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Review Period for Novo Nordisk’s IDegLIra Extended- Novo Nordisk (NVO) announced that the FDA has informed that it needs more time to review its New Drug Application (NDA) seeking approval of IDegLira, a fixed-dose combination of insulin degludec (Tresiba) and liraglutide (Victoza), for the treatment of adults with type 2 diabetes. The agency's action date is now expected to be in December. The company filed the application in September 2015.

BioLineRx Announces Positive Results From Mid-Stage Study of BL-8040- BioLineRx (BLRX) announced results from a Phase 2a clinical trial evaluating its lead product candidate BL-8040 for the treatment of relapsed/refractory acute myeloid leukemia (r/r AML). The data were presented yesterday at the 4th Annual Meeting of the Society of Hematologic Oncology in Houston, TX. The study evaluated BL-8040 as monotherapy and in combination with the chemo agent cytarabine. The reported data set was 45 treatment-resistant AML patients. For the combination therapy, the composite complete remission rate (complete remission + complete remission with incomplete blood count recovery) was 38% (n=15/39) in patients receiving two cycles of BL-8040 at 1 mg/kg or higher. The composite complete remission rate was 41% (n=9/22) in the expansion phase of the study at a dose of 1.5 mg/kg. Both rates were superior to the ~20% historical response rate observed with cytarabine alone. Two-thirds of the patients were still alive during the follow-up period of up to 12 months.

Cytokinetics Earns Milestone Payment From Astellas- Cytokinetics (CYTK) announced that it has earned a $2 million milestone payment from collaboration partner Astellas. The milestone payment was triggered after the initiation of IND-enabling studies for a next-generation fast skeletal muscle activator. The partnership was established in 2013 with the primary aim of developing novel therapies for disorders associated with muscle impairment and weakness. The partnership was expanded in 2016 to include amyotrophic lateral sclerosis (ALS). As part of the expansion, CYTK granted Astellas an option to develop and commercialize tirasemtiv worldwide excluding North America.

Tokai Pharmaceuticals Considering Strategic Alternatives- Tokai Pharmaceuticals (TKAI) announced that it has commenced a review of strategic alternatives focused on maximizing shareholder value. Wedbush PacGrow is advising. Toaki had stopped a late-stage study evaluating lead product candidate galeterone in prostate cancer due to lack of efficacy.

bluebird bio Commences Late-Stage Study of LentiGlobin in Beta Thalassemia- bluebird bio (BLUE) announced that it has launched a Phase 3 clinical trial, HGB-207, in patients with transfusion-dependent beta thalassemia with certain genotypes (non-beta0/beta0). In this particular study, the process by which the patient's cells are transduced (converted) with LentiGlobin will be modified by the addition of two additives during the transduction step in the hematopoietic stem cell manufacturing process. The objective is to increase vector copy number and increase the percentage of cells successfully transduced.

Clovis Rallies on FDA Update- Clovis Oncology (CLVS) shares rallied more than 15% on Thursday after the company announced that it was informed by the FDA that the agency has no plans to hold an Advisory Committee meeting to discuss the company's New Drug Application (NDA) seeking accelerated approval of rucaparib for the treatment of ovarian cancer, normally a bullish development. The FDA's action date (PDUFA) is February 23, 2017.

GTx Rallies as Lead Product Candidate Shows Positive Results in Mid-Stage Breast Cancer Study- GTx (GTXI) shares surged on Thursday after the company announced encouraging results in a Phase 2 clinical trial assessing lead product candidate enobosarm for the treatment of women with advanced estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. The estimated study completion date is August 2018.

No approvals to report.

No patents to report.

NeuroMetrix (NURO) announced that it has entered into an agreement with Comprehensive Pain Specialists to offer its Quell device in selected clinic locations. The specialist physician group was formed in 2005 and now has over 60 clinics in 12 states. Financial terms of the deal have not yet been disclosed.

Sanofi (SNY) executed a euro 3 billion bond issue. The bond issue consists of three tranches: Eur 1 billion Fixed Rate Notes, due January 2020 at 0%
Eur 0.85 billion Fixed Rate Notes, due September 2022 at 0%
Eur 1.15 billion Fixed Rate Notes, due January 2027 at 0.5%
Proceeds from the offering will be used for general corporate purposes.

CoLucid Pharmaceuticals (CLCD) announced that it has commenced a secondary offering of common stock. Price, volume and terms of the offering have not been announced yet.

Aimmune Therapeutics (AIMT) filed a Form S-3 with the U.S. Securities and Exchange Commission (SEC). According to the filing, the company may offer and sell up to $250,000,000 in the aggregate of the securities identified above from time to time in one or more offerings.

Novan announced the terms of its $45 million IPO. The company is offering 3.75 million shares at a price range of $11 to $13. At the midpoint of the proposed range, Novan would command a fully diluted market value of $181 million. The company will list its shares on the NASDAQ under the ticker symbol NOVN. Based in Durham, North Carolina, Novan is focusing on the development of nitric oxide therapies for acne and other skin conditions.

Summit Therapeutics (SMMT) reported a loss of GBP 0.10 per share in its second quarter. The company ended the quarter with GBP 7 million in cash and cash equivalents on its balance sheet.

Cellectis (CLLS) reported a loss of euro 0.63 per share in its second quarter. The company reported revenue of euro 18 million, up 125% on a year-over-year basis.

Peregrine Pharmaceuticals (PPHM) reported a loss of $0.05 per share in its first quarter, missing consensus forecast by a penny. The company reported revenue of $5.6 million, down 42.1% on a year-over-year basis. Revenue missed consensus forecast by $7.49 million.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
AbbVie (ABBV) Goldman Sachs Reiterate Buy

$78

$80

AbbVie (ABBV) JPMorgan Chase & Co. Downgrade/Price Target Cut  From Overweight to Neutral From $75 to $73

$80

AcelRx Pharmaceuticals (ACRX) HC Wainwright Reiterate Buy

$7

N/A
Adamas Pharmaceuticals (ADMS) Mizuho Price Target Raised Buy From $22 to $26 N/A
Agios Pharmaceuticals (AGIO) Canaccord Genuity Reiterate Buy

$90

N/A
Alnylam Pharmaceuticals (ALNY) FBR & Co. Reiterate Buy N/A

$130

Amgen (AMGN) Goldman Sachs Reiterate Buy

$204

$250

Arrowhead Pharmaceuticals (ARWR) Cantor Fitzgerald Price Target Set Buy

$15

N/A
AstraZeneca (AZN) Bank of America Reiterate Buy

$41.37

N/A
AstraZeneca (AZN) Deutsche Bank Reiterate Buy N/A N/A
BioCryst Pharmaceuticals (BCRX) FBR & Co. Reiterate Buy N/A N/A
Biogen (BIIB) HC Wainwright Reiterate Buy

$360

$420

bluebird bio (BLUE) Piper Jaffray Cos. Price Target Set Buy

$95

N/A
bluebird bio (BLUE) Wedbush Reiterate Outperform

$117

N/A
bluebird bio (BLUE) Goldman Sachs Reiterate Buy

$135

N/A
BioMarin Pharmaceutical (BMRN) Cowen and Company Price Target Set Buy

$150

N/A
Egalet (EGLT) Cantor Fitzgerald Reiterate Buy

$21

N/A
Endo International Plc (ENDP) Morgan Stanley Price Target Set Hold

$16

N/A
Halozyme Therapeutics (HALO) Wells Fargo & Co. Reiterate Buy N/A N/A
Horizon Pharma (HZNP) Jefferies Group Reiterate Buy N/A N/A
Horizon Pharma (HZNP) Goldman Sachs Reiterate Buy

$27

N/A
Jazz Pharmaceuticals (JAZZ) BMO Capital Markets Price Target Raised Outperform From $193 to $195 N/A
Keryx Biopharmaceuticals (KERX) JMP Securities Reiterate Outperform N/A

$25

Karyopharm Therapeutics (KPTI) Jefferies Group Reiterate Buy

$12

N/A
Karyopharm Therapeutics (KPTI) HC Wainwright Price Target Raised Buy From $15 to $16 N/A
La Jolla Pharmaceutical (LJPC) Cowen and Company Price Target Set Buy

$40

N/A
La Jolla Pharmaceutical (LJPC) Chardan Capital Price Target Set Buy N/A N/A
Eli Lilly & Co. (LLY) JPMorgan Chase & Co. Upgrade/Price Target Raised From Neutral to Overweight From $92 to $95 N/A
Mallinckrodt (MNK) Morgan Stanley Price Target Set Buy

$82

N/A
Nabriva Therapeutics (NBRV) HC Wainwright Initiation Buy

$16

N/A
Nektar Therapeutics (NKTR) Jefferies Group Reiterate Buy N/A N/A
Ophthotech (OPHT) JPMorgan Chase & Co. Price Target Raised Overweight From $81 to $95 N/A
Prima Biomed (PBMD) FBR & Co. Price Target Set Buy

$6

N/A
Repros Therapeutics (RPRX) S&P Equity Research Price Target Raised N/A From $2.12 to $2.47 N/A
Raptor Pharmaceuticals (RPTP) FBR & Co. Reiterate Hold N/A N/A
Retrophin (RTRX) BMO Capital Markets Price Target Raised Outperform From $28 to $40 N/A
Synergy Pharmaceuticals (SGYP) Rodman & Renshaw Reiterate Buy

$15

$13.50

Synergy Pharmaceuticals (SGYP) HC Wainwright Price Target Set Buy

$15

$13.50

Cymabay Therapeutics (CBAY)- Robert James Wills, Director, bought 25,000 shares at $2.43. The total value of the transaction was $60,858. Wills now owns 25,000 shares of CBAY.

Vertex Pharmaceuticals (VRTX)- Joshua S. Boger, Director, sold 6,500 shares at $95.66. The total value of the transaction was $621,795. Boger still owns 268,225 shares of VRTX.

Sage Therapeutics (SAGE)- Iguchi Kimi, CFO, Secretary and Treasurer, sold 2,500 shares at $40.93. The total value of the transaction was $102,325. Kimi still owns 81,239 shares of SAGE.

Seattle Genetics (SGEN)- Clay B. Siegall, President & CEO, sold 11,653 shares at $45.40. The total value of the transaction was $529,007. Siegall still owns 617,038. Darren S. Cline, EVP, Commercial, sold 5,397 shares at $46.01. The total value of the transaction was $248,307. Cline still owns 51,576 shares of SGEN.

Illumina (ILMN)- Charles Dadswell, Sr. VP & General Counsel, sold 116 shares at $168.01. The total value of the transaction was $19,489. Dadswell still owns 40,016 shares of ILMN.

Otonomy (OTIC)- Carl LeBel, Chief Scientific Officer, sold 21,250 shares at $17.95. The total value of the transaction was $381,438. LeBel still owns 9,458 shares of OTIC.

Eleven Biotherapeutics (EBIO)- Flagship Ventures Fund IV, LP, a 10% owner, sold 129,497 shares of EBIO in two separate transactions. Flagship Ventures Fund sold 35,770 shares at $4.63; and 93,727 shares at $4.51. Flagship Ventures still owns 282,015 shares of EBIO.

Arcadia Biosciences (RKDA) announced the appointment of Matthew Plavan as Chief Financial Officer effective September 12. He joins the firm from Cesca Therapeutics (KOOL) where he served in multiple executive roles.

No big movers data to report.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Amphastar Pharmaceuticals (AMPH)

5.6%

-3.5%

4

Anavex Life Sciences (AVXL)

11.8%

-14.7%

3

Anika Therapeutics (ANIK)

6.2%

-10.3%

5

Antares Pharma (ATRS)

2.5%

-5%

7

Anthera Pharmaceuticals (ANTH)

14.1%

0.4%

12

Applied DNA Sciences (APDN)

4.2%

-8.5%

14

Apricus Biosciences (APRI)

4.5%

-4.1%

4

Aptevo Therapeutics (APVO)

9.5%

100%

1

Aquinox Pharmaceuticals (AQXP)

12.2%

0.3%

11

Aradigm Corp. (ARDM)

-76.2%

-

1