Portfolio Company News

ZS Pharma Announces FDA Acceptance of ZS-9 New Drug Application

REDWOOD CITY, Calif., July 29, 2015 (GLOBE NEWSWIRE) ZS Pharma, Inc. (Nasdaq:ZSPH), today announced that its New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalemia, has been accepted for filing by the United States Food and Drug Administration (FDA). (more…)

Otonomy Initiates Phase 2 Clinical Trial for AuriPro(TM) in Second Label Expansion Indication


AuriPro to be Evaluated in Patients With Acute Otitis Externa

SAN DIEGO, July 28, 2015 (GLOBE NEWSWIRE) Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced the enrollment of the first patients in a Phase 2 clinical trial evaluating AuriProTM for the treatment of patients with acute otitis externa, also known as swimmer’s ear. The study is designed to evaluate the feasibility of administering AuriPro to the ear canal in a physician’s office setting.
(more…)

ZS Pharma Submits New Drug Application to U.S. Food and Drug Administration for ZS-9 for the Treatment of Hyperkalemia

Redwood City, Calif. – May 26, 2015ZS Pharma, Inc. (Nasdaq: ZSPH), a biopharmaceutical company focused on the development and commercialization of highly selective, non-absorbed drugs to treat renal, cardiovascular, liver and metabolic disorders, today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for ZS-9 (sodium zirconium cyclosilicate). The NDA requests FDA approval of ZS-9 for the treatment of hyperkalemia. (more…)

Otonomy Reports Phase 2b Topline Data for OTO-104 in Meniere’s Disease

  • Narrowly missed primary endpoint of reduction in vertigo frequency during Month 3 following treatment compared to a one month baseline period, p = 0.067
  • Achieved statistical significance on multiple prospectively defined secondary endpoints
  • Company believes data provide a strong basis to move forward into two parallel Phase 3 trials
  • Management will conduct a webcast and conference call to discuss the results at 4:30 p.m. EDT today

SAN DIEGO, May 21, 2015 (GLOBE NEWSWIRE)Otonomy, Inc. (Nasdaq:OTIC), a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced topline results from its Phase 2b trial evaluating OTO-104 in patients with unilateral Ménière’s disease. (more…)

Otonomy Reports First Quarter 2015 Financial Results and Provides Corporate Update

SAN DIEGO, May 12, 2015 (GLOBE NEWSWIRE) — Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today reported financial results for the quarter ended March 31, 2015 and provided an update on its corporate activities and product pipeline. (more…)

ZS Pharma Reports First Quarter 2015 Financial Results and Provides ZS-9 Program Update

ZS Pharma Reports First Quarter 2015 Financial Results and Provides ZS-9 Program Update

 

Redwood City, Calif. – May 11, 2015 – ZS Pharma, Inc. (Nasdaq: ZSPH), a biopharmaceutical company focused on the development and commercialization of highly selective, non-absorbed drugs to treat renal, cardiovascular, liver and metabolic disorders, today provided a program update on ZS-9 (sodium zirconium cyclosilicate), the Company’s investigational treatment for hyperkalemia, and reported its financial results for the first quarter ended March 31, 2015. (more…)

Otonomy Completes Enrollment in Phase 2 Clinical Trial for AuriPro(TM) in Pediatric Patients With Acute Otitis Media With Tympanostomy Tubes

SAN DIEGO, May 7, 2015 (GLOBE NEWSWIRE)Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced it has completed enrollment in a Phase 2 clinical trial evaluating AuriPro™, a sustained-exposure formulation of the antibiotic ciprofloxacin, for the treatment of pediatric patients with acute otitis media with tympanostomy tubes (AOMT). (more…)

Otonomy Announces FDA Acceptance of AuriPro(TM) New Drug Application

SAN DIEGO, April 28, 2015 (GLOBE NEWSWIRE) Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that its New Drug Application (NDA) for the approval of AuriProTM as a treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery has been accepted for filing by the U.S. Food and Drug Administration (FDA). The acceptance of the NDA indicates the application is sufficiently complete to permit a substantive review by the FDA. (more…)

Otonomy to Present AuriPro(TM) Phase 3 Results at American Society of Pediatric Otolaryngology Conference

SAN DIEGO, April 21, 2015 (GLOBE NEWSWIRE)Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that previously reported results from two Phase 3 trials evaluating AuriPro™ in pediatric patients with middle ear effusion undergoing tympanostomy tube placement surgery will be presented in a podium presentation at the 2015 American Society of Pediatric Otolaryngology (ASPO) meeting, held during the Combined Otolaryngology Spring Meetings in Boston on April 22-26, 2015. (more…)

Otonomy Completes Enrollment of OTO-104 Multiple-Dose Safety Study in Meniere’s Disease Patients

SAN DIEGO, April 20, 2015 (GLOBE NEWSWIRE)Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that it has achieved target enrollment in its multiple-dose safety study of OTO-104 in patients with Ménière’s disease. (more…)