Company

Ticker

Price

MktCp(M)

Cat-Date

Category

Product

Catalyst Summary

Update

Ziopharm Oncology

ZIOP

$5.49

$376

Phase I / II 12/31/11 Clinical Trial

Indibulin (ZybulinTM or ZIO-301) (oral tubulin binding anticancer agent)

Being evaluated in patients w/ metastatic breast cancer w/ ClinicalTrials.gov ID NCT01113970 and results expected during 4Q11

6/10/11

Endo Pharma

ENDP

$31.28

$3,647

FDA Decision 12/13/11 (NDA)

OPANA ER (new formulation of extendedrelease oxymorphon e)

On 6/23/11, announced FDA accepted its complete response to JAN 2011 CRL seeking approval for new formulation of pain drug designed to deter abuse, PDUFA decision goal date of 12/13/11

6/24/11

Ariad Pharma

ARIA

$9.89

$1,311

On 8/2/11, reported pt enrlmt Ponatinib expected to close during (AP24534) 3Q11 (six months ahd of (pan-BCR- schedule) in ongoing pivotal ABL P2 trial in pts w/ blood-based inhibitor anti- cancers CML and Ph+ ALL, cancer has submitted to present agent) interim data at ASH mtg Dec Pivotal Phase 2 (once-daily 10-13, expects to file NDA in (PACE) Clinical 45 mg mid-2012 w/ six-month 12/10/11 Trial tablet) priority rvw request

8/2/11

YM BioSciences YMI

$1.96

$216

Phase I / II Clinical Trial, Pending Phase 12/10/11 2 Clinical Trial

CYT387 (a JAK1 / JAK2 Kinase Inhibitor)

On 6/3/11 reported interim data w/ 46% spleen response and 50% anemia response, completed enrlmt in MAY 2011 w/ full data expected during 4Q11 at ASH mtg Dec. 10-13 for treatment of myelofibrosis, expects to begin 60-pt P2 twice-daily dosing (BID) trial during 3Q11 to support start of pivotal P3 trial in 1H12

8/1/11

Antares Pharma

AIS

$2.34

$242

12/8/11

FDA Decision (NDA)

On 7/11/11, announced exclusive licensing agmt w/ WPI including regulatory approval and sales-based milestone pmts plus escalating royalties on US ANTUROL and Canada product sales w/ (transderma PDUFA decision goal date of l oxybutynin 12/8/11 under a standard 10ATD gel) month review

7/11/11

Incyte

INCY

$15.53

$1,961

12/3/11

FDA Decision (NDA), MAA / EMA (Europe) Decision

On 8/3/11, announced FDA accepted NDA w/ PDUFA decision goal date of 12/3/11 under six-month priority rvw seeking approval for treatment of myelofibrosis, exUS partner NVS submitted MAA in JUN 2011 w/ Ruxolitinib estimated EU approval (INCB18424 decision by late 2011-early ) 2012 8/3/11

22nd Century

XXII

$1.20

$33

Phase 2b 11/30/11 Clinical Trial

On 8/8/11, first pts enrolled in P2B trial for smoking cessation aid product X-22 (very candidate, expects FDA low nicotine decision on Fast Track status / VLN by SEP 2011, expects to cigarettes report results from trial in late smoking NOV 2011 (four wks of cessation continuous smoking aid) cessation after program)

8/9/11

Alnylam

ALNY

$6.81

$290

ALN-TTR01 (systemic RNA interference or RNAi therapeutic Phase I Clinical for 11/20/11 Trial amyloidosis)

In JUL 2010 began dosing in P1 trial, will enroll up to 28 pts w/ amyloidosis (condition that damages peripheral nerves and heart), expects to present data at scientific mtg Nov. 20-22 in Japan, developed using TKMR RNAi delivery tech

8/2/11

Spectrum Pharma

SPPI

$8.80

$468

On 3/22/11, announced FDA accepted prior approval supplement w/ expected decision by 11/20/11 to ZEVALIN remove bio-scan FDA Decision (ibritumoma requirement as part of (Prior Approval b tiuxetan) treatment regimen for non11/20/11 Supplement) Injection Hodgkins lymphoma (NHL)

3/22/11

Tekmira Pharma

TKMR

$2.01

$24

In AUG 2011 partner ALNY announced plans to present ALN-TTR01 data at scientific mtg Nov. 20(systemic 22 in Japan from ongoing P1 RNA trial in up to 28 pts w/ interference amyloidosis (condition that or RNAi damages peripheral nerves therapeutic and heart), TKMR developed Phase I Clinical for RNAi drug delivery tech for 11/20/11 Trial amyloidosis) this compound

8/2/11

Regeneron Pharma

REGN

$71.27

$6,530

On 8/16/11, reported 3-month delay to 11/18/11 for BLA decision seeking approval for treatment of wet age-related macular degeneration, in JUN 2011 FDA Advisory EYLEA Panel voted 10-0 in favor of FDA Decision (aflibercept approval, co-developed w/ (BLA) ophthalmic Bayer (ex-US), expects to file (11/18/11), FDA solution) BLA 2H11 for treatment of New Filing (VEGF Trap- macular edema due to 11/18/11 (BLA) (2H11) Eye) central retinal vein occlusion 8/16/11

Aastrom Biosciences ASTM

$2.54

$98

In JUL 2011, announced SPA agmt w/ FDA for design of pending pivotal P3 trial for Ixmyelocel- pts w/ no-option critical limb T (bone ischemia (CLI) that is Pending Pivotal marrow, expected to begin during Phase 3 patient4Q11, final 12-month results (REVIVE-CLI) derived cell from Phase 2b RESTOREClinical Trial therapy CLI study will be presented at 11/14/11 under SPA product) AHA mtg on 11/14/11 8/16/11

BioSante Pharma

BPAX

$2.63

$289

FDA Decision 11/14/11 (NDA)

Licensed to TEVA w/ PDUFA action goal date of 11/14/11 for the treatment of low testosterone levels in males (hypogonadism), would Bio-T-Gel receive milestone payments (testosteron and royalties from TEVA if e gel) approved

4/13/11

IntelGenx

IGXT

$0.67

$31

FDA Decision 11/13/11 505(b)(2) NDA

On 8/2/11, announced Pillar5 Pharma passed pre-approval manufacturing inspection w/ no outstanding issues CPI-300 reported by FDA (Form 483), (450mg PDUFA decision goal date of bupropion) 11/13/11 under six-month (novel, high- Class 2 NDA resubmission in strength response to FEB 2010 CRL formulation) issued by FDA

8/2/11

Alimera Sciences

ALIM

$7.27

$228

ILUVIEN (fluocinolone FDA Decision intravitreal (NDA) (Class 2 insert) Resubmission), (sustained MAA / MHRA eye drug (Europe) delivery 11/12/11 Decision system)

In MAY 2011, announced NDA resubmission in response to DEC 2010 CRL, seeking approval for diabetic macular edema w/ PDUFA decision goal date of 11/12/11 under six-month Class 2 review and no advisory panel mtg to be held, MAA filed for EU approval in JUL 2010 w/ MHRA (UK) and expected decision during 1Q12, licensed from PSDV

8/31/11

pSivida

PSDV

$4.51

$94

ILUVIEN (fluocinolone FDA Decision intravitreal (NDA) (Class 2 insert) Resubmission), (sustained MAA / MHRA eye drug Decision delivery 11/12/11 (Europe) system)

In MAY 2011, licensee ALIM announced NDA resubmission to DEC 2010 CRL, seeking approval for diabetic macular edema w/ PDUFA decision goal date of 11/12/11 under a six-month Class 2 review w/ no advisory panel mtg to be held, MAA filed for EU approval in JUL 2010 w/ MHRA and expected decision during 1Q12, PSDV due to receive $25M on FDA approval 8/31/11

Gentium

GENT

$6.88

$103

11/1/11

MAA / EMA (Europe) Decision

Defibrotide

On 6/1/11, announced MAA seeking approval for prevention and treatment of hepatic veno-occlusive disease (VOD) of the liver following stem cell transplant was accepted for accelerated review (150 days) for expected EMA decision by 11/1/11, in AUG 2011 withdrew NDA citing issues related to data and conduct of trials

8/18/11

Anadys Pharma

ANDS

$0.69

$39

Phase 2b 10/31/11 Clinical Trial

In JUL 2011, completed pt enrlmt in ongoing P2B trial in combo w/ PEG-interferon and ribavirin for chronic hepatitis Setrobuvir C virus (HCV) infection, (ANA598) expects all pts to complete (Non12-wk visit by end 3Q11 w/ Nucleoside prelim 12-wk data shortly HCV after (OCT 2011 estimate) w/ Polymerase 24-wk anti-viral data Inhibitor) expected around yr-end 2011 8/12/11

Biodel

BIOD

$1.20

$46

Phase I Clinical Trial, Pending Phase 2 Clinical 10/31/11 Trial

BIOD-105 and BIOD107 (rapidacting insulin)

On 8/4/11, reported completion of P1 testing w/ sig more rapid absorption and similar injection site tolerability to HUMALOG, ongoing P1 insulin pump study w/ top-line results expected in OCT 2011, expects to select lead ultra rapid-acting insulin for further devlmt along w/ timelines 4Q11

8/22/11

Bionovo

BNVI

$0.66

$36

On 8/30/11, announced successful completion of tolerability trial and dosing strategy for pending pivotal P3 trial expected to begin in fall (OCT 2011 estimate) for treatment of hot flashes, MENERBA expects 5 data safety (a selective monitoring board rvws (first estrogen 4Q11) over course of trial, Pending Pivotal receptor expects to complete pt enrlmt Phase 3 Clinical modulator 2Q12 and report top-line data 10/31/11 Trial or SERM) 4Q12 8/30/11

DepoMed

DEPO

$6.15

$340

In MAR 2011, completed enrlmt in pivotal P3 trial for the non-hormonal treatment of menopausal hot flashes w/ results expected during 4Q11 (mid-late OCT 2011 estimate), same drug approved by FDA as Pivotal Phase 3 SERADA GRALISE for post-herpetic (BREEZE-3) (extended neuralgia (nerve pain that Clinical Trial release persists after shingles 10/31/11 under SPA gabapentin) infection) in JAN 2011

8/1/11

Exelixis

EXEL

$7.40

$954

Pivotal Phase 3 (EXAM) Clinical Trial under SPA, Pending Pivotal Phase 3 Clinical Trial w/ 10/31/11 SPA Request

On 9/7/11, reported prespecified number PFS events reached to un-blind data in ongoing pivotal P3 trial for Cabozantini medullary thyroid cancer b (XL184) (MTC) w/ top-line data (MET, expected in early 4Q11 VEGFR2, (October estimate), expects and RET to begin pivotal P3 trial under inhibitor anti- SPA by yr-end 2011 for cancer castration-resistant prostate agent) cancer (CRPC)

9/7/11

Neuralstem CUR

$1.32

$64

Phase 1a 10/31/11 Clinical Trial

NSI-189 (neuron growth stimulator)

In JUN 2011, was cleared to dose final cohort of pts in ongoing P1A trial (ClinicalTrials.gov ID NCT01310881) to test safety of experimental drug for major depression, expects to complete the trial in summer to support planned start of P1B trial by early fall (OCT 2011 estimate)

8/11/11

RegeneRx Biopharma

RGRX

$0.29

$23

RGN-259 (T4 Phase 2 Clinical ophthalmic 10/31/11 Trial solution)

On 8/24/11 completed enrlmt of 72 pts in ongoing P2 trial for dry eye syndrome, expects to complete treatment of all pts by 9/23/11 and report prelim data in OCT 2011, ClinicalTrials.gov ID NCT01387347 8/24/11

Vertex Pharma

VRTX

$46.94

$9,768

VX-770 (Cystic Fibrosis Transmembrane FDA and MAA / ConductEMA New ance 10/31/11 Filings Regulator)

In MAR 2011, reported positive results for oral treatment for cystic fibrosis (CF) from 24-week analysis of P3 ENVISION trial and in JUN 2011 positive P3 final STRIVE trial results to support planned regulatory approval filings in US and Europe in OCT 2011

7/29/11

Pacira Pharma

PCRX

$8.25

$142

FDA Decision 10/28/11 (NDA)

EXPAREL (bupivacaine extendedrelease liposome injection) (300mg / 20mL)

On 6/14/11, announced threemonth delay due to addtl info submitted at FDA request, new PDUFA decision goal date is 10/28/11, seeking approval for post-surgical pain relief by local administration for a novel, long-acting formulation of approved drug bupivacaine 6/14/11

QRxPharma (QRX.AX) QRXPY

$7.01

$202

On 8/25/11, completed NDA filing w/ six-month priority review request following MoxDuo IR initial submission in JUL (immediate 2011, seeking FDA approval FDA Reply to release 3:2 for treatment of moderate to Accept NDA fixed-dose severe acute pain, expected Filing and Issue ratio combo FDA reply w/in two months PDUFA of morphine (10/25/11) to accept NDA Decision Goal and filing and issue PDUFA 10/25/11 Date oxycodone) decision goal date

8/25/11

Amylin Pharma

AMLN

$11.40

$1,663

FDA Decision 10/22/11 (sNDA)

On 12/22/10, announced submission of sNDA, seeking FDA approval for expanded use as add-on therapy to basal insulin for adult type 2 diabetics not achieving adequate blood sugar control, estimated FDA decision by 10/22/11 under a BYETTA standard 10-month review (exenatide) period, partnered w/ LLY 12/22/10

Ariad Pharma

ARIA

$9.89

$1,311

In AUG 2011 EMA completed admin validation process for MAA seeking EU approval for metastatic soft-tissue or bone FDA Reply to sarcomas, submitted by Accept NDA Ridaforolim partner MRK in JUL 2011 w/ and Issue us (mTOR estimated decision 1Q12, PDUFA Date inhibitor, expected FDA reply w/in 60 (mid-Oct), MAA oral antidays (mid-OCT 2011) to / EMA (Europe) cancer accept NDA filing and issue 10/17/11 Decision (1Q12) agent) PDUFA decision goal date 8/18/11

Neoprobe

NEOP

$2.98

$265

On 8/10/11, announced NDA filing seeking approval for use in Intraoperative Lymphatic Mapping for breast FDA Reply to cancer and melanoma, Accept NDA expected FDA reply within 60 Filing and Issue days (10/10/11) to accept PDUFA Lymphosee NDA for review and issue 10/10/11 Decision Date k PDUFA decision goal date 8/11/11

Alexion Pharma

ALXN

$59.54

$10,987

10/7/11

On 6/1/11, announced FDA accepted sBLA filing w/ sixmonth priority review for expected decision by 10/7/11, seeking expanded approval for for treatment of FDA Decision SOLIRIS pts w/ atypical Hemolytic (sBLA) (Priority (eculizumab Uremic Syndrome (rare blood Review) ) clotting disorder)

6/1/11

Aastrom Biosciences ASTM

$2.54

$98

9/30/11

Completed pt enrlmt (21) in DEC 2010 for treatment of Ixmyelocel- severe heart failure (dilated T (bone cardiomyopathy or DCM) via marrow, direct catheter injection and patientexpects to report six-month IMPACT-DCM derived cell results during 3Q11, Catheter Phase therapy ClinicalTrials.gov ID 2 Clinical Trial product) NCT01020968

8/16/11

Amarin

AMRN

$11.20

$1,492

9/30/11

Expects to file NDA by end of SEP 2011 seeking approval for treatment of pts w/ very high triglycerides (>=500 mg/dl) w/ addtl data from P3 FDA New Filing AMR101 trials to be presented at AHA (NDA), Pending (icosapent mtg Nov 15-16, on 8/10/11 Cardiovascular ethyl) reported SPA agmt w/ FDA Outcomes Prescription for long-term (six-year) study Study Grade in 8,000 pts expected to (REDUCE-IT) Omega-3 begin in 2011 w/ target of under SPA Fatty Acid) 50% enrolled by yr-end 2012

8/10/11

AspenBio Pharma

APPY

$3.47

$28

9/30/11

On 7/19/11, announced expected pre-pivotal trial AppyScore interim results during 3Q11, (bloodalso submitted pre-IDE based package to FDA and plans to Pre-Pivotal diagnostic meet to discuss clinical / Clinical Trial screening regulatory pathway including (Medical Device test for design of planned pivotal trial / Diagnostic appendicitis based on the mtg and preTest) ) pivotal trial results

7/19/11

BioDelivery Sciences BDSI

$3.19

$94

9/30/11

BEMA Pivotal Phase 3 BuprenClinical Trial orphine

On 7/25/11, announced last pt completed randomized portion of pivotal P3 trial for treatment of moderate to severe chronic pain and expects to report top-line results in mid-late SEP 2011 to support potential 505(b)(2) NDA filing during 1H12

7/25/11

BioMimetic Therapeutic s BMTI

$3.48

$98

9/30/11

In MAY 2011, FDA Advisory Panel voted 12-6 in support of safety, 10-8 in support efficacy, and 10-8 in support of benefit to risk profile, in JUL 2011 met w/ FDA and Augment expects follow-up letter Bone Graft around SEP 2011 to outline FDA Decision (synthetic, post-panel reqmts for PMA (PMA) (Medical off-the-shelf aprvl and will provide update Device), CE bone growth on status at that time, Mark (Europe) factor expected CE Mark decision Decision product) in 2012 (1H12 estimate)

8/5/11

Chelsea Therapeutic s CHTP

$4.34

$268

9/30/11

Expects to file NDA during 3Q11 seeking approval for treatment of symptomatic NORTHER NOH (neurogenic orthostatic A hypotension), ongoing P3 (droxidopa) trial (Study 306) for potential (orally falls claim indication w/ FDA New Filing active results expected during (NDA), Phase 2 synthetic 2Q12, expects to report topClinical Trial, precursor of line results from ongoing P2 Phase 3 Clinical norepinephri trial by yr-end 2011 for Trial ne) treatment of fibromyalgia

8/8/11

Chelsea Therapeutic s CHTP

$4.34

$268

9/30/11

CH-4051 (orally available anti-folate agent) (LPhase 2 Clinical isomer of Trial CH-1504)

In MAY 2011, announced DSMB rvw of safety data and trial continued as planned to begin enrlmt of high-dose groups for treatment of for rheumatoid arthritis compared to treatment with methotrexate, expects to report un-blinded interim efficacy data in SEP 2011 w/ full results expected during 2Q12

7/26/11

CorMedix

CRMD

$1.09

$12

9/30/11

Deferiprone (CRMD001) (a novel oral, twicedaily formulation of ironPhase 2 Clinical binding Trial drug)

On 9/6/11, amended agmt w/ Shiva Biomedical to extend start of pt dosing in pivotal trial to 1Q12, expects to report results from ongoing biomarker proof of concept trial by end 3Q11 to support start of pivotal trial during 1H12

9/6/11

Cyclacel Pharma

CYCC

$0.75

$40

9/30/11

In JAN 2011, began enrolling pts in pivotal P3 trial as frontline treatment of elderly patients w/ newly diagnosed acute myeloid leukemia Sapacitabin (AML), DSMB review e (CYC682) expected during 3Q11 to Phase 2 Clinical (oral enable start of randomized Trial, Pivotal capsules) (a portion of trial expected to Phase 3 nucleoside complete enrlmt 2H12 w/ final (SEAMLESS) analogue results 2H13, expects to Clinical Trial anti-cancer present P2 lung cancer data under SPA agent) 2H11 8/12/11

DARA BioSciences DARA

$1.97

$10

9/30/11

Phase 1b Clinical Trial

In JUN 2011, reported positive safety results in P1A trial and expects to report DB959 (dual results of ongoing P1B trial PPAR delta during 3Q11, being / gamma developed as oral drug for agonist) treatment of type 2 diabetes

6/28/11

Echo Therapeutic s ECTE

$3.86

$132

9/30/11

FDA Decision 510(k) Medical Device

Prelude SkinPrep and 4% Lidocaine Cream

On 2/8/11, announced expected 510(k) marketing clearance during 3Q11 based on FDA feedback to partner Ferndale Pharma (private), seeking approval as fasteracting local anesthetic (skin numbing agent prior to needle sticks), will receive $750,000 milestone pmt upon FDA approval plus doubledigit royalties

2/8/11

Generex Biotech

GNBT

$0.10

$30

9/30/11

ClinicalTrials.gov ID NCT00668850 for 26-week open-label randomized P3 (084) trial that will be closed in AUG 2011 w/ results expected during 3Q11, evaluating oral insulin spray Generex w/ regular human insulin in Oral-lyn type 1 diabetics, plans to (buccal conduct addtl P3 trials that Phase 3 Clinical insulin spray are expected to be completed Trial product) during 2013

8/2/11

Gilead Sciences

GILD

39.8

$30,704

9/30/11

QUAD single-tablet HIV regimen of elvitegravir, cobicistat and TRUVADA (emtricitabin Pivotal Phase 3 e and Clinical Trial tenofovir)

On 8/15/11, announced first of two pivotal P3 trials (Study 102) met primary endpt of non-inferiority to ATRIPLA for treatment of HIV-1 infection, second P3 trial (Study 103) w/ results expected during 3Q11 to support planned NDA filing in early 2012 8/15/11

Halozyme Therapeutic s HALO

$6.55

$679

9/30/11

Ultrafast PH20Phase 2 Clinical Insulin Trials Analogs

In SEP 2010, began two P2 trials w/ one in Type 1 diabetics (Clinical Trials.gov ID NCT01194245) and one in Type 2 diabetics (ClinicalTrials.gov ID NCT01194258) w/ pt enrlmt completed in JAN 2011 and results expected 3Q11 6/21/11

Horizon Pharma

HZNP

$8.15

$159

9/30/11

Expects to file NDA during 3Q11 seeking approval for novel formulation of approved LODOTRA steroid drug for reduction in (NP01) morning stiffness associated (programme with rheumatoid arthritis d-release (RA), approved in Europe, FDA New Filing low-dose IPO on 7/28/11 for 5.5M (NDA) prednisone) shares priced @$9 7/29/11

Neurocrine Biosciences NBIX

$6.08

$336

9/30/11

NBI-98854 Pending Phase (VMAT2 2 Clinical Trial Inhibitor)

Expects to begin P2 trial in SEP 2011 for treating the symptoms of tardive dyskinesia (TD) in 32 pts over two-week dosing period, expects to report three-month toxicology results during 4Q11, plans to conduct P2B trial in early 2012 7/29/11

Neurocrine Biosciences NBIX

$6.08

$336

9/30/11

ELAGOLIX (orally active nonpeptide Pending Phase GnRH 3 Clinical Trials antagonist)

Expects to begin P3 trial for uterine fibroids during 3Q11 and begin P3 trial for endometriosis during 4Q11, partnered w/ ABT

7/29/11

Novavax

NVAX

$1.75

$201

9/30/11

During 2Q11, completed enrlmt of 150 subjects in ongoing P1 trial to assess Respiratory safety and immune response Syncytial in adults for experimental Virus Fusion RSV vaccine w/ interim topProtein line data expected during Phase I Clinical (RSV-F) 3Q11, ClinicalTrials.gov ID Trial Vaccine NCT01290419

8/15/11

Pharmasset VRUS

$71.94

$5,424

9/30/11

On 8/24/11 received FDA Fast Track status for PSI-938 treatment of chronic hepatitis (nucleotide C virus (HCV) infection, Pending Phase analog HCV expects to begin interferon2b (QUANTUM) polymerase free combo P2 (QUANTUM) Clinical Trial inhibitor) trial w/ PSI-7977 during 3Q11 8/24/11

QLT Inc.

QLTI

$7.12

$356

9/30/11

Expects to report 4-week treatment results for reducing L-PPDS intraocular (eye) pressure in (latanoprost pts w/ glaucoma during 3Q11 punctal plug for novel delivery system of eye drug approved drug XALATAN eye Phase 2 Clinical delivery drops, ClinicalTrials.gov ID Trial system) NCT01229982 8/11/11

Regeneron Pharma

REGN

$71.27

$6,530

9/30/11

ARCALYST (rilonacept) Subcutaneo us Injection (fusion protein that blocks cytokine FDA New Filing interleukin-1 (sBLA) or IL-1)

On 2/28/11, announced second Phase 3 trial for prevention of gout flares in pts receiving uric acid lowering therapy met all primary and secondary endpts, expects to file a sBLA mid-2011 (2-3Q11) to expand use of drug which is currently approved for inherited, auto-inflammatory conditions known as CAPS

6/28/11

Threshold Pharma

THLD

$1.59

$78

9/30/11

TH-302 (a hypoxiaactivated pro-drug or Pending Pivotal HAP antiPhase 3 Clinical cancer Trial under SPA agent)

In FEB 2011 announced SPA agmt w/ FDA for design of pivotal P3 trial for pts w/ advanced / metastatic unremovable soft tissue sarcoma in combo w/ doxorubicin that is expected to begin during 3Q11 7/25/11

Vermillion

VRML

$2.50

$37

9/30/11

Intended-Use Population Clinical Trial (Diagnostic Test Evaluation)

On 8/1/11, announced noticed of allowance for patent covering biomarkers VASCLIR for PAD, expects to report topPeripheral line data during 3Q11 to Artery provide a finalized biomarker Disease algorithm for blood diagnostic (PAD) Blood test to stratify risk of Test developing PAD 8/1/11

Aastrom Biosciences ASTM

$2.54

$98

9/19/11

In JAN 2011, reported sixmonth interim results for pts w/ dilated cardiomyopathy (DCM) w/ no safety concerns and positive trends in quality Ixmyelocel- of life and functional T (bone parameters in treatment marrow, group, will present final 12patientmonth results at heart failure IMPACT-DCM derived cell society mtg on 9/19/11, Surgical Phase therapy ClinicalTrials.gov ID 2 Clinical Trial product) NCT00765518

8/16/11

Talon Therapeutic s (formerly Hana Biosciences ) TLON

$0.95

$21

9/19/11

On 8/29/11, reached SPA agmt w/ FDA for planned P3 trial by yr-end 2011 in pts w/ FDA Reply to acute lymphoblastic leukemia Accept NDA (ALL), on 7/18/11 announced Filing and Issue MARQIBO NDA filing seeking PDUFA (Optisome accelerated FDA approval for Decision Date, encapsulate treatment of adults w/ Pending d Philadelphia Chromosome Confirmatory formulation Negative ALL w/ expected Phase 3 of approved FDA reply by 9/19/11 to (HALLMARQ) cancer drug accept NDA filing and issue Clinical Trial vincristine) decision date 8/29/11

Discovery Labs

DSCO

$2.25

$55

9/16/11

FDA Reply to Accept NDA Resubmission and Issue PDUFA Decision Date

On 9/2/11 submitted complete response to CRL issued by FDA in 2009, seeking approval for the prevention of respiratory SURFAXIN distress syndrome (RDS) in (lucinactant) premature infants, expected (synthetic, FDA reply in two weeks peptide(9/16/11) to accept NDA and containing issue PDUFA decision goal lung date w/ a six-month Class 2 surfactant) review period expected

9/6/11

Repros Therapeutic s RPRX

$5.13

$63

9/12/11

Androxal Phase 2 Clinical (enclomTrial iphene)

In MAY 2011, provided update w/ 66 men w/ Type 2 diabetes randomized in trial, expects to report interim results and be fully enrolled (120-150 pts) in SEP 2011 and report top-line results for full study around year-end 2011, will present update on 9/12/11

9/1/11

Repros Therapeutic s RPRX

$5.13

$63

9/12/11

Proellex (oral selective Low-Dose progest(Safety) erone Proellex Clinical receptor Trial modulator)

In JUN 2011, began enrolling subjects in 9mg cohort following safety rvw after 8 wks of dosing at 6mg w/ no signals of liver toxicity reported, enrolling 12 subjects per dosing group w/ 12mg as last in this study that is expected to be completed during 4Q11, will present update on 9/12/11 at R&R conf

9/1/11