Biotech Values

[DewDiligence]

Clinical-trial / regulatory calendar:

[Please see updating procedure at the end of this post.]


Edits: NKTR: Exubera review delayed until 1/06.
.

ABGX- pivotal Panitumumab results in third-line CRC: mid Nov.

AGEN - Ph III in RCC 1H06.

AGIX - 1H 06 - Ph iii of 1067 on MACE should hit 900+ events for the end of the trial.

ALKS – 12/30/05 PDUFA date for Vivitrex NDA.

AMGN – See ABGX

AORMF -pivotal AMD3100 results 2nd half 06.

AVN – FDA acceptance for filing of NDA for PBA: delayed (was 10/10/05).

AXCA -pivotal Itax results 1st half 06.

BMY – 12/31/05 revised action date for Orencia (CTLA-4).

BOMSF -reporting pivotal MBP8298 results 2 years roughly

CEPH – Nuvigil PDUFA date in EDS: 1/06; Oravescent Fentanyl PDUFA date: 7/6/06.

COR - Oct 2005: Interim analysis - IIa Alzheimer's CX-717 Ampakine trial.
COR - Approx Year end 2005: Results of IIa ADHD CX-717 Ampakine trial.
COR - Early 2006: Results of IIa Simulated Night Shift Work (Sleep Disorder) CX-717 Ampakine trial (funded by DARPA).

CORT - 1H 06 - Results of Ph iii of RU-486 on Psychotic MD

CRME - Phase III RSD1235 ACT 2 CABG data in Q4/05 or Q1/06

CYAHF -20 patient IDE results 4th qtr, then begin the pivotal phase 1st half 06 as well as commercial launch in Europe later this year.

CYPB – Phase-3 Milnacipran in fibromyalgia, second phase-3 study (either 3-mo or 6-mo of follow-up) 3Q06 (maybe —Dew).

DNA - Rituxan ph III results in RA in Q3 05
DNA - Lucentis phase-3 ANCHOR (predominantly-classic AMD) in 4Q05.

DNDN - 10/31/05 full survival data (and possibly less important ttp data as well) from Provenge 9902A trial to be presented at ECCO
DNDN - 1H 06 - Results for Ph iii of Provenge efficacy on PSADT in ADPC

FRX - Milnacipran in fibromyalgia: see CYPB.

GENR – Interim data in phase-2 “209” study: early 2006.

GPCB – Satraplatin SPARC trial: interim efficacy 1Q06, final efficacy 2Q06. (Endpoint is a complex TTP metric.)

GTCB – EMEA opinion on ATryn: Feb. 2006; Merrimack phase-2b MM-093 in RA: mid 2006.

IDBE -begin pivotal Fluinsure trials this winter.

IMCL – Erbitux PFS in (Merck KGaA) CRSYTAL trial in first-line CRC: 2H06; Erbitux H&N PDUFA date: end of Feb 06 (sBLA submitted 8/30/05).

INSM – Approvable letter received—orphan status pending.

ISTKF – 12-week Phase III ISA247 psoriasis results reported in August. 24-week results due in 4Q05.

LBPFF -report Tramadol Phase III U.S. results 2nd half as well as European launch 4th qtr.

Merrimack: see GTCB

MYOG - Top-line data from Ambrisentan phase-3 trials in PAH: ARIES-2 in 4Q05, ARIES-1 in 2Q06.

NABI - ph iii results for vaccine against staph in Q4 05

NKTR – Exubera: endorsed by advisory panel 9/8/05 by 7-2 vote; FDA action by late 1/06.

NVS – LAF237 pivotal data in diabetes: early 2006.

PDLI - Q2 06 volociximab ph II for solid tumors

PTIE - All are 2H05
Oxytrex(TM) Osteoarthritic Pain - Phase III Report top-line results
PTI-901 Irritable Bowel Syndrome - P.III Report top-line results in women

PTN- Q2 2006 ph.IIb results for PTN-141 in male erectile dysfunction

SPPI – See GPCB.

SRDX - Phase-1 AMD data for I-vation w Triamcinilone: mid 2006; Novocell start of phase-1/2 trial in type-1 diabetes: imminent.

TELK - Telcyta 3rd line NSCLC and 3rd line Ovarian results 1H06

Therion (private) – PanVac phase-3 survival results in second-line pancreatic cancer: 1Q06; ProstVac phase-2 (TTP) results of 120-patient trial in asymptomatic HRPC: 1Q06; start of ProstVac phase-3, 600-patient NCI trial in HDPC: 1H06.

TH.TO -report ThGrf Phase III Hiv-associated lipodystrophy results late 06.

VSGN - Celacade phase-3 in chronic HF (ACCLAIM) fiscal 1Q06 (Dec 05-Feb 06).

YMI - early 2006?--672 patients enrolled, 28 to go.YM anticipated that the trial might be completed as early as mid-2006, but seems to be potentially ahead of schedule.
YMI - report pivotal Tesmilifine breast cancer results possibly 2nd qtr 06.
YMI – AeroLEF phase-2b data report: 2Q06.


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