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Sarepta Therapeutics (SRPT) shares rallied on Wednesday amid speculation that the company’s DMD drug eteplirsen will be approved by the FDA. The speculation was fueled by the rumor that eteplirsen reviewer Ron Farkas has left the agency. Farkas was the most direct in his opinion that the company had not submitted sufficient data to prove the efficacy of eteplirsen for the treatment of DMD. The best way to play SRPT is take some profit on the rumors. The upside could be significant if the drug is approved, however, it is advisable to take some profit now.

Exelixis (EXEL) shares hit a 52-week high on Wednesday after the company announced that its  CABOMETYX (cabozantinib) for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior vascular endothelial growth factor (VEGF)-targeted therapy has been approved by the European Commission (EC). Cabo has already been approved by the FDA for the same indication earlier this year.

EXEL shares have been on an upward trajectory since April and I believe that investors should now consider taking profit. The stock has already gained more than 130% so far this year.

OncBioMune in Talks to Buy Vitel Laboratories S.A.- OncBioMune Pharmaceuticals (OBMP) is currently in talks to buy Mexico-based Vitel Laboratorios S.A. de C.V., a company focusing on the development and commercialization of specialty drugs in Mexico and Latin America. Vitel's portfolio includes 12 candidates licensed in Mexico, including Vesanoid (tretioin) an oral anti-cancer chemo drug licensed from German outfit Cheplapharm Arzneimittel GmbH who acquired the rights from Roche in 2012. Financial terms of the deal have not been disclosed.

Acasti Pharma Announces Promising Results from a Bridging Study- Acasti Pharma (ACST) announced successful results from a bridging study supporting its pursuit of an abbreviated approval pathway in the U.S. for CaPre (omega-3 phospholipid), its candidate for the treatment of severe hypertriglyceridemia. The company hopes to use the FDA's 505(b)(2) pathway which allows some of the supporting data to be derived from studies performed by others. The study met its primary objective of demonstrating that the levels of omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) following the administration of CaPre (single dose of 4 mg) did not exceed the levels following administration of LOVAZA in subjects who were fed a high-fat meal. The news sent ACST shares more than 120% higher on Wednesday.

Asterias Rallies on Promising Interim Results- Asterias Biotherapeutics (AST) shares rose nearly 6% on Wednesday after the company announced positive preliminary data from its Phase 1/2a study, SCiSTAR, assessing its AST-OPC1 (oligodendrocyte progenitor) cells for the treatment of complete cervical spinal cord injury. The data were presented at the 55th Annual Scientific Meeting of the International Spinal Cord Society in Vienna, Austria. All five patients treated with 10M cells showed improved upper extremity scores compared to baseline. At Day 90 of follow-up, four of four patients improved one motor level on at least one side while two of four improved two motor levels on at least one side. One patient improved two levels on both sides. Existing research suggests patients with at least a two-level improvement may regain the ability to perform daily activities such as feeding, dressing and bathing.

Aerie Pharmaceuticals’ Roclatan Succeeds in Late-Stage Study- Aerie Pharmaceuticals (AERI) shares surged in after-hours trading on Wednesday after the company announced successful results from a Phase 3 clinical study, Mercury 1, evaluating its Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% for lowering intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The study met its primary endpoint of showing superiority over each of its components, Rhopressa (netarsudil ophthalmic solution) 0.02% and latanoprost, as measured by baseline IOPs from above 20 to below 36 mmHg for each of nine time points. In addition, Roclatan lowered average IOP to 16 mmHg or lower in 61% of patients, significantly higher that the comparator arms. Normal eye pressure ranges from 12 - 22 mmHg.

Shire Plc (SHPG) announced that the FDA has approved its CUVITRU [Immune Globulin Subcutaneous (Human) 20% Solution] for the treatment of adult and pediatric patients at least two years old with primary immunodeficiency (PI), a group of over 300 genetic disorders in which the body's immune system fails to work properly. It affects ~6M people worldwide.

Array BioPharma (ARRY) announced that it has reached an agreement with the FDA on the design of a Phase 3 clinical trial, BEACON CRC, assessing the combination of encorafenib and Eli Lilly's (LLY +0.3%) Erbitux (cetuximab), with or without binimetinib, in patients with BRAF-positive colorectal cancer (CRC) who have previously received first- or second-line systemic therapy. he primary endpoint is overall survival (OS) of the triplet therapy compared to control. Secondary endpoints will compare the efficacy of the doublet therapy to control and the triplet therapy to the doublet therapy, in addition to progression-free survival, objective response rate, duration of response, safety and tolerability. Patient enrollment should be completed in 2018.

No patents to report.

Allergan (AGN) announced the acquisition of Vitae Pharmaceuticals (VTAE) in an all cash transaction valued at approximately $639 million. Allergan is paying $21 per share, which translates to a premium of almost 160%. The acquisition will strengthen Allergan’s dermatology pipeline with the addition of VTP-43742, a retinoic acid receptor-related orphan receptor gamma inhibitor for the treatment of psoriasis and other autoimmune disorders. Vitae’s pipeline also includes VTP-38543, a topical Liver X receptor beta selective agonist for the treatment of atopic dermatitis. The transaction is expected to be completed by the end of this year.

Agios Pharmaceuticals (AGIO) announced a $150 million public offering of its common stock. Price, volume and terms of the offering have not yet been announced.

Immune Design (IMDZ) commenced a public offering of its common stock. The company has not yet announced the price, volume and terms of the offering.

No IPOs to report.

Aviragen Therapeutics (AVIR) reported a loss of $0.18 per share in its fourth quarter. The company reported revenue of $0.6 million, down 85.4% on a year-over-year basis.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Allergan (AGN) Mizuho Reiterate Buy

$305

N/A
Cellectis (CLLS) Oppenheimer Holdings Reiterate Outperform

$65

N/A
Clovis Oncology (CLVS) SunTrust Banks Reiterate Buy

$27.65

N/A
Collegium Pharmaceuticals (COLL) Needham & Company Reiterate Buy

$30

N/A
Cytori Therapeutics (CYTX) Maxim Group Reiterate Buy

$5

N/A
Depomed (DEPO) Janney Montgomery Scott Reiterate Buy

$28

N/A
Gilead Sciences (GILD) Credit Suisse Group Price Target Cut Outperform From $115 to $95

$130

GlaxoSmithKline (GSK) Jefferies Group Reiterate Buy N/A N/A
Eli Lilly & Co. (LLY) Jefferies Group Reiterate Buy

$105

N/A
Medivation (MDVN) SunTrust Banks Reiterate Neutral N/A N/A
Merck & Co. (MRK) Argus Reiterate Buy

$65

N/A
Ultragenyx Pharmaceuticals (RARE) Credit Suisse Group Reiterate Buy

$101

N/A
Sanofi (SNY) Jefferies Group Reiterate Hold N/A N/A
Sarepta Therapeutics (SRPT) Oppenheimer Holdings Reiterate Outperform

$60

N/A
Sarepta Therapeutics (SRPT) Needham & Company Price Target Raised Buy From $47 to $60 N/A
Sarepta Therapeutics (SRPT) SunTrust Banks Reiterate Reduce N/A N/A
StemCells (STEM) S&P Equity Research Price Target Cut N/A From $1.57 to $1.31 N/A
Vitae Pharmaceuticals (VTAE) Stifel Nicolaus Downgrade From Buy to Hold N/A N/A
Vitae Pharmaceuticals (VTAE) Wedbush Downgrade From Outperform to Neutral N/A N/A

Adamas Pharmaceuticals (ADMS)- William W. Ericson, Director, bought 84,376 shares in two separate transactions. Ericson bought 22,342 shares at $15.65; and 62,034 shares at $15.56. Ericson now owns 3,968,827 shares of ADMS. MDV IX LP, a 10% owner in the company, bought 84,376 shares in two separate transactions. MDV IX bought 22,342 shares at $15.65; and 62,034 shares at $15.56. MDV IX LP now owns 3,968,827 shares of ADMS.

Tonix Pharmaceuticals (TNXP)- Ernest Mario, Director, bought 100,000 shares at $0.79. The total value of the transaction was $79,180. Mario now owns 530,724 shares of TNXP.

Aegerion Pharmaceuticals (AEGR)- Broadfin Healthcare Master Fund, a 10% owner, bought 75,000 shares at $1.75. The total value of the transaction was $131,250. Broadfin Healthcare Master Fund now owns 4,361,291 shares of AEGR.

FibroGen (FGEN)- Pat Cotroneo, VP, Finance and CFO, sold 2,345 shares at $18.22. The total value of the transaction was $42,726. Cotroneo still owns 134,359 shares of FGEN.

Alexion Pharmaceuticals (ALXN)- Carsten Thiel, EVP, Chief Commercial Officer, sold 3,225 shares in two separate transactions. Thiel sold 225 shares at $124.20; and 3,000 shares at $129. Thiel still owns 37,354 shares of ALXN.

No management changes and additions to report.

NYSE- Axovant Sciences (AXON) shares were among the major gainers on the NYSE. The stock closed 4.29% higher. Lannett Company (LCI) ended the day 2.12% higher.

NASDAQ- Viate Pharmaceuticals (VTAE) shares were among the major gainers on the NASDAQ. The stock closed 157.41% higher. Sarepta Therapeutics (SRPT) ended the day 26.76% higher. Inotek Pharmaceuticals (ITEK) ended the day 12.64% higher. Aralez Pharmaceuticals (ARLZ) shares were among the major losers on the NASDAQ. The stock closed 10.93% lower. Nivalis Therapeutics (NVLS) ended the day 9.25% lower. Spectrum Pharmaceuticals (SPPI) ended the day 8.20% lower.

NYSEMKT- Asterias Biotherapeutics (AST) shares were among the major movers on the NYSEMKT. The stock closed 5.98% higher.

OTC- Soligenix (SNGX) shares were among the major movers on the OTC market. The stock closed 2.70% lower.

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

10.8%

7.5%

8

Biodel (BIOD)

0.4%

139.3%

1

BioDelivery Sciences International (BDSI)

15.3%

-6.1%

15

Biogen (BIIB)

1%

-14.7%

2

BioLife Solutions (BLFS)

2%

-24.2%

3

BioLineRx (BLRX)

25.4%

-

0

BioMarin Pharmaceutical (BMRN)

-9.9%

3.8%

4

BiondVax Pharmaceuticals Ltd. (BVXV) -

1.2%

28

Bio-Path Holdings (BPTH)

3.1%

-5.8%

22

BioSpecifics Technologies Corp. (BSTC)

3.1%

-2.3%

5