02-Oct-2020:  Update on BLA for Graft Versus Host Disease

MESOBLAST RECEIVES COMPLETE RESPONSE LETTER FROM THE FDA FOR BIOLOGICS LICENSE APPLICATION FOR STEROID-REFRACTORY ACUTE GRAFT VERSUS HOST DISEASE IN CHILDREN

Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter to its Biologics License Application (BLA) for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). While the Oncologic Drugs Advisory Committee (ODAC) of the FDA voted 9:1 that the available data support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD, the FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD.

As there are currently no approved treatments for this life-threatening condition in children under 12, Mesoblast will urgently request a Type A meeting with the FDA, expected within 30 days, to discuss a potential accelerated approval with a post-approval condition for an additional study.

--- click on link above for the remainder of this announcement ---

06-May-2020:  First Patients Dosed in Phase 2/3 Trial for COVID-19 ARDS

24-Apr-2020:  83% Survival in COVID-19 ARDS Patients with Remestemcel-L

83% SURVIVAL IN COVID-19 PATIENTS WITH MODERATE/SEVERE ACUTE RESPIRATORY DISTRESS SYNDROME TREATED IN NEW YORK WITH MESOBLAST’S CELL THERAPY REMESTEMCEL-L

Key points:

• 83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated with two infusions of Mesoblast’s allogeneic cell therapy remestemcel-L within the first five days under emergency compassionate use at New York City’s Mt Sinai hospital during the period March-April 2020
• 75% (9/12) have successfully come off ventilator support within a median of 10 days
• These results contrast with only 9% of ventilator-dependent COVID-19 patients being able to come off ventilators with standard of care treatment and only 12% survival in ventilator-dependent COVID-19 patients at two major referral hospital networks in New York during the same time period
• This compassionate use treatment experience has informed the design of the clinical protocol for the randomized, placebo-controlled Phase 2/3 trial of remestemcel-L in ventilator-dependent COVID-19 moderate/severe ARDS patients across North America 

--- click on link for more ---

MSB were up +39% on this news today.  Since their $1.10 low point on March 23rd, MSB have risen +148% in 4 weeks to close at $2.73 today.  However, they were even higher 3 months ago, on Jan 24th, when they closed at $3.07, so I don't think they're rediculously overpriced... yet...  Quite a news-driven SP recovery, and plenty of positive news to drive it.

Disclosure:  I do NOT hold MSB shares.  Wouldn't be selling if I did though.

09-Apr-2020:  US NIH Trials Network to Conduct COVID-19 Phase 2/3 Trial

MSB is up another +21% today on the back of this announcement, on top of the +35% rise they enjoyed on Monday.

06-Apr-2020:  FDA Clears IND for Remestemcel Use in COVID-19 ARDS

14:15 (2:15pm Sydney Time):  MSB is up around +35% today on the back of that one.