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Shares of ContraVir Pharmaceuticals $CTRV soared in premarket trading in response to its announcement of an encouraging interim results from a Phase 2 a multiple ascending dose trial evaluating CMX157 compared to Gilead Sciences’ $GILD Viread (tenofovir disoproxil fumarate or TDF) for the treatment of chronic hepatitis B virus (HBV) infection. Data from 10 HBV-positive patients who took once-daily dose of 25 mg of CMX157 and two patients who received 300 mg of Viread once-daily for 14 days showed an average 99% reduction in HBV viral load compared to baseline.

Esperion Therapeutics $ESPR announced that patients with hypercholesterolemia (elevated LDL-C) and treated with any dose of statins, will be included in its Phase 3 development program for bempedoic acid. A crucial study, CLEAR LDL-C, should begin by the year-end with top-line results anticipated in mid-2018. If the trial is successful, regulatory submission will follow in H1 2019.

OncoGenex’s custirsen Falls Short of Showing desired results in Phase 3 Study-OncoGenex $OGXI reported on Thursday that its Phase 3 study, ENSPIRIT, evaluating lead product candidate custirsen, in combination with the chemo agent docetaxel in patients with advanced non-small lung cancer (NSCLC) who had progressed after initial chemotherapy, failed to show a statistically valid increase in median overall survival (OS) compared to docotaxel taken alone (9.0 months vs. 7.9 months; p=0.178). The stock had plunged two month ago after it failed in another late-stage study in treatment-resistant prostate cancer. The company is currently looking at strategic options.

Bluebird’s refined LentiGlobin manufacturing process shows higher efficiency-Bluebird bio $BLUE announced that it new LentiGlobin manufacturing process (process 2), based on the addition of two transduction enhancers, produces an average three-fold increase in vector-positive cells and vector copy number (VCN) compared to its original process (process 1). The company said that the Process 2 has been successfully scaled up for clinical manufacturing; and, hereafter all LentiGlobin clinical trials will rely on the new process.

FDA’s Decision on Egalet’s NDA won’t be met on Friday-Egalet Corp $EGLT slumped in afterhours amid increased trading volume in response to its announcement that the FDA will not make its decision, the PDUFA date, regarding its New Drug Application (NDA) seeking approval of ARYMO ER (morphine sulfate) for the management of severe pain. The drug-maker said that FDA requires more time to review the filing, just as they did with other abuse-deterrent opioid NDAs. However, the authority has added no additional data or scientific information is needed for the application.

TG Therapeutics Files Request with FDA to alter protocol for Lead candidate TG-110-TG Therapeutics $TGTX slumped amid increased trading volume after it announced that it has filed a request with the FDA to amend the protocol in its Phase 3 clinical trial, GENUINE, evaluating lead product candidate TG-1101 in patients with high-risk relapsed/refractory chronic lymphocytic leukemia (CLL). The altered protocol, if approved, will drop progression-free survival (PFS) as an efficacy endpoint (Part II of the study) with overall response rate (ORR) serving as the sole primary endpoint (Part I). Enrollment in the revised trial should be finalized this quarter with top-line data likely in H1 2017.

Clinical Hold on Aptose Bio’s APTO-253 to Stay-Nano-cap stock, Aptose Biosciences $APTO plunged in response to its announcement that the FDA’s clinical hold on its Phase 1b clinical trial evaluating lead product candidate APTO-253 will continue until it submits additional data. The regulatory authority put the candidate on clinical hold in November 2015 after problems with an IV infusion pump surfaced at a clinical trial site.

Flex Pharma to initiate Mid-stage Trial of FLX-787 for nocturnal leg cramps in H1 2017-Flex Pharma $FLKS announced its clinical development plan for FLX-787 for the treatment of nocturnal leg cramps (NLCs). Once it receives a feedback from the FDA, it plans a parallel design Phase 2 study, which should start in H1 2017 after its Investigational New Drug (IND) application has been filed and accepted. Flex plans to market FLX-787 as a dietary supplement for reducing NLCs. According to the company, its treatment stimulates the primary sensory neurons in the mouth, stomach and esophagus by activating transient receptor potential (TRP) cation channel receptors. TRP activators are recognized as safe by the FDA when used in food products. FLX-787 is also being developed for the treatment of multiple sclerosis and amyotrophic lateral sclerosis.

No approvals to report.

No patents to report.

Ocular Therapeutics $OCUL soared on Thursday amid heavy trading volume in response to its announcement of a strategic partnership with Regeneron Pharmaceuticals $REGN to develop a sustained release formulation of aflibercept, which is marketed in the U.S. under the brand name, EYLEA, for the treatment of wet age-related macular degeneration (wetAMD) and other retinal disorders. As per the terms of the agreement, $REGN has the option to secure an exclusive license to Ocular’s hydrogel-based technology for a sustained-release formulation of aflibercept and other biologics targeting VEGF for ophthalmic indications. Ocular will be entitled to receive up to $305M in milestones and tiered royalties on net sales from high-single-digit to low-to-mid-teens.

No secondary offerings to report.

No IPOs to report.

Insys Therapeutics $INSY anticipates Q3 revenue between $54mn and $55mn based on expected Subsys sales. On a mid-point basis of $54.5mn, revenue will be down by more than 40%, y-o-y. The company expects positive cash flows at this level, which in turn help to meet its product development and growth objective.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
AMAG Pharmaceuticals $AMAG Leerink Swann Reiterate Outperform $36 N/A
bluebird bio $BLUE Piper Jaffray Cos. Price Target Set Buy $95 N/A
BioMarin Pharmaceutical $BMRN Leerink Swann Reiterate Outperform $127 N/A
Bristol-Myers Squibb $BMY Goldman Sachs Group Downgrade From Conviction Buy to Buy $75 N/A
Cara Therapeutics $CARA HC Wainwright Initiation Buy $20 N/A
Catabasis Pharmaceuticals $CATB Wedbush Reiterate Outperform $17 N/A
ContraVir Pharmaceuticals $CTRV Maxim Group Reiterate Buy $4 N/A
Esperion Therapeutics $ESPR Chardan Capital Price Target Set Hold $13 N/A
Galena Biopharma $GALE FBR & Co. Reiterate Outperform $2 N/A
Merck & Co. $MRK Bank of America Corp. Upgrade/Price Target Raised From Neutral to Buy From $57 to $70 N/A
Neurocrine Biosciences $NBIX BMO Capital Markets Reiterate Outperform $66 N/A
Pfizer $PFE Jefferies Group Downgrade/Price Target Cut From Buy to Hold From $39 to $36 N/A
Regeneron Pharmaceuticals $REGN Piper Jaffray Cos. Price Target Set Hold $447 $475
Rexahn Pharmaceuticals $RNN FBR & Co. Reiterate Outperform $3 N/A
Supernus Pharmaceuticals $SUPN Jefferies Group Price Target Set Buy $28 N/A

Opko Health $OPK- Dr. Phillip Frost, CEO & Chairman, bought 5,400 shares at $9.52. The total value of the transaction was $51,432. Dr. Frost now owns 160,213,743 shares of OPK.

Argos Therapeutics $ARGS- Pharmstandard International, a 10% owner, bought 31,704 shares in four separate transactions. Pharmstandard International bought 7,164 shares at $4.69; 900 shares at $4.85; 2,640 shares at $4.81; and 21,000 shares at $4.73. Pharmstandard International now owns 13,242,279 shares of ARGS.

Ardelyx $ARDX-Jeffrey W. Jacobs, SVP, Technical Operations, sold 6,000 shares at $15. The total value of the transaction was $90,000. Jacobs still owns 49,525 shares of ARDX.

Atara Biotherapeutics $ATRA-John McGrath, Chief Financial Officer, sold 5,000 shares in two separate transactions. McGrath sold 2,500 shares at $18.52; and 2,500 shares at $16.41. McGrath now owns 94,323 shares of ATRA.

No management changes and additions to report.

NYSE- InVitae $NVTA shares were among the major movers on the NYSE. The stock closed 6.04% lower.

NASDAQ- Ocular Therapeutix $OCUL shares were among the major gainers on the NASDAQ. The stock closed 14.42% higher. Genocea Biosciences $GNCA ended the day 12% higher. Intellia Therapeutics $NTLA ended the day 9.88% higher. Flex Pharma $FLKS shares were among the major losers on the NASDAQ. The stock closed 24.73% lower. KemPharm $KMPH ended the day 8.57% lower. Chiasma $CHMA ended the day 8.07% lower.

NYSEMKT- Asterias Biotherapeutics $AST shares were among the major movers on the NYSEMKT. The stock closed 3.84% higher.

OTC- Amarantus Bioscience Holdings $AMBS shares were among the major movers on the OTC market. The stock closed 10% lower.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
AEterna Zentaris $AEZS 6.9% -3.9% 8
Affimed NV $AFMD 4.1% -24.5% 5
Agenus $AGEN 9.6% 6.1% 5
Agile Therapeutics $AGRX 3% -2.3% 10
Agios Pharmaceuticals $AGIO 19.6% 2.8% 8
Aimmune Therapeutics $AIMT 17.6% 8.4% 12
Akari Therapeutics $AKTX 0.2% 1.2% 5
Akebia Therapeutics $AKBA 7.6% 3.2% 11
Akers Biosciences $AKER 0.3% 13.1% 1
Akorn $AKRX 10.9% -0.6% 9