Industry News

• Envista announces IPO closing  Envista announced the closing of its previously announced initial public offering (IPO) of 26,768,000 shares of its common stock at a price to the public of $22.00 per share or $643.4 million in gross proceeds. Underwriters exercised in full their option to purchase an additional 4,015,200 shares.
  September 20, 2019  
• ACADIA Pharmaceuticals announces closing of public offering of common stock and options  ACADIA Pharma announced the closing of its underwritten public offering of 7,187,500 shares of its common stock, which includes 937,500 shares of common stock sold pursuant to the underwriters’ full exercise of their option. Gross proceeds are $287.5 million.
  September 20, 2019  
• Merck’s PIFELTRO™ and DELSTRIGO™ receive FDA approval for use in adults with HIV-1   Merck announced the FDA approved sNDAs for PIFELTRO™ and DELSTRIGO™ that expand their indications to include adult patients with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure.
  September 20, 2019  
• The Lancet publishes results from two positive phase 3 trials of Dupixent® (dupilumab)  Regeneron and Sanofi announced The Lancet has published detailed positive results from two Phase 3 trials evaluating safety and efficacy of Dupixent® (dupilumab) in adults with recurring severe chronic rhinosinusitis with nasal polyps.
  September 20, 2019  
• Novan awarded approximately $1.1 million grant by Department of Defense  Novan announced it has received a grant from the U.S. DoD of $1.1 million as part of its Peer Reviewed Cancer Research Program. The grant will support the development of a product candidate (WH504) for treatment of cervical intraepithelial neoplasia.
  September 20, 2019  
• Astellas receives positive CHMP opinion for XOSPATA® (gilteritinib) as monotherapy for AML  Astellas Pharma announced the CHMP of the EMA has adopted a positive opinion recommending the oral once-daily therapy XOSPATA® (gilteritinib) as a monotherapy for treatment of adult patients who have relapsed or refractory (resistant to treatment) AML with a FLT3 mutation (FLT3mut+).
  September 20, 2019  
• CHMP recommends approval of Dupixent® (dupilumab) for severe chronic rhinosinusitis   Regeneron and Sanofi announced the EMA's CHMP has adopted a positive opinion for Dupixent® (dupilumab) in a third indication. The CHMP recommended Dupixent be approved as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP. .
  September 20, 2019  
• Aerie Pharmaceuticals receives positive CHMP opinion for Rhokiinsa® in the European Union  Aerie Pharma announced the EMA's CHMP has adopted a positive opinion recommending approval of the MAA for Rhokiinsa® (netarsudil ophthalmic solution) 0.02%. The recommended indication is reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma.
  September 20, 2019  
• Evrenzo® (roxadustat) tablets approved in Japan for treatment of anemia with CKD  Astellas Pharma and FibroGen announced that Japan's Ministry of Health, Labour and Welfare approved Evrenzo® (generic name: roxadustat) for the treatment of anemia associated with chronic kidney disease in dialysis patients.
  September 20, 2019  
• FDA approves cobas Babesia, Roche’s first whole blood test for donor screening  Roche announced it has received approval from the FDA for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing. T cobas Babesia detects parasites that live in red blood cells.
  September 20, 2019  

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