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Document Humacyte Statement on Recent Attacks DURHAM, N.C.

Key Takeaway: Dr. Laura Niklason, President and CEO of Humacyte, Inc., publicly addressed a citizen petition aimed at stopping the company's operations in a recent statement. She criticized the petition, highlighting that its signatories lack experience with Humacyte's products and have previous ties to competitors. Niklason urged media outlets to disclose conflicts of interest related to the petition's authors. She affirmed that Humacyte will respond to the petition's claims at the appropriate time, firmly defending the company's reputation and achievements.
Price reaction · baseline $1.55 (2025-04-16 close) · hit after-hours · clean, no other HUMA news in the window
day 0 close · peak
+8.4%
day 1
-6.5%
day 3
-5.2%

Market Sentiment Analysis

POSITIVE FACTORS

  • Humacyte emphasizes its mission to save lives and limbs.
  • The company expresses confidence in countering the citizen petition.
  • Dr. Niklason showcases pride in Humacyte's achievements over two decades.

CONCERNS & RISKS

  • The existence of the citizen petition may indicate potential challenges ahead.
  • Competitors might use underhanded tactics to undermine Humacyte's credibility.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+21%
120-day peak, hindsight
Typical move
7.2%
average across 3 past catalysts
Cash runway
~11 mo
Medium dilution risk
Lead asset
Acellular Tissue Engineered Vessel
Phase 3 · Vascular Trauma

Full Press Release Details

Humacyte Statement on Recent Attacks
DURHAM, N.C., April 17, 2025 - Dr. Laura Niklason, President and CEO of Humacyte, Inc. (Nasdaq HUMA), released the following statement today
"At Humacyte, we're in the business of saving lives and limbs. The authors of a recent citizen petition' to the FDA - four men who have never used our product - want to stop us. We won't let them succeed."
"One of the signatories of this petition, Hooman Noorchashm, has filed nine previous petitions with the FDA, none of which has resulted in agency action. Another signatory, our chief critic, Robert E. Lee, left the FDA last fall - several months before Symvess was approved - to found Echelon, a private consulting firm focused on providing services to medical device companies. Two of Dr. Lee's colleagues on the leadership team at Echelon also serve as key advisors to Phraxis, Inc., one of Humacyte's potential competitors in providing vascular access for hemodialysis."
"It's perhaps no surprise that someone with competitive interests would resort to libel and slander against Humacyte. However, I hope that media outlets engaging with Dr. Lee disclose his clear and disqualifying personal conflicts of interest to their readers, rather than treating him as a credible voice."
"The citizen petition' itself is without merit. We will respond at the appropriate time with the FDA."
"Over the last two decades, we've worked hard to build Humacyte into what it is today. I take immense pride in that work, and I won't let false, harmful claims go unchallenged."

Frequently Asked Questions

What is Humacyte focused on?

Humacyte is dedicated to saving lives and limbs.

Who authored the recent citizen petition against Humacyte?

The petition was authored by four men, none of whom have used Humacyte's products.

What actions have been taken against Humacyte?

Humacyte faced a petition aimed at halting their operations, deemed without merit.

Who is Dr. Robert E. Lee?

Dr. Lee is Humacyte's chief critic and a former FDA official now at Echelon.

How does Humacyte respond to false claims?

Humacyte plans to contest harmful claims and address the FDA appropriately.

Last updated: Apr 17, 2025