Sign in or Register

Already a member?

Sign in

Or sign in with your account on:

Not a member yet?


Discovery Labs Surges as FDA Agrees to Updated Surfaxin Specifications

By  +Follow October 4, 2013 2:07AM
Tickers Mentioned:

Shares of Discovery Laboratories, Inc. (DSCO) leapt forward immediately in Friday trading after the U.S. Food and Drug Administration agreed to updated product specifications for Surfaxin® Intratracheal Suspension, the company’s approved drug for the prevention of respiratory distress syndrome, or RDS, in premature infants at high risk for RDS. Surfaxin is the first synthetic, peptide-containing surfactant approved by the FDA and the only alternative to animal-derived surfactants. 

A surfactants is a liquid that coats the inside of the lungs and helps to keep them open.  Premature infants are not able to produce enough surfactant, resulting in lungs collapsing and the infant having difficulty breathing.

Other surfactants on the market are Survanta (beractant), Infasurf (calfactant) and Cornerstone Therapeutics’ (CRTX) Curosurf (poractant alpha), but, as mentioned, these drugs are derived from animals. Curosurf sales in the second quarter were $11.3 million, its best quarter on record. Italy’s Chiesi Farmaceutici, which already owns 58 percent of Cornerstone, agreed in September to pay $115 million for the remaining stake in the company that it didn’t already own to take it private.

In March 2012, the FDA approved Surfaxin for RDS and the drug was expected to be launched in the fourth quarter of 2013, but Discovery determined through a routine review that one of its analytical chemistry methods used to assess the performance of Surfaxin required improvement, delaying the launch by two quarters. 

Then in April, Warrington, Pennsylvania-based Discovery disclosed that the FDA requested more information on product specifications of Surfaxin, further delaying the launch and sending shares of DSCO plunging about 40 percent to lows of $1.50.

Discovery has now met the demands of the FDA that have plagued product launch. The company has initiated manufacturing of Surfaxin for its planned commercial introduction in the fourth quarter of 2013.

"We are pleased that the FDA has agreed with our updated product specifications and are appreciative of the process that has lead to this decision," said John G. Cooper, chief executive of Discovery in a statement today. "Surfaxin represents the first milestone in our goal of transforming the treatment of RDS and is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants for the prevention of RDS."

Shares of DSCO drove north of $3.00 shortly after Friday’s opening from Thursday’s closing price of $1.97, but have cooled off to $2.75 1-1/2 hours into the trading session for gains of around 40 percent.  Through Thursday’s close, shares were down about 6 percent in 2013, but have reversed the losses with today’s climb

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions.

Signup for our daily newsletter and get our best articles emailed right to you!

Results for dsco
Rod Goodger
30 Jan 15 13:22:30
$DSCO, off the radar biotech making interesting moves since early December (note the big green volume bars) http://t.co/5kTU5UHToU
Will Clint
30 Jan 15 12:32:14
Nice bounce off support, rolling in $DSCO for a few fuck it
30 Jan 15 10:25:25
$DSCO DISH Statement on AWS-3 Auction Results From our Stock News Alerts App
Jet Life PennyStock$
30 Jan 15 03:08:05
DollarsOnPennies: $DSCO Gallery View http://t.co/LjgicEfBA6
30 Jan 15 03:00:05
DollarsOnPennies: $DSCO Gallery View http://t.co/RCNmaisQei
Chasing Stars
29 Jan 15 13:15:23
29 Jan 15 08:10:29
$DSCO El Rey Network to Launch on DISH From our Stock News Alerts App
Investors Hangout
29 Jan 15 07:45:53
Stocks Trending Now: http://t.co/oFJbweffVo $SHGP $EKTAF $FIO $WTCZF $LGGNF $CLF $FMOCY $FMBP $BITA $DSCO $UG $VEGPF ~
29 Jan 15 06:10:10
$DSCO DISH Invites Customers to Deflate the Game Not the Ads From our Stock News Alerts App
Bio Penny Picks
29 Jan 15 04:00:16
RT @adamfeuerstein: $APPY is the new $DSCO
HotStockAlert $PKGM$
29 Jan 15 03:31:13
DollarsOnPennies: $DSCO Gallery View http://t.co/ctwxfOdfdN
29 Jan 15 03:31:05
DollarsOnPennies: $DSCO Gallery View http://t.co/DjjrMFqNEp
il falso guaritore
29 Jan 15 03:27:52
RT @adamfeuerstein: $APPY is the new $DSCO
_ is the new _
29 Jan 15 03:25:08
RT @adamfeuerstein: $APPY is the new $DSCO
Jet Life PennyStock$
29 Jan 15 03:19:35
DollarsOnPennies: $DSCO Gallery View http://t.co/I1tLsdRxdG
Adam Feuerstein
29 Jan 15 03:18:02
$APPY is the new $DSCO
Danton Qu
28 Jan 15 10:29:04
@unemon1 why are you long $DSCO ?
28 Jan 15 07:15:51
$DSCO New SEC Document(s) for DISH Network Corporation From our Stock News Alerts App
27 Jan 15 07:44:26
Very Strong buying in $ZIOP February 11$ Call Options. Interesting. Keep also an eye on $DSCO ve been buying for 6 months. Will it go up?
27 Jan 15 04:32:50
DollarsOnPennies: $DSCO Gallery View http://t.co/MXV5hICXG9
WallStreet Pennies
27 Jan 15 04:25:34
DollarsOnPennies: $DSCO Gallery View http://t.co/mYEkk0Oyd1
26 Jan 15 21:25:17
26 Jan 15 13:00:04
$DSCO it's just the beginning, it has plenty of space to run.
26 Jan 15 12:59:21
Blast move by $DSCO
26 Jan 15 12:40:38
26 Jan 15 11:38:32
$DSCO :))))
Penny Stock Secret
26 Jan 15 01:22:52
This Guy Turned $100 into over $10,000 In Just 30 Days! http://t.co/vezCDY95do .. $DSCO $NBS $VRTU
25 Jan 15 15:56:02
$DSCO: Stocks Underperform for the Week: Discovery Laboratories Inc ...: http://t.co/Vqh74msToC
By  +Follow October 4, 2013 2:07AM



blog comments powered by Disqus

About us

Equities.com is the most advanced interactive online social ecosystem for the financial industry, serving as a resource center and next-generation communication platform that connects self-directed investors with public issuers, market experts, and professional service providers and vendors. Registered members can leverage our exclusive proprietary research tools such as the Small-Cap Stars, which outperformed 90% of all small-cap mutual funds, and robust do-it-yourself E.V.A. research reports. The Equities.com Issuer Dashboard is the ideal tool to communicate and manage investor awareness campaigns to the investment community, as well as to access valuable resources to help your company grow.

Market Data powered by QuoteMedia.
Copyright © QuoteMedia. Data delayed 15 minutes unless otherwise indicated. Terms of Use.