Cyclopropanes

Nicox’s NCX 470 Mont Blanc Phase 3 Glaucoma Trial Reaches 50% Enrollment Milestone

Retrieved on: 
Tuesday, March 23, 2021

Mont Blanc is a 3-month multi-regional Phase 3 clinical trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005%, for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Key Points: 
  • Mont Blanc is a 3-month multi-regional Phase 3 clinical trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005%, for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • The Mont Blanc trial was initiated in the U.S. in June 2020 with an initial adaptive design portion wherein the highest dose of NCX 470 tested in the Dolomites Phase 2 clinical trial, 0.065%, was evaluated together with a higher 0.1% concentration of NCX 470.
  • The 0.1% dose of NCX 470 was selected in the adaptive stage of the Mont Blanc trial and enabled the second part of the Mont Blanc Phase 3 trial and the start of Denali Phase 3 trial.
  • Nicoxs lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma.

Shareholder Alert: Robbins LLP Announces that Vanda Pharmaceuticals Inc. (VNDA) Class Action Survives Motion to Dismiss

Retrieved on: 
Thursday, March 11, 2021

Shareholder rights law firm Robbins LLP announces that Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) may face damages caused by a pending securities lawsuit.

Key Points: 
  • Shareholder rights law firm Robbins LLP announces that Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) may face damages caused by a pending securities lawsuit.
  • Vanda Pharmaceuticals Inc. is a biopharmaceutical company that focuses on the development and commercialization of products for the treatment of central nervous system disorders.
  • Specifically, Vanda schemed to promote its drugs Fanapt and Hetlioz for "off-label" uses in addition to other prohibited promotional strategies.
  • On March 10, 2021, U.S. District Judge Frederic Block denied Vanda and its CEO's motion to dismiss the securities class action against, paving the way for litigation to proceed.

Nicox’s NCX 470 Receives Approval by Chinese Authorities for Local Start of Denali Phase 3 Trial

Retrieved on: 
Thursday, March 4, 2021

Nicoxs lead clinical product candidate, NCX 470, is a novel nitric oxide (NO)-donating prostaglandin analog licensed exclusively to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets.

Key Points: 
  • Nicoxs lead clinical product candidate, NCX 470, is a novel nitric oxide (NO)-donating prostaglandin analog licensed exclusively to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets.
  • Dr. Jos Boyer, Interim Head of R&D at Nicox, said: This approval allows us to initiate Chinese patients in the Denali trial on schedule.
  • Denali, the second Phase 3 trial of NCX 470 for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, was initiated in the U.S. on November 9, 2020.
  • Denali is a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005% and will also include a long-term safety extension.

Exelixis Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, February 10, 2021

Based upon cabozantinib-related revenues generated by Exelixis collaboration partners during the quarter and year ended December 31, 2020, Exelixis earned $23.3 million and $78.4 million, respectively, in royalty revenues.

Key Points: 
  • Based upon cabozantinib-related revenues generated by Exelixis collaboration partners during the quarter and year ended December 31, 2020, Exelixis earned $23.3 million and $78.4 million, respectively, in royalty revenues.
  • Exelixis received a $15.0 million milestone payment from Takeda upon the first commercial sale of CABOMETYX for unresectable HCC, which occurred in the fourth quarter of 2020.
  • Based on these positive results, Exelixis intends to file an sNDA for cabozantinib monotherapy in a DTC indication in 2021.
  • Exelixis management will discuss the companys financial results for the fourth quarter and full year 2020 and provide a general business update during a conference call beginning at 5:00 p.m. EST / 2:00 p.m. PST today, Wednesday, February 10, 2021.

Bausch Health Announces Vyzulta® (latanoprostene Bunod Ophthalmic Solution), 0.024%, is Now Approved in South Korea

Retrieved on: 
Tuesday, February 9, 2021

Bausch + Lomb remains focused on bringing forward innovative eye health treatment options to help address unmet medical needs around the world.

Key Points: 
  • Bausch + Lomb remains focused on bringing forward innovative eye health treatment options to help address unmet medical needs around the world.
  • VYZULTA is now approved in nine markets, including Argentina, Canada, Colombia, Hong Kong, Mexico, South Korea, Taiwan, Ukraine and the United States.
  • VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on helping people see.

Exelixis Announces Positive Findings at ASCO GU for CABOMETYX® (cabozantinib) in Patients with Brain Metastases from Renal Cell Carcinoma

Retrieved on: 
Monday, February 8, 2021

Exelixis, Inc. (NASDAQ: EXEL) today announced results from a retrospective analysis evaluating CABOMETYX (cabozantinib) activity in brain metastases in patients with renal cell carcinoma (RCC).

Key Points: 
  • Exelixis, Inc. (NASDAQ: EXEL) today announced results from a retrospective analysis evaluating CABOMETYX (cabozantinib) activity in brain metastases in patients with renal cell carcinoma (RCC).
  • Patients were divided into two cohorts based on the presence (n=25) or absence (n=44) of progressing intracranial metastases at start of CABOMETYX therapy.
  • Prior brain-directed therapy was received by 65% of patients with progressing brain metatstases and by 93% of those without.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.

PhaseBio Announces Dosing of First Patient in European Union as Part of REVERSE-IT Global Phase 3 Trial of Bentracimab for Reversal of Antiplatelet Effects of Ticagrelor

Retrieved on: 
Thursday, January 28, 2021

Bentracimab is a novel, human monoclonal antibody fragment that in earlier clinical trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta (ticagrelor).

Key Points: 
  • Bentracimab is a novel, human monoclonal antibody fragment that in earlier clinical trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta (ticagrelor).
  • We are pleased to announce the expansion of our global Phase 3 study of bentracimab into a number of European Union countries.
  • Additionally, in a translational study, bentracimab achieved equivalent reversal of branded ticagrelor and multiple ticagrelor generics.
  • Additionally, the Phase 2a trial investigated a bentracimab regimen for the reversal of supratherapeutic doses of ticagrelor in healthy younger subjects.

Eisai to Present Abstracts on Lenvatinib at 2021 Gastrointestinal Cancers Symposium

Retrieved on: 
Tuesday, January 12, 2021

TOKYO, Jan 12, 2021 - (JCN Newswire) - Eisai Co., Ltd. has announced that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the Gastrointestinal Cancers Symposium Virtual Meeting, from January 15 to 17, 2021.

Key Points: 
  • TOKYO, Jan 12, 2021 - (JCN Newswire) - Eisai Co., Ltd. has announced that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the Gastrointestinal Cancers Symposium Virtual Meeting, from January 15 to 17, 2021.
  • In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.
  • Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer.
  • Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.

Calithera Biosciences Reports CANTATA Study of Telaglenastat in Renal Cell Carcinoma Did Not Achieve Primary Endpoint

Retrieved on: 
Monday, January 4, 2021

As compared to treatment with cabozantinib, the combination of telaglenastat and cabozantinib did not meet the primary endpoint of improving progression free survival (PFS) in the study population.

Key Points: 
  • As compared to treatment with cabozantinib, the combination of telaglenastat and cabozantinib did not meet the primary endpoint of improving progression free survival (PFS) in the study population.
  • The primary study endpoint is PFS by blinded independent review.
  • Median PFS was 9.2 months among patients treated with telaglenastat and cabozantinib as compared to 9.3 months with cabozantinib and placebo.
  • Calithera is conducting the randomized Phase 2 KEAPSAKE trial to evaluate telaglenastat in patients with advanced non-small cell lung cancer harboring KEAP1/NRF2 mutations.

Aerpio Announces Statistically Significant Topline Results from Razuprotafib Glaucoma Phase 2 Trial

Retrieved on: 
Friday, December 11, 2020

The razuprotafib once-daily (QD) dose group did not show a statistically significant improvement at Day 28.

Key Points: 
  • The razuprotafib once-daily (QD) dose group did not show a statistically significant improvement at Day 28.
  • The study was designed to evaluate the safety and efficacy of a topical ocular formulation of razuprotafib as an adjunct to standard of care latanoprost.
  • The primary endpoint of the study was mean diurnal IOP at 28 days in the razuprotafib treated groups compared to the latanoprost monotherapy group.
  • Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy.