Special Report: 2016 Biotech Calender

Development-stage biotech is what you could call a feast-or-famine market.

Crucial trial data, expert advisory panels, and regulatory approval decisions can all send a stock soaring (or tanking) in the blink of an eye.

For this reason, it's incredibly helpful to keep a calendar of biotechnology catalysts on hand so you can be prepared for when these events happen. Doing so will allow you to either side-step risk or skillfully play the volatile trading that surrounds these events.

In this report, you'll learn about several common catalysts in biotech as well as what they mean for a company. Most importantly, you'll learn when they'll be happening throughout the year.

The Catalyst Glossary below will briefly explain each step of the drug development process. This is followed by our full 2016 Biotech Calendar, covering well over 200 different biotech events.

Let's get started.

Catalyst Glossary

Phase I

The first clinical stage of drug development, phase I, is performed on a small group of volunteers (20 to 100) and looks primarily at safety. The purpose of phase I is to see how the new product is metabolized in the human body and to determine a tolerable dose range. The wider the dose range, the better for the developer.

Phase II

This is the second clinical stage of drug development, often referred to as the safety and efficacy study. The sample size for phase II is larger than phase I, usually between 100 and 300 patients. The purpose is to demonstrate the drug's efficacy (how well it works), to monitor side effects, and to further establish proper dosage.

Patients taking the drug candidate are generally compared to a control group receiving an inactive placebo. The greater the efficacy between drug and placebo, the better.

Phase II trials are sometimes divided into phase II-a pilot trials and phase II-b well-controlled trials.

Phase III

The third stage of clinical drug development, phase III, is often referred to as the confirmation phase, because the primary goal is to see a repeat of the positive effects seen in phase II after looking at a larger group of patients (usually 500 to 2,000 people). Phase III has a strong focus on safety issues, data control, and production preparations.

New Drug Application (NDA)

A new drug application is a request for permission to introduce a new product into interstate commerce. The purpose of an NDA is to provide enough information for the FDA to decide a drug candidate is:

  • Safe
  • Effective
  • Appropriately labeled
  • Manufactured effectively

Upon NDA approval, a license is issued, allowing the firm to market the product.

Biologics License Applications (BLA)

A biologics license application, like an NDA, is a request for permission to introduce a biologic product into interstate commerce. BLAs are governed by the Public Health Service Act (PHS Act), which defines biologics as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product.”

The FDA requirements for a BLA include:

  • Applicant information
  • Product/Manufacturing information
  • Pre-clinical studies
  • Clinical studies
  • Labeling

Upon BLA approval, a license is issued, allowing the firm to market the product.

Prescription Drug User Fee Act (PDUFA) Dates

PDUFA dates are target deadlines for the FDA to approve new drugs. Specifically, the FDA must either approve the candidate or issue a Complete Response Letter (CRL) to explain why approval is being denied.

The FDA is normally given 10 to 12 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six to eight months to review the drug. These time frames begin on the date an NDA is submitted.

2016 Biotech Catalyst Calendar

Below is our full calendar of biotech catalysts through the end of 2016. First, a few quick things worth noting:

As a general rule of thumb, we can attribute more weight to catalysts later in the development stage. These are your PDUFA decisions and phase III trial data releases. The closer a product is to commercialization, the more the market is going to react.

Additionally, the smaller the market cap, the greater the impact of a catalyst. A new product approval of Johnson & Johnson will have little impact on the top line because the company is so large already. A small-cap biotech company with no revenue, however, could be an absolute boom or bust.

In other words, look for small companies in late development stages if you want those high-risk, high-reward plays.

There are also several other factors you'll need to consider before investing in any of these companies. Primarily, you want to look at size of the relative disease market, expected share penetration, and the payout structure for commercialization.

There are many ways you can play a catalyst date to your advantage. Here's a quick rundown of a few strategies:

  • One method is to either go short or long on a company one to three months in advance of a significant catalyst date. If the general sentiment is negative, go short. If the general sentiment is positive, go long.

    Leading up to a catalyst, investors have little to no new information to go off of, so they tend to feed off emotion more than common sense. As the catalyst date approaches, fear or greed will take over, and the stock will begin to move at an accelerated rate. Play this momentum, and then get out right before the catalyst occurs. This strategy is very useful for avoiding risk.

  • Another strategy is to purchase shares just days before an expected catalyst. This is a short-term strategy with high risk but also incredibly high reward. In this strategy, you take a position and actually see the results through. The more you research a drug candidate and its mechanism of action, the greater your chances of being on the right side of the proverbial coin toss.
  • The last method we'll discuss is to take a contrarian position almost immediately following a catalyst.

On positive news, you would take a short position after the stock rockets upward. A positive catalyst often creates an irrational buying frenzy that quickly exhausts. People start to take their profits, and a sell-off begins.

On negative news, you would buy, but only if the company has adequate financing. If a company can see itself through another catalyst event without diluting shares, you can often pick up shares at a bargain.

TickerPriceMarket CapCandidateIndicationCatalyst TypeCatalyst Date (due by)
ESALY 68.70 20.9b Fycompa Seizures PDUFA 08/19/2015
ALKS 67.05 9.7b Aripiprazole lauroxil Schizophrenia PDUFA 08/22/2015
AMGN 159.35 118.7b Evolocumab LDL cholesterol Levels PDUFA 08/27/2015
BMY 69.85 116.4b Opdivo (nivolumab) Advanced melanoma PDUFA 08/27/2015
CLVS 58.31 3.0b Rociletinib Non-small cell lung cancer NDA filing 08/31/2015
OPK 16.80 7.6b Rolapitant Chemotherapy induced nausea and vomiting PDUFA 09/05/2015
TSRO 60.91 2.3b Rolapitant Chemotherapy induced nausea and vomiting PDUFA 09/05/2015
VSTM 7.76 267.0m VS-6063 COMMAND trial Mesothelioma (cancer) Phase 2 09/30/2015
TRVN 6.74 258.1m TRV130 Moderate to severe acute-pain Phase 2b 09/30/2015
TTPH 48.93 1.8b Eravacycline Complicated urinary tract infections Phase 3 09/30/2015
AERI 19.28 452.3m Rhopressa Glaucoma Phase 3 09/30/2015
VTL 26.74 637.4m VTI-208 Alcohol-induced liver decompensation Phase 3 09/30/2015
AKBA 9.12 252.1m AKB-6548 Chronic Kidney Disease Phase 2a 09/30/2015
CNAT 5.22 95.0m Emricasan Portal Hypertension Phase 2 09/30/2015
CORI 13.88 247.2m MicroCor PTH Osteoporosis Phase 2a 09/30/2015
CPRX 5.16 404.9m Firdapse Lambert-Easton Myasthenic Syndrome NDA filing 09/30/2015
EGLT 12.34 217.3m Egalet-001 Abuse-deterrent morphine Phase 3 09/30/2015
LXRX 8.70 839.1m Telotristat etiprate Carcinoid Syndrome Phase 3 09/30/2015
PLX 1.86 656.4m PRX-102 Fabry disease Phase 1/2 09/30/2015
SGYP 9.28 921.9m Plecanatide Chronic idiopathic constipation Phase 3 09/30/2015
XNPT 7.25 421.8m XP23829 Plague psoriasis Phase 2 09/30/2015
XENE 10.42 139.2m  TV-45070 Osteoarthritis Phase 2b 09/30/2015
ANAC 126.58 3.6b AN2728 Atopic dermatitis Phase 3 09/30/2015
ZSAN 9.64 99.0m ZP-Glucagon Severe hypoglycemia Phase 2 09/30/2015
APRI 1.72 89.0m RayVa Secondary Raynaud's Phenomenon Phase 2a 09/30/2015
MRK 57.95 163.9b Keytruda Non-small cell lung cancer PDUFA 10/02/2015
RLYP 32.14 1.3b Patiromer Oral Suspension with Hyperkalemia PDUFA 10/21/2015
BDSI 8.86 452.3m BEMA Buprenorphine Severe pain PDUFA 10/23/2015
ENDP 85.21 17.5b BEMA Buprenorphine Severe pain PDUFA 10/23/2015
MACK 11.75 1.3b MM-398 Second line pancreatic cancer PDUFA priority review 10/24/2015
SHPG 256.88 50.8b Lifitegrast Dry eye disease PDUFA Priority Review 10/25/2015
BMY 69.85 116.4b Yervoy Stage 3 melanoma PDUFA 10/28/2015
MCUR 13.44 205.5m CureXcel Diabetic foot ulcers Phase 3 10/31/2015
RPRX 7.89 190.8m Androxal Secondary hypogonadism Advisory Committee 11/03/2015
GILD 117.38 168.6b Elvitegravir, cobicistat,... HIV PDUFA 11/06/2015
JNJ 99.23 275.3b  Yondelis Soft-tissue sarcoma PDUFA 11/24/2015
RPRX 7.89 190.8m  Androxal  Secondary hypogonadism PDUFA 11/30/2015
BAX 37.65 20.5b  BAX 855 Hemophilia A PDUFA 12/01/2015
BAYRY 151.03 122.2b BAY 81-8973 Hemophilia A PDUFA 12/17/2015
BAX 37.65 20.5b BAX 111 Von Willebrand Disease PDUFA 12/22/2015
ALIOF 149.45 17.3b Selexipag - Uptravi Pulmonary arterial hypertension PDUFA 12/22/2015
TTNP 0.72 79.4m  Probuphine  Opioid dependence Phase 3 12/31/2015
AEZS 0.24 27.5m AEZS-108 Endometrial cancer Phase 3 12/31/2015
ADMA 9.54 101.4m RI-002 Primary Immune Deficiency BLA filing 12/31/2015
CERU 4.52 123.3m CRLX101 Ovariam cancer Phase 2 12/31/2015
ACAD 48.78 4.4b Pimavanserin Parkinson's disease NDA filing 12/31/2015
BIND 5.95 114.6m BIND-014 Non-small-cell lung carcinoma Phase 2 12/31/2015
ACHN 9.35 1.0b ACH-3102 + sovaprevir + sofobuvir Hepatitis C Phase 2 12/31/2015
ACHN 9.35 1.0b ACH-3422 + ACH-3102 Hepatitis C Phase 2 12/31/2015
ADMS 28.48 489.9m ADS-5102 Levodopa-induced dyskinesia Phase 3 12/31/2015
ALDR 48.53 2.1b ALD403 Migraines Phase 2b 12/31/2015
ALDX 8.30 80.9m NS2 Sjogren-Larsson Syndrome Phase 2 12/31/2015
ALDX 8.30 80.9m NS2 Acute anterior uveitis Phase 2 12/31/2015
ALNY 128.74 10.1b Revusiran TTR cardiac amyloidosis Phase 2 12/31/2015
APRI 1.72 89.0m RayVA Secondary Raynaud's phenomenon Phase 2a 12/31/2015
ATRA 63.00 1.3b PINTA-745 protein-energy wasting Phase 2 12/31/2015
BCRX 16.28 1.1b OPuS-2 trial  Hereditary angiodema Phase 2b 12/31/2015
BIND 5.95 114.6m BIND-014 Advanced Non-small-cell lung cancer Phase 2 12/31/2015
BLRX 2.29 127.7m BL-8040 Acute myeloid leukemia Phase 2 12/31/2015
BMRN 147.26 23.2b BMN-190  Batten disease Phase 1/2 12/31/2015
BMRN 147.26 23.2b BMN-201 Pompe disease Phase 2 12/31/2015
CAPR 4.97 75.5m Cenderitide  Ambulatory heart failure Phase 2 12/31/2015
CNAT 5.22 95.0m Emricasan Liver cirrhosis Phase 2 12/31/2015
CORT 5.91 631.5m Korlym Breast cancer Phase 1/2 12/31/2015
DPRX 14.43 132.2m Locilex Diabetic foot ulcer infections Phase 3 12/31/2015
ENTA 48.03 838.9m ABT-493 Hepatitis C Phase 2b 12/31/2015
FLXN 24.88 503.0m FX006 Osteoarthritis of the knee Phase 2b 12/31/2015
GEVA 238.60 8.9b SB-103 Mucopolysaccharidosis Phase 1/2 12/31/2015
GNCA 14.98 348.2m  GEN 004 Universal vacine for pneumococcus Phase 2 12/31/2015
GWPH 127.49 2.8b Epidiolex Dravet syndrome Phase 2 12/31/2015
GWPH 127.49 2.8b Epidiolex Lennox-Gastaur syndrome  Phase 3 12/31/2015
GWPH 127.49 2.8b Sativex  Cancer pain Phase 3 12/31/2015
GWPH 127.49 2.8b GWP42003 Schizophrenia Phase 3 12/31/2015
IMGN 16.84 1.2b Trastuzumab emtansine Metastic gastric cancer Phase 3 12/31/2015
IRWD 11.56 1.6b Linaclotide Chronic idiopathic constipation Phase 2 12/31/2015
IRWD 11.56 1.6b Linaclotide  Opioid induced constipation Phase 3 12/31/2015
HTBX 6.07 54.8m HS-110 Non-small-cell lung cancer Phase 2 12/31/2015
ISIS 55.67 6.4b ISIS-GCCRRx Type 2 diabetes Phase 2 12/31/2015
LPCN 8.85 157.6m LPCN 1021 Low testosterone NDA filing 12/31/2015
LGND 104.82 2.0b Captisol-enabled Delafloxin Bacteria skin infections Phase 3 12/31/2015
MDWD 7.09 152.1m EscharEx Chronic wounds Phase 2 12/31/2015
NBIX 52.18 4.2b VMAT2 Kinect 3 trial Tardive dyskinesia Phase 3 12/31/2015
NBIX 52.18 4.2b Elagolix Endometriosis Phase 3 12/31/2015
NBIX 52.18 4.2b Elagolix Uterine fibroids Phase 2b 12/31/2015
OCUL 24.56 516.2m OTX-DP Glaucoma and ocular hypertension Phase 2b 12/31/2015
OGXI 2.38 55.8m Custirsen + Jevtana Castrate-resistant prostate Phase 3 12/31/2015
PTCT 49.07 1.6b Ataluren  Duchene muscular dystrophy Phase 3 12/31/2015
PLX 1.86 656.4m PRX-102 Fabry disease Phase 1/2 12/31/2015
RARE 126.44 4.2b Triheptanoin  Glucose transporter type-1 deficiency syndrome Phase 2 12/31/2015
RARE 126.44 4.2b Triheptanoin Long-chain fatty acid oxidation disorders Phase 2 12/31/2015
RDUS 79.91 2.8b Abaloparatide-SC Osteoporosis NDA filing 12/31/2015
RPTP 14.80 1.2b RP103 Non-alcoholic fatty liver disease Phase 2b 12/31/2015
RPTP 14.80 1.2b RP103 Mitochondrial disorders/Leigh syndrome Phase 2 12/31/2015
RVNC 31.21 744.0m RT002 Moderate to severe glabellar/frown lines Phase 2 12/31/2015
SGMO 10.73 681.6m CERE-110 Alzheimer's disease Phase 2 12/31/2015
SGMO 10.73 681.6m SB-728-1401 HIV/AIDS Phase 2 12/31/2015
SPHS 0.83 14.0m PRX302 Benign prostatic hyperplasia Phase 3 12/31/2015
STEM 0.53 54.7m HuCNS-SC  Spinal cord injury Phase 2 12/31/2015
TSRO 60.91 2.3b Niraparib - NOVA Ovarian cancer Phase 3 12/31/2015
TTPH 33.19 1.8b Eravacycline  Complicated intra-abdominal infections NDA filing 12/31/2015
VSTM 7.76 267.0m VS-6063 KRAS-mutated NSCLC Phase 2 12/31/2015
AMGN 159.35 118.7b Brodalumab Moderate-to-severe plaque psoriasis BLA filing 12/31/2015
AMGN 159.35 118.7b Bevacizumab Lung cancer Phase 3 12/31/2015
BLCM 20.03 505.4m BPX-501 Hematopojetic stem cell transplantation Phase 1/2 12/31/2015
NEOT 11.50 135.0m LIPO-202 Reduction of central abdominal bulging due to subcutaneous fat in non-obese patients Phase 3 12/31/2015
TCON 10.60 133.1m TRC105 Soft tissue sarcoma Phase 2 12/31/2015
ONCE 61.13 1.5b SPK-RPE65 Inherited retinal dystrophies Phase 3 12/31/2015
PBYI 108.93 3.4b PB272 HER2+ MBC that has metastasized to the brain Phase 2 12/31/2015
PBYI 108.93 3.4b PB272 HER2-negative breast cancer patients who have a HER2 mutation Phase 2 12/31/2015
TTHI 2.15 75.9m TT401 Type 2 diabetes Phase 2 12/31/2015
KERX 9.94 1.0b Auryxia Iron deficiency anemia in non-dialysis dependent CKD patients Phase 3 12/31/2015
TLOG 2.82 78.8m Birinapant Ovarian cancer Phase 1/2 12/31/2015
TLOG 2.82 78.8m SHAPE Trial Cutaneous t-cell lymphoma Phase 2 12/31/2015
TLOG 2.82 78.8m Birinapant Acute myelogenous leukemia Phase 1/2 12/31/2015
ISIS 55.67 6.4b ISIS-DMPK Rx Myotonic Dystrophy Type 1 Phase 1/2 12/31/2015
ISIS 55.67 6.4b ISIS-GCCRRx Type-2 diabetus Phase 2 12/31/2015
ISIS 55.67 6.4b ISIS-APO(a)Rx High lipoprotein Phase 2 12/31/2015
TNXP 7.46 133.1m TNX-201  Episodic tension-type headache Phase 2 12/31/2015
EGLT 12.34 217.3m Egalet-001 Abuse-deterrent morphine NDA filing 12/31/2015
CTIC 1.97 352.4m Pacritinib Myelefibrosis NDA filing 12/31/2015
MRNS 14.25 193.4m Ganaxolone Female children with epilepsy Phase 2 12/31/2015
SPPI 69.85 478.0m Apaziquone Bladder cancer PDUFA 12/31/2015
TKMR 69.85 634.2m TKM-Ebola-Guinea Ebola Phase 2 12/31/2015
FOLD 14.91 1.6b Migalastat HCI  Fabry disease NDA filing 12/31/2015
SYN 3.79 261.6m  SYN-004 Constipation-Predominant IBS Phase 2 12/31/2015
SYN 3.79 261.6m SYN-004 C. difficile infection Phase 2 12/31/2015
ACRX 4.38 187.1m ARX-04 Moderate-to-severe pain Phase 3 12/31/2015
RARE 126.44 4.2b KRN23 X-linked hypophosphatemia Phase 2 12/31/2015
CARA 13.71 304.4m Oral CR845 Acute pain Phase 2 12/31/2015
ALXA 1.16 23.0m AZ-002 Acute repetitive seizures Phase 2 12/31/2015
CLVS 86.85 3.0b Lucitanib Breast cancer Phase 2 12/31/2015
SGYP 9.28 921.9m Lecanatide Constipation-predominant IBS Phase 3 12/31/2015
OCUL 24.56 516.2m OTX-DP Post-surgical ocular pain NDA filing 12/31/2015
ZFGN 38.08 963.3m Beloranib Severe obesity Phase 2b 12/31/2015
RVNC 31.21 744.0m  RT001 Hyperhidrosis Phase 2 12/31/2015
IDRA 3.56 417.3m  IMO-8400 Waldenstrom's Macroglobulinemia Phase 1/2 12/31/2015
ONTX 2.53 54.9m Oral Rigosertib and azacitidine Lower-risk MDS Phase 2 12/31/2015
AFMD 88.72 475.4m AFM13 Hodgkin Lymphoma Phase 2a 12/31/2015
VCEL 3.65 86.8m MACI Focal chondral knee cartilage defects BLA filing 12/31/2015
HRTX 32.78 1.1b HTX-011 Post-operative pain Phase 2 12/31/2015
ZFGN 38.08 963.3m Beloranib Prader-Willi syndrome Phase 3 01/31/2016
AQXP 1.88 20.1m AQX-1125 Atopic dermatitis Phase 2 03/31/2016
INNL 14.70 354.1m XaraColl Post-operative pain Phase 3 03/31/2016
MRNS 14.25 193.4m Ganaxolone Epilepsy Phase 3 03/31/2016
BMRN 147.26 23.2b PEG-PAL Phenylketonuria Phase 3 03/31/2016
CMRX 48.32 2.1b Brincidofovir Cytomegalovirus infection Phase 3 03/31/2016
CPXX 2.24 72.0m  CPX-351 Secondary AML Phase 3 03/31/2016
EARS 5.28 180.3m  AM-101 Acute inner ear tinnitus Phase 3 03/31/2016
GWPH 127.49 2.8b Epidiolex  Dravet syndrome Phase 3 03/31/2016
THLD 4.45 297.2m TH-302 Soft tissue sarcoma Phase 3 03/31/2016
MSTX 0.50 76.3m ANX-288 Sickle cell disease Phase 3 03/31/2016
PBYI 108.93 3.4b PB272 HER2-positive breast cancer NDA filing 03/31/2016
PTLA 48.74 2.4b Betrixaban Venous thromboembolism Phase 3 03/31/2016
RIGL 3.33 269.5m  R348 Chronic dry eye disease Phase 2 03/31/2016
RIGL 3.33 269.5m Fostamantinib IgA nephropathy Phase 2 03/31/2016
SCMP 18.41 838.2m Lubiprostone  Pediatric functional constipation Phase 3 03/31/2016
VCEL 3.65 86.8m Ixmyelocel-T Ischemic dilated cardiomyopathy Phase 2b 03/31/2016
THLD 4.45 297.2m TH-302 Pancreatic cancer Phase 3 03/31/2016
APRI 1.72 89.0m Fispemifene Symptomatic secondary hypogonadism Phase 2b 03/31/2016
CANF 2.09 22.1m CF101 Glaucoma Phase 2 06/30/2016
INNL 14.70 354.1m Cogenzia Diabtic foot ulcer infections Phase 3 06/30/2016
BOTA 2.39 79.3m Vapendavir Human rhinovirus Phase 2b 06/30/2016
CERU 4.52 123.3m  CRLX101 Relapsed renal cell carcinoma Phase 2 06/30/2016
DERM 20.48 460.4m  DRM01 Acne Phase 2 06/30/2016
GLMD 10.40 113.7m Aramchol Non-alcoholic steatohepatitis Phase 2b 06/30/2016
IMMU 4.20 391.6m Clivatuzumab tetraxetan Pancreatic cancer Phase 3 06/30/2016
INSM 25.08 1.5b ARIKAYCE Non-tb mycobacterial lung disease Phase 3 06/30/2016
ARRY 7.14 979.3m Selumetinib  Thyroid cancer Phase 3 06/30/2016
IRWD 11.56 1.6b IW-9179 Gastroparesis Phase 2a 06/30/2016
PTN 1.06 39.5m Bremelanotide Female sexual dysfunction Phase 3 06/30/2016
RCPT 202.52 6.1b RPC4046 Eosiniphilic esophagitis Phase 2 06/30/2016
RGDO #N/A 0.0m Cenicriviroc Non-alcoholic steatophatitis Phase 2b 06/30/2016
RIGL 3.33 269.5m Fostamatinib  Immune Thrombocytopenic Phase 3 06/30/2016
TRVN 6.74 258.1m TRV027 Acute heart failure Phase 2b 06/30/2016
AMGN 159.35 118.7b Romosozumab Postmenopausal osteoporosis Phase 3 06/30/2016
TCON 10.60 133.1m TRC105 Hepatocellular carcinoma Phase 2 06/30/2016
TCON 10.60 133.1m TRC105 Breast cancer Phase 2 06/30/2016
TCON 10.60 133.1m TRC105 Glioblastoma Phase 2 06/30/2016
MCUR 13.44 205.5m CureXcell Venous Leg Ulcers Phase 3 06/30/2016
OGXI 2.38 55.8m OGX-427 NSCLC Phase 2 06/30/2016
NERV 5.77 140.2m MIN-101 Schizophrenia Phase 2b 06/30/2016
PSDV 4.48 119.5m Medidur Posteriour uveitis Phase 3 06/30/2016
RARE 126.44 4.2b rhGUS Mucopolysaccharidosis Phase 3 06/30/2016
SCYX 8.80 126.6m SCY-078 Invasive fungal infections Phase 2 06/30/2016
GWPH 127.49 2.8b GWPH42006 Epilepsy Phase 2 06/30/2016
BIOD 1.10 65.8m BIOD-531 Type-2 diabetus Phase 2b 06/30/2016
ARRY 7.14 979.3m Selumetinib NSCLC lung cancer Phase 3 07/31/2016
ANTH 3.78 301.5m Blisibimod Lupus Phase 3 09/30/2016
PRTK 27.60 472.5m Omadacycline Acute bacterial skin infections Phase 3 09/30/2016
MNOV 3.80 93.0m MN-166 Progressive MS Phase 2b 10/31/2016
NKTR 12.01 1.6b Cipro DPI Non-cystic fibrosis bronchiectasis Phase 3 12/31/2016
OGXI 2.38 55.8m Custirsen NSCLC Phase 3 12/31/2016
XENE 10.42 139.2m TV-45070 Postherpetic neuralgia Phase 2b 12/31/2016
VSAR 19.48 546.8m VRS-317 Growth hormone deficiency Phase 3 12/31/2016
CYTR 4.07 222.1m Aldoxorubicin Refractory soft tissue sarcoma Phase 3 12/31/2016
ANTH 8.76 301.5m Blisibimod IgA nephropathy Phase 3 12/31/2016
HTBX 6.07 54.8m HS-410 Bladder cancer Phase 2 12/31/2016
ALKS 67.05 9.7b ALKS 5461 Major depressive disorder Phase 3 12/31/2016
ASPX 100.96 3.2b SD-809 Tardive Dyskinesia Phase 3 12/31/2016
CYTR 4.07 222.1m Aldoxorubicin Relapsed/refractory lung cancer Phase 2b 12/31/2016
DYAX 27.96 3.9b Anti-LINGO Relapsing forms of MS Phase 2 12/31/2016
GLMD 10.40 113.7m Aramchol Non-alcoholic steatohepatitis Phase 2b 12/31/2016
FLXN 24.88 503.0m FX006 Osteoarthritis of the knee Phase 3 12/31/2016
GWPH 127.49 2.8b GWP42004 Type-2 diabtus Phase 2b 12/31/2016
INCY 116.92 20.3b Ruxolitinib Pancreatic cancer Phase 3 12/31/2016
INSY 39.00 2.8b Buprenorphine Acute pain in bunionectomy procedures Phase 3 12/31/2016
INSY 39.00 2.8b Subsys Acute post-operativ pain Phase 3 12/31/2016
KPTI 33.50 907.0m Selinexor B-cell lymphoma Phase 2b 12/31/2016
MDCO 33.48 2.2b CARBAVANCE Bacterial infections Phase 3 12/31/2016
NKTR 12.01 1.6b Fovista Wet-AMD Phase 3 12/31/2016
OCRX 4.47 81.9m OCR-002 Hepatic encephalopathy Phase 2b 12/31/2016
OPHT 57.85 1.9b Fovista Wet-AMD Phase 3 12/31/2016
OPXA 0.48 24.0m Tovaxin Secondary Progressive MS Phase 2b 12/31/2016
PTCT 49.07 1.6b Ataluren Cystic fibrosis Phase 3 12/31/2016
VTL 26.74 637.4m  ELAD (VTI-212) Acute liver failure Phase 2 12/31/2016
INCY 116.92 20.3b Ruxolitinib Breast cancer Phase 2 12/31/2016
INCY 116.92 20.3b Ruxolitinib Pancreatic cancer Phase 3 12/31/2016
INCY 116.92 20.3b Ruxolitinib Lung cancer Phase 2 12/31/2016
TNXP 7.46 133.1m TNX-102 SL Fibromyalgia Phase 3 12/31/2016
SGEN 48.94 5.9b ADCETRIS T-cell lymphoma Phase 3 12/31/2016
BCLI 3.34 62.8m NurOwn Amytrophic lateral sclerosis Phase 2 12/31/2016
HRTX 32.78 1.1b HTX-019 Prevention of chemotherapy-induced nasea and vomiting NDA filing 12/31/2016
IDRA 3.56 417.3m IMO-8400 DLBCL patients with MYD88 L265P mutation Phase 1/2 12/31/2016
AFMD 88.72 475.4m AFM13 Hodgkins lymphoma Phase 2a 12/31/2016
ADMS 28.48 489.9m ADS-5102 Multiple sclerosis Phase 2 12/31/2016
TKAI 14.48 303.1m Galeterone Prostate cancer Phase 3 12/31/2016

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