We fully expected that pSivida(NASDAQ: PSDV) and Alimera Sciences(NASDAQ:ALIM) will receive another Complete Response Letter for ILUVIEN in the treatment of diabetic macular edema (DME). We see little reason for the FDA to approve this NDA, based on the safety and efficacy data. Both PSDV and ALIM will be hard up for cash if ILUVIEN […]
ARIA – Initiate Coverage on Ariad
ARIAD Pharmaceuticals: Initiate Coverage Overview Ariad is a clinical stage biotech company with three compounds in development, ranging from Phase I to NDA submission. The most important of these is ponatinib, a pan BCR-ABL inhibitor for the treatment of Chronic Myeloid Leukemia (CML) and potentially other cancers. The compound is in a global registration study […]
SNTS – Initiating Coverage on Santarus
On November 8th, Santarus (NADSAQ:SNTS) reported third quarter earnings of $0.01 per share, which was in-line with estimates. Interesting to note, SNTS management has guided higher on Glumetza sales, and has indicated that they are hiring 40 more sales reps to detail the drug. Management further indicated that they anticipate at least $25 million in […]
INHX – Trade Idea
Video: http://content.screencast.com/users/biotechtraderHB/folders/Default/media/e7f5888c-ae53-412d-ad9e-36eee29a425b/$INHX110911.swf Analyst Notes: INHX showed only 7 day viral reduction data, which has not been shown to be highly correlated to a sustained viral response. What we want to see are 4 week results demonstrating high rates of rapid virologic response, or undetectable levels of viral rna. 4 week data is highly predictive of […]
INCY – PDUFA Trade Note
Incyte Pharmaceuticals is awaiting FDA approval of its lead compound Ruxolitinib (INCB18424) for the treatment of Myelofibrosis (MF) with an expected decision date on December 3, 2011. Our analysis suggests a high probability of approval (please see our recent Research Report). We expect the shares to trade over $15 a share. Analyst estimates currently place […]
DEPO, XNPT, PFE – Managed-care to stunt Lyrica, Horizant and Gralise with step-edits
The Neurology and Pain sectors have been very interesting for biotech investors focused over the past year. Xenoport (NASDAQ:XNPT), Depomed (NASDAQ:DEPO), GlaxoSmithKline (NYSE:GSK) and Pfizer (NYSE:PFE) have all had regulatory successes over the past several months. The problem is the regulatory successes haven’t necessarily resulted in financial success for companies and their shareholders. At a […]
Trade Strategy: Approaching Catalysts
Its end of year 2011 and there are a large quantity of trading opportunities approaching. On the docket: $ALIM – PDUFA (NOV 12, 2011) $SPPI – PDUFA (NOV 20, 2011) $TSPT – PDUFA (NOV 27, 2011) $INCY – PDUFA (DEC 3, 2011) $AFFY – Advisory Committee (DEC 2, 2011 / PDUFA on MAR 27, 2012) […]
EXEL – Exelixis Update November 2, 2011- FDA Denies SPA
Exelixis Update November 2, 2011- FDA Denies SPA After hours on Halloween, Exelixis announced it could not reach an agreement with the FDA for the design of its pivotal ‘306 trial of cabozantinib in metastatic castrate resistant prostate cancer (mCRPC) four months after its initial application. That said, the company has decided to initiate the […]
EXEL – Exelixis Update And Catalyst Report
Exelixis Update and Catalyst Report Overview: Lots going on at Exelixis end of this year. The company gave an overview of top-line data from recently announced successful EXAM medullary thyroid cancer (MTC) trial. As previously mentioned, patients on XL184 (cabozantinib) had progression free survival (PFS) of 11.2 months compared to 4.0 months for placebo. The […]
PCYC – Pharmacyclics: Initiate Coverage
Overview: Pharmacyclics is a mid-stage drug discovery company with several compounds in clinical development. The company’s major focus is a Bruton’s Tyrosine Kinase (Btk) inhibitor for non-Hodgkin’s Lymphoma (NHL) and Multiple Myeloma, PCI-32765, now in Phase II trials. It is in a broad program in testing against the major NHL subtypes both as monotherapy and […]
EXEL – Initiating Coverage on Exelixis
(Updated October 25th- MTC trial meets primary endpoint) Overview: Exelixis is a developmental stage oncology company with a single wholly owned compound XL184, or “cabozantinib” in Phase III trials for medullary thyroid carcinoma (MTC). This is a double blind placebo controlled trial with a final endpoint of progression free survival (PFS) initiated in 2008 after […]
INCY – Incyte: Q3 2011 Update
Incyte Corporation: October 27, 2011 Q3 Report Highlights: Incyte provided updates on its third quarter finances and key clinical programs this morning. The company is anticipating approval of ruxolitinib by the PDUFA date of December 3. Launch preparations are advancing; 60 reps have been hired. A request for modification of the Phase III RESPONSE trial […]
DEPO – Buying Opportunity after Serada failure
Earlier in October, Depomed (DEPO), announced results from it’s Phase 3 trial, called BREEZE 3, testing Serada, an extended release gabapentin formulation for the use in post menopausal hot flashes. The trial failed to meet 1 of 4 primary endpoints, and failed to meet its key secondary endpoints. Below is an excerpt from Depomed’s press […]
BMTI – Trade Note
HIGHLY SPECULATIVE TRADE Overview In May 2011 BioMimetic Therapeutics (BMTI) received a positive recommendation from the FDA Advisory Committee for their Augment Bone Graft technology. Despite this, the FDA was not supportive of the clinical data testing for Augment causing the shares to plunge from $13 to around $8 (the shares currently trade around $3 […]
DEPO – Trading BREEZE-3 Results
Overview In the next several weeks Depomed (DEPO) is expected to announce top-line results from it’s large Phase 3 clinical trial for Serada, an investigational non-hormonal treatment for post-menopausal hot flashes. Our analysis suggests a 35-40% probability of positive outcome for all endpoints with an expected share price move from $1.00 to $3.00(1) from current […]
DEPO – Initiating Coverage on Depomed & Examining BREEZE-3
Initiating Coverage: Depomed is a commercial-stage specialty pharmaceutical company with three FDA approved products; ProQuin for infection, Glumetza for Adult Onset Diabetes Mellitus & Gralise for Post Herpetic Neuralgia. Within the next several weeks Depomed will launch Gralise in the USA with a detailing focus to high prescribing neurologists and pain specialists. Also, within the […]
INCY – Initiate Coverage on Incyte
Incyte Pharmaceuticals (INCY) Initiating Coverage: Incyte Pharmaceuticals is a small biotech company focused on developing treatments for cancer and inflammatory disorders. Lead compound Ruxolitinib (INCB18424) is awaiting FDA approval for the treatment of Myelofibrosis (MF) with an expected decision date on December 3rd. Ruxolitinib is also recruiting patients in a global Phase III study for […]
Is Pharmasset The Next Gilead?
The HCV landscape is looking eerily similar to that of HIV treatments at its infancy, with a few differences. While the development of drugs for HIV took off quickly after identification of the disease, only now are truly effective therapies coming to market for HCV, led by pioneering work from Vertex. HIV drug development was […]
Niche Drugs Won’t Save Big Pharma
It seems many in the science community think niche drugs are the salvation for Big Pharma’s woes. With Pfizer’s crizotinib and Roche’s Zelboraf each expected to reach blockbuster status while targeting narrow populations, many are of the belief that future drugs should be aimed toward similarly small populations. This strategy is unlikely to generate consistent […]
Where Is Lilly In The PI3K Race?
Some 15 years ago, scientists at Eli Lilly discovered the first PI3kinase inhibitor, code name LY294002. Although only of modest potency and selectivity, it became widely used by the research community as a tool compound to elucidate the PI3K pathway. In recent years, the field has taken off with compounds in development for oncology and […]
