[Please keep these entries up to date! See the updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: HGSI Roche TSPT VRUS.
ABT – Certriad PFDUFA date early Apr 2010 (NDA submitted 6/5/09).
ACHN – ACH-1625 HCV protease inhibitor: complete phase-1b monotherapy study end 2009; report top-line data early 2010, likely at JPM conference in January; present full dataset 2Q10 probably at EASL; start phase-2 trial (with or w/o a partner) 1H10. ACHN – ACH-1095 HCV NS4A inhibitor: submit pre-IND package to FDA 4Q09. (See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=41217537 for status of GILD partnership.) ACHN – Unnamed HCV compound with novel MoA: reveal initial details to investors 1H10.
Actelion – BUILD-3 phase-3 trial of Tracleer in IPF: PFS primary endpoint due Dec 2009.
AGN – Botox for migraine: sBLA submission done in late 3Q09 (not PR’d); no reply yet from FDA on possible priority review. AGN – Botox for spasticity: reply to FDA’s CRL submitted in Oct 2009 (not PR’s); Class-2 response from FDA 1H10.
AMLN – Exenatide LAR: PDUFA date early Mar 2010 (NDA submitted 5/5/09 and accepted for review 7/7/09).
ANDS – ANA598 phase-2 trial: safety and RVR data from 200mg arm: end 2009; safety and RVR data from 400mg arm: 1H10; SVR data: 2H10.
Bayer – Xarelto: see JNJ. Bayer – VEGF Trap-Eye: see REGN.
DNDN – Provenge BLA PDUFA date 5/1/10.
DORB - Orbec P3 confirmatory study in treatment of GVHD: expects to begin in 2H 09. DORB - Orbec P2 in prevention of GVHD ongoing.
DYAX – DX-88 for HAE: response to FDA’s CRL submitted 6/8/09.
ELN – AAB-001 phase-3: final data mid-2011 (est.). (First patient dosed 12/21/07.) ELN – ELND005 for AD phase-2: final data 1H10 (est.) (First patient dosed 12/21/07.)
GILD – GS9190 HCV non-nucleoside polymerase inhibitor: start phase-1/2 combination studies with GS9256 protease inhibitor 1H10. (The refocusing of the GS9190 program and the existence of GS9256 were disclosed on GILD’s 3Q09 CC: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42717806 .) GILD – Elvitegravir phase-3 vs Isentress: complete enrollment 4Q09. GILD – ‘Quadro’ phase-2: report primary-endpoint data (24 weeks) end 2009. GILD – GS9450 (caspase inhibitor to inhibit fibrosis): report phase-2a data at AASLD (the HCV study, not the NASH study) GILD – TMC278 + Truvada combo pill: complete bioequivalence studies and submit NDA/MAA 2H10 simultaneously with, or soon after, JNJ’s NDA/MAA submissions for standalone TMC278.
HGSI – Zalbin (Albuferon): PDUFA date Sep 2010 if standard review (BLA submitted 11/25/09). HGSI – Benlysta in SLE: submit BLA/MAA early 2010. (Data from 2nd phase-3 trial reported 11/2/09.)
ITMN – ITMN-191: see Roche. ITMN – pirfenidone: FDA decision on priority review late Dec 2009/early Jan 2010 (NDA submitted 11/4/09); MAA submission 1Q10. ITMN – ITMN-520 qD pirfenidone analog for IPF and other conditions: IND filing mid 2010..
JNJ – TMC278 for HIV: report phase-3 data early 2010; submit NDA/MAA mid 2010. (See GILD me TMC278 + Truvada combo pill.) JNJ – TMC278 + Truvada combo pill: see GILD. JNJ – Xarelto: reply to FDA’s CRL 4Q09. JNJ – PurTox botulinum toxin: submit BLA calendar 4Q10 after completion of two ongoing phase-3 trials. (First phase-3 trial reported positive data 10/1/08.) JNJ – Telaprevir: see VRTX.
MRK – Isentress sNDA for qD dosing: submission 2011. (Phase-3 trial called QDMRK started 4Q08: Isentress BID + Truvada vs Isentress qD + Truvada in first-line setting.)
NVS – FTY720 in RRMS: NDA and EU MAA to be submitted in late 2009. (Positive data from the FREEDOMS trial were reported on 9/30/09. The FREEDOMS trial plus the TRANFORMS trial and a portion of the FREEDOMS-II trial will comprise the NDA/MAA package.) NVS – Albuferon: see HGSI.
ONTY – Phase-3 trial in Stage III NSCLC: first interim analysis (at 50% of deaths relative to trigger for final analysis): 2H10.
REGN - Rilonacept in flare prevention upon initiation of allopurinol - results expected in 2010 REGN - Rilonacept in flare treatment - results expected in 2010 REGN - Aflibercept in 3 different ph iii's (total enrollment expected is ~4000). VELOUR (2nd line colorectal + chemo cocktail), VITAL (2nd line NSCLC with docetaxel), VENICE (1st line HRPC with docetaxel + pred) REGN - VEGF Trap-Eye: results from ph-3 trials in AMD 4Q10.
Roche – ITMN-191 (a/k/a/ RG7127): phase-2b trial of SoC ± ITMN-191: RVR data from some arms 1Q10; report phase-1b data with ritonavir boosting early 2010. Roche – RG7128: phase-2b trial passed interim safety hurdle 11/23/09, now proceeding to second enrollment cohort.
SGP – Boceprevir NDA: 2011-2012.
TSPT – Intermezzo: FDA meeting scheduled for 1/20/10.
VRTX – Telaprevir phase-3 ADVANCE and ILLUMINATE trials in 1st-line setting: SVR data 1H10. VRTX – Telaprevir phase-3 REALIZE trial in 2nd-line setting: SVR data mid 2010. VRTX – Telaprevir NDA in first- and second-line settings: 2H10. VRTX – VX-222 (f/k/a/ VCH-222) HCV polymerase inhibitor: report 3-day monotherapy data late 2009; MAYBE report outcome of VX-222+Telaprevir DDI study late 2009/early 2010. VRTX – Telaprevir ± VX-222: start phase-2 combo study 4Q09; report interim data (not SVR) mid 2010. VRTX – VX-813 and VX-985 2nd-gen HCV PI’s: maybe report PK data mid 2010. (VRTX appears to have downgraded the importance of these compounds since the acquisition of VX-222 from ViroChem.) VRTX – VX-509 JAK3 inhibitor: start 12-week phase-2 trial in RA 1Q10, interim data 2H10.
VRUS – RG7128 (f/k/a/ R7128) and INFORM-1 all-oral HCV cocktail: see Roche. VRUS – PSI-938 HCV purine-analog nuke: file IND 1Q10.
ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10
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