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Merck ($MRK) announced receiving the FDA approval for its  PD-1 inhibitor KEYTRUDA (pembrolizumab) to treat adult and pediatric patients with refractory classical Hodgkin lymphoma or who have relapsed after three or more prior lines of therapy. The FDA granted the approval based on the results of the KEYNOTE-087 study that showed most of these patients responded to treatment with KEYTRUDA, with 22% complete responders.
The company stock has gained over 20 percent in the past 12 months while it gained 9 percent this year so far. Keytruda is already approved for the treatment of lung, head and neck cancers, among others. It won the approval under the FDA's accelerated program which allows for quicker approval of drugs that fill an unmet medical need.

AstraZeneca ($AZN) reported the results from a Phase 3 clinical trial, SOLO-2 testing the company’s PARP inhibitor Lynparza (olaparib) as maintenance therapy in ovarian cancer showed a pronounced extension in survival compared to placebo.  The study met its primary endpoint of a statistically significant improvement in progression-free survival (PFS) versus placebo.  The Lynparza cohort also demonstrated a statistically significant benefit in time to second progression or death (p=0.0002) (hazard ratio = 0.50) (median not reached vs. 18.4 months).

AstraZeneca now plans to work with regulators to make the tablet formulation available to patients as soon as feasible as tablets will reduce the pill burden to four/day from 16/day. The company stock has shown 2 percent gain in the past 12 months while its Year to Date gain stands at 10 percent.

 

Gelectin Therapeutics ($GALT) reported encouraging early results from a small, open-label, investigator-initiated study of GR-MD-02 in three patients with severe and refractory atopic dermatitis (AD). All three patients responded to therapy, with two achieving 64% and 74% reductions, respectively, in a measure of AD symptoms called EASI score.

Alere ($ALR) reported that it will be unable to file its annual report by the extended filing date of March 16th. The company had received the extension period when it filed a Form 12b-25 with the SEC on March 1. The company added that it requires more time to review certain aspects of revenue recognition at its Korean and Japanese locations, including "inappropriate conduct" at South Korean subsidiary Standard Diagnostics.

AbbVie ($ABBV) reported that its marketing application seeking approval of glecaprevir/pibrentasvir (G/P) for the treatment of hepatitis C virus (HCV) infection has been given Priority Review designation by the Japanese Ministry of Health, Labour and Welfare. The company's marketing applications in the U.S. and EU are also being reviewed under accelerated status.

Teleflex ($TFX) reported that its Twin-Pass Dual Access Catheter which is designed for procedures that require the delivery of two interventional guidewires from a single catheter, has received 501(k) clearance from the FDA. The device is used for accessing discreet regions of the coronary and/or peripheral vasculature.

 
Cardiome Pharma ($CRME) reported that it has received a Notice of Compliance for BRINAVESS (vernakalant hydrochloride, IV) from Health Canada, enabling the company to begin commercializing the product there. The product is meant for the rapid conversion of recent-onset atrial fibrillation to sinus rhythm in certain patients.

Biocept ($BIOC) announced its new collaboration with Catalyst Pharmaceuticals ($CPRX). Under this deal, Biocept will provide its Target Selector platform to screen participants in a Phase 3 study assessing Firdapse (amifampridine phosphate) in patients with Eaton Myasthenic Syndrome (LEMS).

 

Clearside Biomedical Inc. ($CLSD) reported its quarterly and annual results. The company’s net loss for the fourth quarter of 2016 was $9.7 million, or $0.45 per share of common stock, compared to $5.2 million, or $1.95 per share of common stock, for the fourth quarter of 2015. Clearside Biomedical’s net loss for the year ended December 31, 2016 was $25.9 million, or $1.97 per share of common stock, compared to $17.6 million for the year ended December 31, 2015, or $7.54 per share of common stock.

Albireo Pharma Inc. ($ALBO)  reported a net loss of $16.3 million for the year ended December 31, 2016, compared with a net loss of $6.8 million for 2015. For the year ended December 31, 2016, the company’s revenue totaled $11.4 million compared with $5.1 million for 2015, an increase of $6.3 million. Based on current operating plans, Albireo expects that its current cash resources will be sufficient to meet its operating requirements at least through mid 2018. 

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Rodman & Renshaw
Initiates
Applied Genetic Technologies Corp (AGTC)
Buy -> Buy
$16.00
Low
Stephens
Downgrades
Air Methods Corp (AIRM)
Overweight -> Equal Weight

Low
Stifel Nicolaus
Raises Target
Achaogen (AKAO)
Buy -> Buy
$27.00 -> $28.00
High
Aegis
Reiterates
Achaogen (AKAO)
Buy
$39.00
Low
Cann
Reiterates
Amgen (AMGN)
Outperform -> Positive
$189.00
Low
Chardan Capital
Lowers Target
Aralez Pharmaceuticals (ARLZ)
Buy -> Buy
$10.00 -> $5.50
Medium
Cowen and Company
Reiterates
BioMarin Pharmaceutical (BMRN)
Outperform
$150.00
Low
HC Wainwright
Reiterates
Celldex Therapeutics (CLDX)
Buy

Low
Jefferies Group LLC
Lowers Target
Celldex Therapeutics (CLDX)

$4.00
Low
Goldman Sachs Group
Raises Target
Clovis Oncology (CLVS)

$75.00
High
JPMorgan Chase & Co.
Reiterates
Clovis Oncology (CLVS)
Hold

High

Gainers (% price change)
Last Trade
Change
Mkt Cap
Clovis Oncology Inc
CLVS
66.95
+6.35 (10.48%)
2.90B
Orthofix International NV
OFIX
38.37
+3.45 (9.88%)
688.41M
Antares Pharma Inc
ATRS
2.59
+0.10 (4.02%)
409.91M
Air Methods Corp
AIRM
43.00
+1.60 (3.86%)
1.55B
BioDelivery Sciences Intl
BDSI
2.08
+0.08 (3.75%)
112.29M
Losers (% price change)

Valeant Pharmaceuticals
VRX
10.89
-1.22 (-10.07%)
3.66B
Trinity Biotech plc (ADR)
TRIB
5.31
-0.47 (-8.13%)
129.24M
Corcept Therapeutics Inc.
CORT
9.93
-0.84 (-7.80%)
1.11B
Rockwell Medical Inc
RMTI
5.49
-0.43 (-7.26%)
285.30M
Endocyte, Inc.
ECYT
2.43
-0.19 (-7.25%)
102.71M
Most Actives (dollar volume)

Johnson & Johnson
JNJ
127.05
+0.37 (0.29%)
344.73B
Valeant Pharmaceuticals
VRX
10.89
-1.22 (-10.07%)
3.66B
Bristol-Myers Squibb Co
BMY
56.69
-0.26 (-0.46%)
92.57B
Merck & Co., Inc.
MRK
64.20
+0.05 (0.08%)
172.37B
Pfizer Inc.
PFE
34.22
+0.11 (0.32%)
203.67B