Moonlight Tx nets $5M in Series A round

Moonlight Tx nets $5M in Series A round

With the investment, Georgia Tech-launched Moonlight Therapeutics will evaluate its first food allergy treatment in clinical trials.
 
How and why: Called MOON101, the treatment is a skin stamp (above) that delivers drugs through needles small enough to be painless. The platform’s first drug is aimed at people with peanut allergies.
 
What’s unique: MOON101 overcomes skin barriers to deliver an allergen to an area of the skin that has an abundance of immune cells. It’s a complex drug delivery system in a simple stamp that’s applied daily. 

The latest backers: Portal Innovations, Inc. co-led the investment round, with AllerFund and Invest Georgia also investing. Based in Chicago, Portal Innovations held its grand opening for its Georgia HQ on Sept. 24 in Atlanta.
 
Significance: Clinical trials for MOON101 can now begin sooner.
 
 Read the Hypepotamus article on the investment >
 See GRA’s recent feature on Moonlight Therapeutics >

Georgia’s Life Sciences Momentum is Getting Noticed Nationally.

August 21, 2026
Genetic Engineering & Biotechnology News (GEN) has named Georgia #4 among its “Next 5 States” for emerging U.S. biopharma clusters . The article highlights UCB’s planned $2 billion investment at in Gwinnett County, Micron Biomedical’s new Alpharetta facility, Manus Bio’s expansion in Augusta, Science Square, Emory University, the CDC — and Georgia Life Sciences’ 10-year Life Sciences Roadmap . This recognition is exciting. But even more importantly, it validates the work happening across our entire ecosystem — and perfect momentum as we head into the 2026 Georgia Life Sciences Summit next week. Read more by visiting: Next 10 U.S. Biopharma Clusters

BIO Supports PDUFA VIII Commitment Letter and Urges Timely Reauthorization

August 17, 2026
Biotechnology Innovation Organization (BIO) Senior Vice President of Science & Regulatory Affairs Annetta Beauregard issued the following statement on the release of the Prescription Drug User Fee Act (PDUFA) VIII commitment letter: “For more than 30 years, PDUFA has helped deliver hundreds of new medicines to American patients. As a lead industry negotiator for the PDUFA VIII agreement, BIO supports the PDUFA VIII commitment letter and its strengthening of regulatory review, advancing innovation, and helping deliver safe and effective treatments to patients. “Specifically, the PDUFA VIII agreement includes important commitments that bolster the FDA’s core review activities, ensure accountability for predictable performance, improve financial sustainability and improve communication, transparency and efficiency. “Timely, bipartisan reauthorization of PDUFA is vital for protecting the health of Americans, strengthening U.S. competitiveness, and maintaining America’s global leadership in medical innovation. BIO is committed to working with Congress to ensure reauthorization by September 30, 2027.” The FDA has announced plans to hold a hybrid public meeting at 9am on 9/16 to discuss the proposed enhancements for the reauthorization of PDUFA for fiscal years (FYs) 2028 through 2033. Learn More about PDUFA and the PDUFA VIII commitment letter HERE .

Georgia Life Sciences Submits Comments on Medicare Drug Price Negotiation Program

August 17, 2026
Representing Georgia’s life sciences community, GLS emphasized the importance of advancing policies that improve affordability and patient access while preserving the environment necessary for continued biomedical innovation. In its comments, GLS urged CMS to maintain a framework grounded in FDA regulatory determinations and raised concerns about how certain proposed policies could affect post-approval research and development, investment in new indications, and patient access to innovative therapies. GLS also encouraged CMS to consider the broader implications for healthcare delivery, including the potential impact on patients and providers in rural and underserved communities. As federal drug pricing policy continues to evolve, Georgia Life Sciences will continue to advocate for approaches that balance affordability, access, and innovation while ensuring Georgia’s life sciences community has a voice in the policymaking process. Read Georgia Life Sciences’ full comments to CMS ( click here ).
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