Pipeline news

• Marinus Pharmaceuticals Receives Positive Response from FDA on Sufficiency of One Phase 3 Clinical Trial for Filing of New Drug Application (NDA) for the Use of Ganaxolone in CDKL5 Deficiency Disorder (CDD)

  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.

• Clearside Biomedical Announces First Patients Enrolled in Phase 1/2a Clinical Trial of CLS-AX (axitinib injectable suspension) for the Treatment of Wet AMD

  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.

• 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.

• FemTech startup OCON Healthcare completes funding round and appoints Dr. Anula Jayasuriya to Chairwoman

  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™.

• 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.

• Syndax Pharmaceuticals To Be Added to the NASDAQ Biotechnology Index

  18 December 2020

  

  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 Company has been selected for addition to the NASDAQ Biotechnology Index® (NASDAQ: ^NBI), effective prior to market open on  Monday, December 21, 2020 .

• Atea Pharmaceuticals Added to Russell 2000 Index

  18 December 2020

  

  Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that it has been added to the Russell 2000® Index, effective December 21, 2020, as part of the index's quarterly initial public offering (IPO) additions.

• Rhia Ventures Invests in OCON Healthcare's Ballerine®, the first ever 3D spherical copper intrauterine contraceptive with a superior safety profile, a breakthrough in women's hormone-free birth control options

  18 December 2020

  

  Rhia Ventures invested in Israeli-based OCON Healthcare to assist the US launch of Ballerine®, the first and only 3D spherical copper IUBTM (Intrauterine Ball). Ballerine®'s unique shape reduces irritation to the endometrium with fewer malpositions and perforations, which are significant drawbacks associated with current T-shaped IUDs. The financing will also help expand Phase II clinical trials for OCON's SEADTM product, which offers point-of-care therapy for abnormal uterine bleeding (AUB).

• binx health receives EUA authorizing At-Home COVID-19 sample collection by universities and employers

  15 December 2020

  

  binx health, a first-of-kind population health technology company, announced today that it received an important amendment to its COVID-19 Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), this time for centralized specimen collection kit distribution and retrieval by large partners.

• Syndax Announces Closing of Public Offering and Exercise in Full of the Underwriters' Option to Purchase Additional Shares

  11 December 2020

  

  Syndax Pharmaceuticals, Inc.  ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the closing of its previously announced underwritten public offering of 6,250,000 shares of its common stock, which includes the exercise in full of the underwriters' option to purchase 815,217 additional shares, at a price to the public of  $23.00  per share. The gross proceeds to Syndax from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately  $143.8 million .