Meg Flippin, Benzinga Staff WriterData reviewed by Dr. Helen Sabzevari at last week&#39;s Goldman Sachs healthcare conference suggests potential of extended surgical holidays for patients with RRP, a rare respiratory disease

<p><i><strong>Meg Flippin, Benzinga Staff Writer</strong></i></p><p><i><strong>Data reviewed by Dr. Helen Sabzevari at last week's Goldman Sachs healthcare conference suggests potential of extended surgical holidays for patients with RRP, a rare respiratory disease</strong></i></p> <p><strong id="dateline">GERMANTOWN, MD / <a href='https://www.accessnewswire.com/'>ACCESS Newswire</a> / June 15, 2026 / </strong><strong>Precigen Inc. </strong>(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/PGEN">PGEN</a>) has gained an important advantage in the marketing of its new treatment for adults with recurrent respiratory papillomatosis (RRP), a rare and debilitating disease of the respiratory tract.</p><a href="https://app.accessnewswire.com/imagelibrary/ba627f92-c161-4878-98bb-ab8347d57b91/1177080/precigen-061426.jpg" rel="nofollow"><img src="https://app.accessnewswire.com/imagelibrary/ba627f92-c161-4878-98bb-ab8347d57b91/1177080/precigen-061426.jpg" style="width:715px;text-align:center;margin:0.9em auto;"></a><div> </div><div> </div><div> </div><div><p>The commercial-stage precision medicines company was just granted orphan drug exclusivity by the FDA for PAPZIMEOS&#8482; (zopapogene imadenovec-drba), its treatment for RRP, a disease that typically requires patients to undergo multiple surgeries each year to remove benign tumors called papillomas that grow in the respiratory tract.</p><p>Orphan drug exclusivity is granted to certain drugs and biologics approved for rare diseases or conditions that affect fewer than 200,000 people in the United States. The orphan drug exclusivity means the FDA can't approve any similar drugs to treat RRP for seven years, extending PAPZIMEOS' market exclusivity through August 2032.</p><p>"This regulatory exclusivity, together with Precigen's patent portfolio covering PAPZIMEOS and its therapeutic use, enhances the product's value by strengthening market protection and long-term revenue potential, which in turn supports continued innovation for rare diseases," said Helen Sabzevari, PhD, President and CEO of Precigen.</p><p><strong>How It Works</strong></p><p>PAPZIMEOS uses a modified adenovirus to teach the immune system to spot and attack the proteins found in HPV 6 and HPV 11, which are the main cause of RRP. PAPZIMEOS reduces the number of surgeries a patient needs and provides a more effective way of clearing the airway, reports the company. Discovered, designed and developed in Precigen's labs using its proprietary AdenoVerse therapeutic platform, the company says PAPZIMEOS represents a new therapeutic paradigm for RRP.</p><p>The drug is commercially available in the U.S. and is being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment.</p><p><strong>Encouraged By Long-Term Study Results</strong></p><p>The orphan drug exclusivity of PAPZIMEOS comes at a time when Precigen released encouraging long-term durability data from its pivotal study at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.</p><p>The data showed that 15 out of 18 complete responders, or 83%, demonstrated ongoing complete responses for at least 36 months without any additional treatment for RRP. Five didn't need treatments after four years. Participants did not receive any additional treatments for RRP, including surgery or off-label investigational treatments, during the follow-up period, and no new safety events were observed during long-term follow-up.</p><p>"The presentation at ASCO marks an important maturation of the PAPZIMEOS pivotal study data, with all complete responders now followed for at least 36 months, 83% with ongoing response, including 5 patients who are surgery-free beyond 4 years," said Dr. Sabzevari. "For adults living with RRP, durability matters. These results continue to show that PAPZIMEOS provides sustained complete responses, reinforcing its role as the new standard of care for a disease historically managed through repeated surgeries." Follow-up for the study remains ongoing.</p><p>PAPZIMEOS gives RRP patients another option besides surgery, and now Precigen offers a solution with some protection from competition for the next several years. With promising long-term durability results added to the mix, Dr. Sabzevari shared updates on the launch when she spoke at last week's Goldman Sachs 47th Annual Global Healthcare Conference.</p><p>Contact: <br/>Steven Harasym<br/><a rel="nofollow" href="mailto:investors@precigen.com">investors@precigen.com</a></p><p><a rel="nofollow" href="https://pr.report/mklf"><i>Click here</i></a><i> for more information on Precigen and PAPZIMEOS</i></p><p><i>Featured image from </i><a rel="nofollow" href="https://pr.report/mklg"><i>Shutterstock</i></a><i>.</i></p><p><i>This post contains sponsored content and was created in collaboration with a third-party partner. Benzinga is a publisher and does not provide personalized investment advice or act as a broker or dealer. This content is for informational purposes only and is not intended to be investing advice or an offer or solicitation to buy or sell any security.</i></p></div><p><strong>SOURCE: </strong>Precigen, Inc.</p><br/><br/>View the original <a href='https://www.accessnewswire.com/newsroom/en/biotechnology/precigen-gains-advantage-as-papzimeos-granted-orphan-drug-exclusivity-by-fda-long-ter-1177080'>press release</a> on ACCESS Newswire<br/><br/>
      <img src="https://app.accessnewswire.com/img.ashx?id=1177080" width="0" height="0"/>

PGEN

Precigen Gains Advantage as PAPZIMEOS Granted Orphan Drug Exclusivity by FDA; Long-Term Data From Clinical Study Encouraging

Precigen gains FDA orphan exclusivity as PAPZIMEOS shows durable RRP responses

<section class="insight" data-version="1">
  <section data-block="information">
    <h3>Information</h3>
    <p>Meg Flippin, Benzinga Staff WriterData reviewed by Dr. Helen Sabzevari at last week&amp;#39;s Goldman Sachs healthcare conference suggests potential of extended surgical holidays for patients with RRP, a rare respiratory disease</p>
  </section>

  <section data-block="ai-summary-paragraph">
    <h3>AI Summary</h3>
    <p>Precigen announced FDA orphan-drug exclusivity for PAPZIMEOS, extending protection through Aug 2032. New long-term ASCO durability data show 83% of complete responders sustaining responses for at least 36 months, with several patients surgery-free for over four years. These factors bolster market access, long-run revenue potential, and upside for PGEN shares.</p>
  </section>

  <section data-block="ai-summary-bullets">
    <h3>Key Points</h3>
    <ul><li>FDA grants orphan-drug exclusivity for PAPZIMEOS through Aug 2032.</li><li>ASCO data: 83% (15/18) complete responders durable ≥36 months.</li><li>Orphan exclusivity plus patents strengthen PAPZIMEOS&#039; market protection.</li><li>PAPZIMEOS is already commercially available and prescribed nationwide.</li></ul>
  </section>

  <section data-block="companies-mentioned">
    <h3>Companies Mentioned</h3>
    <ul><li><strong>Precigen, Inc. (PGEN)</strong>: Orphan-drug exclusivity for PAPZIMEOS strengthens market protection and potential revenue.</li><li><strong>PAPZIMEOS (N/A)</strong>: Product; exclusivity extends to 2032; durable efficacy data enhance moat.</li></ul>
  </section>

  <section data-block="category">
    <h3>Corporate Developments</h3>
    <p>Category: Corporate Developments. Regulatory exclusivity milestones and supportive trial data for PAPZIMEOS represent a key corporate milestone with direct implications for PGEN&#039;s revenue potential and competitive positioning.</p>
  </section>

  <section data-block="market-moving">
    <h3>Market-Moving</h3>
    <ul><li>FDA orphan-drug exclusivity through Aug 2032 creates near-term moat.</li><li>ASCO durability data bolster evidence of durable efficacy.</li><li>PAPZIMEOS is commercially available and prescribed nationwide.</li><li>Positive investor sentiment anticipated from Goldman Sachs healthcare conference coverage.</li></ul>
  </section>

  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>FDA granted orphan-drug exclusivity for PAPZIMEOS through Aug 2032.</li><li>83% (15/18) complete responders had ongoing responses ≥36 months.</li><li>5 patients were surgery-free beyond 4 years.</li><li>ASCO 2026 data presented on long-term durability.</li><li>RRP affects fewer than 200,000 people in the US.</li></ul>
  </section>

  <section data-block="trading-thesis">
    <h3>Trading Thesis</h3>
    <p>Bullish within 12–18 months as exclusivity and durability data support growth.</p>
  </section>
</section>


<p><i><strong>Meg Flippin, Benzinga Staff Writer</strong></i></p><p><i><strong>Data reviewed by Dr. Helen Sabzevari at last week's Goldman Sachs healthcare conference suggests potential of extended surgical holidays for patients with RRP, a rare respiratory disease</strong></i></p> <p><strong id="dateline">GERMANTOWN, MD / <a href='https://www.accessnewswire.com/'>ACCESS Newswire</a> / June 15, 2026 / </strong><strong>Precigen Inc. </strong>(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/PGEN">PGEN</a>) has gained an important advantage in the marketing of its new treatment for adults with recurrent respiratory papillomatosis (RRP), a rare and debilitating disease of the respiratory tract.</p><a href="https://app.accessnewswire.com/imagelibrary/ba627f92-c161-4878-98bb-ab8347d57b91/1177080/precigen-061426.jpg" rel="nofollow"><img src="https://app.accessnewswire.com/imagelibrary/ba627f92-c161-4878-98bb-ab8347d57b91/1177080/precigen-061426.jpg" style="width:715px;text-align:center;margin:0.9em auto;"></a><div> </div><div> </div><div> </div><div><p>The commercial-stage precision medicines company was just granted orphan drug exclusivity by the FDA for PAPZIMEOS&#8482; (zopapogene imadenovec-drba), its treatment for RRP, a disease that typically requires patients to undergo multiple surgeries each year to remove benign tumors called papillomas that grow in the respiratory tract.</p><p>Orphan drug exclusivity is granted to certain drugs and biologics approved for rare diseases or conditions that affect fewer than 200,000 people in the United States. The orphan drug exclusivity means the FDA can't approve any similar drugs to treat RRP for seven years, extending PAPZIMEOS' market exclusivity through August 2032.</p><p>"This regulatory exclusivity, together with Precigen's patent portfolio covering PAPZIMEOS and its therapeutic use, enhances the product's value by strengthening market protection and long-term revenue potential, which in turn supports continued innovation for rare diseases," said Helen Sabzevari, PhD, President and CEO of Precigen.</p><p><strong>How It Works</strong></p><p>PAPZIMEOS uses a modified adenovirus to teach the immune system to spot and attack the proteins found in HPV 6 and HPV 11, which are the main cause of RRP. PAPZIMEOS reduces the number of surgeries a patient needs and provides a more effective way of clearing the airway, reports the company. Discovered, designed and developed in Precigen's labs using its proprietary AdenoVerse therapeutic platform, the company says PAPZIMEOS represents a new therapeutic paradigm for RRP.</p><p>The drug is commercially available in the U.S. and is being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment.</p><p><strong>Encouraged By Long-Term Study Results</strong></p><p>The orphan drug exclusivity of PAPZIMEOS comes at a time when Precigen released encouraging long-term durability data from its pivotal study at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.</p><p>The data showed that 15 out of 18 complete responders, or 83%, demonstrated ongoing complete responses for at least 36 months without any additional treatment for RRP. Five didn't need treatments after four years. Participants did not receive any additional treatments for RRP, including surgery or off-label investigational treatments, during the follow-up period, and no new safety events were observed during long-term follow-up.</p><p>"The presentation at ASCO marks an important maturation of the PAPZIMEOS pivotal study data, with all complete responders now followed for at least 36 months, 83% with ongoing response, including 5 patients who are surgery-free beyond 4 years," said Dr. Sabzevari. "For adults living with RRP, durability matters. These results continue to show that PAPZIMEOS provides sustained complete responses, reinforcing its role as the new standard of care for a disease historically managed through repeated surgeries." Follow-up for the study remains ongoing.</p><p>PAPZIMEOS gives RRP patients another option besides surgery, and now Precigen offers a solution with some protection from competition for the next several years. With promising long-term durability results added to the mix, Dr. Sabzevari shared updates on the launch when she spoke at last week's Goldman Sachs 47th Annual Global Healthcare Conference.</p><p>Contact: <br/>Steven Harasym<br/><a rel="nofollow" href="mailto:investors@precigen.com">investors@precigen.com</a></p><p><a rel="nofollow" href="https://pr.report/mklf"><i>Click here</i></a><i> for more information on Precigen and PAPZIMEOS</i></p><p><i>Featured image from </i><a rel="nofollow" href="https://pr.report/mklg"><i>Shutterstock</i></a><i>.</i></p><p><i>This post contains sponsored content and was created in collaboration with a third-party partner. Benzinga is a publisher and does not provide personalized investment advice or act as a broker or dealer. This content is for informational purposes only and is not intended to be investing advice or an offer or solicitation to buy or sell any security.</i></p></div><p><strong>SOURCE: </strong>Precigen, Inc.</p><br/><br/>View the original <a href='https://www.accessnewswire.com/newsroom/en/biotechnology/precigen-gains-advantage-as-papzimeos-granted-orphan-drug-exclusivity-by-fda-long-ter-1177080'>press release</a> on ACCESS Newswire<br/><br/>
      <img src="https://app.accessnewswire.com/img.ashx?id=1177080" width="0" height="0"/>

Precigen announced FDA orphan-drug exclusivity for PAPZIMEOS, extending protection through Aug 2032. New long-term ASCO durability data show 83% of complete responders sustaining responses for at least 36 months, with several patients surgery-free for over four years. These factors bolster market access, long-run revenue potential, and upside for PGEN shares.

Precigen Gains Advantage as PAPZIMEOS Granted Orphan Drug Exclusivity by FDA; Long-Term Data From Clinical Study Encouraging

AI Summary

Sentiment Rationale

Trading Thesis

Market-Moving

Key Facts

Companies Mentioned

Corporate Developments

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