Jaguar Health Inc (JAGX)

[Tahoe2468]

Charts looks like a few down days then cup up Nike symbol uhhhh oh well I’m holding…

[Tahoe2468]

This study, conducted by Jaguar family company Napo Pharmaceuticals in collaboration with Puma Biotechnology, is one of three important studies providing scientific rationale for the use of crofelemer for prevention and treatment of CTD Studies published in peer-reviewed journals and continuum of datapoints highlight the neglected and growing need for treatment of one of the most common and debilitating side effects of patients undergoing cancer therapy SAN FRANCISCO, CA / ACCESSWIRE / January 25, 2024 /Jaguar Health, Inc.(NASDAQ:JAGX) today announced that a dog study evaluating the effects of crofelemer in providing symptomatic relief of diarrhea associated with the irreversible pan-human epidermal growth factor receptor (HER) tyrosine kinase inhibitor (TKI) neratinib (Nerlynx®) has been published in the peer-reviewed journal PLOS ONE. The study, titled Effects of orally administered crofelemer on the incidence and severity of neratinib-induced diarrhea in female dogs, was conducted by Jaguar family company Napo Pharmaceuticals in collaboration with Puma Biotechnology, Inc. and can be viewed by clicking here. "We are very pleased with the results of this prophylactic study, which was undertaken to ‘model' the human situation with neratinib," said Lisa Conte, Jaguar's president and CEO. "Crofelemer, our novel, oral, plant-based, non-opioid antidiarrheal prescription medication, is also the subject of OnTarget, Jaguar's pivotal Phase 3 clinical trial for the follow-on indication of the preventative treatment of cancer therapy-related diarrhea (CTD), an indication we also refer to as chemotherapy-induced overactive bowel (CIOB) - which includes symptoms such as unpredictable and/or chronic debilitating diarrhea and GI urgency. Diarrhea, which has the potential to cause dehydration, infections, and non-adherence to treatment in cancer patients, is a growing unmet medical need in the age of targeted cancer therapies." Conte added, "This neratinib study was the first of three studies over the past several years that provide scientific rationale for the use of crofelemer in humans for treatment of CTD. This continuum of datapoints highlights the neglected and growing need for prophylaxis of diarrhea in cancer patients. Prophylactic therapies exist to help prevent chemotherapy-induced nausea and vomiting (CINV) in cancer patients, but no antidiarrheal medications are currently approved for treatment of CTD. Interestingly, there is currently one available product for diarrhea in dogs undergoing cancer treatment: Canalevia®-CA1 (crofelemer delayed-release tablets), our FDA conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs." Effects of orally administered crofelemer on the incidence and severity of neratinib-induced diarrhea in female dogs "This 28-day preclinical pharmacological study in healthy female dogs was designed to evaluate the scientific rationale for the use of crofelemer in humans in reducing the severity and incidence of diarrhea associated with a tyrosine kinase inhibitor (neratinib)," said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's vice president of preclinical and nonclinical studies. "The study was conducted without the prophylaxis or concomitant use of loperamide and demonstrated that crofelemer caused an approximate 30% reduction in the incidence and severity of diarrhea associated with daily oral administration of neratinib, which was statistically significant. Crofelemer also demonstrated significant improvement in the proportion of responder dogs, and there was a trend for fewer neratinib dose reductions in both crofelemer treatment groups when compared to the control group." Nerlynx, a drug product of Puma Biotechnology, Inc., is a pan HER TKI indicated for the extended adjuvant treatment of adult patients with early stage HER2 positive breast cancer and also for metastatic HER2 positive breast cancer. "Diarrhea was reported in 95% of Nerlynx-treated patients in ExteNET, a randomized placebo-controlled trial in the extended adjuvant setting who were not required to receive antidiarrheal prophylaxis," said Dr. Guy. "Nerlynx dose reductions due to diarrhea are often needed, and patients are advised to initiate antidiarrheal prophylaxis. Unlike crofelemer, which is already approved for a chronic use, synthetic antidiarrheal antimotility drugs are opioids and can bring risks in higher doses, often lead to constipation, and are thus not suitable for long-term use." Crofelemer for the Management of Neratinib-Associated Diarrhea in Patients With HER2+ Early-Stage Breast Cancer This independent pilot phase 2 study, which was published in the peer reviewed journal Clinical Breast Cancer in October 2023, can be viewed by clicking here. The study results indicate that crofelemer may be effective for the management of neratinib-induced diarrhea. "Seven patients underwent treatment with crofelemer and loperamide in this study, 5 of whom were able to control diarrhea with crofelemer alone. Though this study involved a small number of patients, the results show activity of crofelemer for the management of neratinib-induced diarrhea, which warrants further investigation of crofelemer for treatment of cancer therapy-related diarrhea (CTD)," said study investigator Hope S. Rugo, MD, Professor of Medicine and Winterhof Family Professor of Breast Oncology, University of California San Francisco Helen Diller Family Comprehensive Cancer Center. Dr. Rugo is a member of Jaguar's Scientific Advisory Board. This single center, open label trial enrolled patients with Stage 2 to 3 HER2+ breast cancer receiving neratinib in the extended adjuvant setting. One cohort took prophylactic crofelemer 125 mg BID and loperamide in the first 2 cycles, and as needed in the subsequent cycles. The second cohort received escalating doses of neratinib with loperamide. The primary endpoint was incidence of grade ≥3 diarrhea in the first 2 cycles. HALT-D: A Randomized Open-Label Phase II Study of Crofelemer for the Prevention of Chemotherapy-Induced Diarrhea in Patients with HER2-Positive Breast Cancer Receiving Trastuzumab, Pertuzumab, and a Taxane This investigator-initiated study, which was published in the peer reviewed journal Breast Cancer Research and Treatment in October 2022 and funded with support from Genentech, Inc., a member of the Roche group, can be viewed by clicking here. The targeted cancer therapies evaluated in the study cause diarrhea in up to 80% of breast cancer patients, reaching grade 3, which often requires hospitalization, in 8-12% of patients. "Diarrhea is a debilitating side effect that many people experience when undergoing breast cancer treatment that demands research attention," said the study's senior investigator, Sandra M. Swain, MD, professor of medicine at Georgetown University and a member of its Lombardi Comprehensive Cancer Center. "This is one of few studies to explore ways of proactively preventing diarrhea in women undergoing lifesaving treatment for their breast cancer. While we have more work to do, this study revealed important information about the treatment of diarrhea in this particular population." The results of the HALT-D study were released previously by the investigators at the 2021 San Antonio Breast Cancer Symposium by lead study investigator Paula Pohlmann, MD, PhD, formerly from Georgetown University and now Associate Professor, MD Anderson Cancer Center. HALT-D included 51 breast cancer patients scheduled to receive at least three cycles of chemotherapy and randomly assigned to either crofelemer in cycles 1 and 2 or the control group, which received standard of care. Antidiarrheal medications for breakthrough diarrhea were permitted but not given prophylactically. REMINDER: Multinational Association of Supportive Care in Cancer (MASCC) Webinar on January 29, 2024 A Multinational Association of Supportive Care in Cancer (MASCC) webinar titled "GI Toxicities from Cancer Therapies - Prevention and Management" is taking place Monday, January 29, 2024 from 11:30 AM to 12:30 PM Eastern Standard Time. The webinar was made possible by an unrestricted educational grant from Jaguar family company Napo Pharmaceuticals. To register for the webinar, click here. MASCC does not endorse or promote products or services of any industry partner including Jaguar Health, Inc. About Cancer Therapy-Related Diarrhea (CTD) More than 1.9 million people were expected to be diagnosed with cancer in 2023 in the U.S., according to the American Cancer Society. A significant proportion of patients undergoing cancer therapy experience diarrhea, and diarrhea has the potential to cause dehydration, infections, and non-adherence to treatment in this population. Novel "targeted cancer therapy" agents, such as epidermal growth factor receptor (EGFR) antibodies and tyrosine kinase inhibitors (TKIs), with or without cycle chemotherapy agents, may cause increased electrolyte and fluid content in the gut lumen, which results in passage of loose/watery stools (i.e., diarrhea). Diarrhea has been reported as one of the most common side effects of TKIs and may result in cancer therapy drug holidays or reductions from therapeutic dose, potentially impacting patient outcome. Diarrhea is also a common side effect of some approved CDK 4/6 inhibitors. Patients with CTD are 40% more likely to discontinue their chemotherapy or targeted therapy than patients without CTD,1 and the cost of care of CTD patients is estimated to be 2.9 times higher than for patients who are not experiencing CTD.2 About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, a pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

Read more at: https://www.miamiherald.com/press-releases/article284671171.html#storylink=cpy

[Tahoe2468]

This is the BIG PR WE ARE ALL WAITING FOR… NOT THE DOG ONE….


JAGX the company is awaiting results from its Good Clinical Practice vendors supporting the trial. The results are “forthcoming,” the San Francisco-based company said. “The OnTarget trial is our paramount near-term clinical milestone,” said Chief Executive Lisa Conte. “We look forward to announcing and presenting the top line results when they are available

[SonicTheHedgeFun]

it's on their website, if you're a serious investor I suggest signing up for their email list. they will send you all updates :)

https://jaguarhealth.gcs-web.com/

[Tahoe2468]

Just keeping it real been daytrading 20 years hype is fun but once it dries up move on…. Plenty of opportunities

[timberwolf7]

Tahoe
your comment on the potential market is spot on. Just how many DOGS need diarrhea medicine can there be?? What will it sell for,? Profit margin
all come to mind as questions.

Why I said my biggest concern is with whats a justifiable target price even if they get the PH3 results approved by the fda..

That said tho, when it comes to momentum on PR, there is no way to judge how long a 'run' will last, how high the share price goes, till its over..

Good luck..

Disclaimer: still observing the 'skirmish' taking place for direction. Who knows, maybe it will consolidate at the price range of 30-32 cents.. That would be nice to
see.. Would show nice support...

[Sauerkraut]

But let's do .48 first. Then pull back.....

[User-846645]

Looking on the daily, i still think it can revisit ~.26 before going higher, a healthy pullback. If no news the following days, it could do this, imo.

[Tahoe2468]

The issue is that there are already a bunch of old school meds that are very effective and also very cheep.

So…. If marketing just towards chemotherapy patients, pretty small market in animals.

From my Vet friend

[timberwolf7]

still looking for direction.. Volume appears to be tapering off in comparison to the prior 2 days of heavy volume as it rallied up.

Now appears that 'both' sides are wondering who 'blinks' first..

[Tahoe2468]

Breaks .33 it’s off to the races again 10% up days I’m cool with slow and steady not rocketship and dump

[Tahoe2468]

Told everyone over at MOMO group maybe they jumping in now

[Tahoe2468]

Shot just go green Positive already! the surge will come this afternoon

[hole-in-one]

Hoping it goes over .40 this week. That would be sweet. Jags should be able to push over a dollar without a split.

[Tahoe2468]

Looks like the heard jumped into other 20%+ bangers today… AGBA MULN SOUN.. oh well they will be back in… GMZP if you wanna play that kinda game. JAGX is my highest position right now with 50,777 shares yes I love gambling lol

[RammageRaul]

Next leg up coming :)
JAGX

[Tahoe2468]

Even looking at a elementary level 5 and 1 month line chart all points to going North!

[Tahoe2468]

Guessing the whole bit on rumor sell on news??? So dumb

[Tahoe2468]

Talked to one of my customers who is a Colorectal surgeon he said thumbs up looks legit so I’m buying more….

[knrorrel]

sounds very exciting - do you have a link to read this great NEWS?

[SonicTheHedgeFun]

Hey everyone happy monday! It is a warzone over on stocktwits lol, I'm doing my best to educate people to not listen to the paid shorts. The news today is amazing honestly, how cool is it that Crofelemer has multiple indications and JAGX is the only company with full rights to all licensing??! It made my day!

[knrorrel]

for a few minutes now, JAGX has been turning green - wow, look how strong - and apparently wants to take off upwards, so I jumped back in 🔥🔥🔥🔥🔥🔥🔥 https://www.nasdaq.com/market-activity/stocks/jagx/real-time 🚀🚀🚀🚀
imho

[knrorrel]

$JAGX boom apparently it's just starting up again https://www.nasdaq.com/market-activity/stocks/jagx/real-time

[timberwolf7]

Bit of profit taking on the open this morn??
Lot of volume, running in place kind of guides to this conclusion (??)

And its early, so see how it goes today. Still a good % above its MA line.. Question is, does it run in place while the MA line catches up or does it go looking for it?? TBD'd..
Note: The MA is now at 22 cents/sh with a steep upslope to it, so it can catch up in a hurry.. but its 50% below the current share price.. but it can move in a hurry... so ....
Disclosure: I sold out Friday at 30.2 cents... happy with what I was able to get. Pondered it pulling back.. if it does consolidate?? Might get another round Good luck

[chadlewis78]

Crofelemer, Jaguar Health’s Prescription Drug Conditionally Approved by the FDA for Chemotherapy-Induced Diarrhea in Dogs, is the Subject of the Company’s Investigational New Animal Drug Application for the Indication of General Diarrhea in Dogs

https://jaguarhealth.gcs-web.com/news-releases/news-release-details/crofelemer-jaguar-healths-prescription-drug-conditionally

[EmperorVoyager30]

10th Annual Elite Ped-GI Congress, which takes place May 2-4, 2024 in Abu Dhabi in the United Arab Emirates (UAE)
WONDER IF WE HEAR ANYTHING BACK ON THIS TODAY???

[INV4]

Crofelemer, Jaguar Health’s Prescription Drug Conditionally Approved by the FDA for Chemotherapy-Induced Diarrhea in Dogs, is the Subject of the Company’s Investigational New Animal Drug Application for the Indication of General Diarrhea in Dogs

Jaguar Health, Inc.
Mon, May 6, 2024

Diarrhea is one of the most common reasons for veterinary visits for dogs and the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved anti-secretory agents to treat canine diarrhea

SAN FRANCISCO, CA / ACCESSWIRE / May 6, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that it has established a new Investigational New Animal Drug (INAD) file with the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) for the company's novel plant-based prescription drug crofelemer to treat general, non-infectious diarrhea in dogs.

Crofelemer delayed-release tablets, under the name Canalevia®-CA1, received conditional approval in December 2021 from the FDA for the treatment of chemotherapy-induced diarrhea (CID) in dogs.

"We're very pleased to have established this new INAD file," said Michael Guy, DVM, MS, PhD, Jaguar's Vice President of Preclinical and Nonclinical Studies. "We've been pleased with the marketplace reception of crofelemer for treatment of CID in dogs, and believe there is clearly an unmet need for a product to treat general, non-infectious diarrhea in dogs as well. We estimate that U.S. veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs, and we look forward to evaluating the possibility of expanding the indication of crofelemer to include treatment of all types of non-infectious diarrhea in dogs. The next step in our development process is to request a pre-submission conference with the CVM to discuss our proposed protocol for the clinical field study for this new indication."

Jaguar previously issued results from a multicenter, randomized, double-blind, controlled proof-of-concept study that assessed the efficacy of crofelemer administered orally in alleviating clinical signs associated with secretory diarrhea in dogs. The study results showed that crofelemer was superior to placebo.

Diarrhea is one of the most common reasons for veterinary office visits for dogs and is the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved anti-secretory agents to treat canine diarrhea. According to the American Veterinary Medical Association, there were an estimated 83 million to 88 million dogs in the United States in 2020, and 45% of U.S. households owned a dog in 2020. Devastating dehydration can occur rapidly for the animal, and the lack of control in urban settings where owners don't have easy access to outdoor facilities is a significant problem for families with dogs.

Important Safety Information About Canalevia-CA1
For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, a pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Visit Jaguar on LinkedIn: https://www.linkedin.com/company/jaguar-health/

Visit Jaguar on X: https://twitter.com/Jaguar_Health

Visit Jaguar on Instagram: https://www.instagram.com/jaguarhealthcommunity/

https://finance.yahoo.com/news/crofelemer-jaguar-health-prescription-drug-123000791.html?guccounter=1&guce_referrer=aHR0cHM6Ly9kdWNrZHVja2dvLmNvbS8&guce_referrer_sig=AQAAAKJJfX_vPfZTzE_Hfko3f-AE6cU-Azs2AH1wLCrYSoE3uAIjnXNZwk5SkxgM1j93Qn5jZP59Ff_GM7A4nlhLykve6b1vhJ9z2qcttGb87M8Z6SulNJZhqydV6N4Vb-NXyXfHBEmZYoaH0mY_UQmwV7PUmBvJmjOvadD38vV3zHy4

$JAGX

[EmperorVoyager30]

ANIMALS AND HUMANS..... YOU MUST BE NEW......

[ShadowDiviner72]

''We estimate that U.S. veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs''

BENZINGA: Diarrhea is one of the most common reasons for veterinary visits for dogs and the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved anti-secretory agents to treat canine diarrhea

[bambam56]

dogs...

[Tahoe2468]

LIFT OFF!!!

[EmperorVoyager30]

Jaguar Health Applies for Investigational New Animal Drug Status for Potential Dog Diarrhea Treatment

[EmperorVoyager30]

REUTERS
Crofelemer, Jaguar Health’s Prescription Drug Conditionally Approved by the FDA for Chemotherapy-Induced Diarrhea in Dogs, is the Subject of the Company’s Investigational New Animal Drug Application for the Indication of General Diarrhea in Dogs

[1-1 is 4]

JAGX seems to be consolidating in a northward trajectory as shown in the monthly chart as compared to 4/30-5/2.. However consider dips in low 20's to high teens a possibility yet a terrific buying opportunity if all else stays the same. IMO

[stockgringo]

https://healthstockshub.com/news/nasdaq/jagx/crofelemer-jaguar-health-s-prescription-drug-conditionally-approved-by-the-fda-for-chemotherapy-induced-diarrhea-in-dogs-is-the-subject-of-the-company-s-investigational-new-animal-drug-application-for-the-indication-of-general-diarrhea-in-dogs

[ShadowDiviner72]

New PR : Crofelemer, Jaguar Health’s Prescription Drug Conditionally Approved by the FDA for Chemotherapy-Induced Diarrhea in Dogs, is the Subject of the Company’s Investigational New Animal Drug Application for the Indication of General Diarrhea in Dogs

[EmperorVoyager30]

.40c next resistance level

[RammageRaul]

Good morning Jaguarundis JAGX

[knrorrel]

Monday could be a nice green day.

[knrorrel]

yep

[knrorrel]

sounds great

[timberwolf7]

Not sure what you are 'concerned' about, but I would be asking about the POTENTIAL REVENUE stream..

And ponder, how many 'units' of product will the market DEMAND/NEED.. and how much could they sell it for...

et al.. Thats the part that I am looking for clarification on as it will help guide the 'target price'..

Right now, its running on expectations, momentum.. Which is more than ok as it gets off the 'floor'.

Course, at this point, ANY additional sales would be a positive..

[Tahoe2468]

And Sam Bankman-Fried knew a lot about bitcoin too just saying….

[oilin07]

Jagx has a board of certified doctors

[Tahoe2468]

Common sense would tell me if anyone in the house is a doctor or knows of a doctor if they could get back to all of us who are non-medical and see if this is really legit or what their thoughts are thanks!!!

[stockgringo]

$JAGX another huge week coming up .

[Tahoe2468]

Just hope we all just not drinking the kool-Aid… no way been daytrading for 20 years ALLL SIGNS POINT UP!!!!!

[oilin07]

Im hearing .50+ this week

[Itsabdellio]

Check this video I saw on TikTok https://www.tiktok.com/t/ZTLCL6C7W/

[Tahoe2468]

Gotcha… PR comes out what we all waiting for and they have until Aug this year to get to $1.00 or RS coming once again