Traws Pharma Inc (TRAW)

Traws Pharma Shares Slide After UK Regulator Postpones Influenza StudyJune 15, 2026 6:26 AM
IH Market News Traws Pharma (NASDAQ:TRAW) shares fell sharply in premarket trading on Monday after the company revealed that UK regulators had delayed a planned mid-stage clinical trial for its influenza treatment candidate. The setback adds to previous regulatory challenges facing the programme and prompted investors to reassess the drug’s development timeline. MHRA Issues Negative Assessment Late on Friday, Traws Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) had issued an unfavourable review of the proposed human challenge study for tivoxavir marboxil. As a result, the company said the trial has been deferred while it evaluates next steps for the programme. Human challenge studies involve intentionally exposing participants to a pathogen under controlled conditions to assess the effectiveness of an investigational treatment. Shares Fall in Premarket Trading Following the announcement, Traws Pharma stock declined 17% in premarket trading as investors reacted to the regulatory setback. The delay introduces additional uncertainty around the development path and timing for tivoxavir marboxil, which has been one of the company’s key clinical-stage assets. Company Advances Alternative Candidates Despite the delay, Traws Pharma said it continues to progress alternative drug candidates designed to replicate the original therapy’s long-acting characteristics and antiviral potency. According to the company, these backup programmes are being developed without the mutagenic concerns that have drawn scrutiny from regulators. Regulatory Concerns Mirror Earlier FDA Action The decision by UK authorities follows a similar move by U.S. regulators earlier this year. In February, the U.S. Food and Drug Administration placed a clinical hold on Traws Pharma’s investigational new drug application for tivoxavir marboxil, citing concerns related to the mutagenicity data package submitted by the company. Mutagenicity refers to a substance’s potential to cause genetic mutations, a factor that can present significant safety considerations during the drug development process. Development Focus Shifts to Next Steps With regulatory concerns now raised by both UK and U.S. authorities, investors will be closely watching how Traws Pharma addresses the issues surrounding tivoxavir marboxil and whether its alternative candidates can maintain the company’s progress in developing new influenza treatments. The latest development highlights the regulatory hurdles often faced during clinical-stage drug development, particularly when safety-related questions emerge during the review process. Traws Pharma stock price Original: Traws Pharma Shares Slide After UK Regulator Postpones Influenza Study

TRAW....................................https://stockcharts.com/sc3/ui/?s=TRAW&p=w&b=5&g=0&id=p86431144783

TRAW Traws Pharma to Advance Potential Clinical Candidates for the Treatment of Hantavirus Infections https://finance.yahoo.com/sectors/healthcare/articles/traws-pharma-advance-potential-clinical-113000406.html

Back in 1.40 ave, buys 150k/sells 70k
https://investorshub.advfn.com/stock-market/NASDAQ/traws-pharma-TRAW/trades

)2.30 will jumpSome today 

Moved up well today,until shorts jumped on it,most tickers just getting killed by mms/banks/blackrock crooks and their darkpool crap.
The mms theft is biggest I have seen ever

2.68

$2.42

44,564 watchers,some eyes 👀 on TRAW

TRAW,1.74 up 5%,higher highs and lows,watch for demand and volume surges to start pop

Big institutional buying,ceo was head of merger/acquisition for Merck,cmo is former cdc director,many catalysts coming,dd is key

zero borrow/70%fee,(no rebate just started so uptrend should start any minute)
Bio pharma bird flu ect. Good potential here
First In 1.83 ,bids in for more

... On June 3, 2025, the Company issued a press release the (the “Press Release”) announcing the publication of clinical efficacy data for recessive dystrophic epidermolysis bullosa associated locally advanced or metastatic squamous cell carcinoma patients treated with rigosertib in an investigator sponsored, open-label, single arm Phase 2 study. The results of the study indicated an overall response rate of 80% with complete responses in 50% of evaluable patients. A copy of the Press Release is filed herewith as Exhibit 99.3 and is incorporated by reference into this Item 8.01....

Two domestic cats in New Jersey have tested positive for the highly pathogenic avian influenza (H5N1) in Hunterdon County. One feral cat developed severe disease, including neurologic signs, and was euthanized. Another indoor-outdoor cat also tested positive, and tests on other cats on the property are pending.Additional Details:Symptoms in Cats: Clinical signs of bird flu in cats can include respiratory signs (discharge from the eyes and mouth, sneezing, coughing, difficulty breathing) and neurologic signs.Transmission: Cats can contract the virus through exposure to infected birds or other animals, contaminated environments, or by consuming raw/undercooked meat or milk from infected sources.Prevention: Pet owners are advised to avoid feeding cats raw milk or meat, avoid contact with sick or dead birds and wildlife, and thoroughly wash hands and change clothes after handling sick animals.Human Risk: While the risk of H5N1 infection to the general population remains low, close contact with infected animals can pose a risk. No human cases have been reported in New Jersey.Reporting: New Jersey residents should contact their veterinarian if they have concerns about their pets. Suspect feline cases should be reported to the New Jersey Department of Health at 609-826-4872 or zoonoticrn@doh.nj.gov.

How does TRAW's tivoxavir marboxil perform against drug-resistant influenza strains?

Preclinical studies demonstrated potent inhibition of drug-resistant influenza viruses both in vitro and in vivo.
...
When will Traws Pharma (TRAW) begin Phase 2 trials for its H5N1 treatment?

Traws Pharma plans to begin Phase 2 studies in the first half of 2025.

How effective was TRAW's tivoxavir marboxil in preclinical H5N1 studies?

In mouse studies, oral treatment resulted in complete survival and reduced lung virus levels below quantitation limits when tested against human H5N1.

What were the key results from TRAW's Phase 1 trial of tivoxavir marboxil?

The Phase 1 trial showed no treatment-related adverse events and maintained plasma drug levels above EC90 for more than 23 days with a single dose.

What populations are currently at highest risk for H5N1 according to TRAW's research?

According to the company, poultry and dairy workers are at highest occupational risk for H5N1 bird flu exposure

$7.95 from $5 to $8 past few weeks .Dont flip the bird 

TRAW: As I noted, pure JUNK!!!! (Or, the MOUSE that roared, for a minute!!!)

TRAW: That old adage, to wit --- "The Best Laid Plans of MIce & Men" --- applies to the (fluff) PR last Friday by TRAW company. WHY?? Because their cheap "Phase-1" trial indicated that their Bird Pox therapeutic purportedly SAVED all those previously-infected MICE. (WOW!!! Glory to God on the highest!!!)


"Thanks, TRAW company, for saving my LIFE --- after I volunteered for your epic Phase-1 MIce Trial!!! And, I got 23-days of FREE CHEESE, during the 3-week trail!!! While all those HUMANS in the trial got one lousy McDonald's Happy Meal, once a day, while crashing at a cheap Motel-6 across the street from the hospital!!!"

PS: But, TRADE this classic snake oil NASDAQ firm anyway?? Sure!! Scam THEM, before they sucker YOU!! (I recommend, at best, a quick FLIP not more than circa 5-minutes into the Open starting gate tomorrow, at which time it may run-up quickly (& then crash). Or, if you have "WeBull" --- and are on the EAST COAST --- then play it in the Pre-Market tomorrow --- but NOT for me, way over here in San Diego, at 1:00 in the flucking dark morning!!!)

You need healthy humans to try out the goods for side effects in combination with AI approval.
Phase 2 2025 I'm sure should be granted fast track 

Who can be everywhere just AI perhaps watching and laughing at us 

TRAW: Below is pasted some of my interaction with COPILOT regarding TRAW's (fluffy) PR last Friday ---

ME: "And even MORE worrisome is the lack of any mention at all as to were those Phase-1 Human subjects even INFECTED or EXPOSED to any manner of Bird Flu during that Phase-1 study. Very troubling."

COPILOT: "You're right, that is concerning. The Phase 1 study for Traws Pharma's bird flu drug, Tivoxavir Marboxil, was conducted on healthy, influenza-negative volunteers. This means the study didn't involve actual exposure to bird flu, which raises questions about the real-world efficacy of the drug. It's definitely something investors should keep an eye on as the company moves forward with Phase 2 studies. Do you think this lack of clarity might affect the company's credibility with investors?"

TRAW: I saw TRAW --- which spells WART, backwards --- yesterday (Post-M) at the top of my daily Post-M data source, as follows:
https://www.tradingview.com/markets/stocks-usa/market-movers-after-hours-gainers/
However, conspicuously MISSING from their PR is any beneficial EFFECT (if any) upon the Phase-1 trial SUBJECTS themselves --- other than the typical jargon about "safety" & "adverse effects". (I.e., a FLUFFY PR, at best.) Nevertheless, I may indeed toss BUCKS at it anyway, since we ALL know Wall Street is about making MONEY, and NOT nit-picking news nor PR's, RIGHT???)
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TRAW (3.7-Mil. Flt., 0.1%): $8.06, 58%-Up; XXX ; (Post-M) news Bird Flu, Phase-1; Virology & Oncology, Penn.

Thanks for the alert

even though I missed it
🥴

Good run here today, congrats to all. Had a feeling should have bought this yesterday when it had bottomed out, looked at it twice during the day.

Live from SAN DIEGO, Jan. 10, 2025 /PRNewswire/ -- Expert Systems, a hybrid AI enabled drug discovery and development accelerator, announced a significant milestone in a development of Traws Pharma, Inc. 's (NASDAQ: TRAW) H5N1 antiviral program. The investigational drug, Tivoxavir Marboxil, has shown encouraging results as a single-dose treatment for H5N1 avian influenza, representing a potentially pivotal advance in addressing this serious health challenge.

Bird alert bird 🦅 🐥🐥🐥🐥🐥🐥🐥🐥🚀🚀🚀

Grab those $11s then maybe $15s

Grab those $8s

I don't feel bad at least he saw the $5. It should be a buy at some point 

Then you have 52 million non prepaid warrants

yes $TRAW with 20 mio. US$ financing at roughly 5 US$ per share? Lol pic.twitter.com/6r5nyVEg29— Lord_of_Biotechs (@Lord_of_Biotech) December 30, 2024

Guess it depends on how you read offering does it average to $5 a share for 4 million shares?

$8.28- $9.60'some support there may jump back in thanks 

strange action 17-9 on rasing $76M from Institutional investors

https://www.prnewswire.com/news-releases/traws-pharma-inc-announces-financing-up-to-72-6-million-from-leading-healthcare-institutional-investors-to-advance-tivoxavir-marboxil-development-for-h5n1-bird-flu-to-approval-302340168.html


https://x.com/KavodCapital/status/1873718092444172603

$16.84 halt

$19.44 held resistance 

$17.89 halt tiny resistance at $17.96 then $20 then it's up to $27 blow Santa up

$17.37

$16.40 now 

"In laboratory testing, tivoxavir marboxil inhibited multiple isolates of highly pathogenic avian influenza H5N1. We evaluated the effects of drug treatment in mice exposed to human H5N1, where the virus was isolated from a dairy worker exposed to infected cattle," said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. "Oral treatment with tivoxavir marboxil after the virus infection resulted in complete survival and lung virus levels below the limit of quantitation1. This result is highly encouraging for future clinical development of tivoxavir marboxil for treating human H5N1 influenza.""Current topline data from our Phase I clinical trial demonstrated safety and tolerability of tivoxavir marboxil, and maintenance of drug levels in blood above the EC90 for longer than 23 days1, with topline data for a higher dose still to come," said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. "In addition, the potential for tivoxavir marboxil as a treatment for H5N1 bird flu was demonstrated in an animal model."Topline Phase 1 Results with Tivoxavir Marboxil
The Phase 1 trial was a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (PK) of ascending doses for one-time tivoxavir marboxil treatment in healthy, influenza-negative, adult volunteers. No treatment-related adverse events were reported during the Phase 1 study. Current topline data from this study showed that a single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 for more than twenty-three days, with topline data for a higher dose still to come. Preclinical studies showed that tivoxavir marboxil demonstrated potent inhibition of drug-resistant influenza viruses, as well as potent inhibition of highly pathogenic bird flu viruses1 both in vitro and in vivo.About H5N1 Bird FluThe virus, also known as Type A H5N1 was detected for the first time in U.S. dairy cattle in March 2024. Since then, bird flu has been confirmed in at least 866 herds in 16 states. More than 60 people in eight states have been infected according to the U.S. Centers for Disease Control and Prevention. Health officials confirmed in December 2024 the first known severe illness in the U.S. caused by bird flu7. The California governor declared a state of emergency as the virus rampages through dairy cattle in that state8.

TRAW: 'Kentucky-Fried-Chicken-Flu', special --- for Xmas LUNCH??? (And remember!! TRAW spelled backwards spells WART!!!)

Just need to cure the chickens lol

In at average 9.80 back out at 12.20s

TRAW: A 'Bird Flu' therapy in the HUMAN, is worth two in the BUSH!! (And 'Bird Flu' is often a very TRAW-matic disease!!)
https://finance.yahoo.com/news/traws-pharma-announces-progress-developing-120000871.html
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Click below to also see one BIRD that was totally CURED of the 'Bird Flu' infection!! (I.e., it's NOT just Humans!!)
https://www.youtube.com/shorts/Ra_6SqtmEh0