Kissei

Iktos opens a subsidiary in Japan and entrusts its management to Hideyoshi Fuji

Retrieved on: 
Wednesday, February 14, 2024
Molecule, Urology, Pharmacy, Doctor of Philosophy, AI, Yann, Saas, Generative, Drug design, Drug discovery, RIKEN, Kissei, Retrosynthetic analysis, Software as a service, Astellas Pharma, Artificial intelligence, Computational chemistry, Toyotomi Hideyoshi, Ono Pharmaceutical, Pharmaceutical industry

Paris (France) and Tokyo (Japan), February 14, 2024 – Iktos, a company specialized in Artificial Intelligence for new drug design, announces the opening of Iktos K.K., its new subsidiary in Japan.

Key Points: 
  • Paris (France) and Tokyo (Japan), February 14, 2024 – Iktos, a company specialized in Artificial Intelligence for new drug design, announces the opening of Iktos K.K., its new subsidiary in Japan.
  • Hideyoshi Fuji has been appointed Representative Director of Iktos K.K., and Vice-President, Japan Business Development and Operations.
  • Hideyoshi, 42, spent 13 years at Astellas Pharma Inc. (2009-2021) as an expert in computational chemistry and chemoinformatics.
  • After his career with Astellas Pharma, Hideyoshi became an entrepreneur in 2022 and supported business development and marketing efforts in Japan for overseas software companies.

Kissei introduces Iktos AI Drug Discovery System

Retrieved on: 
Tuesday, July 4, 2023
Acceleration, Keyword Services Platform, History, Drug design, Artificial intelligence, Drug discovery, Urology, Software, Pharmaceutical industry, Kissei

“We are excited and proud to join forces with Kissei, a leading Japanese pharmaceutical company and to have their scientists use our software in their drug discovery projects", said Yann Gaston-Mathé, Co-founder and CEO of Iktos. “At Iktos, we strive to build an innovative technology platform capable of improving the efficiency of small molecule discovery by combining our powerful algorithmic technology, our know-how derived from the experience of the many collaborations we have established to date, and an intuitive and user-friendly user interface which is essential to an optimal user experience.” --About IktosIncorporated in October 2016, Iktos is a French start-up company specialized in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry, and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, to design molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis. Iktos has already validated its technology through more than 50 collaborations with pharmaceutical and biotech companies such as Chiesi Group, Galapagos, Janssen, Merck, Teijin, Ono Pharmaceuticals, Pfizer, Servier, UCB...

Key Points: 
  • Paris, France, July 3, 2023 – Iktos, a company specialized in Artificial Intelligence for new drug design, today announced that Kissei Pharmaceutical Co., Ltd. (“Kissei”), a Japanese pharmaceutical company with approximately 75 years of history, specialized in the field of urology, kidney-dialysis and unmet medical needs, has introduced Makya™, Iktos Software as a Service Platform for AI-driven drug discovery.
  • This will enable the rapid and efficient design of new small molecules, leading to an increase in the speed of drug discovery and development.
  • "Iktos has cutting-edge AI technology in small molecule drug discovery research, and their focus on further small molecule drug discovery technology development fits well with our strategy."
  • “We are excited and proud to join forces with Kissei, a leading Japanese pharmaceutical company and to have their scientists use our software in their drug discovery projects", said Yann Gaston-Mathé, Co-founder and CEO of Iktos.

ObsEva Announces Third Quarter 2022 Financial Results and Provides a Business Update

Retrieved on: 
Thursday, December 1, 2022
Risk, SIX Swiss Exchange, Research, Drug development, Security (finance), Cleveland Cultural Gardens, Retirement, Workforce, Coronavirus, Amendment, Forbearance, Clinical trial, Pregnancy, Safety, Pharmacokinetics, IND, Female, BioScience, Center for Drug Evaluation and Research, Sale, Fertilisation, Woman, JGB, Cryptocurrency, Birth control, Pharmaceutical industry, Kissei, Yu Garden

53 LR of the SIX Swiss Exchange

Key Points: 
  • 53 LR of the SIX Swiss Exchange
    GENEVA, Switzerland December 1, 2022 ObsEva SA (NASDAQ: OBSV; SIX: OBSN) (ObsEva or the Company), a biopharmaceutical company developing novel therapies for womens health, today reported financial results for the third quarter ended September 30, 2022 and provided a business update.
  • Financial Results for the Third Quarter Ended September 30, 2022
    ObsEva had cash and cash equivalents of $9.7 million at September 30, 2022 compared to $54.7 million at December 31, 2021.
  • The third quarter 2022 financial statements can be accessed in the financial reports section here of the Companys website, or directly here .
  • These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements.

ObsEva Announces Progress on Cost Reduction Initiatives and Stay of Moratorium Proceedings

Retrieved on: 
Wednesday, October 26, 2022
IND, Sister republic, SEC, Company, Drug development, Security (finance), Achievement, NASDAQ, Private Securities Litigation Reform Act, Investor, U.S. Securities and Exchange Commission, CEO, JGB, Risk, Coronavirus, Pregnancy, Contract, SIX Swiss Exchange, Hearing, Program, Birth certificate, Report, Compliance, Fertilisation, Woman, Fine chemical, Online gambling, Pharmaceutical industry, Nasdaq, Kissei

These assignments represent savings of approximately $16.0 million in contractual commitments, including $3.7 million of accounts payable.

Key Points: 
  • These assignments represent savings of approximately $16.0 million in contractual commitments, including $3.7 million of accounts payable.
  • On October 20, 2022, ObsEva attended its first hearing with the competent court in Geneva, Switzerland.
  • The Company continues to progress various corporate initiatives intended to resolve its over-indebtedness and support future pipeline development.
  • ObsEva retains worldwide, exclusive, commercial rights, except for the Peoples Republic of China which has been sub-licensed to YuYuan BioScience.

ObsEva Announces Progress on Restructuring Initiatives

Retrieved on: 
Tuesday, September 13, 2022
Birth certificate, Inflammation, Fertilisation, Organon, Risk, Investor, Woman, Bankruptcy, Contract, Company, Compliance, Private Securities Litigation Reform Act, Hearing, Achievement, Calendar, Letter, Pregnancy, U.S. Securities and Exchange Commission, SIX Swiss Exchange, CEO, Organon International, Report, Coronavirus, Drug development, NASDAQ, Board, Security (finance), SEC, Board of directors, Lease, Auction, Pharmaceutical industry, Risk management, Nasdaq, Kissei

53 LR of the SIX Swiss Exchange

Key Points: 
  • 53 LR of the SIX Swiss Exchange
    GENEVA, Switzerland September 13, 2022 ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing novel therapies for womens health, today announced an update on its previously announced restructuring efforts.
  • We have made meaningful progress toward restructuring our operations during the third quarter, with the implementation of significant cost cutting measures, said Brian OCallaghan, CEO of ObsEva.
  • These measures, along with our previously announced debt restructuring, are important steps as we focus our efforts toward advancing our license agreements and assessing the potential for further nolasiban development.
  • Moratorium update: As previously announced, ObsEva has applied to the competent court in Geneva, Switzerland, for a court-sanctioned moratorium.

ObsEva Announces Corporate Updates

Retrieved on: 
Wednesday, July 27, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Bankruptcy, SIX Swiss Exchange, Documentation, Food, U.S. Securities and Exchange Commission, Woman, SEC, New Drug Application, Risk, Royal commission, Private Securities Litigation Reform Act, NDA, Uterine fibroid, Organon, NASDAQ, Pregnancy, Achievement, Inflammation, European Commission, Review, Fertilisation, Drug development, FDA, Company, Security (finance), Medicines and Healthcare products Regulatory Agency, Birth certificate, Report, Nasdaq, Investor, PDUFA, Coronavirus, Pharmaceutical industry, Financial adviser, Kissei

53 LR of the SIX Swiss Exchange

Key Points: 
  • 53 LR of the SIX Swiss Exchange
    GENEVA, Switzerland July 27, 2022 ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing novel therapies for womens health, today announced that it plans to initiate a corporate restructuring and refocus the Companys development and commercialization strategy.
  • The FDAs review of the NDA is still ongoing and ObsEva has not been informed of any final decision by the agency.
  • In addition, ObsEva will assess strategic options with respect to pipeline development and the worldwide rights it holds for nolasiban, excluding China.
  • Consistent with ObsEvas plans to restructure its operations, ObsEva will initiate a mass dismissal process, pursuant to Swiss law.

ObsEva Announces UK MHRA Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids

Retrieved on: 
Tuesday, June 28, 2022
SIX Swiss Exchange, Patient, Gynaecology, Marketing, Company, Hormone, Birth, MHRA, Royal commission, Birth certificate, Quality of life, Urology, Osteoporosis, Drug development, Nasdaq, Pregnancy, Coronavirus, Uterine fibroid, NDA, Security (finance), FDA, European, ABT, Woman, Anemia, Nephrology Dialysis Transplantation, Uterus, SEC, Risk, Central Research Laboratories, Solution, CEO, Report, New Drug Application, Linzagolix, European Commission, Menopause, Investor, Private Securities Litigation Reform Act, Health, U.S. Securities and Exchange Commission, NASDAQ, Mental health, Bloating, Review, Anxiety, Fertility, Adult, Pain, Theramex, Endometriosis, Gonadotropin-releasing hormone, PDUFA, Medicines and Healthcare products Regulatory Agency, Medical device, Pharmaceutical industry, Birth control, EU, Kissei, UF

Yselty is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF.

Key Points: 
  • Yselty is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF.
  • The MHRA approval follows the granting of marketing authorization by the European Commission earlier in June 2022.
  • For women with UF who cannot or do not want to take hormones, Yselty is the first and only approved oral GnRH antagonist with a non-hormonal dosing option.
  • As the first and only approved GnRH antagonist to offer flexible dosing options with and without additional hormonal therapy, we hope to redefine care for women suffering from uterine fibroids.

Theramex Announces European Commission Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonist, for the Treatment of Symptoms of Uterine Fibroids

Retrieved on: 
Friday, June 17, 2022
Medical Supplies, Health, Consumer, Women, Pharmaceutical, Biotechnology, Solution, Gonadotropin-releasing hormone, Fertility, Uterine fibroid, Nasdaq, CHMP, Menopause, Contraindication, Endometriosis, Urology, Theramex, Central Research Laboratories, Pregnancy, Linzagolix, SIX Swiss Exchange, Kissei, Birth, Committee, Physician, Health, Nephrology Dialysis Transplantation, European Commission, European Directive on Traditional Herbal Medicinal Products, Partnership, Adult, Patient, Life, Committee for Medicinal Products for Human Use, Osteoporosis, ABT, Woman, EC, Pharmaceutical industry, UF, EU

The European Commission (EC) has granted Marketing Authorization for Yselty (linzagolix), an oral GnRH antagonist, indicated for the treatment of moderate to severe symptoms of Uterine Fibroids (UF) in adult women (over 18 years of age) of reproductive age.

Key Points: 
  • The European Commission (EC) has granted Marketing Authorization for Yselty (linzagolix), an oral GnRH antagonist, indicated for the treatment of moderate to severe symptoms of Uterine Fibroids (UF) in adult women (over 18 years of age) of reproductive age.
  • The EC decision follows the Committee for Medicinal Products for Human Use (CHMP) confirmation of positive opinion in April 2022.
  • Linzagolix is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF.
  • Uterine Fibroids affect 25% of women within reproductive age, many with severe symptoms requiring surgery.

ObsEva Announces Confirmation of Positive CHMP Opinion for Linzagolix, an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids

Retrieved on: 
Monday, April 25, 2022
EMA, Hormone, Nasdaq, Pain, Uterine fibroid, Osteoporosis, Woman, Menopause, Security (finance), NASDAQ, Risk, Patient, PDUFA, Review, Royal commission, UF, U.S. Securities and Exchange Commission, European Commission, Central Research Laboratories, Urology, FDA, Health, Investor, Drug development, Food, Private Securities Litigation Reform Act, Syneos Health, CCO, Theramex, Linzagolix, Endometriosis, Pregnancy, Company, Solution, Contract research organization, Food and Drug Administration, Committee, CEO, European Medicines Agency, Birth certificate, SIX Swiss Exchange, CRO, SEC, Coronavirus, New Drug Application, CHMP, Gonadotropin-releasing hormone, Gynaecology, Clinical trial, EC, Birth, Fertility, Pharmaceutical industry, Kissei

The positive CHMP opinion, which was initially adopted on December 16, 2021, was confirmed at the April 2022 CHMP meeting following further review of the linzagolix marketing authorization application.

Key Points: 
  • The positive CHMP opinion, which was initially adopted on December 16, 2021, was confirmed at the April 2022 CHMP meeting following further review of the linzagolix marketing authorization application.
  • European Commission decisions are valid in the European Union Member States, as well as Iceland, Norway, and Liechtenstein.
  • ObsEva has entered into a licensing agreement with Theramex to support the commercialization and market introduction of linzagolix in Europe.
  • Linzagolix has completed clinical trial development for the treatment of uterine fibroids and is currently in late-stage clinical development for the treatment of pain associated with endometriosis.

ObsEva Announces Additional Efficacy Results for Linzagolix 200 mg with Add-Back Therapy (ABT) and Linzagolix 75 mg without ABT in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain

Retrieved on: 
Tuesday, March 22, 2022
EAP, Private Securities Litigation Reform Act, Menstrual cycle, Drug development, Nephrology Dialysis Transplantation, Risk, Norethisterone, Dyspareunia, Investor, Analgesic, SIX Swiss Exchange, Ovulation, EDELWEISS, Fertility, Clinical trial, Infertility, Birth certificate, Coronavirus, Uterine fibroid, Constipation, Urology, Pelvic pain, SEC, Pregnancy, Uterus, Research, Woman, Endometrium, Patient, CEO, Gonadotropin-releasing hormone, Pain, Gynaecology, Security (finance), Sexual intercourse, Safety, Defecation, ABT, Estradiol, U.S. Securities and Exchange Commission, Dysmenorrhea, Endometriosis, Nasdaq, Linzagolix, Fatigue, Disease, Pharmaceutical industry, Birth control, Kissei

EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.

Key Points: 
  • EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.
  • The study included a 200 mg once-daily dose in combination with ABT (1 mg estradiol / 0.5 mg norethindrone acetate), and a 75 mg once-daily dose without ABT.
  • Results from the post-treatment follow-up of EDELWEISS 3 are expected in early 3Q2022.
  • Results from the treatment phase of the extension study (EDELWEISS 6) and its post-treatment follow-up phase are expected in early 3Q2022 and 4Q2022, respectively.