Afrezza, Type 1 and 2 diabetes
Top-line results from two phase III studies expected in August.
After two FDA rejections, MannKind is back seeking another shot at approval of its inhaled, fast-acting insulin. The data from these two phase III studies, if positive, will form the basis of the Afrezza resubmission. Vical ( VICL)
Allovectin for melanoma
Top-line results from a phase III study expected in the third quarter
The long-delayed Allovectin study is finally almost complete. I explained the bear thesis on Vical and Allovectin in a previous Mailbag. Orexigen Therapeutics ( OREX) and Takeda
Interim analysis of the cardiovascular outcomes study could take in the second or third quarter.
Under an agreement with FDA, Orexigen and its partner Takeda will conduct an interim analysis of the Contrave study once 87 major adverse cardiovascular events have been recorded. If the interim analysis returns clean heart-safety data for Contrave, the obesity drug will be resubmitted to FDA for a second review.
Amigal, Fabry disease
One-year results from the Amigal monotherapy phase III study are expected in the middle of the year.
Amicus presented disappointing six-month results from this Amigal study last year but an alternative theory explaining the failure may bode well for the 12-month results. Xoma ( XOMA)
Top-line results from a phase II study expected in July or August. Achillion Pharmaceuticals ( ACHN)
Sovaprevir, ACH-3102 in hepatitis C
Early response (RVR) results from this combination study of Achillion's protease inhibitor sovaprevir and NS5A inhibitor ACH-3102 in treatment-naive, genotype 1 hepatitis c patients will be announced in the third quarter. Alnylam Pharmaceuticals ( ALNY)
ALN-TTR02, transthyretin-related hereditary amlyoidosis
Top-line results from a phase II study expected in the third quarter. Biodel ( BIOD)
BIOD-123, a fast-acting mealtime injectable insulin for diabetes patients.
Top-line results from the phase II study expected between August and September. TheStreet contributor Mark Messier wrote recently about Biodel. GTx ( GTXI)
Enobosarm for cancer-related muscle wasting
Phase III results expected in the third quarter. Keryx Pharmaceuticals ( KERX)
Zerenex for non-dialysis dependent chronic kidney disease.
Phase II results expected in the third quarter. Merrimack Pharmaceuticals ( MACK)
MM-398 for second-line pancreatic cancer
Top-line results from phase III study expected before year end. Rockwell Medical ( RMTI)
Soluble Feric Pyrophosphate (SFP) for anemia in kidney dialysis patients.
Results from two phase III studies expected in July and October, respectively. ChemoCentryx ( CCXI)
CCX140 for diabetic nephropathy
12-week data from a phase II study in the third quarter. Coronado BioSciences ( CNDO)
CNDO-201 for Crohn's disease
Phase II results in the second half of the year. Special thanks to BioMedTracker for use of its research databases to help put together this clinical trials calendar. Back to more of your emails and tweets next week. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein