Algeta: The prostate cancer radio-pharmaceutical Alpharadin was submitted to FDA in December so Algeta is still waiting to hear on filing acceptance and priority review. Even though Alpharadin is much easier to use than previous radio-pharmaceutical disappointments like Bexxar and Zevalin and despite stellar survival data, Wall Street investors remain generally suspect about Algeta's commercial prospects. The company needs a speedy FDA approval and a strong launch (hopefully in the back half of 2013) to reverse the skepticism.
Opko Health (OPK): I'm finally going to dig into Opko, to figure out if there's anything more substantive to the company beyond the celebrity status of Chairman and CEO Phil Frost.
Wednesday, Jan. 9 (Feeling really tired by now)
Spectrum Pharmaceuticals (SPPI): What, if anything, can CEO Raj Shrotriya say to scare the shorts, who have nested comfortably in this stock for a year? For starters, Shrotriya should offer more details from the phase III study of belinostat in peripheral T-cell lymphoma. Disclosure to date has been woefully inadequate. Shrotriya will also surely be peppered with questions about the future growth of Fusilev in the face of leucovorin supply slowly coming back on line.Nektar Therapeutics (NKTR): Like many investors, I'm still waiting for Nektar and its partner AstraZeneca to tell us what really happened with the phase III study of opioid constipation drug naloxogel. How much bio-statistical jujitsu was necessary to turn a failed study into one with "positive" results? NPS Pharmaceuticals (NPSP): You're really going to price Gattex at $295,000 per year? Isis Pharmaceuticals (ISIS): When European regulators rejected Isis' HoFH drug Kynamro, supporters defended, claiming the company's real value lies in its deep antisense drug pipeline. Okay, show us what you got. Ziopharm Oncology (ZIOP): The only thing that matters are data from the phase III study of palifosfamide in soft-tissue sarcoma. Results expected before the end of the first quarter. Amicus Therapeutics (FOLD): What caused the failure of the Amigal study in Fabry disease? We may not get the answer until data are presented at a medical meeting in February, but Amicus management will be needled with questions during the breakout session. Arena Pharmaceuticals (ARNA): The commercial launch of its weight-loss pill Belviq is imminent, making Arena the best short of 2013 or a soon-to-be blockbuster. [You know my stance.] Idenix Pharmaceuticals (IDIX): 2012 started off bright for Idenix with shares soaring on optimism about its hepatitis C drug portfolio and speculation about a takeout. That all went to crap in August when FDA placed two Idenix drugs on clinical hold -- casualties of the cardiovascular toxicities that killed Bristol-Myers Squibb's BMS-094. Those two Idenix drugs, IDX-184 and IDX-368, remain on FDA clinical hold, although the company hopes to hear good news from the agency in the first quarter. After that, Idenix needs to play a serious game of catch-up drug development if it wants to remain a viable Hep C player. Exact Sciences (EXAS): Top-line results from the pivotal validation study of Cologuard, the company's non-invasive colon cancer screening test, will be released in March. Sarepta Therapeutics (SRPT): Expect incremental updates from CEO Chris Garabedian about timelines for eteplirsen in 2013. Thursday, Jan. 10 (I'll be on a plane flying home but in case you're still paying attention...) MannKind (MNKD): Round two of Afrezza phase III data coming. Al Mann still can't find a partner or enough investors to care about inhalable insulin. Questcor Pharmaceuticals (QCOR): Is there anything Questcor management can do to stem the criticisms about its Acthar pricing and marketing practices? Keryx Pharmaceuticals (KERX): Investors are still waiting for results from the long-term safety study of the phosphate binder Zerenex. Even if approved, Keryx needs to figure out how to sell a premium-priced drug in a generic and highly competitive dialysis market. Vical (VICL): Waiting to hear if Allovectin melanoma data will be pushed back again -- this time to 2016. Geron (GERN): Condolences. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein
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