Celldex Therapeutics (NASDAQ: CLDX) had many biotech investors quite excited for the upcoming 2012 American Society of Clinical Oncology meeting in June, where they had hoped to present initial Phase 2B results of their EMERGE study of CDX-011 in patients with advanced breast cancer. However, news came this morning that a clerical error lead to […]
PLX – Analysis of Protalix BioTherapeutics
It’s 2012 and Protalix BioTherapeutics(AMEX: PLX) Gaucher’s disease treatment, UPLYSO (taliglucerase alfa) is up for approval again. The FDA is set to make a decision on their application tomorrow, May 1st, after delaying the application from February 1st. We think this time around with the FDA will approve Uplyso. UPLYSO was originally granted all the […]
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 […]
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 […]
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 […]
MAPP – Thoughts on MAPP’s PDUFA for LEVADEX
With MAP Pharmaceutical’s upcoming PDUFA for tomorrow, I just wanted to lay out some of my thoughts on their LEVADEX application going into this. Bull case – 505b(2) NDA utilizing the FDA’s familiarness with DHE via injectable DHE and nasal spray, Migranal. – Successful Phase 3 trial; hit required efficacy endpoints – Compares well to […]
Quick take on some upcoming FDA decisions and clinical data
A few comments to highlight some upcoming data or PDUFA events. Threshold Pharmaceuticals (NASDAQ: THLD) has been quite the stock the past few months after landing a partnership with Merck KGaA and reporting positive top-line PFS data from their Phase 2 study in pancreatic cancer. On Monday, April 2nd @ 10:30AM PST, Threshold will be […]
ASCO 2012: American Society of Clinical Oncology Preview Part 2
The 2012 American Society of Clinical Oncology (ASCO) Annual Meeting[link] will take place from June 1st to 5th in Chicago. This is the world’s largest meeting of oncology professionals where some of the industry’s most important data presentations will take place. With conferences like these, come the abstracts releases for presentations; this year abstracts will […]
ARIA – Quick take on Ariad’s upcoming FDA panel
Glancing at the catalyst calendar, we see that ARIAD Pharmaceuticals (NASDAQ: ARIA) Ridaforolimus is scheduled to go before a FDA Oncologic Drugs Advisory Committee on March 20th(Monday)[link] to review their NDA. (The proposed tradename for Ridaforolimus is Taltorvic.) The briefing documents should be available for this meeting tomorrow morning. ARIAD has gone to great lengths […]
ASCO 2012: American Society of Clinical Oncology Preview Part 1
The 2012 American Society of Clinical Oncology (ASCO) Annual meeting[link] will take place from June 1st to 5th in Chicago. This is the world’s largest meeting of oncology professionals where some of the industry’s most important data presentations will take place. With conferences like these, come the abstracts releases for presentations; this year abstracts will […]
ANTH – A look at Anthera’s VISTA-16 and PEARL-SC studies
The recent corporate update[link] from Anthera Pharmaceuticals(NASDAQ: ANTH) warrants further input on our part. Antera revealed more detail about 2 important upcoming catalysts with respect to their lead programs, Varespladib methyl (A-002) for acute coronary syndrome and Blisibimod (A-623) for systemic lupus erythematosus (lupus). Notably, Varespladib’s VISTA-16 ACS study has a Data and Safety Monitoring […]
ARIA – Update on Ariad Pharmaceuticals
Below we have an update on ARIAD Pharmaceuticals(NASDAQ: ARIA) that includes our take on the Ponatinib data at ASH 2011, Ridaforolimus PDUFA thoughts, fourth quarter and full year 2011 updates. Ponatinib At ASH 2011, one of the main presentations to be at was ARIAD’s Ponatinib update,“Initial Findings from the PACE Trial:A Pivotal Phase 2 Study […]
CELG – Key events for Celgene in 2012
For the most part, investors in Celgene (NASDAQ: CELG) have been fully focused on their blockbuster drug, Revlimid. Celgene recently reported 2011 full year Non-GAAP net sales of $4.6 billion, net income of $1.75 billion(or EPS of $3.79), coming largely from the spectacular growth of Revlimid. With full year 2011 REVLIMID sales of $3.2 billion, […]
Quick take on some upcoming catalysts
With Gilead’s (NASDAQ: GILD) recent announcement about the 7977 data(100% RVR, 25/25 in genotype 1 patients so far) should have Idenix(NASDAQ: IDIX) and Achillion(NASDAQ: ACHN) investors thinking hard about the relative risk-reward at this point. GILD announced that data would be available at CROI12 on March 5th-8th; they plan to annouce more SVR data on […]
AMGN, REGN, MNTA & THLD – Quick Updates
Below are some brief note on about a dozen stocks that we felt compelled to brief subscribers on. Today, the briefing documents and panel attendees list for Amgen’s (NASDAQ: AMGN) Xgeva were posted. The panel is schedule for February 8, 2012 with a PDUFA date of April 26, 2012. Amgen hopes to add the indication […]
MDVN – ASCO GU Update
Last night, the abstracts for clinical trials presenting at the 2012 ASCO Genitourinary Cancers Symposium. For now, we want to focus on the most important abstract: Medivation’s (NASDAQ: MDVN) MDV3100 Phase III AFFIRM study of men with castration-resistant prostate cancer(CRPC) that were previously treated with docetaxel. After reviewing the abstract, we believe MDV3100 will replace […]
ARQL – Quick Update on Arqule
On January 17th, ArQule Inc (NASDAQ: ARQL) announced that their Phase 2 trial of ARQ197(Tivantinib) met its primary endpoint in 2nd-line hepatocellular carcinoma(liver cancer). This was somewhat of a surprising results given the difficulty of treating 2nd-line HCC and previous failures in this disease. There are currently no approved drugs for this indication. The recent […]
Trade Ideas for some upcoming catalysts
We wanted to throw out some trading ideas for some stocks that we are following, but may not necessarily get full write-ups on in time. Ideally, we will have research pieces on some of the companies below in the near future. – On Thursday January 26th, Celgene(NASDAQ:CELG) will be reporting earnings and financial guidance for […]
MNTA – Update on Momenta
Over the past several weeks, Momenta Pharmaceuticals (Nasdaq:MNTA) has had interesting developments on multiple fronts that we want to update subscribers on. Novartis (NYSE:NVS) reported 4Q’11 earnings of $225 million in generic Lovenox sales, which is very high given Sanofi launched an authorized-generic Lovenox briefly. These are very good sales numbers that put Momenta back […]
