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

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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 […]

Exelixis- Why The Holdup?

Why so long to file an SPA (Special Protocol Assessment), investors wonder. An SPA in itself is not necessary, but sets up agreed upon protocols and endpoints of a pivotal trial that will be used to file for a new drug application (NDA). Having one in place may give the trial sponsor more confidence while […]

On Eli Lilly And Innovation

Eli Lilly CEO John Lechleiter is calling for U.S. immigration officials to issue more green cards, saying a shortage of highly skilled immigrants is stifling innovation in the pharmaceutical industry. (Bloomberg) Really? Last I heard the industry has been on a firing binge, cutting back on R&D while outsourcing a multitude of functions to CROs. […]

AstraZeneca- How Much Longer Can It Go On?

A great article in the Wall Street Journal by Hester Plumridge AstraZeneca’s Too-Concentrated Solution talks about the company’s sale today of its medical devices unit AstraTech to Dentsply International. With the sale, AstraZeneca is focusing its resources the core prescription drugs business. This doesn’t sound like a good plan considering AstraZeneca doesn’t exactly have the […]

Opioid Pain Drug by Pfizer and Acura approved by FDA

The FDA has granted approval for an abuse-resistant opioid formulation made by Acura Pharmaceuticals (NASDAQ:ACUR) and Pfizer (NYSE:PFE).  The drug is a reformulation of immediate release oxycodone.  The trade name of the drug will be OXECTA, it was previously known as ACUROX.  Pfizer’s media relations said that they can provide more information once the press […]

Exelixis May Have Competition For Its Prostate Cancer Drug

Bone metastases is a painful condition that occurs in about 90% of advanced prostate cancer patients and is associated with shorter overall survival. In the last few years, many advances have been made in the treatment of prostate cancer, with several new drugs approved and more on the horizon. Approved drugs include Provenge, Jevtana, Zytiga, […]

YM Biosciences Continues Post-ASCO Fall

YM Biosciences has taken it on the chin after its ASCO presentation failed to impress investors. Its stock is now down about 21% from a high of $3.78. The company has several projects but practically all its value is placed on lead JAK inhibitor CYT387, in development for the treatment of the blood cancer Myelofibrosis. […]