Insmed Inc (INSM) ニュース

INSM range bound

INSM website contains “Phase 3 Data Presentation at the 7th World Bronchiectasis Conference” dated July 4, 2024. The presentation may be downloaded in slide form.

The additional data presentation likely accounts for the share price increase at 4 pm close = $70, + 12.9%.

BRIDGEWATER, N.J., May 28, 2024 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced positive topline results from the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis. The study met its primary endpoint, with both dosage strengths of brensocatib demonstrating statistically significant reductions in the annualized rate of pulmonary exacerbations (PEs) versus placebo. The study also met several of its prespecified secondary endpoints with statistical significance.

Based on these results, Insmed plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for brensocatib in patients with bronchiectasis in the fourth quarter of 2024. Pending regulatory approvals, Insmed anticipates a U.S. launch for brensocatib in mid-2025 followed by launches in Europe and Japan in the first half of 2026. If approved, brensocatib would be the first approved treatment for patients with bronchiectasis as well as the first approved dipeptidyl peptidase 1 (DPP1) inhibitor—a new mechanism of action with the potential to address a range of neutrophil-mediated diseases.

Topline efficacy results from the ASPEN study are as follows:









Brensocatib 10 mg
compared to placebo

Brensocatib 25 mg
compared to placebo

Primary Endpoint

Reduction in annualized rate of PEs








21.1 %

p=0.0019*

19.4 %

p=0.0046*

Secondary Endpoints

Prolongation of time to first PE








18.7 %

p=0.0100*

17.5 %

p=0.0182*

Increase in odds of remaining exacerbation free over 52 weeks








41.2 %

p=0.0059*

40.0 %

p=0.0074*

Change from baseline in post-bronchodilator forced
expiratory volume in 1 second (FEV1) at week 52








11 mL

p=0.3841

38 mL

p=0.0054*

Reduction in annualized rate of severe PEs








25.8 %

p=0.1277

26.0 %

p=0.1025

Change from baseline in the Quality of Life –
Bronchiectasis (QOL-B) Respiratory Score at week 52








2.0 points

p=0.0594

3.8 points

p=0.0004^

*Statistically significant

^Nominally significant p-value

"I am thrilled that the ASPEN study has demonstrated a statistically significant and clinically meaningful treatment effect for brensocatib compared with placebo, underscoring the impact this investigational therapy may have on patients with bronchiectasis," said lead study investigator James Chalmers, MBChB, Ph.D., Professor and Consultant Respiratory Physician at the School of Medicine, University of Dundee, UK. "Today, there is no approved treatment for bronchiectasis and there remains an urgent need for a therapy that can reduce exacerbations. As a DPP1 inhibitor, brensocatib would be the first treatment in its class and could offer a completely new approach to managing this difficult-to-treat patient population, heralding a new era in clinical management of bronchiectasis."

As part of the ASPEN study's conduct, more than 460 trial sites were engaged in nearly 40 countries. After excluding sites that did not enroll any patients and all sites in Ukraine, the total number of active sites in ASPEN was 391 sites in 35 countries. Adult patients (ages 18 to 85 years) were randomized 1:1:1 and adolescent patients (ages 12 to

Conference call - results Brensocatib

https://investor.insmed.com/2024-05-27-Insmed-to-Host-Investor-Call-to-Discuss-Topline-Results-from-Phase-3-ASPEN-Study-of-Brensocatib-in-Patients-with-Bronchiectasis

This could be the turning point for insmed

New 52-week high today, $36.48, backed off since ~ 10:15 am.

lookin good

* * $INSM Video Chart 02-04-2020 * *

Link to Video - click here to watch the technical chart video

* * $INSM Video Chart 02-03-2020 * *

Link to Video - click here to watch the technical chart video

Blueyedcatch,
Are you still around?
Yesterday was a great day for insmed!

GLTU
FTR

Very exciting times for Insmed. Great data,,major expansion app potential,,Japan totally in the works,and ready to be submitted once the data is ready, and translated. KaChing. 300 a share is not a stretch by any means for Insm,going forward. Next years a big year.

Chart that

Thanks for the encouragement. I will wait for a pullback. Or for the RSI to get back down to 50 or so. If I miss it, so be it. It looks a bit top heavy to me right now. GLTU

Oxnous,
I just think you're in time.
Take you're time to do some dd.

You will find out this is going a lot higher..,

http://files.shareholder.com/downloads/INSMED/399897590x0x690054/37e9b63d-74e7-4892-965b-a0ea6fb7cccf/INSMED-IR-Deck.pdf

See slide 6-7

Approval is around the corner....

LooKS like I missed this one. GLTA

Ahh yes,,but Gottlieb is transforming the FDA to make approval or disapproval times much faster. The FDA wants Arikace approved and so does the CDC,and everyone who`ll benefit from the drug. We`re getting approved,IMO,and we`re just waiting for the FDA letter to go before the FDA panel for our majority yes vote. I really want to hear about Iplex,because that`s icing on the cake big time,and no one`s expecting anything out of it,so that news breaks and we run a bunch more. I`m with Pianoman and others of long term,on where the share price should get to after approval,but throw in iplex and we`re definitely over 100-125.

I will continue to monitor for news. I have been burned too many times by the FDA--FDA taking too long before eventual approval.

And the FDA NOT approving a drug.

But, that is why there is a potential high return. Because there definitely high risk.

GLTU

Iplex is free and clear for Insm from the settlement in October,next month.Not sure if it`s clear October 1st or the 31st.

Been a long time. Was the drug involved there Iplex and the DNA patent one of Cabiily that evolved from an interference DNA lost in PTO but won in settlement in D.Ct.? That DNA/Roche patent should be about to expire, if it hasn't already expired.

Smart man.

In since DNA patent battle that was settled....sold off a 1/3 of shares for LTCG in SEP-IRA, other 2/3 remain there

PGA$. Worked good today for me :).

Knew this was pumped and would head down soon enough

Thank you JK.

Blueyedcatch,
Sorry I don't have an account to post..
Just lurking...

Can you do us a favor and post a message over there and tell them to come over here? I`d like to hear what Pianoman is saying these days. Thanks in advance. Oh,don`t tell terry,we don`t want him over here.

Reluctant,
Welcome back...
I'm still here since 2001...

The other oldies are on InvestorVillage...

GLTY

I am. Since 2006

Anyone here from the "old days"?
2008 ish?

Wow that`s a lot of cash. More than enough extra to get Iplex going again. 377 million plus cash on hand,which is probably around 60 mln. They said 75 on the call,but that was for the end of June,so they`ve probably spent some of that 75 mln since,and that`s where I get the 60 mln. So a grand total of 430 mln minimum,and certainly a company in a position to start the new year off with super strength. Will Lewis has stated several times that he plans to turn Insmed into a stand alone big pharma,with multiple App`s for Arikace,and we`re hoping Iplex reborn,or another acquisition of a late stage drug,who knows. Point is the companies situated perfectly to achieve what Lewis declared he would do.Is it a ploy to sell Insm for the highest price possible?or is he really gonna do it?

Insmed Announces Closing of Public Offering - https://finance.yahoo.com/news/insmed-announces-closing-public-offering-200100479.html

INSM looks higher

not yet

Thanks man. Did you take a look at $CLF$. Yet? Do you think it could reach $20 or higher in the next 2 years?

I am happy for you great work

I'm out at. 30.25. From 24. Quick three day. 6k

I`m wondering how fast, with the new FDA under Gottleib,we will see approval,especially when the CDC wants what we have, as well as the FDA practically holding Insmeds hand through this whole thing. Everyone wants it approved,so it`s just a question of how long. IMO,the EU will get us done for sure,and the FDA should be a gimme considering everything. So how long? Shorts aren`t gonna get anything because approval could happen anytime now,and the offering set the bottom while we wait for it.

good luck hope it works for you

Trailing stop man. Trying to make some money back I lost in GIG$. I'm up 7k. If my stop hits I will make 5k . Nothing is long term

this was pumped up to sell shares good luck holding this one

After the offering they will have around 450 million in cash and they have 55 million in debt and burning around 38 million a quarter. I have a trailing stop on this one. :)

There is no revenue yet but and approved by FDA yet but I would be careful shorting this jk. If approved watch this move up quickly . Of course very risky. I only own 1k shares. Got at $24. We will see.

Nonsense pure nonsense. Its not an FDA approval no revenue pump and dump. Shorting this POS

Only around 12 millions shares. This is a game changer. If they can pull in 1.6 billion a year on this and give it a x15 multiple. =. That is a 24 billion market cap. That is a 366. 96 a share

Plenty of working capital! INSM is a great $$$$$ opportunity.

I TRIED GETTING FILLED


THEY WOULDNT FILL ME, SO I GAVE UP LOL



Canceled Buy 1000 INSM Limit 29.69 -- 09/07/17 10:18:25 09/07/17



Canceled Buy 1000 INSM Limit 29.60 -- 09/07/17 10:18:16 09/07/17



Canceled Buy 1000 INSM Limit 29.50 -- 09/07/17 10:17:52 09/07/17

Heard we got news today

That`s a lot of cash for? IPLEX?

Investors here are forward looking and loading INSM shares.

$350M+ Wow! This company is in fantastic cash position going forward. With the high volume sessions this week, that cash could be raised in three hours. Smart management!

That`s right,,I talked to a bunch of big boys about it and they thought it would be 25.00 a share. I was hoping for 29.-29.50,but 28.50 is still big enough to wreck shorts by the way side. Any that are shorting here hoping for a pullback,are playin with fire. Upgrades with inflated price targets are certainly on the way.