Rigel Pharmaceuticals Wins FDA Approval, Potential Clinical Catalysts and Analyst Review

Rigel Pharmaceuticals, Inc., (NASDAQ: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms.

 

The company recently announced that TAVALISSE™ (fostamatinib disodium hexahydrate) is available by prescription for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatment. TAVALISSE, an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of the disease by impeding platelet destruction, was approved by the U.S. Food and Drug Administration in April 2018.

 

As per management, Healthcare providers and adults living with chronic ITP have been in need of a new and different treatment option. The company is excited to bring TAVALISSE to this patient population and to have an experienced team in place to answer questions and help patients and providers to start accessing TAVALISSE.

 

Before this, the company reported financial results for the first quarter ended March 31, 2018 and discussed the following achievements:

  • On April 30th, Rigel announced that the American Journal of Hematology published positive results from the Fostamatinib in Thrombocytopenia (FIT) Phase 3 clinical program. The study, “Fostamatinib for the Treatment of Adult Persistent and Chronic Immune Thrombocytopenia: Results of Two Phase 3, Randomized, Placebo-Controlled Trials,” is available on the journal website.
  • On April 24, Rigel completed an underwritten public offering of common stock with proceeds of approximately $58.4 million, net of underwriting discounts and commissions and other estimated offering expenses.
  • On April 3, the company announced topline data from its proof-of-concept Phase 2 study of fostamatinib in patients with IgA nephropathy (IgAN), an orphan autoimmune disease of the kidneys.
  • On March 8, Rigel presented data from Stage 1 of the Phase 2 study of fostamatinib in patients with warm antibody autoimmune hemolytic anemia (AIHA) at the Thrombosis and Hemostasis Societies of North America.

 

As per management, the company has made incredible progress in the recent quarter and the second half of 2018 holds great potential for the company. In addition to the approval of TAVALISSE this quarter, RIGL also completed significant financing for the company which furthered its runway substantially.

Upcoming Catalysts:

The company has top-line data from its proof of concept Phase II study with fostamatinib in patients with IgA nephropathy, showing a positive trend in patients with higher levels of proteinuria at baseline. The company also provided an updated to stage one of its Phase II study with fostamatinib in autoimmune hemolytic anemia which showed an excellent response rate.

Analysts tracking the stock believes that the company is well poised for significant value creation via efficient development and commercialization. Notably, The FDA’s approval of TAVALISSE for chronic ITP represents a huge milestone for Rigel and allows the company to advance its efforts to transition the company into commercialization, so that it may bring this therapy to a patient population in need of treatment options.  Also, the recent financing is expected to support company’ liquidity for at least next one year.

 

The company is in an extremely favorable risk-reward position, and there is enormous potential which we are yet to see in terms of share appreciation of the company. Considering all this, the market cap of just $523.4 million and share now ruling at $3.20, can move to a level of $7.50 in next six months.

 

About the company: The company’s first FDA approved product is TAVALISSE™ (fostamatinib disodium hexahydrate), an oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to previous treatment. Rigel’s current clinical programs include Phase 2 studies of fostamatinib in autoimmune hemolytic anemia and IgA nephropathy. Besides, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics.

 

Pipeline:

First Quarter 2018 Results:

 

  • For the first quarter of 2018, Rigel reported a net loss of $24.4 million, or $0.17 per share, compared to a net loss of $15.3 million, or $0.13 per share, in the first quarter of 2017.
  • There were no contract revenues from collaborations in the first quarter of 2018. Contract revenues from collaborations of $3.6 million in the first quarter of 2017 were comprised primarily of the $3.3 million payment from BerGenBio AS, as a result of advancing BGB324, a selective, potent and orally available small molecule AXL kinase inhibitor, to a Phase 2 clinical study.
  • As of March 31, 2018, Rigel had cash, cash equivalents and short-term investments of $94.3 million, compared to $115.8 million as of December 31, 2017. In April 2018, Rigel completed an underwritten public offering in which it received proceeds of approximately $58.4 million, net of underwriting discounts and commissions and estimated offering expenses. Rigel expects that its cash, cash equivalents, and short-term investments will be sufficient to support its current and projected funding requirements, including the launch of fostamatinib for chronic ITP in the U.S., through at least the next 12 months.

 

Key risk factors and potential stock drivers:

  • Successful completion of the upcoming milestones would lead future direction for the company. Any adversities related to these forthcoming milestones might adversely impact the overall investor sentiments.
  • RIGL is still an early stage entity and has not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it. The company’ prospects are significantly dependent on TAVALISSE, which might have limited sales potential initially. Moreover, fostamatinib is still away from commercialization.
  • RIGL has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.

 

Stock Chart:

Comments:

  • On Friday, June 15th, 2018, RIGL closed at $3.20, on an average volume of 9.3 million shares exchanging hands. Market capitalization is $523.456 million. The current RSI is at 37.39
  • In the past 52 weeks, shares of RIGL have traded as low as $2.14 and as high as $4.71
  • At $3.20, shares of RIGL are trading below its 50-day moving average (MA) at $3.68 and below its 200-day moving average (MA) at $3.68
  • The present support and resistance levels for the stock are at $3.08 & $3.36 respectively.

 

 

Disclaimer
Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Traders News Source has not been compensated for this report by anyone and the opinions if any are that of the author Vikas Agrawal, CFA. Author’s Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I, wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in the article.
This web site, published by TNS LLC, and is an investment newsletter that is built on the premise of assisting individual investors in learning about investing. Our goal as publishers of financial information is to provide research and analysis of investments to our subscribers. TNS LLC does not give buy or sell recommendations. We do purchase distribution rights from analyst, financial writers and bloggers for a fee that may be licensed to issue price targets and recommendations. Furthermore, we encourage you to speak to a licensed professional prior to making an investment in any type of publicly traded security.
We do sell advertising to other companies including brokerage firms, web sites, publicly traded issuers, investor relations firms, and investment publications, among others. TNS LLC makes no warranty as to the policies of these organizations, and in no way endorses their offers, services, or the content of their advertisements.
When an advertiser is a publicly traded company or a third party acting on behalf of a public company, we fully disclose all compensation in the email advertisement. Such disclosure is included in a disclosure statement in each of the advertisements sent via email.
17B Disclosure
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: TNS 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 TNS LLC, its operator’s 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. TNS 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 TNS 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 TNS 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.
TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS 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 an extremely high degree of risk. It is possible that an investor’s 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, TNS 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, TNS 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. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.