Are Investors Overreacting to This Achromatopsia Study?

Applied Genetic Technologies Corp. (NASDAQ: AGTC) shares were crushed early Thursday after the firm reported interim data from its midstage trial in patients with achromatopsia. While the company says that the results are positive, this seems to be a case of “sell the news” among investors.

Specifically, the interim six-month data come from the ongoing Phase 1/2 clinical programs in patients with achromatopsia due to mutation in the ACHM CNGB3 or ACHM CNGA3 genes. The interim results from both studies demonstrate encouraging signs of biologic activity and a favorable safety profile. The company plans to report data from additional dose groups, age groups and time-points in the second half of 2020.

Furthermore, the data demonstrate encouraging signs of biologic activity, as shown by positive changes in light discomfort testing and encouraging patient anecdotes describing real-world improvements in visual function.

The company is currently dosing two higher dose groups in adults and three groups of pediatric patients at the three highest dose groups in both trials. Accordingly, management will use the additional data, which is expected to be available in the second half of 2020, to inform decision-making regarding readiness to move the product candidates to pivotal trials.

Achromatopsia is an inherited retinal disease that is present from birth and is characterized by the lack of cone photoreceptor function. The condition results in markedly reduced visual acuity, extreme light sensitivity causing day blindness, and complete loss of color discrimination.

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Sue Washer, president and CEO of AGTC, commented:

We are pleased that both of our achromatopsia clinical candidates are demonstrating preliminary signs of biologic activity for patients who have no current treatment options for a disease that significantly compromises their vision and quality of life. We are further encouraged by many patients’ real-world positive anecdotes. We are continuing dose escalation in order to determine the highest safe dose with the potential to provide maximal benefit. Combined with the positive six-month data presented earlier this month from our ongoing Phase 1/2 clinical trial in patients with X-linked retinitis pigmentosa, the results presented today further validate our AAV vector technology, clinical development expertise and ability to innovate and advance product candidates that have the potential to transform patient care.

Shares of Applied Genetic Tech traded down 32% early Thursday at $6.70, in a 52-week range of $2.52 to $10.42. The consensus price target is $14.42.
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