Tcelna (imilecleucel-T)
/ EMD Serono, Zevra Therap
- LARVOL DELTA
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December 18, 2012
Lazard Capital Market Healthcare Conference
(Opexa Therapeutics)
- "Following two years of treatment, no worsening of physical condition and improvement in psychological condition"
P1 data • P1/2 data • Multiple Sclerosis
August 12, 2013
The highs and the lows: Opexa's changing market trends
(SeekingAlpha)
- P2b; N=180; Abili-T (NCT01684761); Anticipated data in 2016; Anticipated P3 trial; "Furthermore, if the TCELNA is approved by regulatory standards and commercialized by Merck, Opexa Therapeutics should receive royalties of up to 15% in annual sales, even stepping up should sales reach the $500 million, $1 billion and $2 billion milestones."
Anticipated commercial • Anticipated new P3 trial • Anticipated P2b data • Multiple Sclerosis
September 26, 2015
Tcelna clinical trial estimate: Initiation of P3 trial in multiple sclerosis by mid-2017; Tcelna US regulatory estimate: Approval for multiple sclerosis by 2020; Tcelna US launch estimate: By 2021
(Taglich Brothers)
- A subscription to Thomson ONE is required to gain full access to Report 26896609; REPORT TITLE: “Opexa Therapeutics Inc: Opexa Therapeutics initial report”; AUTHOR: Noble, Juan V; DATE: 09/02/2015
Anticipated BLA • Anticipated launch US • Anticipated new P3 trial • Financial analyst • Multiple Sclerosis
August 21, 2014
Opexa therapeutics: Corporate Presentation
(Opexa Therapeutics)
- Anticipated completion of P2b Abili-T immune monitoring trial for secondary progressive multiple sclerosis in H2 2016
Anticipated trial completion date • Multiple Sclerosis
November 08, 2011
Opexa’s Tovaxin for the treatment of multiple sclerosis granted fast track designation by FDA
(Business Wire)
- Tovaxin has been granted Fast Track designation by FDA for the treatment of patients with Secondary Progressive Multiple Sclerosis (SPMS); Company planning to initiate a P2b clinical trial with Tovaxin in SPMS subject to securing the necessary resources, while remaining committed to further advancing Tovaxin in Relapsing Remitting MS at a later date
Fast track designation • Multiple Sclerosis
December 18, 2012
Lazard Capital Market Healthcare Conference
(Opexa Therapeutics)
- "80% of subjects had no disease progression by EDSS at 2 years"
P2b data • Multiple Sclerosis
September 16, 2014
Opexa Therapeutics, Inc. announces termination of public offering of common stock
(Businesswire)
- "Opexa Therapeutics...today announced that it has terminated the public offering of shares of its common stock previously announced on Monday, September 15, 2014. The termination results from an assessment by Opexa’s management that current market conditions are not conducive for an offering on terms that would be in the best interests of Opexa’s stockholders. As a result of such termination, no shares will be sold pursuant to the offering."
Commercial • Multiple Sclerosis
January 10, 2017
Abili-T: Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis
(clinicaltrials.gov)
- P2; N=183; Completed; Sponsor: Opexa Therapeutics, Inc.; Active, not recruiting ➔ Completed
Trial completion • Biosimilar • Immunology • Multiple Sclerosis
May 03, 2016
Opexa’s CEO gives update on T-Cell Therapy at vatican conference
(Multiple Sclerosis News Today)
- "Top-line results from the Abili-T trial (NCT01684761) are expected in late 2016."
Anticipated P2 data • Multiple Sclerosis
March 05, 2016
Opexa Therapeutics: Clinical Trial Update
(Opexa Therapeutics)
- Anticipated top-line data from P2 Abili-T trial (NCT01684761) for secondary progressive multiple sclerosis in early Q4 2016
Anticipated P2 data • Multiple Sclerosis
March 10, 2014
Opexa Therapeutics: A long-term perspective for price appreciation
(SeekingAlpha)
- "The problem though is that the results for the Abil-T trial aren't out until the middle of 2016 so there will definitely be a dilution on the company's common stock before the phase 2b results are out for Tcelna in patients with SPMS. The good news though is that if the results are positive for Tcelna then the financial position would improve substantially for Opexa."
Anticipated P2b data • Commercial • Multiple Sclerosis
May 15, 2015
Opexa Therapeutics: Corporate Presentation
(Opexa Therapeutics)
- “Reversal of Disability in Prospective Analysis in More Active Patients”; “Sub-population of patients (n=50) with more progressed/active disease profile (baseline ARR > 1)"
P2b data • Multiple Sclerosis
March 07, 2014
Opexa Therapeutics: YE 2013 Results
(Opexa Therapeutics)
- Anticipated completion of enrollment in P2b Abili-T trial for secondary progressive multiple sclerosis in Q2 2014
Anticipated enrollment status • Multiple Sclerosis
July 09, 2014
Opexa Therapeutics: Corporate Presentation
(Opexa Therapeutics)
- "TERMS Study"; "A Completed Phase IIb Clinical Trial in RRMS"; "mITT population (n=142): 37% reduction in ARR vs. placebo; ARR 0.214 vs. 0.339"; "Superior safety and promising efficacy trend demonstrated"
P2b data • Multiple Sclerosis
September 12, 2012
Opexa initiates late stage clinical study of Tcelna in patients with secondary progressive multiple sclerosis (SPMS)
(Business Wire)
- Opexa Therapeutics has initiated new P2b trial named Abili-T; The trial is expected to enroll 180 pts at approximately 30 leading clinical sites in the U.S. and Canada with each patient receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year
New P2b trial • Multiple Sclerosis
August 14, 2012
Q2 2012 Results
(Opexa Therapeutics)
- Anticipated initiation of enrollment in US based sites for P2b trial in patients with secondary progressive MS in Q3 2012; Anticipated initiation of enrollment in Canada after finalization of regulatory approval
Anticipated enrollment status • Multiple Sclerosis
August 14, 2014
Opexa Therapeutics reports second quarter 2014 financial results and provides corporate update
(Businesswire)
- "Opexa believes it has sufficient liquidity to support its current clinical activities for the Abili-T trial and general operations to sustain itself into the fourth quarter of 2015."
Financing • Multiple Sclerosis
January 15, 2013
Opexa Therapeutics regains compliance with NASDAQ minimum bid price listing requirement
(Businesswire)
- "Opexa Therapeutics...developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today announced that it has received a letter from The NASDAQ Stock Market LLC notifying the Company that it has regained full compliance with the NASDAQ Capital Market's minimum bid price continued listing requirement."
Stock price • Multiple Sclerosis
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