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Selecta (SELB) Down on FDA's Clinical Hold on Phase I/II Study
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Selecta Biosciences, Inc. announced that the FDA has placed a clinical hold on its phase I/II study, which is evaluating its pipeline candidate SEL-302 for the treatment of patients with methylmalonic acidemia (“MMA”), an inherited rare metabolic disorder.
We note that SEL-302 consists of MMA-101 plus ImmTOR.
The FDA issued the clinical hold to get additional information on the chemistry, manufacturing and controls related to the MMA-101 product candidate. Selecta plans to work closely with the FDA to address the latter’s demand for additional information. The phase I/II study has not been initiated yet. The company does not expect to begin dosing in the study until the FDA’s queries are resolved.
Shares of Selecta were down 12.9% in after-hours trading on Wednesday following the announcement of the news. The stock has rallied 4.9% so far this year against the industry’s decrease of 17.6%.
Image Source: Zacks Investment Research
We remind investors that the FDA had granted an orphan drug designation to MMA-101 for the treatment of MMA in November last year. The regulatory body has also granted Rare Pediatric Disease designation to MMA-101 in October 2020 for the treatment of isolated MMA.
Please note that Selecta’s lead pipeline candidate is SEL-212. The company has a strategic license agreement with Swedish Orphan Biovitrum AB (Sobi) to help advance the development and commercialization of SEL-212. The candidate is being evaluated in the phase III DISSOLVE study for the treatment of patients with chronic refractory gout. Top-line data from the same is expected in the second half of 2022.
Selecta’s top line primarily comprise of revenues recognized under the license agreement with Sobi resulting from the shipment of clinical supply and the reimbursement of costs incurred for the phase III DISSOLVE program.
Image: Bigstock
Selecta (SELB) Down on FDA's Clinical Hold on Phase I/II Study
Selecta Biosciences, Inc. announced that the FDA has placed a clinical hold on its phase I/II study, which is evaluating its pipeline candidate SEL-302 for the treatment of patients with methylmalonic acidemia (“MMA”), an inherited rare metabolic disorder.
We note that SEL-302 consists of MMA-101 plus ImmTOR.
The FDA issued the clinical hold to get additional information on the chemistry, manufacturing and controls related to the MMA-101 product candidate. Selecta plans to work closely with the FDA to address the latter’s demand for additional information. The phase I/II study has not been initiated yet. The company does not expect to begin dosing in the study until the FDA’s queries are resolved.
Shares of Selecta were down 12.9% in after-hours trading on Wednesday following the announcement of the news. The stock has rallied 4.9% so far this year against the industry’s decrease of 17.6%.
We remind investors that the FDA had granted an orphan drug designation to MMA-101 for the treatment of MMA in November last year. The regulatory body has also granted Rare Pediatric Disease designation to MMA-101 in October 2020 for the treatment of isolated MMA.
Please note that Selecta’s lead pipeline candidate is SEL-212. The company has a strategic license agreement with Swedish Orphan Biovitrum AB (Sobi) to help advance the development and commercialization of SEL-212. The candidate is being evaluated in the phase III DISSOLVE study for the treatment of patients with chronic refractory gout. Top-line data from the same is expected in the second half of 2022.
Selecta’s top line primarily comprise of revenues recognized under the license agreement with Sobi resulting from the shipment of clinical supply and the reimbursement of costs incurred for the phase III DISSOLVE program.
Zacks Rank & Stocks to Consider
Selecta currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the biotech sector include Sarepta Therapeutics, Inc. (SRPT - Free Report) , vTv Therapeutics Inc. (VTVT - Free Report) and Editas Medicine, Inc. (EDIT - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sarepta Therapeutics’ loss per share estimates have narrowed 31.3% for 2021 and 26% for 2022, over the past 60 days.
Earnings of Sarepta Therapeutics have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions.
vTv Therapeutics’ loss per share estimates have narrowed 21.7% for 2021 and 2.9% for 2022, over the past 60 days.
vTv Therapeutics’ earnings have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Editas Medicine’s loss per share estimates have narrowed 11.2% for 2021 and 4.6% for 2022, over the past 60 days.
Editas Medicine’s earnings have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.