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Genocea Biosciences’ $GNCA gained sharply amid heavy trading volume in response to its announcement of encouraging long-term data for its lead product candidate GEN-003, an investigational immunotherapy, for the treatment of genital herpes. The data was presented at the Infectious Disease Society of America annual meeting, held in New Orleans, LA.

Opexa’s Phase 2b study on multiple sclerosis fails- Nano-cap stock Opexa Therapeutics $OPXA was hammered on Friday amid heavy trading volume after the company said that its Phase 2b clinical trial, Abili-T, evaluating Tcelna (imilecleucel-T) in patients with secondary progressive multiple sclerosis failed to meet the primary endpoint of a reduction in brain volume change (atrophy). The study also failed to meet the secondary endpoint of reduction in the rate of sustained disease progression. However, Tcelna was safe and well-tolerated. The company intends to continue with data analysis and will consider cash preservation scenarios.

 Regeneron’s Sarilumab marketing application rejected- The FDA on Friday rejected the marketing application of Regeneron’s $REGN Sarilumab, citing manufacturing issues at Sanofi’s manufacturing site. The agency issued a Complete Response Letter (CRL) to both Regeneron and Sanofi $SNY after REGN disclosed the issues. Sarilumab is meant for the treatment of rheumatoid arthritis. Following the announcement, trading of $RGN shares were briefly halted. Meanwhile, Sanofi has responded to the FDA about the shortcomings and is cooperating with the agency to quickly resolve the issues. Once this is done, a new action date will be announced. The two companies say they remain committed to the development of the drug.

 Novo’s cut on long-term profit growth puts slight pressure on Merck- As the insulin leader Novo  Nordisk $NVO presented its Q3 results which saw a cut on long-term growth projections from 10% to 5% mainly due to pricing pressure in the U.S, shares of Merck’s $MRK also slipped 4% on Friday . Merck's Januvia/Janumet accounted for about 15% of its Q3 sales.

 Amgen Plunges as it rules-out price hikes boosting operating income-Amgen $AMGN sunk amid 2x increase in trading volume in response to its statement that it does not foresee any benefit from price increases in top-seller Enbrel next year with regard to ongoing negotiations with pharmacy benefit managers. The treatment’s price hikes resulted in more than 80% growth in operating income for the past six quarters.

 FDA accepts Biogen’s NDA for nusinersen- The FDA accepted under its Priority Review Biogen’s New Drug Application (NDA) for nusinersen meant for the treatment of spinal muscular atrophy (SMA). The treatment also got its Marketing Authorization Application approved in Europe under Accelerated Assessment status. Both statuses will shorten the review clock. SMA is an inherited syndrome characterized by the loss of motor neurons in the spinal cord and lower brain stem, resulting into severe and progressive muscular atrophy and weakness.

 EpiPen’s Overpricing Issue: Price hikes added millions to DOD spending- Mylan’s $MYL overpricing on EpiPens added millions to DOD spending since 2008 as the agency covered more prescriptions for the lifesaving allergy shot at almost retail prices, according to Reuters’ report, which cited government data. However, that might change. Both the Pentagon and Mylan told Reuters that discussions are going on, which could extend a military discount to EpiPens filled at retail pharmacies through the use of rebates.

No approvals to report.

No patents to report.

No deals and collaborations to report.

Theravance $TBPH priced its secondary offering of 3.85 million ordinary shares at $26 on Friday. Underwriters will have an option to purchase an additional 577.5K shares. Its $200M aggregate principal amount of 3.25% Convertible Senior Notes due 2023 have a conversion rate of 29.0276 ordinary shares per $1,000 principal amount of the Notes implying an initial conversion price of $34.45. The net proceeds from the equity offering would be about $93.7 million from the stock and about $193.4 million from convertible debt.

No IPOs to report.

ImmunoGen $IMGN reported FYQ1 results. EPS was of -$0.51, missing consensus estimate by $0.13. Revenue for the quarter was $7.66 million, a drop of 48.4% Y-o-Y, and missing consensus estimate by $13.46 million. The company said that its Phase 3 Forward 1 Trial of Mirvetuximab Soravtansine is on track and will commence before the year-end. FORWARD 2 study assessing Mirvetuximab Soravtansine combinations with Avastin®, Carboplatin, Doxil®, and Keytruda® is Ongoing, the drug-maker said.

 Sanofi $SNY posted Q3 EPS of €1.79. Revenue for the quarter was €9.03B, a growth of 2%, Y-o-Y. Key products sales: Jevtana sales increased 12.8% to €88 million driven by the U.S. market and Japan. Year-to-date sales of Jevtana rose 12.7% to €266 million. Thymoglobulin sales rose 12.7% to €70 million driven by sales in China. Year-to-date sales of Thymoglobulin increased 11.2% to €204 million. Eloxatin sales were down 24.1% to €43 million as generic competition in Canada hurt the top-line growth. Sales of Taxotere (docetaxel) fell 22.4% to €45 million due to generic competition in Japan.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Alcobra $ADHD Barclays Plc Downgrade/Price Target Cut From Equal Weight to Underweight From $3 to $2 N/A
Aerie Pharmaceuticals $AERI Royal Bank of Canada Price Target Raised Outperform From $48 to $49 N/A
Agenus $AGEN HC Wainwright Downgrade/Price Target Cut From Buy to Neutral From $10 to $5 N/A
Alexion Pharmaceuticals $ALXN FBR & Co. Upgrade From Underperform to Market Perform $130 N/A
Alexion Pharmaceuticals $ALXN Goldman Sachs Group Upgrade From Neutral to Buy N/A N?A
Alexion Pharmaceuticals $ALXN Wedbush Price Target Raised Neutral From $132 to $135 N/A
Ariad Pharmaceuticals $ARIA William Blair Price Target Raised Outperform From $12 to $15 N/A
Ariad Pharmaceuticals $ARIA Jefferies Group Price Target Cut Buy From $13 to $11 N/A
BioMarin Pharmaceutical $BMRN Wedbush Price Target Raised Neutral From $102 to $104 N/A
Bristol-Myers Squibb $BMY Hilliard Lyons Upgrade From Neutral to Buy N/A N/A
Bristol-Myers Squibb $BMY Deutsche Bank Price Target Cut Hold From $59 to $52 N/A
Idera Pharmaceuticals $IDRA Wedbush Reiterate Outperform $6 N/A
ImmunoGen $IMGN Canaccord Genuity Price Target Set Buy $6 N/A
Jazz Pharmaceuticals $JAZZ Leerink Swann Price Target Set Buy $178 N/A
Ligand Pharmaceuticals $LGND Roth Capital Price Target Set Buy $154 N/A
Eli Lilly & Co. $LLY Jefferies Group Price Target Cut Buy From $105 to $100 N/A
Novo Nordisk $NVO Bank of America Corp. Downgrade From Neutral to Underperform N/A N/A
Opexa Therapeutics $OPXA Maxim Group Downgrade From Buy to Hold N/A N/A
Opexa Therapeutics $OPXA Aegis Downgrade From Buy to Hold N/A N/A
Opexa Therapeutics $OPXA Chardan Capital Downgrade From Buy to Neutral N/A N/A
Regeneron Pharmaceuticals $REGN Roth Capital Price Target Set Buy $520 N/A
Sarepta Therapeutics $SRPT Royal Bank of Canada Price Target Cut Outperform $106 N/A
United Therapeutics $UTHR Ladenburg Thalmann Upgrade/Price Target Raised From Neutral to Buy From $128 to $138 N/A
Vertex Pharmaceuticals $VRTX Jefferies Group Price Target Cut Buy From $150 to $145 N/A
Vertex Pharmaceuticals $VRTX Stifel Nicolaus Price Target Cut Buy From $109 to $108 N/A

Opko Health $OPK- Dr. Phillip Frost, CEO & Chairman, bought 10,000 shares at $9.46. The total value of the transaction was $94,566. Dr. Frost now owns 160,271,143 shares of OPK.

Atara Biotherapeutics $ATRA- Isaac E. Ciechanover, CEO, sold 4,800 shares in two separate transactions. Ciechanover sold 2,400 shares at $13.91; and 2,400 shares at $13.70. Ciechanover still owns 396,378 shares of ATRA.

SciClone Pharmaceuticals $SCLN- Friedhelm Blobel, President & CEO, sold 40,000 shares at $9.30. The total value of the transaction was $371,892. Blobel still owns 86,784 shares of SCLN.

Agios Pharmaceuticals $AGIO- Lewis Clayton Cantley Jr., Director, sold 2502 shares in four separate transactions. Cantley still owns 107,778 shares of AGIO.

No management changes and additions to report.