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Bellus (BLU) Stock Surges on Data From Chronic Cough Study
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Bellus Health’s shares surged 48.2% on Dec 13 after the player announced positive top-line data from the pivotal phase IIb SOOTHE study, which is evaluating its refractory chronic cough (RCC) candidate, BLU-5937.
The SOOTHE study evaluated three doses of BLU-5937 (12.5 mg, 50 mg and 200 mg BID) over a four-week period in RCC participants. The participants were randomized across four equal arms to evaluate the three doses of BLU-5937 and placebo. The primary efficacy endpoint is the placebo-adjusted change in the 24-hour cough frequency from baseline to day 28 collected with a cough recorder.
The study achieved statistical significance in its primary endpoint with 34% placebo-adjusted reduction in 24-hour cough frequency observed at day 28 in the 50 mg and 200 mg doses. Bellus Health also reported that the 12.5 mg dose achieved a 21% placebo-adjusted reduction in 24-hour cough frequencywith a dose response observed between the 12.5 mg and 50 mg BID doses. BLU-5937 was well-tolerated at all doses with low rates of taste-related adverse events.
Bellus Health plans to hold an end of phase II meeting in second-quarter 2022 to discuss its plans of initiating a phase III program by second-half 2022.
The stock has skyrocketed 171.2% so far this year against the industry’s 21.6% fall.
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Bellus Health also reported top-line data from the phase IIa BLUEPRINT study, evaluating BLU-5937 for chronic pruritus associated with atopic dermatitis. Though BLU-5937 was well-tolerated in participants, the BLUEPRINT study did not achieve any statistical significance in its primary endpoint of change from the baseline in weekly mean Worst Itch-Numeric Rating Scale (WI-NRS) score at week four.
Following these results, Bellus Health decided not to pursue the development of BLU-5937 for pruritic conditions but evaluate the candidate for indications wherein cough hypersensitivity plays an important role.
However, competition for BLU will be as stiff as Merck’s (MRK - Free Report) , which developed its own drug for RCC.
Merck’s candidate for RCC or unexplained chronic cough (UCC) is MK-7264 (gefapixant). MRK already filed a new drug application with the FDA based on data from the phase III companion studies, namely COUGH-1 and COUGH-2, seeking approval for gefapixant to address RCC or UCC in adults. The FDA had initially provided a target action date of Dec 21, 2021.
However, in July 2021, Merck announced that the FDA had extended the target action date to Mar 21, 2022. Merck also filed regulatory submissions in the EU and Japan, both of which are currently under review.
IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.09 in the past 60 days. The same for 2022 has narrowed from $1.17 to $1.03 in the past 60 days. Shares of IVERIC bio have gained 119.4% in the year so far.
Earnings of IVERIC bio missed estimates in three of the last four quarters and surpassed expectations once, the negative surprise being 5.6%, on average. IVERIC bio’s stock price closed at $15.16 at the end of the Dec 13 trading session.
Precision BioSciences’ loss per share estimates for 2021 have narrowed from $1.17 to $0.65 in the past 60 days. The same for 2022 has narrowed from $2.39 to $1.91 in the past 60 days.
Earnings of Precision BioSciences beat estimates in all the last four quarters, delivering a surprise of 76.9%, on average. Precision BioSciences’ stock price closed at $8.23 at the end of the Dec 13 trading session.
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Bellus (BLU) Stock Surges on Data From Chronic Cough Study
Bellus Health’s shares surged 48.2% on Dec 13 after the player announced positive top-line data from the pivotal phase IIb SOOTHE study, which is evaluating its refractory chronic cough (RCC) candidate, BLU-5937.
The SOOTHE study evaluated three doses of BLU-5937 (12.5 mg, 50 mg and 200 mg BID) over a four-week period in RCC participants. The participants were randomized across four equal arms to evaluate the three doses of BLU-5937 and placebo. The primary efficacy endpoint is the placebo-adjusted change in the 24-hour cough frequency from baseline to day 28 collected with a cough recorder.
The study achieved statistical significance in its primary endpoint with 34% placebo-adjusted reduction in 24-hour cough frequency observed at day 28 in the 50 mg and 200 mg doses. Bellus Health also reported that the 12.5 mg dose achieved a 21% placebo-adjusted reduction in 24-hour cough frequencywith a dose response observed between the 12.5 mg and 50 mg BID doses. BLU-5937 was well-tolerated at all doses with low rates of taste-related adverse events.
Bellus Health plans to hold an end of phase II meeting in second-quarter 2022 to discuss its plans of initiating a phase III program by second-half 2022.
The stock has skyrocketed 171.2% so far this year against the industry’s 21.6% fall.
Bellus Health also reported top-line data from the phase IIa BLUEPRINT study, evaluating BLU-5937 for chronic pruritus associated with atopic dermatitis. Though BLU-5937 was well-tolerated in participants, the BLUEPRINT study did not achieve any statistical significance in its primary endpoint of change from the baseline in weekly mean Worst Itch-Numeric Rating Scale (WI-NRS) score at week four.
Following these results, Bellus Health decided not to pursue the development of BLU-5937 for pruritic conditions but evaluate the candidate for indications wherein cough hypersensitivity plays an important role.
However, competition for BLU will be as stiff as Merck’s (MRK - Free Report) , which developed its own drug for RCC.
Merck’s candidate for RCC or unexplained chronic cough (UCC) is MK-7264 (gefapixant). MRK already filed a new drug application with the FDA based on data from the phase III companion studies, namely COUGH-1 and COUGH-2, seeking approval for gefapixant to address RCC or UCC in adults. The FDA had initially provided a target action date of Dec 21, 2021.
However, in July 2021, Merck announced that the FDA had extended the target action date to Mar 21, 2022. Merck also filed regulatory submissions in the EU and Japan, both of which are currently under review.
Bellus Health Inc. Price
Bellus Health Inc. price | Bellus Health Inc. Quote
Zacks Rank & Stocks to Consider
Bellus Health presently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the biotech sector include IVERIC bio and Precision BioSciences (DTIL - Free Report) , each currently carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.09 in the past 60 days. The same for 2022 has narrowed from $1.17 to $1.03 in the past 60 days. Shares of IVERIC bio have gained 119.4% in the year so far.
Earnings of IVERIC bio missed estimates in three of the last four quarters and surpassed expectations once, the negative surprise being 5.6%, on average. IVERIC bio’s stock price closed at $15.16 at the end of the Dec 13 trading session.
Precision BioSciences’ loss per share estimates for 2021 have narrowed from $1.17 to $0.65 in the past 60 days. The same for 2022 has narrowed from $2.39 to $1.91 in the past 60 days.
Earnings of Precision BioSciences beat estimates in all the last four quarters, delivering a surprise of 76.9%, on average. Precision BioSciences’ stock price closed at $8.23 at the end of the Dec 13 trading session.