Arena Pharmaceuticals Reports Positive Ralinepag Results, Shares Rise!

Arena reports successful primary efficacy analysis in Phase 2 trial of ralinepag

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Arena Pharmaceuticals (ARNA) announced Phase 2 results for ralinepag, an investigational, long-acting, orally administered prostacyclin receptor agonist under development for the treatment of pulmonary arterial hypertension, or #PAH.

In this 61-patient study, the primary efficacy analysis demonstrated a statistically significant absolute change from baseline in pulmonary vascular resistance compared to placebo.

#Ralinepag also demonstrated numerical improvement in 6-minute walk distance.

Ralinepag improved median PVR by 163.9 dyn.s.cm-5 from baseline compared to a 0.7 dyn.s.cm-5 worsening from baseline in the placebo arm. Patients treated with ralinepag had a 29.8% improvement in PVR compared to the placebo arm and a 20.1% improvement in PVR compared to baseline.

Additionally, adverse events observed in the study were consistent with other prostacyclin treatments for the management of PAH, with headache, nausea, diarrhea, jaw pain and flushing being the most commonly reported adverse events.

“The positive outcome of this Phase 2 trial in a contemporary PAH patient population is an important milestone in the development of ralinepag for the treatment of patients suffering from this grievous illness. It is exciting to see the positive nonclinical pharmacological profile translating into potentially the first oral prostacyclin therapy that may approach consistent therapeutic levels without the complexity of parenteral therapy. These data give us confidence to move expeditiously toward a Phase 3 clinical program,” said Preston Klassen, Chief Medical Officer of Arena.

ARNA closed at $18.39 on Monday, shares last traded at $25.50.

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Shares of bluebird bio Jump on ASCO Presentation

bluebird bio, and Celgene presented data on bb2121, their investigational anti-BCMA CAR T cell therapy for multiple myeloma

Leerink says bluebird bio’s bb2121 dose-escalation data in multiple myeloma is among the most impressive early data sets he’s seen

 

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American Society of Clinical Oncology’s #ASCO Annual Meeting is taking place June 2 to June 6 in Chicago. Several pharmaceutical firms and biotechnology companies are presenting their new drugs and/or present progress on the status of their drugs under development. bluebird bio $BLUE is one of the presenters.

#bluebird bio (BLUE) is a clinical-stage company developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies. The company’s objective is to develop and bring to market the most advanced products based on the transformative potential of gene therapy to provide patients hope for a better life in the face of limited or no long-term safe and effective treatment options.

bluebird bio, and Celgene Corporation (CELG) announced that updated results from the ongoing CRB-401 Phase 1 clinical study of bb2121, an investigational anti-BCMA CAR T cell therapy, in 18 patients with relapsed/refractory multiple myeloma were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

The objective of this Phase 1 dose-escalation study is to evaluate safety and efficacy of bb2121 and determine a recommended Phase 2 dose. bluebird bio and Celgene are jointly developing bb2121.

As of the May 4, 2017, 21 patients had been enrolled and dosed in four dose cohorts. All 21 dosed patients were evaluable for safety, and 18 patients have undergone their first multiple myeloma tumor restaging and were evaluable for efficacy. This study has enrolled patients at seven sites in the U.S., with an anticipated total enrollment of up to 50 patients.

Patients received a conditioning regimen of cyclophosphamide and fludarabine, followed by an infusion of bb2121 anti-BCMA CAR T cells. The CAR T cells were produced from each patient’s own blood cells, which were modified using a lentiviral vector encoding the anti-BCMA CAR.

“It is impressive to see objective responses in all patients treated at dose levels of 150 x 106 CAR+ T cells or higher in such a heavily pretreated population, including those with high tumor burden. We are encouraged by the duration and depth of responses, and pleased that the safety profile remains readily manageable,” said David Davidson, M.D., chief medical officer, bluebird bio.

Analysts Reaction

#BMO Capital upgraded bluebird bio to Outperform from Market Perform. Analyst Matthew Luchini says that a trial of the company’s bb2121 drug showed that its efficacy is “compelling,” while its safety is “generally clean.” Raised his price target to $108 from $83.

#SunTrust analyst Edward Nash says that the data for the Phase I trial of bluebird’s bb2121 in relapsed/refractory multiple myeloma.was “impressive.” He says that the drug’s efficacy was “robust,” while its safety appears to be “manageable.” The analyst keeps a $108 price target and Buy rating on the stock.

#Leerink analyst Michael Schmidt says bluebird bio’s (BLUE) bb2121 dose-escalation data in multiple myeloma is among the most impressive early data sets he’s seen in the #CAR-T space to date. The data sets a high bar for the competition, which includes #Juno Therapeutics (JUNO), #Kite Pharma (KITE) and #Novartis (NVS), Schmidt tells investors in a research note. Being one year ahead of the competition provides bluebird and Celgene (CELG) with an ideal position in multiple myeloma, the analyst adds. He keeps an Outperform rating on bluebird shares with a $100 price target.

Price Action

BLUE last traded at $102.92, up 13% on the day. It has a 52-week trading range of $36.62 – $104.90.

CELG last traded at $116.83, down one percent on the day.   It has a 52-week trading range of $94.42 – $127.64.

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The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

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