CMC

Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 14, 2024
Research, EGFR, NSCLC, Disease, AML, Cullinan, Patient, Tissue, Sale, Multiple myeloma, G&A, CMC, Enrollment, IND, Lymph, Investment, MDS, FDA, Lymphoma, Spleen, CD19, CGEM, Pharmaceutical industry

CAMBRIDGE, Mass., March 14, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted oncology therapies, today reported on recent and upcoming business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2023. The company also announced that Chief Financial Officer Jeff Trigilio will depart the company effective March 29. Following his departure, Jeff has agreed to support the company through a transition period.

Key Points: 
  • R&D Expenses: Research and development (R&D) expenses were $34.8 million for the fourth quarter of 2023, compared to $33.8 million for the third quarter of 2023.
  • R&D expenses for the fourth and third quarters of 2023 included $2.7 million and $3.2 million of equity-based compensation expenses, respectively.
  • G&A Expenses: General and administrative (G&A) expenses were $10.6 million for the fourth quarter of 2023, compared to $11.0 million for the third quarter of 2023.
  • Net Loss: Net loss (before items attributable to noncontrolling interest) for the fourth quarter of 2023 was $25.6 million, compared with net loss of $39.2 million for the third quarter of 2023.

BioXcel Therapeutics Reports Financial Results for the Fourth Quarter and Full Year 2023

Retrieved on: 
Tuesday, March 12, 2024
The Orange Book, Patent Cooperation Treaty, Agitation, Administration, Conference call, Type, PCT, Conference, Database, Schizophrenia, Intelligence, Caregiver, Webcast, Patient, DSM-IV codes, Neuroscience, Fast Track, Food and Drug Administration, CMC, Wind, Orange Book, SCNC, Positive, Microsatellite instability, Dexmedetomidine, Clinical trial, Therapy, Safety, Patent, Research and development, Collection, FDA, Approved drug, Dementia, CAD, Food, Pharmaceutical industry

NEW HAVEN, Conn., March 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today provided an update on its late-stage TRANQUILITY and SERENITY clinical programs. In addition, the Company reported its financial results for the fourth quarter and full year 2023.

Key Points: 
  • In addition, the Company reported its financial results for the fourth quarter and full year 2023.
  • Net Revenue: Net revenue from IGALMI was $376,000 for the fourth quarter of 2023, compared to $238,000 for the same period in 2022.
  • Net Loss: BioXcel Therapeutics had a net loss of $22.3 million for the fourth quarter of 2023, compared to a net loss of $54.8 million for the same period in 2022.
  • ET to provide an update on recent operational highlights and to discuss its fourth quarter and full year 2023 financial results.

ProMed Pharma Acquires SpineThera Manufacturing Capabilities and an Option to License Intellectual Property

Retrieved on: 
Wednesday, April 3, 2024
Chemicals, Plastics, Electronic Design Automation, Manufacturing, Technology, Pharmaceutical, Physical Therapy, Medical Devices, Clinical Trials, Other Technology, Biotechnology, Science, Veterinary, Other Science, Research, Health, Engineering, CDMO, Business, Patient, CNS, ProMED-mail, CGMP, Animal Health, Sale, Business development, CMC, Acquisition, Clinical trial, Fine chemical

ProMed Pharma also obtained an option to license SpineThera’s microsphere intellectual property with the potential to sub-license to ProMed Pharma’s customers.

Key Points: 
  • ProMed Pharma also obtained an option to license SpineThera’s microsphere intellectual property with the potential to sub-license to ProMed Pharma’s customers.
  • Importantly, SpineThera is maintaining exclusive ownership of intellectual property that enables SX600.
  • With this transaction, our manufacturing team joins a highly capable CDMO, ProMed Pharma, a company we have worked with closely for many years.
  • SpineThera becomes a customer of ProMed, who will manufacture SX600 in the same cleanroom in which we previously developed the technology and manufactured clinical batches.

Zura Bio Reports Full Year 2023 Financial Results, Business Highlights, and Appoints Robert Lisicki as Chief Executive Officer

Retrieved on: 
Thursday, March 28, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, IL-17A, Administration, Ulcerative colitis, Congress, Thymic stromal lymphopoietin, Atopic dermatitis, Alopecia areata, Inflammation, Chronic obstructive pulmonary disease, Allergy, TSLP, BCA, CMC, G&A, Interleukin 7, Benaroya Research Institute, Business analyst, Abstract, Asthma, IL-7, Research and development, Drug development, Senior management, BAFF, Eli Lilly and Company, Translational medicine, Autoimmunity, Management

Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”) a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today reported full year 2023 financial results and recent business highlights.

Key Points: 
  • Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”) a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today reported full year 2023 financial results and recent business highlights.
  • The Company has also announced the appointment of Robert Lisicki as Chief Executive Officer (CEO), effective April 8, 2024, succeeding its Founding CEO, Someit Sidhu, M.D.
  • Mr. Lisicki joined Zura Bio in January 2024 as President and Chief Operating Officer.
  • Dr. Sidhu continued, "On behalf of the Management Team and Board, I am pleased to welcome Robert as the Chief Executive Officer.

Egle Therapeutics Strengthens its Leadership Team with the Appointment of Monica Gostissa, PhD, as Chief Scientific Officer and Reno Winter, PhD, as Chief Technical Officer

Retrieved on: 
Wednesday, March 27, 2024
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Egle, Natural science, Leukemia, Patient, Cell biology, CMC, Head, Doctor of Philosophy, MD, IND, Clinical trial, Investigational New Drug, Therapy, International school, CSO, Pharmaceutical industry

Egle Therapeutics, a biotechnology company focused on advancing the next generation of regulatory T cell-focused therapies for oncology and auto-immunity, announced today the appointment of Monica Gostissa, PhD, as Chief Scientific Officer and Reno Winter, PhD, as Chief Technical Officer.

Key Points: 
  • Egle Therapeutics, a biotechnology company focused on advancing the next generation of regulatory T cell-focused therapies for oncology and auto-immunity, announced today the appointment of Monica Gostissa, PhD, as Chief Scientific Officer and Reno Winter, PhD, as Chief Technical Officer.
  • “I'm excited to join Egle Therapeutics to help develop novel immunotherapies targeting T regulatory cells for oncology and autoimmune diseases.
  • “I am happy to be part of Egle Therapeutics’ leadership team to contribute my expertise in CMC and beyond to the company’s mission.
  • Dr. Winter is a trained biochemist and received his PhD in Natural Sciences from the Martin Luther University Halle-Wittenberg, Germany.

Biocytogen Enters Collaboration with ABL Bio to Develop New Bispecific Antibody-Drug Conjugates

Retrieved on: 
Monday, March 25, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Medication, KOSDAQ, Partnership, CNS, Epitope, CMC, Quality of life, ABL, Antibody, HKEX, Therapy, ADC

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, and ABL Bio Inc. (“ABL”, KOSDAQ: 298380), a Korean clinical-stage biotechnology company developing novel therapeutics in oncology and CNS diseases, today announced a collaboration to develop new bispecific antibody-drug conjugates (bsADCs).

Key Points: 
  • Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, and ABL Bio Inc. (“ABL”, KOSDAQ: 298380), a Korean clinical-stage biotechnology company developing novel therapeutics in oncology and CNS diseases, today announced a collaboration to develop new bispecific antibody-drug conjugates (bsADCs).
  • Based on this platform, both companies will be able to discuss expanding their collaboration for various types of ADC development.
  • Dr. Yuelei Shen, President and CEO of Biocytogen, said, “We are very pleased to collaborate with ABL, a company that possesses advanced platforms for cancer immunotherapy and treatments against CNS diseases.
  • Together, we aim to expedite the development of innovative bsADC therapies.”
    Sang Hoon Lee, CEO of ABL, said, “We are excited to establish this partnership with Biocytogen for bsADCs.

Biocytogen Enters Collaboration with ABL Bio to Develop New Bispecific Antibody-Drug Conjugates

Retrieved on: 
Monday, March 25, 2024
Oncology, Health, Neurology, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Medication, KOSDAQ, Partnership, CNS, Epitope, Research, CMC, Quality of life, ABL, Antibody, HKEX, Therapy, ADC

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, and ABL Bio Inc. (“ABL”, KOSDAQ: 298380), a Korean clinical-stage biotechnology company developing novel therapeutics in oncology and CNS diseases, today announced a collaboration to develop new bispecific antibody-drug conjugates (bsADCs).

Key Points: 
  • Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, and ABL Bio Inc. (“ABL”, KOSDAQ: 298380), a Korean clinical-stage biotechnology company developing novel therapeutics in oncology and CNS diseases, today announced a collaboration to develop new bispecific antibody-drug conjugates (bsADCs).
  • Based on this platform, both companies will be able to discuss expanding their collaboration for various types of ADC development.
  • Dr. Yuelei Shen, President and CEO of Biocytogen, said, “We are very pleased to collaborate with ABL, a company that possesses advanced platforms for cancer immunotherapy and treatments against CNS diseases.
  • Together, we aim to expedite the development of innovative bsADC therapies.”
    Sang Hoon Lee, CEO of ABL, said, “We are excited to establish this partnership with Biocytogen for bsADCs.

GenSight Biologics Reports Full Year 2023 Consolidated Financial Results

Retrieved on: 
Friday, March 22, 2024
Health, Neurology, Genetics, Pharmaceutical, Optical, Biotechnology, Control, URD, Three-body problem, Safety, Partnership, Research, CIR, ANSM, CMC, EMA, BofA Securities, Risk, Chapter, MHRA, Clinical trial, European Investment Bank, ATU, AMF, Workforce, EIB, AAP, Marketing, FDA, Amendment, AAC, Cryptocurrency

From 2022 to 2023, the Company's research and development expenses remained stable, at €19.3 million in 2022 and €19.4 million in 2023.

Key Points: 
  • From 2022 to 2023, the Company's research and development expenses remained stable, at €19.3 million in 2022 and €19.4 million in 2023.
  • The Company's general and administrative expenses also remained stable and amounted to €5.4 million in 2022 and 2023.
  • The weighted average number of shares outstanding increased from 46.3 million in 2022 to 48.3 million in 2023, thereby reducing the loss per share from (€0.54) in 2023 to (€0.60) in 2023.
  • GenSight Biologics will report its cash position as of March 31, 2024 on April 4 2024.

AffyImmune Therapeutics Appoints Matt Britz as Chief Executive Officer and Pete Gelinas as SVP of CMC

Retrieved on: 
Tuesday, March 19, 2024
Research, Genetics, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, CALD, Control, Thyroid cancer, Growth, Bluebird bio, MAA, Drug discovery, Business, MIT, Britz, Patient, SVP, Marketing Authorisation Application, Merck, MSAT, Business development, Acquisition, CMC, Betibeglogene autotemcel, Technology transfer, Senior, MBA, CMCF, Therapy, Takeda, Equinox Group, Dana–Farber Cancer Institute, Multimedia, Chemical engineering, DFCI, Partnership, Biology, BLA, Pharmaceutical industry

AffyImmune Therapeutics, Inc ., a clinical-stage biopharmaceutical company committed to developing novel, first-in-class, affinity-tuned CAR T cell therapies, announced today the appointment of Matt Britz to Chief Executive Officer and Pete Gelinas as Senior Vice President of Chemistry, Manufacturing, and Controls.

Key Points: 
  • AffyImmune Therapeutics, Inc ., a clinical-stage biopharmaceutical company committed to developing novel, first-in-class, affinity-tuned CAR T cell therapies, announced today the appointment of Matt Britz to Chief Executive Officer and Pete Gelinas as Senior Vice President of Chemistry, Manufacturing, and Controls.
  • Matt is well-suited to lead AffyImmune as CEO as the Company accelerates clinical development of AIC100 in thyroid cancer, and in other indications with high unmet medical need.
  • Matt Britz joined AffyImmune in June 2021 as Senior Vice President (SVP), Business Development and was promoted to Chief Operating Officer in January 2022.
  • Pete Gelinas brings over 15 years of extensive experience in Manufacturing and CMC Product Development to AffyImmune.

LIB Therapeutics and Partner Hasten Biopharmaceuticals Announce Lerodalcibep Clinical Trial Application Acceptance by the Center for Drug Evaluation at the National Medical Products Administration in China

Retrieved on: 
Tuesday, March 19, 2024
Research, FDA, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Other Science, Science, Cardiovascular disease, NMPA, PCSK9, CVD, MAA, Refrigeration, CMC, EMA, CDE, Clinical trial, Therapy, National Medical Products Administration, Pharmaceutical industry

LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.

Key Points: 
  • LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.
  • In September 2023, LIB announced that it had entered into an agreement granting Hasten the rights to develop and commercialize Lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan) and will be responsible for clinical development and regulatory approval in these territories.
  • The acceptance of the Lerodalcibep clinical trial application by the NMPA was based on the integrated data dossier provided by LIB, including CMC, non-clinical and clinical studies completed in the U.S., Europe, and rest of world as well as the clinical development plan in China proposed by Hasten.
  • “We are preparing our own Lerodalcibep BLA submission to the FDA, to be followed by MAA submission to EMA.