Depomed (DEPO) shares are up more than 14% in pre-market trading after the company announced that it plans to put itself up for sale. The company has taken the decision after it was urged by activist investor Starboard. DEPO could fetch a decent premium in my opinion. My fair value for the stock is $30.

AcelRx Pharmaceuticals (ACRX) shares rose nearly 10% on Thursday after the company announced successful results in the last of three Phase 3 studies evaluating ARX-04 (sufentanil sublingual tablet 30 mcg) for the management of moderate-to-severe acute pain. The company plans to file a New Drug Application (NDA) with the FDA by year end. The primary efficacy endpoint was time-weighted summed pain intensity difference (SPID) over 12 hours. Treatment with ARX-04 reduced pain starting 30 minutes after the first dose. The mean reductions in pain intensity from baseline at one hour, two hours and 12 hours were 27%, 49% and 57%, respectively. Despite the positive development, ACRX shares are still nearly 6.50% for the year. The stock is also trading well below its 52-week high of $5.88. The company currently has more than $2 per share in cash on its balance sheet. Given the progress it has made and its valuation, ACRX is certainly worth a look at current levels.

FDA Action Date for Lexicon Pharmaceuticals’ Telotristat Etiprate NDA Extended- Lexicon Pharmaceuticals (LXRX) announced that the FDA requires more time to review its New Drug Application (NDA) for telotristat etiprate for the treatment of carcinoid syndrome. Its action date has been extended 90 days to February 28, 2017 from November 30, 2016. Per the agency's request, the company submitted additional analyses of the clinical data which will require additional time to review.

Epizyme Earns Milestone Payment from GlaxoSmithKline- Epizyme (EPZM) announced that it has earned a $6 million milestone payment from GlaxoSmithKline (GSK). The milestone payment was triggered after the British drug maker initiated a Phase 1 clinical trial evaluating cancer therapy candidate GSK3326595 (formerly EPZ015938). According to the two companies collaboration and license agreement, GSK has exclusive global rights to methyltransferase inhibitors directed to three targets. GSK3326595 is the first one to enter the clinic.
Rigel Pharmaceuticals Announces Workforce Reduction- Rigel Pharmaceuticals (RIGL) announced that it is eliminating 38% of its workforce as it looks to build a commercial organization to support the potential launch of lead product candidate fostamatinib. The job cuts will mostly impact the company’s research department. Rigel expects annual savings of between $17 million and $20 million from the workforce reduction. The company expects to take a charge of $5.7 million due to the restructuring in its third quarter.

Merck and Pfizer’s Diabetes Candidate Succeeds in Late-Stage Study- Merck & Co. (MRK) and Pfizer (PFE) announced positive results from a Phase 3 clinical trial, VERTIS SITA2, evaluating ertugliflozin in patients with type 2 diabetes on a background of sitagliptin and stable metformin. The data were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes in Munich, Germany. The study met its primary endpoint of a statistically valid reduction in HbA1c at Week 26 compared to placebo. Secondary endpoints met included the proportion of patients achieving HbA1c levels less than 7.0%, placebo-adjusted mean reduction in body weight, placebo-adjusted mean reductions in fasting plasma glucose and placebo-adjusted mean reductions in systolic blood pressure.

Full Results from GlaxoSmithKline’s Late-Stage Study of Shingles Vaccine Candidate Published in NEJM- GlaxoSmithKline (GSK) announced that the full results of its Phase 3 study, ZOE-70, evaluating its shingles vaccine candidate Shingrix have been published in the New England Journal of Medicine (NEJM). Headline results were initially reported in October 2015. The study showed that the two-dose regimen of Shingrix had 90% efficacy versus placebo in participants over 70 years old. Vaccine efficacy was maintained across the age groups in the trial: 90% in ages 70 - 79 and 89% in ages 80 and above.

Cara Therapeutics Commences Mid-Stage Study of Lead Product Candidate- Cara Therapeutics (CARA) announced that patient enrollment in a Phase 2b study evaluating an oral tablet formulation of lead product candidate CR845 for the treatment of pain related to osteoarthritis. Top-line data should be available in H1 2017. The primary endpoint is the change from baseline in the weekly average of the daily pain intensity score as measured by a scale called NRS. Positive top-line results from a Phase 2a study were reported in late 2015.

Calithera Biosciences Initiates Early Stage Study of CB-1158- Calithera Biosciences (CALA) announced that patient dosing has begun in a Phase 1 study of arginase inhibitor CB-1158, in development for the treatment of advanced solid tumors. Results will be reported next year. The company signed an exclusive license agreement with Mars Corp's Symbioscience Division in December 2014 to develop its portfolio of arginase inhibitors for human use.

KemPharm Updates Development Timelines- KemPharm (KMPH) has extended its views for regulatory submissions for its product candidates, KP415 and KP201/IR in 2018 and an extended-release formulation of KP511 in 2019. The development timelines have been extended after an FDA Advisory Committee thumbs down on abuse-deterrent labeling for Apadaz (benzhydrocodone hydrochloride and acetaminophen). The company says it will submit a Formal Dispute Resolution Request with the agency after receiving a Complete Response Letter (CRL) related to abuse-deterrent labeling for Apadaz. The process may take up to a year to complete.

Novavax Tumbles on Disappointing Results from Vaccine Trials- Novavax (NVAX) shares tumbled in after-hours trading on Thursday, loising more than 80% of its value, after the company reported disappointing data from two vaccine trials. Topline data from the Resolve Phase 3 trial didn't meet the efficacy objectives (primary or secondary) the company had set. Data from the Phase 2 rollover trial suggested improved vaccine efficacy from a second year of dosing.

Aralez Pharmaceuticals (ARLZ) announced that the FDA has approved its YOSPRALA (aspirin + omeprazole) for the secondary prevention of cardiovascular and cerebrovascular events in patients at risk for aspirin-induced gastric ulcers. The company is expanding its salesforce to 110 from 25 as it prepares for the U.S. launch next month.

BioMarin Pharmaceutical (BMRN) announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) seeking approval of enzyme replacement therapy Brineura (cerliponase alfa) for the treatment of CLN2 disease, a form of Batten disease, a rare inherited disorder in which the body's cells lose their ability to dispose of wastes. Validation means that the application is complete and the review process begins.The company requested accelerated review for the Orphan Drug-designated use, but the shortened time line is not guaranteed. Assuming a positive opinion from CHMP and the standard 210-day review period, a decision should be announced no later than Q3 of next year.

No patents to report.

Caladrius Bioscience (CLBS) announced that it has entered into a  Securities Purchase Agreements with accredited investors for the direct sale of 4,449,153 shares of common stock at $4.72. Buyers include its largest institutional investor, Sanford Health, who invested $5M in the deal. The $21 million investment will be made in two tranches: $12.6 million will be paid no later than September 19 and the remaining amount after the enrollment of 70 patients in the company's Phase 2 Sanford Project T-Rex Study of CLBS03 in adolescents with recent onset type 1 diabetes.

Lion Biotechnologies (LBIO) announced that it has signed an  exclusive license agreement with Stockholm, Sweden-based PolyBioCept AB securing global rights to two international patent applications related to a specific combination (cocktail) of cytokines for use in expanding and enriching tumor-infiltrating lymphocytes (TIL) for the treatment of a range of cancers. Lion also has co-exclusive rights with PolyBioCept to make genetically engineered TIL using the cytokine cocktail for multiple cancer indications.

Aerie Pharmaceuticals (AERI) has commenced a $75 million public offering of common stock. The offering has been priced at $29.50 per share.

Capricor Therapeutics (CAPR) has commenced a public offering of its common stock. Price, volume and terms of the offering have not yet been announced.

Agios Pharmaceuticals (AGIO) announced the pricing of its public offering of 3,370,786 shares of common stock at $44.50. Underwriters to the offering have been granted an option to purchase an additional 505,617 shares.

No IPOs to report.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Achillion Pharmaceuticals (ACHN) FBR & Co. Initiation Outperform

$16

$7.50

AcelRx Pharmaceuticals (ACRX) Roth Capital Price Target Raised Buy From $11.25 to $15 N/A
Aerie Pharmaceuticals (AERI) Brean Capital Price Target Set Buy

$48

N/A
Aerie Pharmaceuticals (AERI) Royal Bank of Canada Price Target Raised Outperform From $51 to $55 N/A
Aerie Pharmaceuticals (AERI) Cantor Fitzgerald Price Target Raised Buy From $44 to $50 N/A
Aerie Pharmaceuticals (AERI) Needham & Company LLC Price Target Raised Buy From $45 to $52 N/A
Aerie Pharmaceuticals (AERI) Stifel Nicolaus Price Target Raised Buy From $40 to $50 N/A
Akorn (AKRX) Piper Jaffray Cos. Upgrade/Price Target Raised From Neutral to Overweight From $33 to $34 N/A
Alexion Pharmaceuticals (ALXN) FBR & Co. Initiation Underperform N/A N/A
Aralez Pharmaceuticals (ARLZ) Guggenheim Reiterate Buy N/A N/A
Arena Pharmaceuticals (ARNA) FBR & Co. Initiation Outperform

$6

N/A
Atara Biotherapeutics (ATRA) Goldman Sachs Downgrade/Price Target Cut From Neutral to Sell From $23 to $16 N/A
Cara Therapeutics (CARA) Cantor Fitzgerald Price Target Set Buy

$24

N/A
CoLucid Pharmaceuticals (CLCD) Piper Jaffray Cos. Reiterate Buy

$36

N/A
Celsion Corp. (CLSN) Maxim Group Price Target Set Buy

$4

N/A
Exelixis (EXEL) Stifel Nicolaus Price Target Raised Buy From $12 to $15

$12.50

Exelixis (EXEL) William Blair Reiterate Outperform N/A

$12.50

Heat Biologics (HTBX) Roth Capital Reiterate Buy

$2.75

N/A
Jazz Pharmaceuticals (JAZZ) Mizuho Reiterate Buy N/A N/A
Perrigo (PRGO) Guggenheim Price Target Set Buy

$125

N/A
Rigel Pharmaceuticals (RIGL) Piper Jaffray Cos. Reiterate Buy

$11

N/A
Rigel Pharmaceuticals (RIGL) HC Wainwright Reiterate Buy N/A N/A
Sanofi (SNY) JPMorgan Chase & Co. Reiterate Underweight N/A N/A
Sophiris Bio (SPHS) Roth Capital Buy

$8

N/A N/A
Spectrum Pharmaceuticals (SPPI) RBC Capital Markets Price Target Set Buy

$10

N/A
Spectrum Pharmaceuticals (SPPI) FBR & Co. Reiterate Buy N/A N/A
Sarepta Therapeutics (SRPT) JMP Securities Reiterate Underperform

$10

N/A
Sarepta Therapeutics (SRPT) Jefferies Group Reiterate Underperform

$7

N/A
Vertex Pharmaceuticals (VRTX) Stifel Nicolaus Price Target Raised Buy From $105 to $109 N/A
Vertex Pharmaceuticals (VRTX) Leerink Swann Reiterate Outperform

$113

N/A
Vertex Pharmaceuticals (VRTX) Jefferies Group Reiterate Buy

$107

N/A
Vertex Pharmaceuticals (VRTX) BMO Capital Markets Reiterate Hold

$87

N/A
Vitae Pharmaceuticals (VTAE) BMO Capital Markets Downgrade/Price Target Raised From Outperform to Market Perform From $17 to $21 N/A

MediciNova (MNOV)- Yutaka Kobayashi, Director, bought 11,800 shares at $6.44. The total value of the transaction was $75,992. Kobayashi now owns 81,800 shares of MNOV.

FibroGen (FGEN)- K. Peony Yu, Chief Medical Officer, sold 2,345 shares at $18.66. The total value of the transaction was $43,758. Yu still owns 206,502 shares of FGEN.

Seattle Genetics (SGEN)- Eric Dobmeier, Chief Operating Officer, sold 22,918 shares at $54.04. The total value of the transaction was $1.24 million. Dobmeier still owns 87,767 shares of SGEN.

bluebird bio (BLUE)- Eric Sullivan, Principal Accounting Officer, sold 416 shares at $59. The total value of the transaction was $24,544. Sullivan still owns 5,641 shares of BLUE.

Ocera Therapeutics (OCRX) Chief Business Officer Gaurav Aggarwal, M.D., has resigned to pursue a new career opportunity. A successor has yet to be appointed.

NYSE- Taro Pharmaceutical Industries (TARO) shares were among the major movers on the NYSE. The stock closed 2.44% lower.

NASDAQ- Aerie Pharmaceuticals (AERI) shares were among the major gainers on the NASDAQ. The stock closed 44.87% higher. CoLucid Pharmaceuticals (CLCD) ended the day 14.78% higher. bluebird bio (BLUE) ended the day 11.37% higher. Summit Therapeutics (SMMT) shares were among the major losers on the NASDAQ. The stock closed 12% lower. Atara Biotherapeutics (ATRA) ended the day 10.08% lower. Gemphire Therapeutics (GEMP) ended the day 9.10% lower.

NYSEMKT- Asterias Biotherapeutics (AST) shares were among the major movers on the NYSEMKT. The stock closed 1.54% lower.

OTC- Amarantus Bioscience Holdings (AMBS) shares were among the major movers on the OTC market. The stock closed 2.86% higher.

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

2.4%

-66.2%

0

Bio-Techne (TECH)

4.2%

1.4%

9

bluebird bio (BLUE)

23.3%

-0.3%

9

Blueprint Medicines Corp. (BPMC)

8.6%

-6.7%

9

Bristol-Myers Squibb (BMY)

0.7%

27.9%

1

Caladrius Biosciences (CLBS)

0.4%

-34.9%

1

Calithera Biosciences (CALA)

9.7%

-4.6%

12

Cancer Genetics (CGIX)

3.5%

62.8%

3

Capricor Therapeutics (CAPR)

0.9%

-8.6%

3

Cara Therapeutics (CARA)

9.6%

34.4%

4