Pulled from yahoo finance...this stock could explode 4x if phase 3 does well...cheers ziggy
Protagonist Therapeutics Announces Topline Data from Phase 2 IDEAL Study of PN-943 in Ulcerative Colitis
April 25, 2022, 4:25 pm
PN-943 achieved 27.5% clinical remission with a delta of 13% versus placebo, with strong concordance across all key proxies including histological and endoscopic endpoints for efficacy, in the twice daily 150 mg dose arm
Achieved clinical proof-of-concept and validation for oral, gut-restricted approach for ulcerative colitis via blockade of the alpha-4-beta-7-integrin pathway
Plans underway for a registrational Phase 3 study anchored around twice daily 150 mg dose of PN-943, pending regulatory guidance
Protagonist to host a conference call today at 6:00 p.m. ET
NEWARK, Calif., April 25, 2022 /PRNewswire/ -- Protagonist Therapeutics (Nasdaq: PTGX) today announced topline results from the Phase 2 IDEAL study evaluating PN-943 in patients with moderate-to-severe ulcerative colitis (UC).
"We are delighted with the strength of the results from the IDEAL study and look forward to working with the regulatory agencies as we prepare for a Phase 3 registrational program for PN-943 in moderate-to-severe ulcerative colitis," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Our oral, gut-restricted alpha-4-beta-7-integrin antagonist agent PN-943 has demonstrated clinical efficacy on par with the approved injectable antibody drug working through the same biological target. We believe the results of the IDEAL study may be paradigm shifting and of broad scientific relevance in understanding IBD pathogenesis and gut-restricted drug development via intervention of the integrin-MAdCAM pathway. Based on its convenience of oral administration and the favorable efficacy and safety results observed to date, we believe that PN-943 has the potential to become a first-in-class, foundational oral medicine for individuals living with moderate-to-severe ulcerative colitis."
"With the IDEAL study, we have demonstrated clinical proof-of-concept and validation for potential treatment of ulcerative colitis via oral, gut-restricted blockade of the alpha-4-beta-7-integrin pathway," said Scott Plevy, M.D., Executive Vice President and Therapeutic Head of Gastroenterology at Protagonist. "The study assessed two doses of PN-943, 150 mg BID and 450 mg BID, and demonstrated a very clear and consistent treatment effect at the lower 150 mg BID dose across key endpoints. The dose response demonstrated by this study is consistent with several other modalities in the integrin pathway. The findings in the lower-dose arm provide consistent evidence of clinical efficacy and safety, and clear direction on the dosing regimen for the Phase 3 registrational program."
"The oral, gut-restricted agent PN-943 appears to exert similar effects at the twice daily 150 mg dose in comparison to the approved injectable alpha-4-beta-7-integrin antibody drug and its mechanism of action," said Bruce Sands, M.D., M.S., the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, principal investigator for the IDEAL study and consultant to Protagonist. "There is a clear unmet need and strong clinical benefit for patients with an oral agent working through such a proven IBD specific mechanism, and the IDEAL study results provide good rationale for moving PN-943 forward in a Phase 3 registrational study."
Summary of Key Results
IDEAL is a randomized, double-blinded, placebo-controlled, multicenter Phase 2 study to evaluate the safety and efficacy of PN-943, an oral, gut-restricted, alpha-4-beta-7-integrin antagonist. 159 patients with moderate-to-severe active UC were randomized to either twice daily (BID) with 450 mg or 150 mg PN-943, or placebo, for 12 weeks and analyzed for outcome measures.
While the 450 mg BID dose did not meet the prespecified primary endpoint, the 150 mg dose achieved a placebo versus treatment delta of 13% (p=0.08) in the modified Intent to Treat (mITT) group, and a delta of 16% (p=0.04) in the bio-naïve group. In addition, the 150 mg BID data showed strong concordance across multiple parameters including statistically significant histological remission and endoscopic improvement.
PN-943 150 mg BID dose forms the basis for a Phase 3 registrational program
27.5% clinical remission vs 14.5% in placebo (delta 13%, p=0.08) for mITT analysis
Strong concordance with efficacy across multiple key secondary endpoints with statistically significant differences in histologic remission/improvement and endoscopic improvement
Safety analysis similar for the 150 mg BID dose versus the placebo group
Protagonist Therapeutics: Biotechnology company Protagonist Therapeutics (NASDAQ:PTGX) remains on the Fintel short squeeze leaderboard at the same position it held last week. Fintel shows 12.8% of the float short and a borrow fee rate of 16.88. Short interest is climbing in the company’s shares, according to the report.
Trading volume picking up...let's see what happens.
Watch what happens in the next 4 hrs.....I truly think it was an aggressive short attack....a week ago...this was trading at $25....as of 10:30am today...$12.???????...a billion market cap company ...with $27 million rev and some analysts looking at $50 rating does not implode this quickly.....remember...they are going forward with 150mg dosage in their new drug via phase III.....but reevaluating the 450mg dosage that did not perform well..
..I think novice investors just panicked and dump when shorter attacked last night and they only read the negative test results... you have to have a set of stones to hold on right now....but a 4x return on my $12 price would be nice return for me.
Remember what Warren buffet say...".when investors are fearful...buy!!!"
Good luck...... cheers ziggy
Analysts have been eager to weigh in on the Healthcare sector with new ratings on Protagonist Therapeutics (PTGX – Research Report), Gossamer Bio (GOSS – Research Report) and Black Diamond Therapeutics (BDTX – Research Report).
Protagonist Therapeutics (PTGX)
H.C. Wainwright analyst Douglas Tsao reiterated a Buy rating on Protagonist Therapeutics today and set a price target of $50.00. The company’s shares closed last Monday at $18.80, close to its 52-week low of $12.80.
According to TipRanks.com, Tsao is a 3-star analyst with an average return of 3.2% and a 40.4% success rate. Tsao covers the Healthcare sector, focusing on stocks such as Biohaven Pharmaceutical Holding Co, Cerevel Therapeutics Holdings, and Praxis Precision Medicines.
Protagonist Therapeutics has an analyst consensus of Strong Buy, with a price target consensus of $49.20, implying a 163.0% upside from current levels. In a report issued on April 11, BTIG also maintained a Buy rating on the stock with a $55.00 price target.
See Insiders’ Hot Stocks on TipRanks >>
I'm bewildered because their Ph2 results were very good from my reading of it - prepping for Ph3 on their UC candidate.
Analyst maintains a $50 price target
It's gotta be a short attack unless someone else can find more info on the drop.
Not sure....I thought buying back at 12 was a good bottom .... but see if you can bring some light to the avalanche! Ziggy
That would do it - thanks
FDA revoked break-through therapy designation for one of its meds. No PR yet from PTGX after hours.
I agree. pullback was to be expected. Suoport is just under $30. likely to be tested AH
Had hoped that this would continue to move back up. But I believe with the huge run the stock had yesterday, a healthy pull back is fine. We'll see what tomorrow brings. Lots of buying yesterday and many who bought would be out of the money after 24 hours. I still think this moves higher. Best of luck to the longs./ok2
Volume has tapered off, but still getting ugly. Heading under $30.
I'm not the on to ask about PTGX, sorry...
Any thoughts on where this is going to go?
Company asked to present at the AASLD "Liver Meeting". Hoping that goes well and provides some positive exposure. Remember, if you are fortunate to own some shares, this one is mostly held by large institutions. In my opinion, buy on weakness, still expecting good things with this one. Here is the link./ok2
I like to scan for panic sales like PTGX and try to buy the dips, but I'm outa powder now...I had one last year and the next day it popped 400% AND kept on going for awhile...itsa good buy in the dipping cycle when Institutions load up...
For investors, the following information:
From Refinitiv stock reports (Sept.24/21), they quote amongst 8 analysts polled, a 12 month price target, Low - $18.00, High - $93.00, with a Mean - $44.30.
JMP Securities (Sept. 22/21) reduced their target from $55.00 to $47.00.
From Morningstar (Sept. 24/21), PTGX is reported to be held at a level of 100 % by Institutional investors.
If you are a retail investor and are lucky enough to have grabbed some shares, in my opinion it may be wise to hold. Please do your own dd!
If we look at Friday's close @ $18.81 and compare that to the Refinitv Mean price target, you are looking at an increase of $44.30/$18.81 = 235.5 %.
The current 52 week high that is listed for the stock is $50.54, that would be an increase on Fridays' close, $50.54/$18.81 = 268.7 %.
Finally, pie in the sky, the high end of analyst estimates is $93.00/share, that would be an increase on Friday's close, $93.00/$18.81 = 494.4 %.
As always, please do your own due diligence. My personal opinion, is that there is still $$ to be made on this one! Good luck to all investors, but especially the retail investors. And remember, Institutional investors don't like to lose their money! Best of luck./ok2
The company is cooperating with the FDA. Nothing but transparency here. Once resolved I see a rapid movement back above $20 and then higher. Retailers, hold your shares. Some patience required here. Smart money has accumulated on the dip. Institutions have a large presence here. They don't want to lose their money. IMO. Best of luck to the longs./ok2
what a dip for PTGX...back to the drawing board...
Will be buying about 5000 shares here before the EOD. I see this being in the green at least 5-10% easy on Monday. Massive consolidation here at the $17 PPS.
Add at $7.44. And I know the idiots I brought it from. Just cracking up at their last effort to breathe before their killing
Imo this goes a bid more then 9
this is crazy, crashed to 4.47 on bad data, then almost total recovery after bunch of insider buying filings come out after hours
Protagonist Therapeutics Inc (NASDAQ: PTGX)(announced results from mid-stage study of PTG-300 in transfusion-dependent beta-thalassemia)
this is very unusual to see this type of recovery that fast
is there any other news or catalyst that would support this up here?