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Shire Plc. ($SHPG) announced that its drug candidate SHP655 has been designated for Fast Track Review by the FDA. The drug is under trial for treating acute episodes of hereditary thrombotic thrombocytopenic purpura in patients with a deficiency in an enzyme called ADAMTS13. Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
The new development is expected to provide some fillip to the stock price which has appreciated 3 percent in the past 12 months. Recently, the company’s Cinryze had received label extension approval from the European Commission. The drug is now indicating for three new conditions, expanding its  coverage to treat children with hereditary angioedema.

Moleculin Biotech Inc. ($MBRX) stock jumped up as the company announced that its Annamycin drug candidate has recevied an Orphan Drug for the treatment of relapsed/refractory acute myeloid leukemia (AML). The designation will offer various benefits for the company. Among such benefits is the one that will provide a seven-year period of market exclusivity to the drug for the indication, if it is approved.

The FDA grants this designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S.  Apart from market exclusivity, it also leads to other benefits such as tax credits and exemptions from some FDA fees. The company stock jumped over 14 percent on this news. The company stock had lost over 85 percent of its value in past 12 months.

 

Actinium Pharmaceuticals ($ATNM) announced that  has received positive guidance (Scientific Advice) from the European Medicines Agency (EMA) regarding its late-stage trial design and statistical analysis plan for lead product candidate Iomab-B in acute myeloid leukemia. If approved, Iomab-B will be used as an induction and conditioning agent prior to bone marrow transplant in patients with relapsed/refractory AML who are at least 55 years old.

Asterias Biotherapeutics ($AST) announced update for its SciStar Phase 1/2a clinical trial assessing the 10M-cell dose of AST-OPC1 (oligodendrocyte progenitor cells) in patients with sub-acute C-5 to C-7 cervical spinal cord injury (SCI). The data on the sixth and final patient in the AIS-A (complete injury, no motor function below the injury site) 10M cell cohort showed upper extremity motor function improvement at month 3 and further improvement in month 6. 

Mylan ($MYL) annoucend receiving tentative FDA approval for its Efavirenz, Lamivudine and Tenofovir Disproxil Fumarate Tablets, 400 mg/300 mg/300 mg, abbreviated as TLE40, for the first-line treatment of HIV-1 infection. The tentative approval is under the President’s Emergency Plan for AIDS Relief. The dose of efavirenz is 400 mg, lower than  600 mg dose in Bristol-Myers Squibb's  Sustiva.

Pulmatrix ($PULM) announced that it has been awarded a new patent in he EU covering its drug delivery technology and its use in treating a range of diseases. The patent is similar to those already in place in the U.S. and Japan. The company’s new technology makes the delivery of dry powders more efficient.

 

Galapagos NV ($GLPG) announced that it has initiated a Phase 1 study of cystic fibrosis (CF) candidate GLPG3067. The event has triggered a $7.5 million milestone payment from collaboration partner AbbVie. The companies are working on combination therapy for CF that addresses three complementary components. The single center study will assess GLPG3067's safety, tolerability and pharmacokinetics in 48 healthy volunteers in Belgium.

Varex Imaging ($VREX) announced inking a new deal with Toshiba Medical Systems. This three year pricing agreement pertains to its computed tomography (CT) tubes for integration into Toshiba's CT systems.  The companies expects total three sales to be in the range of $345 million and $385 million. The new deal will come into effect on April 1.

 

Neogen Corporation ($NEOG) reported that its net income for the third quarter of fiscal 2017, which ended Feb. 28, increased 24% to $10.28 million, compared to the prior year's $8.3 million. Its revenue for the third quarter of fiscal 2017 increased 15% to $88.38 million from the previous year's third quarter revenues of $76.72 million. The third quarter was the 100th of the past 105 quarters that Neogen reported revenue increases as compared with the previous year — including all consecutive quarters in the last 11 years.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
BMO Capital Markets
Reiterates
AbbVie (ABBV)
Hold
$63.00
Low
Piper Jaffray Companies
Reiterates
Aimmune Therapeutics (AIMT)
Overweight

Low
FBR & Co
Raises Target
Aurinia Pharmaceuticals (AUPH)
Outperform -> Outperform
$9.00 -> $11.00
Low
JMP Securities
Initiates
Blueprint Medicines Corp (BPMC)
Outperform
$46.00
Low
Maxim Group
Reiterates
Cytosorbents Corp (CTSO)
Buy
$10.00
N/A
JMP Securities
Initiates
Fortress Biotech (FBIO)
Outperform

Low
Barclays PLC
Reiterates
Gilead Sciences (GILD)
Buy
$90.00
Low
Jefferies Group LLC
Reiterates
Gilead Sciences (GILD)
Buy

Low
Chardan Capital
Raises Target
Healthequity (HQY)
Buy -> Buy
$53.00
Low

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