Cyclopropanes

Development Update: U.S. FDA Grants Breakthrough Designation to CytoSorb for Removal of Ticagrelor During Cardiopulmonary Bypass in Emergent and Urgent Cardiothoracic Surgery

Retrieved on: 
Monday, April 20, 2020

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification.

Key Points: 
  • CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification.
  • These are conditions where the risk of death is extremely high, yet no effective treatments exist.
  • CytoSorb has received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.
  • CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

BRILINTA reduced bleeding vs dual therapy in high-risk coronary patients in sub-analyses from Phase IV TWILIGHT trial

Retrieved on: 
Monday, March 30, 2020

BRILINTA is not indicated for use without aspirin or in patients undergoing PCI who have not had an ACS event.

Key Points: 
  • BRILINTA is not indicated for use without aspirin or in patients undergoing PCI who have not had an ACS event.
  • BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.
  • When possible, interrupt therapy with BRILINTA for 5 days prior to surgery that has a major risk of bleeding.
  • The TWILIGHT subgroup analyses evaluated patients with diabetes (TWILIGHT-DM) and patients who had successfully undergone a complex PCI (TWILIGHT-COMPLEX).

Exelixis Announces Partner Takeda Receives Approval in Japan for CABOMETYX® (cabozantinib) Tablets for the Treatment of Curatively Unresectable or Metastatic Renal Cell Carcinoma

Retrieved on: 
Wednesday, March 25, 2020

In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.

Key Points: 
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.
  • In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.
  • Markedly increased amounts of messenger RNAs for vascular endothelial growth factor and placenta growth factor in renal cell carcinoma associated with angiogenesis.

Merck Announces Top-Line Results from Phase 3 Trials Evaluating Gefapixant, an Investigational Treatment for Refractory or Unexplained Chronic Cough

Retrieved on: 
Tuesday, March 17, 2020

The gefapixant 15 mg twice daily treatment arms did not meet the primary efficacy endpoint in either Phase 3 study.

Key Points: 
  • The gefapixant 15 mg twice daily treatment arms did not meet the primary efficacy endpoint in either Phase 3 study.
  • The safety and tolerability profile of gefapixant during the trials to date is consistent with the previously reported Phase 2 study.
  • COUGH-1 (NCT03449134) and COUGH-2 (NCT03449147) are international Phase 3, randomized, double-blind, placebo-controlled, studies to evaluate the efficacy and safety of gefapixant in reducing cough frequency in adult participants with refractory or unexplained chronic cough.
  • Gefapixant is an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough.

Nicox’s Partner Secures Additional Approval of VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% in Taiwan

Retrieved on: 
Monday, March 9, 2020

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its partner, Bausch + Lomb, has received approval for VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% in Taiwan.

Key Points: 
  • Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its partner, Bausch + Lomb, has received approval for VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% in Taiwan.
  • VYZULTA is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension and is commercialized in the U.S. and Canada.
  • Nicox receives increasing tiered net royalties of 6% to 12% on global sales of VYZULTA as well as up to $150 million in potential future milestones.
  • Bausch + Lomb is a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC).

Exelixis Announces Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 25, 2020

Exelixis earned $17.0 million in royalty revenues based upon Ipsens cabozantinib-related revenues in the fourth quarter of 2019.

Key Points: 
  • Exelixis earned $17.0 million in royalty revenues based upon Ipsens cabozantinib-related revenues in the fourth quarter of 2019.
  • Under the collaboration agreement with Ipsen, Exelixis received a $3.0 million milestone payment for the Health Canada approval, which was recognized as revenue in the fourth quarter of 2019.
  • Under the collaboration agreement with Ipsen, Exelixis received a $2.0 million milestone payment for the Health Canada approval, which was recognized as revenue in the fourth quarter of 2019.
  • Exelixis management will discuss the companys financial results for the fourth quarter and full year 2019 and provide a general business update during a conference call beginning at 5:00 p.m.

Exelixis Announces Webcasts of Investor Conference Presentations in February

Retrieved on: 
Thursday, February 6, 2020

Guggenheim Healthcare Talks Oncology Day: Exelixis is scheduled to present at 9:00 AM EST / 6:00 AM PST on Thursday, February 13, 2020 in New York.

Key Points: 
  • Guggenheim Healthcare Talks Oncology Day: Exelixis is scheduled to present at 9:00 AM EST / 6:00 AM PST on Thursday, February 13, 2020 in New York.
  • Exelixis is a member of Standard & Poors (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies.
  • For more information about Exelixis, please visit www.exelixis.com , follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
  • Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks.

Exelixis Announces Partner Takeda Files New Drug Application in Japan for CABOMETYX® (cabozantinib) for Advanced Hepatocellular Carcinoma

Retrieved on: 
Wednesday, January 29, 2020

In April 2019, Takeda applied for approval to manufacture and sell cabozantinib as a treatment for unresectable and metastatic renal cell carcinoma (RCC) in Japan.

Key Points: 
  • In April 2019, Takeda applied for approval to manufacture and sell cabozantinib as a treatment for unresectable and metastatic renal cell carcinoma (RCC) in Japan.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.
  • In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan.
  • Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Cassava Sciences Announces Completion of Patient Enrollment of a Phase 2b Study in Alzheimer’s Disease

Retrieved on: 
Tuesday, January 28, 2020

This completes patient enrollment in a randomized, double-blind, placebo-controlled, Phase 2b study of PTI-125, Cassava Sciences investigational drug to treat Alzheimers disease.

Key Points: 
  • This completes patient enrollment in a randomized, double-blind, placebo-controlled, Phase 2b study of PTI-125, Cassava Sciences investigational drug to treat Alzheimers disease.
  • Our previously announced results of a Phase 2a study with PTI-125 generated promising biomarker data in Alzheimers patients.
  • Phase 2b is a randomized, double-blind, placebo-controlled, multi-center study of PTI-125 in patients with mild-to-moderate Alzheimer's disease in the United States.
  • Over the past 10 years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimers disease.

IntelGenx Announces Pricing of Equity Offering

Retrieved on: 
Monday, January 27, 2020

The Offering is being conducted on a commercially reasonable best efforts basis by Echelon Wealth Partners Inc. (the Agent) in the provinces of British Columbia, Alberta, Manitoba and Ontario.

Key Points: 
  • The Offering is being conducted on a commercially reasonable best efforts basis by Echelon Wealth Partners Inc. (the Agent) in the provinces of British Columbia, Alberta, Manitoba and Ontario.
  • Closing of the Offering is expected to occur on or about February11, 2020.
  • The net proceeds from the Offering will be used for the Companys Phase 2A Montelukast Study and general working capital requirements.
  • IntelGenx is a drug delivery company focused on the development and manufacturing of pharmaceutical films.