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Wired News – Bioverativ Doses First Patient in Phase-3 Study of BIVV009 for Treatment of Cold Agglutinin Disease

Stock Monitor: Alder Biopharma Post Earnings Reporting

LONDON, UK / ACCESSWIRE / March 08, 2018 / has just released a free research report on Bioverativ Inc. (NASDAQ: BIVV). If you want access to this report all you need to do is sign up now by clicking the following link as the Company's latest news hit the wire. On March 06, 2018, the Company, which is a global biopharmaceutical organization that works towards transforming the lives of people with hemophilia and other rare blood disorders, declared that the first patient has been dosed in the Phase-3 clinical program of its investigational therapy BIVV009 for the treatment of cold agglutinin disease (CAgD). The Phase-3 trial comprises two parallel Phase-3 studies, Cardinal and Cadenza, for assessing the efficacy and safety of BIVV009 in adult patients suffering with primary CAgD. Register today and get access to over 1000 Free Research Reports by joining our site below: is currently working on the research report for Alder Biopharmaceuticals, Inc. (NASDAQ: ALDR), which also belongs to the Healthcare sector as the Company Bioverativ. Do not miss out and become a member today for free to access this upcoming report at: is focused on giving you timely information and the inside line on companies that matter to you. This morning, Bioverativ most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

CAgD, A Disease With No Approved Therapies

CAgD is a severe blood disease in which the complement system, which is a part of the body's immune system, erroneously attacks the person's own red blood cells. This premature destruction of red blood cells is called hemolysis. This medical condition is characterized by chronic anemia, severe fatigue, and an increased risk of life-threatening thromboembolic (TE) events such as stroke, pulmonary embolism, and heart attack.

This condition currently affects approximately 10,000 people in the United States and Europe. The recent CAgD Optum study, which was the largest retrospective study of CAgD, demonstrated that CAgD patients had a 55% overall increased rate of TE events compared to matched controls (31% vs. 20% p<0.0001). Besides, CAgD patients also had a statistically significant higher frequency of multiple TE events. However, at present, there are no approved therapies for CAgD.

About BIVV009

BIVV009 is a first-in-class, humanized, monoclonal antibody that has been specifically designed to block C1s, which is a serine protease within the C1-complex. BIVV009 activates the classical complement pathway, which is the central mechanism responsible for the development of hemolytic anemia, and thus directly stops the CAgD disease process.

The US Food and Drug Administration (FDA) awarded the Breakthrough Therapy Designation and the Orphan Drug Designation to BIVV009 in May 2007. These designations recognize the potential of novel drugs and biologics, and would help expedite the development and regulatory review of BIVV009.

About the Cardinal and Cadenza Trials

The Cardinal trial is an open-label, single-arm study that intends to assess the safety and efficacy of BIVV009 in 20 adult patients with primary CAgD, who have had at least one recent blood transfusion. The first patient has been dosed in the Cardinal trial.

On the other hand, the Cadenza trial is a randomized, double blind, placebo-controlled study that intends to assess the safety and efficacy of BIVV009 in 40 adult patients with primary CAgD, who have not recently had a blood transfusion.

An Ideal Treatment Option for BIVV009

The commencement of the Phase-3 trials of BIVV009 takes Bioverativ a step closer to a new era of treatment for people living with CAgD.

Joachim Fruebis, Senior Vice-President of Development at Bioverativ, believes that the initiation of the Phase-3 trials is a critical development in the first approved therapy for CAgD. The results of the Phase-1b trial validated that BIVV009 has the potential to significantly improve the lives of people suffering with CAgD. The Phase-1b trial was specifically designed to evaluate the long-term efficacy, safety, and PK/PD profile of BIVV009 in six severely anemic primary CAgD patients. In this trial, BIVV009 achieved its primary and secondary outcome measures. The hemoglobin levels increased in all six patients (median >4g/dl), eradicating the need for transfusions.

Stock Performance Snapshot

March 07, 2018 - At Wednesday's closing bell, Bioverativ's stock slightly dropped 0.07%, ending the trading session at $104.65.

Volume traded for the day: 13.41 million shares, which was above the 3-month average volume of 2.41 million shares.

Stock performance in the last month – up 1.11%; previous three-month period – up 108.05%; past twelve-month period – up 104.71%; and year-to-date - up 94.08%

After yesterday's close, Bioverativ's market cap was at $11.32 billion.

Price to Earnings (P/E) ratio was at 38.26.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.5% at the end of the session.


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