Pipeline news
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04 February 2021
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in the Phase 2 virology trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. The trial will enroll patients in the United Kingdom (UK), Ireland and other countries. AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea’s purine nucleotide prodrug platform.
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27 January 2021
OCON Healthcare, a women’s health company which develops, manufactures and commercializes innovative 3D intrauterine drug delivery devices based on its patented IUB (Intra-Uterine Ball) platform, announced new positive world-wide data exploring the efficacy and safety of IUB Ballerine, the company’s smart 3D hormone-free intrauterine contraceptive.
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26 January 2021
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced the enrollment of the first patient in a Phase 3 clinical trial of IV ganaxolone (RAISE trial) for the treatment of refractory status epilepticus (RSE), a life-threatening occurrence of continued or intermittent seizures lasting more than five minutes in duration without recovery of consciousness. RSE is considered a medical emergency that can cause permanent brain damage or death if not quickly controlled.
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19 January 2021
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that it has expanded its senior management team with the appointments of Jayanthi Wolf, Ph.D., Senior Vice President of Regulatory Affairs and Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications.
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13 January 2021
Adastra Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, today announced the completion of the Phase 1b clinical trial conducted by the NCI with its lead clinical candidate zotiraciclib (ZTR/TG02), a potent oral cyclin-dependent kinase 9 (CDK9) inhibitor. The trial investigated the safety and efficacy of ZTR, in combination with temozolomide (TMZ), in patients with recurrent high-grade gliomas.
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13 January 2021
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has received a positive response from the U.S. Food and Drug Administration (FDA) that the efficacy and safety data resulting from the company’s pivotal Phase 3 Marigold Study on the use of oral ganaxolone in children and young adults with CDKL5 deficiency disorder (CDD) appear sufficient to support the filing of a New Drug Application (NDA). Adequacy of these data to support an approval of ganaxolone for the proposed indication will be a matter of future FDA review.
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12 January 2021
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 the first patients have been enrolled in its Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD). Clinical sites, all based in the United States, are activated and currently screening wet AMD patients for this Phase 1/2a trial, known as OASIS, involving CLS-AX, a proprietary suspension of axitinib for suprachoroidal injection.
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Clearside Biomedical Announces Pricing of $12 Million Registered Direct Offering
06 January 2021
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 it has entered into a securities purchase agreement with institutional investors and certain existing stockholders, providing for the purchase and sale of 4,209,050 shares of common stock at a price of $2.851 per share, priced at-the-market under Nasdaq rules based on the five-day average closing price of the common stock, in a registered direct offering, resulting in total gross proceeds of approximately $12.0 million, before deducting the placement agent’s fees and other estimated offering expenses.
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21 December 2020
OCON Healthcare, a women's health company which develops, manufactures and commercializes innovative 3D intrauterine devices based on its patented IUB™ (Intra-Uterine Ball) platform, announced that it has completed a USA-focused funding round led by Rhia Ventures, to bring its IUB Ballerine® contraceptive and IUB SEAD™ point-of-care therapy for Abnormal Uterine Bleeding (AUB), to the US market, and to expand Phase II clinical trials for the IUB SEAD™.
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Marinus Pharmaceuticals Announces Its Addition to the Nasdaq Biotechnology Index
21 December 2020
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has been selected for inclusion in the Nasdaq Biotechnology Index (NBI), which became effective prior to market open today.
