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Discovery Labs Surges as FDA Agrees to Updated Surfaxin Specifications

By  +Follow October 4, 2013 2:07AM
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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

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Results for dsco
Mark Trader
19 Apr 15 14:40:21
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Mark Trader
18 Apr 15 17:31:52
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Mark Trader
18 Apr 15 11:20:42
Cool trading site I just found. https://t.co/T2poBgnyFu $BORK $PALD $CICI $FNRG $DSCO $OOIL $WSTI $FONU
Trader News Daily
18 Apr 15 09:53:47
Check out http://t.co/PeRPkYu8Uk for some awesome trade ideas. Their 6 pro's are amazing. $AMCN $TRQ $XCO $SID $DSCO $HERO $OMLS $OOIL
dailystockplays.com
18 Apr 15 07:18:30
Volume Losers http://t.co/dSfR7QML4E $RSX $AMD $DBEF $ATHX $IEFA $TWC $IEMG $IWF $NKTR $ENZN $AKBA $RGP $DSCO $PRO $XUE $SREV $SBRCY $MTCN
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18 Apr 15 06:19:12
Interesting trading website here... http://t.co/x8wgJ5pQBd $PLUG $REXX $EGO $MEIP ANVGQ $AMCN $TRQ $XCO $SID $DSCO
Stock Forums
18 Apr 15 00:13:09
Stocks Trending Now: http://t.co/gLXIst6tkJ $ESCA $NRGT $LVFHF $HALN $DGIX $OPXA $DSCO $VGM $EMINF $TCCLF $STIA $SGLN ~
Stock Forums
17 Apr 15 20:14:58
Stocks Trending Now: http://t.co/gLXIst6tkJ $WLT $AOGC $CHKVZ $CNS $MFM $MWE $GECFF $DSCO $NISOF $KRCH $BSDM $IIF ~
Jake13
17 Apr 15 16:30:16
Stocks Trending Now: http://t.co/j1I70PbkX8 $MCN $BSDGY $RKLIF $SALTF $HUWX $AZBCF $DSCO $DPMLF $KORS $AGTMF $HWRI $QUAD ~
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17 Apr 15 12:46:18
$DSCO down -18.84% today! Check out this trade I made on $ JOIN US LIVE: http://t.co/EQWvokRIdO
Large Void Bot
17 Apr 15 12:03:16
15:03 Drops: $DSCO -3.5%
Seeking Alpha Alerts
17 Apr 15 11:55:17
@tj2222000 $DSCO Midday Gainers / Losers http://t.co/Ieji4nyqpR
Irma Doucet
17 Apr 15 11:02:11
$DSCO Discovery Laboratories Latest Stock Surge Intriguing (DSCO) http://t.co/8cnG7Y53QI
Seeking Alpha Alerts
17 Apr 15 10:55:15
@tj2222000 $DSCO Discovery Labs completes enrollment in AEROSURF study; SURFAXIN to be discontinued http://t.co/DODWQyf9TF
BreakingStocksNews
17 Apr 15 10:10:39
$NOW $DSCO $CHOP: Mid Day Movers: ServiceNow Inc (NYSE:NOW), Discovery ...: http://t.co/Sgd2NaBA04
Barry
17 Apr 15 09:34:29
RT @theflynews: On The Fly: Pre-market Movers $CE $MAT $SLB $RAI $GE $GMO $UNXL $IGTE $ROSG $AMD $NOW $MTW $ATHX $DSCO: Full Story http:/…
Joe K.
17 Apr 15 09:23:37
$DSCO on watch...this is not a dead company...
Joe K.
17 Apr 15 09:06:15
$DSCO....chart
John Wu
17 Apr 15 08:48:00
Waited 2 days for $FNRG. Perfect bottom at $4, buying as much as I can below $4.50. Also watching $ATHX $IPDN $DSCO $HNR $SPPR $VPCO $GMO
Nick zheng
17 Apr 15 08:25:03
@SuperNovaAlerts The pattern mirrors failed rebounds like $DSCO, $OCUL, $CTSO. $ATHX will hit new lows slowly. May under cash if partner bye
Healthcare Stocks
17 Apr 15 08:21:23
Discovery Labs completes enrollment in AEROSURF study; SURFAXIN to be discontinued http://t.co/gbunK83pVJ $DSCO
SA Breaking News
17 Apr 15 08:21:23
Discovery Labs completes enrollment in AEROSURF study; SURFAXIN to be discontinued http://t.co/vT7XgeXDUN $DSCO
Clark Joseph Kent
17 Apr 15 07:19:05
Pre-Market Losers: $ATHX -54% $IPDN -27% $AMD -12% $NOW -9% $DSCO -8% $CHOP -8% $AMCN -8% $WUBA -6% $AKBA -6% $NBG -5%
Gabriel Cloutier
17 Apr 15 06:59:14
$DSCO Real bargain at that price
studentoflife
17 Apr 15 06:40:58
$DSCO Completes Enrollment of AEROSURF® Phase 2a Clinical Trial and Restructures its Bus... http://t.co/eDX9XEij8k via @YahooFinance
Stock Trade Alerts
17 Apr 15 06:34:45
Pre-Open Stock Movers 04/17: $CE $UNXL $MAT Higher; $ATHX $DSCO $AMD Lower (more...) http://t.co/O0TBAGqMJA ~ via @AlertTrade
Streetinsider.com
17 Apr 15 06:30:32
Pre-Open Stock Movers 04/17: $CE $UNXL $MAT Higher; $ATHX $DSCO $AMD Lower (more...) http://t.co/WFmDlfHmb2
FonsieTrader
17 Apr 15 06:18:15
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The Fly
17 Apr 15 06:14:44
On The Fly: Pre-market Movers $CE $MAT $SLB $RAI $GE $GMO $UNXL $IGTE $ROSG $AMD $NOW $MTW $ATHX $DSCO: Full Story http://t.co/andRyQXbXz
explodeprofits
17 Apr 15 04:16:17
DollarsOnPennies: $DSCO Gallery View http://t.co/JmWNF37Epm
Jet Life PennyStock$
17 Apr 15 04:10:10
DollarsOnPennies: $DSCO Gallery View http://t.co/rW4D4lo5gZ
A. Vespasian
16 Apr 15 22:46:21
RT @theflynews: On The Fly: After Hours Movers $CE $MAT $CYT $SLB $SSH $PRO $NOW $AMD $DSCO $DATA: Full Story http://t.co/Z2x0zURD1A
CantDoIt
16 Apr 15 20:19:21
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dailystockplays.com
16 Apr 15 19:31:52
Stocks Down After Hours Trading http://t.co/yZvd2TWS8K $PRO $DSCO $NOW $AMD $AXP $MTW
Alpha Maven
16 Apr 15 19:09:58
RT @BioRunUp: $DSCO Completes Enrollment of AEROSURF® Phase 2a Clinical Trial and Restructures its Business to Focus on Development of AERO…
Alpha Maven
16 Apr 15 18:59:08
RT @zbiotech: oh no, $DSCO voluntarily ceases commercialization of surfaxin
John George
16 Apr 15 18:29:54
Bucks County biopharmaceutical firm cutting its work force in half. $dsco http://t.co/3wHHaW6Hs7 via @PHLBizJournal
Marassasta
16 Apr 15 17:51:09
RT @theflynews: On The Fly: After Hours Movers $CE $MAT $CYT $SLB $SSH $PRO $NOW $AMD $DSCO $DATA: Full Story http://t.co/Z2x0zURD1A
RealTrader Network
16 Apr 15 17:39:40
RT @zbiotech: oh no, $DSCO voluntarily ceases commercialization of surfaxin
The Fly
16 Apr 15 16:00:40
On The Fly: After Hours Movers $CE $MAT $CYT $SLB $SSH $PRO $NOW $AMD $DSCO $DATA: Full Story http://t.co/Z2x0zURD1A
James DiPlata
16 Apr 15 15:57:22
RT @Street_Insider: After-Hours Stock Movers 04/16: $MAT $SLB $AAPL Higher; $PRO $DSCO $NOW $AMD Lower (more...) http://t.co/pakx3CvJt6
Ivan Bunin
16 Apr 15 15:41:44
RT @VisualStockRSRC: $DSCO - Discovery Labs Completes Enrollment of AEROSURF® Phase 2a Clinical Trial and Restructures its Business http://…
Stock Trade Alerts
16 Apr 15 15:09:14
After-Hours Stock Movers 04/16: $MAT $SLB $AAPL Higher; $PRO $DSCO $NOW $AMD Lower (more...) http://t.co/Tu4vBAWbvo ~ via @AlertTrade
ProVesting
16 Apr 15 15:04:23
$PRO $DSCO: After-Hours Stock Movers 04/16: (MAT) (SLB) (AAPL) Higher; (PRO ...: http://t.co/SP86KT8wOo
Streetinsider.com
16 Apr 15 15:03:37
After-Hours Stock Movers 04/16: $MAT $SLB $AAPL Higher; $PRO $DSCO $NOW $AMD Lower (more...) http://t.co/pakx3CvJt6
MAISA
16 Apr 15 14:58:08
$DSCO AEROSURF phase 2a trial = a single dose of aerosolized KL4 surfactant in premature infants = RESULTS in3-4 weeks
AussieFragranceMall
16 Apr 15 14:44:07
RT @biotechvalue: $DSCO quitting on surfaxin
Momentum21
16 Apr 15 14:34:50
RT @dannytrades: $DSCO https://t.co/NG0DqE1bvW somebody gonna get it.
David Miller
16 Apr 15 14:16:51
@NathanAhron @AndyBiotech @zbiotech $DSCO is a great lesson in how biotech investors have to look at operations, too.
dannytrades
16 Apr 15 14:15:26
$DSCO https://t.co/NG0DqE1bvW somebody gonna get it.
				
				
By  +Follow October 4, 2013 2:07AM
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