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BAML initiation and concerns just re-inforces that PRTK has to find a buy-out.
Without it, will just follow the same horrible path that SGYP did
Bank of America Initiates with $13pt
Paratek Pharmaceuticals (NASDAQ:PRTK) initiated with Neutral rating and $13 (25% upside) price target at BofA/Merrill Lynch citing challenges in driving omadacycline sales above $300M if it commercializes on its own.
ANY sniff of a rumour on buyout and we jump $2 or $3 bucks. I think
Apparently, wants $9.20 visit on the technical chart.
I'll hold off to add any until there.
This valuation is more than ridiculous, but hey... it's a tale of the tape after all.
A
Trying PRTK here at 10.65 again for another trade. Don't understand why shares are not up more with committee recommendation.
We have our HALT and FDA pane today. the decision will be between 1 p.m. first hour of after hours trading today
+.90 today means a lot to me. just waiting for the rug pull...
I need $13.80s to break even across 3 accounts
1st buy here with a starter position at 9.48 hope I want this. Looks oversold.
BioTech Investors calling out buys for upcoming ADCOM
AntiBiotic Market in Doghouse. plain and simple.
all undervalued at moment, for the moment
Each Glimmer of Hope keeps fizzling out
$10.00 drops keep getting defended, for now
Why do I get feeling I'm gonna get jacked? got $150K riding on this... will just have to tune out and check back in 6 months....
PLease, Please, Please. Just saying
Wonder if somethings up with priority review
don't like this Price Action today. actually it sucks
https://www.streetinsider.com/Corporate+News/Parateks+%28PRTK%29+NDA+for+Oral+and+Intravenous+Omadacycline+Accepted+for+Priority+Review+by+FDA/14022837.html
Added 500 at $10.95... seems there's a worry about delays and/or warning labels required. much to be seen.
reality is that longer term ( Unless something is wrong with the drug ) that this is a multiple from $10.95
JMO
Some day over the rainbow................
last add was $13.00, still holding full... one day. hopefully soon
Cowen Conference was a home run. The stock will run up to October, assuming PDUFA in the early part of the month. Omadcycline is a differentiated product in many ways that will allow for the prescribing of the product aside from the usual worries of antibiotic resistance. Lots of opportunity left for partnering for both of PRTK's products.
Excellent presentation today.
1. Going to have a European partner by Mid Year.
2. Going to have a Pan Pacific Partner as talks are active (no time frame given). I suspect soon.
3. Launch date may be moved up from Jan 19 to a month earlier due to many reasons as there may not be an ADCOM. Huge.
4. CABP opportunity is very big as 60% of patients are the elderly and they are resistance, safety, and drug tolerability concerns. Trust will be built up by the hospital focus and the community setting will follow.
5. US Govt legislation will be helpful if passed:
"Ready Act" helps to credit R&D and monetize it for PRTK.
6 C Difficile opportunity.
7. 240 million ABX RX's per year so the talk of limited use is silly.
8. OMAD is the first broad spectrum ABX with multiple indications coming into the market in 20 years. It sets a "PRECEDENT" and allows for flexible pricing among the payors.
9. Payors are excited by OMAD. Coverage for the drug in hospital and managed care formularies is expected to be robust and without step edits.
Leerink Conference very informative and eye opening and many take home points. These are just a few. I'm tired:
1. No competition from sales representatives of competitive companies because the competition is generic. Generic drugs are 99% never actively promoted by generic companies. Huge advantage for Omad.
No drug in generic space for CAP has as high an efficacy as Omad does.
2. Partnering will not be required the first two years as Paratek focuses on hospitals.
3. Formulary access looks like a very sure thing as this drug will be priced right with flexibility as it will come in oral and IV and no broad spectrum antibiotics for community acquired pneumonia (CAP) have been approved since 1999.
4. Doctors have not had conversations with reps about new CAP antibiotics since 1999! Doctors will want to hear about this drug from the reps or at dinner programs etc. Access to providers will be excellent.
Leerink Conference Call Replay:
http://wsw.com/webcast/leerink30/register.aspx?conf=leerink30&page=prtk&url=http://wsw.com/webcast/leerink30/prtk/index.aspx
You can't ask for a better set up.
As we all know, the antibiotic drugs/companies like PRTK etc, have been ignored, or beaten for a while now, but the tide is starting to turn. The threat of antibiotic resistance is growing, and new drugs to help slow it down or potentially stop it, will be at a premium. Look, for example, 12 hours ago, a new class of "dirt" antibiotics, was discovered. Look at the big publicity for it:
http://www.bbc.com/news/health-43032602
The "dirt" antibiotics are a long way from human testing and potential approval. So what new antibiotic, the first one likely to be approved in 10 years, later this year, will be coveted by the press and by investors????
PRTK, is a rare opportunity to buy in to a company that is in an arena that has been overlooked, and quite frankly, sold off to oblivion. Now is the time to load up and hold. That's what I have done fwiw.
Really shows the need
A reversal has begun. Friday was the hammer and today is the first green candle. Expect 20 plus in a month or two. Market cap is unreasonably low.
Don't expect a european partner for Omadacycline before Q4 2019.
This could test $10 as the correction isn't over yet.
The market is taking everything down with it. Patience will pay. Hold on tight.
Add little $13.80 new basis closer to $15.50 now.
just need our Euro Partner announcement and then we'll get that bump
Added a bunch more. Patience will pay here.
Crazy Market Cap..just added $14.10
only 500 shares.. luckily few other positions keeping me green as this RED number grows
Paratek Completes Submission of New Drug Applications to U.S. Food and Drug Administration for Oral and Intravenous Omadacycl...
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that on February 2, 2018, it completed the submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for the Company’s once-daily oral and IV formulations of its broad-spectrum investigational antibiotic, omadacycline. Omadacycline is the first in a new class of tetracycline antibiotics known as aminomethylcyclines. Paratek is seeking FDA approval for omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), based on the results of three successful Phase 3 pivotal studies. The FDA has previously granted omadacycline both Qualified Infectious Disease Product and Fast Track designation for these indications, which provide for a Priority Review of the NDAs, once accepted.
“The completion of our NDA submissions marks a significant milestone for Paratek and we are deeply grateful to the patients, investigators, and entire Paratek team for their commitment to advancing omadacycline’s development path to this major milestone,” said Evan Loh, MD, President, COO & CMO of Paratek. “With antibiotic resistance on the rise, we look forward to working with the FDA during the regulatory review process with the goal of bringing a modernized tetracycline antibiotic, omadacycline, to clinicians and patients for the treatment of serious community-acquired bacterial infections.”
The NDAs are supported by the Company’s Phase 3 program for omadacycline, which includes three pivotal registration trials: two studies in ABSSSI and one study in CABP. Omadacycline met all FDA and European Medicines Agency (EMA) primary endpoints in each study and demonstrated a generally safe and well-tolerated profile.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. The Company’s lead product candidate, omadacycline, is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the target indications of ABSSSI, CABP, uUTI and cUTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI and has completed its New Drug Applications to the U.S. FDA and is preparing a marketing authorization in the European Union. Paratek has licensed rights for omadacycline to Zai Lab for the greater China region and retains all remaining global rights.
Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.
Paratek's second Phase 3 product candidate, Seysara™ (sarecycline), is being developed by Allergan in the U.S. as a new once-daily oral therapy for the treatment of acne. Allergan has completed Phase 3 development activities for Seysara and its new drug application was accepted for review by the U.S. FDA in December 2017. Paratek retains all ex-U.S. rights to sarecycline.
Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
CONTACTS:
Media Relations: Investor Relations:
Michael Lampe Hans Vitzthum
(484) 575-5040 LifeSci Advisors, LLC.
michael@scientpr.com (617) 535-7743
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This video tells the PRTK potential. Very compelling:
NDA in March and PFUDA in September.
In between they have a Phase II for UTI.
European partner for Omad will be announced during the year.
...and then there is the Buy-Out Potential
Added today at 15.45.. way undervalued
Added some more at the 15.70 range. May need to do another round if this keeps up.
People will be wondering six months to a year from now why they didn't load up in the 15/16 range. Now is the time to back up the truck. The video below spells out how big of an opportunity this is for tiny PRTK:
This is a good youtube summary of the resistance issue and how PRTK can make a huge difference with Omadacycline:
Learn how investigational omadacycline is designed to overcome the 2 main mechanisms of tetracycline resistance:
Get in now while you can. Once a new antibiotic hits the market it ALWAYS makes a big splash....
Started a new position today at $16.25 and may have to take advantage of cheapies.
The two drugs will probably be approved and improve the prospects of this company regardless of the stupid $50 million offering. The bottom line is that the float is pretty small, and the potential is large to hit $50 or more with the present market cap at $444 million. That's a relatively small market cap making this one of the best antibiotic/acne drug company opportunities in a while?
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