IDIX – Quick chat w/ IDIX CEO Ron Renaud

I had a brief conversation w/ Idenix CEO Ron Renaud this afternoon. Not surprisingly, he was caught up in the deluge of EASL abstracts that were released today. Of particular concern for Idenix was one from Roche involving a trial of their nuc mericitabine and protease inhibitor danoprevir in combination with ribavirin. The trial was […]

IDIX – Is IDX-184 Good Enough?

Idenix may have a new lease on life now that the FDA has lifted all holds on its lead nucleotide IDX184. The company is very keen to put its nuc in combination with a pan-genotypic compound, either a protease inhibitor or NS5a inhibitor. To ensure it doesn’t run into the same toxicity problems it had […]

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 […]

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 […]

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 […]