Categories Other Industries

Sage shares skyrocket after FDA allows expediting development of depression drug

Shares of Sage Therapeutics (SAGE) rose nearly 6% before the bell today after the FDA allowed it to accelerate the development of the company’s experimental depression drug SAGE -217 that is intended to treat two types of depression.

The FDA chief Scott Gottlieb has improved the drug approval process significantly. Not only did he encourage faster approvals but the entire process has gone more transparent. In order to streamline drug approvals, the FDA has introduced various designations. SAGE-217 benefited from one such designation — the breakthrough therapy. This is used to speed approvals.

Shares of Sage Therapeutics (SAGE) rose nearly 6% before the bell today after the FDA allowed it to accelerate the development of the company’s experimental depression drug SAGE -217

The drug SAGE – 217 had won the breakthrough therapy designation from the regulators early this year. Following a meeting with the FDA, the Cambridge-based company will now speed up its development plan for the antidepressant that can cure major depression and postnatal depression that affects 1 in 7 women during the initial months after childbirth.

Based on the quickened development plan, Sage will conduct a single Phase 3 trial in major depression. For post-delivery depression, the company will use the ongoing Phase 2 study, whose results are expected during Q4. The Phase 3 trial is expected to begin during the second half of 2018. If the company gets positive results from the trials, then the FDA will permit SAGE to seek approval for daily oral dosing antidepressant. SAGE-217 is also being evaluated to treat Parkinson’s disease and insomnia.

Over the last three months, Sage shares dropped 17.8% and year-to-date, the stock fell nearly 11%. However, backed by the FDA’s decision, Sage had surged 17% during the morning session today.

Most Popular

AVGO Earnings: All you need to know about Broadcom Q1 2021 earnings results

Broadcom Limited (NASDAQ: AVGO) reported first quarter 2021 earnings results today. Total revenue increased 14% year-over-year to $6.65 billion. GAAP net income was $1.3 billion, or $3.05 per share, compared

Infographic: Costco (COST) Q2 2021 sales up 15%; earnings miss

Retail giant Costco Wholesale Corporation (NASDAQ: COST) reported higher earnings and revenues for the second quarter of 2021. Earnings missed analysts’ expectations, while sales beat. Net profit was $951 million

Will shifting to as-a-service model help Hewlett Packard in emerging stronger from COVID?

With the corporate world rapidly shifting to cloud-native computing after the virus outbreak changed work culture and the way businesses operate, technology providers are aggressively innovating their offerings. Hewlett Packard

Tags

Add Comment
Loading...
Cancel
Viewing Highlight
Loading...
Highlight
Close
Top