Market Cap: $150
On Monday, announced revised PDUFA decision date of 6/23/11 for morphine sulfate
NDA following successful completion of pre-approval inspections, also two generic
product ANDAs pending but no formal decision deadlines.
Market Cap: $203
RPTP completed last patient visit on 6/3/11 for a novel twice-daily formulation of
treatment for metabolic disorder (cystinosis), Orphan Drug status in US / EU. RPTP
expects to report data by end of July 2011.
Talon Therapeutics (formerly Hana Biosciences)
Market Cap: $20
On Monday, TLON presented PHASE 2 trial data with 35.4% overall and 20% complete
response rate for treatment of adults with Philadelphia Chromosome Negative acute
lymphoblastic leukemia (Ph- ALL) and plans to file NDA seeking accelerated approval
by end June 2011.
Market Cap: $333
On 5/3/11, reported PHASE 3 (NEO3-09) trial met all endpoints vs. vital blue dye for
lymph node mapping procedure in patients with melanoma or breast cancer, along with
previously reported PHASE 3 (NEO3-05) trial. NEOP plans to file NDA during 3rd
quarter of 2011, on 6/7/11 hedge fund with short position filed Citizen Petition requesting
denial of NDA filing based on deficient trials but NEOP will file NDA as planned.
Market Cap: $262
Began enrolling patients 1st quarter of 2011 for pivotal EU acute heart attack (MI) trial
and expects to complete patient enrollment during 1st half of 2013. CYTX expects to
receive CE Mark clearance for next-gen Celution One in 2011, and CYTX expects a
late 2011-early 2012 indication-for-use decision for no-opatiention chronic myocardial
ischemia patient, reported results persisted over 18 months in 14-patient APOLLO trial.
Market Cap: $287
Licensed to UCB for all auto-immune indications, IMMU began enrolling patients in two
pivotal trials in December 2010 for moderate to severe lupus (SLE). Results are expected
in the 1st quarter of 2014.
Market Cap: $294
On 5/25/11, DVAX completed a 12-month follow-up for all 2,449 subjects for PHASE 3
lot-to-lot consistency and safety trial of vaccine for prevention of hepatitis B infection in
subjects with chronic kidney disease and expects to report results within 8 weeks (mid-
July estimate) to support potential BLA filing by year-end 2011.
Market Cap: $3
Phase 2b trial in patients with advance gastric cancer (lead indication for this compound)
with results expected mid-2012, in September 2010 initiated new Phase 2 study for
bladder cancer (NCT01215877 with results expected 4th quarter of 2012), expected start
of PHASE 3 trial with SPA request for gastric cancer during 2nd half of 2011.
Market Cap: $44
Expects to begin pivotal PHASE 3 clinical trials under SPA during 1st half of 2012 as
adjuvant therapy for women with low-to-intermediate HER2+ status breast cancer not
eligible for HERCEPATIENTIN. In June 2011, presented PHASE 2 trial results in
combo with HERCEPATIENTIN.
Market Cap: $294
In April 2011, CHTP confirmed plans to file NDA for treatment of sympatientomatic
NOH (neurogenic orthostatic hypotension) based on two completed PHASE 3 trials
(Study 301 & 302 with new data reported in June 2011) during 3rd quarter of 2011.
CHTP will continue clinical development (Phase 3 Study 306) for potential falls claim
indication with results expected during 2nd quarter of 2012.