Sage Therapeutics (SAGE) Posts Q2 Loss of $4.57/Share
Sage Therapeutics (NASDAQ: SAGE) reported Q2 EPS of ($4.57), $3.34 worse than the analyst estimate of ($1.23).
"This has been a great year for SAGE in several areas," stated Jeff Jonas, M.D., chief executive officer at SAGE. "We’ve made great progress with our lead product candidate, SAGE-547, having reported preliminary results from the first four patients with super-refractory status epilepticus in our ongoing Phase 1/2 clinical trial. The data, to date, demonstrated both clinically relevant activity and safety with SAGE-547. We completed a successful initial public offering, and we also made significant progress in several of our pipeline programs. With the proceeds from the IPO, we are in a strong position to invest in new SAGE-547 trials and complete the work necessary to advance two additional product candidates towards the clinic. We look forward to reporting further progress this year."
Recent Business Highlights
- Completion of Initial Public Offering (IPO): On July 23, 2014, SAGE announced that it had completed its IPO of common stock, raising net proceeds of $94.0 million, after deducting underwriting discounts and commissions and estimated offering expenses.
- Granted Fast Track Designation: In July, SAGE announced that the FDA had granted fast track designation for the SAGE-547 development program. Fast track designation is intended to facilitate the review of drug candidates that are meant to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
- Reported Preliminary Phase 1/2 Clinical Data on SAGE-547: SAGE reported preliminary results from its ongoing Phase 1/2 clinical trial of SAGE-547 in patients with SRSE. These data indicated that the first four patients enrolled in the clinical trial met the key efficacy endpoint, in that each was successfully weaned off his or her anesthetic agent while SAGE-547 was being administered. In addition, these data have not shown any reported drug-related serious adverse events in these four patients.
- Granted Orphan Drug Designation: In March, SAGE announced that it had been granted orphan drug designation for SAGE-547 for the treatment of status epilepticus, a life-threatening seizure condition, by the FDA.
- Strengthened Leadership Team: SAGE strengthened its leadership team with the addition of Howard Pien and James Frates to its Board of Directors and the appointment of Thomas Anderson as chief commercial strategy officer.
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