Thanks Vinn,I mistakenly thought they had 60 days to approve it...

First 99 Last

Share
Profile

Follow
Tuhorangi

340 Posts.

60

03/02/20

17:03

Post #: 42721486
Share

Originally posted by vinn: ↑

Bell Potter ....
Mesoblast (MSB) has announced today the completion of its BLA filing for product Ryoncil to treat SR-aGvHD (steroid refractory GvHD) in children to the FDA. The last module covering quality control and manufacturing under the rolling BLA submission was filed on 31st January ‘20.

MSB has also requested Priority Review of the BLA by the FDA under Ryoncil’s existing Fast Track designation for SR-aGvHD.

We view this as a very important milestone in the history of the companyas it gets it one step closer to having its first product commercialised in the US.

FDA now has a 60 day window to confirm acceptance and eligibility for priority review with a PDUFA date. If the product will also be put in front of an advisory committee (ADCOM), then FDA will also advise MSB of the ADCOM date. We note that the ADCOM is generally held 1-2 months before the PDUFA date.

Assuming MSB gets priority review, we expect approval and launch is likely in 4QCY20 (given that the the 6 month review clock generally starts from the day FDA confirms the PDUFA date to MSB).

In preparation, MSB is building inventory with Lonza (US$15.1m minimum commitment) and building targeted sales force of ~15 to target 15 sites that treat >50% of patients with aGvHD in US.

We note that the adoption curve for MSB’s GvHD product temcell in Japan has been very strong (royalties for 2QFY20 were up 61% y/y, market penetration over 30% of addressable market in 4 years) and we continue to believe it has important read throughs for Ryoncil in the US market, which we believe will have even a faster growth trajectory. We expect Ryoncil could reach 35% penetration in US within 3 years. The US GvHD opportunity for Ryoncil is larger both in terms of value (double pricing vs. Japan) and addressable market size (adult + children is 4x of Japan). At peak penetration of 50% we forecast in-market sales in US in the paediatric GvHD population alone at US$117m, which is more than 2x of our assumptions for JCR’s in-market sales in Japan at peak.

Apart from the US launch of its first product, we also expect results from key Phase 3 trials in mid-CY20 for back-pain and heart failure to act as significant inflexion points for the stock.

MSB remains one of key stock picks for the year.

We retain Buy (spec) with A$5.15/sh valuation.

Expand

Thanks Vinn,

I mistakenly thought they had 60 days to approve it carte blanche silly me. An exiting year ahead.

Cheers

MSB Price at posting: $2.96 Sentiment: Buy Disclosure: Held
2 Upvote

0 Great analysis

Reply

Top Stories

ITM

iTech Minerals flags high-grade rockchip finds, boasting one sample at +18% copper. What lies underground remains to be seen

M4M

Macro Metals picks up 80% in Firebird's manganese plays; mining services operations to launch if decision to mine passed

ARU

Arafura updates on total US$1B funding as export banks and lenders take notice; heading toward FID for Nolans

Pilot Energy awarded $6.5M in govt funding for Mid West Clean Energy Project

DTM

Dart on-target for high-grade structures and multiple reefs at VIC's Rushworth

There are more pages in this discussion • 23 more messages in this thread...

First 99 Last

Add MSB (ASX) to my watchlist

(20min delay)
Last $1.31		Change 0.150(13.0%)		Mkt cap ! $1.490B

Open	High	Low	Value	Volume
$1.15	$1.33	$1.15	$25.26M	19.99M

Buyers (Bids)

No.	Vol.	Price($)
7	161000	$1.30

Sellers (Offers)

Price($)	Vol.	No.
$1.31	50400	2

View Market Depth

No.	Vol.	Price($)
7	161000	1.300
6	101986	1.295
6	226866	1.290
4	70613	1.285
5	137074	1.280

Price($)	Vol.	No.
1.310	50400	2
1.315	2007	1
1.320	40992	3
1.325	20772	3
1.330	139522	8

Last trade - 16.10pm 23/07/2024 (20 minute delay)

MSB (ASX) Chart

Thanks Vinn,I mistakenly thought they had 60 days to approve it...

iTech Minerals flags high-grade rockchip finds, boasting one sample at +18% copper. What lies underground remains to be seen

Macro Metals picks up 80% in Firebird's manganese plays; mining services operations to launch if decision to mine passed

Arafura updates on total US$1B funding as export banks and lenders take notice; heading toward FID for Nolans

Pilot Energy awarded $6.5M in govt funding for Mid West Clean Energy Project

Dart on-target for high-grade structures and multiple reefs at VIC's Rushworth

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Thanks Vinn,I mistakenly thought they had 60 days to approve it...

Top Stories

iTech Minerals flags high-grade rockchip finds, boasting one sample at +18% copper. What lies underground remains to be seen

Macro Metals picks up 80% in Firebird's manganese plays; mining services operations to launch if decision to mine passed

Arafura updates on total US$1B funding as export banks and lenders take notice; heading toward FID for Nolans

Pilot Energy awarded $6.5M in govt funding for Mid West Clean Energy Project

Dart on-target for high-grade structures and multiple reefs at VIC's Rushworth

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News