News & Events

Otonomy Reports Second Quarter 2015 Financial Results and Provides Corporate Update

SAN DIEGO, Aug. 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 ear, today reported financial results for the quarter ended June 30, 2015 and provided an update on its corporate activities and product pipeline.Second Quarter 2015 and Subsequent Highlights Filed New Drug Application (NDA) for AuriProTM: In April 2015, Otonomy announced that the U.S. Food and Drug...

read more

ZS Pharma Reports Second Quarter 2015 Financial Results and Provides Corporate Update

REDWOOD CITY, Calif., Aug. 6, 2015 (GLOBE NEWSWIRE) — ZS Pharma, Inc. (Nasdaq:ZSPH), today reported its financial results for the second quarter ended June 30, 2015, and provided an overview of recent accomplishments. Recent Highlights Announced the submission of a New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate) requesting FDA approval of ZS-9 for the treatment of hyperkalemia. In July the NDA was accepted for filing and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 26, 2016. Added key members...

read more

Tryton Medical Announces Completion of Enrollment in the EXTENDED ACCESS Registry for its Tryton Side Branch Stent

Tryton remains on schedule to file pre-market approval application for its Side Branch Stent in 2015 DURHAM, N.C.–(BUSINESS WIRE [1])–August 3, 2015–Tryton Medical, Inc., the leading developer of stents designed to treat bifurcation lesions, today announced the completion of enrollment in the Extended Access Registry, a single arm study of its Tryton Side Branch Stent. The Tryton registry is designed to confirm the results from Tryton’s Pivotal IDE Trial, and has successfully enrolled 133 patients from Europe and the...

read more

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). We have been informed that the Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is May 26, 2016. “Hyperkalemia is a serious condition with few treatment options and ZS-9 could be the first selective agent...

read 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...

read 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, 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 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. “The submission of the NDA for ZS-9 is a major...

read 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...

read 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. First Quarter 2015 and Subsequent Highlights Filed New Drug Application (NDA) with FDA for AuriProTM: On February 25, 2015, Otonomy submitted an NDA to...

read 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...

read 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). “We are very encouraged by the...

read more