Shares of Q32 Bio QTTB lost nearly 77% yesterday after it reported mixed results from two separate phase IIa studies evaluating its investigational drug bempikibart one in atopic dermatitis (AD or eczema) and the other in alopecia areata (AA).
While data from the AA study showed promising clinical activity for the drug, the study did not meet its primary endpoint in part B of the eczema study.
Based on the above results, management has decided to proceed with developing the drug for AA, but will no longer pursue development in the eczema indication.
Following the news, shares of Q32 Bio hit an all-time low of $5.80. The latest announcement did not impress investors, who raised concerns about the drug’s efficacy. Wall Street analysts were also not impressed with the results, one even calling it ‘messy.’
Year to date, Q32 Bio’s shares have lost 45.6% compared with the industry’s 8.7% decline.
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Data from the AA study revealed that treatment with bempikibart over 24 weeks showed improvement in the Severity of Alopecia Tool (SALT) score, a standardized method for assessing the extent of hair loss on the scalp. The study showed that patients treated with the drug exhibited a mean reduction in SALT score of 16% compared to 2% in the placebo group. Per management, 9% of patients treated with bempikibart achieved a SALT score less than or equal to 20 compared to nil in placebo.
However, Q32 Bio was unable to ascertain the primary endpoint due to an unforeseen decrease in study participants: three participants from the placebo arm were eliminated based on ‘marked protocol violations of entry criteria.’ Management now plans to enroll around 20 additional patients in a Part B expansion of this mid-stage study in AA patients.
In the eczema study, patients receiving the placebo demonstrated a slightly higher rate of improvement compared to those treated with bempikibart. Per management, 76% of placebo recipients showed improvement compared to 74% in the bempikibart-treatment group. The results were measured using the Eczema Area and Severity Index, a standardized scale for assessing eczema symptoms and severity.
While management intends to review the above data to get a better understanding of the results, it has decided not to advance the drug’s development in eczema.
Q32 Bio currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, 2024 estimates for Castle Biosciences have improved from a loss of 58 cents per share to earnings of 34 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.84. Year to date, shares of Castle Biosciences have surged 36.6%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 35 cents during the same timeframe. Year to date, CTMX stock has lost 23.9%.
CytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents during the same timeframe. Year to date, Spero’s shares have lost 21.8%.
SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.
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