Iterum Therapeutics PLC (ITRM) Quote

Very important drug. Big pharma like Pfizer may come calling or has called already

Gonna be a multi day run imo

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Excellent

Label is about as expected. They did recommend culture testing (to insure proper agent is used for specific bug), bt did so in a general way that implies it is universal. No black box (was mentioned as possible to warn against creating resistence).

Stuck in this halt but up 13% not  complaining 
1.40+ 20%

Agree

Big Pharma bribes, rules and runs the FDA its the American way of doing business meanwhiles urinary tract infection a big markets

Any strength shown is met with selling

Plus it’s not right to tie the company’s hands and restrict their ability to sell a product which will actually help people by having specific instructions on labels.

I tend to think if this was a big company such as Merck or Pfizer we wouldn’t have this issue

Yes it sounds like there will be some stipulations the FDA will enact.
It’s a shame! I understand the bug resistance aspect being in the medical field tho.

Im still a believer in the MD’S being the problem of which they don’t want to take full responsibility.
The FDA shouldn’t punish a biotech company for developing a new product which is needed. The AMA needs to do a better job of educating the educated 😆

I went through the ADCOM material a few weeks ago, but mainly from the pov of understanding what the FDA analysis was. I am very comfortable the FDA is willing to bless sulo as being safe and effective, the only open question is how to try to restrict use to avoid resistance.

Replaying it and listening more closely to the details of the discussion of creating resistance, I can understand how this is a tough issue to tackle.

The proposed label by ITRM (designated susceptible micro-organisms) is clearly a non-starter. Nobody at the ADCOM could even say what that means, and even if they could, the family doc is not about to call for a several hundred dollar test just to prescribe a cheap pill that almost always "works". Alternatives such as use after failure or use for resistant bugs had no supportable data,. Certainly a problem for the FDA, but they will find some label that expresses the concern.

I would be certain they will exclude use as a step down following IV treatments. I suspect they will somehow say use for cases where the doctor finds treatment via augmenten is not suitable.

I would not at all be surprised to see the FDA go off the farm and issue a black box against abuse due to risk of generating carbo-penum resistant bugs.

I wold be certain there will be a REMS and/or post approval study on these issues.

On the broader issue of antibiotic management, I was encouraged everybody took it seriously. I was discouraged that most all felt the community docs will broadly ignore it and take the easy way out.

.

Yes! Cipro and augmentin have been around for a long time.
It will take a while for the bugs to become resistant to this one.
And yes the doctors are the ones that caused this over prescribing. They give it away like candy and use it as a prophylactic after just about every surgery

For some explanation on that subject, the absurd off-label use of all antibiotics is a huge issue. That is true for all, nothing specific here. Go to most any third world or developing country and you can buy Cirpro for a few bucks for 2 weeks(?) worth, no prescription.

This is what is causing the problem with "super bugs". So yes, the FDA has a concern here.

OTOH, the same thing is why we need more choice in the field of antibiotics. And that is what this is, another choice for bugs that are are resistent to other antibiotics.

AI Overview
According to recent updates, the FDA appears to be leaning towards approving Sulopenem for the treatment of uncomplicated urinary tract infections (uUTIs), but with significant concerns regarding antimicrobial resistance and the need for careful monitoring through post-marketing surveillance to ensure appropriate usage; the FDA Advisory Committee acknowledged the potential benefit for a subset of patients while emphasizing the importance of managing off-label use and potential impact on antimicrobial resistance if approved.

Sounds like the drug works well. FDA has to have the appropriate usage on the label it sounds like

Odds of approval are high, but I would not expect a huge gain.

Maybe up to $2-3 on thumbs up. Certainly down to almost $0 on thumbs down.

Again, I think the odds are good, so a good bet. Just think this is not one of those huge jumps you see on some drug approvals.

Any believers their drug gets approved Oct 25th?
Should fly if it does

dang it should have run right after you sold

No update or feedback, I dumped all shares

Anyone understand the strategic planning behind the dilutive prospectus?
ITRM wants to raise cash now in the event the NDA Hearing is not good?
Or ITRM wants to raise cash now to hit the ground running with advertising after the successful NDA Hearing(s) in Sept and Oct.?
One indicator will be after subscription rights end 5 PM on August 6. Did investors jump on this or luke-warm maybe?

Good News https://www.iterumtx.com/news/press-releases/detail/124/iterum-therapeutics-receives-fda-acceptance-of-resubmission

ITRM.......................https://stockcharts.com/h-sc/ui?s=ITRM&p=W&b=5&g=0&id=p86431144783

$ITRM > https://ih.advfn.com/stock-market/NASDAQ/iterum-therapeutics-ITRM/stock-news/93781831/iterum-therapeutics-to-report-first-quarter-2024-f

ITRM.............................................https://stockcharts.com/h-sc/ui?s=ITRM&p=W&b=5&g=0&id=p86431144783

Hopefully some bad news for Utility Therapeutics' pivmecillinam has leaked. They are a direct competitor and up for an FDA decision in a couple weeks. The FDA could very well send them the same letter they sent ITRM, one P3 trial is not enough.

Will know by end of the month.

Of course the move could just be specs getting in ahead of the quasi binary. I doubt it is anybody who knows anything of ITRMs partner/buyout negotiations as that would move the needle harder (more volume).

Looking good here!

Looks like wait and see if this actually gets done.

ITRM under $2

Thank you, sir, for the update

Annual Report on Thursday, March 28, before market opens.

ITRM 10Q due March 13

ITRM...................................https://stockcharts.com/h-sc/ui?s=ITRM&p=W&b=5&g=0&id=p86431144783

--HC Wainwright Upgrades Iterum Therapeutics to Buy From Neutral, Price Target is $6
12:46 PM ET, 02/07/2024 - MT Newswires
12:46 PM EST, 02/07/2024 (MT Newswires) -- (MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www.mtnewswires.com/contact-us)

Why the huge up swings and heavy reversals?
Microcap bio while digesting news.

I am bit surprised the PPS has not reacted better. The results are solid wrt approval.

On the commercial side the results we have not yet seen are important. The entire patient population includes patients who should respond well to both drugs (the m-MITT population) and patients who might not (non m-MITT) . The results presented only the former (per the agreed SPA with the FDA). But commercially the full trial (ITT) matters.

On the non- m-MITT patients all they have is disclosed is not stat sig due to insufficient patients. That to me implies it trended positive, but not much. If so, then we know the full trial was decent, though almost certainly not stat sig as they would have PR'd that.

They do not need stat sig on the ITT to gain approval. They do need it for the label to reflect the use. And that is the commercial issue which is offsetting the approval news and causing the choppy PPS, IMO.

Like the company especially since wife is suffering from UTI> Why the huge up swings and heavy reversals?

As always timing is everything. I don’t feel terrible buying in at 1.72 today.

1.75 YIKE$

WHOOPS!!!!!! Someone left the water running

Hahahaha I'm jumping in LOL :)

2.22 KERPLUNK~!

As of October 31, 2023, the registrant had 13,050,007 ordinary shares, $0.01 par value per share, outstanding.

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Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
Phase 3 REASSURE Trial Met Primary Endpoint of Non-Inferiority to Augmentin®; Demonstrated Statistical Superiority

Re-submission of NDA to FDA Expected in Q2 2024

Potential to be First Oral Penem Approved in the U.S.

Management to host a conference call at 8:30 a.m. ET today

DUBLIN and CHICAGO, Jan. 30, 2024 /PRNewswire/ -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next-generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced positive topline results from its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) Phase 3 clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTIs).

"We are very pleased to announce positive data from this confirmatory trial, which was conducted under special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA)," said Corey Fishman, Iterum's Chief Executive Officer. "With the positive data from this trial, we plan to resubmit our New Drug Application (NDA) for oral sulopenem for the treatment of uUTI in the second quarter of 2024. At the same time, with these results in hand, we will be focusing on a strategic process to sell, license, or otherwise dispose of our rights to sulopenem with the goal of maximizing value for our stakeholders. We believe there is tremendous value in sulopenem as a potential new, oral antibiotic for the uUTI indication which has over 30 million infections annually in the U.S., rising resistance to all currently prescribed oral antibiotics, and a complete lack of new product innovation over the last 20 years."

Results demonstrate that oral sulopenem was non-inferior to Augmentin® with respect to the trial's primary endpoint, overall response (combined clinical cure plus microbiologic eradication) at the test-of-cure (TOC) visit in the microbiological-modified-intent-to-treat susceptible (m-MITTS) population. Oral sulopenem showed overall success in 61.7% of patients compared to 55.0% for Augmentin®, demonstrating statistically significant superiority of oral sulopenem versus Augmentin®.

The table below summarizes the key efficacy data from the REASSURE trial at the TOC visit:


Sulopenem/probenecid500 mg/500 mgBIDN=480n (%)

Augmentin® (Amoxicillin/clavulanate)875 mg/125 mgBIDN=442n (%)

Treatment Differencei (95% CI)

Overall Responseii

296 (61.7)

243 (55.0)

6.7 (0.3, 13.0)

Clinical Successiii

371 (77.3)

339 (76.7)

0.6 (-4.8, 6.1)

Microbiological Successiv

361 (75.2)

295 (66.7)

8.5 (2.6, 14.3)





Difference in oral sulopenem versus Augmentin® in the m-MITTS population

[ii]

Combined clinical and microbiological success (primary endpoint)

[iii]

Clinical success at TOC = symptom resolution + no new uUTI symptoms

[iv]

Eradication of qualifying uropathogen to

They are probably a little ways off from approval, and ramping up delivery, etc. So I think there will need to be a raise, until something else happens, like a partnership, or takeover, or buyout. I haven't heard anything.

Anticipation of issuing more shares???

$ITRM >Iterum Therapeutics Regains Compliance with Nasdaq Bid Price Rule
December 04 2023 - 08:00AM

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Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that it has received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Rule") for continued listing on The Nasdaq Capital Market.
The Company was previously notified on September 26, 2023, that it was not in compliance with the Bid Price Rule because its ordinary shares failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided with 180 calendar days, or until March 25, 2024, to regain compliance. To regain compliance with the Bid Price Rule, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days. This requirement was met on November 30, 2023, the tenth consecutive trading day when the closing bid price of the Company's ordinary shares was over $1.00.

About Iterum Therapeutics plc

Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Investor Contact:
Judy Matthews
Chief Financial Officer
312-778-6073
IR@iterumtx.com



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$ITRM Buying Continues to come in, something Good is in the Works glta