Join Now - it is FREE

Basic level includes our interactive biotech chatroom, forum, biotech stock screener; you also receive the biotech digest in your email everyday.

Pain Therapeutics Inc. ($PTIE) stock jumped over 55 percent in the pre-market session as the company announced receiving the FDA feedback regarding  the additional studies needed to refile its New Drug Application seeking approval of abuse-deterrent REMOXY ER (extended-release oxycodone capsules CII). The update followed a meeting between Pain Therapeutics and the FDA held on February 13, 2017. Both the parties had reached an agreement on the requirements for additional assessment for Remoxy’s approval. 
Pain Therapeutics will conduct the studies to fulfill dual requirements including an assessment of clinical abuse potential via the intranasal route of abuse, and an assessment of a non-clinical abuse potential using household solvents. The company stock has gained 19 percent this year so far.

Loxo Oncology Inc. ($LOXO) announced its new collaboration with Ventana Medical Systems, Inc., a member of the Roche Group. The collaboration pertains to the development and commercialization of a pan-TRK immunohistochemistry (IHC) test as a companion diagnostic to identify patients across tumor types suitable for treatment with larotrectinib.
Both the parties plan to utilize an investigational assay piloted by Loxo Oncology that will be further developed by Roche using its flagship OptiView DAB detection technology.  Loxo stock has gained over 43 percent this year so far and its 12 months gain stands at 115 percent. It is currently trading close to its 52 weeks high of $47.46.

 

Jazz Pharmaceuticals ($JAZZ) announced that it has received positive results from two Phase 3 trials assessing Orphan Drug-tagged JZP-110, a selective dopamine and norepinephrine reuptake inhibitor, for the treatment of excessive sleepiness in adults with obstructive sleep apnea. Both studies, TONES 3 and TONES 4, met their co-primary endpoints. The company plans to file an NDA in the fourth quarter.

Cerulean Pharma ($CERU) announced selling certain assets for $7.5 million in conjunction with a stock purchase deal with Daré Bioscience, making Dare the majority stakeholder in the firm. Cerulean has also inked a deal with NewLink Genetics subsidiary BlueLink Pharmaceuticals for the sale of product candidates CRLX101 and CRLX301 for $1.5 million. It signed another agreement with Novartis for the sale of all rights to its Dynamic Tumor Targeting Platform for $6 million, subject to Cerulean shareholder’s approval.

Esperion Therapeutics ($ESPR) reported that the FDA has confirmed that the design of its Phase 3 program developing bempedoic acid for lowering low density lipoprotein cholesterol (LDL-C) is sufficient to support approval. Three Phase 3 studies (Study 2, Study 3, Study 4) specific to LDL-C lowering are currently recruiting patients. The company plans to  submit a New Drug Application by the first half of 2019.

Allergan ($AGN) reported receiving the FDA approval for JUVEDERM VOLLURE XC for the correction of moderate-to-severe facial wrinkles and folds in adults at least 21 years old. It is formulated with the company’s proprietary VYCROSS technology that gives the gel extended duration. The company plans to release the product in the markets next month.

 

Nektar Therapeutics ($NKTR) announced positive results from a Phase 3 clinical trial, SUMMIT-07, evaluating opioid analgesic candidate NKTR-181 for the treatment of patients with chronic low back pain. The trial met its primary endpoint of showing statistically valid improved pain relief compared to placebo. The study also met its secondary endpoints.

Blueprint Medicine ($BPMC) reported that the it has dosed the first patient has been dosed for its Phase 1 clinical trial for assessing  BLU-667 for the treatment of non-small cell lung cancer, medullary thyroid cancer and other solid tumors. The co-primary endpoints are safety-related and the estimated final data collection date for the primary outcome measures is March 2021. The estimated study completion date is March 2023.

 

Tenax Therapeutics Inc. ($TENX) reported a net loss of $44.0 million, or $(1.56) per share, for the year ended December 31, 2016, compared to a net loss of $15.9 million, or $(0.57) per share, for the prior year. As of December 31, 2016, the Company had $21.9 million in cash, including the fair value of its marketable securities, compared to $38.2 million at December 31, 2015.

Novan inc. ($NOVN) reported total operating expenses for the three months ended Dec. 31, 2016, at approximately $13.1 million, up from $10.1 million it had incurred for the corresponding quarter of the previous year. The total operating expenses for the twelve months ended Dec. 31, 2016, were approximately $59.8 million.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
HC Wainwright
Reiterates
Catabasis Pharmaceuticals (CATB)
Buy
$8.00
Low
Jefferies Group LLC
Downgrades
Medgenics (GNMX)
Buy -> Hold
$2.50
Low
Credit Suisse Group AG
Reiterates
Eli Lilly and Co (LLY)
Buy

Low
First Analysis
Initiates
LeMaitre Vascular (LMAT)
Overweight
$29.00
Low
Robert W. Baird
Downgrades
MEDNAX (MD)
Outperform -> Neutral
$72.00
Low
Barclays PLC
Initiates
Molina Healthcare (MOH)
Equal Weight
$51.00
Low
BMO Capital Markets
Reiterates
Merck & Co. (MRK)
Buy
$70.00
Low
Citigroup
Downgrades
Merus NV (MRUS)
Buy -> Neutral
$31.00
Low
Jefferies Group LLC
Raises Target
Nektar Therapeutics (NKTR)
Positive
$25.00
Low
Barclays PLC
Reiterates
Pacira Pharmaceuticals (PCRX)
Overweight
$59.00
Low
BMO Capital Markets
Reiterates
Pfizer (PFE)
Hold
$33.00
Low
Northcoast Research
Upgrades
Wright Medical Group (WMGI)
Neutral -> Buy

N/A

Gainers (% price change) Last Trade Change Mkt Cap
Nektar Therapeutics NKTR 22.21 +6.71 (43.29%) 3.37B
Omeros Corporation OMER 11.75 +1.21 (11.48%) 467.86M
Idera Pharmaceuticals Inc IDRA 2.23 +0.17 (8.25%) 344.17M
Alnylam Pharmaceuticals ALNY 59.71 +4.46 (8.07%) 5.21B
Keryx Biopharmaceuticals KERX 6.29 +0.46 (7.89%) 713.97M
Losers (% price change)
Vermillion, Inc. VRML 2.14 -0.19 (-8.15%) 118.46M
Infinity Pharmaceuticals INFI 3.36 -0.19 (-5.35%) 185.07M
Community Health Systems CYH 8.91 -0.43 (-4.60%) 1.01B
Addus Homecare Corp. ADUS 31.95 -1.35 (-4.05%) 366.72M
Accuray Incorporated ARAY 4.85 -0.20 (-3.96%) 406.07M
Most Actives (dollar volume)
Amgen, Inc. AMGN 169.21 +0.60 (0.35%) 116.66B
Merck & Co., Inc. MRK 64.11 +0.21 (0.33%) 175.25B
Johnson & Johnson JNJ 128.07 +0.01 (0.01%) 346.10B
UnitedHealth Group Inc UNH 168.00 -1.70 (-1.00%) 158.30B
Pfizer Inc. PFE 34.38 +0.06 (0.17%) 204.08B