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Celebrating my 2nd win this year!
Please excuse me for this post... NBRV@2.39 GOT THIS NEWS THIS AFTERNOON..
First New IV and Oral Antibiotic with a Novel Mechanism of Action Approved in Nearly Two Decades Provides Critically Needed Treatment Option for Adult Patients with CABP
https://finance.yahoo.com/news/nabriva-therapeutics-receives-u-fda-194136149.html
First New IV and Oral Antibiotic with a Novel Mechanism of Action Approved in Nearly Two Decades Provides Critically Needed Treatment Option for Adult Patients with CABP
https://ml.globenewswire.com/media/a1c350bb-358c-4fa1-a16e-11280b2dcdb7/medium/xenleta-vial-bottle-carton-tablets.jpg
Nabriva Therapeutics Receives U.S. FDA Approval of Xenleta™ (lefamulin) to Treat Community-Acquired Bacteria Pneumonia (CABP)
https://seekingalpha.com/pr/17607415-nabriva-therapeutics-receives-u-s-fda-approval-xenleta-lefamulin-treat-community-acquired
I will sleep well tonight, anticipating a early rise tomorrow morning!
[/bNabriva Therapeutics PLC – ADR (NASDAQ: NBRV)]announced, following the receipt of the final minutes of a Type A meeting it had with the FDA, it expects to resubNabriva Therapeutics PLC – ADR (NASDAQ: NBRV)mit the NDA for Contepo injection for treating complicated urinary tract infections, including acute pyelonephritis, early in the fourth quarter of 2019.
The Type A meeting was convened to resolve the issues identified in the complete response letter to the originally submitted NDA, which related to facility inspections and manufacturing deficiencies at one of Nabriva's contract manufacturers. The FDA had not sought any additional clinical or non-clinical data.
The stock was seen rising 4.17% to $2.25 in pre-market trading Friday.
Is the Options Market Predicting a Spike in Nabriva (NBRV) Stock?
https://finance.yahoo.com/news/options-market-predicting-spike-nabriva-170205180.html
YES I liked the article also!
I bought more shares today!
GOOD MOVE BUYING TODALY
RedHill files for $150M shelf offering
Jul. 24, 2019 12:38 PM ET|About: RedHill Biopharma Ltd. (RDHL)|By: Douglas W. House, SA News Editor
RedHill Biopharma (RDHL -3%) has filed a preliminary prospectus for a shelf offering of $150M of American Depositary Shares (ADSs), warrants to purchase ADSs, subscription rights and/or units.
Yesterday, it disclosed an agreement with Leerink for the sale of up to $60M of ADSs.
FINALLY GOT ONE RIGHT-KPTIstill hoping for NBVR!
Why Karyopharm Therapeutics Is Up Today
Motley Fool
Brian Feroldi, The Motley Fool
Motley FoolJuly 23, 2019
What happened
Shares of Karyopharm Therapeutics (NASDAQ: KPTI), a commercial-stage biopharmaceutical company focused on oncology, rose as much as 10% in early-morning trading on Tuesday. Shares were up about 7% as of 11:45 a.m. EST.
So what
Investors can thank Eric Joseph, an analyst at JPMorgan, for today's bullish move. Joseph upgraded Karyopharm's stock to overweight and raised his price target to $16. That's much higher than yesterday's closing price of $8.33.
Joseph's bullishness on Karyopharm's stock is a result of a recent survey of doctors that showed 75% of respondents planned on prescribing its newly FDA-approved multiple myeloma drug Xpovio within the next year.
Traders are cheering in response to the analyst upgrade and the upbeat survey results.
8/19/2019!!!
Will Karyopharm Therapeutics Continue to Surge Higher?
Zacks
Zacks Equity Research
ZacksJuly 9, 2019
https://finance.yahoo.com/news/karyopharm-therapeutics-continue-surge-higher-113511287.html
I hope you trading a lotta shares with low commissions!
Revisiting Karyopharm Therapeutics
Jul. 8, 2019 2:57 PM ET | About: Karyopharm Therapeutics Inc. (KPTI)
Summary
One of the biggest risers in the market last week was a small oncology concern called Karyopharm Therapeutics, which was up some 45%.
An early and unexpected FDA approval triggered the big rise in the shares.
We revisit Karyopharm in the paragraphs below and highlight some other potential catalysts on the horizon.
Looking for a portfolio of ideas like this one? Members of The Busted IPO Forum get exclusive access to our model portfolio. Get started today »
"A ship is safe in harbor, but that's not what ships are for." - John A. Shedd
One of the big winners in the market last week and for the model portfolio of The Busted IPO Forum was a small-cap oncology concern named Karyopharm Therapeutics (KPTI). The stock soared just over 45% this week on the unexpected early FDA approval for its primary drug candidate selinexor.
Today, we revisit the investment case for Karyopharm now that a major uncertainty has been removed for the company.
Company Overview
Karyopharm Therapeutics is a now a "Tier 3" biotech concern based in Massachusetts. The firm is focused on creating novel, first-in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other diseases. With last week's rally, the stock currently has a market capitalization of just under $550 million and trades just south of $9.00 share.
FDA Approval
On Wednesday, the FDA approved selinexor whose brand name will be XPOVIO for the treatment of penta-refractory multiple myeloma. XPOVIO will be "list" priced at $22,000 per month and will start being marketed this month. Approval on July 3rd was unexpected given the PDUFA date was July 6th. In addition, the Ad Comm Panel for XPOVIO voted 8-5 to delay recommendation for approval until results of a large-scale study known as "BOSTON" came out. This data will not be disclosed until late this year or early 2020.
Source: Company Presentation
XPOVIO is an oral, first-in-class, reversible, potent, selective inhibitor of nuclear export (SINE) that specifically blocks XPO1
Source: Company Presentation
The myeloma market is quite large with multiple players and an annual spend north of $17 billion annually. The niche Karyopharm is targeting is already significant and projected to grow rapidly in the coming years.
Analyst Commentary & Balance Sheet
On Friday, H.C. Wainwright reiterated its Buy rating and $32 price target on KPTI with the following updated view on the company:
"We find the label compelling and in line with expectations. Commercial launch for Xpovio expected next week. Karyopharm has developed a strategic plan going forward in order to ensure a successful launch of Xpovio, which management believes gives support to future launches in other indications as well. The company hired over 70 employees, with an average of about 20 years pharmaceutical experience and approximately five years of MM experience, in sales and nursing liaison positions in January 2019. The sales team plans on educating professionals and patients regarding how to effectively administer the drug and guiding them through the drug's side effect profile. Karyopharm is working with payors and is attempting to minimize access barriers for appropriate patients as well as helping them stay on treatment."
Wedbush also reissued its Buy rating Friday, but with a more subdued $11 price target. In addition, William R. Baird boosted its target by 10 bucks a share to $25. The analyst there is modeling $150 million peak annual sales for the later-line approval and states that accelerated approval de-risks the market in second-line relapsed multiple myeloma which is more meaningful market.
RBC Capital also maintained its buy rating on KPTI, but raised its target to $22 from $16 previously. RBC's analyst noted "the label includes no boxed warning, a win, and while it describes in detail the many AEs (adverse events) associated with Xpovio and the need for monitoring, it provides clear dose- adjustment schemes and guidelines for AE management."
The company ended the first quarter with approximately $265 million in cash and marketable securities on the balance sheet.
Verdict
Source: Company Presentation
Thanks to approval, the investment case for Karyopharm is now considerably derisked. The company also has several potential catalysts on the horizon. Obviously, the BOSTON data will be heavily scrutinized when it comes out. Karyopharm also plans to file an NDA for XPOVIO to treat cancer - diffuse large B-cell lymphoma (DLBCL) in the first half of 2020.
In addition, top line Phase 3 data for XPOVIO studies for treating Dedifferentiated liposarcoma should be out sometime in 2020 as well. While the stock had a good rally this week, the shares are still significantly below 52-week price targets as well as recently revised analyst price targets. This investment story could have further to go in the weeks and months ahead.
Option Strategy
Image result for Stock Purchase
An efficient way to add exposure or to KPTI is via a Buy-Write order. Using the November $10 call strikes, fashion a Buy-Write order with a net debit in the $6.80 to $7.00 range (net stock price - option premium). This mitigates some downside risk and sets up a more than solid potential return for its just over four month hold period.
"So we shall let the reader answer this question for himself: who is the happier man, he who has braved the storm of life and lived or he who has stayed securely on shore and merely existed?" - Hunter S. Thompson
Busted IPO Forum writes on Seeking Alpha and runs The Busted IPO Forum on the Seeking Alpha Marketplace, our platform for guided investing communities and research services.
Bret Jensen is the Founder of and authors articles for the Biotech Forum, Busted IPO Forum and Insiders Forum.
Busted IPO Forum writes on Seeking Alpha and runs The Busted IPO Forum on the Seeking Alpha Marketplace, our platform for guided investing communities and research services. Here’s a little bit about the service.
Author's note: I present and update my best small-cap Busted IPO stock ideas only to subscribers of my exclusive marketplace, The Busted IPO Forum. Try a free 2-week trial today by clicking on our logo below! As of market close 07/05/2019, our 18 stock model portfolio has generated an overall return of 31.22% since its launch in the summer of 2017. The Russell 2000 has produced a return of 4.17% over the same time frame.
Disclosure: I am/we are long KPTI. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Karyopharm +3% as analysts boost targets on FDA approval
Jul. 5, 2019 11:39 AM ET|About: Karyopharm Therapeutics Inc. (KPTI)|By: Jason Aycock, SA News Editor
Karyopharm Therapeutics (NASDAQ:KPTI) is up 3% on its return to regular-session trading after it spiked 36% in Wednesday's shortened session amid an FDA approval for its selinexor, for treatment of penta-refractory multiple myeloma.
Shares today hit their highest point since mid-November, while analysts responded by raising price targets.
Baird boosted its target to $25 from $15 -- implying 173% upside -- and modeled $150M peak annual sales for the later-line approval. It says accelerated approval de-risks the market in second-line relapsed multiple myeloma, the more meaningful market.
Meanwhile RBC raised its target to $22 from $16, pointing to the lack of the most serious caution on the label: "The label includes no boxed warning, a win, and while it describes in detail the many AEs (adverse events) associated with Xpovio and the need for monitoring, it provides clear dose- adjustment schemes and guidelines for AE management.”
$17 BY END OF DAY!
Anybody feel analyst “BUY” rating coming?
FDA OKs Karyopharm's selinexor for treatment-resistant multiple myeloma; shares up 36%
Jul. 3, 2019 10:51 AM ET|About: Karyopharm Therapeutic... (KPTI)|By: Douglas W. House, SA News Editor
Karyopharm Therapeutics (KPTI +35.5%) is up on more than a 6x surge in volume in response to the FDA nod for XPOVIO (selinexor) for the treatment of penta-refractory multiple myeloma.
The agency's action date was July 6.
https://seekingalpha.com/news/3475710-fda-oks-karyopharms-selinexor-treatment-resistant-multiple-myeloma-shares-36-percent
Karyopharm Reports New and Updated Selinexor Combination Data from the Phase 1b/2 STOMP Study at the European Hematology Association 2019 Annual Meeting
https://seekingalpha.com/pr/17544827-karyopharm-reports-new-updated-selinexor-combination-data-phase-1b-2-stomp-study-european
I BOUGHT SHARES TODAy@5.40
You have been here a while my friend don’t give up now!
Maybe you shooting to p/u some more cheap shares
7/06/2019!!!
YES, I believe it will FINALLY...
Once they get that 1st one approved here we GO!!!
Just bought more at 2.24 today!
[bThe FDA did not request any new clinical data and did not raise any concerns with regard to the safety of CONTEPO.
Volume through the ROOF we over $3!!!
THANKS, that is GREAT
Wish me well guys/gals...
Options Bulls Bet on This Drug Stock to Double....
https://finance.yahoo.com/news/options-bulls-bet-drug-stock-180643707.html
Wish me well guys/gals...
Options Bulls Bet on This Drug Stock to Double....
https://finance.yahoo.com/news/options-bulls-bet-drug-stock-180643707.html
Option Buyers....
Options Bulls Bet on This Drug Stock to Double
https://finance.yahoo.com/news/options-bulls-bet-drug-stock-180643707.html
Volume picking up!
FDA's decision looming on Nabriva's experimental antibiotic
Nabriva's new drug application for its Contepo antibiotic is being reviewed by the FDA.
Enlarge
By John George – Senior Reporter, Philadelphia Business Journal
2 hours ago
The Food and Drug Administration is expected to make a decision this week on a new application filed by Nabriva Therapeutics for what the company describes as “the first truly new antibiotic in nearly two decades."
Nabriva is seeking approval for Contepo as a treatment for complicated urinary tract infection still
The two conditions combined afflict 8 million to 9 million patients annually in the United States, according to Nabriva.
The FDA is scheduled to rule on the company's Contepo application by the end of the day on April 30.
Contepo and Lefamulin, according to company officials, are designed to kill bacteria in a different way than other recently approved antibiotics.
“Doctors and their patients are in significant need of new treatment options,” Schroeder said. “A growing number of bacterial and fungal infections have become resistant to currently available antibiotics, creating an urgent need for new antibiotics that work in different ways. If approved by the FDA, Contepo will be the first novel intravenous antibiotic to be introduced in the U.S. in nearly two decades for the treatment of (complicated urinary tract infections).”
Schroeder said Narbriva, which has grown to 110 employees, has assembled an experienced executive and commercial team with extensive backgrounds in the development and commercialization of antimicrobial and hospital medicine. “We have also invested in the expertise of a medical science liaison team to spearhead scientific and patient community education and awareness,” he said. “We plan to expand our workforce in a focused and targeted manner with approximately 60 sales representatives in the field” should Contepo receive FDA approval.
Nabriva developed Lefamulin internally and acquired the rights to Contepo last year as part of its purchase of San Diego-based Zavante Therapeutics in a deal valued at up to $124.5 million.
BIG WEEK IS HERE!
HERE WE GO!
Try this one...
https://www.nasdaq.com/symbol/nbrv/analyst-research
Vowed 3 tomorrow!
Good links!
This is embarrassing to admit... I bought 10k shares of REGN in 1994 @ 4 bucks a share, sold at 17 bucks a share.... Just looked REGN is selling at 345 bucks a share WITH 27 I SAY AGAIN 27 DRUGS in human trials!!!
I’M SICK