As promised, I wanted to go over the price targets for various outcomes associated with Orexigen’s Contrave PDUFA date on January 31.
Feel free to skip to the end if you’re impatient as I’m going to first go through an awful lot of explanation.
I recently published the following approval odds:
50% – Approval . . . → Read More: Orexigen’s Contrave: Post-PDUFA Price Targets
Next week, we will likely hear the FDA response to the final of the three obesity treatments currently vying for approval in the U.S. Orexigen’s (OREX) Contrave – a sustained release formulation of bupropion and naltrexone – has a scheduled PDUFA date of January 31 (although snow may push the response to . . . → Read More: Orexigen’s Contrave: Approval Odds
Upcoming Catalyst:
FDA announcement whether or not to file Delcath’s 505b2 NDA for the melphalan chemosaturation delivery system for metastatic liver cancer. In addition, Delcath has requested a priority review. The decision is usually communicated within 60 days of the company’s NDA submission, which occurred on December 22, 2010, but can take as . . . → Read More: BIP Quick Analysis: Delcath Systems (DCTH)
Those of you who missed the action we experienced in October were certainly got it this third week of January. One of the most dramatic weeks in recent memory came to a climax late last night as the FDA announced that Clinical Data’s Vilazodone had received approval. The week in general was decidedly . . . → Read More: Recent Analyst Activity – 1/22/11
Yesterday evening the FDA announced that Vilazodone, a novel combination SSRI/5HT1A receptor agonist antidepressant from Clinical Data (CLDA), received approval for marketing in the U.S. This is certainly cause for celebration among Clinical Data’s shareholders as this was a ‘first pass’ approval, a feat that is becoming rarer and rarer with today’s increasingly risk . . . → Read More: Clinical Data’s Vilazodone Approved!
Yesterday evening the FDA announced that Vilazodone, a novel combination SSRI/5HT1A receptor agonist antidepressant from Clinical Data (CLDA), received approval for marketing in the U.S. This is certainly cause for celebration among Clinical Data’s shareholders as this was a ‘first pass’ approval, a feat that is becoming rarer and rarer with today’s increasingly risk . . . → Read More: Clinical Data’s Vilazodone Approved!
Upcoming Catalyst:
Phase III STEPS trial data release for Gattex (teduglutide) for Short Bowel Syndrome (SBS) – 1Q2011.
“With the last patient’s final clinical visit, we remain on track with our development timelines for GATTEX in short bowel syndrome,” said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. “We look . . . → Read More: BIP Quick Analysis: NPS Pharmaceuticals
After an exciting trading day than involved a suspected ‘bear raid’ and, not one, but two trading stops during the day, MannKind was issued a complete response letter (CRL) for its inhalable insulin therapy Afrezza. There was certainly a lot of hype leading up to the decision as news of the new therapy swept . . . → Read More: FDA Requests More Clinical Trials for MannKind’s Afrezza
Today, Depomed’s (DEPO) share price dipped mysteriously mid-day by over 10%. Upon market close, a press release was issued by Depomed potentially explaining the mysterious drop. Abbott is apparently convinced that they are not responsible for launching and commercializing Depomed’s DM-1796, an extended release form of gabapentin for the treatment of post-herpetic nueralgia.
I’ve . . . → Read More: Depomed “Puzzled” by Abbott’s Unwillingness to Launch DM-1796
This Thursday, Aastrom Biosciences (ASTM) is scheduled to present interim phase II data on its tissue repair cell (TRC) therapy for dilated cardiomyopathy (DCM). In preparation of this event, I wanted to bring together the known data for this trial and provide a prediction of what you can expect the data to look . . . → Read More: Aastrom Phase II DCM Data Primer
