Farmas USA

estan siendo buens los ER por ahora!

GILD

Gilead Sciences (GILD) '4997 Data 'Impressive & Underappreciated', KOL Suggests - Jefferies; PT to $95
Jefferies analyst Brian Abrahams reiterated a Buy rating and bumped his price target on Gilead Sciences (NASDAQ: GILD) to $95.00 (from $93.00) as KOL feedback suggests '4997 data, while limited, was impressive and underappreciated.
Abrahams commented, "Following discussions with a NASH KOL, we believe the Street underappreciated the impressiveness of last week's ph.II '4997 data. While we acknowledge small pt numbers remain a meaningful limitation, given our feedback we believe it is appropriate to incorporate prob-adjusted out-year revs, which raises our PT by $2 to $95. We continue to believe HCV declines are baked in, and GILD shares do not reflect HIV stability and potential pipeline upside"

MERK

Merck (MRK) Tops Q3 EPS by 8c; Narrows FY16 Outlook
Merck (NYSE: MRK) reported Q3 EPS of $1.07, $0.08 better than the analyst estimate of $0.99. Revenue for the quarter came in at $10.5 billion versus the consensus estimate of $10.18 billion.
Pipeline Highlights
Merck significantly advanced the clinical development program for KEYTRUDA (pembrolizumab), an anti-PD-1 therapy. KEYTRUDA is now approved in the United States for the treatment of previously untreated metastatic NSCLC in patients whose tumors express high levels of PD-L1 (TPS of 50 percent or more) and previously treated metastatic NSCLC in patients whose tumors express PD-L1 (TPS of 1 percent or more), as well as advanced melanoma and previously treated recurrent or metastatic head and neck cancer (HNSCC). Earlier this month at the European Society for Medical Oncology (ESMO) 2016 Congress, data were presented from 30 studies evaluating the use of KEYTRUDA as a monotherapy and in combination in 23 cancers.
Lung Cancer
Yesterday the U.S. Food and Drug Administration (FDA) approved two supplemental Biologics License Applications (sBLA) for KEYTRUDA in lung cancer.
Based on the KEYNOTE-024 study, KEYTRUDA was approved for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (TPS of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. The data from KEYNOTE-024 were published in The New England Journal of Medicine and highlighted at ESMO.
The FDA also approved a sBLA to include data from the pivotal KEYNOTE-010 study in which KEYTRUDA showed superior overall survival compared to chemotherapy in patients with previously treated advanced NSCLC whose tumors express PD-L1 (TPS of 1 percent or more) as determined by an FDA-approved test.
Data were presented at ESMO from KEYNOTE-021, Cohort G, showing superior efficacy of KEYTRUDA plus chemotherapy compared to chemotherapy alone as a first-line treatment for patients with metastatic non-squamous NSCLC regardless of PD-L1 expression. These data were simultaneously published in The Lancet Oncology.
The European Commission approved KEYTRUDA for the treatment of locally advanced or metastatic NSCLC in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.
Head and Neck Cancer
The FDA approved a sBLA for KEYTRUDA for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
Bladder Cancer
On Friday the company announced that the KEYNOTE-045 trial investigating the use of KEYTRUDA in patients with previously treated advanced bladder cancer (urothelial cancer) met its primary endpoint. In the study, KEYTRUDA met the primary endpoint of overall survival and was superior compared to investigator choice chemotherapy.
Interim Phase 2 data were presented at ESMO for the first time investigating the use of KEYTRUDA in previously untreated patients with advanced bladder cancer.
GUIDANCE:
Merck sees FY2016 EPS of $3.71-$3.78, versus the consensus of $3.75. Merck sees FY2016 revenue of $39.7-40.2 billion, versus the consensus of $39.78 billion.

Vaya tela... Y yo que dije el otro día que offering antes de acabar el año y sueltan deuda al 10%...madre mía. Esto ya es un todo o nada. Ya no hay ni fondos dispuestos a comprar un solo cromo más. Si no hay aprobación de Heplisav a parte de hundirse la cotización (lógico) veo difícil su subsistencia a medio plazo.

DVAX

Pues por 32$ antes de la aprobación de la FDA, pero venía de los 23$ cuando se aprobó el ADCOM un mes antes

ACAD

TGTX

TG Therapeutics, Inc. Announces Publication in Blood Describing a Novel Complimentary Mechanism of the PI3K-delta Inhibitor, TGR-1202

http://finance.yahoo.com/news/tg-therapeutics-inc-announces-publication-113000095.html

TIG

TiGenix provides update on proposed initial public offering in the United States

The number and price of the ADSs to be offered will be determined if and when the initial public offering is launched.

BofA Merrill Lynch and Cowen and Company are acting as joint book-running managers for the proposed offering. Canaccord Genuity Inc. is acting as lead manager and BTIG, LLC is acting as co-manager.

http://finance.yahoo.com/news/tigenix-provides-proposed-initial-public-210827377.html

OMER

Suma y sigue con su deuda. Ahora crédito de 125M...

Omeros Announces $125 Million New Credit Facility
http://investor.omeros.com/phoenix.zhtml?c=219263&p=irol-newsArticle_Print&ID=2216459