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Publicly-Traded Companies Disclosure Requirements Pharmaceutical Industry

Snell & Wilmer

Securities Class Action Litigation Surges in Dollar Value Despite Steady Filing Numbers

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Cornerstone Research recently published its Securities Class Action Filings—2025 Mid-Year Assessment. The report contains useful data and information about the securities class action landscape thus far this year. The...more

Morgan Lewis - As Prescribed

FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more

McDermott Will & Schulte

New SEC Leadership Signals Continued Focus on FDA-Related Disclosures

Lawyers inside and outside the US Securities and Exchange Commission (SEC) have speculated that the agency’s new leadership will take a “lighter touch” when it comes to enforcement. The ultimate approach of the new SEC...more

Fenwick & West LLP

Clinical Data FAQs: How to Approach Fundraising and Investor Relations

Fenwick & West LLP on

For publicly traded biotech companies, disclosing clinical trial data can be an exciting milestone as you build towards an exit or public offering—but disclosure is a double-edged sword....more

Orrick, Herrington & Sutcliffe LLP

Managing and Maintaining Clinical Trial Disclosure for Publicly Traded Life Sciences Companies

One of the fastest ways to garner unwanted attention as a publicly-traded life sciences company is to be accused by either a regulator or stockholder that the company disclosed materially misleading information about the...more

Ballard Spahr LLP

COVID-19 Disclosures Bring Risks For Life Sciences Cos.

Ballard Spahr LLP on

COVID-19 has upended every corner of the financial markets, including the disclosure regime for publicly traded companies. Over the last few weeks, the number of disclosures relating to COVID-19 has exploded, with as many...more

Orrick, Herrington & Sutcliffe LLP

What's New in Corporate Governance and Securities Law - October 18, 2019

Corporate Governance and Securities Law Developments - Directors Can Be Held Liable for Failure to Oversee “Mission Critical” Regulatory Compliance - On October 1, the Delaware Court of Chancery refused to dismiss a...more

Faegre Drinker Biddle & Reath LLP

SEC: Here Is When Loss Contingencies Must Be Disclosed and Reserved

When confronted with government inquiries, public companies commonly grapple with the issue of when events have escalated to the point that they are subject to disclosure obligations—or, further yet, require recognition as a...more

Stinson - Corporate & Securities Law Blog

SEC Brings Enforcement Action for Loss Contingency Disclosure

The SEC recently settled an enforcement action against Mylan N.V., claiming Mylan failed to timely disclose to investors a possible loss relating to a nearly two-year Department of Justice  probe into whether Mylan...more

Foley & Lardner LLP

Selective Disclosure Violation Results in SEC Order

Foley & Lardner LLP on

Recently, the Securities and Exchange Commission (SEC) issued an order charging a publicly traded pharmaceutical company with violations of Regulation FD as a result of selectively disclosing material, nonpublic information....more

Dorsey & Whitney LLP

SEC Files First Reg FD Action In Years

Dorsey & Whitney LLP on

Regulation Fair Disclosure was passed in 2002 to fill what many saw as a regulatory gap – the selective disclosure of material non-public information by issuers.  Essentially the Regulation – now known as Reg FD – requires a...more

Dorsey & Whitney LLP

SEC Charges TherapeuticsMD with Regulation FD Violations

Dorsey & Whitney LLP on

Last week, the SEC issued a reminder that Regulation FD remains a vital element of the federal securities regulations. In the first enforcement action regarding Regulation FD since 2013, the SEC charged TherapeuticsMD Inc., a...more

Mayer Brown Free Writings + Perspectives

SEC Brings Regulation FD Action

On August 20, 2019, the SEC charged a pharmaceutical company with violations of Regulation FD based on its sharing of material, nonpublic information with sell-side research analysts on two separate occasions without also...more

Herbert Smith Freehills Kramer

SEC Brings Enforcement Action against TherapeuticsMD for Violations of Regulation FD

On Aug. 20, 2019, the Securities and Exchange Commission (SEC) announced that it had charged public pharmaceutical company TherapeuticsMD, Inc. for violations of Regulation FD and Section 13(a) of the Exchange Act related to...more

Bass, Berry & Sims PLC

Recent SEC Enforcement Action Drives Home the Importance of Regulation FD Policies and Training

Bass, Berry & Sims PLC on

On August 20th, 2019, the SEC charged TherapeuticsMD Inc., a pharmaceutical company headquartered in Boca Raton, Florida, with violations of Regulation FD based on its sharing of material, nonpublic information with sell-side...more

Ballard Spahr LLP

SEC Signals New Phase of Regulation FD Enforcement

Ballard Spahr LLP on

The United States Securities and Exchange Commission (SEC) announced yesterday, August 20, 2019, that it charged TherapeuticsMD, Inc., a pharmaceutical company headquartered in Boca Raton, Florida, with violations of...more

Stinson - Corporate & Securities Law Blog

SEC Charges Issuer for Reg FD Violation for Selective Disclosure to Analysts

The SEC charged TherapeuticsMD Inc., a pharmaceutical company headquartered in Boca Raton, Florida, with violations of Regulation FD based on its sharing of material, nonpublic information with sell-side research analysts...more

Skadden, Arps, Slate, Meagher & Flom LLP

SEC Disclosure Trends Related to Brexit and the Trump Administration

The Brexit vote and President Donald Trump’s election and proposed regulatory and other reforms have led to worldwide geopolitical uncertainty. We expect reporting companies will continue to disclose risk factors relating to...more

King & Spalding

Eleventh Circuit Confirms that Issuers are not Required to Disclose Retention of Outside Promotional Firms

King & Spalding on

On December 15, 2016, the United States Court of Appeals for the Eleventh Circuit affirmed the dismissal of a securities class action against Galectin Therapeutics Inc., a Georgia-based biotechnology company. The suit...more

Carlton Fields

Dismissal for Drugmaker Affirmed: Galectin Had No Duty to Disclose Payments to Promoters

Carlton Fields on

In re: Galectin Therapeutics, Inc. Securities Litigation, No. 16-10324, 2016 WL 7240146, ____ , F2d ___ (11th Cir. Dec. 15, 2016). The Eleventh Circuit recently addressed the circumstances under which a public company...more

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