$AQXP looks like a steal under 17$ . I am planning to buy 100 shares Aquinox is exploring AQX-1125 for atopic dermatitis in its ongoing KINSHIP Phase 2 trial with top line data expected in Q4 2015.

If the PI3K pathway is overactive, immune cells can produce an abundance of pro-inflammatory signaling molecules and migrate to and concentrate in tissues, resulting in excessive or chronic inflammation. SHIP1 is predominantly present in immune cells and when activated, SHIP1 redirects signaling in immune cells to reduce their activation and migration, thereby reducing inflammation while still allowing these cells to maintain cell growth and survival, taking advantage of the natural modulation of the PI3K pathway. Consequently, drugs that activate SHIP1 can reduce the function and migration of immune cells and have an anti-inflammatory effect.

$ADMP I am planning to buy under $3.50 in Roth IRA for 2016 FDA decision

ADMP Mkt Cap 48 Million? Micheal Castor loves it Approval was denied on MINOR issue . They are resubmitting again in Q4

MARCH 2015 === Adamis Pharma receives Complete Response Letter from FDA for its Epinephrine Pre-Filled Syringe NDA (5.39)
Co announced that it received a Complete Response Letter from the FDA regarding its New Drug Application Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe product, for the emergency treatment of acute anaphylaxis, which is a severe allergic reaction.
A CRL is issued by the FDA’s Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form.
The questions raised by the FDA pertain only to Chemistry, Manufacturing and Controls relating to the volume of dose delivered by the syringe, including the ability to deliver volume within the levels contained in the labeling claim and as required by the FDA.
No other safety or efficacy issues were raised, and the New Drug Application will remain open until the CMC issues are resolve

06-Aug-15 09:02 ET
Adamis Pharma gives an update on its NDA with the FDA for its Epinephrine Pre-filled Syringe product (4.23)
On August 5th, the Company had a telephonic meeting with the U.S. FDA to discuss the agency’s Complete Response Letter. The Company has made several improvements to the performance, size and functionality of its PFS, and based on the Company’s interactions with the FDA to date, it plans to resubmit the NDA before year end, assuming successful continued product development efforts


Adamis will pursue 505 (b) (2) regulatory approval filings whenever possible in order to minimize costs and shorten the time to market. The focus is to create high quality, low-cost therapeutic alternatives to existing treatments. The company’s specialty pharmaceutical pipeline has several inhaled products for the treatment of asthma and chronic obstructive pulmonary disease (COPD) that include a new platform Taper Dry Powder Inhaler (DPI) technology that was acquired from 3M (NYSE:MMM). ADMP’s first pipeline product, if approved, with this new technology will be APC-5000 which has been designed to compete with other dry powder inhalers such as GlaxoSmithKline’s (GSK) Advair Diskus®. Adamis intends to pursue other products using this Taper DPI patented platform technology.

$IDRA Follow Mr. Julian and Felix Baker a Long Journey !!!FEW YEARS AGO !!

The following poem is for Mr Julian Baker

He has been blessed  God gifted eyes and mind few years ago

INCY was 2 few years ago

GEVA was under 10 few years ago

PCYC was .57c few years ago

SLXP was teens few years ago

AVNR was pennies few years ago

VPHM was teens few years ago

RCPT was under 25 few months ago

ITMN was teen few years ago

and story goes on forever

Is there Guarantee IDRA will be one of this kind ?

NO ONe knows for now BUT

I will be singing in few years

WOOW IDRA was 4 FEW years AGO

I cann’t remmebr those names which were bpought out few years ago

What is common in all these few years ago

THEY were blessed by Mr. Julian and Feix Baker’s hand few years ago.

Milano said he was approached about the CEO job from an Idera board member who was also a ViroPharma investor

“They have really interesting science,” Milano said. “The company has been around for a while and the science has evovled. We are at a place now where we are looking to advance the science into clinical development.”

MRTX $15.00 very high risk upcoming catalysts But they might do Secondary offering before data

“We are excited to report that each of our clinical oncology programs are advancing and are positioned to deliver proof of concept data in the coming months,” said Charles M. Baum, M.D., Ph.D., president and CEO of Mirati. “We have opened the expansion cohorts for MGCD265 in selected patients with MET and Axl mutations at a dose we are confident is fully inhibiting MET and Axl and should result in clinical responses. In addition, Phase 2 studies of mocetinostat are underway in patient populations selected for CREBBP and EP300 genetic mutations in Bladder Cancer and Diffuse Large B-cell Lymphoma. We look forward to delivering multiple data readouts in early 2015 that could result in the launch of registration studies in 2015.”

Pipeline Highlights


  • We have reached MTD and selected a dose for the expansion cohorts that we believe will fully inhibit MET and Axl
  • Expansion cohorts are open to enroll selected patients with Non-Small Cell Lung Cancer and other solid tumors that have MET driver mutations, MET amplifications, and Axl gene fusions
  • Initial proof of concept data expected in early 2015

Mocetinostat in Bladder Cancer

  • Initiated a multi-center registration-enabling study in patients with bladder cancer who have mutations of CREBBP or EP300 genes
  • Mirati is partnering with Foundation Medicine to use their comprehensive genomic profile to screen patients for genomic alterations of CREBBP and EP300 genes prior to clinical trial enrollment
  • Initial proof of concept data expected in early 2015

Mocetinostat in Diffuse Large B-cell Lymphoma (DLBCL)

  • Memorial-Sloan Kettering has initiated a Phase 2 study enrolling patients with relapsed/refractory DLBCL whose tumors harbor CREBBP or EP300 gene mutations
  • Initial proof of concept data is anticipated in early 2015


  • Phase 1 safety dose escalation study is ongoing and on track to identify a Phase 2 dose and initiate expansion cohorts in selected patients in the first half of 2015

AUPH a $3.90 hidden Gem with Potential gain of 200% to 400 % but HIgh risk

The Company has cash, cash equivalents and short term investments of $35.5 million at September 30, 2014. Aurinia believes its cash position will be sufficient to finance its operational needs until at least December 31, 2016. However, future cash requirements could vary materially from current estimations due to a number of factors including the costs associated with its clinical trial and strategic opportunities.

On July 29, 2014, Mr. Charles A. Rowland, Jr. was appointed to the Board of Directors and has assumed the role of Audit Committee Chair. Mr. Rowland, a CPA, has over 32 years of diversified financial experience and most recently was Vice-President and CFO of ViroPharma Inc., which was acquired in January of 2014 by Shire PLC for over $4.2 billion.

The Company is also pleased to announce the appointment of Benjamin (Beni) Rovinski, PhD, Managing Director of Lumira Capital, as a member of its Board of Directors, effective immediately. Dr. Rovinski joined Lumira Capital in 2001 with an investment focus on mid- to late-stage private and public life sciences companies. Prior to joining Lumira Capital, he held several senior management positions in the biotechnology sector, including 13 years at Sanofi Pasteur where he was a senior scientist and director of molecular virology. Dr. Rovinski received a PhD in biochemistry from McGill University in Montréal with post-doctoral studies in molecular oncology and retrovirology at the Ontario Cancer Institute in Toronto. –

Many members of Aurinia’s current leadership team are former senior managers of Aspreva Pharmaceuticals (“Aspreva”), which Galenica acquired for C$915 million in 2008. While at Aspreva, this management team executed one of the largest and most important lupus nephritis studies ever conducted, called the Aspreva Lupus Management Study (“ALMS”), which resulted in the emergence of mycophenolate mofetil as a new standard treatment for patients suffering from this devastating and potentially fatal disease. Aurina holds global rights to all indications for voclosporin and has development and commercialization partners in Canada, Israel, South Africa and Greater China. Aurinia also has a development and commercialization partner for ophthalmologic indications. In addition, Aurinia holds certain rights to exploit the ALMS database.
November 2014 Presentation

$XOMA Bakers bros. own 20% should we, I know it’s too late now that’s why I risked less and got March 10 calls .70c risking $350 on 5 calls

XOMA’s flagship candidate, gevokizumab, is being studied in a global Phase 3 clinical program, termed EYEGUARD, which is being conducted by SERVIER and XOMA. This program is designed to determine gevokizumab’s ability to treat acute non-infectious uveitis (“NIU”) in EYEGUARD-A, to prevent disease flares in patients with Behçet’s uveitis in EYEGUARD-B, and to prevent disease flares in NIU patients who are controlled with steroids and immunosuppressants in EYEGUARD-C.

Gevokizumab Proof-of-Concept Program

XOMA has a Proof-of-Concept (POC) program underway in which the Company is exploring the efficacy and safety of gevokizumab in multiple indications.  The Company reported promising data in January 2013 from the interim analysis of a Phase 2 study in moderate to severe inflammatory acne.  Data from the National Eye Institute’s study of gevokizumab in patients with active non-infectious anterior scleritis is expected in 2014.  XOMA anticipates full results from its two POC studies in patients with erosive osteoarthritis of the hand (EOA) in the first quarter of 2014.  Separately, SERVIER initiated a Phase 2 study to determine gevokizumab’s ability to reduce arterial wall inflammation in patients with marked atherosclerotic plaque inflammation and who have experienced an acute coronary syndrome in the previous twelve months, as well as POC studies in polymyositis/dermatomyositis, giant cell arteritis, and Schnitzler syndrome. 

More information on all of XOMA’s clincial programs can be found at  www.clinicaltrials.gov orwww.clinicaltrialsregister.eu.


ONCS I like .30c and under

OncoSec plans to present long term PFS data from its Phase I melanoma program. Please note that the date for this milestone is tentative and subject to change.

August 15, 2013 — December 31, 2013
Present interim response data on Phase II Merkel cell carcinoma program

OncoSec plans to present interim response data on Phase II Merkel cell carcinoma program. Please note that the date for this milestone is tentative and subject to change.

October 31, 2013 — December 31, 2013
Present top line interim data for Phase II melanoma program

OncoSec plans to present top line interim data for Phase II melanoma study. Please note that the date for this milestone is tentative and subject to change


Get every new post delivered to your Inbox.