Pipeline news

• Adastra Pharmaceuticals Announces FDA and EMA Orphan Drug Designation Has Been Granted for Zotiraciclib in the Treatment of Glioma

  04 December 2019

  

  Adastra Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Drug Designation to zotiraciclib for the treatment of glioma. Zotiraciclib is currently the subject of two separate Phase 1b clinical trials in glioblastoma (GBM).  Adastra expects to report results from the two studies during 2020.

• Syndax Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Clinical and Business Update

  07 November 2019

  

  Syndax Pharmaceuticals, Inc.  (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the third quarter ended  September 30, 2019 . In addition, the Company provided a clinical and business update. As of  September 30, 2019 , Syndax had  $72.2 million  in cash, cash equivalents and short-term investments.

• Clearside Biomedical Announces Third Quarter 2019 Financial Results and Provides Corporate Update

  06 November 2019

  

  Clearside Biomedical , Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the third quarter of 2019 and provided a corporate update.

• Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter Financial Results

  06 November 2019

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today provided a business update on its clinical development activities and reported its financial results for the third quarter ended September 30, 2019.

• Syndax Announces First Patient Dosed in Phase 1/2 AUGMENT-101 Trial of SNDX-5613 for the Treatment of Adults with Relapsed/Refractory Acute Leukemias

  06 November 2019

  

  Syndax Pharmaceuticals, Inc.  ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the first patient has been dosed in AUGMENT-101, a Phase 1/2 clinical trial evaluating SNDX-5613, Syndax's potent, highly selective oral Menin inhibitor, in patients with relapsed/refractory (R/R) acute leukemias.  

• Marinus Pharmaceuticals Appoints Joe Hulihan, M.D., as Chief Medical Officer

  29 October 2019

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) (“Marinus” or “Company”), a pharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy, depression and other neuropsychiatric disorders, today announced that Joe Hulihan, MD, has been appointed Chief Medical Officer. Dr. Hulihan will succeed outgoing CMO, Lorianne Masuoka, MD, who is retiring from the position.

• Clearside Biomedical Announces Option Exercise by REGENXBIO for Global License for Use of SCS Microinjector™ in AAV Gene Therapy Delivery

  29 October 2019

  

  Clearside Biomedical , Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that  REGENXBIO Inc.  (Nasdaq: RGNX) has exercised its option under the previously announced option and license agreement to license Clearside’s proprietary, in-office SCS Microinjector™ for the delivery of adeno-associated virus (AAV)-based therapeutics, including but not limited to RGX-314 delivery to the suprachoroidal space to potentially treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other conditions for which chronic anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care.

• Bausch Health Licenses Clearside Biomedical's XIPERE™ (Triamcinolone Acetonide Suprachoroidal Injectable Suspension), An Investigational Treatment For Macular Edema Associated With Uveitis

  24 October 2019

  

  Bausch Health Companies Inc.  (NYSE/TSX: BHC) (" Bausch Health ") and Bausch + Lomb, its leading global eye health business, and  Clearside Biomedical, Inc., a biopharmaceutical company dedicated to developing and delivering treatments that can restore and preserve vision for people with serious back of the eye diseases, announced today that an affiliate of  Bausch Health  has acquired an exclusive license for the commercialization and development of XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) in  the United States  and  Canada .

• Clearside Biomedical confirms timeline for Xipere

  22 October 2019 Sean Whooley / Drug Delivery Business News

  Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere drug-delivery technology and will not ask for further clinical efficacy studies. The Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. In October 2018, Clearside touted data from a Phase III pivotal trial, which reported that 40% of people using Xipere experienced resolution of uveitis, compared to 0% in the control. The company submitted a new drug application the following December, and that NDA was accepted in February.

• Clearside Biomedical Suprachoroidal Injection Platform Featured in Multiple Presentations at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting

  18 October 2019

  

  Clearside Biomedical , Inc. (Nasdaq:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside’s pipeline and proprietary SCS Microinjector™ targeting the suprachoroidal space were given at the  American Academy of Ophthalmology  (AAO) 2019 Annual Meeting.