FDA Calendar

Monday, December 3, 2018

Time to start posting?

About to jump into the biotech world again after taking some time off.

Currently holding $STML with PDFUA in February 2019

https://ir.stemline.com/news-releases/news-release-details/stemline-therapeutics-announces-fda-accepts-elzonristm-biologics


$GBT for a swing.  $GBT, I will likely hold for a few days and see how much I can squeeze in profits.

Cheers,
Biotechtrader34

Wednesday, June 10, 2015

Random Catalysts : $GALE, $EXEL $IMGN

Today's focus is on ONCOLOGY, will add more over the next few days.

$GALE -

Phase 3 NeuVax Phase 3 PRESENT breast cancer immunotherapy clinical trial 

Expected Catalyst: Interim analysis in Q4 2015 or Q1 2016

http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=911858

'NeuVax is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent cancer recurrence after standard of care treatment in the adjuvant setting in breast and gastric cancers. '

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$GALE -

Phase 2 GALE-401 (Anagrelide Controlled Release) Phase 2 Clinical Trial Data at the European Hematology Association 20th Congress

Expected Catalyst: June @ EHS conference

http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=914567

"GALE-401 is a reformulated, controlled release version of anagrelide. In Phase 1 studies in healthy volunteers, GALE-401 was shown to significantly reduce the Cmax while maintaining plasma exposure to reduce platelet counts. Thus, GALE-401 may reduce treatment-related adverse events while maintaining effective therapeutic levels to decrease platelet production.''

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$EXEL

PDUFA: cobimetinib, to be used in combination with vemurafenib for patients with advanced melanoma harboring a BRAF V600 mutation

Expected Catalyst - August 11th, 2015

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$IMGN

Phase 3 GATSBY Kadcyla using IMGN's  ADC technology - HER2 + Gastric with partner Roche

Expected Catalyst 2H 2015

http://files.shareholder.com/downloads/ABEA-5VU3S1/267484631x0x808585/F5C7CB12-072F-45F4-BB4F-44899C84386A/IMGN_Corporate_presentation_as_of_6-2-15_for_website.pdf

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Tuesday, June 9, 2015

Random Catalyst $APRI, $LPCN $SGYP

Some random upcoming catalyst for 6/9

$APRI

Generate safety and proof-of-concept data from the RayVa Phase 2a clinical trial in patients with Raynaud's phenomenon secondary to scleroderma in order to make a go/no go decision, subject to guidance received from our Data Monitoring Committee (DMC) expected in June 2015

Visit StockCharts.com to see more great charts.



$LPCN

Pivotal Phase 3 clinical study evaluating efficacy and safety of LPCN 1021, its Oral Testosterone product for hypogonadal men with low testosterone.Expected to announce top-line results from the 52 week safety assessment portion of the SOAR clinical study by mid-year, as well as file the New Drug Application ("NDA") with the U.S. Food and Drug Administration in the second half of this year.

Visit StockCharts.com to see more great charts.
 


$SGYP

Completed enrollment in both phase 3 clinical trials with plecanatide for chronic idiopathic constipation (CIC) - pivotal data readouts expected in 2Q and 3Q 2015

Visit StockCharts.com to see more great charts.

Monday, June 8, 2015

Sold $POZN - bye bye #teampozen

Sometimes it can pay off to be patient in the stock market.  I bought POZN November of 2014, joining #teampozen, the twitter traders who bought and sold POZN over the past 12-18 months.  I watched it go all the way to 7's before coming back up and then back down to 6's before the new CEO was announced.  Then today on the merger and financing news, I sold at 9.53 for a modest gain.  To be honest I was hoping I could break even once some news related to YOSPRALA was released, but I did not have to wait that long.


So what value lesson did I learn?  --- I should have sold back in December when it hit 9.50.  Go #teampozen



Visit StockCharts.com to see more great charts.

Thursday, June 4, 2015

Xoma: Upcoming Catalyst Event



Xoma is a late-stage biotechnology company which focuses on the development and eventual commercialization of therapeutic antibodies.  Xoma's leading commercial candidate is gevokizumab an IL-1 beta modulating antibody.  Gevokizumab bind strongly to IL-1 Beta and modulates the cellular signals that lead to inflammation.  Interleukin-1 Beta (IL-1 Beta ), also known as catabolin is a cytokine protein that is an important mediator of inflammatory response and other cellular activities. IL-1B can be over-secreted and contribute to the development of autoimmune diseases such as BDU. Xoma owns the commercial rights to in the U.S. market and Japan, with co-development partner Servier (France) holding rest-of-world development rights.

BACKGROUND

gevokizumab is undergoing Phase 3 trials called EYEGUARD. The trial is split into 3 different sections, EYEGUARD-A, EYEGUARD-B and EYEGUARD-C.  In A, it will stydy gevokizumab's ability to treat acute non-anterior non-infectious uveitis (NIU). In B, it will focus on how to prevent disease flares in patients with Behçet's uveitis.  Finally C, will focus on prevention disease flares in NIU patients who are controlled with steroids and immunosuppressants.



For further information see below: EYEGUARD Studies

https://clinicaltrials.gov/ct2/show/NCT01684345
https://clinicaltrials.gov/ct2/show/NCT01747538
https://clinicaltrials.gov/ct2/show/study/NCT0196514

Recent Updates

On May 28th Xoma announced that  Phase 3 EYEGUARD-B Study had Reached Target Exacerbation Event and primary endpoint data will be available in about 7 weeks.

Catalyst(s)

Primary endpoint data for phase 3 EYEGUARD-B (a randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis) will be released during the 1st 2 weeks of July.
I have been away from trading for a few months.  Life has kept me pretty busy, but I've always been itching to get back to what I love.  This week I made a few trades and looking forward to making some money.

Currently holding:

POZN
XOMA
BLUE
MEIP

Will provide more details tomorrow..

Good Night!

Friday, November 30, 2012

$CLDX additonal information

Thanks to Patrick from Chimera Research for the additional points:

"Worth noting that data is almost exclusively presented in poster presentations. They also have a $40M ATM active"