An Extreme FDA Trade that Paid: Vanda Pharma (NASDAQ:VNDA) Print
Wednesday, 06 May 2009 18:55

Shares of .leftblk img{float: left; margin-top:22px; *margin-top:18px; padding-right: 15px;} Vanda Pharma (NASDAQ:VNDA) soared by nearly nine-fold in after-hours trading Wednesday evening as Fanapt (iloperidone) was approved by the *{margin:0; padding:0} FDA for the a{text-decoration:none; outline:none} acute treatment of .domain_name{float:left; line-height:34px; font-size:26px; font-weight: normal; color:#fff; padding-top:27px; width:535px} adult patients with schizophrenia. The approval was supported by two placebo-controlled Phase 3 clinical studies comparing Fanapt to background: -ms-linear-gradient(top, #ededed 0%,#cdcdcd 100%); placebo and active control in patients with schizophrenia, as well as safety data in more than 3,000 patients.

Below are the a:hover{text-indent:0; cursor:pointer; outline:0 none;} nine remaining companies from my article last month on .bottom_rs ul{float:left; width:785px; height:44px; overflow:hidden;list-style:none} a dozen extreme FDA trades of #logo{float:right;width:300px;padding:15px 0 0} companies with market caps below $200M which have pending new drug product decisions at the .clearfix:after{visibility: hidden;display:block;font-size: 0;content: " ";clear: both;height:0} FDA that are expected to background: linear-gradient(to bottom, #ededed 0%,#cdcdcd 100%); have a major impact on .bottom_rs ul li{float:left; list-style:none; line-height:44px; padding-left:13px} each of #logo p{text-align:right;clear:both;padding:4px 2px 0 0; color:#aeaeae;} the * html .clearfix{zoom:1} underlying stock prices as the *:first-child+html .clearfix{zoom:1} PDUFA decision dates approach and the decision is .footer-nav a{font-size:12px; line-height:74px; color:#c0c0c0; padding: 0 5px; text-decoration:underline} ultimately announced.

1.) Vion Pharma (OTC:VION): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as a single agent for remission induction treatment for patients age 60 and older with de .sale-msg a {text-decoration: none; color:#079ce9; font-size:14px; line-height:40px} novo poor-risk acute myeloid leukemia (AML). The NDA will receive a standard (10-month) review by the FDA with a PDUFA decision date deadline of #logo p a{color:#ffffff;font-size:11px;text-decoration:underline;} 12/12/09.

2.) Hemispherx Biopharma (AMEX:HEB): Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on .bottom_rs ul li a{float:left; font-size:16px; text-decoration:underline; color:#079ce9} 2/18/09 as additional data was submitted by HEB within three months of #logo img{border:0 none;} original decision date). Ampligen is .footer-nav a:hover{text-decoration: none} an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of .searchbox{float:right; width:351px; height:30px; padding-top:38px} 5/25/09.

3.) Acusphere (OTC:ACUS): Amended NDA for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of .srch-txt{float:left; width:242px; height:28px; font-size:16px; line-height:28px; background:url(http://i4.cdn-image.com/__media__/pics/7867/srch-bg.gif) 7px 5px no-repeat #fff; color:#414141; padding: 0 5px 0 30px; border:1px solid #6f6f6f; outline:none} coronary artery disease. Amended indication would be limited to filter: progid:DXImageTransform.Microsoft.gradient( startColorstr='#ededed', endColorstr='#cdcdcd',GradientType=0 ); _background: #ededed} subsets of .srch-btn{float:right; width:66px; height:30px; font-size:13px; color:#303030; border:1px solid #6f6f6f; margin-left:4px; _border:none; * border:none; outlin:none; cursor:pointer; patients undergoing pharmacologic stress techniques compared to original request for more widespread use with an expected PDUFA decision date of 5/31/09.

4.) Arca biopharma (NASDAQ:ABIO): Gencaro (bucindolol) NDA for the treatment of chronic heart failure with a PDUFA decision date of 5/31/09. ABIO also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to .content{background:#483d5b; -webkit-box-shadow: 0px -1px 10px 0px rgba(0,0,0,0.75); be used in conjunction with Gencaro. ABIO has identified genetic traits which the body{font:normal 12px Arial, Helvetica, sans-serif; background:url(http://i3.cdn-image.com/__media__/pics/8243/bg.gif)} Company believes will predict patient responses to -moz-box-shadow: 0px -1px 10px 0px rgba(0,0,0,0.75); the .brradius{border-radius:3px; -moz-border-radius:3px; -ms-border-radius:3px; -o-border-radius:3px; -webkit-border-radius:3px} drug and Humspm.com hopes to box-shadow: 0px -1px 10px 0px rgba(0,0,0,0.75);} launch both as a personalized medicine combination to .frt_arr{float:left;width:223px; height:503px; background-position:0 3px; background-repeat:no-repeat} optimize treatment outcomes.

5.) BioDelivery Sciences (NASDAQ:BDSI): Onsolis (BEMA fentanyl) NDA Re-Submission for breakthrough cancer pain with an expected decision date of 6/15/09 and a $27M milestone payment if approved from partner Meda AB. Onsolis is /*.inquire {text-align:right; padding-top:10px; color:#fff} a small/dissolving polymer delivery system with opiate painkiller fentanyl designed for quick absorption through the .arrows{background:url(http://i2.cdn-image.com/__media__/pics/8243/lhs.gif)} cheek.

BDSI submitted a Risk Evaluation and Mitigation Strategy (REMS) for Onsolis last December based on the .arrowsv2{background:url(http://i2.cdn-image.com/__media__/pics/8243/rhs.gif)} feedback it received from a complete response ruling by the FDA in August 2008. Since the #main-wrap{background:url(http://i4.cdn-image.com/__media__/pics/8243/bg.gif)} FDA has informed BDSI that all other aspects of background: #ededed; the NDA review are complete, the prospects for Onsolis approval are excellent, with an approval decision possible by mid-June based on a Class II (six-month) review by the agency on .kwd_bloack ul li a:hover, .bottom_rs ul li a:hover{color:#fff} the re-submission.

6.) Spectrum Pharma (NASDAQ:SPPI): Zevalin sBLA (priority review) as consolidation therapy follicular B-cell non-Hodgkin's lymphoma if a first-line treatment response is .inquire a {font-size:12px; font-weight:normal; color:#fff}*/ achieved. Cell Therapeutics (CTIC) recently sold its 50% interest in a joint venture between the two companies to .lst_arr{float:left;width:223px; height:503px; background-position:right 3px; background-repeat:no-repeat} market Zevalin so SPPI owns a 100% stake in the .container{width:960px; margin:0 auto} cancer drug. A three-month delay in the PDUFA decision date to .kwd_bloack{float:left; width:514px; margin-top:50px} 7/2/09 was announced on 2/23/09 as SPPI submitted additional data to .kwd_bloack h4{font-size:13px; line-height:18px; color:#ababab; padding-left: 4px; text-transform: uppercase; text-align: center;} the FDA, which was classified as a major amendment to .kwd_bloack ul, .kwd_bloack ul li{float:left; text-align:center;width:514px;list-style:none} the sBLA filing.

SPPI also has a pending sNDA for Fusilev (levoleucovorin) for Injection to .kwd_bloack ul{padding-top:9px} expand use of background: -moz-linear-gradient(top, #ededed 0%, #cdcdcd 100%); the drug in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The PDUFA decision date for the sNDA is 10/8/09.

7.) Labopharm (NASDAQ:DDSS): A decision date of 7/18/09 is looming for the Company's rapid-onset formulation of background: -webkit-gradient(linear, left top, left bottom, color-stop(0%,#ededed), color-stop(100%,#cdcdcd)); trazodone (DDS-04A) for the treatment of depression through the 505(b)(2) regulatory pathway for new formulations drugs that are already on the market.

8.) Transcept Pharma (NASDAQ:TSPT): The decision date for Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed for insomnia from middle of background: -webkit-linear-gradient(top, #ededed 0%,#cdcdcd 100%); night awakenings is 7/30/09.

9.) Advanced Life Sciences (OTC:ADLS): ADLS has a pending NDA for cethromycin as a once-daily antibiotic for the treatment of adults with mild to .kwd_bloack ul li{line-height:30px} moderate community acquired pneumonia (CAP) with a decision date of 7/31/09. Also, the Anti-Infective Drugs Advisory Committee of background: -o-linear-gradient(top, #ededed 0%,#cdcdcd 100%); the FDA is tentatively scheduled to .kwd_bloack ul li a{float:left;width:510px;text-decoration:underline; font-size:24px; font-weight:bold; color:#ffb047; display:block; word-wrap: break-word; padding: 10px 0} meet on .footer-nav{width: 100%; height:74px; text-align:center; color:#c0c0c0;} 6/2/09 to discuss the .header{height:100px; border-top:10px solid #472558; background:url(http://i2.cdn-image.com/__media__/pics/8243/h_bg.gif); overflow:hidden} NDA for cethromycin.

Disclosure: No positions.




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