News & Analysis as of

Securities and Exchange Commission (SEC) Life Sciences

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – May 2025

Key Points - - The SEC’s Crypto Task Force acknowledges past hostility toward digital assets and aims to create more sensible regulations. - Tokenized securities face complex regulatory challenges, including compliance...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

Fenwick & West LLP

SEC Expansion of Availability of Confidential Submissions of Registration Statements Could Help Life Sciences Companies Raise...

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In an attempt to facilitate capital raising, the SEC announced that it was expanding the ability of issuers to submit draft registration statements for confidential review by the staff. Historically, this procedure was mostly...more

Wilson Sonsini Goodrich & Rosati

2024 Technology and Life Sciences IPO Report

Wilson Sonsini's 2024 Technology and Life Sciences IPO Report provides in-depth analysis on 33 initial public offerings (IPOs) completed by U.S.-based technology and life sciences companies in 2024 with deal values exceeding...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: Securities Enforcement

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the eighth episode of When Your Life Sciences Are on the...more

Fenwick & West LLP

The Life Sciences IPO Market Is Off to a Solid Start in 2025

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Various biotech companies have completed or launched their IPOs so far in 2025. As of early February, five sizeable life sciences companies have priced their IPOs and one has filed to go public soon. ...more

Fenwick & West LLP

Clinical Data FAQs: How to Prepare for Disclosure

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When it comes to disclosing clinical trial data in the biotechnology arena, in particular for public biotech companies, timing is everything. Disclosures are not just about when to reveal the information, but also what is...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: FCPA Enforcement

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Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the seventh episode of When Your Life Sciences Are on...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - December 2024

Key Points - - During its 2024 term, the U.S. Supreme Court is poised to provide important guidance on the Private Securities Litigation Reform Act’s (PSLRA’s) particularity requirement in NVIDIA Corp. v. E. Ohman J:or...more

Cooley LLP

SEC charges biopharma with misleading investors about status of INDs

Cooley LLP on

The SEC has announced that it filed settled charges against Kiromic BioPharma and two of its executives for alleged failure to disclose in its public statements and filings, including in its public offering prospectus,...more

Fenwick & West LLP

Is the SEC Cracking Down on Life Science Companies Misleading Investors?

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On December 3, the U.S. Securities and Exchange Commission settled charges against biotherapeutics company Kiromic BioPharma, Inc., its former CEO, and its former CFO for failing to disclose material information about...more

Hogan Lovells

Publicly Traded Life Sciences Companies and Artificial Intelligence: Disclosing Risk Factors

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Although the rise of artificial intelligence (AI) has created many opportunities and breakthroughs for life sciences companies in preclinical and clinical development, risks associated with the use of AI cannot be ignored....more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: Cybersecurity

Morrison & Foerster LLP on

Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fifth episode of When Your Life Sciences Are on the Line, where leading...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - October 2024

Ninth Circuit Affirms Dismissal of Insider Trading Claims Against Satellite Operator Investors Based on Stock Sales After FCC Chairman Vote - In re Silver Lake Grp., LLC Sec. Litig. (9th Cir. July 24, 2024) What to...more

Foley Hoag LLP - Public Companies & the Law

Biotech Public Markets Finally Thawing(?): Two Massachusetts Biotechs file S-1s

In an encouraging sign that the equity capital markets may be improving for biotechnology companies, Bicara Therapeutics Inc. and Zenas Biopharma, Inc. filed S-1 registration statements yesterday, signaling their intention to...more

Fenwick & West LLP

Securities Law Update - August 2024

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Welcome to the latest edition of Fenwick’s Securities Law Update. This issue contains news on...more

Fenwick & West LLP

Disclosure Trend: Risk Factors Post-Chevron

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Life sciences companies are adding risk factor language in response to the U.S. Supreme Court overturning the Chevron Doctrine. As you may recall, the U.S. Supreme Court recently overturned the Chevron Doctrine....more

Skadden, Arps, Slate, Meagher & Flom LLP

Insights – June 2024

Explore the unique considerations for mergers and acquisitions in the AI sector, the return of IPOs, the implications of new Supreme Court decisions and other developments in this edition of Skadden’s quarterly Insights....more

J.S. Held

IP and Tech: Twin Engines of Innovative Sustainability

J.S. Held on

In the quest for a sustainable future, the United Nations’ Sustainable Development Goals (SDGs) represent goalposts, albeit lofty ones, that countries can aim for. These 17 interconnected goals address pressing global...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - May 2024

Spotlight - Macquarie Ruling Raises the Bar for Securities Fraud Claims - Key Points - - On April 12, 2024, the U.S. Supreme Court unanimously reversed and vacated the Second Circuit’s decision in Macquarie...more

McDermott Will & Emery

Dual Track Reboot: Five Key Considerations for Supercharging Your Life Science Company Exit

McDermott Will & Emery on

There have been 44 initial public offerings (IPOs) listed on the US stock markets in 2024 thus far, many of which continue to trade at a premium to their initial offering price, demonstrating the strength and buoyancy of...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - February 2024

Securities Class Actions Show No Signs of Slowing in 2024 - Key Points - While the volume of securities class actions filings has remained consistently elevated over the past several years, the composition of the class...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

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