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Loxo Oncology Inc. ($LOXO) reported that it has received an Orphan Drug designation from the FDA for its larotrectinib (LOXO-101), for the treatment of solid tumors with rare genetic abnormalities called NTRK-fusion proteins. The drug inhibits a group of enzymes called tropomyosin receptor kinases (TRK), a group of proteins that plays a key role in cellular communications.
The company stock has gained over 34 percent this year so far while its 12 months gain stands at 85 percent. The Orphan Drug designation provides several benefits such as a seven-year period of market exclusivity for the indication, if approved. The company had started the drug’s Phase 2 clinical trial nearly two months back.

AstraZeneca PLC ($AZN) stock received a fillip as the company reported positive results from its Phase 3 PACIFIC study assessing PD-L1 inhibitor durvalumab, for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) who had not progressed following platinum-based chemo concurrent with radiation therapy. The treatment has been branded as Imfinzi.
The company stock jumped over 9 percent over this news while its Year to Date gain touched over 24 percent. The stock is currently trading close to its 52 weeks high of $35.04. AstraZeneca drug is expected to provide competition to existing treatments including Opdivo and Keytruda. The FDA recently granted accelerated approval of durvalumab for advanced bladder cancer. 

 

Akari Therapeutics ($AKTX) announced that its CEO Dr. Gur Roshwalk has been placed on administrative leave while a special committee of the board investigates the potential involvement of company employees related to a report published by Edison Investment Research.

AbbVie ($ABBV) reported positive outcomes from an analysis of pooled data from three Phase 3 clinical trials, which are RESONATE, RESONATE-2 and HELIOS, for assessing IMBRUVICA (ibrutinib) in high-risk patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. The BTK inhibitor offered improved results in patients with certain genetic abnormalities associated with poor prognoses.

Celsion Corporation ($CLSN) announced that it met with the China Food and Drug Administration (CFDA) to review the ongoing Phase 3 OPTIMA liver cancer study and a regulatory pathway for ThermoDox. The company was informed that if OPTIMA is successful, the data could serve as the basis for a marketing application there without prior approval in the U.S. or EU.

Obalon Therapeutics ($OBLN) announced receiving regulatory approval in select Middle East markets to commercialize the Obalon six-month balloon and inflation dispenser. The product will be distributed by Bader Sultan. It is a swallowable gas-filled intragastric balloon designed to fill much of the stomach which reduces food intake.

 

Quorum Health ($QHC) announced inking a definitive deal of divesting its two Tennessee hospitals to SSH Tennessee. These hospitals are Henderson Country Community Hospital and McKenzie Regional Hospital, both with 45 beds capacity each. Quorum Health runs a portfolio of 35 hospitals with about 3,400 licensed beds. The deal is expected to be closed by August 1.

Covalon Technologies ($CVALF) announced that it has raised $2.6 million capital through a non-brokered private placement. The company placed 931,121 units at $1.96, where each unit comprised one share of common stock and one three-year warrant to purchase one share of common at $2.30. Company insiders will acquire 752,551 units constituting 78% of the offering.

 

Tonix Pharmaceuticals ($TNXP) reported a net loss of $5.1 million, or $1.27 per share, for the first quarter of 2017, compared to a net loss of $14.0 million, or $7.41 per share, for the first quarter of 2016. The company’s cash used in operations was $4.8 million for the three months ended March 31, 2017, compared to $15.5 million for the three months ended March 31, 2016.
Acura Pharmaceuticals Inc. ($ACUR) reported net income of $1.5 million, or $0.13 per diluted share, for the fourth quarter of 2016, compared to net loss of $0.9 million or $0.08 per diluted share for the same period in 2015. The company incurred $4 million worth of research and development expenses associated with product candidates utilizing the Company’s LIMITX™, AVERSION® and IMPEDE Technologies.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Craig Hallum
Downgrades
Alere (ALR)
Buy -> Hold

N/A
Bank of America Corp
Upgrades
Cerner (CERN)
Underperform -> Neutral

N/A
BTIG Research
Upgrades
Foundation Medicine (FMI)
Neutral -> Buy

N/A
Royal Bank of Canada
Initiates
Jazz Pharmaceuticals plc - (JAZZ)
Outperform
$210.00
N/A
JPMorgan Chase & Co.
Upgrades
Johnson & Johnson (JNJ)
Neutral -> Overweight

N/A
Bank of America Corp
Initiates
Allscripts Healthcare Solutions (MDRX)
Neutral

N/A
Evercore ISI
Upgrades
PAREXEL International (PRXL)
Outperform

N/A
Deutsche Bank AG
Upgrades
Dr.Reddy's Laboratories Ltd (RDY)
Sell -> Hold

N/A

Gainers (% price change)
Last Trade
Change
Mkt Cap
Sangamo Therapeutics Inc
SGMO
8.20
+1.20 (17.14%)
947.23M
Endocyte, Inc.
ECYT
2.90
+0.39 (15.54%)
125.16M
Synergy Pharmaceuticals
SGYP
4.33
+0.45 (11.60%)
912.84M
AstraZeneca plc (ADR)
AZN
34.00
+2.87 (9.22%)
85.14B
Rexahn Pharmaceuticals
RNN
4.26
+0.29 (7.30%)
132.29M
Losers (% price change)

HMS Holdings Corp
HMSY
18.01
-1.02 (-5.36%)
1.52B
Alere Inc
ALR
46.70
-2.55 (-5.18%)
4.06B
Rockwell Medical Inc
RMTI
6.63
-0.34 (-4.88%)
334.12M
China Biologic Products
CBPO
110.17
-4.25 (-3.71%)
2.98B
BioSpecifics Tech. Corp.
BSTC
56.18
-1.82 (-3.14%)
414.99M
Most Actives (dollar volume)

AstraZeneca plc (ADR)
AZN
34.00
+2.87 (9.22%)
85.14B
Merck & Co., Inc.
MRK
63.57
-0.86 (-1.33%)
175.21B
Becton Dickinson and Co
BDX
184.62
-0.24 (-0.13%)
40.50B
Pfizer Inc.
PFE
33.01
-0.03 (-0.09%)
196.64B
Regeneron Pharmaceuticals
REGN
442.05
+1.62 (0.37%)
47.95B