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9 Meters (NMTR) Up on Results From Bowel Syndrome Candidate
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9 Meters Biopharma was up 31.7% pre-market on Sep 27, after the company announced top-line results from its phase II study of its lead candidate, vurolenatide. The candidate is being developed for adults with short bowel syndrome (SBS). The company also reported a successful end-of-phase II meeting with the FDA to progress the candidate to a phase III study. This also impacted the surge in 9 Meters’ stock price.
However, shares of 9 Meters have plunged 78.8% year-to-date compared with the industry’s fall of 28.1%.
Image Source: Zacks Investment Research
9 Meters announced the completion of its phase II VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT (VIBRANT) study evaluating vurolenatide, a proprietary long-acting GLP-1 receptor agonist, in SBS.
The multi-center, double-blind-placebo-controlled study evaluating the safety, efficacy and tolerability of vurolenatide consisted of four parallel treatment arms — vurolenatide 50 mg every two weeks (Q2W), vurolenatide 50 mg every week, vurolenatide 100 mg Q2W and placebo.
The study’s primary endpoint was the change in baseline total stool output (TSO) volume in 24 hours throughout six weeks.
The arm treating patients with 50 mg vurolenatide every two weeks witnessed a 30% decline in the 24-hour TSO volume against a 32% increase in the placebo arm. This arm exhibited an optimal pharmacokinetic profile of the candidate.
The 50 mg vurolenatide every week treatment arm witnessed an 8% fall in TSO for a relative reduction compared with a placebo of 40%. Both arms demonstrated evidence of drug accumulation, resulting in a suboptimal pharmacokinetic profile of the candidate.
No serious adverse events were reported related to vurolenatide.
Thus, the results from the phase II study affirmed the safety and efficacy of vurolenatide and contributed to 9 Meters’ decision to take the study forward to phase III.
Based on the positive results of the phase II study, the company also reported the outcome of its end-of-phase II meeting with the FDA regarding its candidate.
According to the outcome of the end-of-phase II meeting, the company intends to submit the phase III protocol to the FDA by the fourth quarter of 2022. After the protocol’s finalization, 9 Meters will provide the investors with further details on the phase III study of vurolenatide.
Notably, vurolenatide also received Orphan Drug designation from the FDA.
Investors must also note that the company is also developinglarazotide, a tight junction regulator for multi-system inflammatory syndrome in children. The company also has several early-stage pipeline candidates being developed for rare undisclosed diseases.
Aridis Pharmaceuticals' loss estimates for 2022 have remained steady at 23 cents over the past 30 days. The loss estimates for 2023 also remained steady at 53 cents per share in the same time frame.
ARDS surpassed earnings in three of the trailing four quarters, missing the same in one. The average negative earnings surprise for Aridis is 238.54%.
Immunocore’s loss per share estimates for 2022 widened from $1.34 to $1.46 in the past 30 days. The same for 2023 has narrowed from $1.78 to $1.65 in the same time frame.
Earnings of Immunocore missed estimates in three of the trailing four quarters, while beating the same in the remaining occasion. The average earnings surprise for IMCR is 33.28%.
Satsuma’s loss per share estimates for 2022 remained steady at $1.97 in the past 30 days. The loss per share for 2023 has widened from 98 cents to $1.50 in the same time frame.
Earnings of Satsuma beat estimates in three of the trailing four quarters, while missing the same in one. The average negative earnings surprise for STSA is 0.54%.
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9 Meters (NMTR) Up on Results From Bowel Syndrome Candidate
9 Meters Biopharma was up 31.7% pre-market on Sep 27, after the company announced top-line results from its phase II study of its lead candidate, vurolenatide. The candidate is being developed for adults with short bowel syndrome (SBS). The company also reported a successful end-of-phase II meeting with the FDA to progress the candidate to a phase III study. This also impacted the surge in 9 Meters’ stock price.
However, shares of 9 Meters have plunged 78.8% year-to-date compared with the industry’s fall of 28.1%.
Image Source: Zacks Investment Research
9 Meters announced the completion of its phase II VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT (VIBRANT) study evaluating vurolenatide, a proprietary long-acting GLP-1 receptor agonist, in SBS.
The multi-center, double-blind-placebo-controlled study evaluating the safety, efficacy and tolerability of vurolenatide consisted of four parallel treatment arms — vurolenatide 50 mg every two weeks (Q2W), vurolenatide 50 mg every week, vurolenatide 100 mg Q2W and placebo.
The study’s primary endpoint was the change in baseline total stool output (TSO) volume in 24 hours throughout six weeks.
The arm treating patients with 50 mg vurolenatide every two weeks witnessed a 30% decline in the 24-hour TSO volume against a 32% increase in the placebo arm. This arm exhibited an optimal pharmacokinetic profile of the candidate.
The 50 mg vurolenatide every week treatment arm witnessed an 8% fall in TSO for a relative reduction compared with a placebo of 40%. Both arms demonstrated evidence of drug accumulation, resulting in a suboptimal pharmacokinetic profile of the candidate.
No serious adverse events were reported related to vurolenatide.
Thus, the results from the phase II study affirmed the safety and efficacy of vurolenatide and contributed to 9 Meters’ decision to take the study forward to phase III.
Based on the positive results of the phase II study, the company also reported the outcome of its end-of-phase II meeting with the FDA regarding its candidate.
According to the outcome of the end-of-phase II meeting, the company intends to submit the phase III protocol to the FDA by the fourth quarter of 2022. After the protocol’s finalization, 9 Meters will provide the investors with further details on the phase III study of vurolenatide.
Notably, vurolenatide also received Orphan Drug designation from the FDA.
Investors must also note that the company is also developinglarazotide, a tight junction regulator for multi-system inflammatory syndrome in children. The company also has several early-stage pipeline candidates being developed for rare undisclosed diseases.
9 Meters Biopharma, Inc. Price
9 Meters Biopharma, Inc. price | 9 Meters Biopharma, Inc. Quote
Zacks Rank and Stocks to Consider
9 Meters currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector include Aridis Pharmaceuticals (ARDS - Free Report) , Immunocore (IMCR - Free Report) and Satsuma Pharmaceuticals , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Aridis Pharmaceuticals' loss estimates for 2022 have remained steady at 23 cents over the past 30 days. The loss estimates for 2023 also remained steady at 53 cents per share in the same time frame.
ARDS surpassed earnings in three of the trailing four quarters, missing the same in one. The average negative earnings surprise for Aridis is 238.54%.
Immunocore’s loss per share estimates for 2022 widened from $1.34 to $1.46 in the past 30 days. The same for 2023 has narrowed from $1.78 to $1.65 in the same time frame.
Earnings of Immunocore missed estimates in three of the trailing four quarters, while beating the same in the remaining occasion. The average earnings surprise for IMCR is 33.28%.
Satsuma’s loss per share estimates for 2022 remained steady at $1.97 in the past 30 days. The loss per share for 2023 has widened from 98 cents to $1.50 in the same time frame.
Earnings of Satsuma beat estimates in three of the trailing four quarters, while missing the same in one. The average negative earnings surprise for STSA is 0.54%.