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Acorda Therapeutics ($ACOR) reported positive results from  two studies of CVT-301, an inhaled formulation of levodopa for the treatment of OFF periods in Parkinson's disease patients. The results showed positive long term safety data. The two studies viz. CVT-301-004E and CVT-301-005 involved approximately 700 subjects. Acorda is looking to file an NDA in the next quarter. It also intends to file an MAA in Europe by the end of this year.

Acorda stock is currently 38 percent up on Year to Date basis. Its 12 months gain stands at 1 percent. The company said that the latest results are consistent with previously reported data from Phase 2b and Phase 3 clinical trials.

Sonoma Pharmaceuticals ($SNOA) announced that it has received 510(k) clearance from the FDA for its Loyon Skin Descaler. The treatment is designed to manage skin scaling experienced with a range of dermatoses. A quarter of the US population is believed to be suffering from one form or another of scaling. The company plans to launch the product in the US markets this summer. It will use its inhouse IntraDerm Pharmaceuticals direct salesforce for this purpose.

Sonoma stock responded positively to the news as the prices jumped up over 18 percent in the pre-market session. The stock has shown robust performance this year and gained 40 percent. In the past 12 months, it has shown meteoric rise of over 637 percent.

 
Replicel Life Sciences ($REPCF) announced results from its Phase ½ clinical trial ReaCT, for assessing a single injection of RCT-01 into the Achilles tendon of patients with Achilles tendinosis. The study showed that the injection led to clinically important improvements including pain sensation, physical function, blood supply and tendon composition. Participants showed clinically relevant signs of healing six months after injection as measured by an overall 15.3% improvement in a scale called VISA-A. Two patients achieved almost total recovery.

Cempra ($CEMP) reported that it has withdrawn its Marketing Authorization Application (MAA) from the European Medicines Agency  seeking approval of oral capsule and IV formulations of solithromycin for the treatment of community-acquired pneumonia in adults. The company took action after receiving the Day 120 list of questions from the advisory committee CHMP that implied that additional data would be required for a positive opinion backing approval.

RXi Pharmaceuticals ($RXII) announced that the Japan Patent Office has issued a patent covering lead product candidate RXI-109 for the treatment or prevention of fibrotic disorders, including but not limited to skin fibrosis and proliferative retinopathy. The drug candidate is in Phase 2 development for the treatment of dermal scarring and Phase 1 for retinal scarring.

CRISPR Therapeutics ($CRSP) reported that the European Patent Office has issued a patent covering its in-licensed gene editing technology, specifically the CRISPR/Cas9 single-guide gene editing system for uses in both non-cellular and cellular settings. The approval also includes cells from vertebrate animals (eukaryotic) in addition to composition claims for use in any setting, including claims for use in a method of therapeutic treatment of a patient.

 

Tesaro ($TSRO) announced that it plans to substantially expand the  clinical development of just-FDA-approved niraparib (ZEJULA). The company will initiate registration programs for metastatic ovarian, breast and lung cancers. ZEJULA is approved by the FDA for the maintenance treatment of ovarian cancer. It is the first PARP inhibitor that does not require BRCA mutation or other biomarker testing. Market launch of the treatment will commence in late April.

Egalet ($EGLT) announced that it has received the approval of the FDA for allowing it to distribute promotional materials and communications to healthcare professionals regarding the abuse-deterrent properties of ARYMO ER (morphine sulfate) extended-release tablets via the intranasal route. The letter received from the FDA stated that the agency “does  not object" to the company’s stated plans for distributing the materials if they are based on the NDA data.

 

Delcath Systems ($DCTH) reported its fourth quarter and financial year results. Its fourth quarter revenue increased 54.0% to $0.7 million and full year 2016 revenue increased 18% to $2.0 million. The Company reported a net loss for 2016 of $18.0 million or $10.59 per share, compared with a net loss for 2015 of $14.7 million or $14.56 per share.

Quorum Health ($QHC) announced that the company’s net operating revenues for the three months ended December 31, 2016 totaled $515.2 million, compared to $558.2 million for the same period in 2015. the net loss for the quarter was $90.7 million or $3.19 per share, up from the net loss of $0.6 million or $0.02 per share it incurred for the corresponding quarter of the previous year.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Jefferies Group LLC
Reiterates
Array Biopharma (ARRY)
Buy
$8.00
Low
Jefferies Group LLC
Reiterates
Becton Dickinson and Co (BDX)
Buy
$200.00
Low
Gabelli
Downgrades
Cempra (CEMP)
Hold -> Sell

High
Royal Bank of Canada
Lowers Target
Depomed (DEPO)
Sector Perform -> Sector Perform
$22.00 -> $19.00
Low
Cantor Fitzgerald
Reiterates
Depomed (DEPO)
Hold
$19.00
Low
Mizuho
Lowers Target
Depomed (DEPO)
Neutral -> Neutral
$16.00 -> $13.00
Low
Jefferies Group LLC
Reiterates
La Jolla Pharmaceutical Company (LJPC)
Buy
$40.00
Low
KeyCorp
Initiates
Medpace Holdings (MEDP)
Overweight
$34.00
Low

Gainers (% price change)
Last Trade
Change
Mkt Cap
Omeros Corporation
OMER
14.10
+1.43 (11.29%)
677.22M
Cumberland
CPIX
7.06
+0.56 (8.62%)
115.00M
CyberOptics Corporation
CYBE
25.65
+1.25 (5.12%)
177.23M
Corcept Therapeutics Inc.
CORT
11.19
+0.54 (5.07%)
1.33B
Rockwell Medical Inc
RMTI
6.63
+0.30 (4.74%)
357.44M
Losers (% price change)

CTI BioPharma Corp
CTIC
4.16
-0.21 (-4.81%)
119.33M
GenMark Diagnostics, Inc
GNMK
12.45
-0.59 (-4.52%)
570.05M
Progenics Pharmaceuticals
PGNX
10.35
-0.49 (-4.52%)
699.37M
Depomed Inc
DEPO
14.23
-0.67 (-4.50%)
884.27M
Community Health Systems
CYH
9.25
-0.39 (-4.05%)
1.06B
Most Actives (dollar volume)

UnitedHealth Group Inc
UNH
165.35
+0.74 (0.45%)
156.89B
Amgen, Inc.
AMGN
164.71
-0.20 (-0.12%)
120.69B
Johnson & Johnson
JNJ
125.66
-0.13 (-0.10%)
341.52B
Merck & Co., Inc.
MRK
63.34
+0.13 (0.21%)
173.93B
Pfizer Inc.
PFE
34.16
-0.02 (-0.06%)
204.50B