SlideShare ist ein Scribd-Unternehmen logo
1 von 35
FDA Phase III Approval Historical Stock Performance The Path to Liquidity
To understand what Stage III FDA Approval has Historically done to the share price we can take a look at the below relative companies  2
DHTH – April 21st 2010 Oncology-focused medical device manufacturer Delcath Systems, Inc. (DCTH), said that its Phase III National Cancer Institute or NCI-led multi-center clinical trial has successfully met the study's primary endpoint of extended hepatic progression-free survival or hPFS in patients with cancer to the liver based on an independently corroborated intent-to-treat analysis.
DCTH Performance Between March 15 - April 20  DCTH: Moved from $6.09 to $10.60 (74.06% return) S&P 500 Index: Moved from 1150.51 to 1207.17 (4.92% return) Nasdaq Biotech Index: Moved from 935.19 to 952.45 (1.85% return) A Month before leading up to announcement
DCTH Announces FDA Stage III Approval  DCTH: Moved from $10.60 to $10.85 (2.36% return) S&P 500 Index: Moved from 1207.17 to 1205.94 (-0.10% return) Nasdaq Biotech Index: Moved from 952.45 to 935.58 (-1.77% return) Aril 20th 2010
Performance Between April 21 - July 21  DCTH: $10.85 to $7.19 (-33.73% return) S&P 500 Index: 1205.94 to 1069.59 (-11.31% return) Nasdaq Biotech Index: 935.58 to 799.84 (-14.51% return) Note - Significant event dated June 7, 2010: Delcath Systems Inc. shares fell 26% after Cowen & Co. said the company's experimental chemotherapy system drew criticism at an oncology meeting. http://www.marketwatch.com/story/mondays-biggest-gaining-and-declining-stocks-2010-06-07 3 Months after the announcement
AMRN – November 29th 2010 Reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101. The MARINE study, investigating AMR101 as a treatment for very high triglycerides (greater-than or equal to 500 mg/dL), met its primary efficacy endpoints as defined in the clinical trial protocol and demonstrated a positive safety profile. The Company believes that AMR101 has the potential to be the best-in-class product for this indication and that the MARINE study results may support additional patentable claims that could further protect the Company's rights to this product through 2030.
AMRN Performance Between Oct 28th 2010 – Nov 26th 2010  AMRN: Moved from $3.10 to $3.55 (14.52% return) S&P 500 Index: Moved from 1183.78 to 1189.4 (0.47% return) Nasdaq Biotech Index: Moved from 929.75 to 924.6 (-0.55% return) A Month before leading up to announcement
AMRN Announces FDA Stage III Approval  AMRN: Moved from $3.55 to $5.85 (64.79% return) S&P 500 Index: Moved from 1189.4 to 1187.76 (-0.14% return) Nasdaq Biotech Index: Moved from 924.6 to 917.68 (-0.75% return) November 29th 2010
AMRN Performance Between Nov 29th 2010 – Feb 25th 2010  AMRN: Moved from $5.85 to $8.09 (38.29% return) S&P 500 Index: Moved from 1187.76 to 1319.88 (11.12% return) Nasdaq Biotech Index: Moved from 917.68 to 982.48 (7.06% return) 3 Months after the announcement
CORT – December 22nd 2010 Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced positive top-line results from its Phase 3 study of CORLUX for the treatment of Cushing's Syndrome. The study evaluated the response of two patient groups to CORLUX treatment: one included patients who were glucose intolerant and one included patients who were hypertensive. Statistically significant improvement in the primary endpoint was achieved for both groups: with 60% responding in the glucose intolerant group and 43% in the hypertensive group. An initial review of safety data indicates that CORLUX was well tolerated by Cushing's Syndrome patients in this Phase 3 study.
CORT Performance Between Nov 19th 2010 – Dec 21st 2010  CORT: Moved from $3.52 to $4.19 (19.03% return) S&P 500 Index: Moved from 1199.73 to 1254.6 (4.57% return) Nasdaq Biotech Index: Moved from 919.93 to 983.97 (6.96% return) A Month before leading up to announcement
CORT Announces FDA Stage III Approval  CORT: Moved from $4.19 to $3.90 (-6.92% return) S&P 500: Moved from 1254.6 to 1258.84 (0.34% return) Nasdaq Biotech Index: Moved from 983.97 to 982.98 (-0.10% return) December 22, 2010
CORT Performance Between Dec 22, 2010 - Feb 25, 2011  CORT: Moved from $3.90 to $3.79 (-2.82% return) S&P 500 Index: Moved from 1258.84 to 1319.88 (4.85% return) Nasdaq Biotech Index: Moved from 982.98 to 982.48 (-0.05% return) Note - Buy The Rumor, Sell The News Price Action: The stock had a strong run-up to the announcement, but traders chose to sell the news announcement. "You are talking about a company that has been anticipating the data for some time and the buying rate was generally strong in the run-up from $3, a couple of months ago to $4.50," StifelNicolaus & Co analyst Annabel Samimy said.  Read more here: http://in.reuters.com/article/2010/12/22/corcept-idINSGE6BL0AD20101222 3 Months after the announcement
ARIA – January 18, 2011  Announced top-line data showing that ridaforolimus, an investigational oral mTOR inhibitor, met the primary endpoint of improved progression-free survival (PFS) compared to placebo in the Phase 3 SUCCEED trial conducted in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy. Merck is currently developing ridaforolimus in multiple cancer indications under an exclusive license and collaboration agreement with ARIAD.
ARIA Performance Between Dec 15, 2010 - Jan 14, 2011  ARIA: Moved from $4.42 to $5.25 (18.78% return) S&P 500 Index: Moved from 1235.23 to 1293.24 (4.70% return) Nasdaq Biotech Index: Moved from 955.78 to 1001.44 (4.78% return) A Month before leading up to announcement
ARIA Announces FDA Stage III Approval  ARIA: Moved from $5.25 to $7.04 (34.10% return) S&P 500: Moved from 1293.24 to 1295.02 (0.14% return) Nasdaq Biotech Index: Moved from 1001.44 to 1010.69 (0.92% return) January 18th 2010
ARIA Performance Between Jan 18th - Feb 25th 2011  ARIA: Moved from $7.04 to $6.08 (-13.64% return) S&P 500 Index: Moved from 1295.02 to 1319.88 (1.92% return) Nasdaq Biotech Index: Moved from 1010.69 to 982.48 (-2.79% return) 3 Months after the announcement
CHTP – December 20th 2010  Chelsea Therapeutics International Ltd. announced that FDA may not require further efficacy studies for the new drug application filing for its Northera in symptomatic, neurogenic orthostatic hypotension or NOH associated with Parkinson's disease. The company further said it would accelerate the filing for new drug application.
CHTP Performance Between Dec 1st 2010 - Dec 17th 2010  CHTP: Moved from $5.34 to $6.01 (12.55% return) S&P 500 Index: Moved from 1206.07 to 1243.91 (3.14% return) Nasdaq Biotech Index: Moved from 920.16 to 978.98 (6.39% return) A Month before leading up to announcement
CHTP Announces FDA Stage III Approval  CHTP: Moved from $6.01 to $7.69 (27.95% return) S&P 500 Index: Moved from 1243.91 to 1247.08 (0.25% return) Nasdaq Biotech Index: Moved from 978.98 to 979.72 (0.08% return) December 20th 2010
CHTP Performance Between Dec 20th 2010 - Feb 25th 2011  CHTP: Moved from $7.69 to $4.32 (-43.82% return) S&P 500: Moved from 1247.08 to 1319.88 (5.84% return) Nasdaq Biotech Index: Moved from 979.72 to 982.48 (0.28% return) Note: Since the announcement, Chelsea Therapeutics has announced that it plans to offer $35 million in shares of its common stock in a registered public offering pursuant to its existing shelf registration statement. This dilution seems to have dragged down the stock. (Read more here: http://www.rttnews.com/ArticleView.aspx?Id=1556190) 3 Months after the announcement
REGN – November 22nd 2010  Announced that in two parallel Phase 3 studies conducted by the company and Bayer HealthCare in patients with the neovascular form of age-related macular degeneration, or wet AMD, all regimens of VEGF Trap-Eye, including VEGF Trap-Eye dosed every two months, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month.
REGN Performance Between Oct 19th 2010 - Nov 19th 2010  REGN: Moved from $27.40 to $24.67 (-9.96% return) S&P 500 Index: Moved from 1165.9 to 1199.73 (2.90% return) Nasdaq Biotech Index: Moved from 914.75 to 919.93 (0.57% return) A Month before leading up to announcement
REGN Announces FDA Stage III Approval  REGN: 24.67 to 29.53 (19.70% return) S&P 500 Index: 1199.73 to 1197.84 (-0.16% return) Nasdaq Biotech Index: 919.93 to 924.63 (0.51% return) November 22, 2010
REGN Performance Between Nov 22nd 2010 - Feb 25th 2011  REGN: Moved from $29.53 to $37.00 (25.30% return) S&P 500 Index: Moved from 1197.84 to 1319.88 (10.19% return) Nasdaq Biotech Index: Moved from 924.63 to 982.48 (6.26% return) 3 Months after the announcement
SGEN – September 27, 2010  A robust 75 percent of Hodgkin's lymphoma patients in a pivotal trial responded to a cancer-targeting antibody developed by Seattle Genetics (SGEN.O), sending the company's shares up more than 17 percent on Monday. Results of the Phase III trial clear the way for an application for U.S. regulatory approval of the drug, called brentuximabvedotin, in the first half of 2011.
SGEN Performance Between Aug 24th 2010 - Sep 24th 2010  SGEN: $11.70 to $12.60 (3.93% return) S&P 500 Index: 1051.87 to 1148.67 (9.20% return) Nasdaq Biotech Index: 812 to 905.07 (11.46% return) A Month before leading up to announcement
SGEN Announces FDA Stage III Approval  SGEN: $12.16 to $14.30 (17.60% return) S&P 500 Index: 1148.67 to 1142.16 (-0.57% return) Nasdaq Biotech Index: 905.07 to 895.54 (-1.05% return) September 27, 2010
SGEN Performance Between Sep 27th 2010 - Dec 27th 2010   SGEN: $14.30 to $15.71 (9.86% return) S&P 500 Index: 1142.16 to 1257.54 (10.10% return) Nasdaq Biotech Index: 895.54 to 984.75 (9.96% return) 3 Months after the announcement
DNDN – April 29, 2010  Dendreon Corp. (DNDN: News ) saw its prostate cancer vaccine Provenge pass muster with the FDA, which lifted its stock to a record high of $54.58. Provenge, which belongs to a new class of therapy known as active cellular immunotherapy, becomes the first therapeutic cancer vaccine to be approved by the FDA. It works by stimulating the immune system to recognize a protein known as the prostatic acid phosphatase or PAP, which is found in about 95% of all prostate cancer cells and attacks the cancer cells.
DNDN Performance Between March 26th 2010 - April 28th 2010  DNDN: Moved from $36.87 to $39.62 (7.46% return) S&P 500 Index: Moved from 1166.59 to 1191.36 (2.12% return) Nasdaq Biotech Index: Moved from 943.3 to 923.79 (-2.07% return) A Month before leading up to announcement
DNDN Announces FDA Stage III Approval  DNDN: $39.62 to $50.18 (26.65% return) S&P 500 Index: 1191.36 to 1206.78 (1.29% return) Nasdaq Biotech Index: 923.79 to 950.03 (2.84% return) April 29, 2010
DNDN Performance Between April 29th 2010 and July 29th 2010   DNDN: $50.18 to $32.78 (-34.68% return) S&P 500 Index: 1206.78 to 1101.53 (-8.72% return) Nasdaq Biotech Index: 950.03 to 822.41 (-13.43% return) 3 Months after the announcement
Get into NASDAQ: VTUS before they DO	 IPO in December 2010 3.335 million shares at $6.00 per share Exchange: Nasdaq (“VTUS”) Capital Structure Cash and Short‐term Investments $17.6 million Debt $2.7 mm Common Shares Outstanding 7.2 million (9.3 million fully diluted) Market Cap ~$45 million

Weitere ähnliche Inhalte

Andere mochten auch

Pyramid (GROUP 3)
Pyramid (GROUP 3)Pyramid (GROUP 3)
Pyramid (GROUP 3)asita warda
 
BillMyParents Investor Presentation January 2012 (OTCBB: BMPI)
BillMyParents Investor Presentation January 2012 (OTCBB: BMPI)BillMyParents Investor Presentation January 2012 (OTCBB: BMPI)
BillMyParents Investor Presentation January 2012 (OTCBB: BMPI)ProActive Capital Resources Group
 
éRase una vez
éRase una vezéRase una vez
éRase una vezamapola08
 
Prelimenary task
Prelimenary taskPrelimenary task
Prelimenary taskEDPRICE93
 
fOSSa 2010 - Spago4Q: Quality of OSS Forges
fOSSa 2010 - Spago4Q: Quality of OSS ForgesfOSSa 2010 - Spago4Q: Quality of OSS Forges
fOSSa 2010 - Spago4Q: Quality of OSS ForgesDavide Dalle Carbonare
 
fOSSa 2010 - OSS Tools Framework for Agile Project Management
fOSSa 2010 - OSS Tools Framework for Agile Project ManagementfOSSa 2010 - OSS Tools Framework for Agile Project Management
fOSSa 2010 - OSS Tools Framework for Agile Project ManagementDavide Dalle Carbonare
 
Kemaskini sps online bagi guru
Kemaskini sps online bagi guruKemaskini sps online bagi guru
Kemaskini sps online bagi guruRoiamah Basri
 
让H5页面适配移动设备全家 - 设计师篇
让H5页面适配移动设备全家 - 设计师篇让H5页面适配移动设备全家 - 设计师篇
让H5页面适配移动设备全家 - 设计师篇peun zhang
 
Innovatie in de Sierteelt & het Businessmodel, door Sander de Leeuw, 16 nov 2011
Innovatie in de Sierteelt & het Businessmodel, door Sander de Leeuw, 16 nov 2011Innovatie in de Sierteelt & het Businessmodel, door Sander de Leeuw, 16 nov 2011
Innovatie in de Sierteelt & het Businessmodel, door Sander de Leeuw, 16 nov 2011KennisKring Amsterdam
 
Llmlibraryresearchskills2011
Llmlibraryresearchskills2011Llmlibraryresearchskills2011
Llmlibraryresearchskills2011catherineca
 
Rodman & Renshaw Report May 2011 - NAPCO Security Technologies (Nasdaq: NSSC;...
Rodman & Renshaw Report May 2011 - NAPCO Security Technologies (Nasdaq: NSSC;...Rodman & Renshaw Report May 2011 - NAPCO Security Technologies (Nasdaq: NSSC;...
Rodman & Renshaw Report May 2011 - NAPCO Security Technologies (Nasdaq: NSSC;...ProActive Capital Resources Group
 
Outthinker Speech to Fortune Gazelles Growth Summit
Outthinker Speech to Fortune Gazelles Growth SummitOutthinker Speech to Fortune Gazelles Growth Summit
Outthinker Speech to Fortune Gazelles Growth SummitKaihan Krippendorff
 
Dissertationresearch2012
Dissertationresearch2012Dissertationresearch2012
Dissertationresearch2012catherineca
 

Andere mochten auch (19)

Pyramid (GROUP 3)
Pyramid (GROUP 3)Pyramid (GROUP 3)
Pyramid (GROUP 3)
 
BillMyParents Investor Presentation January 2012 (OTCBB: BMPI)
BillMyParents Investor Presentation January 2012 (OTCBB: BMPI)BillMyParents Investor Presentation January 2012 (OTCBB: BMPI)
BillMyParents Investor Presentation January 2012 (OTCBB: BMPI)
 
VTUS Jan 2012 One on One Presentation
VTUS Jan 2012 One on One PresentationVTUS Jan 2012 One on One Presentation
VTUS Jan 2012 One on One Presentation
 
The Marketing Data Box from Hubspot
The Marketing Data Box from HubspotThe Marketing Data Box from Hubspot
The Marketing Data Box from Hubspot
 
Business intelligence
Business intelligenceBusiness intelligence
Business intelligence
 
éRase una vez
éRase una vezéRase una vez
éRase una vez
 
Prelimenary task
Prelimenary taskPrelimenary task
Prelimenary task
 
fOSSa 2010 - Spago4Q: Quality of OSS Forges
fOSSa 2010 - Spago4Q: Quality of OSS ForgesfOSSa 2010 - Spago4Q: Quality of OSS Forges
fOSSa 2010 - Spago4Q: Quality of OSS Forges
 
fOSSa 2010 - OSS Tools Framework for Agile Project Management
fOSSa 2010 - OSS Tools Framework for Agile Project ManagementfOSSa 2010 - OSS Tools Framework for Agile Project Management
fOSSa 2010 - OSS Tools Framework for Agile Project Management
 
Kemaskini sps online bagi guru
Kemaskini sps online bagi guruKemaskini sps online bagi guru
Kemaskini sps online bagi guru
 
让H5页面适配移动设备全家 - 设计师篇
让H5页面适配移动设备全家 - 设计师篇让H5页面适配移动设备全家 - 设计师篇
让H5页面适配移动设备全家 - 设计师篇
 
Innovatie in de Sierteelt & het Businessmodel, door Sander de Leeuw, 16 nov 2011
Innovatie in de Sierteelt & het Businessmodel, door Sander de Leeuw, 16 nov 2011Innovatie in de Sierteelt & het Businessmodel, door Sander de Leeuw, 16 nov 2011
Innovatie in de Sierteelt & het Businessmodel, door Sander de Leeuw, 16 nov 2011
 
Llmlibraryresearchskills2011
Llmlibraryresearchskills2011Llmlibraryresearchskills2011
Llmlibraryresearchskills2011
 
Rodman & Renshaw Report May 2011 - NAPCO Security Technologies (Nasdaq: NSSC;...
Rodman & Renshaw Report May 2011 - NAPCO Security Technologies (Nasdaq: NSSC;...Rodman & Renshaw Report May 2011 - NAPCO Security Technologies (Nasdaq: NSSC;...
Rodman & Renshaw Report May 2011 - NAPCO Security Technologies (Nasdaq: NSSC;...
 
Outthinker Speech to Fortune Gazelles Growth Summit
Outthinker Speech to Fortune Gazelles Growth SummitOutthinker Speech to Fortune Gazelles Growth Summit
Outthinker Speech to Fortune Gazelles Growth Summit
 
Law 1102
Law 1102Law 1102
Law 1102
 
Dissertationresearch2012
Dissertationresearch2012Dissertationresearch2012
Dissertationresearch2012
 
Sunsi Dec 2011 Power Point
Sunsi Dec 2011 Power PointSunsi Dec 2011 Power Point
Sunsi Dec 2011 Power Point
 
Les Chateaux
Les ChateauxLes Chateaux
Les Chateaux
 

Mehr von ProActive Capital Resources Group

Mehr von ProActive Capital Resources Group (20)

Pegasi Energy Research Note July 18, 2012
Pegasi Energy Research Note July 18, 2012Pegasi Energy Research Note July 18, 2012
Pegasi Energy Research Note July 18, 2012
 
Islet defense in bio century week of 5 28-12
Islet defense in bio century week of 5 28-12Islet defense in bio century week of 5 28-12
Islet defense in bio century week of 5 28-12
 
Insider transaction detail for Isa Odidi (IPCI)
Insider transaction detail for Isa Odidi (IPCI)Insider transaction detail for Isa Odidi (IPCI)
Insider transaction detail for Isa Odidi (IPCI)
 
Caprock risk management, llc
Caprock risk management, llcCaprock risk management, llc
Caprock risk management, llc
 
VTUS SEC Filing Form 8-K
VTUS SEC Filing Form 8-KVTUS SEC Filing Form 8-K
VTUS SEC Filing Form 8-K
 
TNXP Fact Sheet May 2012
TNXP Fact Sheet May 2012TNXP Fact Sheet May 2012
TNXP Fact Sheet May 2012
 
Arcis Exec Summary
Arcis Exec Summary Arcis Exec Summary
Arcis Exec Summary
 
SSIE 4.20.12
SSIE 4.20.12 SSIE 4.20.12
SSIE 4.20.12
 
Kerx zerenex phase3
Kerx zerenex phase3Kerx zerenex phase3
Kerx zerenex phase3
 
ARM Stroke
ARM StrokeARM Stroke
ARM Stroke
 
ARM Parkinsons
ARM ParkinsonsARM Parkinsons
ARM Parkinsons
 
ARM Heart Disease
ARM Heart DiseaseARM Heart Disease
ARM Heart Disease
 
ARM Diabetes
ARM DiabetesARM Diabetes
ARM Diabetes
 
Arm ALS
Arm ALSArm ALS
Arm ALS
 
Tonix12 ceocfo-article-clean newphoto
Tonix12 ceocfo-article-clean newphotoTonix12 ceocfo-article-clean newphoto
Tonix12 ceocfo-article-clean newphoto
 
Applied DNA Sciences (OTCBB: APDN)
Applied DNA Sciences (OTCBB: APDN)Applied DNA Sciences (OTCBB: APDN)
Applied DNA Sciences (OTCBB: APDN)
 
Daily Dose Equities - Intracoronary Bone Marrow
Daily Dose Equities - Intracoronary Bone MarrowDaily Dose Equities - Intracoronary Bone Marrow
Daily Dose Equities - Intracoronary Bone Marrow
 
Daily Dose Equities - Effect of Transendocardial Delivery
Daily Dose Equities - Effect of Transendocardial Delivery Daily Dose Equities - Effect of Transendocardial Delivery
Daily Dose Equities - Effect of Transendocardial Delivery
 
Daily Dose Equities - Exosomes from human cd34
Daily Dose Equities - Exosomes from human cd34Daily Dose Equities - Exosomes from human cd34
Daily Dose Equities - Exosomes from human cd34
 
2012 MHCC Web resentation proposal-3-19-2012-published
2012 MHCC Web resentation proposal-3-19-2012-published2012 MHCC Web resentation proposal-3-19-2012-published
2012 MHCC Web resentation proposal-3-19-2012-published
 

Kürzlich hochgeladen

Cyber Security Training in Office Environment
Cyber Security Training in Office EnvironmentCyber Security Training in Office Environment
Cyber Security Training in Office Environmentelijahj01012
 
MAHA Global and IPR: Do Actions Speak Louder Than Words?
MAHA Global and IPR: Do Actions Speak Louder Than Words?MAHA Global and IPR: Do Actions Speak Louder Than Words?
MAHA Global and IPR: Do Actions Speak Louder Than Words?Olivia Kresic
 
Youth Involvement in an Innovative Coconut Value Chain by Mwalimu Menza
Youth Involvement in an Innovative Coconut Value Chain by Mwalimu MenzaYouth Involvement in an Innovative Coconut Value Chain by Mwalimu Menza
Youth Involvement in an Innovative Coconut Value Chain by Mwalimu Menzaictsugar
 
Kenya’s Coconut Value Chain by Gatsby Africa
Kenya’s Coconut Value Chain by Gatsby AfricaKenya’s Coconut Value Chain by Gatsby Africa
Kenya’s Coconut Value Chain by Gatsby Africaictsugar
 
Market Sizes Sample Report - 2024 Edition
Market Sizes Sample Report - 2024 EditionMarket Sizes Sample Report - 2024 Edition
Market Sizes Sample Report - 2024 EditionMintel Group
 
Buy gmail accounts.pdf Buy Old Gmail Accounts
Buy gmail accounts.pdf Buy Old Gmail AccountsBuy gmail accounts.pdf Buy Old Gmail Accounts
Buy gmail accounts.pdf Buy Old Gmail AccountsBuy Verified Accounts
 
Ten Organizational Design Models to align structure and operations to busines...
Ten Organizational Design Models to align structure and operations to busines...Ten Organizational Design Models to align structure and operations to busines...
Ten Organizational Design Models to align structure and operations to busines...Seta Wicaksana
 
8447779800, Low rate Call girls in Uttam Nagar Delhi NCR
8447779800, Low rate Call girls in Uttam Nagar Delhi NCR8447779800, Low rate Call girls in Uttam Nagar Delhi NCR
8447779800, Low rate Call girls in Uttam Nagar Delhi NCRashishs7044
 
Pitch Deck Teardown: Geodesic.Life's $500k Pre-seed deck
Pitch Deck Teardown: Geodesic.Life's $500k Pre-seed deckPitch Deck Teardown: Geodesic.Life's $500k Pre-seed deck
Pitch Deck Teardown: Geodesic.Life's $500k Pre-seed deckHajeJanKamps
 
Financial-Statement-Analysis-of-Coca-cola-Company.pptx
Financial-Statement-Analysis-of-Coca-cola-Company.pptxFinancial-Statement-Analysis-of-Coca-cola-Company.pptx
Financial-Statement-Analysis-of-Coca-cola-Company.pptxsaniyaimamuddin
 
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607(Best) ENJOY Call Girls in Faridabad Ex | 8377087607
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607dollysharma2066
 
International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...ssuserf63bd7
 
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCRashishs7044
 
Innovation Conference 5th March 2024.pdf
Innovation Conference 5th March 2024.pdfInnovation Conference 5th March 2024.pdf
Innovation Conference 5th March 2024.pdfrichard876048
 
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxThe-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxmbikashkanyari
 
8447779800, Low rate Call girls in Tughlakabad Delhi NCR
8447779800, Low rate Call girls in Tughlakabad Delhi NCR8447779800, Low rate Call girls in Tughlakabad Delhi NCR
8447779800, Low rate Call girls in Tughlakabad Delhi NCRashishs7044
 
APRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfAPRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfRbc Rbcua
 

Kürzlich hochgeladen (20)

Cyber Security Training in Office Environment
Cyber Security Training in Office EnvironmentCyber Security Training in Office Environment
Cyber Security Training in Office Environment
 
MAHA Global and IPR: Do Actions Speak Louder Than Words?
MAHA Global and IPR: Do Actions Speak Louder Than Words?MAHA Global and IPR: Do Actions Speak Louder Than Words?
MAHA Global and IPR: Do Actions Speak Louder Than Words?
 
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCREnjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
 
Youth Involvement in an Innovative Coconut Value Chain by Mwalimu Menza
Youth Involvement in an Innovative Coconut Value Chain by Mwalimu MenzaYouth Involvement in an Innovative Coconut Value Chain by Mwalimu Menza
Youth Involvement in an Innovative Coconut Value Chain by Mwalimu Menza
 
Kenya’s Coconut Value Chain by Gatsby Africa
Kenya’s Coconut Value Chain by Gatsby AfricaKenya’s Coconut Value Chain by Gatsby Africa
Kenya’s Coconut Value Chain by Gatsby Africa
 
Market Sizes Sample Report - 2024 Edition
Market Sizes Sample Report - 2024 EditionMarket Sizes Sample Report - 2024 Edition
Market Sizes Sample Report - 2024 Edition
 
Buy gmail accounts.pdf Buy Old Gmail Accounts
Buy gmail accounts.pdf Buy Old Gmail AccountsBuy gmail accounts.pdf Buy Old Gmail Accounts
Buy gmail accounts.pdf Buy Old Gmail Accounts
 
Ten Organizational Design Models to align structure and operations to busines...
Ten Organizational Design Models to align structure and operations to busines...Ten Organizational Design Models to align structure and operations to busines...
Ten Organizational Design Models to align structure and operations to busines...
 
8447779800, Low rate Call girls in Uttam Nagar Delhi NCR
8447779800, Low rate Call girls in Uttam Nagar Delhi NCR8447779800, Low rate Call girls in Uttam Nagar Delhi NCR
8447779800, Low rate Call girls in Uttam Nagar Delhi NCR
 
No-1 Call Girls In Goa 93193 VIP 73153 Escort service In North Goa Panaji, Ca...
No-1 Call Girls In Goa 93193 VIP 73153 Escort service In North Goa Panaji, Ca...No-1 Call Girls In Goa 93193 VIP 73153 Escort service In North Goa Panaji, Ca...
No-1 Call Girls In Goa 93193 VIP 73153 Escort service In North Goa Panaji, Ca...
 
Pitch Deck Teardown: Geodesic.Life's $500k Pre-seed deck
Pitch Deck Teardown: Geodesic.Life's $500k Pre-seed deckPitch Deck Teardown: Geodesic.Life's $500k Pre-seed deck
Pitch Deck Teardown: Geodesic.Life's $500k Pre-seed deck
 
Financial-Statement-Analysis-of-Coca-cola-Company.pptx
Financial-Statement-Analysis-of-Coca-cola-Company.pptxFinancial-Statement-Analysis-of-Coca-cola-Company.pptx
Financial-Statement-Analysis-of-Coca-cola-Company.pptx
 
Call Us ➥9319373153▻Call Girls In North Goa
Call Us ➥9319373153▻Call Girls In North GoaCall Us ➥9319373153▻Call Girls In North Goa
Call Us ➥9319373153▻Call Girls In North Goa
 
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607(Best) ENJOY Call Girls in Faridabad Ex | 8377087607
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607
 
International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...
 
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR
8447779800, Low rate Call girls in Shivaji Enclave Delhi NCR
 
Innovation Conference 5th March 2024.pdf
Innovation Conference 5th March 2024.pdfInnovation Conference 5th March 2024.pdf
Innovation Conference 5th March 2024.pdf
 
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxThe-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
 
8447779800, Low rate Call girls in Tughlakabad Delhi NCR
8447779800, Low rate Call girls in Tughlakabad Delhi NCR8447779800, Low rate Call girls in Tughlakabad Delhi NCR
8447779800, Low rate Call girls in Tughlakabad Delhi NCR
 
APRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfAPRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdf
 

FDA Phase III Approval Historical Stock Performance

  • 1. FDA Phase III Approval Historical Stock Performance The Path to Liquidity
  • 2. To understand what Stage III FDA Approval has Historically done to the share price we can take a look at the below relative companies 2
  • 3. DHTH – April 21st 2010 Oncology-focused medical device manufacturer Delcath Systems, Inc. (DCTH), said that its Phase III National Cancer Institute or NCI-led multi-center clinical trial has successfully met the study's primary endpoint of extended hepatic progression-free survival or hPFS in patients with cancer to the liver based on an independently corroborated intent-to-treat analysis.
  • 4. DCTH Performance Between March 15 - April 20 DCTH: Moved from $6.09 to $10.60 (74.06% return) S&P 500 Index: Moved from 1150.51 to 1207.17 (4.92% return) Nasdaq Biotech Index: Moved from 935.19 to 952.45 (1.85% return) A Month before leading up to announcement
  • 5. DCTH Announces FDA Stage III Approval DCTH: Moved from $10.60 to $10.85 (2.36% return) S&P 500 Index: Moved from 1207.17 to 1205.94 (-0.10% return) Nasdaq Biotech Index: Moved from 952.45 to 935.58 (-1.77% return) Aril 20th 2010
  • 6. Performance Between April 21 - July 21 DCTH: $10.85 to $7.19 (-33.73% return) S&P 500 Index: 1205.94 to 1069.59 (-11.31% return) Nasdaq Biotech Index: 935.58 to 799.84 (-14.51% return) Note - Significant event dated June 7, 2010: Delcath Systems Inc. shares fell 26% after Cowen & Co. said the company's experimental chemotherapy system drew criticism at an oncology meeting. http://www.marketwatch.com/story/mondays-biggest-gaining-and-declining-stocks-2010-06-07 3 Months after the announcement
  • 7. AMRN – November 29th 2010 Reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101. The MARINE study, investigating AMR101 as a treatment for very high triglycerides (greater-than or equal to 500 mg/dL), met its primary efficacy endpoints as defined in the clinical trial protocol and demonstrated a positive safety profile. The Company believes that AMR101 has the potential to be the best-in-class product for this indication and that the MARINE study results may support additional patentable claims that could further protect the Company's rights to this product through 2030.
  • 8. AMRN Performance Between Oct 28th 2010 – Nov 26th 2010 AMRN: Moved from $3.10 to $3.55 (14.52% return) S&P 500 Index: Moved from 1183.78 to 1189.4 (0.47% return) Nasdaq Biotech Index: Moved from 929.75 to 924.6 (-0.55% return) A Month before leading up to announcement
  • 9. AMRN Announces FDA Stage III Approval AMRN: Moved from $3.55 to $5.85 (64.79% return) S&P 500 Index: Moved from 1189.4 to 1187.76 (-0.14% return) Nasdaq Biotech Index: Moved from 924.6 to 917.68 (-0.75% return) November 29th 2010
  • 10. AMRN Performance Between Nov 29th 2010 – Feb 25th 2010 AMRN: Moved from $5.85 to $8.09 (38.29% return) S&P 500 Index: Moved from 1187.76 to 1319.88 (11.12% return) Nasdaq Biotech Index: Moved from 917.68 to 982.48 (7.06% return) 3 Months after the announcement
  • 11. CORT – December 22nd 2010 Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced positive top-line results from its Phase 3 study of CORLUX for the treatment of Cushing's Syndrome. The study evaluated the response of two patient groups to CORLUX treatment: one included patients who were glucose intolerant and one included patients who were hypertensive. Statistically significant improvement in the primary endpoint was achieved for both groups: with 60% responding in the glucose intolerant group and 43% in the hypertensive group. An initial review of safety data indicates that CORLUX was well tolerated by Cushing's Syndrome patients in this Phase 3 study.
  • 12. CORT Performance Between Nov 19th 2010 – Dec 21st 2010 CORT: Moved from $3.52 to $4.19 (19.03% return) S&P 500 Index: Moved from 1199.73 to 1254.6 (4.57% return) Nasdaq Biotech Index: Moved from 919.93 to 983.97 (6.96% return) A Month before leading up to announcement
  • 13. CORT Announces FDA Stage III Approval CORT: Moved from $4.19 to $3.90 (-6.92% return) S&P 500: Moved from 1254.6 to 1258.84 (0.34% return) Nasdaq Biotech Index: Moved from 983.97 to 982.98 (-0.10% return) December 22, 2010
  • 14. CORT Performance Between Dec 22, 2010 - Feb 25, 2011 CORT: Moved from $3.90 to $3.79 (-2.82% return) S&P 500 Index: Moved from 1258.84 to 1319.88 (4.85% return) Nasdaq Biotech Index: Moved from 982.98 to 982.48 (-0.05% return) Note - Buy The Rumor, Sell The News Price Action: The stock had a strong run-up to the announcement, but traders chose to sell the news announcement. "You are talking about a company that has been anticipating the data for some time and the buying rate was generally strong in the run-up from $3, a couple of months ago to $4.50," StifelNicolaus & Co analyst Annabel Samimy said. Read more here: http://in.reuters.com/article/2010/12/22/corcept-idINSGE6BL0AD20101222 3 Months after the announcement
  • 15. ARIA – January 18, 2011 Announced top-line data showing that ridaforolimus, an investigational oral mTOR inhibitor, met the primary endpoint of improved progression-free survival (PFS) compared to placebo in the Phase 3 SUCCEED trial conducted in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy. Merck is currently developing ridaforolimus in multiple cancer indications under an exclusive license and collaboration agreement with ARIAD.
  • 16. ARIA Performance Between Dec 15, 2010 - Jan 14, 2011 ARIA: Moved from $4.42 to $5.25 (18.78% return) S&P 500 Index: Moved from 1235.23 to 1293.24 (4.70% return) Nasdaq Biotech Index: Moved from 955.78 to 1001.44 (4.78% return) A Month before leading up to announcement
  • 17. ARIA Announces FDA Stage III Approval ARIA: Moved from $5.25 to $7.04 (34.10% return) S&P 500: Moved from 1293.24 to 1295.02 (0.14% return) Nasdaq Biotech Index: Moved from 1001.44 to 1010.69 (0.92% return) January 18th 2010
  • 18. ARIA Performance Between Jan 18th - Feb 25th 2011 ARIA: Moved from $7.04 to $6.08 (-13.64% return) S&P 500 Index: Moved from 1295.02 to 1319.88 (1.92% return) Nasdaq Biotech Index: Moved from 1010.69 to 982.48 (-2.79% return) 3 Months after the announcement
  • 19. CHTP – December 20th 2010 Chelsea Therapeutics International Ltd. announced that FDA may not require further efficacy studies for the new drug application filing for its Northera in symptomatic, neurogenic orthostatic hypotension or NOH associated with Parkinson's disease. The company further said it would accelerate the filing for new drug application.
  • 20. CHTP Performance Between Dec 1st 2010 - Dec 17th 2010 CHTP: Moved from $5.34 to $6.01 (12.55% return) S&P 500 Index: Moved from 1206.07 to 1243.91 (3.14% return) Nasdaq Biotech Index: Moved from 920.16 to 978.98 (6.39% return) A Month before leading up to announcement
  • 21. CHTP Announces FDA Stage III Approval CHTP: Moved from $6.01 to $7.69 (27.95% return) S&P 500 Index: Moved from 1243.91 to 1247.08 (0.25% return) Nasdaq Biotech Index: Moved from 978.98 to 979.72 (0.08% return) December 20th 2010
  • 22. CHTP Performance Between Dec 20th 2010 - Feb 25th 2011 CHTP: Moved from $7.69 to $4.32 (-43.82% return) S&P 500: Moved from 1247.08 to 1319.88 (5.84% return) Nasdaq Biotech Index: Moved from 979.72 to 982.48 (0.28% return) Note: Since the announcement, Chelsea Therapeutics has announced that it plans to offer $35 million in shares of its common stock in a registered public offering pursuant to its existing shelf registration statement. This dilution seems to have dragged down the stock. (Read more here: http://www.rttnews.com/ArticleView.aspx?Id=1556190) 3 Months after the announcement
  • 23. REGN – November 22nd 2010 Announced that in two parallel Phase 3 studies conducted by the company and Bayer HealthCare in patients with the neovascular form of age-related macular degeneration, or wet AMD, all regimens of VEGF Trap-Eye, including VEGF Trap-Eye dosed every two months, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month.
  • 24. REGN Performance Between Oct 19th 2010 - Nov 19th 2010 REGN: Moved from $27.40 to $24.67 (-9.96% return) S&P 500 Index: Moved from 1165.9 to 1199.73 (2.90% return) Nasdaq Biotech Index: Moved from 914.75 to 919.93 (0.57% return) A Month before leading up to announcement
  • 25. REGN Announces FDA Stage III Approval REGN: 24.67 to 29.53 (19.70% return) S&P 500 Index: 1199.73 to 1197.84 (-0.16% return) Nasdaq Biotech Index: 919.93 to 924.63 (0.51% return) November 22, 2010
  • 26. REGN Performance Between Nov 22nd 2010 - Feb 25th 2011 REGN: Moved from $29.53 to $37.00 (25.30% return) S&P 500 Index: Moved from 1197.84 to 1319.88 (10.19% return) Nasdaq Biotech Index: Moved from 924.63 to 982.48 (6.26% return) 3 Months after the announcement
  • 27. SGEN – September 27, 2010 A robust 75 percent of Hodgkin's lymphoma patients in a pivotal trial responded to a cancer-targeting antibody developed by Seattle Genetics (SGEN.O), sending the company's shares up more than 17 percent on Monday. Results of the Phase III trial clear the way for an application for U.S. regulatory approval of the drug, called brentuximabvedotin, in the first half of 2011.
  • 28. SGEN Performance Between Aug 24th 2010 - Sep 24th 2010 SGEN: $11.70 to $12.60 (3.93% return) S&P 500 Index: 1051.87 to 1148.67 (9.20% return) Nasdaq Biotech Index: 812 to 905.07 (11.46% return) A Month before leading up to announcement
  • 29. SGEN Announces FDA Stage III Approval SGEN: $12.16 to $14.30 (17.60% return) S&P 500 Index: 1148.67 to 1142.16 (-0.57% return) Nasdaq Biotech Index: 905.07 to 895.54 (-1.05% return) September 27, 2010
  • 30. SGEN Performance Between Sep 27th 2010 - Dec 27th 2010  SGEN: $14.30 to $15.71 (9.86% return) S&P 500 Index: 1142.16 to 1257.54 (10.10% return) Nasdaq Biotech Index: 895.54 to 984.75 (9.96% return) 3 Months after the announcement
  • 31. DNDN – April 29, 2010 Dendreon Corp. (DNDN: News ) saw its prostate cancer vaccine Provenge pass muster with the FDA, which lifted its stock to a record high of $54.58. Provenge, which belongs to a new class of therapy known as active cellular immunotherapy, becomes the first therapeutic cancer vaccine to be approved by the FDA. It works by stimulating the immune system to recognize a protein known as the prostatic acid phosphatase or PAP, which is found in about 95% of all prostate cancer cells and attacks the cancer cells.
  • 32. DNDN Performance Between March 26th 2010 - April 28th 2010 DNDN: Moved from $36.87 to $39.62 (7.46% return) S&P 500 Index: Moved from 1166.59 to 1191.36 (2.12% return) Nasdaq Biotech Index: Moved from 943.3 to 923.79 (-2.07% return) A Month before leading up to announcement
  • 33. DNDN Announces FDA Stage III Approval DNDN: $39.62 to $50.18 (26.65% return) S&P 500 Index: 1191.36 to 1206.78 (1.29% return) Nasdaq Biotech Index: 923.79 to 950.03 (2.84% return) April 29, 2010
  • 34. DNDN Performance Between April 29th 2010 and July 29th 2010  DNDN: $50.18 to $32.78 (-34.68% return) S&P 500 Index: 1206.78 to 1101.53 (-8.72% return) Nasdaq Biotech Index: 950.03 to 822.41 (-13.43% return) 3 Months after the announcement
  • 35. Get into NASDAQ: VTUS before they DO IPO in December 2010 3.335 million shares at $6.00 per share Exchange: Nasdaq (“VTUS”) Capital Structure Cash and Short‐term Investments $17.6 million Debt $2.7 mm Common Shares Outstanding 7.2 million (9.3 million fully diluted) Market Cap ~$45 million