In early March, Idenix announced the USPTO (US Patent and Trademark Office) had declared a patent interference between its U.S. Patent Application no. 12/131,868 and Pharmasset’s (now Gilead’s) U.S. Patent no. 7,429,572. Idenix, with the earlier filing date, has been designated the senior party in this dispute, where the principal issue is to determine priority […]
EXEL – On Overall Survival And Bone Scans
Exelixis’ abstract of its final data from its pivotal Phase III study of cabozantinib in medullary thyroid (MTC) cancer was released on May 16th during the ASCO abstracts data dump. Investors already knew from top-line data released October 2011 that the drug was highly active and met the primary endpoint of progression free survival (PFS) […]
CLDX – Departing comments on Celldex
With Celldex Therapeutics (NASDAQ: CLDX) due to report results today at 4:30pm EST, we wanted to take a few moments to review a few additional points. For those unfamiliar with the Celldex story, see our recent article[link]. In my opinion, success in this and future trials depends on several variables: whether CDX-011 actually hits GPNMB […]
Quick commentary on ASCO12 abstracts
Last night we had the release of the abstracts for the 2012 Annual Meeting of the American Society of Clinical Oncology(ASCO12 for short). It’s quite the data deluge. Below is some quick commentary on my read on abstracts related to several companies. Onyx(NASDAQ: ONXX) and Seattle Genetics (NASDAQ: SGEN) both had interesting datasets that we […]
INCY – An Acquisition Target?
Today, any biotech company with a promising product may be considered a potential acquisition target. Incyte Pharmaceuticals can certainly be considered one such candidate. It is well known that Big Pharma has been struggling with a lack of productivity, exacerbated by expiring patents on their biggest drugs. Some companies have managed this better than others. […]
ARNA, VVUS & OREX – Update after Lorcaserin AdCOM
Yesterday, the FDA Advisory Committee voted strongly in favor of approving Lorcaserin, for the treatment of obesity. Previously, our group felt that ARNA’s Lorcaserin along with OREX’s Contrave would eventually gain regulatory approval, but that there would be some delay. In the case of ARNA, we were impressed at how eager the Advisory Committee was […]
DEPO, SNTS, XNPT, PFE – Update on Q1 Earnings
DEPO – Reaffirming Buy Yesterday, Depomed reported better-than-expected earnings for the first quarter. Gralise revenue was $1.75 million, Glumetza revenue was $9.2 million, Janumet XR was $0.2 million. We are reaffirming our BUY recommendation for this company. We feel that increases in total sales for Glumetza, price increases, and an increase in the percentage revenue […]
IDIX – To Market By 2015?
Idenix presented at the 37th Deutsche Bank Annual Health Care Conference May 7th. Yeah, not the most exciting event, but still worth mentioning. CEO Ron Renault gave a run-down of the company’s highlights, mostly rehashed from previous presentations, but there were some interesting tidbits. It will be key to be on the market by the […]
ARNA – Quick take on FDA Adcom
Our coverage of the anti-obesity sector continues. Yesterday, the FDA released the briefing documents regarding Arena’s application for Lorcaserin. Lorcaserin, or Lorqess, is a novel therapeutic candidate for treatment of obesity. Brief History: In 2010, Arena submitted the NDA for Lorcaserin, a subsequent AdCom voted against the application, five on the roster voted for the […]
Updates from the Needham Healthcare Conference
The Needham Healthcare conference was held April 3-4, 2012, and as usual, find my notes below. The webcasts can be accessed at this link with the username “needham” and password “healthcare.” Remember that you can always search with a ticker symbol or keyword in the upper right corner of the Chimera site to bring up all articles […]
CLDX – Analysis of Celldex Therapeutics
Celldex Therapeutics (NASDAQ: CLDX) had many biotech investors quite excited for the upcoming 2012 American Society of Clinical Oncology meeting in June, where they had hoped to present initial Phase 2B results of their EMERGE study of CDX-011 in patients with advanced breast cancer. However, news came this morning that a clerical error lead to […]
PLX – Analysis of Protalix BioTherapeutics
It’s 2012 and Protalix BioTherapeutics(AMEX: PLX) Gaucher’s disease treatment, UPLYSO (taliglucerase alfa) is up for approval again. The FDA is set to make a decision on their application tomorrow, May 1st, after delaying the application from February 1st. We think this time around with the FDA will approve Uplyso. UPLYSO was originally granted all the […]
INCY – Summary Q1 2012 Report
Incyte Pharmaceuticals had a very good quarter- the company recorded $25.1 million of total product shipped to distributors, and $19.3 million in net sales. This compares to $2 million in net sales during the last few weeks of Q4 following Jakafi’s FDA approval on November 16 2011. Shares have jumped about 16% the last couple […]
POZN – FDA Asks For More Data
During a pre-submission meeting for the filing of PA32540, the FDA asked Pozen to seek approval for a lower aspirin dosage formulation of 81mg along with their current 325mg. The FDA indicated that without a lower dosage form, it may restrict PA32540’s indication to use in use in post coronary artery bypass graft surgery (CABG) […]
CHTP – Commentary on Chelsea Therapeutics
Chelsea Therapeutics (NASDAQ: CHTP) didn’t quite start 2012 off like some had hoped. On March 28th, the company received a complete response letter on their NDA of Northera (Droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension(NOH). The company plans on discussing what exactly the FDA will require for approval; we imagine they hope the […]
FOLD – Update on Amicus Therapeutics
Investors in Amicus Therapeutics (NASDAQ: FOLD) are anxiously awaiting data from several ongoing trials in rare-diseases. We initiated coverage on Amicus back in January[link]. We are waiting data from the Phase II co-treatment data for Amigal in Fabry disease(Study 013) and the Phase 2 study of AT2220 in combo with enzyme-replacement therapy(ERT) for Pompe disease. […]
GEVA – Hype or Substance?
Synageva shares have risen sharply in the last few months from a low of $8.30 to $38.04 today, now sporting a market cap of $800 million. Its most recent catalyst came on a Morgan Stanley analyst initiation on April 20th with a $76 price target. Synageva has only been a public company for less than […]
PCYC – Update on Pharmacyclics
With the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) rapidly approaching, Pharmacyclics will be providing several updates there that the Street will be watching closely. Their lead drug is a Bruton’s Tyrosine Kinase (Btk) inhibitor for hematological disorders, Ibrutinib(PCI-32765), which is in multiple Phase II trials. PCI-32765 is the company’s major […]
DEPO – Quick Update on Depomed’s plan to file NDA for Serada
On Tuesday, Depomed announced that they intend to file an NDA for Serada. At one point, in after hours trading the stock peaked up almost 7%, at which point we cautioned investors, here, to consider selling into this strength. Since then, it seems that the stock price had settled back down pre-news levels until […]
SGEN – Update on Seattle Genetics
A series of recent moves by Seattle Genetics is positioning the company to capitalize on its current success to build for future growth. As previously mentioned in our last report, Seattle Genetics is on track to start three Phase III studies for Adcetris in the front line setting this year: Hodgkin’s Lymphoma (HL), Mature T-cell […]
