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Cempra (CEMP) has several catalysts coming up. The FDA’s Ad Comm will meet on November 4 to review and discuss its New Drug Application (NDA) seeking approval for intravenous (IV) and oral formulations of solithromycin for the treatment of community-acquired bacterial pneumonia. I recently initiated coverage on CEMP, with a $45 price target. The price target implies substantial upside from current price levels.

Mylan Faces Further Scrutiny- Mylan (MYL) faces further scrutiny from lawmakers after the House Oversight and Government Reform Committee has launched an investigation into the cost of EpiPens. The committee noted that Mylan has a “virtual monopoly” over the auto-injector market. The committee also described the company’s pricing strategy as “unreasonable.”

Portola Announces Positive Interim Results from Phase 3b/4 Study of Andexanet Alfa- Portola Pharmaceuticals (PTLA) announced positive interim results from a Phase 3b/4 study, ANNEXA-4, evaluating its Factor Xa inhibitor antidote AndexXa (andexanet alfa) in reversing acute major bleeding associated with the anticoagulant. The data were presented today at the European Society of Cardiology Congress in Rome. Preliminary analysis on interim results from 67 patients (47 evaluated for efficacy) showed a 30-minute bolus of AndexXa rapidly and substantially reversed anti-Factor Xa activity and sustained the reversal when followed by a 120-minute infusion. The majority of patients (79%) achieved good or excellent hemostasis (bleeding stopped) over a 12-hour period after the infusion. The interim data showed no AndexXa-associated infusion reactions and no patients developed antibodies to Factor Xa or Factor X or neutralizing antibodies to AndexXa.

Rigel Pharmaceuticals’ Late-Stage Study Achieves Primary Endpoint- Rigel Pharmaceuticals (RIGL) shares surged almost 50% on Tuesday after the company announced results from a Phase 3 clinical trial, Study 047, assessing lead product candidate fostamatinib for the treatment of immune thrombocytopenia (ITP), a bleeding disorder resulting from a person's immune system destroying blood platelets that affects ~60K people. 18% (n=9/51) achieved the primary endpoint compared to 0% for placebo, a statistically valid result. The rates of treatment-related adverse events (TRAEs) were 77% (n=39/51) for fostamatinib and 28% (n=2/25) for placebo.

Kamada’s Mid-Stage Study of Inhaled AAT Therapy Succeeds- Kamada (KMDA) announced ositive results in a Phase 2 clinical trial assessing its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD), an orphan disease currently treated by intravenous AAT augmentation therapy. The primary efficacy endpoints included antigenic AAT levels and Anti-Neutrophil Elastase Inhibitory (ANEC) levels in the lung as well as additional anti-proteolitic and anti-inflammatory biomarkers. Patients in the inhaled AAT therapy cohort showed a statistically significant increase in endothelial lining fluid (ELF) AAT antigenic level compared to placebo (p<0.0005). The levels were more than twice the increase observed in an earlier study of intravenous (IV) AAT therapy.

Array BioPharma Announces Encouraging Results From Mid-Stage Study of ARRY-797- Array BioPharma (ARRY) announced positive results from a Phase 2 clinical trial evaluating ARRY-797 for the treatment of patients with lamin A/C-related dilated cardiomyopathy (LMNA-DCM), a rare degenerative cardiovascular disease caused by mutations in the LMNA gene that is associated with a poor prognosis. The data were presented at the European Society of Cardiology Congress in Rome. The mean change from baseline in the six-minute walk test (6MWT), the primary endpoint, was 69 meters. Sustained improvement in related biomarkers was also observed. A trend for greater improvement was seen with the 400 mg dose.

ARIAD Completes NDA Submission for Brigatinib- ARIAD Pharmaceuticals (ARIA) announced that it completed he rolling submission of its New Drug Application (NDA) to the FDA seeking approval of Breakthrough Therapy- and Orphan Drug-tagged brigatinib for the treatment of patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to Pfizer’s (PFE) XALKORI (crizotinib). The company has requested accelerated review of the filing.

OncoMed Announces Completion of Enrollment in Phase 2 Study of Tarextumab- OncoMed Pharmaceuticals (OMED) announced that it has completed enrollment in its Phase 2 clinical trial, PINNACLE, evaluating tarextumab (OMP-59R5) for the treatment of small cell lung cancer (SCLC). Top-line data should be available by the end of this year or early next year. The study is expected to be completed in April 2018.

Veltassa Succeeds in Late-Stage Study- Relypsa (RLYP) announced that a Phase 4 study evaluating its Veltassa (patiromer) for oral suspension, taken with or without food, for the treatment of hyperkalemia (excess blood potassium) met its primary endpoint. Results showed no statistically significant difference in the proportion of patients achieving serum potassium levels within the target range (3.8 - 5.0 mEq/L) by Week 3 or 4 between those taking Veltassa with food or without. Adverse events were consistent with earlier trials. Relypsa agreed to a $32 per share takeover by Vifor Pharma earlier in the year.

The Medicines Company’s Mid-Stage Study of MDCO-216 Fails to Achieve Efficacy Results-  The Medicines Company (MDCO) announced that a Phase 2 proof-of-concept study evaluating its MDCO-216 for educing atherosclerotic plaque burden failed to achieve the efficacy results necessary for an early end to the trial. The Independent Data Monitoring Committee recommended the study continue citing the inconclusiveness of the interim data from 40 subjects. Results from the full group of 120 patients will be presented at the American Heart Association Scientific Sessions in mid-November.

Onconova Announces Workforce Reduction- Onconova Therapeutics (ONTX) announced that it is terminating 21% of its workforce. The workforce reduction will save around $1.4 million per year.

The FDA has approved Erelzi, a biosimilar to Amgen’s (AMGN) nbrel (etanercept). The biosimilar drug was developed by Swiss drug maker Novartis’ (NVS) Sandoz unit.

No patents to report.

Orexigen (OREX) announced that it has signed an agreement with Valeant Pharmaceuticals’ (VRX) Canadian unitfor the commercialization of obesity med Contrave (naltrexone HCl) in Canada. According to the terms of the agreement, Valeant Canada will be responsible for securing Canadian regulatory approval and all commercialization activities and expenses. Orexigen will supply Contrave at a specific transfer price and will be eligible for certain regulatory- and sales-based milestone payments. Specific financial terms are not disclosed. The marketing application to Health Canada should be filed in January 2017.

Clovis Oncology (CLVS) disclosed in a regulatory filing that it has amended its 2011 license agreement with Pfizer (PFE) that will allow Clovis to defer the payment of milestones due Pfizer upon the approval of an NDA in the U.S. and MAA in the EU for the first indication of rucaparib (PF-01367338). The change allows Clovis to defer such payment for 18 months in exchange for agreeing to pay a higher (undisclosed) amount.

Atossa Genetics (ATOS) has commenced a public offering of common stock. Price, volume and terms of the offering have not yet been announced. Net proceeds from the offering will be used to fund working capital and general corporate purposes.

OpGen (OPGN) announced that it has filed a Form S-3 with the U.S. Securities and Exchange Commission (SEC). According to the filing, the company may offer and sell from time to time, in one or more offerings, up to $50 million of its common stock.

Cormedix (CRMD) also filed a Form S-3 with the SEC. The company may from time to time offer up to $150 million of any combination of the securities described in the prospectus, either individually or in units, in one or more offerings in amounts, at prices and on the terms that will be determined at the time of the offering.

No IPOs to report.

Alcobra (ADHD) reported a loss of $0.21 per share in its second quarter, beating consensus forecast by a penny. The company ended the quarter with $15.1 million in cash and cash equivalents on its balance sheet.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Alcobra (ADHD) Piper Jaffray Cos. Reiterate Overweight N/A N/A
Allergan (AGN) Piper Jaffray Cos. Reiterate Neutral

$227

N/A
Array BioPharma (ARRY) Leerink Swann Reiterate Positive N/A N/A
Cerulean Pharma (CERU) Barclays Plc Price Target Cut Overweight From $5 to $2 N/A
Conatus Pharmaceuticals (CNAT) FBR & Co. Reiterate Outperform

$16

N/A
Cynapsus Therapeutics (CYNA) Noble Financial Reiterate Buy

$50

N/A
EDAP TMS SA (EDAP)  HC Wainwright Reiterate Buy N/A N/A
Gemphire Therapeutics (GEMP) Canaccord Genuity Initiation Buy

$17

N/A
Gemphire Therapeutics (GEMP) Jefferies Group Initiation Buy

$15

N/A
Gemphire Therapeutics (GEMP) Royal Bank of Canada Initiation Outperform

$25

N/A
Gemphire Therapeutics (GEMP) RBC Capital Markets Initiation Outperform

$25

N/A
Galapagos (GLPG) Janney Montgomery Scott Initiation Buy

$64

N/A
Kite Pharma (KITE) BTIG Research Initiation Neutral N/A N/A
Karyopharm Therapeutics (KPTI) Jefferies Group Upgrade/Price Target Raised From Hold to Buy From $9 to $12 N/A
Karyopharm Therapeutics (KPTI) S&P Equity Research Price Target Cut N/A From $9.06 to $7.55 N/A
Mylan (MYL) Leerink Swann Reiterate Outperform

$55

N/A
Neurocrine Biosciences (NBIX) Robert W. Baird Reiterate Outperform

$66

N/A
Nivalis Therapeutics (NVLS) Piper Jaffray Cos. Reiterate Buy

$16

N/A
Rigel Pharmaceuticals (RIGL) Piper Jaffray Cos. Price Target Raised Overweight From $10 to $11 N/A
Rigel Pharmaceuticals (RIGL) BMO Capital Markets Price Target Raised Outperform From $4 to $6 N/A
Shire Plc (SHPG) Shore Capital Reiterate Buy N/A N/A
Sophirs Bio (SPHS) Piper Jaffray Cos. Initiation Overweight

$7

N/A

No insider buys to report.

Codexis (CDXS)- Dennis P. Wolf, Director, sold 18,000 shares in two separate transactions. Wolf sold 9,000 shares at $4.25; and 9,000 shares at $4.19. Wolf still owns 123,360 shares of CDXS.

BioMarin Pharmaceuticals (BMRN)- Henry J. Fuchs, EVP, Chief Medical Officer, sold 15,000 shares at $95.06. The total value of the transaction was $1.425 million. Fuchs still owns 113,878 shares of BMRN.

Xencor (XNCR)- John S Stafford, III, a 10% owner, sold 24,351 shares at $21.48. The total value of the transaction was $523,059. Stafford still owns 5,095,561 shares of XNCR.

SciClone Pharmaceuticals (SCLN)- Nancy T. Chang, Director, sold 25,040 shares in three separate transactions. Chang sold 7,500 shares at $10.25; 10,000 shares at $10.31; and 7,540 shares at $10.33. Chang does not own any shares of SCLN following the sale.

Perrigo (PRGO)- Judy L. Brown, EVP, Business Ops & CFO, sold 2,095 shares at $88.28. The total value of the transaction was $184,947. Brown still owns 16,292 shares of PRGO.

No management changes and additions to report.

NYSE- Perrigo (PRGO) shares were among the major gainers on the NYSE. The stock closed 2.22% higher. InVitae (NVTA) shares were among the major losers on the NYSE. The stock closed 5.60% lower.

NASDAQ- Rigel Pharmaceuticals (RIGL) shares were among the major gainers on the NASDAQ. The stock closed 48.86% higher. Karyopharm Therapeutics (KPTI) ended the day 36.86% higher. Syros Pharmaceuticals (SYRS) ended the day 15.81% higher. Mirna Therapeutics (MIRN) shares were among the major losers on the NASDAQ. The stock ended the day 19.73% lower. Macrocure (MCUR) ended the day 13.43% lower. Argos Therapeutics (ARGS) ended the day 8.43% lower.

NYSEMKT- Asterias Biotherapeutics (AST) shares were among the major losers on the NYSEMKT. The stock closed 1.47% higher.

OTC- Amarantus Bioscience Holdings (AMBS) shares were among the major movers on the OTC market. The stock closed 7.85% lower.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
VistaGen Therapeutics (VTGN)

0.2%

322.5%

0

Vitae Pharmaceuticals (VTAE)

5.7%

-8%

5

Vital Therapies (VTL)

8.7%

-1.3%

37

VIVUS Inc. (VVUS)

7.2%

-6.8%

17

Voyager Therapeutics (VYGR)

6.6%

-5.6%

22

vTv Therapeutics (VTVT)

3.7%

-2%

9

WAVE Life Sciences (WVE)

3.9%

1.7%

29

Windtree Therapeutics (WINT)

4%

-3.1%

19