Tobira Therapeutics (TBRA) announced that it has initiated a Phase 1 study  evaluating the combination of cenicriviroc (CVC) and evogliptin (EVO) for the treatment of non-alcoholic steatohepatitis (NASH). The single-center, open-label trial will evaluate the safety, tolerability and pharmacokinetics of EVO with administered with and without CVC. TBRA had seen a huge sell-off in July after the company announced that CVC failed a Phase 2b NASH study. However, at current levels, TBRA is worth a look.

ContraVir Pharmaceuticals (CTRV) announced encouraging results from preclinical studies evaluating the ability of its CRV432 and CMX157 to inhibit hepatitis B virus (HBV) replication. The data were presented in a poster during a joint meeting of the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver.

The data showed that multiple combinations of CRV431 and CMX157 synergistically reduced HBV DNA in human liver models. In addition, the combo inhibited the production/secretion of surface antigen (HBsAg) and e antigen (HBeAg) by infected cells, a key requirement for a curative HBV regimen.

The preclinical development of CRV431 is ongoing. An Investigational New Drug (IND) application may be filed in the U.S. in late 2017.

Starboard Acquires Stake in Perrigo- Hedge fund Starboard Value has taken a 4.6% stake in Perrigo (PRGO). The hedge fund is also urging Perrigo to refocus on its core business by selling non-core assets and also exploring other alternatives. The activist fund has criticized PRGO for failing to live up to the performance targets it set. Perrigo issued a statement, saying it would review the letter from the fund and looks forward to having a constructive and productive dialogue.

Amarin’s REDUCE-IT CV Outcomes Study to Continue As Planned- Amarin (AMRN) announced that its cardiovascular (CV) outcomes study, REDUCE-IT, assessing whether Vascepa (icosapent ethyl) reduces CV events in patients with elevated triglyceride levels and other CV risk factors despite being on stabilized statin therapy, will continue as planned. The decision was based on the recommendation of the independent Data Monitoring Committee after its review of the first pre-specified interim efficacy analysis.

Celgene’s Crohn Disease Candidate Shows Encouraging Results in Early-Stage Study- Celgene (CELG) announced interim top-line data from an exploratory study evaluating the effects of its GED-0301 (mongersen) on endoscopic and clinical outcomes in Crohn's disease patients. The data showed positive effects after a 12-week treatment period. he primary endpoint was an assessment of GED-0301 on endoscopic outcomes as measured by the change from baseline in a scale called SES-CD (Simplified Endoscopic Activity Score for Crohn's disease) at Week 12. The results showed endoscopic improvement (at least a 25% improvement from baseline) in a proportion of patients and clinical response and remission across all treatment groups at Week 12.

Geron Tumbles on Uncertainties Over Imet Studies- Geron Corporation (GERN) shares tumbled almost 20% on Monday following an update on two clinical trials being conducted by collaboration partner and licensee Janssen (JNJ) evaluating imetelstat in certain blood disorders. The first trial, IMbark, is a Phase 2 study assessing two dosages of imetelstat (4.7 mg/kg and 9.4 mg/kg) in ~200 patients with intermediate/high risk myelofibrosis (MF) who have relapsed or did not respond to prior treatment with a JAK inhibitor. To date, over 90 subjects have been enrolled in the two arms. The 4.7 mg/kg dose has not demonstrated an acceptable amount of activity so the arm will be closed to further enrollment. Enrollment in the 9.4 mg/kg arm will continue. The minimum number of patients needed for the Week 12 analysis was not met so the analysis will be done on 24-week data instead. Janssen will conduct an additional internal data review in Q2 2017. The second trial, IMerge, evaluating imetelstat in patients with low/intermediate risk myelodysplastic syndromes who have relapsed or failed to respond to an erythropoiesis stimulating agent, will continue unmodified. Janssen will conduct another assessment in Q2 2017.

Foamix Pharma’s FMX103 Succeeds in Mid-Stage Study- Foamix Pharmaceuticals (FOMX) announced that a Phase 2 trial evaluating FMX103 for the treatment of moderate-to-severe papulopustular rosacea (PR) met its primary and secondary endpoints showing a statistically significant reduction in inflammatory lesions compared to vehicle. The primary endpoint was the absolute change from baseline in inflammatory lesion count at Week 12. The mean reductions in lesion count for the 1.5% concentration, 3.0% concentration and vehicle (control) were 21.1, 19.9 and 7.8, respectively (p<0.001). The percent reductions were 61.4%, 55.5% and 29.7%, respectively (p<0.001). Both doses of FMX103 were also statistically significantly better than vehicle in reducing IGA score by two grades and in reaching "clear" (score = 0) or "almost clear" (score = 1) at Week 12 (p<0.01 and p<0.05, respectively).

Eyegate Earns Milestone Payment from Valeant- Eyegate Pharmaceuticals (EYEG) announced that it has earned another milestone payment from Valeant Pharmaceuticals (VRX). The company is eligible to eceive up to $32.5M in milestones under its July 2015 agreement for uveitis. It earned its first milestone in March.

Janssen Files MAA For Single Tablet HIV Regimen- Janssen (JNJ) announced that its European unit Janssen-Cilag International NV has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of a once-daily single-tablet regimen for the treatment of HIV-1 infection in patients at least 12 years old with a minimum body weight of 40 kg. The therapy consists of darunavir 800 mg, cobicistat 150, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg in a single tablet. Darunavir is a protease inhibitor, cobicistat a pharmacokinetic enhancer, emtricitabine a nucleoside reverse transcriptase inhibitor and TAF. Janssen licensed the latter three from Gilead Sciences (GILD) in December 2014 for a single-tablet regimen.

TESARO (TSRO) announced that the FDA has granted its niraparib a Fast Track status or the treatment of recurrent platinum-sensitive ovarian, fallopian tube and peritoneal cancer. The company has initiated its rolling New Drug Application (NDA) submission and expects to complete the filing in Q4.

No patents to report.

Sanofi (SNY) and Alphabet’s life sciences unit Verily will invest around $500 million in a diabetes oint venture combining devices with services. The two companies said in a statement that they seek to leverage Verily’s experience in miniaturized electronics, analytics, and consumer software development, with Sanofi's clinical expertise and experience.

Horizon Pharma (HZNP) announced that it is acquiring Raptor Pharmaceuticals (RPTP) for $9 a share in cash ($800M). The deal, to be  financed with debt and cash, should close in Q4.

CytoDyn (CYDY) announced a direct placement of stock and warrants with institutional investors that should net ~$9M. The offering consists of 13,333,334 shares of common stock at $0.75 and five-year warrants to purchase 6,666,667 shares of common at $1.00. Closing date is September 15. Net proceeds will fund clinical trials and general corporate purposes.

SciClone Pharmaceuticals (SCLN) and Soligenix (SNGX) have entered into a licensing agreement under which SciClone has been granted the exclusive right to develop and commercialize dusquetide (SGX942) for the treatment of oral mucositis (OM) in patients with head and neck cancer in China, Taiwan, South Korea and Vietnam. According to the terms of the agreement, SciClone will make an upfront equity investment in Soligenix for $3M by buying 3,359,412 shares of common stock at $0.893. It will be responsible for all development, product registration and commercialization in the Territory. Soligenix will earn royalties on net sales and will supply the product to SciClone on a "cost-plus" basis.

No secondary offerings to report.

No IPOs to report.

Pluristem Therapeutics (PSTI) reported a loss of $0.29 per share in its fiscal year 2016, beating consensus forecast by a penny. The company’s revenue for the quarter was $2.85 million, up 650% on a year-over-year basis, in-line with the consensus forecast.

Applied Genetics (AGTC) reported fourth-quarter earnings of $0.15 per share, beating consensus forecast by 8 cents. The company’s revenue for the quarter was $12.1 million, up 1604.2% on a year-over-year basis. Revenue missed consensus forecast by $0.83 million.

pSivida (PSDV) reported a loss of $0.19 per share in its fourth quarter, missing consensus forecast by 6 cents. The company’s revenue for the quarter was $0.3 million, down 26.8% on a year-over-year basis. Revenue missed consensus forecast by $1.13 million.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Alcobra (ADHD) WBB Securities Downgrade/Price Target Cut From Hold to Sell From $5 to $4 N/A
Allergan (AGN) Goldman Sachs Group Reiterate Buy N/A N/A
AstraZeneca (AZN) Jefferies Group Upgrade From Hold to Buy N/A N/A
Bristol-Myers Squibb (BMY) Jefferies Group Price Target Cut Hold From $69 to $57 N/A
Bristol-Myers Squibb (BMY) Goldman Sachs Group Reiterate Buy N/A N/A
Celgene (CELG) Cowen and Company Reiterate Outperform

$150

$140

Celgene (CELG) Piper Jaffray Cos. Reiterate Buy N/A

$140

Celgene (CELG) Leerink Swann Reiterate Market Perform N/A

$140

Celgene (CELG) Morgan Stanley Reiterate Equal Weight

$120

$140

Neuralstem (CUR) Brean Capital Reiterate Buy N/A N/A
Dimension Therapeutics (DMTX) Jefferies Group Price Target Set Buy

$12

N/A
Geron Corp. (GERN) BTIG Research Reiterate Neutral N/A

$15

Gilead Sciences (GILD) Berenberg Bank Initiation Buy

$112

$130

Gilead Sciences (GILD) Jefferies Group Reiterate Buy N/A

$130

Horizon Pharma (HZNP) Cowen and Company Reiterate Outperform

$42

N/A
Horizon Pharma (HZNP) Brean Capital Reiterate Buy

$32

N/A
Illumina (ILMN) Citigroup Price Target Raised Buy From $175 to $190 N/A
Lexicon Pharmaceuticals (LXRX) Citigroup Price Target Raised Buy From $21 to $25 N/A
Lexicon Pharmaceuticals (LXRX) Needham & Company Reiterate Buy

$21

N/A
Merck & Co. (MRK) Jefferies Group Price Target Cut Hold From $57 to $56 N/A
Oasmia Pharmaceutical AB (OASM) Rodman & Renshaw Initiation Buy

$6

N/A
Oasmia Pharmaceutical AB (OASM) HC Wainwright Initiation Buy

$6

N/A
Peregrine Pharmaceuticals (PPHM) FBR & Co. Reiterate Outperform

$1

N/A
Pluristem Therapeutics (PSTI) Maxim Group Reiterate Buy

$3

N/A
Ultragenyx Pharmaceutical (RARE) Jefferies Group Price Target Set Buy

$109

N/A
Raptor Pharmaceutical Corp. (RPTP) Wedbush Reiterate Neutral

$9

N/A
Sunesis Pharmaceuticals (SNSS) Cowen and Company Reiterate Hold N/A N/A
Teva Pharmaceutical Industries (TEVA) Morgan Stanley Price Target Set Buy

$63

N/A
Teva Pharmaceutical Industries (TEVA) Jefferies Group Price Target Set Buy

$69

N/A

Opko Health (OPK)- Dr. Phillip Frost, CEO & Chairman, bought 10,000 shares at $9.79. The total value of the transaction was $97,869. Dr. Frost now owns 160,135,143 shares of OPK.

Aegerion Pharmaceuticals (AEGR)- Broadfin Healthcare Master Fund, a 10% owner, bought 276,000 shares in two separate transactions. Broadfin Healthcare bought 100,000 shares at $1.60 and 176,000 shares at $1.70. Broadfin Healthcare now owns 4,286,291 shares of AEGR.

Seattle Genetics (SGEN)- Clay B. Siegall, President & CEO, sold 21,269 shares at $50.08. The total value of the transaction was $1.56 million. Siegall still owns 636,835 shares of SGEN.

Epizyme (EPZM)- Andrew E. Singer, EVP & CFO, sold 1,013 shares of $7.55. The total value of the transaction was $7,651. Singer still owns 27,485 shares of EPZM.

Codexis (CDXS)- VIVO Ventures VII LLC, a 10% owner, sold 111,600 shares at $4.25. The total value of the transaction was $474,624. VIVO Ventures still owns 112,940 shares of CDXS.

No management changes and additions to report.

NYSE- Puma Biotechnology (PBYI) shares were among the major gainers on the NYSE. The stock closed 8.35% higher. Perrigo (PRGO) ended the day 7.35% higher. Kadmon Holdings (KDMN) shares were among the major losers on the NYSE. The stock closed 5.14% lower. Taro Pharmaceutical Industries (TARO) ended the day 3.97% lower.

NASDAQ- Raptor Pharmaceutical (RPTP) shares were among the major gainers on the NASDAQ. The stock closed 20.54% higher. Foamix Pharmaceuticals (FOMX) ended the day 15.70% higher. Reata Pharmaceuticals (RETA) ended the day 13.26% higher. Geron Corp. (GERN) shares were among the major losers on the NASDAQ. The stock closed 19.58% lower. Catabasis Pharmaceuticals (CATB) ended the day 8.49% lower. Amarin (AMRN) ended the day 6.94% lower.

NYSEMKT- Asterias Biotherapeutics (AST) shares were among the major movers on the NYSEMKT. The stock closed 1.29% higher.

OTC- Soligenix (SNGX) shares were among the major movers on the OTC market. The stock closed 1.96% higher.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Atara Biotherapeutics (ATRA)

16.2%

4.4%

24

Athersys (ATHX)

8.9%

1%

36

Atossa Genetics (ATOS)

2.8%

87%

1

aTyr Pharma (LIFE)

5.9%

8.6%

5

Aurinia Pharmaceuticals (AUPH)

5.7%

307.6%

0

AVEO Pharmaceuticals (AVEO)

2.1%

85.5%

7

AveXis (AVXS)

8.5%

-23%

3

Aviragen Therapeutics (AVIR)

0.3%

-2.4%

3

AxoGen (AXGN)

4.7%

-10%

9

Axsome Therapeutics (AXSM)

2.9%

-11.8%

19