VVUS, OREX, ARNA – Understanding the Advisory Committee
Playing VVUS, OREX, ARNA through FDA Adcomm and Qnexa PDUFA Over the past several months, these three companies, with their respective late-stage anti-obesity drug candidates, have experienced a considerable increase in volatility and share price, due in part to new regulatory revelations regarding clinical pathways to regulatory approval. We believe there will continued volatility leading […]
Updates from the Cowen & Co. Healthcare Conference
The early spring biotech investor conference calendar continued with the annual Cowen & Co. Healthcare Conference held March 5-7, 2012 in Boston, MA. As always, my webcast notes below contain only key updates, changes, or new information, and do not represent a complete reprise of any presentation. Additional details on many of these companies can […]
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 […]
POZN – Succeeds In Two Pivotal Trials- A Chat With Management:
POZN Succeeds In Two Pivotal Trials- A Chat With Management: (Apologies in advance- no transcript, just some notes.) As we know, Pozen announced yesterday positive top-line results from two pivotal Phase 3 clinical trials of PA32540, a novel, coordinated-delivery tablet of immediate-release omeprazole (40 mg) and delayed release aspirin (325 mg). I spoke briefly with […]
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 […]
POZN – Focusing on PA32540
POZN: Focusing on PA32540 In Pozen’s last earnings call on February 28, CEO John R. Plachetka told analysts top-line results originally projected for the first half of this year, are now expected in mid-March. Refresher: PA32540 is Pozen’s aspirin/omeprazole co-formulation for the prevention of NSAID-associated upper gastrointestinal (UGI) toxicity. It contains 325 mg aspirin and […]
TZYM – Pivotal Results Approaching
TZYM: Pivotal Results Approaching Durham, North Carolina’s Tranzyme Pharma is a small biotechnology company focused on the development of novel treatments for Gastrointestinal (GI) disorders. Its main product is Ulimorelin for post-operative ileus (POI), a Ghrelin agonist designed to aid the recovery of GI function after bowel surgery. It is set to report results from […]
Updates from the Citi Global Healthcare Conference
The annual Citi Global Healthcare Conference was held February 27-29, 2012, and as always we listened in on the webcasts to identify key takeaways for Chimera Research Group shareholders. These write-ups may be brief due to overlap with comments at other recent investor conferences – see links below. Amarin $AMRN (Leerink Swann notes – company overview) “We […]
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 […]
