View Full Version : Biopharm Stock Analysis
I have to give credit where it is due, this did not come from me I am simply reposting the info. This comes from here: http://www.mystockbuddy.com/forum/blogs/w00tw00t/50-fda_plays.html
As some of you may know I have been busy in the past few weeks collecting data about past FDA approval dates. I have managed to create a list of 62 dates going back to December 2007 and I’m going to extend this list in the near future. I’m going to perform as small analysis even if the list is somewhat small. The results are temporary and will be adjusted in the near future.
Description:
%2MBDtoDate: % return if you buy the stock 2months before approval date and sell it the day before the approval date.
%1MBDtoDate: % return if you buy the stock 1month before approval date and sell it the day before the approval date.
%2WBDtoDate: % return if you buy the stock 2weeks before approval date and sell it the day before the approval date.
%2MBDto1MBD: % return if you buy the stock 2months before approval date and sell it 1month before the approval date.
%1MBDto2WBD: % return if you buy the stock 1month before approval date and sell it 2weeks before the approval date.
I decided to split the list into small groups using the the pps 2 months before the approval date as a criterion(or is it criterium?? :p)
The approval date is the date based upon the FDA guidelines that is mentioned everywhere.
Here are the results:
1)The first group I created is the one containing pps from 0-4.99 2 months before the approval date.
%2MBDtoDate 0,72 statistically significant (5% confidence interval)
%1MBDtoDate 0,52 statistically significant (5% confidence interval)
%2WBDtoDate 0,22 statistically significant (10% confidence interval)
%2MBDto1MBD 0,15 statistically significant (10% confidence interval)
%1MBDto2WBD 0,22 statistically significant (5% confidence interval)
Conclusion: The sample size for this test was smaller then allowed (20 (<30)) so I’m not going to see this as a definitive conclusion but we can see that holding a share for 2months before the approval date and selling it at the date before the approval will earn you an average of 72%. Doing so for shares bought 1month before the approval will give you an average return of 52% and 22% for shares bought 2 weeks before approval. Even if you buy shares 2months before approval and sell them 1month before approval, they could give you a return of 15%
(I have let the 10% confidence interval slip through this time because of the smaller sample. I normally only work with 5% confidence intervals or lower)
2) The second group I created contains pps from 5-14.99 2 months before the approval date.
%2MBDtoDate 0/06
%1MBDtoDate 0/05
%2WBDtoDate 0,01
%2MBDto1MBD 0,01
%1MBDto2WBD 0, 04
Conclusion: none of the found results are statistically significant. Basically this tells us that shares with pps in this range don’t move by much on average before a possible FDA approval. The market forces have more influence on them than the speculators playing on FDA approvals.
3) the third groups contains pps from 15 and higher 2 months before the approval date
Conclusion: The found results are even worse than the ones shown in the previous group so I wont even bother to post them.
As my list gets bigger I can use smaller ranges for groups which will give me even better results. I’m also indentifying all the possible factors that can influence the pps in those FDA play stocks and by how much those affect them. This information could be used to create time series regressions in order to predict possible future movements. This concludes my small analysis. I hope this was informative.
Now the reason I'm posting that is because of this: First part clinical trial reports
MNTA (trades at 11.5) 7/11 and 9/26
Momenta Pharma's Three-Part Strategy - BioMedReports.com (http://biomedreports.com/blog/Momenta-Pharmas-Three-Part-Strategy.html)
---------- Post added at 09:54 AM ---------- Previous post was at 09:51 AM ----------
NSPH, trades at 4.19, FDA 510K decision due 7/31/09 (remember 510k dates are approximate).
BVX,NSPH,NEPH BiomedReports: FDA Medical Device Trade Updates for Nephros (OTC:NEPH), Bovie Medical (AMEX: BVX), and Nanosphere (NASDAQ: NSPH) (http://www.tradingmarkets.com/.site/news/Stock%20News/2363993/)
RIGL, trading at 11.5, has Phase II clinical trial info due re: arthritis drug in July. Am a bit leary of clinical trials after NEXM and ARYX, so proceed with CAUTION. Sell BEFORE news, IMO.
BioMedReports FDA Calendar: 19 Hot Summer Trades - BioMedReports.com (http://biomedreports.com/articles/most-popular/1355-biomedreports-fda-calendar-hot-summer-trades.html)
Bulls pile into Rigel Pharmaceuticals (http://www.optionmonster.com/news/article.jsp?page=commentary/in_the_news/bulls_pile_into_rigel_pharmaceuticals_35013.html)
New RA Data Could Be Magic Pill for Rigel | Biotech | Financial Articles & Investing News | TheStreet.com (http://www.thestreet.com/story/10515499/1/new-ra-data-could-be-magic-pill-for-rigel.html?cm_ven=GOOGLEN)
INTERVIEW-Rigel's oral arthritis drug as good as Pfizer's: COO (http://www.forexyard.com/en/reuters_inner.tpl?action=2009-06-25T192614Z_01_BNG504730_RTRIDST_0_RIGELPHARMACEUTI CALS-INTERVIEW)
Here is a list of dates I've been tracking. Approximate dates (i.e. 2Q09) are for clinical trial results.
ISTA 6/26/09
ACUR 6/30/09
KG 6/30/09
INSM 2Q09
TDLP 3Q09
TRIB 6/30/09 or 3Q09
NSPH 2H09
CTIC 8/24/09
BIOD 2H09
IMMU 2-3Q09
ARUXF 3Q09
SPPI 7/2/09
ARYX 7/6/09
MNTA 7/11/09
ARDM 7/15/09
RIGL 7/15/09
HGSI 7/20/09
DDSS 7/18/09
MEDX 7/30/09
TSPT 7/30/09
NSPH 7/31/09
SVNT 8/1/09
NRIFF 8/5/09
NGSX 8/16/09 possible delay to 11/16/09
ICAD 8/26/09
ISTA 9/12/09
ALTH 9/24/09
MNTA 9/26/09
SPPI 10/8/09
KG 10/18/09
MEDX 10/21/09
ACOR 10/22/09
GTXI 10/30/09
TSPT 10/31/09
NGSX 11/16/09
BIIB 11/19/09
CTIC 12/01/09
DYAX 12/01/09
SOMX 12/4/09
SNTS 12/4/09
MELA 12/4/09
VION 12/12/09
BIEL 12/15/09
ICAD 12/31/09
OSUR 12/31/09
ILE 01/04/10
MNKD 1/16/10
SKYEF 1/31/10
MEDX 1Q09
IGXT 2/10/10 New dosing option for antidepressant for people with MDD
AMLN 3/05/10
CADX 3/14/10
APPA 3/18/10 Anti nausea medicine for chemotherapy
HGSI 3/21/10
KAMAF 4/2/10
ONTY 2010/2011
List of FDA dates
STOCK PICS AWAITING FDA APPROVAL
This post features companies with expected FDA approval decision dates for the year. Further insight can be found using the key codes which designate each drug candidate's likelihood of approval and potential competition.
KEY DEFINITIONS
PDUFA (Prescription Drug User Fee Act)
NDA (New Drug Application)
RED DATES - Dates confirmed directly w/company (this research provided by paid resource publication) or indirectly through company filings and press releases.
UNDERLINED DATES - Estimated dates based on NDA submissions
PMOA - Primary Mode of Action; The means by which a product achieves its intended therapeutic effect or action
Y - Yes
N - No
Proven PMOA? - Y designates yes, the drug has proven PMOA; N designates PMOA not yet proved.
Two or Fewer Alternatives? - <2 designates upon approval drug is likely to compete with two or fewer alternative sources in same drug class. <2! designates drug is the sole candidate with this PMOA. Additional information provided refers to potential competitors; 3+ designates there are many competitors for this drug.
1-2 Previously Approved? - Y designates at least 1-2 drugs were previously approved by FDA for this company; N designates no drugs were previously approved. If criteria is left empty, information was not available.
NOTES
Drug candidates are sometimes filed jointly by two companies.
CREDITS
Data is comprised from paid resource report (compliments of colorwonder) and BioMedReports and/or anything else I can get my hands on!
Spinner: FDA FUNDS
Garyd: FDA CALENDAR
JUNE 2009
Currently under $10/per share
HEB- 5/25 - DATE EXTENDED UFN (%$#@@!)
Ampligen (Poly I: Poly C12U) experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug. BioMedReports
VPHM 6/3
Cinryze (Human C1 Inhibitor): Treatment of acute attacks of hereditary angioedema.
BDSI 6/12 (mid-June)
Onsolis (Fentanyl Buccal Soluble Film)/Formerly BEMA Fentanyl: Breakthrough cancer pain in opioid tolerant patients. BioMedReports
6/2/09 UPDATE: Since the FDA has informed BDSI that all other aspects of 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 the re-submission. SeekingAlpha
ISTA FDA REVIEW 6/26/09:
Bepreve (bepotastine ophthalmic solution)
On 6/1/09, ISTA announced the Dermatologic and Ophthalmic Drugs Advisory Committee will review ISTA's NDA for Bepreve on June 26, 2009. SeekingAlpha
ACUR 6/30
Remoxy (Time-Release Oxycodone) PTIE Y
Acurox (Abuse Resistant Oxycodone/Niacin )/Formerly OxyADF: Abuse resistant relief of moderate to severe pain
KG 6/30
Acurox (Oxycodone/Niacin Abuse Resistant)/Formerly OxyADF: Abuse resistant relief of moderate to severe pain.
JULY 2009
Currently under $10/per share
SPPI 7/2
Zevalin (Ibritumomab Tiuxetan): First-line consolidation therapy in for previously untreated follicular indolent Non-Hodgkin's Lymphoma. BioMedReports
TSPT REVISED DATE (cancel 7/3 - refer 10/31/09)
Zolpimist (Zolpidem Tartrate Oral Spray)NVD; Ambien (Zolpidem Tartrate)SNY Y
Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed to treat insomnia from middle of the night awakenings.
UPDATE (thumbs up for Ingew): Transcept Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual tablet). The Intermezzo(R) NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009. Under this revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009. PR NEWS WIRE 6/11/09
ARDM 7/15 (refer spinner)
Sumavel (of privately-held company Zogenix). Zogenix have bought Aradigm's non-injection delivery system and ARDM stand to reap potential licensing rewards from this drug if approved.
DDSS 7/18
Y 3+ Y
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. BioMedReport
MEDX 7/30
Y <2 Genzyme Oncology CAMPATH (Alemtuzumab) GENZ Y
Arzerra (Ofatumumab): B-Cell Chronic Lymphocytic Leukemia
SVNT 7/30
Y <2! Y
Krystexxa (Pegloticase): Elimination of excess uric acid (Hyperuricemia) in individuals with symptomatic gout that is unresponsive to conventional treatment.
ADLS.OB (ADLS Google) 6/2 7/31
Y <2 Ketek (Telithromycin) SNY N
Restanza (cethromycin) as a once-daily antibiotic for the treatment of adults with mild to moderate community acquired pneumonia. 5/19 OTC Investor
ADLS UPDATE 6/2/09: Anti-Infective Drugs Advisory Committee of the FDA is scheduled to meet on 6/2/09 to discuss the NDA for cethromycin and provide a recommendation for the final FDA approval decision. Briefing documents for the panel meeting can be accessed here.
ADLS UPDATE 6/2/09 AH - AP Newswire: FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP. ...Although it is not binding, the Committee's recommendation will be considered by the FDA as it completes its review of Restanza's NDA in CAP.
ADLS UPDATE: 6/23/09 BioMedReported good news after the company announced that a second non-human primate study showed that a 14-day course of Restanza achieved a 100% survival rate against an inhaled lethal dose of anthrax.
AUGUST 2009
Currently under $10/per share
NRIFF.PK 8/5 (NRIFF.PK Google)
Pennsaid, 8/5 expected decision date of PDUFA for company's NDA re-submission for topical NSAID for arthritis pain and inflammation. BioMedReport
NGSX 8/16
Qutenza (formerly NGX-4010) for treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. BioMedReport
UPDATE 5/21/09: NGSX announced that the European Commission has formally granted marketing authorization of Qutenza 179 mg cutaneous patch for the prescription-only treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain. The centralized marketing authorization allows Qutenza to be marketed in all 27 countries of the European Union. SeekingAlpha 6/2/09
UPDATE 6/2/09: The Office of Orphan Product Development of FDA granted orphan drug designation for Qutenza. PR NewWire
UPDATE 7/24/09: NGSX Announces Preliminary Results of FDA-Requested Qutenza Study - NeurogesX, Inc. announced today the preliminary results of a short-term clinical study (Study C123) of Qutenza(TM) in patients with postherpetic neuralgia (PHN) following pretreatment with an FDA-approved topical anesthetic. ...Preliminary results of Study C123 showed the mean duration of patch application was 60.2 minutes, versus a target duration of Qutenza patch application of 60 minutes. No patients removed the Qutenza patch prematurely (i.e.< 90% of the intended full application time).
The company expects to provide results from Study C123 to the FDA prior to the PDUFA date of August 16, 2009. The impact on the agency's timing, if any, for an ultimate decision on the NDA is not yet known.
SEPTEMBER 2009
Currently under $10/per share
ISTA 9/12/09:
<2!
Bepreve (bepotastine ophthalmic solution)
Last November, ISTA announced it had filed its NDA with the FDA for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. STA continues to expect a standard review of ten months and has been given a PDUFA decision date of 9/12/09. SeekingAlpha
OCTOBER 2009
Currently under $10/per share
SPPI 10/8/09
Fusilev (levoleucovorin) for Injection to expand use of the drug in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. SeekingAlpha
TSPT 10/31
Y <2 Zolpimist (Zolpidem Tartrate Oral Spray) NVD; Ambien (Zolpidem Tartrate) SNY Y
Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed to treat insomnia from middle of the night awakenings.
PR NEWSWIRE UPDATE: Transcept Pharmaceuticals, Inc. (NASDAQ: TSPT) announced today that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual tablet). The Intermezzo(R) NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009. Under this revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009.
DECEMBER 2009
Currently under $10/per share
SNTS FDA REVIEW 12/4/09 Google
(No name) New tablet formulation to add to its Zegerid family of branded prescription pharmaceutical products. SeekingAlpha 6/2/09
VION.OB 12/12
Info not yet available
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 novo poor-risk acute myeloid leukemia. BioMedReport
NDA submissions – PDUFA dates pending
Currently under $10/per share
ACUS.PK - N/A (ACUS Google chart)
Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. BioMedReport 5/24/09 BioMedReport (Article states, "There is no definitive timeline for a FDA decision on the NDA until further notice from the Comapany...)
APPA - N/A
Product (APF530) to the FDA for the prevention of chemotherapy-induced nausea and vomiting. APF530 is a long-acting formulation of granisetron that utilizes the Company’s proprietary Biochronomer drug delivery system. BioMedReport
THTCF - N/A NDA filed 6/1/09
<2!
Tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy. Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence. SeekingAlpha
SampaGuy
07-24-2009, 12:52 PM
Thanks!!!! This thread is a gold mine lol. Maybe I can add some useful info:
1. Here are some statistics venture capitalists use to calculate risk when considering financing a start-up pharma/biotech company, so I think it would also work for us:
If a new drug (not medical devices) passes:
-Pre-clinical testing - 10% Likelihood of eventual FDA approval
-Phase I clinical trials - 20% Likelihood of eventual FDA approval
-Phase II - 30% Likelihood of eventual FDA approval
-Phase III - 67% Likelihood of eventual FDA approval
Overall average FDA approval rate is 81% (again for drugs, not for medical devices and other stuff)
2. Patents don't mean shit!!!! I could pull out a bunch of scientific words from my ass, title it as "The cure to cancer" and it WOULD get patented! Testing is too expensive, there is none done when you apply to a patent, it doesn't mean anything other than you have legal rights over your invention. The only time your patent will be closely analyzed is in court, when you or someone else claims infringement on it, or some other legal issue. If you look for commentary on LLBO stock right now, you will see many investment websites that say "LLBO has just been awarded a patent for their technology, blah blah blah". These are investors trying to hype up speculation by using wording that make it sound good to someone who is not knowledgeable about the topic. There is nothing wrong with that I guess and can actually be helpful, just be aware that investing websites and blogs do in fact do this, on purpose.
3. I could go to, for example, LLBO's website and find the number to their patent. Then I look up their patent, print it out, and take it to my boss who has among a bunch of degrees, a PhD from Johns Hopkins in biotechnology. He would read it, probably completely understand every word on there and how their drug is supposed to work. BUT even with all his education, he cannot say if a drug is going to work or not unless it is tested. We are still practically in the dark ages of medicine/genetics, intelligent design cannot predict side effects and what not. So the important things is to ride the wave of speculation that comes with a new drug being developed, do not actually bet that the drug is going to be approved or not because you and I don't know shit!
Thanks!!!! This thread is a gold mine lol. Maybe I can add some useful info:
1. Here are some statistics venture capitalists use to calculate risk when considering financing a start-up pharma/biotech company, so I think it would also work for us:
If a new drug (not medical devices) passes:
-Pre-clinical testing - 10% Likelihood of eventual FDA approval
-Phase I clinical trials - 20% Likelihood of eventual FDA approval
-Phase II - 30% Likelihood of eventual FDA approval
-Phase III - 67% Likelihood of eventual FDA approval
Overall average FDA approval rate is 81% (again for drugs, not for medical devices and other stuff)
2. Patents don't mean shit!!!! I could pull out a bunch of scientific words from my ass, title it as "The cure to cancer" and it WOULD get patented! Testing is too expensive, there is none done when you apply to a patent, it doesn't mean anything other than you have legal rights over your invention. The only time your patent will be closely analyzed is in court, when you or someone else claims infringement on it, or some other legal issue. If you look for commentary on LLBO stock right now, you will see many investment websites that say "LLBO has just been awarded a patent for their technology, blah blah blah". These are investors trying to hype up speculation by using wording that make it sound good to someone who is not knowledgeable about the topic. There is nothing wrong with that I guess and can actually be helpful, just be aware that investing websites and blogs do in fact do this, on purpose.
3. I could go to, for example, LLBO's website and find the number to their patent. Then I look up their patent, print it out, and take it to my boss who has among a bunch of degrees, a PhD from Johns Hopkins in biotechnology. He would read it, probably completely understand every word on there and how their drug is supposed to work. BUT even with all his education, he cannot say if a drug is going to work or not unless it is tested. We are still practically in the dark ages of medicine/genetics, intelligent design cannot predict side effects and what not. So the important things is to ride the wave of speculation that comes with a new drug being developed, do not actually bet that the drug is going to be approved or not because you and I don't know shit!
GREAT information, basically its a matter of narrowing it down. Since this market is based on speculation it would be great to get in on the ground floor before anticipation rises. 72% rate of return on AVERAGE when buying 2 months out before decision.. I think at the least right here in this thread we have a good roadmap to profits especially with your knowledge.
Powered by vBulletin® Version 4.2.2 Copyright © 2024 vBulletin Solutions, Inc. All rights reserved.