Shares of ACAD are surging this morning. Here's why:
http://www.marketwatch.com/story/acadia-announces-pimavanserin-meets-primary-and-key-secondary-endpoints-in-pivotal-phase-iii-parkinsons-disease-psychosis-trial-2012-11-27
Showing posts with label Phase III clinical trials. Show all posts
Showing posts with label Phase III clinical trials. Show all posts
Tuesday, November 27, 2012
Tuesday, August 4, 2009
Lorcaserin clinical trial
Ed Susman, a medical doctor who participated as a patient in an obesity clinical trial, blogs about it on MedPage. He still doesn't know if he was part of the Lorcaserin group or the placebo control group--as it is a double-blinded study, but the extreme weight loss for the diabetic points toward the Lorcaserin active group.
Here's the video:
http://neurologicalcorrelates.com/wordpress/2009/02/20/weight-loss-trial-final-report-52-pounds-of-fat-melted-away/
Here's his personal account of it:
http://www.medpagetoday.com/PrimaryCare/Obesity/13506
The results of Bloom, the first of two pivotal Phase III clinical trials, were announced in March. Researchers were upbeat about Lorcaserin's FDA approvability, due to its safety and tolerability profile, as well as meeting one of the FDA weight loss efficacy guidances. Wall Street analysts were underwhelmed, causing the share price of Arena Pharmaceuticals to decline by 25% overnight. I later picked up some more shares when the price per share (pps) bottomed out around $2.50.
Results for Blossom, the second of two pivotal trials will be announced next month, and due to the statistical significance of Bloom's 3000+ patients, Blossom results for 4000+ patients should be similar to Bloom's.
Dr. Susman participated in the non-pivotal Bloom-DM Phase III clinical trial for diabetics. Anecdotally, diabetics find it more difficult to lose weight, so his weight loss of 52 points is especially significant.
Disclosure: Long ARNA shares.
Here's the video:
http://neurologicalcorrelates.com/wordpress/2009/02/20/weight-loss-trial-final-report-52-pounds-of-fat-melted-away/
Here's his personal account of it:
http://www.medpagetoday.com/PrimaryCare/Obesity/13506
The results of Bloom, the first of two pivotal Phase III clinical trials, were announced in March. Researchers were upbeat about Lorcaserin's FDA approvability, due to its safety and tolerability profile, as well as meeting one of the FDA weight loss efficacy guidances. Wall Street analysts were underwhelmed, causing the share price of Arena Pharmaceuticals to decline by 25% overnight. I later picked up some more shares when the price per share (pps) bottomed out around $2.50.
Results for Blossom, the second of two pivotal trials will be announced next month, and due to the statistical significance of Bloom's 3000+ patients, Blossom results for 4000+ patients should be similar to Bloom's.
Dr. Susman participated in the non-pivotal Bloom-DM Phase III clinical trial for diabetics. Anecdotally, diabetics find it more difficult to lose weight, so his weight loss of 52 points is especially significant.
Disclosure: Long ARNA shares.
Wednesday, April 1, 2009
What's Gone Wrong
I'm looking at live video of the restless masses forming in London to greet the G-20 members and I'm thinking this is a microcosm of what's going on worldwide--not just apathy against globalization and banking, but outright anger against capitalism. This is a bad omen on equities and risk capital, in general. We officially now have blood on the streets for the world to see. This is only the beginning, in my opinion.
Buyers of Arena Pharmaceuticals shares took a bath, despite good results in the phase III clinical trials. Lorcaserin, the obesity drug with huge potential, met all FDA end point guidelines regarding efficacy and safety, yet the market punished its stoct because apparently, it wasn't enough to satisfy analysts with poor understanding of the biochemistry behind it. Two years ago, when risking capital was in vogue, the share price of this drug soars from $4.50 to $25 on this good news. Instead, it dropped to $3.
With investing, one has to be grounded with reality--intellectual honesty is fine, but one has to play the cards one is dealt. The price is what it is--no time to play coulda shoulda woulda. Lorcaserin should be approved and this should drive its share price up, whether it's via a co-marketing agreement or an outright buy out offer by a big pharmaceutical company looking to bolster its depleting drug pipeline, as more and more blockbusters go off-patent, impacting profit margins.
So here I am, sitting on losses of 25% to 50%, depending on my entry points. What to do? Two things I plan on doing:
1) Sell covered calls - for each 100 shares owned of ARNA, sell 1 covered call option at a strike price of $5 and as far out in expiration as I can stand to hold on to the stock. The further out expiration month I sell, the more premium I collect. This should completely or partially offset any losses from this trade. This strategy will allow me to collect the premium upfront, irrespective of the direction of ARNA shares. And if ARNA stays at or below $5 during this expiration period, I keep the premium no matter what, and the call option I sold expires worthless--good for me, bad for the option buyer. If ARNA soars above 5, my call will be exercised, meaning I sell my shares at $5, and I still kept my premium. This limits my upside, but that also means I made a 67% profit from selling my shares at $5, PLUS I still kept my premium. This gives me a profitable exit strategy as well as a great hedging opportunity. The only way I lose is if the stock goes down further, but again, I still kept the premium, so it reduces my losses. Covered calls are a way to increase my income while reducing my downside. Just remember to stay covered: I will not write (sell) more call options than I have actual underlying shares. 1 call option contract= 100 shares of underlying stock. In other words, if I own 1000 shares of ARNA, I will sell 10 call option contracts, as each options contract obligates me the right to sell 100 shares at that strike price.
2) To further reduce my downside, I can also buy put options, betting on a further decline in ARNA share prices. But now I have to pay the premium to the put option seller, and now I can lose that premium if the stock doesn't decline. In other words, now I am the casino player--instead of the casino as I was in a covered call. But it protects my position, in case ARNA runs out of cash and drops to $1 or zero, for instance. The value of the put option increases as the share price decreases, so I can profit from the put in the case of the decline in share price. This strategy requires cash outlay, but it gives me leverage and protects me from catastrophe.
As a shareholder, the covered call strategy really has no downside, and only limits my upside. The put options have some downside, because the options can expire worthless whether ARNA stays constant or increases in price (which is a good thing as my underlying stock value rises). A put option is insurance, albeit carries a premium. By contrast, selling a call option makes me the insurer, as I collect the premium. So definitely sell a covered call, and possibly buy put options. Both buying and selling options requires an upgrade one's account, so one has to apply or contact the broker. One needs the ability to write covered calls, and to buy call and put options.
ARNA could have a nice run, and the profits will come in long-term as big pharma should see value in Lorcaserin. But this market is so skittish that if no offer for a buy out or partnership agreement comes through, we as shareholders need to protect ourselves. And if the stock price does rise, we can also participate on the upside. The covered call is a sure way to hedge, while the put option COULD be a great hedge, but also costly--I could lose 100% of my premium upon expiration. As a minimum, one should utilize covered calls. Depending on how pessimistic I am with ARNA, I may or may not buy put options. I could also do both, as the premiums I collect on the covered call can offset the premiums I pay for the put option.
Disclosure: I own shares of ARNA. This is not a recommendation, and do your own diligence. While covered calls are a conservative strategy of increasing income, the downside is that the price of the underlying stock could decline. Put options are inherently risky because one can lose 100% of the premium on expiration.
Buyers of Arena Pharmaceuticals shares took a bath, despite good results in the phase III clinical trials. Lorcaserin, the obesity drug with huge potential, met all FDA end point guidelines regarding efficacy and safety, yet the market punished its stoct because apparently, it wasn't enough to satisfy analysts with poor understanding of the biochemistry behind it. Two years ago, when risking capital was in vogue, the share price of this drug soars from $4.50 to $25 on this good news. Instead, it dropped to $3.
With investing, one has to be grounded with reality--intellectual honesty is fine, but one has to play the cards one is dealt. The price is what it is--no time to play coulda shoulda woulda. Lorcaserin should be approved and this should drive its share price up, whether it's via a co-marketing agreement or an outright buy out offer by a big pharmaceutical company looking to bolster its depleting drug pipeline, as more and more blockbusters go off-patent, impacting profit margins.
So here I am, sitting on losses of 25% to 50%, depending on my entry points. What to do? Two things I plan on doing:
1) Sell covered calls - for each 100 shares owned of ARNA, sell 1 covered call option at a strike price of $5 and as far out in expiration as I can stand to hold on to the stock. The further out expiration month I sell, the more premium I collect. This should completely or partially offset any losses from this trade. This strategy will allow me to collect the premium upfront, irrespective of the direction of ARNA shares. And if ARNA stays at or below $5 during this expiration period, I keep the premium no matter what, and the call option I sold expires worthless--good for me, bad for the option buyer. If ARNA soars above 5, my call will be exercised, meaning I sell my shares at $5, and I still kept my premium. This limits my upside, but that also means I made a 67% profit from selling my shares at $5, PLUS I still kept my premium. This gives me a profitable exit strategy as well as a great hedging opportunity. The only way I lose is if the stock goes down further, but again, I still kept the premium, so it reduces my losses. Covered calls are a way to increase my income while reducing my downside. Just remember to stay covered: I will not write (sell) more call options than I have actual underlying shares. 1 call option contract= 100 shares of underlying stock. In other words, if I own 1000 shares of ARNA, I will sell 10 call option contracts, as each options contract obligates me the right to sell 100 shares at that strike price.
2) To further reduce my downside, I can also buy put options, betting on a further decline in ARNA share prices. But now I have to pay the premium to the put option seller, and now I can lose that premium if the stock doesn't decline. In other words, now I am the casino player--instead of the casino as I was in a covered call. But it protects my position, in case ARNA runs out of cash and drops to $1 or zero, for instance. The value of the put option increases as the share price decreases, so I can profit from the put in the case of the decline in share price. This strategy requires cash outlay, but it gives me leverage and protects me from catastrophe.
As a shareholder, the covered call strategy really has no downside, and only limits my upside. The put options have some downside, because the options can expire worthless whether ARNA stays constant or increases in price (which is a good thing as my underlying stock value rises). A put option is insurance, albeit carries a premium. By contrast, selling a call option makes me the insurer, as I collect the premium. So definitely sell a covered call, and possibly buy put options. Both buying and selling options requires an upgrade one's account, so one has to apply or contact the broker. One needs the ability to write covered calls, and to buy call and put options.
ARNA could have a nice run, and the profits will come in long-term as big pharma should see value in Lorcaserin. But this market is so skittish that if no offer for a buy out or partnership agreement comes through, we as shareholders need to protect ourselves. And if the stock price does rise, we can also participate on the upside. The covered call is a sure way to hedge, while the put option COULD be a great hedge, but also costly--I could lose 100% of my premium upon expiration. As a minimum, one should utilize covered calls. Depending on how pessimistic I am with ARNA, I may or may not buy put options. I could also do both, as the premiums I collect on the covered call can offset the premiums I pay for the put option.
Disclosure: I own shares of ARNA. This is not a recommendation, and do your own diligence. While covered calls are a conservative strategy of increasing income, the downside is that the price of the underlying stock could decline. Put options are inherently risky because one can lose 100% of the premium on expiration.
Sunday, March 29, 2009
ARNA Press Release tomorrow at 5:30 am Pacific time
Now that the press release is issued, I can mention the name of the company I've been raving about. I didn't want to invite scrutiny from regulators about pumping and dumping. Some of my friends and family have known about this speculative play for several weeks and months. I'm glad to say a few acted upon it. It was entirely their decision and they performed their own due diligence.
The timing of the conference call, 5:30 am Pacific time, is significant. It is pre-market opening, which suggests good results from their Phase III clinical trials. A positive announcement post-market close, leaves market manipulators plenty of time that evening and the next morning to manipulate the stock price, punishing shareholders in after hours training. Regarding the timing of announcements of pivotal trials: negative announcements are usually scheduled after market close, while positive announcements usually occur before market opening.
In fact, market manipulation is why this stock stayed at $4 for many days in March. The shorts drove the share prices down, making a profit on the share price decline. Shorting also benefited institutions betting on the share price rising, as they get to buy shares at a lower price. That's why it's common to see analysts downgrade stocks before an important announcement, which is exactly what happened with Arena. Market manipulation is nefarious and illegal, and these individuals and institutions should be bird-dogged and reported to the SEC. However, as an individual investor, and as one who acknowledge sometimes the system is rigged, one should adjust one's investment strategies accordingly. In my case, it allowed me multiple entry points to accumulate shares, because investor sentiment was negative, and I had conviction that Arena was on to something big--I had confidence that Lorcaserin is a game-changer.
Friday's close was $4.50. After positive results, I expect the market to gap up before tomorrow's market opening in the teens, with high volatility throughout the week, amid price spikes for the next few days. I will avoid trading as orders will be difficult to fill--I will just monitor it and watch the shorts scramble, while the share price soars.
Investing is risky and investing in biotech stocks even riskier. Do your own due diligence and consult your financial advisor, altho 99% of them are behind the learning curve. Proceed with caution, and good luck to all.
Disclosure: I own shares in ARNA underlying shares and ARNA call options.
http://finance.yahoo.com/news/Arena-Pharmaceuticals-to-Host-prnews-14777035.html
SAN DIEGO, March 29 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA - News) today announced it will hold a conference call and webcast on Monday, March 30, 2009 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss top-line results from BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management. Jack Lief, President and Chief Executive Officer, Dominic P. Behan, Ph.D., Senior Vice President and Chief Scientific Officer, William R. Shanahan, M.D., Vice President and Chief Medical Officer, and Christen M. Anderson, M.D., Ph.D., Vice President, Clinical Development, will host the conference call.
The conference call may be accessed by dialing 877.874.1565 for domestic callers and 719.325.4758 for international callers. Please specify to the operator that you would like to join the "Lorcaserin BLOOM Trial Results" conference call. The conference call will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for weight management. Arena's broad pipeline of novel compounds target G protein-coupled receptors, an important class of validated drug targets, and includes compounds being evaluated independently and with partners, including Merck & Co., Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
The timing of the conference call, 5:30 am Pacific time, is significant. It is pre-market opening, which suggests good results from their Phase III clinical trials. A positive announcement post-market close, leaves market manipulators plenty of time that evening and the next morning to manipulate the stock price, punishing shareholders in after hours training. Regarding the timing of announcements of pivotal trials: negative announcements are usually scheduled after market close, while positive announcements usually occur before market opening.
In fact, market manipulation is why this stock stayed at $4 for many days in March. The shorts drove the share prices down, making a profit on the share price decline. Shorting also benefited institutions betting on the share price rising, as they get to buy shares at a lower price. That's why it's common to see analysts downgrade stocks before an important announcement, which is exactly what happened with Arena. Market manipulation is nefarious and illegal, and these individuals and institutions should be bird-dogged and reported to the SEC. However, as an individual investor, and as one who acknowledge sometimes the system is rigged, one should adjust one's investment strategies accordingly. In my case, it allowed me multiple entry points to accumulate shares, because investor sentiment was negative, and I had conviction that Arena was on to something big--I had confidence that Lorcaserin is a game-changer.
Friday's close was $4.50. After positive results, I expect the market to gap up before tomorrow's market opening in the teens, with high volatility throughout the week, amid price spikes for the next few days. I will avoid trading as orders will be difficult to fill--I will just monitor it and watch the shorts scramble, while the share price soars.
Investing is risky and investing in biotech stocks even riskier. Do your own due diligence and consult your financial advisor, altho 99% of them are behind the learning curve. Proceed with caution, and good luck to all.
Disclosure: I own shares in ARNA underlying shares and ARNA call options.
http://finance.yahoo.com/news/Arena-Pharmaceuticals-to-Host-prnews-14777035.html
SAN DIEGO, March 29 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA - News) today announced it will hold a conference call and webcast on Monday, March 30, 2009 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss top-line results from BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management. Jack Lief, President and Chief Executive Officer, Dominic P. Behan, Ph.D., Senior Vice President and Chief Scientific Officer, William R. Shanahan, M.D., Vice President and Chief Medical Officer, and Christen M. Anderson, M.D., Ph.D., Vice President, Clinical Development, will host the conference call.
The conference call may be accessed by dialing 877.874.1565 for domestic callers and 719.325.4758 for international callers. Please specify to the operator that you would like to join the "Lorcaserin BLOOM Trial Results" conference call. The conference call will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for weight management. Arena's broad pipeline of novel compounds target G protein-coupled receptors, an important class of validated drug targets, and includes compounds being evaluated independently and with partners, including Merck & Co., Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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