vurolenatide (NM-002)
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March 28, 2023
9 Meters Biopharma Provides Business Update and Reports Financial Results for Fourth Quarter and Full Year 2022
(Yahoo Finance)
- "Key Anticipated Near-Term Milestones: Presentation of Phase 2 study results of vurolenatide in SBS at ASPEN 2023 Nutritional Science & Practice Conference in April."
P2 data • Gastroenterology • Short Bowel Syndrome
March 07, 2023
9 Meters Biopharma to Present at the Oppenheimer 33rd Annual Healthcare Conference
(Yahoo Finance)
- "9 Meters Biopharma, Inc...announced that John Temperato, President and Chief Executive Officer of 9 Meters, is scheduled to present at the Oppenheimer 33rd Annual Healthcare Conference....The presentation will highlight the Company's pipeline, with a focus on vurolenatide, its long-acting GLP-1 agonist in Phase 3 development for short bowel syndrome, as well as upcoming milestones."
Clinical • Gastroenterology • Short Bowel Syndrome
January 31, 2023
9 Meters Biopharma to Present at the 2023 BIO CEO & Investor Conference
(Yahoo News)
- "9 Meters Biopharma, Inc...announced that John Temperato, President and Chief Executive Officer of 9 Meters is scheduled to present on Monday, February 6, 2023, at 10:00 AM ET as part of the BIO CEO & Investor Conference being held in New York City. The presentation, which is accessible to registered conference attendees, will highlight the Company's pipeline, with a focus on vurolenatide, its long-acting GLP-1 agonist in Phase 3 development for short bowel syndrome, as well as upcoming milestones."
Clinical • Short Bowel Syndrome
December 20, 2022
VIBRANT Study of Vurolenatide in Adult Patients With Short Bowel Syndrome.
(clinicaltrials.gov)
- P2 | N=12 | Terminated | Sponsor: 9 Meters Biopharma, Inc. | N=22 ➔ 12 | Trial completion date: Dec 2021 ➔ Aug 2022 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2021 ➔ Aug 2022; Trial terminated by Sponsor
Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Gastrointestinal Disorder • Short Bowel Syndrome
November 29, 2022
9 Meters Biopharma Announces Phase 3 Study of Vurolenatide in Short Bowel Syndrome
(Yahoo Finance)
- "US IRB approval secured; study to include up to 50 sites in North America and Europe and remains on track with study initiation as early as end-of-year...9 Meters Biopharma, Inc...announced the design of its Phase 3 clinical trial of vurolenatide for adults with short bowel syndrome (SBS). The study design follows the Company's successful End-of-Phase 2 meeting and incorporates input received from the U.S. Food and Drug Administration (FDA)....This international clinical study is designed to enroll approximately 105 patients with SBS..."
Clinical protocol • New P3 trial • Gastroenterology • Short Bowel Syndrome
November 08, 2022
9 Meters Biopharma Provides Business Update and Reports Financial Results for Third Quarter 2022
(Yahoo Finance)
- "...the Company entered into a senior secured convertible notes facility (the 'Convertible Note') for up to $70 million as part of an overall financing strategy to support the continued development of vurolenatide for short bowel syndrome through NDA submission."
Commercial • Gastroenterology • Short Bowel Syndrome
October 18, 2022
9 Meters Biopharma to Present at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting
(Yahoo Finance)
- "9 Meters Biopharma, Inc...announced two poster presentations at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting taking place in Charlotte, North Carolina on October 21-26, 2022....Representatives of the Company will be present on-site to address medical questions on the Company's product pipeline, particularly vurolenatide for short bowel syndrome, which recently showed positive results in a Phase 2 study."
Clinical data • Gastroenterology • Short Bowel Syndrome
September 27, 2022
9 Meters Biopharma Announces Positive Final Results from Phase 2 VIBRANT Study and Successful End-of-Phase 2 Meeting with FDA for Vurolenatide in Short Bowel Syndrome
(Yahoo Finance)
- P2 | N=22 | VIBRANT (NCT04988997) | Sponsor: 9 Meters Biopharma, Inc. | "9 Meters Biopharma, Inc...announced today positive final results from the Phase 2 study of vurolenatide and the outcome from its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA)....Based on the outcome from the meeting and the Phase 2 data, 9 Meters intends to finalize the Phase 3 protocol in collaboration with the FDA during the fourth quarter....The mean 24-hour TSO decrease for the 50 mg vurolenatide Q2W treatment arm was 30% versus an increase of 32% in the placebo arm, for a relative reduction compared to placebo of 62%."
P2 data • Short Bowel Syndrome
September 01, 2022
9 Meters Biopharma to Participate at the 44th European Society for Clinical Nutrition and Metabolism (ESPEN) Congress
(Yahoo Finance)
- "9 Meters Biopharma, Inc...announced that the company will participate at the 44th European Society for Clinical Nutrition and Metabolism (ESPEN) Congress taking place September 3-6, 2022, in Vienna....Representatives of the Company will be present on site to address medical questions on the Company's product pipeline, particularly vurolenatide for short bowel syndrome (SBS). 9 Meters recently reported positive preliminary Phase 2 results for vurolenatide in SBS..."
P2 data • Short Bowel Syndrome
August 31, 2022
9 Meters Biopharma to Participate in the Citi 17th Annual BioPharma Conference
(Yahoo Finance)
- "9 Meters Biopharma, Inc...announced today that the Company will participate in Citi's 17th Annual BioPharma Conference on September 8, 2022, in Boston. Management will be hosting one-on-one meetings with investors highlight the 9 Meters pipeline, with a focus on vurolenatide, its long-acting GLP-1 agonist for short bowel syndrome as well as upcoming milestones."
Clinical • Gastroenterology • Short Bowel Syndrome
August 15, 2022
9 Meters Biopharma Provides Business Update and Reports Financial Results for Second Quarter 2022
(Yahoo News)
- "...the Company entered into a senior secured convertible notes facility for up to $70 million as part of an overall financing strategy to support the continued development of vurolenatide for short bowel syndrome through NDA submission. The Company drew an initial net $20 million upon closing of the convertible note on July 15, 2022 and has the ability to access up to an additional $50 million in $5 - $20 million tranches per quarter over an 18-month period, provided the Company meets certain requirements, including raising additional capital."
Commercial • Gastroenterology • Short Bowel Syndrome
June 30, 2022
9 Meters Biopharma Announces Positive Preliminary Results from Phase 2 Study of Vurolenatide in Short Bowel Syndrome
(Streetinsider.com)
- P2 | N=22 | VIBRANT (NCT04988997) | Sponsor: 9 Meters Biopharma, Inc. | "9 Meters Biopharma, Inc...announced positive preliminary topline results from the VIBRANT study (VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT), its Phase 2 trial of vurolenatide...Based on positive results from this Phase 2 study and other supportive data, an end-of-Phase 2 meeting with FDA has been scheduled for mid-third quarter....Overall, 7 of 11 patients met the primary efficacy definition of TSO responder (greater than or equal to 10% reduction from baseline in 24-hour mean TSO) over the 6-week efficacy evaluation period....The Company currently anticipates initiating the VIBRANT-2 Phase 3 study as early as the fourth quarter of 2022. Plans for the study, including site identification and recruitment, are well underway."
New P3 trial • P2 data • Short Bowel Syndrome
June 13, 2022
9 Meters Biopharma to Participate in the 2022 BIO International Convention
(Streetinsider.com)
- "9 Meters Biopharma, Inc...announced the Company's participation in the 2022 BIO International Convention on June 13 - 16, 2022, in San Diego, California. Attendance at the 2022 BIO International Convention is aligned with the Company's strategy to secure partners for the global and/or regional development and future commercialization of its advanced development stage assets, vurolenatide for short bowel syndrome and larazotide for celiac disease."
Clinical • Gastroenterology • Short Bowel Syndrome
May 19, 2022
9 Meters Biopharma to Exhibit at Digestive Disease Week 2022
(Yahoo Finance)
- "9 Meters Biopharma, Inc...announced that the company will host an exhibit at Digestive Disease Week (DDW) which takes place May 21-24, 2022, in San Diego, CA....Representatives of the company will be present on site to provide medical information regarding 9 Meters' co-lead product candidates, vurolenatide for short bowel syndrome and larazotide for celiac disease, as well as information about the other candidates in its development pipeline."
Clinical • Short Bowel Syndrome
May 16, 2022
9 Meters Biopharma Provides Business Update and Reports Financial Results for First Quarter 2022
(BioSpace)
- "Key Anticipated Near-Term Milestones; Phase 2 vurolenatide data in SBS anticipated in June...Phase 3 vurolenatide SBS study expected to start in 2H 2022; Vurolenatide R&D Day is anticipated in Q3 2022 following the end-of-Phase 2 meeting with FDA."
New P3 trial • P2 data • Short Bowel Syndrome
May 05, 2022
9 Meters Biopharma to Present at the H.C. Wainwright Global Investment Conference and the LifeSci Partners Immunology & Inflammation Symposium
(Yahoo Finance)
- "9 Meters Biopharma, Inc...announced today that John Temperato, President & Chief Executive Officer of 9 Meters, will present at the LifeSci Partners Immunology & Inflammation Symposium on May 10, 2022, and the H.C. Wainwright Global Investment Conference to be held on May 23-26, 2022....The presentation will highlight the Company's advanced pipeline and upcoming clinical milestones for vurolenatide..."
Clinical • Gastroenterology • Short Bowel Syndrome
March 23, 2022
9 Meters Biopharma Provides Business Update and Reports Financial Results for Fourth Quarter and Full Year 2021
(BioSpace)
- "Key Anticipated 2022 Milestones...First patient dosed in vurolenatide Phase 3 study for SBS could be as early as Q3 2022."
New P3 trial • Gastroenterology • Short Bowel Syndrome
March 21, 2022
9 Meters Biopharma to Present at the Maxim Group 2022 Virtual Growth Conference
(Yahoo Finance)
- "9 Meters Biopharma, Inc...announced today that John Temperato, President & Chief Executive Officer of 9 Meters, will present at the Maxim Group 2022 Virtual Growth Conference hosted by M-Vest on March 28 - 30, 2022....The presentation will highlight the Company's advanced pipeline and upcoming clinical milestones for vurolenatide, its long-acting GLP-1 agonist for short bowel syndrome, currently in a Phase 2 clinical study..."
Clinical • Gastroenterology • Short Bowel Syndrome
March 09, 2022
9 Meters Biopharma to Present at the Oppenheimer 32nd Annual Healthcare Conference
(Yahoo Finance)
- "9 Meters Biopharma, Inc...announced today that John Temperato, President & Chief Executive Officer of 9 Meters, will present at the Oppenheimer 32nd Annual Healthcare Conference on Wednesday, March 16, 2022, at 10:00 a.m. (ET). The conference will take place on March 15-17, 2022, and is being held virtually....The presentation will highlight the Company's advanced pipeline and upcoming clinical milestones for vurolenatide, its long-acting GLP-1 agonist for short bowel syndrome currently in a Phase 2 clinical study..."
Clinical • Gastroenterology • Short Bowel Syndrome
March 01, 2022
9 Meters Biopharma Provides Clinical Update on Late-Stage Pipeline Products Vurolenatide for Short Bowel Syndrome and Larazotide for Celiac Disease
(Yahoo Finance)
- "9 Meters Biopharma, Inc...announced today an update on its late stage pipeline products vurolenatide, a proprietary long-acting glucagon-like peptide (GLP-1) agonist in a Phase 2 trial for adults with short bowel syndrome (SBS)...Enrollment is expected to be completed in the coming weeks, and the company will report top-line data in the second quarter of this year."
Enrollment status • P2 data • Gastroenterology • Short Bowel Syndrome
February 09, 2022
9 Meters Biopharma to Present at the 2022 BIO CEO & Investor Conference
(Yahoo Finance)
- "9 Meters Biopharma, Inc...announced today that John Temperato, President & Chief Executive Officer of 9 Meters Biopharma, Inc., will deliver a virtual presentation as part of the 2022 BIO CEO & Investor Conference taking place February 14-17, 2022. Registered attendees of the conference will have access to an on-demand presentation highlighting the Company's advanced pipeline and upcoming clinical milestones for vurolenatide, its long-acting GLP-1 agonist for short bowel syndrome currently in a Phase 2 clinical study..."
Clinical • Gastroenterology • Short Bowel Syndrome
January 10, 2022
Vurolenatide: End of P2 meeting with FDA for short bowel syndrome in H1 2022
(H.C. Wainwright Bioconnect Conference 2022 (Virtual Meeting), 9 Meters Biopharma)
FDA event • Short Bowel Syndrome
January 10, 2022
Vurolenatide: End of P2 meeting with FDA for short bowel syndrome in H1 2022
(H.C. Wainwright Bioconnect Conference 2022 (Virtual Meeting), 9 Meters Biopharma)
FDA event • Short Bowel Syndrome
January 10, 2022
Vurolenatide: Initiation of P3 trial for short bowel syndrome in H1 2022
(9 Meters Biopharma, H.C. Wainwright Bioconnect Conference 2022 (Virtual Meeting))
New P3 trial • Short Bowel Syndrome
January 10, 2022
Vurolenatide: Initiation of P3 trial for short bowel syndrome in H1 2022
(9 Meters Biopharma, H.C. Wainwright Bioconnect Conference 2022 (Virtual Meeting))
New P3 trial • Short Bowel Syndrome
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