When Biotechs Cancel Conference Presentations (ALNY)
There was an intersting note out of Alnylam Pharmaceuticals Inc. (NASDAQ: ALNY). The company has withdrawn from an upcoming investor presentation for this coming Friday.
While it is very possible that this is something completely harmless or just over a scheduling conflict, traders right now are looking for any and all things that could point to the next buyout candidate in a rapidly consolidating biotech sector.
Whether or not anything comes from that or whether this is just noise will be debated by traders and analysts alike. We saw 17,371 shares trade after the close, but a few hundred shares traded up at $36.00 since after this news was released.
JON OGG
AUGUST 4, 2008
New Potential Diabetes Treatments On The Horizon?
Telik, Inc. (Nasdaq: TELK) has announced that the publication of research in “Bioorganic & Medicinal Chemistry Letters” describes a novel class of small molecule compounds that could potentially lead to a new treatment for diabetes. The company noted that these unique compounds are the result of an extensive medicinal chemistry effort at Telik to optimize the original lead structure identified through the application of Telik’s TRAP technology.
Telik noted that the compounds developed activate the insulin receptor and may have the potential to be an orally administered treatment for diabetes. It also notes that such small molecules have been actively sought and could represent a completely different approach to the treatment of Type 1 and Type 2 diabetes.
Telik’s publication “5-Substituted isophthalamides as insulin receptor sensitizers” describes a series of compounds capable of activating the insulin receptor and were also shown to increase glucose transport into adipocytes.
Telik shares are indicated slightly higher, although no trades have been seen as of 9:10 AM EST. This closed at $0.95 yesterday and its 52-week trading range is $0.93 to $4.96. Its market cap based on the close was only $50.5 million.
Jon Ogg
July 8, 2008
MS & Diabetes Hopeful Bayhill No Longer IPO Candidate
Bayhill Therapeutics Inc. was a company we had been expecting to come public for a while. This was going to be a play on autoimmune diseases like multiple sclerosis, but the company has now has withdrawn registration for what it had listed as an $86.25 million IPO.
You can probably guess the reason: unfavorable market conditions.
This was one of the ones we had followed ahead of the IPO because the company has raised what appears to be north of $60 million in venture capital funding rounds. Traditionally, companies in biotech that raise more than $25 million in venture capital tend to come onto many investor radars from VC’s to investors to institutions.
U.S. Venture Partners, Morgenthaler Ventures, De Novo Ventures, CMEA Ventures, Lilly Ventures,and others have stakes from various funding stages.
The company’s MS treatment study is actually beyond initial Phase II stage, and its diabetes study is still in Phase I studies. Investors are likely going to have to hold out longer for a new IPO that would have served these major opportunities.
Jon C. Ogg
June 30, 2008
Insulet Downgrade Scuttles Insulin System Maker (PODD)
Insulet Corporation (NASDAQ: PODD) is seeing shares hit pretty hard today on strong volume. The news is that Canaccord Adams issued an stock ratings Downgrade this morning and it slashed its prior Buy rating down to an unenthusiastic Hold rating. Of all the analysts that cover the stock, this is the first rating to go cautious on the stock. The medical device company of an insulin infusion system for people with insulin-dependent diabetes is down over 9% today at $16.14. This one has been public for a just over a year.
Jon Ogg
June 20, 2008
Vivus’ Qnexa: Better for Diabetes, or Better for Weight Loss? (VVUS)
Vivus Inc. (NASDAQ: VVUS) issued its awaited results on its mid-stage trial of its experimental drug Qnexa, showing that it lowered blood sugar levels and led to weight loss in patients with Type II diabetes.
The results are from its 28-week trial involving 206 subjects, and Vivus said that patients on Qnexa achieved a 1.2% reduction in the key blood sugar measurement hemoglobin A1c compared to a drop of -0.6% for those who received only the placebo.
Qnexa is also being developed for obesity, and the disclosed amount was a loss of approximately 8% of the patients’ starting body weigh. The placebo group reported a loss of 1.2% of their starting body weight.
Vivus also reported that Qnexa trial patients also had significant improvement in cardiovascular risk factors including blood pressure, triglyceride levels and waist circumference.
Qnexa is potentially not going to go entirely unchallenged or at least might not escape without at least some controversy, particularly considering the history of the company and the history of the compounds. It is a combination of phentermine from “fen-phen” and an epilepsy drug Topamax (generic as topiramate).
Shares have been mixed today despite this being reported as and being perceived as positive news. Shares are up less than 1% at $7.05 after 90 minutes of being open, although shares have traded in a $6.81 to $7.22 trading range today alone.
Jon Ogg
June 10, 2008
Amylin Results Better Than Stock Performance? (AMLN, LLY, ALKS, NVO)
Last night we saw the long-awaited results from Amylin Pharmaceuticals Inc. (NASDAQ: AMLN), Eli Lilly & Co. (NYSE: LLY) and Alkermes Inc. (NASDAQ: ALKS) announce their results from their one-year open-label clinical study for a once/week Byetta treatment in type II diabetes in patients who are taking metformin but still don’t have their blood sugar under control.
The results showed that the durable efficacy sustained a similar improvement in their glucose control compared to those receiving treatment for 30 weeks. The results also showed that patients who switched from a BYETTA injection after 30 weeks to exenatide once weekly also experienced additional improvements in A1C and fasting plasma glucose.
Byetta has been on the market since 2005 and exenatide is not yet approved.
If you have watched Amylin over the last few days, it has been a tough patch for the stock as the diabetes competitor Novo-Nordisk AS (NYSE: NVO) results were far better than Wall Street was expecting. On Friday, shares were north of $32.00 and they closed down at $26.84 yesterday.
While there has been relatively thin volume with under 30,000 shares with 1 hour and 10 minutes to the open, shares are up marginally in pre-market trading but are also already off the highs. Unfortunately with an over an hour and a low-grade reaction to what seems like good news it is hard to see any major reaction so far.
Jon Ogg
June 10, 2008
Analysts Chase Diabetes and Insulin Stocks (AMLN, NVO)
Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) is seeing some major trading volume this morning to the downside. The culprit today after prior weakness is a downgrade over at Jefferies & Co. where the firm cut its stock ratings from a “Buy” down to a much less attractive “Hold” rating.
This is the second such day consecutively that Amylin is being pounded. Friday its shares fell from almost $33.00 down to $29.93 after a study showed that Novo-Nordisk AS (NYSE: NVO) outperformed it in diabetes trial results.
Amylin has seen over 4.2 million shares trade by 11:30 AM EST and shares are down over 9% to $27.24. Its 52-week trading range is $23.75 to $53.25.
Elsewhere, Novo Nordisk AS (NYSE: NVO) shares are essentially flat today on an analyst upgrade. HSBC Securities raised a prior unattractive rating of “UNDERWEIGHT” to a “Neutral” rating. As that isn’t exactly a ringing endorsement, there has been little activity there and share have risen from $64.00 in the last 5-day trading period.
Jon Ogg
June 9, 2008
Auxilium Diabetes Drug Meets Endpoints, Yet Shares Slide (AUXL)
Auxilium Pharmaceuticals Inc. (NASDAQ: AUXL) has reported that its experimental treatment for Dupuytren’s contracture met its primary endpoint in two Phase III studies. Auxilium plans to submit an application for approval with the Food and Drug Administration in early 2009.
Dupuytren’s contracture is a diabetes-related condition where fingers and/or the palm of the hand thicken and shorten, causing fingers to curve inward. The company noted that this could become the first new first-line treatment option for Dupuytren’s contracture. The company results reported a 77.8% patient response in those treated with Xiaflex, which saw a reduction in joint curvature. The placebo group saw a 14.3% improvement.
The company used 850 patients who were given Xiaflex injections in trials through May 2008. Of the group, 7 serious adverse events possibly related to the drug have been reported and possible side effects were 3 tendon ruptures, 1 ligament injury, and 1 case of a serious blood clot. As far as how that compares to traditional treatments Auxilium noted that the rate of adverse events is comparable to that involved in surgery.
What is interesting is that if you read through the release it all sounds good. But shares are down by close to 10% in pre-market trading. Shares closed at $31.53 Monday and are down at $28.50 in pre-market trading on more than 400,000 shares at 8:20 AM EST. The 52-week trading range is $14.37 to $36.14, and its market cap before today’s drop was about $1.3 Billion.
Jon Ogg
June 3, 2008