Conatus Pharmaceuticals (CNAT) shares have edged higher in pre-market trading today, extending their gains from the previous trading session. CNAT shares have been gaining momentum after the company announced a collaboration with Exalenz Bioscience under which Conatus will use its BreathID Methacetin Breath Test (MBT) to monitor patients in a Phase 2b clinical trial assessing lead product candidate emricasan for the treatment of patients with non-alcoholic steatohepatitis (NASH).

Tonix Pharmaceuticals (TNXP) edged higher on Monday after the company announced that it sees a clear path of registration for its TNX-102 SL for the treatment of post-traumatic stress disorders (PTSD). The company’s confidence stems from written minutes it received from the FDA from its End-of-Phase 2/Pre-Phase 3 meeting. The FDA has confirmed that the positive results from two Phase 3 trials along with safety studies should be sufficient to demonstrate efficacy for PTSD.

The news lifted TNXP shares more than 10% in pre-market trading on Monday. But the stock failed to hold on to its gains and closed around 2% higher. While the development was positive, the bigger catalyst for TNXP is results from its late-stage study for its lead product candidate. Results are expected to be announced in the current quarter. As I have said earlier, there is a strong chance of positive results, which makes TNXP worth holding.

Mylan Announces Launch of First Generic EpiPen- Mylan (MYL) announced the launch of first generic to its allergy auto-injector at a discount of more than 50% to the branded product's list price. Mylan expects to release the $300 two-pack carton in several weeks, pending completion of labeling revisions.

CTI BioPharma Announces Data From Late-Stage Study of Lead Product Candidate- CTI BioPharma (CTIC) announced top-line data from a Phase 3 clinical trial, PERSIST-2, evaluating  lead product candidate pacritinib against physician-specified best available therapy (BAT), including Novartis' (NYSE:NVS) Jakavi (ruxolitinib), in patients with advanced myelofibrosis showed statistically valid results in one of two co-primary endpoints. The results were generated from 221 patients who reached the primary analysis time point of Week 24 at the time the clinical hold was imposed by the FDA. Preliminary results showed a statistically significant response rate as measured by minimum spleen volume reduction (SVR) of 35% compared to BAT, including Jakavi (p<0.01). The other primary endpoint, at least a 50% reduction in Total Symptom Score (TSS) was not met (p=0.0791). The FDA suspended the company's clinical development of pacritinib in February because of an abnormal number of deaths from intracranial hemorrhage, cardiac failure and cardiac arrest. The company has withdrawn its New Drug Application (NDA) for the drug.

Amgen Reports Positive Data from Late-Stage Study of Prolia- Amgen (AMGN) announced top-line data from a Phase 3 study assessing its Prolia (denosumab) compared to risedronate n patients with glucocorticoid-induced osteoporosis met all primary and secondary endpoints at Month 12. Patients receiving Prolia experienced greater gains in bone mineral density at the lumbar spine and total hip versus those treated with risedronate (4.4% vs. 2.3% at the lumbar spine and 2.1% vs. 0.6% at the total hip). The results also favored Prolia over risedronate in patients just starting glucocorticoid therapy (3.8% vs. 0.8% at the lumbar spine and 1.7% vs . 0.2% at the total hip).

Amgen also announced new clinical data presented at the European Society of Cardiology Congress in Rome reinforce Repatha's (evolocumab) efficacy in lowering low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups and in those with familial (inherited) hypercholesterolemia (FH).

Regeneron and Sanofi Announce Data from ODYSSEY ESCAPE- Regeneron Pharmaceuticals (REGN) and its partner, French drug maker Sanofi (SNY) announced that a Phase 3 clinical trial, ODYSSEY ESCAPE, evaluating their PCSK9 inhibitor Praluent (alirocumab) in patients with heterozygous familial hypercholesterolemia (HeFH) who require weekly/bi-weekly apheresis treatment, showed adding Praluent to existing therapy lowered LDL cholesterol (LDL-C) by ~50% from baseline versus a 2% increase for placebo. In addition, treatment with Praluent reduced the need for apheresis treatment by 75% compared to placebo (p<0.0001), the primary endpoint. The results were presented at the European Society of Cardiology Congress in Rome.

Shkreli Sells Entire Stake in KaloBios- KaloBios Pharmaceuticals (KBIO) said in a statement that its former CEO Martin Shkreli has sold his entire stake in the company to other investors in private transactions. KBIO emerged from Chapter 11 Bankruptcy on June 30th.
Cerecor Commences Second Mid-Stage Study of CERC-501- Cerecor (CERC) announced that it has launched its second Phase 2 clinical trial evaluating CERC-501's ability to help smokers kick the habit. The study, funded in part by the National Institutes of Health, is exploring the premise that reducing stress can reduce the urge to smoke. The co-primary endpoints are the latency to the time of first cigarette smoking during the delay period and the number of cigarettes smoked during the self-administration period.

Kadmon Commences Mid-Stage Study of Tesevatinib- Kadmon Holdings (KDMN) announced that a Phase 2 clinical trial evaluating lead oncology candidate tesevatinib in patients with recurrent glioblastoma. The open-label study will enroll up to 40 subjects in the U.S. Tesevatinib is also under development for the treatment of polycystic kidney disease and EGFR-positive non-small cell lung cancer.

Inovio Commences Early-Phase Zika Vaccine Study- Inovio Pharmaceuticals (INO) announced that it has commenced a clinical study in Puerto Rico evaluating the safety, immune responses and signals of efficacy of GLS-5700, its Zika vaccine candidate. If successful, the company plans to meet with regulators next year to clarify a development path to registration.

Neurocrine Biosciences Submits NDA for Valbenazine- Neurocrine Biosciences (NBIX) announced that it has submitted a New Drug Application (NDA) o the FDA seeking approval of once-daily valbenazine for the treatment of tardive dyskinesia, a neurological disorder characterized by involuntary repetitive movements of the face. The FDA's formal notice of acceptance should happen in October.

Syros Pharma Soars on Update About New Drug Candidate- Syros Pharmaceuticals (SYRS) shares surged in after-hours trading on Monday after the company announced that its scientific founders Nathanael Gray and Richard Young have employed a novel chemistry approach to design the first selective inhibitor of difficult-to-drug enzymes cyclin-dependent kinase 12 (CDK12) and CDK13. The chemistry method is the same one that created SY-1365, a selective CDK7 inhibitor in development for the treatment of blood cancers and others. The scientists showed that selectively inhibiting CDK12 and CDK13 with a small molecule decreases the expression of DNA damage response genes and super-enhancer-associated transcription factors implicated in cancer, including leukemia, breast cancer and ovarian cancer. The research was published in a paper in the journal Nature Chemical Biology.

Roche (RHHBY) announced that the FDA has issued an Emergency Use Authorization for its "Lightmix Zika" test, a quick diagnostic check that allows healthcare professionals to quickly detect the virus.

Cynapsus (CYNA) announced that the FDA has granted its Phase 3-stage AL-130277 for Fast Track status for the treatment of OFF episodes in patients with Parkinson's disease (PD).

Alexion Pharma (ALXN) announced that the European Commission (EC) has granted Orphan Drug status to its omplement protein C5a-targeting monoclonal antibody ALXN1007 for the treatment of graft-versus-host disease (GVHD).

No patents to report.

N0 deals and collaborations to report.

Ampio Pharmaceuticals (AMPE) announced the pricing of its direct sale of 5 million shares of common stock and accompanying warrants to an institutional investor at $0.75 for both. The five-year warrants are exercisable at $1.00 per common share. Net proceeds from the offering will help to fund the advancement of the Ampion BLA and general corporate purposes.

Oragenics (OGEN) has filed a Form S-3 with the U.S. Securities and Exchange Commission (SEC). According to the filing, the company from time to time, may offer, issue and sell up to $30,000,000 of any combination of the securities described in the prospectus.

Proteostasis Therapeutics (PTI) has filed for a Form S-1 with the SEC.

No secondary offerings to report.

No IPOs to report.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Adamis Pharmaceuticals (ADMP) Maxim Group Reiterate Buy N/A N/A
Array BioPharma (ARRY) Jefferies Group Price Target Raised Buy From $6 to $7 N/A
AstraZeneca (AZN) Argus Upgrade From Hold to Buy

$38

N/A
Can-Fite Biopharma (CANF) Rodman & Renshaw Initiation Buy

$6

N/A
CTI BioPharma (CTIC) Piper Jaffray Cos. Reiterate Neutral N/A N/A
Exelixis (EXEL) Leerink Swann Reiterate Buy

$12

$12.50

Inovio Pharmaceuticals (INO) HC Wainwright Initiation Buy

$17

N/A
Mallinckrodt (MNK) Mizuho Reiterate Buy

$91

N/A
Novavax (NVAX) Guggenheim Reiterate Buy

$25

N/A
uniQure (QURE) Leerink Swann Reiterate Buy N/A N/A
Recros Pharma (REPH) Janney Montgomery Scott Initiation Buy

$21

N/A
Theravance BioPharma (TBPH) Evercore ISI Initiation Buy

$41

N/A
Vanda Pharmaceuticals (VNDA) Brean Capital Reiterate Buy From $20 to $24 N/A
Valeant Pharmaceuticals International (VRX) RBC Capital Markets Reiterate Sector Perform

$36

N/A

No insider buys to report.

FibroGen (FGEN)- Thomas B. Neff, CEO, sold 37,798 shares in two separate transactions. Neff sold 18,899 shares at $17.78; and 18,899 shares at $17.81. Neff still holds 3,379,932 shares of FGEN.

SciClone (SCLN)- Wilson Wai-Shun Cheung, CFO & Senior VP, Finance, sold 1,872 shares at $10.35. The total value of the transaction was $19,370. Cheung still owns 15,604 shares of SCLN.

Innovus Pharmaceuticals (INNV) announced the appointment of Robert Hoffman as EVP and Chief Financial Officer effective September 6. Previously, he was CFO at AnaptysBio.

NYSE- InVitae (NVTA) shares were among the major gainers on the NYSE. The stock closed 8.59% higher. Intrexon (XON) shares were among the major losers on the NYSE. The stock closed 2.49% lower.

NASDAQ- CoLucid Pharmaceuticals (CLCD) shares were among the major gainers on the NASDAQ. The stock closed 10.35% higher. Aquinox Pharmaceuticals (AQXP) ended the day 8.27% higher. Argos Therapeutics (ARGS) ended the day 7.41% higher. Forward Pharma (FWP) shares were among the major losers on the NASDAQ. The stock closed 6.91% lower. Strongbridge Biopharma (SBBP) ended the day 6.24% lower. Aptevo Therapeutics (APVO) ended the day 4.97% lower.

NYSEMKT- Palatin Technologies (PTN) shares were among the major movers on the NYSEMKT. The stock closed 4% higher.

OTC- Amarantus Bioscience Holdings (AMBS) shares were among the major movers on the OTC market. The stock closed 5.38% higher.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
United Therapeutics (UTHR)

20%

-4.3%

16

Vanda Pharmaceuticals (VNDA)

6.3%

-13%

5

Vascular Biogenics (VBLT)

4.3%

-3.5%

3

VBI Vaccines (VBIV)

0.8%

14.8%

3

Veracyte (VCYT)

7.9%

-3.5%

21

Verastem (VSTM)

1.1%

-1.1%

2

Vermillion (VRML)

1.6%

-0.5%

28

Versartis (VSAR)

7.9%

6.1%

18

Vertex Pharmaceuticals (VRTX)

2.2%

-4.2%

4

Viking Therapeutics (VKTX)

2.7%

-29.7%

2