Today’s Daily Dose brings you news about FDA’s refusal to approve Alkermes’ antipsychotic drug ALKS 3831, BrainStorm’s NurOwn failing in amyotrophic lateral sclerosis study, Lexicon Pharma’s Sotagliflozin acing phase III trials and Kazia’s updated data of Paxalisib in glioblastoma.
1. FDA Says “No” To Alkermes’ Antipsychotic Drug ALKS 3831
The FDA has declined to approve Alkermes plc’s (ALKS) ALKS 3831, proposed for the treatment of adults with schizophrenia and adults with bipolar I disorder.
ALKS 3831 is composed of Samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, Olanzapine, in a single bilayer tablet.
The company has been asked to resolve certain conditions related to the tablet coating process at the company’s Wilmington, OH facility before ALKS 3831 may be approved. No concerns regarding the clinical or non-clinical data in the New Drug Application have been raised by the regulatory agency.
ALKS closed Tuesday’s trading at $18.30, up 2.58%.
2. BrainStorm Cell’s NurOwn Flunks Phase II ALS Study
BrainStorm Cell Therapeutics Inc.’s (BCLI) phase III trial evaluating NurOwn as a treatment for amyotrophic lateral sclerosis has failed to meet statistical significance in primary and key secondary efficacy endpoints.
However, NurOwn has shown a clinically meaningful treatment response compared to placebo in a pre-specified subgroup, the company noted.
Amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig’s disease, is a progressive and fatal neuromuscular disease. NurOwn consists of autologous mesenchymal stem cells derived from a patient s own bone marrow.
BCLI closed Tuesday’s trading at $4.02, down 66.3%.
3. Kazia’s New Glioblastoma Trial Data Consistent with Previous Results
Kazia Therapeutics Limited (KZIA) has revealed that results from a new interim analysis of a phase II study of Paxalisib in glioblastoma are highly consistent with prior data.
The interim data reported from the phase II study, reported in June, showed that Paxalisib was associated with an overall survival of 17.7 months and a progression-free survival of 8.5 months. As per the updated data, Paxalisib is associated with an overall survival of 17.5 months and a progression-free survival of 8.4 months, consistent with the June data.
The existing, FDA-approved standard of care, Temozolomide, is associated with an overall survival of 12.7 months and a progression-free survival of 5.3 months.
The study is expected to conclude in the first half of calendar 2021.
KZIA closed Tuesday’s trading at $9.88, up 6.47%.
4. Lexicon Aces Two Phase 3 Studies Of Sotagliflozin
Lexicon Pharmaceuticals Inc.’s (LXRX) phase III clinical trials evaluating the cardiovascular efficacy of Sotagliflozin in patients with type 2 diabetes, dubbed SOLOIST and SCORED, have achieved their primary endpoints.
SOLOIST evaluated the cardiovascular efficacy of Sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure.
SCORED evaluated the cardiovascular efficacy of Sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.
Both the trials have achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with Sotagliflozin compared with placebo, according to the company.
LXRX closed Tuesday’s trading at $1.81, up 40.31%.
5. Stocks Hitting New Highs/Lows
ALX Oncology Holdings Inc. (ALXO) closed Tuesday’s trading at a new high of $65.58, up 22.99%.
Biodesix Inc. (BDSX) closed at a new high of $16.35, up 17.88%.
Relay Therapeutics Inc. (RLAY) closed at a new high of $53.74, up 8.30%.
GoodRx Holdings Inc. (GDRX) closed at a new low of $36.21, down 22.50%.
Freeline Therapeutics Holdings plc (FRLN) closed at a new low of $14.94, down 4.84%.
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