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Lexicon Pharmaceuticals Inc. ($LXRX) reported that it has received the FDA approval for its oral drug, Xarmelo, for treating carcinoid syndrome diarrhea, a condition that develops in patients with gastrointestinal tumors. The drug has been tested on patients unable to tolerate somatostatin analog therapy. In September, last year, the FDA has stated that it it required more time to review the drug, extending its decision date by three months, but did not request an additional trial.
The drug is now available by prescription and will be in select specialty pharmacies with effect from March 6, 2017. Xarmelo had been granted "orphan drug" and "fast track" status by the FDA. The company stock is expected to gain a boost from the news. The price is up nearly 16 percent this year so far.

Synergy Pharmaceuticals Inc. ($SGYP) recently announced the detailed results from a pivotal Phase 3 trial that demonstrated the efficacy and safety of TRULANCE™ for the treatment of adults with chronic idiopathic constipation. The drug was earlier approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic idiopathic constipation. The drug is expected to hit the markets this quarter itself.
The company stock has shown strong performance as it has gained over 70 percent in the past 12 months. Synergy had recently announced the pricing of its recent public offering as well. The stock was priced at $6.15 per share. The offering was closed on February 6.

 

• Perrrigo Company Plc ($PRGO) announced that it plans to sell its royalty stream for multiple sclerosis drug Tysabri to an affiliate of Royalty Pharma for up to $2.85 billion. Under the terms of the deal, Royalty Pharma will be required to pay $2.2 billion in cash up front and up to $650 million in potential milestone payments. The company took the decision following a campaign launched in September by activist fund Starboard Value. The fund ultimately gained five director seats on the company's board and its founder, Jeff Smith, a spot on two critical strategic review committees.
• Akorn Inc. ($AKRX) reported that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Mycophenolate Mofetil for Injection, USP, 500 mg/vial. This approval is the first new product approval received out of Akorn’s Decatur, Illinois manufacturing facility since the FDA re-inspection in December 2016.

• Ampio Pharmaceuticals ($AMPE) reported that it has been provided additional guidance by the Office of Tissue and Advanced Therapies (OTAT), a branch of the Center for Biologics Evaluation and Research (CBER) of the FDA, regarding the approval of Ampion™ as a treatment for pain due to severe Osteoarthritis of the knee (OAK). The FDA acknowledged an unmet medical need in patients with pain due to severe OAK, graded as Kellgren-Lawrence Grade 4 (KL 4), where there are currently no FDA approved treatments for this population.
• Cellectar Biosciences Inc. ($CLRB) offered an update of its Phase I clinical study of CLR 131 in patients with relapsed or refractory multiple myeloma. The data from Cohort 3 show that the 25 mCi/m2 dose was safe and well tolerated, and those patients experienced a similar adverse event profile to that experienced by patients in the previous two cohorts. All four Cohort 3 patients achieved stable disease and continue to be followed for progression-free survival (PFS) and median overall survival (mOS).

 
• Advaxis Inc. ($ADXS) announced that it has inked a new deal with SELLAS Life Sciences Group, granting the latter a license to develop a novel cancer immunotherapy agent using Advaxis' proprietary Lm-based antigen delivery technology with SELLAS' patented WT1 targeted heteroclitic peptide antigen mixture (galinpepimut-S). Under the terms of the collaboration, Advaxis will conduct all pre-clinical activities required for an IND filing while SELLAS will be responsible for all clinical development and commercial activities.
• Clearside BioMedical Inc. ($CLSD) announced that it has initiated a strategic realignment of its research and development resources from its pre-clinical development program for axitinib for the treatment of wet age-related macular degeneration. The resources will now be deployed for its ongoing clinical development program for the treatment of diabetic macular edema assessing ZuprataTM, the company’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide.

 
• Zosano Pharma Corporation ($ZSAN) announced a net loss for 2016 of $29.8 million, or $2.17 per share on a basic and diluted basis, compared with a net loss of $28.4 million, or $2.49 per share on a basic and diluted basis, for 2015. Its fourth quarter net loss stood at $7.7 million, or $0.46 per share on a basic and diluted basis, compared with a net loss of $7.6 million, or $0.64 per share on a basic and diluted basis, for the same quarter in 2015. Total revenue for the year ended December 31, 2016, was nil, compared with $0.3 million in 2015. Zosano had no revenue for the fourth quarters of 2016 and 2015.
• Amicus Therapeutics Inc. ($FOLD) reported its full year revenue at close to $5 million, mainly derived from commercial sales of Galafold (migalastat) in Germany as well as reimbursed Expanded Access Programs (EAPs) in two countries during the third and fourth quarter of 2016. Its net loss for the same period was $200.0 million, or $1.49 per share, compared to a net loss of $132.1 million, or $1.20 per share, for the full year 2015.

Brokerage Action Company Rating Price Target
Craig Hallum Downgrades The Advisory Board Company (ABCO)
Buy -> Hold
RBC Capital Markets Raises Target Abbott Laboratories (ABT)
Outperform $46.00 -> $50.00
Royal Bank of Canada Raises Target Abbott Laboratories (ABT)
Outperform $46.00 -> $50.00
Needham & Company LLC Reiterates ACADIA Pharmaceuticals (ACAD)
Buy $49.00
Mizuho Raises Target Amedisys (AMED)
Neutral $33.00 -> $50.00
Needham & Company LLC Reiterates AtriCure (ATRC)
Buy $23.00
Morgan Stanley Raises Target bluebird bio (BLUE)
$87.00
Piper Jaffray Companies Downgrades Community Health Systems (CYH)

Cantor Fitzgerald Lowers Target Depomed (DEPO)
$19.00
Jefferies Group LLC Raises Target DexCom (DXCM)
$91.00
Canaccord Genuity Reiterates Endo International PLC (ENDP)
Hold $14.00
Royal Bank of Canada Lowers Target Envision Healthcare Corporation (EVHC)
Outperform $87.00 -> $80.00
Jefferies Group LLC Reiterates Envision Healthcare Corporation (EVHC)
Buy $82.00

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