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 […]
CRIS – Updates from Curis 2011 year-end conference call
Curis (NASDAQ: CRIS) currently trades with an enterprise valuation slightly over $300m. The company’s best known asset is the Hedgehog inhibitor vismodegib (ERIVEDGE) which was recently approved for advanced basal cell carcinoma (BCC) and launched by Roche/Genentech ($5.5m in sales were booked in 1q-2012 representing about the first 6 weeks on the market). This article […]
ARQL – Update on Arqule
We wanted to take some time to review some of Arqule’s (NASDAQ: ARQL) plans going forward in 2012. Management seems more confident than ever in Tivantinib(ARQ197) following their successful Phase 2 in 2nd-line hepatocellular carcinoma(HCC, liver cancer). This success helped convince investors to participate in their recent 7.1M share offering that brought in around $48.7 […]
ARRY – Initiating Coverage – The curious case of Array BioPharma
Array BioPharma (NASDAQ: ARRY) has always been one of those biotech oddities: over 9 partnerships[link] with big pharma but a marketcap under $300M? Weird. Unfortunately, I think Array has been a victim of poor clinical trial design and execution in the past by themselves and partner Astra Zeneca. Some of these missteps appear to be […]
IDIX – Interview With CEO Ron Renaud
Idenix CEO Ron Renaud Q&A April 11, 2012 Idenix has been the subject of considerable attention with EASL (The European Association for the Study of the Liver) approaching and embargoed abstracts flying around the web. The company’s shares have been battered, dropping nearly 50% from January highs as questions have arisen over the potency of […]
IDIX – Quick chat w/ IDIX CEO Ron Renaud
I had a brief conversation w/ Idenix CEO Ron Renaud this afternoon. Not surprisingly, he was caught up in the deluge of EASL abstracts that were released today. Of particular concern for Idenix was one from Roche involving a trial of their nuc mericitabine and protease inhibitor danoprevir in combination with ribavirin. The trial was […]
Updates from the Roth Captial Partners Growth Conference
The annual Roth Capital Partners Growth Conference was held March 11-14, 2012. Find the complete presentation schedule and links to webcasts here. Isis Pharma (NASDAQ: ISIS) KYNAMRO (mipomersen) NDA will be filed in the next few weeks before end of quarter (missing this guidance would destroy the last shred of credibility ISIS management has […]
IDIX – Is IDX-184 Good Enough?
Idenix may have a new lease on life now that the FDA has lifted all holds on its lead nucleotide IDX184. The company is very keen to put its nuc in combination with a pan-genotypic compound, either a protease inhibitor or NS5a inhibitor. To ensure it doesn’t run into the same toxicity problems it had […]
VVUS, OREX, ARNA – Understanding the Advisory Committee
Playing VVUS, OREX, ARNA through FDA Adcomm and Qnexa PDUFA Over the past several months, these three companies, with their respective late-stage anti-obesity drug candidates, have experienced a considerable increase in volatility and share price, due in part to new regulatory revelations regarding clinical pathways to regulatory approval. We believe there will continued volatility leading […]
