News & Analysis as of

Publicly-Traded Companies Pharmaceutical Industry

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Pivots on Publishing Complete Response Letters, Raising SEC Disclosure and Securities Litigation Implications

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more

Snell & Wilmer

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

Snell & Wilmer on

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

Goodwin

BioNTech Announces Transaction to Acquire CureVac

Goodwin on

On June 12, 2025, BioNTech SE (“BioNTech”) announced its entry into a definitive purchase agreement to acquire all shares of CureVac N.V. (“CureVac”), with an implied aggregate equity value for CureVac of approximately $1.25...more

Goodwin

Securities Litigation Against Life Sciences Companies 2024 Year in Review

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Welcome to our ninth annual report on US securities class actions filed against publicly traded life sciences companies, which include pharmaceutical, biotechnology, medical device, and healthcare companies....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

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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

Jones Day

SEC Prevails in Novel "Shadow Trading" Insider Trading Trial

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The Securities and Exchange Commission ("SEC") won at trial in its first "shadow trading" case, holding a corporate official liable for insider trading for using nonpublic information about his company's acquisition to trade...more

Vinson & Elkins LLP

Out from the Shadows: The SEC Succeeds on Shadow Insider Trading Theory

Vinson & Elkins LLP on

The Securities and Exchange Commission obtained a victory in a closely-watched trial when a jury found Matthew Panuwat liable for insider trading based on a “shadow trading” theory. The jury’s verdict, as well as increased...more

A&O Shearman

Global M&A Insights: Deal-making predictions for 2024

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Welcome to our year-end edition of M&A Insights, where we preview some of the themes we expect to shape deal-making over the next 12 months. Continued volatility in the debt markets has resulted in another subdued year for...more

McDermott Will & Schulte

[Event] Life Sciences Dealmaking Symposium - November 9th, Boston, MA

McDermott Will & Schulte on

Please join McDermott for our highly anticipated Life Sciences Dealmaking Symposium! Now in its 12th year, the Symposium offers a unique platform for education, insight sharing, purposeful networking and strategic...more

Akerman LLP - Health Law Rx

Teva FCA Decision Sheds Light on Varying Interpretations of the Elements of an FCA Claim

How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District...more

White & Case LLP

Mixed Signals: US M&A FY 2022

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Although the record-breaking deal activity of 2021 spilled over into 2022, headwinds in the first quarter developed into a significant slowdown during the rest of 2022, with an expectation of continued slowness as we enter...more

White & Case LLP

Pharma and healthcare deliver strong results

White & Case LLP on

Despite the absence of megadeals, M&A in the sector climbed from 2020 levels thanks in part to strong PE and SPAC activity - Healthcare and pharmaceutical deals continued at a robust pace through 2021, registering the...more

A&O Shearman

California District Court Allows Novel SEC Insider Trading Theory To Proceed

A&O Shearman on

On January 14, 2022, Judge William Orrick of the United States District Court for the Northern District of California issued an order denying a former biopharmaceutical company executive’s motion to dismiss and allowing the...more

White & Case LLP

SEC Extends the Misappropriation Theory of Insider Trading Beyond Targets of Acquisitions to Companies “Economically Linked” to...

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In a landmark action, the US Securities and Exchange Commission ("SEC") filed a complaint alleging insider trading that expands the potential reach of insider trading law. On August 17, 2021, the SEC charged a former employee...more

BCLP

SEC Brings First Case Charging Shadow Insider Trading

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The SEC’s filing of its first shadow trading case earlier this month signals the agency’s willingness to pursue actions based on expanded theories of insider trading liability. In a federal court complaint, the SEC on...more

White & Case LLP

Healthcare displays strong deal activity post-pandemic

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The value of healthcare M&A in H1 surpassed pre-pandemic levels - Healthcare M&A (including pharma, biotech and medical) saw strong growth over the first half of 2021 as investors continued to pursue deal opportunities in...more

Goodwin

Q1 2021 Earnings Roundup: Biologics and Biosimilars Update

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Below are some highlights from first quarter 2021 earnings reports recently released by biologics and biosimilars companies...more

Proskauer - Corporate Defense and Disputes

Stumbling Through Securities Law Challenges for COVID-19 Vaccine Developers

As the world waits to overcome the COVID-19 pandemic, publicly traded pharmaceutical companies waging in that fight are facing the multifaceted challenge of developing COVID-19 responses, informing the public of their...more

Mayer Brown Free Writings + Perspectives

Recent SEC Enforcement Actions Involving Accounting Misstatements and Non-GAAP Financial Measures

In July  2020, a publicly traded pharmaceutical company entered into a settlement with the Securities and Exchange Commission, without admitting or denying findings, and agreed to pay a financial penalty relating to various...more

Skadden, Arps, Slate, Meagher & Flom LLP

Hong Kong Regulatory Update - July 2020

This update provides an overview of key regulatory developments in the past three months relevant to companies listed, or planning to list, on The Stock Exchange of Hong Kong Limited (HKEx), and their advisers. In particular,...more

Mayer Brown Free Writings + Perspectives

Ninth Circuit Affirms Dismissal in Stock-Drop Lawsuit, Citing Shareholder’s “Implausible” Scienter Theory

On June 10, 2020, the US Court of Appeals for the Ninth Circuit affirmed the dismissal of a putative securities fraud class action against Endologix, Inc., a medical device company, on the grounds that the shareholder’s core...more

Skadden, Arps, Slate, Meagher & Flom LLP

Ninth Circuit Holds That Courts Should Scrutinize Economic Plausibility of Securities Fraud Complaints in Evaluating Scienter

On June 10, 2020, the Ninth Circuit affirmed the dismissal of a putative securities fraud class action in a potentially significant decision for securities defendants, particularly those in the pharmaceutical, biotech and...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

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