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12.15.18 01:19:49AM
Biotech Upcoming data
| Ticker | Phase | Drug | Notes | Data Results |
|---|---|---|---|---|
| ACRS | 2 | ATI-502 | data end of year | |
| ALDX | 3 | Reproxalap | Allergic conjunctivitis data end of quarter or 1Q '19 | |
| ALKS | 3 | ALKS 3831-ENLIGHTEN-2 | Top-line results (fall) | |
| AVEO | 3 | TIVO-3 | due to slower enrollment, data is now in Q4 | announced 'positive' result. Stock fall -20.08% |
| BHVN | 2 | Trigriluzole | Top-line data | achieved significance on co-primary endpoitns. |
| BLPH | 3 | INOvation-1 | pulmonary arterial hypertension (PAH), with top-line data for the complete study anticipated around the end of the year | |
| CMRX | 2 | CMX001 | IV Brincidofovir for treatment of Viral infections | |
| CMTA | 3 | MOVE trial | evaluating palovarotene. Fibrodysplasia | |
| FOMX | 3 | FX 2016-11 and FX2016-12 | topical minocycline foam 1.5%, for the treatment of rosace. Top-line early fourth quarter. | |
| FOMX | 3 | FX2016-11 and FX2016-12 | evaluating the safety and efficacy of FMX103, topical minocycline foam 1.5%, for the treatment of papulopustular rosacea. Top-line results are expected early in the fourth quarter of 2018. | report positive data |
| GILD | 2 | GS-9674 | Clinical data end of year. Liver diseases | |
| GLPG | 3 | FINCH 2 | Topline data 2H 2018 | |
| GTHX | 2a | trilaciclib | triple-negative breast cancer. trilaciclib for patients undergoing chemotherapy, are expected in the fourth quarter of 2018. | preliminary result at #SABCS18 |
| GTXI | 2 | ASTRID | Top-line result expected early Q4 | trial did not meet primary endpoint. 9/21 |
| KPTI | 2b | SADAL | for the treatment of patients with relapsed or refractory DLBCL | |
| KURA | 2 | Tipifarnib | data from multiples phase 2 tipifarnib in solid tumor and hematologic | Stock down -18.85% after data update at #ESMO |
| MNLO | 2 | Seropitant | Data in Refractory Chronic Cough Expected in Oct 2018. | Data failed |
| MNLO | 2 | Pruritus associated with psoriasis | data in December | |
| MRNS | 2 | Intravenous (IV) ganaxolone | Report top-line P2 Magnolia study in women with PPD | Data updated 12/10/18 |
| MRNS | 2 | MAGNOLIA | Report top-line oral ganaxolone data from Amaryllis study in women with moderate PPD fourth quarter 2018 | data updated 12/4/18 |
| NOVN | 2 | SB206 | Viral infections data | |
| OBSV | 3 | IMPLANT 2 | Clinical trial of nolasiban in IVF. Also P2a PRLONG Safety, tolerability and pharmacokinetics in pregnant women, and interim efficacy . | |
| OPHT | 2a | Zimura | In April 2018, complete patients enrollments. Evaluate data at six months. | |
| PBYI | 2 | CONTROL | Top-line data | |
| PRTO | 3 | PATENCY-2 | data Q1 '19 and possibly late '18 | |
| PULM | 2a | PUR1800 | for COPD | |
| QURE | 2b | AMT-061 | in hemophilia B by end of year | |
| SBBP | 3 | COR-003-LOGICS | Topline data | |
| SRRA | I/II | SRA737 | Interim data | |
| SUPN | 3 | P301 and P303 | Pediatric trials in early December | data updated 12/6/18. |
| SYBX | 1b/2a | SYNB1020 | In development for the treatment hyperammonemia. Data end of 18 | |
| SYRS | 2 | SY-1425 | Expect to Report Initial Data from Combination Arms | Data updated, stock up 10.28% on news. |
| TCON | 3 | TRC105 | interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in the second half of 2018. | |
| UTHR | 3 | FREEDOM-EV | clinical data | |
| VKTX | 2 | VK2809 | data from P2 fatty liver and hypercholesterolemia data 2H 2018 | early data on Sep 18, Stock popped +87.30% |
| VNDA | 2 | Tradipitant | for gastroparesis (gastroenterology) data end of year. | met primary endpoint, stock +25.68% |
| VTVT | 3 | STEADYFAST- Part B | data late 2018 | |
| XNCR | 2 | XmAb®5871 | Systemic Lupus Erythematosus (SLE). |
| Ticker | Phase | Drug | Notes | Data Results |
|---|---|---|---|---|
| ALDX | 2 and 3 | Reproxalap Ocular | Phase 3 Allergic Conjunctivitis , P2b Dry Eye Disease, P3 Noninfectious Anterior Uveitis and P3 sjogren-Larsson Syndrome. All expected second half 2018 | positive P2 dry eye data |
| ALNY | 3 | ENVISION | interim analysis mid-2018. Givosiran (Acute Hepatic Porphyrias) | positive data |
| AMRN | 3 | REDUCE-IT | Topline results expected to be available before the end of Q3 2018 | RDUCE-IT meets primary endpoint |
| ANAB | 2a | ANAB020 | in Eosinophilic Asthma Expected in the Third Quarter of 2018 | positive data |
| ARGS | 2 | AGS-004 | interim data due 2h 2018 | |
| ARNA | 2 | Olorinab | study in pain associated with Crohn's disease | report 'positive' results |
| ATNX | 3 | Oraxol KX-ORAX-001 | second inerim analysis in 3Q 2018 | |
| ATXI | 3 | IV tramadol | for management of moderate to moderately severe postoperative pain in patients following bunionectomy surgery. | |
| AXON | 2 | Nelotanserin | REM Behavior Disorder in subject with LBD | |
| AXSM | 2 | AXS-05 | ASCEND study for major depressive disorder (MDD). Top-line results 2H '18 | |
| BLPH | 3 | PAH INOvation-1 | The company continues to expect the readout of interim analyst in mid-2018. | DMC recommends stopping Phase 3. |
| BYSI | 3 | Piabulin | Interim P3 mid-2018 | |
| CANF | 2 | Namodenoson | Namodenoson in the treatment of heaptacellular carcinoma (HCC) expected later in 2018 | |
| CTIC | 3 | PIX306 | trial of PIXUVRI, top-line results are expected 2Q | PIXUVRI did not meet endpoint |
| EIGR | 2 | Exendin 9-39 IN PBH | Exedin 9-39 phase 2 PREVENT study, and Ubenimex in Lymphedema; phase 2 ULTRA study completion. | Phase 2 PREVENT announce positive result |
| ENTX | 2 | PTH (1-34) and NatPar | Complete the first part of Phase 2 in Aug 1, data in coming months. Hypoparathyroidism | |
| ESPR | 3 | Bempedoic Acid | Global pivotal P3 study 2 52 weeks LDL-C | |
| FLKS | 2b | COMMEND trial FLXS-787 | Topline 3q 2018 | Discontinue trial |
| FOMX | 3 | FX2017-22 | he Company’s minocycline foam 4%, in patients with moderate-to-severe acne. | Positive late stage data |
| GALT | 2 | KEYTRUDA | enroll cohort 3 (GR-MD-02 8 mg/kg) of the pembrolizumab (KEYTRUDA) combination immunotherapy clinical trial, data mid-2018 | |
| GERN | 2 | IMbark | Geron expects Janssen to inform the Company of its decision by the end of the third quarter of 2018. | Discontinuation Imetelstat |
| GLPG | 3 | FINCH 2 | Expect FINCH 2 results in 3Q | Data meets primary endpoint |
| IONS | 2 | AKCEA-APO(a)-LRx and AKCEA-ANGPTL3-LRx | six Phase 2 programs throughout 2018 | |
| OBSV | 2B | OBE2109 | due mid 2018 | |
| OCUL | 3 | OTX-TP | Expects topline efficacy data 2h 2018 | |
| OMER | 2 | OMS721 | Immunoglobulin A (IgA) nephropathy. | Mixed data result |
| ONCE | I/II | Hemophila A- SPK-8011 | investigational gene therapy | |
| ONCS | 2b | PISCES/KEYNOTE-695 | Dosing of first patient on Dec 14, 2017. data in 2018. (No specific quarter given) | |
| OVID | 2 | OV101- STARS | Enrollment i n STARS trial to adolescent Angelman syndrome. Trial to be available 2H 2018 | Positive data, but investors concerned stock -36.55% for the day. |
| PBYI | 3 | PB272 (neratinib) | third-line metastatic breast cancer patients in the second half of 2018 | |
| RARE | 2 | Crysvita (burosumab) | his is an open label Phase 2 study evaluating the safety and efficacy of burosumab in 17 adult patients with TIO. | |
| RDHL | 3 | RHB-104 | Topline data | Primary endpoint successfully achieved. |
| RYTM | 2 | setmelanotide | Studies of setmelanotide in BBS and Alstrom Syndrome. Sept 27-29 data. | |
| SCYX | 2b | SCY-078 | Topline data by July | positive results oral SCY-078 |
| SPPI | 2 | Poziotinib | Breast Cancer. Data possibly release in fall | Updated data on September 24 |
| TGTX | 3 | UNITY-CLC | Top-line ORR and relapsed/refractory Chronic Lymphocytic Leukemia (CLL). | DSMB trial ORR cannot be conducted. |
| TNXP | 3 | HONOR study of Tonmya | Interim Analysis 3Q 2018;Topline results expected in 3Q 2018 | discontinue Phase 3 HONOR |
| TOCA | 3 | TOCA 5 | conducting 50% interim analysis 2H '18 | trial continued as planned |
| TORC | 2b | TORC1 | top-line 16 weeks data expected 3Q. trial is designed to evaluate the safety, tolerability and efficacy of RTB101, an orally-administered selective TORC1 inhibitor, | announces 'positive' P2b RTB101 |
| URGN | 3 | OLYMPUS | topline data | |
| VTL | 3 | VTL-308 | ELAD System in subjects with severe alcoholic hepatitis (sAH). Clinical data in second half of September 2018 | Data failed |
| ZGNX | 3 | ZX008 | Second pivotal trial Phase 3 Dravet syndrome program, STUDY 1504. Data late June-early July. | Primary endpoint achieved |
| Ticker | Phase | Drug | Notes | Data Results |
|---|---|---|---|---|
| ACRS | 2 | AT-50002 Topical | Top-line data 1H 2018 | positive interim data |
| ALXN | 3 | PREVENT and ALXN210 | Data mid-2018. Eculizumab- Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD) | Success |
| AQXP | 3 | AQX-1125 | LEADERSHIP data | Failed to meet primary endpoint |
| AXSM | 3 | STRIDE-1 | trial of AXS-05 IN TRD, top-line data 1H 2018 | |
| BMRN | 2 | Hemophilia A | update on the ongoing Phase 2 program with valoctocogene roxaparvovec at the World Federation of Hemophilia 2018 World Congress. May 20-24 | Data were updated at World Congress |
| CARA | 3 | CR845 | Acute Post-Operative Pain, data expected in 2Q | Report 'positive' topline data |
| CLDX | 2b | METRIC | Topline data likely Q2 2018 | Data failed |
| CLSD | 2 | TYBEE | Patients follow-up six months data | -32.19% Stock reaction to 'positive' data. |
| EDGE | 3 | EG-1962 | Interim-topline data | data failed |
| ESPR | 3 | ASCVD and/or HeFH Statin add on | Global pivotal P3 study 1, 52 weeks long term safety. | Company press 'positive' data, but safety concerns dropped stock -35.11%. |
| FOMX | 3 | FMX103 | Topline data mid 2018 | |
| GBT | 3 | HOPE study | Top -line clinical data by end of quarter | Primary endpoint achieved |
| GEMP | 2B | INDIGO-1 | Top-line data | Meet primary endpoint |
| GLMD | 2b | ARREST | Phase IIB data late Q1 or early Q2 2018. | Data update stock up +151.29% |
| GNMX | 2 | AEVI-001 | Phase 2 (ASCEND) for patients with ADHD. Data expected mid-2018 | |
| HRTX | 2 | HTX-011 | data likely late Q2 for kneee arthroplasty | positive topline results. Stock up +30.13% |
| IDRA | 2 | IMO-8400 | Topline data in June | miss primary endpoint |
| INCY | 3 | ECHO-301 | Initial results of the ECHO-301 trial of epacadostat in melanoma and REACH 1 trial of ruxolittinib in acute GVHD | Data failed |
| IONS | P1/2a | IONIS-SOD1 ALS | Topline Data Mid Q2 | |
| JNCE | 1/2 | ICONIC | Preliminary Efficacy data in the first half of 2018 | Underwhelming abstract, stock -35.20% reaction |
| KPTI | 2 | STORM | April data | Positive Phase 2a |
| MDGL | 2 | MGL-3196 | Final 36-week data, top line results by end of May | MDGL-3196 Achieves Endpoints |
| MNLO | 2 | ATOMIK | atopic dermatitis data expected April 2018 | Data failed |
| NBRV | 3 | LEAP 2 | Data are expecting in Spring 2018 | Company press lefamulin meets all primary endpoints. Stock down -16.57% |
| PRTA | IIb | NEOD1 | Top-line data | Data failed, stock down -68.78% |
| SBBP | 3 | RECORLEV | Top-line results on track with SONICS | Positive results. |
| SELB | 2 | SEL-212 | Symtomatic Gout Patients. Updated Clinical data at PANLAR Congress on Tuesday, April 10, 2018 | |
| VICL | 2 | HSV-2 | Therapeutic Vaccine | trial vaccine did not meet primary endpoint |
| VTVT | 3 | STEADFAST | STEADFAST study (azeliragon in Alzheimer's disease) Part A early 2018 | Data failed |
| XLRN | 3 | MEDALIST and BELIEVE | Data mid 2018 | Achieved primary and secondary endpoints |
| Ticker | Phase | Drug | Notes | Data Results |
|---|---|---|---|---|
| ACOR | 3 | Tozadenant | Phase 3 data | |
| AIMT | 3 | PALISADE | "Anticipate sharing topline in first quarter 2018" | |
| ANTH | 3 | Sollpura-RESULT | data due end of Q1 | |
| ARGX | 2 | ARGX-113 | Myasthenia gravis data | |
| AXON | 2 | Intepirdine and Nelotanserin | January data: HEADWAY in patients with dementia with Levy bodies (DLB). subjects with Alzheimer's disease, DLB and Parkinson's disease dementia (PDD). Nelotanserin (LBD). | |
| AXSM | 3 | CREATE-1 | trial of AXS-02 in CRPS, interim efficacy analysis | |
| BLPH | 3 | INO pulse for PAH indication | Topline line data | |
| BOLD | 1/2 | AT132 | Phase 1/2 data readout of AT132 XLMTM | |
| CDTX | 2 | STRIVE | CD101 IV | |
| Cidara Therapeutics Inc (CDTX) | 2 | STRIVE | completing enrollment of the 90-patietn. P2 Rezafungin | |
| CLSD | 3 | PEACHTREE | Macular Edema Associated with Non-infectious Uveitis, top line data. | |
| CPRX | 2 | CMS-001 | Expect top-line results from CMS-001 in first half 2018 | |
| DERM | 3 | CLAREOS 1 and CLAREOS 2 | October 5, 2017 completes patient enrollment in Two Phase 3 pivotal trials of Olumacostat Glasaretil for the treament of Acne Vulgaris. Topline. | |
| EARS | 3 | KEYZILEN | P3 TACTT3 topline data | |
| EIGR | 2 | LIBERTY | Ubenimex in PAH | |
| EYEG | 3 | EGP-437 | Topline data | |
| FGEN | 2 | FG-3019 | Pancreatic caner study results | |
| FLKS | 2 | FLX-787 Multiples Sclerosis | Readout data end of Q1 | |
| GEMP | 2b | INDIGO-1 | top-line data | |
| GTHX | 2a | trilaciclib | trilaciclib first-in-line small cell lung cancer. Data in March | |
| IDRA | 2 | IMO-2125 | Clinical trial of 8mg intratumoral IMO-2125 in combination with ipilimumab in anti-PD1 reffractory melanoma. ORR data | |
| MNOV | 2 | mn-166 | Completion enrollment news on Sept 19,2017. Final data Q1 | |
| MRNS | 2 | CDKL5 | on-going in the Magnolia Study, with data expected in early 2018 | |
| OVID | 2 | STARS | Sometimes 2018 | |
| PTGX | 2b | PTG-300 | interim analysis early 2018 | |
| REGN | 3 | Praluent ODYSSEY OUTCOMES | Cardiovascular events. | |
| TCON | 2 | TRAXAR trial of TRC105 | Top-line data from the randomized P2 | |
| TRPX | IIa | THX-110 | Tourette syndrome. Top-line anticipated in first half 2018 | |
| TTPH | 3 | IGNITE3 | Additional data | |
| VBLT | 3 | VB-111 | top-line results | |
| VICL | 3 | ASP0013 | The multinational phase 3 registration trial in HCT recipients completed enrollment in Sept 2016 with a total 515 subjects. | |
| VRTX | 2 | VX-445 and VX-659 triple combinations in CF patietns | data 1H18 | |
| VTGN | 2 | AV-101 | P2 monotherapy study completion expected early 2018 | |
| VTVT | 3 | STEADFAST | STEADFAST study (azeliragon in Alzheimer's disease) Part A early 2018 | Data failed |
| Ticker | Phase | Drug | Notes | Data Results |
|---|---|---|---|---|
| ADRO | 2 | CRS-207 in combination with pembrolizumab | Report early observations from the ongoing phase 2 mesothelioma study | |
| AGLE | 1 | AEB1102 | Potential data end of year. | |
| ARDX | 3 | T3MPO-2 | Results of Tenapanor for IIBS-C on track early Q4 | |
| AVXL | 2a | ANAVEX 2-73 | PK/PD data | |
| CALA | 2 | CB-839 | In July 2017, Calithera initiated a phase 2 trial of CB-839 with pcitaxel in triple negative breast cancer patietns. | |
| CLDX | 2 | Glembatumumab Vedotin | The company anticipated in fall of 2017 | |
| CNCE | 2b | CTP-543 | End of year data | |
| CPRX | 3 | Firdapse® | Top-line Results expected in early December. Completes enrollment in second phase 3 trial on Oct 31,2017 | |
| CYTK | 3 | VITALITY-ALS | Trial of Tirasemtiv | |
| DBVT | 3 | PEPITES | to report topline results from PEPITES in October 2017 | |
| EARS | 3 | AM-111 HEALOS | The trial enrolled 256 patients with severe to profound idiopathic sudden sensorineural hearing loss. | |
| EIGR | 2 | LIMT HDV | interim data study at AASLD | |
| GALT | 2b | NASH-CX | Clinical data in December | |
| IRWD | 2 | IW-1973 | data from two phase IIa studies with IW-1973 in diabetic patients with hypertension are expected by end of 2017. | |
| KDMN | 2 | KD025 | Randomized, open-label clinical trial in idiopathic pulmonary fibrosis | |
| KDMN | 2 | KD025 | Randomized, open-label clinical trial in idiopathic pulmonary fibrosis and full data to severe psoriasis | |
| KURA | 2 | tipifarnib | Phase 2 trial of tipifarnib in HRAS mutant SCCHN second half 2017 | |
| MDGL | 2 | MGL-3196 for NASH | Top-line results for the primary endpoint of the trial, the reduction of liver fat, assessed by MRI-PDFF at 12 weeks, are expected by year-end | |
| MLNT | 2/3 | Taksta | exploratory trial data in refractory bone and joint infections. | |
| MNOV | 2b | SPRINT-MS/NN 102 | phase 2b Trial of Ibudilast in progressive MS has been accepted for oral platform presentation at 7th Join ECTRIMS*ACTRIMS meeting October 25-28, 2017 in Paris, France | |
| ONTX | 3 | INSPIRE | interim analysis anticipate in Q4 | |
| RARX | 2 | RA101495 | Cohort B of Ra Pharma's Phase 2. The company remains on track to report additional data around year-end. | |
| RVNC | 2 | RT002 | RT002 injectable in management of plantar fascitis | |
| RVNC | 3 | SAKURA 1&2 | rt002 Injectable for the treatment of glabellar (frown) lines | |
| SAGE | 2 | SAGE-217 | SAGE-217 in PPD and essential tumor 2H2017 | |
| SGEN | 3 | ADCETRIS | Full data from ADCETRIS phase 3 ECHELON-1 trial | |
| STML | 2 | SL-401 | In Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). Top line results in 2h17 | |
| SYRS | 2 | SY-1425 | on track to present initial phase 2 clinical data | |
| TGTX | 2 | TG-1101 | multiples sclerosis trial update | |
| VKTX | 2 | VK5211 | Phase 2 hip fractured study full enrolled, data expected Q4 '17. From Aug 19 press released |
| Ticker | Phase | Drug | Notes | Data Results |
|---|---|---|---|---|
| ABBV | 3 | SELECT-BEYOND | top-line data likely 3Q | |
| ABUS | 2 | HBV | ARB1467 data | |
| ABUS | 2 | ARB-1467 | top-line results from the three-month bi-weekly dosing expect to be announced in September | |
| ALDX | 2A | ADX-102 | Clinical trial in Dry Eye Disease | |
| ALNY | 2 | hempohillia | Fitusiran PII OLE dadta | |
| ALNY | 3 | APOLLO | results for Patisiran in near term | |
| ANTH | 2 | BRIGHT | BRIGHT study of blisibimod in IgA | |
| ARRY | 3 | BEACON CRC | data from the safety due at ESMO | |
| AXON | 3 | Alzheimer's disease | Data to be out in September 2017 | |
| AZRX | IIa | MS1819 | expect completion Phase IIa in 3Q | |
| BLPH | 2a | PH-IPF | "results of this study in near futture" -Mr. Tenenbaum | |
| FOLD | 3 | SD-101 | SD-101 for Epidermolysis Bullosa (EB), Top-line P3 late 3Q | |
| GILD | 2 | GS-0976 | NASH data | |
| GTXI | 2 | Enobosarm | top-line results in 3Q | |
| INSM | 3 | ARIKAYCE | data out in September | |
| KDMN | 2 | KD025 | Open-label, dose finding clinical trial in chronic graft-versus-host disease. Also Tesevatinib data | |
| MDCO | 3 | Meropenem-Vaborbactam | TANGO 2 end of 3Q | |
| MRNS | 2 | CDKL5 | Phase 2 trial evaluating children with CDKL5 disorder | |
| MRTX | 2 | NSCLL | AMETHYST trial | |
| NBRV | 3 | Infections | LEAP 1 data. | |
| OTIC | 3 | AVERTS-1 | Phase 3 AVERTS-1 trial for OTIVDEX(tm) in September | |
| RDHL | 2 | BEKINDA | IBS-D data in September | |
| SAGE | 3 | Brexanolone in SRSE | top-line results from STATUS trial | |
| STML | 2 | SL-401 | top-line results in 2h17 | |
| VNDA | 2 | Tradipitant | study for treatment of chronic pruritus in patients with atopic dermatitis. | |
| VSAR | 3 | Pediatric GHD | Top line from pediatric phase 3 Velocity trial around end of September | |
| VSTM | 3 | Duvelisib | Phase 3 DUO top-line latter part of summer | |
| ZYNE | 2 | FAB-C | top-line results from the FAB-C Fragile X study in September |
| Ticker | Phase | Drug | Notes | Data Results |
|---|---|---|---|---|
| FGEN | 3 | Roxadustat | topline data for anemia in chronic kidney disease |
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