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PTC Therapeutics (PTCT) Halts Huntington's Disease Study in US
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PTC Therapeutics, Inc. (PTCT - Free Report) announced that the FDA has requested additional data to allow the company to proceed with its phase II PIVOT-HD study evaluating PTC518 for the treatment of Huntington's disease in the United States.
Subsequently, PTCT paused enrollment in the given study and continues to discuss the issue with the regulatory body for resuming enrollment in the United States.
Shares of the company were down 12.5% in after-hours trading on Tuesday following the announcement of the news. The stock has rallied 22.5% so far this year against the industry’s decline of 28.3%.
Image Source: Zacks Investment Research
The two-part PIVOT-HD study comprises an initial 12-week placebo-controlled part, which is focused on checking the pharmacology and pharmacodynamic effect of PTC518 and another nine-month placebo-controlled part, which is focused on collecting the blood, CSF and radiographic biomarker data.
Enrollment in the 12-week portion of the PIVOT-HD study first began in the United States while it continues globally including in several European countries as well as Australia.
PTC Therapeutics said that no treatment-related adverse events in the above-mentioned study have been reported so far in the United States or even outside the country.
PTCT remains focused on sharing data from the 12-week portion of the PIVOT-HD study by the first half of 2023.
We note that PTC Therapeutics has made certain collaborations and has gained some commercialization rights for several products from other companies. PTCT receives royalties from such collaborations, which strengthens its top line.
Swiss pharma giant Roche AG (RHHBY - Free Report) is developing Evrysdi (risdiplam) in collaboration with the SMA Foundation and PTC Therapeutics. The drug is approved for the treatment of spinal muscular atrophy (“SMA”) in the United States as well as in Europe.
The drug is marketed by Roche and was based on PTC Therapeutics’ splicing platform.
Evrysdi is approved in the United States to treat SMA in children and adults of all ages. The drug is currently being evaluated in five multicenter studies in people with SMA.
PTC Therapeutics receives milestone payments from Roche from the sale of Evrysdi in the United States.
Loss per share estimates for Fusion Pharmaceuticals narrowed 3.5% for 2022 and 6.8% for 2023 in the past 60 days.
Earnings of Fusion Pharmaceuticals have surpassed estimates in each of the trailing four quarters. FUSN delivered an earnings surprise of 16.22%, on average.
Loss per share estimates for Calithera Biosciences narrowed 37.3% for 2022 and 39.8% for 2023 in the past 60 days.
Earnings of Calithera Biosciences surpassed estimates in three of the trailing four quarters and missed on the other occasion. CALA delivered an earnings surprise of 21.08%, on average.
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PTC Therapeutics (PTCT) Halts Huntington's Disease Study in US
PTC Therapeutics, Inc. (PTCT - Free Report) announced that the FDA has requested additional data to allow the company to proceed with its phase II PIVOT-HD study evaluating PTC518 for the treatment of Huntington's disease in the United States.
Subsequently, PTCT paused enrollment in the given study and continues to discuss the issue with the regulatory body for resuming enrollment in the United States.
Shares of the company were down 12.5% in after-hours trading on Tuesday following the announcement of the news. The stock has rallied 22.5% so far this year against the industry’s decline of 28.3%.
Image Source: Zacks Investment Research
The two-part PIVOT-HD study comprises an initial 12-week placebo-controlled part, which is focused on checking the pharmacology and pharmacodynamic effect of PTC518 and another nine-month placebo-controlled part, which is focused on collecting the blood, CSF and radiographic biomarker data.
Enrollment in the 12-week portion of the PIVOT-HD study first began in the United States while it continues globally including in several European countries as well as Australia.
PTC Therapeutics said that no treatment-related adverse events in the above-mentioned study have been reported so far in the United States or even outside the country.
PTCT remains focused on sharing data from the 12-week portion of the PIVOT-HD study by the first half of 2023.
We note that PTC Therapeutics has made certain collaborations and has gained some commercialization rights for several products from other companies. PTCT receives royalties from such collaborations, which strengthens its top line.
Swiss pharma giant Roche AG (RHHBY - Free Report) is developing Evrysdi (risdiplam) in collaboration with the SMA Foundation and PTC Therapeutics. The drug is approved for the treatment of spinal muscular atrophy (“SMA”) in the United States as well as in Europe.
The drug is marketed by Roche and was based on PTC Therapeutics’ splicing platform.
Evrysdi is approved in the United States to treat SMA in children and adults of all ages. The drug is currently being evaluated in five multicenter studies in people with SMA.
PTC Therapeutics receives milestone payments from Roche from the sale of Evrysdi in the United States.
Zacks Rank & Stocks to Consider
PTC Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector are Fusion Pharmaceuticals Inc. (FUSN - Free Report) and Phio Pharmaceuticals Corp. (PHIO - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Fusion Pharmaceuticals narrowed 3.5% for 2022 and 6.8% for 2023 in the past 60 days.
Earnings of Fusion Pharmaceuticals have surpassed estimates in each of the trailing four quarters. FUSN delivered an earnings surprise of 16.22%, on average.
Loss per share estimates for Calithera Biosciences narrowed 37.3% for 2022 and 39.8% for 2023 in the past 60 days.
Earnings of Calithera Biosciences surpassed estimates in three of the trailing four quarters and missed on the other occasion. CALA delivered an earnings surprise of 21.08%, on average.