Stock Monitor: Achillion Pharma Post Earnings Reporting
LONDON, UK / ACCESSWIRE / February 27, 2018 / Active-Investors.com has just released a free research report on Bellicum Pharma, Inc. (NASDAQ: BLCM). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=BLCM as the Company's latest news hit the wire. On February 23, 2018, the Company, which is a clinical stage biopharmaceutical organization that works towards discovering and developing cellular immunotherapies for cancers and orphan inherited blood disorders, shared an update on the clinical hold of US studies for its CAR-T candidate BPX-501. Register today and get access to over 1000 Free Research Reports by joining our site below:
Active-Investors.com is currently working on the research report for Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN), which also belongs to the Healthcare sector as the Company Bellicum Pharma. Do not miss out and become a member today for free to access this upcoming report at:
Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Bellicum Pharma 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:
Bellicum shared that it has received a notification from the US Food and Drug Administration (FDA) which outlines the criteria required for lifting the clinical hold imposed on US studies of BPX-501.
Bellicum's lead product candidate, BPX-501, has been specifically designed to improve outcomes for patients undergoing haplo-identical (i.e. partial match) hematopoietic stem cell transplants (HSCT). BPX-501 is an adjunct T cell therapy administered after HSCT. It comprises genetically modified donor T cells, based on Bellicum's CaspaCIDe® safety switch.
The use of BPX-501 provides the patient with the benefit of having T cells to fight infection, support engraftment, and prevent disease relapse. In case graft versus host disease (GvHD) occurs, the CaspaCIDe® safety switch can be activated to kill the toxic T cells. Thus, BPX-501 can improve outcomes and extend patient eligibility for a haplo-transplant. It also allows physicians to perform stem cell transplants more safely.
Clinical Hold on BPX-501 Studies Due to Encephalopathy Cases
Bellicum received a notice from the FDA to put a clinical hold on the US studies of BPX-501 on January 30, 2018. The agency suspended all studies after three cases of encephalopathy related to BPX-501 were reported.
However, it should be noted that the clinical hold does not affect the Company's BP-004 registration trial in Europe.
Bellicum's Plan of Action
- Since the clinical hold was imposed last month, the Company had been waiting for a formal communication from the FDA to determine the requirements for resuming studies. Now that the FDA has outlined the criteria, Bellicum will work closely with the agency to address their requirements.
- Bellicum intends to implement revisions to the US study protocols, such as the addition of more comprehensive monitoring and management of neurotoxicity.
- Moreover, the Company plans to revise the Investigator Brochure and Informed Consent Documents to notify healthcare providers, patients, and caregivers of the changes.
- The Company intends to provide a full response to the FDA with respect to these issues within a few weeks.
Improved Investor Sentiment
Bellicum's investors are waiting for the clinical hold to be lifted. The FDA's guidelines allow the Company to prepare a plan of action for obtaining the regulatory approval for BP-004.
Thus, the announcement about the FDA's notification went well with the investors. On the day of the announcement, shares were up 33% since bottoming at $5.02 on January 31, 2018, due to the news of clinical hold.
Stock Performance Snapshot
February 26, 2018 - At Monday's closing bell, Bellicum Pharma's stock rose 3.56%, ending the trading session at $7.28.
Volume traded for the day: 672.02 thousand shares.
After yesterday's close, Bellicum Pharma's market cap was at $229.68 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.0% at the end of the session.
Active-Investors (A-I) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. A-I has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.
A-I has not been compensated; directly or indirectly; for producing or publishing this document.
PRESS RELEASE PROCEDURES:
The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third-party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email firstname.lastname@example.org. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by A-I. A-I is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.
A-I, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. A-I, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, A-I, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.
NOT AN OFFERING
This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither A-I nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://active-investors.com/legal-disclaimer/.
For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:
Phone number: 73 29 92 6381
Office Address: 6, Jalan Kia Peng, Kuala Lumpur, 50450 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.