Best Small Cap Stocks to Trade

Small Cap Stock Alerts in Real Time | No one provides consistent winners like Broad Street!

Mar 15 2016

Celator Pharma Surprises With Blood Cancer Drug Survival Benefit

“Alex, I’ll take Biotech Shocking Surprises for $400.”

“This company is the first in 40 years to develop a drug which improves upon the standard of care for elderly patients with high-risk acute myeloid leukemia.”

“Oof, Alex, this is a tough one. Okay, here goes… Who is Celator Pharmaceuticals (CPXX – Get Report) ?”

Brand New – TheStreet’s Biotech Bible! Before you invest one single dime in any biotech stock you have got to KNOW WHAT YOU ARE BUYING! Get THE most comprehensive text covering the 171 biotech companies that have gone public since 2013! There’s nothing else like it for digging into this highly speculative group of stocks. Get a FREE copy today!
“That’s correct! Congratulations, you’re our new Biotech Jeopardy Champion!”

That’s pretty much how Monday night went for Celator, except, few people, if anyone, outside of Celator would have gotten the right answer. The company is tiny, almost unknown and its leukemia drug, Vyxeos, wasn’t expected to demonstrate a significant survival benefit in a phase III study.

But Vyxeos did just that, and as a result, Celator’s stock price nearly quintupled in value.

Based on the positive study results, Celator expects to seek regulatory approval for Vyxeos in the U.S. and Europe later this year.

Vyxeos is an optimized reformulation of the cytarabine/daunorubicin chemotherapy cocktail (known colloquially as 7+3 after its dosing regimen) used for decades as the standard of care in elderly patients with acute myeloid leukemia (AML), a cancer of the bone marrow which primarily affects older people.

Based on early clinical work, Celator believed Vyxeos was superior to the old cytarabine/daunorubicin, or 7+3, combination, so the company designed a straightforward phase III study to prove it. More than 300 elderly patients with secondary (high risk) AML were randomized equally to treatment with Vyxeos or the 7+3 regimen. The primary endpoint of the study was overall survival.

Celator was proven right. Treatment with Vyxeos reduced the risk of death by 31% compared to 7+3. The survival benefit favoring Vyxeos — 3.6 months at the median — was statistically significant, achieving the primary endpoint of the study.

There were no substantial differences in the rate of adverse events between the two arms of the study, Celator said. Within 60 days of beginning treatment, 14% of Vyxeos patients died compared to 21% of 7+3 patients.

“The overall survival advantage seen with CPX-351 [Vyxeos] compared to 7+3, along with a superior response rate and no increase in serious toxicity indicates that we’ll likely have a new standard of care for treating older patients with secondary AML,” said Dr. Jeffrey E. Lancet, a blood cancer specialist at the Moffitt Cancer Center and the principal investigator for the study, in a statement.

Celator believes it can achieve U.S. and European Vyxeos sales in the range of $200-270 million based on the subset of AML patients enrolled in the phase III study. If use of Vyxeos is expanded into other AML patient populations, peak sales could reach $690-780 million, the company estimates.

To hit those targets, Celator will need to convince insurance companies that a reformulation of two generic drugs justifies a higher, branded price. The significant survival benefit favoring Vyxeos, if it holds up, helps the company’s argument.

Heading into Monday night’s Vyxeos study announcement, Celator’s market cap was under $60 million. [This also means Celator managed to become just the second biotech company to escape the Feuerstein-Ratain Rule.]

After dropping the Vyxeos news, Celator shares jumped 368% to $7.86 per share. At that price, the company’s market cap increased to approximately $275 million.

Celator plans to sell Vyxeos in the U.S. and find a marketing partner to handle sales outside the country. The company had $24 million in cash at the end of the September 2015 quarter, enough to last into the second half of this year, according to the company’s SEC filings. Celator will need more money to market Vyxeos, if the drug is approved, but whether that cash comes via dilutive stock sales or through proceeds from a marketing partnership remains to be seen.

Celator could also be an acquisition target. Japanese drug companies, in particular, have shown interest in the past in acquiring smaller blood-cancer drug companies. In 2014, Daiichi Sankyo bought Ambit BioSciences. In 2013, Otsuka acquired Astex Pharmaceuticals. The largest such deal goes back to 2008 when Takeda purchased Millennium Pharmaceuticals.

Celator developed Vyxeos with financial assistance from the Leukemia & Lymphoma Society (LLS.) If Vyxeos is FDA approved, it would mark the first time LLS’s direct investment in a biotech company resulted in bringing a new drug to the market. As part of its deal with Celator, LLS is entitled to royalties on sales of Vyxeos.

“From the start, LLS recognized the potential of CPX-351 [Vyxeos], so we are very gratified with the results of this clinical trial, and we are hopeful that this positive news brings us a step closer to delivering better outcomes for patients with high-risk (secondary) AML,” said LLS CEO Louis DeGennaro, in a statement.

Celator plans to present more detailed data from the Vyxeos AML study at the American Society of Clinical Oncology annual meeting in June.

Source: The Street

Written by broadAdmin · Categorized: Uncategorized

Privacy Policy and Disclaimer

Your Consent
By using our site, you consent to our online privacy policy and disclaimer.
Do we disclose any information to outside parties?
We do not sell, trade, or otherwise transfer to outside parties your personally identifiable information.
What information do we collect?
We collect information from you when you subscribe to our newsletter or fill out a form on one of our social platforms. This includes your email address and or mobile phone number.
Cookie Policy
When registering on our site, as appropriate, you may be asked to enter your: e-mail address and or mobile number.
What do we use your information for?
When we collect your email or mobile number it is used for one purpose to send you the information you requested about small cap stocks. Please read our disclaimer carefully before viewing our emails.
Your information, whether public or private, will not be sold, exchanged, transferred, or given to any other company for any reason whatsoever, other than for the express purpose of delivering the information on small cap stocks that you requested.
We send periodic emails
The email address you provide may be used to send you information, respond to inquiries, and/or other requests or questions.
How do we protect your information?
We implement a variety of security measures to maintain the safety of your personal information when you enter, submit, your email address. We use secure third parties to send email and sms messages to you.
Because we value your privacy we have taken the necessary precautions to be in compliance with the California Online Privacy Protection Act. We therefore will not distribute your personal information to outside parties without your consent.
Online Privacy Policy Only
This online privacy policy applies to information collected through our website and social media platforms.
Contacting Us
If there are any questions regarding this privacy policy or disclaimer you may reply to this email.
DISCLAIMER
This website/newsletter is a wholly owned subsidiary of Small Cap Specialists LLC, herein referred to as SCS LLC.
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: SCS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold SCS LLC, its operators owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. SCS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and SCS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead SCS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D. SCS LLC is compliant with the Can Spam Act of 2003. SCS LLC does not offer such advice or analysis, and SCS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries and extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results.
In preparing this publication, SCS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, SCS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. SCS LLC is not responsible for any claims made by the companies advertised herein, nor is SCS LLC responsible for any other promotional firm, its program or its structure.
SCS LLC is not affiliated with any exchange, electronic quotation system, the Securities Exchange Commission or FINRA.

Copyright © 2021 · Broad Street Alerts · All Rights Reserved