Initiate

Assembly Biosciences Reports Fourth Quarter and Year End 2021 Financial Results and Recent Highlights

Retrieved on: 
星期四, 三月 10, 2022
VBR, C1-inhibitor, U.S. Securities and Exchange Commission, Securities Act of 1933, Antiviral Research, Therapy, HBV, Degenerative disease, Report, AbbVie, Program, Safety, Development, Drug Quality and Security Act, Assembly, ICAR, Asilomar International Conference on Climate Intervention Technologies, Sumathi Best Television Current Reporting Award, DNA, Securities Exchange Act of 1934, GLOBE, Doctor of Philosophy, Patient, SEC, Research, ATM, Annual report, Conference, MD, Treatment, BeiGene, 2021 Essex County Council election, CccDNA, Liver, Initiate, Acquisition, COVID-19, Hepatitis B virus, AO, SAN, AASLD, Pharmaceutical industry, Allergan

SOUTH SAN FRANCISCO, Calif., March 10, 2022 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and other viral diseases, today reported financial results and recent highlights for the fourth quarter and year ended December 31, 2021.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 10, 2022 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and other viral diseases, today reported financial results and recent highlights for the fourth quarter and year ended December 31, 2021.
  • We look forward to introducing the first of these during a web event at the end this month.
  • Revenues from collaborative research were $6.3 million for the year ended December 31, 2021, compared to $79.1 million in 2020.
  • Research and development expenses were $68.5 million for the year ended December 31, 2021, compared to $106.8 million in 2020.

Graybug Vision Reports Full Year 2021 Financial Results and Recent Corporate Developments

Retrieved on: 
星期四, 三月 10, 2022
Doctor of Pharmacy, IVT, Safety, AMD, Clinical trial, Disease management, Initiate, VEGF, IPO, Annual report, Private Securities Litigation Reform Act, IND, Therapy, Visual acuity, Sunitinib, U.S. Securities and Exchange Commission, Research, Investment, Investor, Completeness, Form 10-K, Retina, GLOBE, Patient, Ophthalmology, CST, Glaucoma, Technology, COVID-19, Johns Hopkins School of Medicine, Insurance, Forward-looking statement, Pharmaceutical industry, Sintering

BALTIMORE, March 10, 2022 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of ocular diseases, today provided an update on recent corporate developments and reported financial results for the full year ended December 31, 2021.

Key Points: 
  • BALTIMORE, March 10, 2022 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of ocular diseases, today provided an update on recent corporate developments and reported financial results for the full year ended December 31, 2021.
  • Graybug made important progress in advancing its retina (GB-102) and glaucoma (GB-401) programs in 2021.
  • Completed ALTISSIMO Phase 2b trial in wet age-related macular degeneration (wet AMD) Final results confirm unprecedented duration in an aflibercept-controlled clinical trial.
  • Best corrected visual acuity (BCVA) of patients in the GB-102 1mg arm trended lower than aflibercepts, mainly driven by 4 subjects.

Prelude Therapeutics Provides Clinical Update and Announces Presentation of New Preclinical Data at the Upcoming 2022 AACR Annual Meeting

Retrieved on: 
星期三, 三月 9, 2022
Safety, BCL2, AACR, MCL1, Initiate, Completeness, Prelude, Company, IND, CDK9, Survival, SMARCA4, SMARCA2, Cancer, Protein, IV, Breast, CNS, PRMT5, IDH1, SWI, Brain, GLOBE, BRM, Patient, Breast cancer, Uveal melanoma, American Association, Central nervous system, BRG1, CDK6, GBM, Association, Program, Glioblastoma, American Association for Cancer Research, Pharmaceutical industry, Medical imaging, Vaccine

Through disciplined and effective execution, Prelude made meaningful progress across all of our portfolio programs in 2021, said Kris Vaddi, Ph.D., Chief Executive Officer.

Key Points: 
  • Through disciplined and effective execution, Prelude made meaningful progress across all of our portfolio programs in 2021, said Kris Vaddi, Ph.D., Chief Executive Officer.
  • Because of these efforts, we now have five distinct precision oncology programs with four internally discovered molecules in clinical development.
  • One of our key objectives in 2022 is to focus our development efforts and generate the clinical data necessary to prioritize these programs.
  • Prelude has identified a number of highly selective SMARCA2 degraders that have the potential to be first-in-class for SMARCA4-deleted cancers.

Instil Bio Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update

Retrieved on: 
星期一, 三月 7, 2022
IMPACT, Research, United Kingdom, BLA, Patient, Investment, Cervical cancer, TIL, European Medicines Agency, Population, TILS, Safety, PD-1, Large-cell lung carcinoma, CSCC, HNSCC, MAA, Company, Cancer, Disease, Head, Trial of the century, BRAF, IND, Costar, Initiate, NSCLC, Melanoma, GLOBE, NASDAQ, Pharmaceutical industry, Renewable energy, Vaccine, Video game, DALLAS, Instil

DALLAS, March 07, 2022 (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 fourth quarter and year end 2021 financial results and provided a corporate update.

Key Points: 
  • In 2022, we look forward to the opportunity to expand the targeted patient population for receiving our therapies in multiple indications with ITIL-168 and ITIL-306."
  • Instil expects top-line safety and efficacy data in 2023 which could potentially support BLA submission and a European Medicines Agency marketing authorization application (MAA) filing.
  • Research and development expenses were $42.6 million and $107.3 million for the fourth quarter and full year ended December31, 2021, compared to $10.2 million and $19.4 million for the fourth quarter and full year ended December31, 2020, respectively.
  • General and administrative expenses were $11.2 million and $48.3 million for the fourth quarter and full year ended December31, 2021, compared to $7.2 million and $14.4 million for the fourth quarter and full year ended December31, 2020, respectively

Fulcrum Therapeutics® Reports Recent Business Highlights and Fourth Quarter and Full Year 2021 Financial Results

Retrieved on: 
星期四, 三月 3, 2022
People, Beta thalassemia, Thalassemia, MFI, Research, Patient, G&A, Adult, Genetics, Quality of life, Quality, Food, HBF, Safety, Hemoglobinopathy, Merck, RWS, Criticism of the Food and Drug Administration, FDA, Therapy, Losmapimod, Volunteering, HBG, Growth, Neuro, Webcast, D, Acceleron, Conference, Ascending limb of loop of Henle, Merck & Co., Sickle cell disease, Bristol Myers Squibb, IND, Facioscapulohumeral muscular dystrophy, PGIC, Initiate, Investigational New Drug, Investor relations, REACH, Nasdaq, GLOBE, Achievement, RNA transfection, Conference call, Pharmaceutical industry, Cryptocurrency, EU, FSHD

CAMBRIDGE, Mass., March 03, 2022 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2021.

Key Points: 
  • Collaboration Revenue: Collaboration revenue was $5.1 million for the fourth quarter of 2021, as compared to $4.2 million for the fourth quarter of 2020.
  • R&D Expenses: Research and development expenses were $18.9 million for the fourth quarter of 2021, as compared to $16.1 million for the fourth quarter of 2020.
  • G&A Expenses: General and administrative expenses were $9.7 million for the fourth quarter of 2021, as compared to $5.9 million for the fourth quarter of 2020.
  • ET to discuss the Companys fourth quarter and full year 2021 recent business highlights and financial results.

Olema Oncology Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update

Retrieved on: 
星期一, 二月 28, 2022
GLOBE, Risk, Human, ER, Tucatinib, NASDAQ Biotechnology Index, Securities Exchange Act of 1934, Pharmacokinetics, Annual report, Therapy, Industry, Initiate, Breast cancer, Trastuzumab, Safety, Trial of the century, NBI, Review, The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, Woman, Forecasting, News, Leadership, Securities Act of 1933, SAN, R, Nasdaq, Conference, Patient, SERD, SECURE Act of 2019, U.S. Securities and Exchange Commission, CMO, CEO, GAAP, Research, CNS, Pharmaceutical industry, Cryptocurrency, Medical imaging, Lithium, G&A

Presented nonclinical data on OP-1250 in a poster session at the San Antonio Breast Cancer Symposium (SABCS), held December 7-10, 2021.

Key Points: 
  • Presented nonclinical data on OP-1250 in a poster session at the San Antonio Breast Cancer Symposium (SABCS), held December 7-10, 2021.
  • Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for womens cancers.
  • We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance.
  • Except as required by law, Olema assumes no obligation to update these forward-looking statements or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

Beam Therapeutics Reports Pipeline and Business Highlights, Planned 2022 Milestones and Fourth Quarter and Full Year 2021 Financial Results

Retrieved on: 
星期一, 二月 28, 2022
Cell, Security (finance), CAR, COVID-19, Annual general meeting, Therapy, Transplant, IND, SCD, Liver, R, Nasdaq, Society for Immunotherapy of Cancer, Private Securities Litigation Reform Act, Research, Society, Gene, Hematology, Initiate, U.S. Securities and Exchange Commission, Biotechnology, Sickle cell disease, Program, Rare, Gene editing, Neoplasm, Administration, Immunotherapy, LNP, G&A, DNA, SITC, HSC, Patient, GLOBE, Central nervous system, Potential, Toxicity, Research and development, Annual report, LNP Media Group, CD5, ASH, Acquisition, Magenta, BioScience Research Collaborative, Health, Glycogen storage disease, Busulfan, Degenerative disease, Technology, General Administration of Sport of China, Patent, Standard of care, Pharmaceutical industry, Vaccine, Medical imaging, Animal, Lithium, Pfizer, Beam

CAMBRIDGE, Mass., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced pipeline and business highlights, outlined key 2022 anticipated milestones and reported fourth quarter and full year 2021 financial results.

Key Points: 
  • This is an exciting time for Beam, and Im optimistic about the year ahead as we work to bring potentially life-changing medicines to patients.
  • The collaboration has an initial term of four years and may be extended up to one additional year.
  • This approach could provide a more accessible option for patients, particularly in regions where ex vivo treatment is challenging.
  • Beam Therapeutics (Nasdaq: BEAM) is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines.

ALX Oncology Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Clinical Development and Operational Highlights and Upcoming Milestones

Retrieved on: 
星期一, 二月 28, 2022
SHIELD, GLOBE, Zymeworks, CD47, Neck, Insurance, Paclitaxel, Head, ALX, Security (finance), Administration, Lead, HNSCC, Azacitidine, AML, ODD, Company, Immunotherapy, Breast cancer, Trastuzumab, Initiate, Lymphatic system, Safety, Society, G&A, U.S. Securities and Exchange Commission, American Society of Hematology, Acquisition, Acute myeloid leukemia, FC, Venetoclax, SITC, Poster, News, Cytopenia, FDA, SAN, Cancer, Microdeletion syndrome, Forward-looking statement, Society for Immunotherapy of Cancer, MDS, GAAP, Research, Cash, Research and development, SEC, Pharmaceutical industry, Medical imaging, Patient

SOUTH SAN FRANCISCO, Calif., Feb. 28, 2022 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (ALX Oncology) (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the fourth quarter and year ended December 31, 2021 and provided clinical development and operational highlights.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Feb. 28, 2022 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (ALX Oncology) (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the fourth quarter and year ended December 31, 2021 and provided clinical development and operational highlights.
  • ALX Oncology achieved key milestones in 2021 to advance our lead program, evorpacept, a next-generation CD47 blocker, through multiple clinical trials, said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology.
  • Additionally, our initial clinical data show anti-tumor activity on par or better than other such agents.
  • Full Year and Fourth Quarter 2021 Financial Results:
    Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2021 were $363.7 million.

ImmunoGen Reports Recent Progress and 2021 Financial Results

Retrieved on: 
星期五, 二月 25, 2022
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Head, Security (finance), ID, COVID-19, FACP, CMC, IND, Society of Gynecologic Oncology, Chemistry, Capital expenditure, Research, Society, Board, SGO, Medical Affairs Bureau, Azacitidine, AML, ImmunoGen, Initiate, Sale, Jazz Pharmaceuticals, Gynecologic Oncology (journal), U.S. Securities and Exchange Commission, Medicine, BLA, Food, György Enyedi (geographer), Leadership, Maintenance, Director, Ovarian cancer, Population, MPH, Bevacizumab, Eli Lilly and Company, US Foods, IMGN, Patient, Carboplatin, Control, Clinical trial, ASH, Venetoclax, FDA, Lilly, Cancer, Vaccine, Management, Pharmaceutical industry, Platinum, Risk management, Online gambling, Airline, Company, BPDCN, Huadong Medicine, MD

ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter and year ended December 31, 2021.

Key Points: 
  • ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter and year ended December 31, 2021.
  • Together with the appointment of key leadership positions and an oversubscribed follow-on offering in the fourth quarter, this progress positions us for success in 2022 and beyond.
  • Initiated accrual in PICCOLO, a single-arm study of mirvetuximab monotherapy in FR-high recurrent platinum-sensitive ovarian cancer.
  • ImmunoGen expects that its current cash, combined with anticipated product and collaboration revenues, will fund operations into 2024.

Agios Reports Fourth Quarter and Full Year 2021 Financial Results

Retrieved on: 
星期四, 二月 24, 2022
Workforce, Security (finance), Food, ID, COVID-19, Myelodysplastic syndrome, SG, Private Securities Litigation Reform Act, R, Thalassemia, Research, Genetics, Risk, European Medicines Agency, Â, SEC, Hemolytic anemia, Initiate, Sale, Disease, U.S. Securities and Exchange Commission, Pyruvate kinase deficiency, Treatment, Leadership, General officer, Goal, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pyruvate kinase, NASDAQ, Administration, Sickle cell disease, PKM2, EMA, Patient, MDS, GLOBE, PAH, Income, Investor, Positivity, Research and development, RISE, ASH, FDA, Marketing, Patent, Anemia, PK, Society, Pharmaceutical industry, Vaccine, Video game, EU

CAMBRIDGE, Mass., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today reported business highlights and financial results for the fourth quarter and year ended Dec. 31, 2021.

Key Points: 
  • Research and Development (R&D) Expenses: R&D expenses for continuing operations were$73.3 million for the fourth quarter of 2021 compared to$59.4 millionfor the fourth quarter of 2020, and$257 millionfor the year endedDec.
  • Selling, General and Administrative (SG&A) Expenses: SG&A expenses for continuing operations were$31.5 millionfor the fourth quarter of 2021 compared to $25.9 million for the fourth quarter of 2020, and $121.4 millionfor the year endedDec.
  • Net Loss: Net loss was$98.6 million for the fourth quarter of 2021 compared to a net loss of$84.5 millionfor the fourth quarter of 2020, and $356.5 millionfor the year endedDec.
  • Agios will host a conference call and live webcast with slides today at8:00 a.m. ETto discuss fourth quarter and year end 2021 financial results and recent business activities.