Carbylan Therapeutics Priced, Nasdaq: CBYL

Developing a novel, injectable treatment for osteoarthritis pain in the knee.

Industry: Health Care

Latest Trade: $0.68 -8.83 (-92.9%)

First Day Return: +11.2%

Return from IPO: +90.2%

Industry: Health Care

We are a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel and proprietary combination therapies that address significant unmet medical needs. Our initial focus is on the development of Hydros-TA, our proprietary, potentially best-in-class intra-articular, injectable product candidate to treat pain associated with osteoarthritis of the knee. Current joint injection treatments for OA pain include corticosteroids, which provide short-term relief, and viscosupplements, which provide relief over the longer-term. In contrast, Hydros-TA utilizes our proprietary cross-linking technology to deliver both rapid pain relief with a low dose corticosteroid triamcinolone acetonide and sustained pain relief from our novel hyaluronic acid viscosupplement. In our Phase 2b study of 98 patients, though not designed to show statistical significance, Hydros-TA demonstrated better pain reduction at all time points measured than Synvisc-One, the U.S. market-leading viscosupplement. We are currently studying Hydros-TA in our COR1.1 trial, a Phase 3, multi-center, international, randomized, double-blind, three-arm trial enrolling up to 510 patients with grade two and grade three OA of the knee, comparing treatment with Hydros-TA to treatment with Hydros and with TA, on a standalone basis. As of March 31, 2015, approximately 350 subjects have been enrolled in COR1.1. We expect to initiate COR1.2, our second Phase 3 trial, open an investigational new drug application, or IND, and begin to enroll U.S. patients in COR1.2 in mid-2015. We anticipate reporting primary endpoint results from COR1.1 in early 2016 and COR1.2 by the end of 2016 and submitting our new drug application, or NDA, for Hydros-TA in early 2017. We believe that Hydros-TA will be well-positioned to become a leader in the OA injectable market, if we are able to demonstrate that Hydros-TA provides both rapid and sustained pain relief over a six month period.
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IPO News for Carbylan Therapeutics
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IPO Data
IPO File Date 12/29/2014
Offer Price $5.00
Price Range $5.00 - $5.00
Offer Shares (mm) 13.0
Deal Size ($mm) $65
IPO Data
IPO Date 04/08/2015
Offer Price $5.00
Price Range $5.00 - $5.00
Offer Shares (mm) 13.0
Deal Size ($mm) $65
Underwriters
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Company Data
Headquarters Palo Alto, CA
Founded 2004
Employees 14
Website www.carbylan.com