Flexion Therapeutics announced the FDA informed the company yesterday that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase IIb trial evaluating FX006 in patients with osteoarthritis (OA) of the knee. Flexion has not yet received written notice of the hold, but verbal communication from the FDA indicates it […]
[Free Report] Endo Makes Bid For Auxilium; Gilead Fails Pancreatic Cancer Trial
Endo International made an unsolicited proposal yesterday to acquire all the outstanding shares of Auxilium Pharmaceuticals for $28.10 per share in a mixed cash and stock transaction valuing the company at $2.2 billion. Endo intends on funding the deal with existing cash as well as debt financing. Endo expects the addition of Auxilium to be […]
[Free Report] SIGA Files for Bankruptcy; NeuroDerm Files for IPO
SIGA Technologies filed for Chapter 11 bankruptcy protection Tuesday as it seeks time to appeal a court order favoring PharmAthene. In an earlier ruling, the Delaware Court of Chancery found SIGA had failed to execute its licence agreement with PharmAthene relating to the smallpox drug Tecovirimar. SIGA believes the lump sum payment and damages it […]
[Free Content] Avanir Scores Positive Alzheimer’s Data; NPS Gets Nod From Panel
Avanir announced positive results from its Phase II trial evaluating the safety of AVP-923 in a 10-week study of 220 alzheimer’s patients. Treatment with AVP-923 resulted in a statistically significant reduction in agitation and caregiver burden. Complete data will be presented at the American Neurological Association’s (ANA) 2014 Meeting , October 12-14. The company plans […]
[Free Report] Merck KGaA Ends Cancer Vaccine Trials; RTRX Takes Heat
Following the failure of tecemotide (formerly known as Stimuvax) in a Phase I/II study in Japanese patients, Merck has decided to discontinue all clinical development of the drug, including the Phase III START2 and INSPIRE non-small cell lung cancer trials. Tecemotide is a MUC1 antibody-specific immunotherapy licensed from biotech company Oncothyreon. It had previously failed […]
Arrowhead Research (ARWR)– Great Technology, But is the Company Over-Promising on ARC-520?
Two billion people globally have been infected with hepatitis B (HBV), and approximately 350 million are chronic carriers, including approximately 750,000 persons in the US. Among the chronically infected, 15% – 40% will develop cirrhosis and/or hepatocellular carcinoma. Each year approximately 5000 people in the US and 1 million worldwide die from cirrhosis, liver failure […]
Analysis of TGR-1202, a PI3K Delta Inhibitor From TGTX
This is a quick take on the TGTX efficacy data presented at ASH this past weekend. TG Therapeutics reported PK data as well as results from the higher 800 mg cohort. It appears this step up from 400 mg has finally resulted in some activity and the company continues to dose escalate; an 1800 mg […]
Quick take on Geron’s Imetelstat abstract
Today we finally got a glimpse at the ongoing investigator sponsored study of Geron (GERN) imetelstat in myelofibrosis. We have previously discussed this program here. The abstract can be found here. An oral presentation is scheduled for Monday, December 9th at 4:45 PM. The study was carried out by Dr. Tefferi at the Mayo Clinic. […]
Horizon Pharma continues cash burn and dilution
We last wrote on Horizon Pharma (NASDAQ: HZNP) following their FDA approval of RAYOS, but seems not much has changed. However, the stock has risen roughly 60% year to date with no apparent change in fundamentals. We view this company as overvalued given their products exorbitant price, no data to support superiority claims over cheap […]
MYGN – To Myriad Investors – Your Risks are MyRisk
Co-Author: Dr. Tro Kalayjian Myriad (NASDAQ:MYGN) is a molecular diagnostics company that focuses on the development and marketing of predictive medicine, personalized medicine, and prognostic medicine tests in the United States. Their most well-known tests include BRACAnalysis/ BART, which are tests for hereditary breast and ovarian cancer, and COLARIS, another hereditary cancer test for colon […]
RTRX – Notes on Retrophin’s PKAN program
August was a month full of news for Retrophin (RTRX): financing, PR on preclinical results of their PKAN candidate (RE-024), PR on agreement to negotiate a candidate for autism and schizophrenia. In addition, rumors came out on Alexion making an offer for $10 a share, motivated by the strong preclinical results of RE-024. All this […]
VICL – Quick take on Vical’s Allovectin failure
(With Patrick Crutcher) Today Vical (NASDAQ: VICL) reported top-line data from a Phase III trial of Allovectin-7 (A7) in patients with advanced melanoma. As we predicted in this article, the trial failed. A7 not only didn’t meet the survival endpoint, but it also missed the primary endpoint of durable response rate. Shares of Vical fell […]
BCRX – BioCryst – Entering The HAE Market
BioCryst announced on Monday July 22 the successful completion of a Phase I study on the safety and PK of BCX4161, a candidate for the treatment of Hereditary angioedema (HAE). HAE is a genetic disorder resulting from the loss or dysfunction of complement C1 Inhibitor (C1INH). Among the functions performed by C1INH is regulation of […]
Biotech IPO’s hot in the first half of 2013
(jointly with Jason Chew and Juan Pedro Rodriguez Serrate) To say biotech IPOs have been hot seems like an understatement. The past year has been an open feeding frenzy for biotech companies looking to raise capital on the public markets. It would seem there is significant pent up pent up supply and demand for these […]
EDAP – A look at microcap device maker, EDAP TMS
Last year, we had projected that EDAP TMS (NASDAQ:EDAP) would report data from their Phase 2/3 trial(ENLIGHT) trial for the indication of low risk, localized prostate cancer. However, we have seen no statement on the results of the trial thus far. Ablatherm HIFU has been approved in the EU for quite some time, but their […]
SRPT – A Quick Look At The Chart
Sarepta Therapeutics, Inc – Nasdaq(SRPT) Quick update: A big drop in SRPT today leaving the traders with speculation that there could be a leak about the decision to file for accelerated approval(AA) or not yet. For now, let’s take a look at the chart & check the technical standpoint. Daily Chart The price has been trading […]
DCTH – Soaring Ahead of The Upcoming Advisory Committee
Delcath Systems, Inc. (DCTH) -Nasdaq DCTH has been on our watch list for a while, looking for an entry point. we kept following out the stock performance at the forum and stated a position at $1.63 just after the price found a support around the 200-day Moving Average, also added more shares to the position at […]
PPHM – Peregrine’s Bavituximab future looks bleak
We have previously discussed[1][2] the numerous shortcomings of the overhyped oncology developer, Peregrine Pharmaceuticals (NASDAQ: PPHM). With further details on a botched Phase II trial that still leave many questions, investors still have not woken up to the fact that Bavituximab is worthless. In 2013, we expect to see another failed trial in first-line lung […]
SGMO – Sangamo Getting Ahead Of Itself
SGMO: Sangamo Getting Ahead Of Itself Sangamo BioSciences has received a great deal of attention in recent weeks with the unveiling of a broad orphan drug therapy initiative at JPMorgan. This has overshadowed what appears to be weak data in its leading HIV drug candidate SB-728-T. Background: SB-728-T is an autologous zinc finger nuclease (ZFN) […]
ZIOP – Preparing for an Explosive Move
ZIOPHARM Oncology, Inc. (ZIOP)-Nasdaq Since November 11, 2012 ZIOP was trading in a horizontal channel, the upper resistance line at $4.81 and the lower support line at $4.01, till February 12, 2013, the day ZIOP announced that the Phase 3 (PICASSO 3) trial of palifosfamide (ZIO-201) in first-line metastatic soft tissue sarcoma has reached its […]
