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Merrimack Pharmaceuticals $MACK announced its final results from the Phase 3 clinical trial, NAPOLI-1 study evaluating ONIVYDE (irinotecan lipsome injection), in combination with standard-of-care fluorouracil (5-FU) and leucovorin, for the treatment of patients with metastatic pancreatic ductal adenocarcinoma following gemcitabine-based therapy. The outcome of the trial was presented at the European Society for Medical Oncology 2016, Annual General Meeting in Copenhagen.

Supernus Pharmaceuticals $SUPN announced encouraging results from a 222-participants Phase 2b clinical trial evaluating SPN-812 (viloxazine hydrochloride) for the treatment of children with attention deficit hyperactivity disorder (ADHD). The trial met its primary endpoint of demonstrating a statistically valid progress in ADHD symptoms from baseline from the daily treatment of 200 mg, 300 mg, and 400 mg of SPN-812. All doses were well-tolerated.

Daiichi Sankyo’s Late Stage Trial of leukemia candidate in progress-The enrollment process begun for Phase 3 clinical study, QuANTUM-First, evaluating Daiichi Sankyo’s $DSKYF, $DSNKY, orally available quizartinib for the treatment of patients with newly dignosed acure myeloid leukemia (AML), having a genetic mutation called FLT3-ITD, which occurs in about 30% of AML classes. The mutation is associated with quickly worsening cancer, which characterizes higher relapse rate and lower survival rate (OS). The anticipated final data collection for the primary endpoint is January 2020, according to ClinicalTrial.gov.

Quizartinib, came under its development program following the September 2014 acquisition of Ambit Biosciences. It is a small molecule inhibitor of FLT3-ITD (FMS-like tyrosine kinase-3-internal tandem duplication), a growth driver of abnormal cells that contributes to the development of AML. It has Orphan Drug status in the U.S. and Europe.

Biostar Pharma to launch new treatment in China-Nano cap Biostar Pharmaceuticals $BSPM skyrocketed in response to its announcement that it will launch a new topical product in China next month called “Easy Breathing” for the treatment of rhinitis and sinusitis. The treatment, based on the principles of traditional Chinese medicine, was developed internally over the past three years by the company's R&D unit. The company expects to sell about 4000 units in the next two years, which should generate approx. $7.5mn.

Nymox’s BPH Phase-3 candidate shows positive-long term results-Nymox Pharmaceutical $NYMX soared amid heavy trading volume on Tuesday in response to its announcement of  encouraging long-term results in 344 men with  benign prostatic hyperplasia (BPH), or enlarged prostrate, who received a single repeat injection of lead product candidate fexapotide after the intial blinded treatment with the drug placebo in Phase 3 clinical trial. The company has concluded seven phase 3 trials on BPH studies in the U.S. and it now plans to file regulatory application in the next one to two quarters.

Neurocrine Biosciences’ Ingrezza under NDA Review-The FDA accepted under Priority Review Neurocrine Biosciences' $NBIX New Drug Application (NDA) seeking approval of INGREZZA (valbenazine) for the treatment of tardive dyskinesia, an involuntary movement disorder characterized by repetitive movements of the face, trunk or extremities. The agency's action date (PDUFA) is April 11, 2017. Priority Review status reduces the review clock to six months from the standard 10 month-period.

FDA rejects Novo’s NDA for aspart insulin- In an announcement published today, Novo Nordisk $NVO reported that it received a Complete Response Letter (CRL) from the regulator on October 7 concerning its New Drug Application (NDA) seeking approval for faster-acting insulin aspart. The submission was filed in December 2015. The drug-maker did not reveal the specific reasons for the rejection but says it will work closely with the agency to resolve the outstanding issues.

Roche’s Lucentis Gets Priority Review Status-The FDA granted Priority Review status to Roche's $RHHBY supplemental Biologics License Application (sBLA) seeking approval of Lucentis (ranibizumab injection) for the treatment of myopic choroidal neovascularization (mCNV), a complication of new sightedness that can result in to blindness. If approved, it will be the first anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV. Priority Review status reduces the review clock to six months from the usual 10- month period.

KemPharm Inc $KMPH soared on Tuesday amid heavy trading volume in response to the news that the FDA has okayed its Investigational New Drug (IND) application for KP415, an extended-release prodrug for the treatment of attention deficit hyperactivity disorder (ADHD).  The company expects to begin and complete proof-of-concept (POC) studies this quarter followed by additional human trials in H1, 2017. If successful, a New Drug Application (NDA) could be submitted as early as 2018.

Shire Plc $SHPG is nearing in on a “multi-billion” dollar deal to acquire biopharmaceutical firm Radius Health $RDUS. Its lead product candidate is Abaloparatide-SC, which is under regulatory review for the treatment of osteoporosis. In the premarket trading, $RDUS was gaining about 4%, while $SHPG was slipping about 2%.

Horizon Pharma $HZNP, in its regulatory filing, noted that it expects Q3 revenue to fall in the range of $207mn to $209mn, which includes the previously announced settlement with Express Scripts $ESRX linked to a dispute over drug rebates. For the fiscal 2016, it expects the topline to come in at about $960mn. For the third quarter, expected non-GAAP EBITDA is $139mn to $141mn. Quick assets should total about $550mn. The forecast for 2016 non-GAAP EBITDA has been downwardly revised to $450mn to $460mn from $495mn to $510mn. Earnings call is scheduled on November 7.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Allergan (AGN) Miuzho Price Target Cut Buy From $305 to $299 N/A
Celsion (CLSN) Maxim Group Price Target Set Buy $4 N/A
Horizon Pharma (HZNP) Mizuho Reiterate Buy $33 N/A
Illumina (ILMN) Canaccord Genuity Price Target Cut Hold From $165 to $135 N/A
Illumina (ILMN) Barclays Price Target Cut Hold From $150 to $142 N/A
Illumina (ILMN) Cantor Fitzgerald Price Target Cut Hold From $165 to $155 N/A
Illumina (ILMN) Citigroup Downgrade From Buy to Neutral N/A $140
Illumina (ILMN) Janney Montgomery Scott Downgrade/Price Target Cut From Neutral to Sell From $155 to $125 N/A
Neurocrine Biosciences (NBIX) Piper Jaffray Cos. Price Target Set Buy $96 N/A
PTC Therapeutics (PTCT) Wedbush Reiterate Neutral $10 N/A
PTC Therapeutics (PTCT) Credit Suisse Group Price Target Raised N/A $15 N/A

Illumina (ILMN)- Daniel Bradbury, Director, sold 600 shares at $184.36. The total value of the transaction was $110,613. Bradbury still owns 16,465 shares of ILMN.

Acceleron Pharma (XLRN)- Ravindra Kumar, SVP & Chief Scientific Officer, sold 52,486 shares in three separate transactions. Kumar sold 16,009 shares at $34.38; 16,833 shares at $34.14; and 19,644 shares at $33.37. Kumar still owns 75,866 shares of XLRN.

Seattle Genetics (SGEN)- Clay B. Siegall, President & CEO, sold 14,465 shares at $54.41. The total value of the transaction was $787.022. Siegall still owns 638,835 shares of SGEN.

Incyte (INCY)- Barry P. Flannelly, EVP & General Manager U.S., sold 24,204 shares at $97. The total value of the transaction was $2.35 million. Flannelly still owns 11,187 shares of INCY.

Reata Pharmaceuticals $RETA announced the appointment of Dawn Carter Bir as VP and Chief Commercial Officer. Ms. Bir earlier served as VP of US sales at Pharmacyclics LLC. Commenting over the appointment, Reata’s CEO and President, Warren Huff, said, “Dawn is an experienced executive with a proven ability to build and lead sales and marketing organizations. She is also ideally suited to orchestrate our anticipated product launches and collaborate effectively with our global commercial partners.”

NYSE- Puma Biotechnology (PBYI) shares were among the major movers on the NYSE. The stock closed 4.58% lower.

NASDAQ- Momenta Pharmaceuticals (MNTA) shares were among the major gainers on the NASDAQ. The stock closed 12.54% higher. KemPharm (KMPH) ended the day 8.86% higher. Selecta Biosciences (SELB) ended the day 7.53% higher.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Abbott Laboratories (ABT) 4.9% 6.4% 10
AbbVie (ABBV) 2.2% -6.6% 5
Abeona Therapeutics (ABEO) 6.9% 42.8% 3
ABIOMED (ABMD) 4.7% 3.6% 5
ACADIA Pharmaceuticals (ACAD) 15.7% 2.9% 8
Acceleron Pharma (XLRN) 9% 10.2% 7
Acahogen (AKAO) 3.2% 54.5% 3
Achillion Pharmaceuticals (ACHN) 11.4% -0.1% 6
Aclaris Therapeutics (ACRS) 4.8% -6% 4
Acorda Therapeutics (ACOR) 11.1% -9.4% 5