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TG Therapeutics ($TGTX) announced the results from an interim analysis of a Phase 3 clinical trial assessing the combination of TG-1101 (ublituximab) and TGR-1202 and each candidate alone in patients with chronic lymphocytic leukemia (CLL). The analysis showed the contribution of the combination has been established and is safe so recruitment in the single agent arms will cease. The analysis was conducted by the independent Data Safety Monitoring Board.
The company stock reacted positively to the news and jumped over 4 percent in its previous trading session, taking its Year to Date gains to 156 percent. The stock has also gained 55 percent in the past 12 months.

Merck & Co. Inc. ($MRK) announced receiving the FDA approval for the use of the KEYTRUDA (pembrolizumab) to treat adult and pediatric patients with unresectable or metastatic solid tumors that are have a genetic profile called microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This is the second FDA approval for KEYTRUDA (pembrolizumab) in a week. Earlier, the PD-1 inhibitor was approved for bladder cancer. The drug is now the first cancer drug ever approved by the USFDA based on a patients' specific genetic traits, regardless of where in the body the disease originated.
The company stock has shown strong performance this year as it gained over 9 percent so far. In the past 12 months, the company stock price has increased over 17 percent.

 

Aeglea BioTherapeutics ($AGLE) announced results from its Phase 1 clinical trial assessing the safety, tolerability and pharmacokinetics of lead product candidate AEB1102. The company said that the trial showed clinical proof of mechanism. It plans to start the study’s expansion phase in the fourth quarter of this year or in the first quarter of the next. It will feature three single-agent tumor arms.

Neurocrine Biosciences (NBIX) reported negative results from a Phase 2 clinical trial, T-Force Green, assessing its INGREZZA for treating Tourette syndrome. The results showed that the selected doses were sub-therapeutic for adequate tic reduction in the majority of pediatric subjects. The company said that the study showed that the INGREZZA dose needed for the pediatric population was underestimated.

Spring Bank Pharmaceuticals Inc. ($SBPH) announced top line results from a Phase 2a clinical trial, ACHIEVE, assessing its SB 9200 for the treatment of chronic hepatitis B virus (HBV) infection. The study showed no serious adverse events during the 12-week study.  Thus, the results showed an encouraging safety profile.

Veracyte ($VCYT) announced that the clinical validation studies of its  Envisia Genomic Classifier in enhancing the diagnosis of idiopathic pulmonary fibrosis showed positive results including its ability  to detect usual interstitial pneumonia (UIP), a pattern whose presence is necessary for the diagnosis of IPF. The results were generated from a 30-site study, BRAVE, involving 236 transbronchial biopsy samples from 49 patients.

 

ImmunoGen ($IMGN) announced divesting its antibody-drug conjugate candidate IMGN529/DEBIO 1562 to Swiss firm Debiopharm International SA. Under the terms of the agreement, the company will received upfront payment of $25 million. It will also be entitled to $5 million milestone after the technology transfer and a $25 million milestone triggered by the initiation of a Phase 3 clinical trial.

Immune Therapeutics ($IMUN) announced receiving the approval from Nigeria's drug regulator NAFDAC for its immune system regulator Lodonal for the treatment of HIV/AIDS.  The approval was given on the basis of data from a 90-day bridging study conducted there which showed treatment with Lodonal increased CD4 count 44% compared to 11% for standard of care.

 

FitLife Brands Inc. ($FTLF) announced 29 percent decline in its first quarter revenue to $5.6 million. The company reported its quarterly net loss at $0.3 million, down from net income of $0.8 million. On per share basis, the company incurred a loss of $0.03 per share, while its net income for the corresponding previous quarter stood at $0.07.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Barclays PLC
Downgrades
Momenta Pharmaceuticals (MNTA)
Overweight -> Equal Weight
$20.00 -> $17.00
High
Barclays PLC
Upgrades
Mylan (MYL)
Equal Weight -> Overweight
$47.00 -> $50.00
Low
BMO Capital Markets
Reiterates
Amgen (AMGN)
Buy
$198.00
Low
Canaccord Genuity
Set Price Target
Aerie Pharmaceuticals (AERI)
Buy
$56.00
Low
Canaccord Genuity
Reiterates
Alere (ALR)
Buy
$51.00
Low
Canaccord Genuity
Set Price Target
Celgene (CELG)
Buy
$156.00
Low
Canaccord Genuity
Set Price Target
Endo International plc - (ENDP)
Hold
$14.00
High
Canaccord Genuity
Set Price Target
Entellus Medical (ENTL)
Hold
$18.00
Low

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