SCYX looking nice under $4.00

SCY-078 Update

We developed an IV formulation of SCY-078 and are enrolling healthy volunteers in a single ascending dose Phase 1 study. We expect to complete the study and report results in the second quarter of 2016;
We initiated enrollment of a multicenter Phase 2 study with primary endpoints of safety and efficacy of the oral formulation of SCY-078 in patients with VVC in the fourth quarter of 2015. We expect to complete the study and report top line data in the second quarter of 2016;
We continue to enroll patients in the Phase 2 study with primary endpoints of safety, tolerability, and pharmacokinetics of the oral formulation of SCY-078 as step-down treatment in patients initially treated with echinocandin therapy for invasive Candida infections. We have opened new investigational sites in the U.S. and in Latin America and we are in the process of opening more sites in these regions and in Europe. Based on the data collected on the enrolled patients, together with the data from our recently completed Phase 1 biocomparison study, we expect to achieve the primary objectives of the study with fewer patients than originally planned. We expect to report top line data by the end of the second quarter of 2016;
We completed a Phase 1 biocomparison study of a new, well-tolerated citrate salt formulation of SCY-078 that has a comparable pharmacokinetic profile and potential formulation advantages over the previously used phosphate salt formulation. This new formulation will be used in development of both the oral and IV formulations going forward, and has the potential to extend composition of matter patent protection up to 2035; and
We secured Fast Track and Qualified Infectious Disease Product designations from the U.S. Food and Drug Administration for the IV formulation of SCY-078 in both invasive candidiasis and invasive aspergillosis.

SVACF 11c Interting merger with VBIV $2.40

SciVac is the developer of a third generation hepatitis B vaccine (HBV) called Sci-B-Vac . It is approved in several countries including SciVac’s home country of Israel, where it is administered to hundreds of thousands of newborns each year. While first generation HBV vaccines are mostly effective, their effectiveness is still only 90%. In a clinical trial of over 5,000 people, Sci-B-Vac was shown to have an effectiveness of greater than 98% with higher immunogenicity, or immune response in terms of antibodies produced.

The difference between Sci-B-Vac and the current standard-of-care HBV vaccine is that Sci-B-Vac is derived from mammalian cells instead of yeast cells, and carries on it the three main HBV surface antigens instead of just one. It is believed that the 10% of people who do not respond to first generation HBV vaccines are infected with mutant versions of HBV that escape the single antigen vaccine. It is much harder for HBV to mutate all three surface antigens simultaneously to escape Sci-B-Vac.

Despite vaccines available, HBV is still a huge pandemic. According to the World Health Organization, one third of the world’s population is infected with HBV, with up to 400M people suffering chronic infections leading to chronic liver disease. 250M of those people are in the Asia-Pacific region alone.

SciVac’s next regulatory goal is approval in the United States, where 12M people are infected every year despite the current first generation vaccine available. What regulatory hurdles have to be overcome remains to be seen, given that Sci-B-Vac is already clinically tested and approved in several countries. SciVac will be aiming at the immunocompromised as well as end stage renal disease and HIV patients, as these are patient populations who have special difficulties responding to current HBV vaccines.
http://www.globes.co.il/en/article-phillip-frost-seeks-scigen-reverse-merger-1000985030

XBIO watching at .26C

NOv 20, 2015 PR

Baxalta to Initiate a First-in-Human Clinical Trial of BAX 826, an Investigational, Extended Half-Life FVIII Treatment Targeting Weekly Dosing for Hemophilia A

  • Company confirms submission of clinical trial application (CTA) to initiate the clinical study in the United Kingdom
  • Baxalta’s second investigational extended half-life candidate based on ADVATE [Antihemophilic Factor (Recombinant)] uses proprietary polysialic acid (PSA) technology that aims to extend dosing intervals
  • Ongoing pipeline development for hemophilia treatments aims to introduce new therapeutic options based on the innovative science of factor replacement to help as many patients as possible achieve a goal of zero bleeds
Business Wire

BANNOCKBURN, Ill.–(BUSINESS WIRE)–

Baxalta Incorporated (BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced the submission of a Clinical Trial Application (CTA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a first-in-human clinical trial to evaluate the safety and efficacy of BAX 826, an investigational, extended half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A.

“We are advancing a number of approaches, including BAX 826 as well as our gene therapy program, to evaluate potential new options for hemophilia patients that can offer efficacy while also easing the treatment burden with a goal of once-weekly or even less frequent infusions,” said John Orloff, M.D., head of Research & Development and chief scientific officer, Baxalta. “The CTA submission represents an important advancement in our efforts to expand our portfolio of extended half-life treatments and further reinforces our leadership in hemophilia innovation.”

The open-label, dose-finding study of BAX 826 aims to enroll 30 patients; Baxalta expects to begin treating participants in the study by early 2016. BAX 826 is a next-generation rFVIII treatment based on the full length ADVATE [Antihemophilic Factor (Recombinant)] molecule. The compound is modified using proprietary polysialic acid (PSA) technology licensed from Xenetic Biosciences, Inc.(XBIO) to extend its circulating half-life. Baxalta has partnered with Xenetic to develop novel forms of polysialylated blood coagulation factors, including factor VIII. Xenetic’s PolyXen™ technology utilizes the biopolymer PSA in order to extend the circulating half-life and improve the pharmacokinetic profile of therapeutic proteins, peptides, and small molecules. Preclinical studies indicated BAX 826 offered an extended half-life compared to standard rFVIII.

With the BAX 826 program, Baxalta aims to augment its growing portfolio of direct factor replacement treatments for hemophilia, including ADVATE as well as ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], which was recently approved in the United States. In addition, the company continues to advance hemophilia innovation with the development of new advances like gene therapy, which has the potential to transform the treatment of hemophilia.

$ADMP low in cash but High Potential if FDA approves

Adamis’ version of the EpiPen for anaphylaxis as a key catalyst in 2016, as it represents the company’s transition to a commercial company. The billion-dollar market is dominated today by one premium-cost brand-name product — EpiPen by Mylan (MYL) — and is ready for a viable low-cost, high-quality branded generic alternative, in their view. They believe Adamis’ product is ideally positioned to capture market share.

$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
HUGE PIPELINE

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
ADMP
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

HUGE PIPELINE

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.
http://www.adamispharmaceuticals.com/pipeline/

$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.”
http://www.bizjournals.com/philadelphia/blog/health-care/2014/12/former-viropharma-chairman-and-ceo-gets-a-new-job.html

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

MGCD265

  • 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

MGCD516

  • 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
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