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 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 […]

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?

Private: Patrick Crutcher

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

Interakt Thumbnail Image 706

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 […]

Run Biologics- The JAKs Are Coming

A new class of drugs targeting the JAK kinases is set to challenge today’s biggest selling biologics for the treatment of arthritis and other inflammatory diseases. Heading this class is Pfizer’s tofacitinib; this potent, but relatively un-selective JAK inhibitor demonstrated positive results in five pivotal trials earlier this year. Pfizer intends on filing for marketing […]

Antibody Engineering Wars

Therapeutic antibodies have been in use for decades now, becoming a mainstay for the treatment of cancer and inflammatory diseases. The molecules have evolved quickly through scientific advancements from simple mouse antibodies to complex humanized antibody-drug conjugates. Rapid growth in this category has grabbed Big Pharma’s attention, shifting its focus away from traditional small molecule […]

Borrowing Ideas In Drug Development

In the world of small molecule drug development, companies often talk about their large compound screening libraries or special chemistry platforms. You know the story: large numbers of compounds are tested against a target to generate hits, subsequent testing and manipulation narrow down the hits to a small number of leads. Finally, after passing many […]

Celsion- Approval Seems Likely

Celsion is working on a cancer therapy called ThermoDox, a heat sensitive liposomal doxorubicin formulation. The technology was developed as a way to target drug delivery to the tumor. Liposomes were designed to be stable at normal body temperatures but mild hyperthermia (increasing body temperature) in the range of 41 to 42°C would trigger the […]

YMI- Is It Investment Grade?

After taking a post-ASCO fall and sinking below $2.50, YM Biosciences is back near $3.00 with a couple assists from biotech columnist Adam Feuerstein, first naming it a top 10 pick for stocks under $300 million then in a separate article called it the best of the ten. Like many biotechs, YMI’s fortunes are tied […]