Kitov Expects to Submit an NDA for KIT-302 in the Third Quarter 2017.Kitov announced that it began the process of compiling the documents necessary to file an NDA for its lead asset KIT-302 as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation, a clinical research organization, to digitalize and formally submit its NDA application. Kitov expects the filing to occur during the third quarter of 2017, with a potential FDA approval during the second quarter of 2018.
KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously
Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial
Marketing potential Pipeline candidates address large, multi-billion dollar markets
Kitov’s current pipeline products, KIT-301 and KIT-302, are combination drugs that treat OA pain and HTN simultaneously. In December 2015, KIT-302 successfully achieved the primary efficacy endpoint for its Phase III clinical trial. In August 2016, the United States Patent Office issued a patent covering KIT-302.
Of the 27 million Americans with OA, 50% also suffer from HTN, which is also a common side effect of stand-alone OA drugs. With no single medication currently treating both conditions, KIT-301 and KIT-302 are targeting this multi-billion dollar market.
why the dump this morning?
The upside potential for XOMA just got a whole lot more interesting. Ive been struggling with this stock lately. Some of my other trades have been from awe*some*stocks which are working out pretty well.
I have a feeling XOMA will see a pullback now. What yall think? if you guys have questions you should ask awe.some.stock_s. They often respond to my emails which is helpful.
Why is this up today? What's wrong?
Wainwright $48 price target. I would still need it to go to $100 just to break even but I'd take it
I think XOMA is due for a pullback. What are your thoughts? Yo you should really check out awesome.stocks, they seem on point with their stocks.
Xoma is a piece a-of#$%$ stock
The scenarios are quite interesting at current levels for XOMA. have you guys heard of awesom-eSTOCKS. i started receiving their allerts and so far i am happy.
AXSM (MC $85 M)(Cash $50 M) 5x BIG Phase 3 in various indications targeting large Markets with first interim results in 2H 2017 = 2000%+ POTENTIAL..UNKNOWN LOW FLOAT GEM !!!
Undiscovered and massive undervalued Biotech Stock with lots of Big News on the way.This Stock is brutally undervalued with a Market cap of just $85 million and $50 million in cash .Founder and Ceo is the larget shareholder holding over 7 million shares (30%) more than 50% of O/S is owned by Insider and Institutions which is a great sign .
This undiscovered stock could be the next 10 bagger gem if just one of their 5 ongoing Phase 3 programs is successful .GL
Market-Cap: $85 Million Cash: $50.6 Million(cash runway into the first quarter of 2019.) Price:$3.70
Shares Out: 23 Million
Anticipated Near-Term Clinical Milestones
Clinical Trial Initiations: -- Phase 2/3 clinical trial of AXS-05 in AD agitation (2Q 2017)
Clinical Trial Readouts:
-- Phase 3 COAST-1 trial of AXS-02 in knee OA associated with BMLs, interim analysis (3Q 2017)
-- Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim efficacy analysis (4Q 2017)
-- Phase 3 STRIDE-1 trial of AXS-05 in TRD, top-line data (1Q 2018)
AXS-05 Treatment Resistant Depression in Phase 3 -(Only 1 approved drug for TRD = unmet medical need. 3M patients in the U.S.)
AXS-05 Agitation in Alzheimer’s Disease in Phase 2/3 -(No approved medication = unmet medical need. 2M patients in the U.S.)
AXS-02 Complex Regional Pain Syndrome (CRPS) in Phase 3 (Orphan+Fast Track Status) -(No approved drug = high unmet need. 80,000 new cases per year in the U.S.)
AXS-02 Knee Osteoarthritis (OA) with Bone Marrow Lesions (BMLs) in Phase 3 (SPA & Fast Track) -(7M patients in the U.S.)
AXS-02 Chronic Low Back Pain(CLBP) with Modic Changes (MCs) in Phase 3 -(1.6M patients in the U.S.)
Herriott Tabuteau, MD 7 351 729 38,4% Fidelity Management & Research Co. 2 361 625 12,3% JPMorgan Asset Management (UK) Ltd. 1 432 456 7,48% Mark Coleman, MD 647 998 3,38% BlackRock Fund Advisors 426 837 2,23% Stifel Trust Co., NA 415 279 2,17% The Vanguard Group, Inc. 272 189 1,42% Lombard Odier Asset Management (USA) Corp. 250 000 1,31% JPMorgan Investment Management, Inc. 156 625 0,82% SSgA Funds Management, Inc. 134 688 0,70%
Here's a cut/paste fron yesterdays SEC filing. Choke on this shareholders. They've been fleecing generations of fools and enriching themselves in the process. Summary Compensation Table The following table sets forth certain summary information for the years indicated concerning the compensation earned by the Company’s current and former Chief Executive Officer, Chief Financial Officer, and two individuals who would have been one of our three most highly compensated executive officers except for the fact that they were not serving as executive officers as of December 31, 2016.
Name and Principal Position
Year Salary ($) Stock Awards ($)(1) Option Awards ($)(2) Non-Equity Incentive Plan Compensation ($)(3) All other Compensation ($)(4) Total ($) James Neal