Pipeline news
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21 March 2019
Epic Sciences, Inc. announced today that new data will be presented at the American Association of Cancer Research (AACR) Annual Meeting 2019, in Atlanta, Georgia, March 29 to April 4, 2019. The data from multiple studies and indications demonstrate the feasibility of Epic's Functional Cell Profiling (FCP) technology to predict patients' response to cancer immunotherapies and drugs that target DNA damage repair pathways.
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20 March 2019
Epic Sciences, Inc. (Epic) announced today that the New York StateDepartment of Health has completed licensure to provide the Oncotype DX® AR-V7 Nucleus Detect™ test for patients with metastatic castration-resistant prostate cancer (mCRPC). The Oncotype DX AR-V7 Nucleus Detect test helps determine which patients may benefit from androgen receptor signaling inhibitor (ARSi) therapy and which may benefit from chemotherapy. The Oncotype DX AR-V7 Nucleus Detect test is a circulating tumor cell (CTC)-based, liquid biopsy test that is commercially available in the United States through Epic's partnership with Genomic Health.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
