The BioPharm Insight™ November Catalyst Monitor Spotlights 12 Key Development and Regulatory Events

Share Article

Companies with upcoming events to watch include Pfizer, Incyte and Exelis

BioPharm Insight’s monthly Catalyst Monitor analyzes the most material events in the sector during the upcoming month. The Catalyst Monitor tracks significant events and announcements such as FDA approvals, Advisory Committee (AdCom) meetings and expected key clinical results. To access the entire 40-page report, featuring proprietary investigative journalism relevant for each profiled event, sign up for a free demo or trial of BioPharm Insight.

While’s Pfizer’s PDUFA date for tofacitinib in rheumatology was set for November 21, the drug won approval on November 5. Although entering into an already crowded market, tofacitinib, a JAK inhibitor, will have a first-to-market advantage over other oral kinase inhibitors coming through the RA pipeline. Among those pipeline competitors is Eli Lilly and Incyte’s baricitinib set to release Phase IIb data at the Ameri¬can College of Rheumatology Annual Meeting on November 11. Assuming the ACR data is good, Lilly will not halt progress. The market is too big and baricitinib will likely be second to market behind Pfizer’s tofacitinib.

After two failed attempts at positive Phase III results for pimavanserin in Parkinson’s disease psychosis, Acadia Pharmaceuticals is set to release results from its ongoing Phase III trial on November 30. A larger-than-expected improvement in the placebo arm ultimately led to the failure of the first Phase III trial. Design changes for the ongoing trial lend themselves to a more sophisticated method for evaluating patient response, which should be good for pimavanserin evaluation; however, ultimately, they may not really lessen the placebo effect.

Showing an advantage over already approved Caprelsa, Exelixis’ cabozantinib in advanced medullary thyroid cancer (MTC) has shown a favorable toxicity profile and based on trial data, it does not seem like cabozantinib leads to any significant cardiovascular (CV) complications including QT prolongation and seems better than Caprelsa in terms of CV impact. Cabozantinib will likely be approved on the back of impressive data from its pivotal clinical trial, experts noted. Exelixis has a PDUFA date of November 29.

Additional catalysts covered in this report include:

  •     Dynavax’s AdCom meeting for HBV candidate, Heplisav
  •     BioMarin’s Phase III results for BMN-110 in Morquio A
  •     Amicus and GlaxoSmithKline’s Phase III data for Amigal in Fabry disease
  •     Biogen Idec and Knopp Biosciences’ Phase III results for dexpramipexole in amyotrophic lateral sclerosis

About BioPharm Insight

BioPharm Insight is the definitive guide to the global biopharma community. BioPharm Insight provides clients with an information edge by combining the most comprehensive real-time database of companies, drugs, contacts, M&A and licensing deals, forecasts and clinical trial data with proprietary forward-looking intelligence uncovered by an independent team of investigative journalists months or even years before it breaks in mainstream media. To learn more, visit

About Infinata, Inc.

Featuring a comprehensive BioPharm Solutions Suite, unique Wealth Prospecting tools and innovative Custom Data Services, Infinata provides personalized technology solutions to turn information into insight. Infinata is a part of Mergermarket, a Financial Times Group company and a division of Pearson plc. To learn more, visit

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Holly Burke
Email >
Follow us on
Visit website