil cytoplasmic antibody, Inflammation, C5a, Squamous cell carcinoma, Hidradenitis suppurativa, Pyoderma, Therapy, CSCC, Technology, Nasdaq, Pharmaceutical industry

JENA, Germany, Oct. 12, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the completion of enrollment of the Phase III part of the Phase II/III vilobelimab study in severe COVID-19 patients.

Key Points: 
  • JENA, Germany, Oct. 12, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the completion of enrollment of the Phase III part of the Phase II/III vilobelimab study in severe COVID-19 patients.
  • The randomized, double-blind and placebo-controlled Phase III part of the Phase II/III study enrolled 369 mechanically ventilated patients with COVID-19 across sites in the EU, South America and other regions.
  • The Phase II part of the study evaluated vilobelimab treatment plus best supportive care compared to best supportive care alone for up to 28 days.
  • The data from the Phase II part of the study have been published in the peer-reviewed journal, The Lancet Rheumatology .