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Mesoblast Limited ($MESO) reported that the United States Food and Drug Administration (FDA) has granted a Fast Track designation for the use of its cell therapy, MSC-100-IV. The treatment is designed to achieve improved overall response rate in children with steroid refractory acute Graft Versus Host Disease (aGVHD). The designation helps in shortening the time to FDA approval through priority review. It also helps in streamlining rolling review process.
The company stock has gained 25 percent this year so far while its 12 months loss stands at 26 percent. The stock is expected to keep up its upward trajectory on the back of its latest achievement.

Galectin Therapeutics Inc. ($GALT) reported results from an exploratory, Phase 2a clinical trial with GR-MD-02 in patients with moderate-to-severe plaque psoriasis.  The trial did not show any serious adverse events. It also achieved an average PASI (Psoriasis Area and Severity Index) reduction of over 50% in all patients that participated in the 24-week trial.
The company stock is expected to react positively to the news and likely will add to its current Year to date gain of over 78 percent. Its 12 months gain stands at 22 percent. Peter G. Traber, M.D., president, chief executive officer and chief medical officer, Galectin Therapeutics said that the trial results demonstrated the ‘safety and efficacy of GR-MD-02 in patients with moderate to severe plaque psoriasis.’

 

Valeant Pharmaceuticals ($VRX) announced that it has paid down its secured senior loans worth nearly $1.1 billion. The company paid down the loans following the successful closure of the skincare products asset sale on March 3, 2017. Valeant is seeking to refinance and amend the Company's existing credit agreement (the "Credit Agreement"), borrow new Term B loans under the Credit Agreement and issue new secured debt securities.
PTC Therapeutics ($PTCT) reported that the U.S. Food and Drug Administration (FDA) has acknowledged the filing over protest of PTC's New Drug Application (NDA) for Translarna™. It is an  oral, first-in-class, protein restoration therapy for the treatment of nonsense mutation Duchenne muscular dystrophy. The company is looking for approval for marketing the drug for the treatment of nmDMD patients in the United States. The drug is already available in more than 25 countries.

ImmunoCellular Therapeutics ($IMUC) announced that it has received the FDA approval for modifying the  the protocol in its Phase 3 clinical trial assessing lead product candidate ICT-107 in newly diagnosed glioblastoma. Under the changed protocol, the patients may be randomized 30 days after the start of screening procedures. This will help in accelerating the time to randomization by nearly two months.
Advaxis ($ADXS) announced that it has received the FDA approval for its cancer immunotherapy drug ADXS-NEO to proceed to clinical trial. The company is developing the drug in collaboration with Amgen. Advaxis said it plans to start a phase 1 trial for the drug in multiple tumor types later this year. This is the second drug of its kind an Investigational New Drug application accepted by the FDA.

 

Celgene Corporation ($CELG) reported results from its phase 4 UNVEIL trial evaluating OTEZLA®. The drug is designed to treat patients with moderate plaque psoriasis with a body surface area of 5-10 percent. The UNVEIL study evaluated the clinical efficacy and safety of oral OTEZLA 30 mg twice daily compared with placebo at week 16 in 221 patients with moderate plaque psoriasis. The primary endpoint was the mean percentage change from baseline in the product of PGA and BSA (PGA×BSA) at week 16. At week 16, patients who received OTEZLA had a significantly greater improvement in mean percentage change from baseline in PGA×BSA compared with those who received placebo.

 

Recro Pharma Inc. ($REPH) reported its quarterly results. The company’s annual revenue stood at $69.3 million, surpassing its own guidance. During the year, Recro completed an underwritten public offering of 6.67 million shares of its common stock at a price of $6.00 per share. The company also reported positive data from the second of two pivotal Phase III efficacy trials of IV meloxicam. 
EnteroMedics Inc. ($ETRM) announced its fourth quarter and full year results. The company reported that it had revenue of $141,900 during the quarter while its net loss per share stood at $2.65. The company also incurred $4.2 million in operating expenses. For the full year, EnteroMedics generated $787,000 in revenue while its net loss was reported at $37.53 per share.

Brokerage
Action
Company
Rating
Price Target
Jefferies Group LLC
Reiterates
AbbVie (ABBV)
Buy

Robert W. Baird
Reiterates
Biogen (BIIB)
Neutral

Rodman & Renshaw
Initiates
Fibrocell Science (FCSC)
Buy
$2.00
BMO Capital Markets
Lowers Target
Ionis Pharmaceuticals (IONS)

$59.00
Cowen and Company
Reiterates
Kite Pharma (KITE)
Outperform

Needham & Company LLC
Reiterates
K2M Group Holdings (KTWO)
Buy
$29.00
Citigroup
Raises Target
Lexicon Pharmaceuticals (LXRX)

$28.00
Piper Jaffray Companies
Reiterates
Neurocrine Biosciences (NBIX)
Outperform

Citigroup
Downgrades
Neuroderm Ltd (NDRM)
Outperform -> Market Perform

Jefferies Group LLC
Reiterates
Ra Pharmaceuticals (RARX)
Buy -> In-Line

BMO Capital Markets
Raises Target
Ra Pharmaceuticals (RARX)
Positive
$31.00
Cantor Fitzgerald
Reiterates
Supernus Pharmaceuticals (SUPN)
Overweight
$31.00
Langenberg & Company
Raises Target
TG Therapeutics (TGTX)
Positive
$30.00
BMO Capital Markets
Reiterates
Vertex Pharmaceuticals Incorporated (VRTX)
Market Perform
$78.00
Deutsche Bank AG
Lowers Target
Valeant Pharmaceuticals Intl (VRX)

$19.00

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