SAN FRANCISCO, Aug. 12, 2020 (GLOBE NEWSWIRE) -- RiskIQ, the global leader in attack surface management, today released a new research report revealing a large-scale digital scam advertisement campaign spread through fraudulent news sites and affiliate ad networks that cater to highly partisan audiences.

Titled ScamNation, the report details how misleading, false, and inflammatory news stories about the COVID-19 pandemic are developed on a massive scale by "content farms," which monetize through ads served by ad networks targeting highly partisan readership such as the Newsmax Feed Network. Some of these ads are purpose-built to lure readers into misleading 'subscription traps' for products billed as remedies or cures for the virus. A subscription trap works by offering a free or deeply discounted trial of a product while hiding clauses in the terms of service that sign victims up for costly payments remitted on a repeated basis, usually monthly. These subscriptions are often difficult, if not impossible, to escape.

Co-authored by RiskIQ threat researcher Jordan Herman and independent researcher Ryan Foote, the report clearly defines an ecosystem between partisan content farms that monetize through ad revenue, ad networks that take a cut of the profit, and advertisers that use the generated traffic to ensnare victims in subscription traps. These traps fraudulent subscriptions are for products such as dietary supplements or beauty products, and more recently, supposed remedies to COVID-19 in the form of CBD oil.

"Scam ads leading to subscription traps seem to be endemic to content farm sites, but there's a particular network of companies and individuals using the COVID-19 pandemic for financial gain," said RiskIQ threat researcher Jordan Herman. "We wanted to do a deep dive into this ecosystem to expose how these shady practices are taking advantage of people on a massive scale and making the schemers a lot of money in the process."

These content farms generate traffic by creating politically charged articles leveraging the fear, anxiety, and uncertainty around COVID-19 and gearing them toward a specific audience. These articles, often misleading or patently false, target readers the creators have assessed will likely read, share, and engage with them. The content farm operators publish these articles on their websites, which use social media accounts and spam email campaigns to further their reach and generate more traffic they can monetize.

Download the report here for an in-depth look at the individuals and companies behind this scam ecosystem and the tactics its operators are using to defraud a massive contingent of internet users: https://www.riskiq.com/resources/research/scamnation/

About RiskIQ

RiskIQ is the leader in digital attack surface management, providing the most comprehensive discovery, intelligence, and mitigation of threats associated with an organization's digital presence. With more than 75 percent of attacks originating outside the firewall, RiskIQ allows enterprises to gain unified insight and control over web, social and mobile exposures. Trusted by thousands of security analysts, security teams, and CISO's, RiskIQ's platform combines advanced internet data reconnaissance and analytics to expedite investigations, understand digital attack surfaces, assess risk, and take action to protect the business, brand, and customers. Based in San Francisco, the company is backed by Summit Partners, Battery Ventures, Georgian Partners, and MassMutual Ventures.

Try RiskIQ Community Edition for free by visiting https://www.riskiq.com/get-started/. To learn more about RiskIQ, visit www.riskiq.com.

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• Completed treatment phase of pivotal EMERGE™ Phase 3 efficacy trial of STS101 as planned and remain on track to report top-line results in late September or early October 2020
  
  
• Initiated patient enrollment in ASCEND™ Phase 3 open-label safety trial of STS101
   
• Cash, cash equivalents and marketable securities of $93.7 million as of June 30, expected to provide cash runway through end of 2021 and planned STS101 NDA filing in Q4 2021

SOUTH SAN FRANCISCO, Calif., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today summarized recent business progress  and reported financial results for the second quarter ended June 30, 2020.

“As evidenced by the completion of the treatment phase of our Phase 3 EMERGE efficacy trial and the recent initiation of patient enrollment in our Phase 3 open-label ASCEND safety trial, we continue to execute our STS101 development program according to plan,” commented John Kollins, Satsuma’s President and Chief Executive Officer.  “We expect to announce EMERGE trial topline results in the near future, and we anticipate the results, if successful, will position STS101 to become an important and differentiated acute treatment option for people with migraine.”

Recent Highlights

STS101

EMERGE Phase 3 efficacy trial

As reported in early June, Satsuma completed enrollment in the EMERGE efficacy trial with more than the planned 1,140 migraine patients randomized to one of two STS101 dosage strengths or placebo.  Following randomization, patients had 56 days in which to treat a single qualifying migraine attack of at least moderate pain severity with study medication.  As of July 30, all patients had completed the treatment phase of the trial.  The Company is on track to report topline data in late September or early October of this year.

ASCEND Phase 3 open-label long-term safety trial

Last week, Satsuma initiated patient enrollment in the ASCEND open-label safety trial in which patients will treat their migraines on an as-needed basis with STS101 for up to 12 months.  The trial is expected to enroll up to 300 migraine patients, with at least 150 treating a minimum of two attacks per month with STS101 over a six-month period and at least 50 over a 12-month period.

Virtual Scientific Meeting Presentations

In May, Satsuma announced that two scientific presentations were selected for the 2020 American Academy of Neurology Science Highlights Virtual Platform:

• Water-insoluble Mucoadhesive Formulation Enables Consistent and Rapid Intranasal Absorption of Drugs, including Granisetron, Zolmitriptan and Dihydroergotamine
• PK Comparison of STS101, an Intranasal Dry Powder Formulation of Dihydroergotamine, with Other Intranasal, Injectable and Oral Inhaled DHE Formulations

In June, Satsuma virtually presented two posters at the 2020 American Headache Society Annual Scientific Meeting:

• Safety of Dihydroergotamine for the Acute Treatment of Migraine: Reality vs. Perception 
• The Efficacy of Dihydroergotamine versus Emerging Acute Migraine Medications

Copies of these poster presentations are available for download in the publications section of Satsuma’s website:  www.satsumarx.com/publications.

Addition to the Board of Directors

In July, Satsuma appointed biopharmaceutical industry veteran Thomas M. Soloway to its Board of Directors.  Mr. Soloway currently serves as Executive Vice President and Chief Operating Officer of Audentes Therapeutics Inc., an Astellas genetic medicines company committed to developing and commercializing innovative gene therapy products for patients living with rare, life-threatening diseases.

Expansion of Intellectual Property Portfolio

Satsuma continues to expand its intellectual property portfolio, with notices of claims allowance recently received from the United States Patent and Trademark Office (USPTO) for two pending patent applications licensed or owned by Satsuma.  The Company anticipates the pending applications will issue around the end of this year and, when issued, will have estimated expiration dates in 2037 and 2039 (not taking into account any adjustments or extensions of term).  When the pending patents issue, they will bring the total number of issued U.S. patents owned or licensed by Satsuma to ten, reflecting the highly innovative and differentiated nature of the proprietary dry-powder nasal delivery and formulation technologies incorporated in STS101. 

Financial Results for Second Quarter 2020

Net loss for the second quarter 2020 was $11.3 million, or $0.65 per share of common stock, compared to a net loss of $6.3 million, or $5.48 per share of common stock, for the same period in 2019. As of June 30, 2020, the Company had $93.7 million of cash, cash equivalents and marketable securities. The Company believes it has sufficient financial resources to fund operations through the end of 2021.

Research and development expenses were $8.8 million for the second quarter 2020, compared to $5.5 million for the same period of 2019. Second quarter expenses increased by $3.3 million, primarily due to additional expenses for the EMERGE clinical trial activities, development and production of clinical trial materials, as well as increases in salaries and employee-related expenses.

General and administrative expenses were $2.7 million for the second quarter 2020, compared to $1.0 million for the same period of 2019. Second quarter expenses increased by $1.7 million, primarily due to an increase of $0.9 million of director and officer liability insurance, professional fees for legal, consulting, accounting, tax and other services and an increase of $0.8 million of payroll and personnel expenses, including salaries, benefits and stock-based compensation expenses, due to increase in headcount.

About the STS101 Clinical Program

EMERGE Phase 3 efficacy trial

Designed to evaluate the efficacy, safety, and tolerability of STS101 (DHE nasal powder) as an acute treatment for migraine, the EMERGE trial is a multi-center, randomized, double-blind, placebo-controlled, parallel group trial in more than 1,140 migraine patients that is being conducted at 121 sites located across 32 U.S. states.  EMERGE is designed in accordance with U.S. FDA recommendations outlined in its 2018 guidance document, Migraine: Developing Drugs for Acute Treatment. Based on dialogue with the FDA, the Company believes that EMERGE, if successful, will fulfill the regulatory requirement for demonstration of STS101 efficacy.

After establishing eligibility during a 28-day screening period, EMERGE trial participants were randomized (1:1:1) to receive one of three treatments: STS101 3.9 mg, STS101 5.2 mg, or placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication.  Following randomization, trial participants have up to 56 days in which to treat a qualifying migraine attack; following treatment of a qualifying attack, trial participants return to their trial sites for a final follow-up visit.

The two co-primary endpoints of the EMERGE trial, both of which are assessed two hours following administration of study medication, are (1) freedom from pain, and (2) freedom from most-bothersome-symptom (MBS) from among photophobia, phonophobia, or nausea. Responder analyses will be conducted on these co-primary endpoints.  The trial is powered at greater than 99% on the freedom-from-pain endpoint and at greater than 95% for the freedom-from-MBS endpoint.

In addition, EMERGE is designed to prospectively evaluate the efficacy of STS101 on a number of secondary endpoints and in patient subgroups that could significantly enhance the differentiated clinical profile of STS101.

ASCEND Phase 3 open-label long-term safety trial

The ASCEND trial, the second of two Phase 3 trials that Satsuma plans to complete in support of STS101 registration, initiated patient enrollment in August 2020. The primary objective of the ASCEND trial is to evaluate the long-term safety of STS101 as an as-needed acute treatment for migraine.  The trial is expected to enroll up to 300 patients, with at least 150 patients treating a minimum of two attacks per month with STS101 over a six-month period and at least 50 patients over a 12-month period.

The Company anticipates that data from the EMERGE trial, if successful, in conjunction with results from the ASCEND open-label safety trial, will support a New Drug Application filing in the fourth quarter of 2021.
                    
For further information regarding the STS101 Phase 3 ASCEND safety trial, see www.ClinicalTrials.gov, identifier NCT04406649:  A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine (ASCEND).

For further information regarding the STS101 Phase 3 EMERGE efficacy trial, see www.ClinicalTrials.gov, identifier NCT03901482:  A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine (EMERGE).

About Satsuma Pharmaceuticals and STS101

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product for the acute treatment of migraine, STS101. STS101 is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate (DHE), which can be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be rapidly self-administered in a matter of seconds. The Company believes STS101 would, if approved, be an attractive migraine treatment option for many patients and may enable a larger number of people with migraine to realize the long-recognized therapeutic benefits of DHE therapy. STS101 has undergone extensive pre-clinical development, completed a Phase 1 clinical trial, and is currently in Phase 3 development.

Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”), as well as the Company’s plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the potential safety and efficacy of STS101; the Company’s clinical and regulatory development plans; the Company’s expectations with regard to the availability of data to be derived from its ongoing Phase 3 clinical trials; the timing and likelihood of regulatory filings and approvals for STS101; the Company’s expected cash needs and sufficiency of cash on hand. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, to be filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; the risk that the COVID-19 worldwide pandemic may negatively impact the Company’s business, operations, clinical trials or ability to raise capital; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release discusses STS101, a product candidate that is in clinical development, and which has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied.

INVESTOR AND CORPORATE CONTACTS:            

Corey Davis, PhD
LifeSci Advisors, LLC
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Tom O’Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
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SATSUMA PHARMACEUTICALS, INC.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)

SATSUMA PHARMACEUTICALS, INC.
BALANCE SHEET DATA
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(unaudited)

MENLO PARK, Calif., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Pacific Biosciences of California, Inc. (Nasdaq: PACB) (“Pacific Biosciences” or the “Company”) today announced that it has priced its previously announced underwritten public offering of 19,430,000 shares of its common stock at a price to the public of $4.47 per share.  The offering is expected to close on or about August 14, 2020 subject to satisfaction of customary closing conditions.  Pacific Biosciences also granted the underwriters a 30-day option to purchase up to an additional 2,914,500 shares of its common stock at the public offering price, less underwriting discounts and commissions.  Before deducting the underwriting discount and estimated offering expenses payable by the Company, the Company expects to receive gross proceeds of approximately $86.9 million, assuming no exercise of the underwriters' option to purchase additional shares.

Morgan Stanley & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.  Cantor Fitzgerald & Co. is also acting as a book-running manager for the offering.

Pacific Biosciences intends to use the net proceeds from the offering for (i) additional product launches and research and development, (ii) commercial infrastructure expansion and (iii) general corporate purposes.  Pacific Biosciences may also use a portion of the net proceeds from the offering to acquire or invest in complementary businesses, technologies, product candidates or other intellectual property, although it has no present commitments or agreements to do so.

A shelf registration statement relating to the shares of common stock was previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective on July 14, 2020.  A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC on August 11, 2020. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website. Copies of the final prospectus supplement (when available) and accompanying prospectus may be obtained from Morgan Stanley & Co. LLC, Prospectus Department, 180 Varick Street, Second Floor, New York, NY 10014 or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at This email address is being protected from spambots. You need JavaScript enabled to view it. or by telephone at (833) 297-2926.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

About Pacific Biosciences

Pacific Biosciences of California, Inc. (Nasdaq: PACB), is empowering life scientists with highly accurate long-read sequencing. The company’s innovative instruments are based on Single Molecule, Real-Time (SMRT®) Sequencing technology, which delivers a comprehensive view of genomes, transcriptomes, and epigenomes, enabling access to the full spectrum of genetic variation in any organism. Cited in thousands of peer-reviewed publications, PacBio® sequencing systems are in use by scientists around the world to drive discovery in human biomedical research, plant and animal sciences, and microbiology.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws. These statements involve risks and uncertainties that could cause actual results to differ materially, including, but not limited to, whether or not Pacific Biosciences will be able to consummate the offering of common stock described herein, including due to the satisfaction of customary closing conditions and prevailing market conditions, the anticipated use of the proceeds of the offering which could change as a result of market conditions or for other reasons, and the impact of general economic, industry or political conditions in the United States or internationally.  Additional risks and uncertainties relating to the proposed offering, Pacific Biosciences and its business can be found under the heading “Risk Factors” in Pacific Biosciences’ most recent periodic, quarterly and annual reports filed with the SEC and in the preliminary prospectus supplement and accompanying prospectus relating to the offering to be filed with the SEC.  Pacific Biosciences assumes no duty or obligation to update or revise any forward-looking statements for any reason.                                         

Contact:
Investors: Trevin Rard
650.521.8450
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HAMILTON, Bermuda, Aug. 11, 2020 (GLOBE NEWSWIRE) -- Hermitage Offshore Services Ltd. and 28 of its subsidiaries including all its vessel-owning subsidiaries (collectively, the “Company”) announced today that they have filed voluntary petitions for reorganization under Chapter 11 of the Bankruptcy Code in the United States Bankruptcy Court for the Southern District of New York.

The Company took this action following a prolonged slump in global oil prices, driven in part by the global coronavirus pandemic, and its effect on the Company’s business.  While the Company would have preferred to complete its financial restructuring out of court, it was unable to reach a consensual agreement with its lenders, which made filing Chapter 11 necessary to provide a single forum for all continuing conversations with its lenders. 

The Company anticipates that the Company’s business operations and relationship with its customers and vendors will not be adversely affected by this proceeding while it works constructively with its lenders toward a consensual resolution.  The Company values the business of its customers and vendors and is committed to continuing its long-standing business relationships with them uninterrupted as it works through this process.  Under Chapter 11 protection, the Company’s vendors are afforded “administrative” status for all shipments made, or services provided, subsequent to the filing.  As a result, payments for new shipments or services will be made in the ordinary course of business either by the Company or one of the Company’s managers, which is not part of the Chapter 11 filing.

The Company’s customers are also afforded the aforementioned “administrative” status.  As such, they will continue to receive uninterrupted service from the Company and the Company will perform all of its duties and obligations under its current and future charter party agreements.

The Company’s customers and vendors have been historically paid by one of the Company’s managers which is outside the Chapter 11 cases and so customers and vendors will be paid amounts due now and in the future without interruption. 

About the Company

Hermitage Offshore Services Ltd. is an offshore support vessel company that owns 21 vessels consisting of 10 platform supply vessels, or PSVs and 11 crew boats. The Company’s vessels primarily operate in the North Sea and the West Coast of Africa. Additional information about the Company is available at the Company’s website www.hermitage-offshore.com, which is not a part of this press release.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Matters discussed in this press release may constitute forward‐looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward‐looking statements in order to encourage companies to provide prospective information about their business. Forward‐looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation. The words “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “target,” “project,” “likely,” “may,” “will,” “would,” “could” and similar expressions identify forward‐looking statements. In addition, statements relating to the Company’s continuing business operations and relationships with customers and vendors and payments for new shipments or services and the Company’s performance under its current and future charter party agreements are forward looking statements.

The forward‐looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, management’s examination of historical operating trends, data contained in the Company’s records and other data available from third parties. Although management believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond the Company’s control, there can be no assurance that the Company will achieve or accomplish these expectations, beliefs or projections. The Company undertakes no obligation, and specifically declines any obligation, except as required by law, to publicly update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise.

Important factors that, in the Company’s view, could cause actual results to differ materially from those discussed in the forward-looking statements include the strength of world economies and currencies, general market conditions, including fluctuations in charter rates and vessel values, changes in demand in the offshore support vessel (“OSV”) market, changes in charter hire rates and vessel values, demand in OSVs, the length and severity of the recent novel coronavirus (COVID-19) outbreak, the results of the Company’s discussions with its lenders, the outcome and timing of the Chapter 11 process, the Company’s operating expenses, including bunker prices, dry docking and insurance costs, governmental rules and regulations or actions taken by regulatory authorities as well as potential liability from pending or future litigation, general domestic and international political conditions, potential disruption of shipping routes due to accidents or political events, the availability of financing and refinancing, vessel breakdowns and instances of off-hire and other important factors described from time to time in the reports filed by the Company with the Securities and Exchange Commission.

Contacts:

Hermitage Offshore Services Ltd.
+377 9798 5717 (Monaco)
+1 646 432 3315 (New York)
Web-site: www.hermitage-offshore.com

WILMINGTON, Del., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Rigrodsky & Long, P.A. announces that it is investigating Sunworks, Inc. (“Sunworks”) (NASDAQ GS: SUNW) regarding possible breaches of fiduciary duties and other violations of law related to Sunworks’ agreement to be acquired by The Peck Company Holdings, Inc. (“Peck Company”) (NASDAQ CM: PECK). Under the terms of the agreement, shareholders of Sunworks will receive 0.185171 shares of Peck Company for each share of Sunworks they own.

To learn more about this investigation and your rights, visit: https://www.rigrodskylong.com/cases-sunworks-inc.

If you would like to discuss this investigation and your rights cost and obligation free, please contact Seth D. Rigrodsky or Gina M. Serra toll free at (888) 969-4242 or by e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it..

Rigrodsky & Long, P.A., with offices in Delaware and New York, has recovered hundreds of millions of dollars on behalf of investors and achieved substantial corporate governance reforms in securities fraud and corporate class actions nationwide.

Attorney advertising. Prior results do not guarantee a similar outcome.

CONTACT:

Rigrodsky & Long, P.A.
Seth D. Rigrodsky
Gina M. Serra
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