Pipeline news

• Large Prospective Trial Validates Detection of AR-V7 Biomarker Using Epic Sciences’ Platform to Predict Treatment Outcomes for Patients with Advanced Prostate Cancer

  13 March 2019

  

  Epic Sciences, Inc. (Epic) today announced the publication of results from a multicenter prospective trial validating the biomarker AR-V7 (androgen receptor splice variant-7) as a predictor of resistance to anti-androgen therapy in men with metastatic castration-resistant prostate cancer (mCRPC). Data from the PROPHECY trial, published in the Journal of Clinical Oncology, demonstrate that detection of AR-V7 in circulating tumor cells (CTCs) in blood is predictive of whether men with mCRPC have become resistant to androgen-receptor signaling (ARS) inhibitors and have a low chance of benefit from further ARS therapy. 

• Clearside Biomedical Announces Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update

  12 March 2019

  

  Clearside Biomedical , Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today reported financial results for the fourth quarter and year ended  December 31, 2018  and provided a corporate update.

• Marinus Pharmaceuticals Provides Business Update and 2018 Financial Results

  11 March 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 year ended December 31, 2018.

• Syndax Pharmaceuticals Reports Fourth Quarter 2018 Financial Results and Provides Clinical and Business Update

  07 March 2019

  

  Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the fourth quarter ended December 31, 2018. In addition, the Company provided a clinical and business update. As of December 31, 2018, Syndax had $80.9 million in cash, cash equivalents and short-term investments.

• Marinus Pharmaceuticals Initiates Phase 3 Study in Children with PCDH19-Related Epilepsy

  06 March 2019

  

  Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS) (“Marinus” or “Company”), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced that it is initiating a single global pivotal Phase 3 clinical study (Violet Study) evaluating oral ganaxolone in children with PCDH19-related epilepsy (PCDH19-RE), a rare genetic epilepsy. If successful, the Violet Study is intended to support the regulatory filings for approval of ganaxolone in this underserved and refractory patient population.

• Marinus Announces Leadership Transition

  26 February 2019

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) (“Marinus” or the “Company”), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced that chief executive officer, Christopher M. Cashman, will leave the Company to pursue other opportunities in the life science industry effective March 18, 2019.  Scott Braunstein, M.D., currently a director on the Company’s Board, has been appointed executive chairman.  Marinus has retained an executive search firm to identify Mr. Cashman’s successor as CEO.

• Clearside Biomedical Receives Notification of FDA Acceptance of NDA Filing for XIPERE™ (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection with PDUFA Date Set for October 19, 2019

  20 February 2019

  

  Clearside Biomedical , Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, announced today that it received notification from the  U.S. Food and Drug Administration  ( FDA ) that the Agency has accepted for review the New Drug Application (NDA) for XIPERE (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection for the treatment of macular edema associated with uveitis. The  FDA  has determined that the application is sufficiently complete to permit a substantive review.

• Marinus Pharmaceuticals Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

  25 January 2019

  

  Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS) (the “Company”, “Marinus”), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced that the Compensation Committee of the Board of Directors of Marinus granted non-qualified stock options to purchase an aggregate of 105,000 shares of its common stock to five new employees, with a grant date of January 24, 2019.

• Presentation of Clearside Biomedical’s Extension Study of PEACHTREE for XIPERE™ Exhibits Durability Following Second Dose

  18 January 2019

  

  Clearside Biomedical , Inc., a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, announced today that data from MAGNOLIA, an extension study of PEACHTREE, its pivotal Phase 3 trial of XIPERE™ (formerly “suprachoroidal CLS-TA”) in patients with macular edema associated with non-infectious uveitis, was presented by Pauline Merrill, MD during the winter symposium of the  American Uveitis Society  in Park City, UT. Dr. Merrill is a Partner at Illinois Retina Associates and Section Director of Uveitis in the  Department of Ophthalmology  at  Rush University Medical Center .

• Syndax Highlights 2019 Clinical and Corporate Outlook

  07 January 2019

  

  Syndax Pharmaceuticals, Inc.  ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today provided a 2019 clinical and corporate outlook.