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US Biotech/Pharma Sector Update: April 11

|Includes: Neurocrine Biosciences, Inc. (NBIX), NBRV, RCKT, TNXP

Neurocrine Biosciences (NASDAQ:NBIX) stock was up about 19% after-hours on the news that FDA had approved Ingrezza (selective VMAT2 inhibitor) for the treatment of Tardive dyskinesia without a black label warning. Ingrezza is the first FDA approved treatment for this movement disorder.

Nabriva Therapeutics (NASDAQ:NBRV) was up about 7% on the news that it has completed patient enrollment in the first phase 3 (LEAP 1) trial of lefamulin in adult community-acquired bacterial pneumonia. Results of the trial are expected in Q3, 2017. Following the news, Cantor Fitzgerald reiterated Buy rating on the stock with PT=$16.

Inotek Pharmaceuticals (ITEK) announced that it has completed patient enrollment in a phase 2 trial of a fixed dose combination of trabedenoson and latanaoprost for the treatment of glaucoma. Results of the trial are expected in July this year. The stock was up more than 5% today.

Tonix Pharmaceuticals (NASDAQ:TNXP) stock was up more than 7% on high volume after FDA confirmed that a single positive phase 3 study will be enough for approval for TNX-102 (cyclobenzaprine) for the treatment of post-traumatic stress disorder, PTSD. The therapy has Breakthrough therapy designation in this indication.

Intellia Therapeutics (NASDAQ:NTLA) announced that it has received a patent broadly covering CRISPR/Cas9 gene editing technology in the EU.

Agile Therapeutics (NASDAQ:AGRX) stock was up about 5% after reporting favorable NDA pre-submission meeting from FDA regarding Twirla (low-dose combined horone contraception patch). The company expects resubmission of NDA by end of Q2, 2017. Following the news, Cantor Fitzgerald reiterated Buy rating on the stock with PT=$9.

Axovant Sciences (NASDAQ:AXON) stock continued its upward march and was up more than 9% on high volume today after the appointment of David Hung, Medivation's former CEO as its new CEO. Baird reiterated Buy rating on the stock with PT=$29 today.

Mesoblast (NASDAQ:MESO) stock continued its upward move today (up more than 8% on high volume) after the company announced successful interim phase 3 data of its allogeneic mesencymal cell therapy in the treatment of chronic heart failure yesterday.

Cytori Therapeutics (NASDAQ:CYTX) was down more than 36% after a secondary equity offering of 8.6 million shares at $1.10 per share.

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More analyst ratings from today:

Celgene (NASDAQ:CELG): Jefferies, reiterated Buy rating with PT=$154.

Illumina (NASDAQ:ILMN): Piper Jeffrey, reiterated Buy rating with PT=$187.

Shire (NASDAQ:SHPG): Goldman Sachs, reiterated Buy rating (upcoming phase 3 trial data in hereditary angioedema).

Cidara Therapeutics (NASDAQ:CDTX): Wedbush, initiated coverage with Buy rating and PT=$13 (upcoming phase 2 data in IV candidemia in Q4, 2017).

Paratek Pharmaceuticals (NASDAQ:PRTK): HC Wainwright, reiterated Buy rating with PT=$36 (company reported successful phase 3 data for omadacycline in adult CABP last week).

Stemline Therapeutics (NASDAQ:STML): Jefferies, reiterated Buy rating with PT=$16.

RegenxBio (NASDAQ:RGNX): Chardan, reiterated Buy rating with increased PT=$50 (after appointment of a leading gene therapy expert from Biogen as its new CSO).

Oncomed (NASDAQ:OMED): Jefferies reiterated Buy rating with PT=$10; HC Wainwright reiterated Buy rating with reduced PT=$9; BMO capital downgraded from Buy to neutral with PT=$6 (company missed phase 2 data in pancreatic cancer).

TherapeuticsMD (NYSEMKT:TXMD): Cantor Fitzgerald, reiterated Buy rating with PT=$34; Jefferies, reiterated Buy rating with PT=$18 (four buy ratings in 2 days; company got notice of deficiencies in its NDA application for '004 yesterday).

Sanofi (NASDAQ:SNY): JP Morgan, Upgraded to neutral from sell.

Mylan (NASDAQ:MYL): Wells Fargo, reiterated neutral rating with PT=$39-41.

Valeant (VRX): Piper Jeffrey, reiterated sell rating with PT=$10.

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Insider transactions:

Insider buying:

A director bought $140K worth of stock in Incyte (NASDAQ:INCY).

The CEO bought $100K worth of stock in Hemispheryx Biopharma (NYSEMKT:HEB).

Insider selling noted in NKTR, MBVX, VRAY, PTLA, NBRV, INCY.

Up on unusual volume:

Neurocrine Biosciences, Axovant Sciences, Conatus Pharmaceuticals (NASDAQ:CNAT), Mesoblast, Genocea Biosciences (NASDAQ:GNCA), Axsome Therapeutics (NASDAQ:AXSM)

Disclosure:

This article represents my own opinion and is not a substitute for professional investment advice. It does not represent solicitation to buy or sell any security. Investors should do their own research and consult their financial adviser before making any investment.

Disclosure: I am/we are long NBIX, NBRV, ITEK, CELG, CDTX, PRTK, STML, INCY, PTLA, CNAT, AXSM.