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Roche ($RHHBY) announced receiving the FDA approval for its TECENTRIQ (atezolizumab). The approval was given under the agency’s Priority Review process. TECENTRIQ (atezolizumab) is designed for treating  patients with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin chemotherapy. The treatment is already for treating  patients with locally advanced or mUIC whose cancer has progressed during or following any platinum-containing chemotherapy or within 12 months of receiving chemo before or after surgery and for treating a type of metastatic lung cancer.
Roche stock is currently trading 11 percent up on Year to Date basis while its 12 months loss stands at 1 percent.

Ultragenyx Pharmaceutical Inc. ($RARE) stock shot up as the company announced positive results from a phase 3 study of a drug to treat x-linked hypophosphatemia, a genetic kidney disorder.  The results demonstrated a statistically significant improvement in serum phosphorus levels, with 94% of patients achieving normal levels compared to 8% on placebo. The company had conducted the study in collaboration with Japan's Kyowa Hakko Kirin Co.
Ultragenyx aims to hold discussions with regulatory agencies in the U.S. and Europe for next steps. The stock gained over 14 percent in the after-hours trading, wiping down its 12 months losses to 15 percent.

 

Pulse Biosciences ($PLSE) has decided to  immediately and irrevocably waived the lock-up provisions for pre-IPO stockholders. These stockholders have nearly 3.9 million shares of common stock. The news have been given by MDB Capital Group,  the underwriter of the IPO. The stockholders  would have been subject to the lock-up until May 17 under the terms of the existing lock-up agreements.

Amedica ($AMED) announced its decision to restate its financial statements for the third quarter of 2016 and the nine-month period ending September 30, 2016. The company said that it failed to  record a one-time cash charge of $3.779M for the dividend related to the accretion of a discount on conversion of Series A Preferred Stock. The adjustment will increase the net loss for third quarter and the nine-month period to $10.616 million and $19.068 million, respectively. It will also increase the loss per share to $0.46 and $1.21, respectively.

Vical ($VICL) announced hitting the enrollment target for its Phase 2 clinical trial  assessing the safety and efficacy of its therapeutic bivalent vaccine for herpes simplex virus type 2 (HSV-2). The enrollment target for the study is 225 subjects. The primary endpoint is the reduction in annualized lesion recurrence rate up to day 450. 

CytRx ($CYTR) reported that  the FDA has agreed to its plan to submit a rolling New Drug Application (NDA) under the abbreviated 505(b)(2) pathway seeking approval of aldoxorubicin for the treatment of soft tissue sarcoma. The company says it expects to complete the filing in the fourth quarter.

 

Nivalis Therapeutics ($NVLS) announced its plan to merge with Alpine Immune Sciences. The deal is on all-stock basis. Nivalis had failed its cystic fibrosis drug clinical trial in January this year. The merger is expected to be completed in the third quarter. The combined entity will be known as Alpine Immune Sciences and will focus on developing protein-based immunotherapy drugs.

Interpace Diagnostics ($IDXG) reported that prominent insurer UnitedHealth will now cover its ThyraMIR test as an aid in evaluating indeterminate thyroid nodule fine needle aspirate biopsies. The decision will help increasing the coverage universe for the test.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Cann
Reiterates
Agios Pharmaceuticals (AGIO)
Buy
$75.00
Low
FBR & Co
Lowers Target
Argos Therapeutics (ARGS)
Mkt Perform
$2.00 -> $1.20
Low
Jefferies Group LLC
Reiterates
AveXis (AVXS)
Buy
$92.00
Low
William Blair
Downgrades
Cardinal Health (CAH)
Outperform -> Market Perform

Low
Jefferies Group LLC
Reiterates
Centene Corp (CNC)
Buy
$79.00
Low
Barclays PLC
Reiterates
Intuitive Surgical (ISRG)
Buy
$830.00
Low
Wedbush
Raises Target
Intuitive Surgical (ISRG)
Outperform
$800.00 -> $835.00
Low
BTIG Research
Reiterates
Johnson & Johnson (JNJ)
Hold

Low
Wedbush
Downgrades
Ultragenyx Pharmaceutical (RARE)
Outperform -> Neutral
$80.00 -> $75.00
Low
HC Wainwright
Downgrades
Ultragenyx Pharmaceutical (RARE)
Buy -> Neutral
$88.00 -> $72.00
Low
Jefferies Group LLC
Reiterates
WellCare Health Plans (WCG)
Hold
$142.00
Low

Gainers (% price change) Last Trade Change Mkt Cap
Cytokinetics, Inc. CYTK 12.95 +1.20 (10.21%) 567.22M
Rockwell Medical Inc RMTI 7.00 +0.39 (5.90%) 392.78M
Immunomedics, Inc. IMMU 6.37 +0.31 (5.12%) 688.22M
Vanda Pharmaceuticals Inc VNDA 14.40 +0.55 (3.97%) 634.01M
Rigel Pharmaceuticals RIGL 3.29 +0.12 (3.79%) 410.09M
Losers (% price change)
Cleveland BioLabs, Inc. CBLI 3.49 -1.31 (-27.29%) 117.99M
Infinity Pharmaceuticals INFI 2.00 -0.19 (-8.68%) 120.04M
Synergy Pharmaceuticals SGYP 4.17 -0.25 (-5.66%) 903.81M
Valeant Pharmaceuticals VRX 8.95 -0.53 (-5.54%) 3.06B
China Cord Blood Corp CO 7.50 -0.40 (-5.06%) 621.79M
Most Actives (dollar volume)
Johnson & Johnson JNJ 121.82 -3.90 (-3.10%) 329.16B
UnitedHealth Group Inc UNH 168.59 +1.41 (0.84%) 164.77B
Pfizer Inc. PFE 33.84 -0.16 (-0.47%) 202.24B
McKesson Corporation MCK 137.60 -6.62 (-4.59%) 29.39B
Eli Lilly and Co LLY 81.20 -1.18 (-1.43%) 85.94B