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GNTA.OB...Sector: Healthcare...Industry: Biotechnology & Drugs

Started by ours, May 09, 2005, 11:33:00 AM

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wrangler

Hi akclide
As you can see it is making a steady climb up. Ended today @1.46 but droped to 1.44 after hours,still not bad.
Goodluck trading  to you also
wrangler

wrangler

#31
I've got to targets set for GNTA. Will use MACD buy and sell signals. When first target of 1.65 is there I will see if MACD is still in upward bullish trend to hold but if it is going to show a curve possibly heading down then I'll sell but if it still shows an upward trend with no sign of turning then I'll hold and shoot for target of 2.00. This is my plan
Goodluck trading to all
wrangler

setravis

AP
Genta Shares Climb on FDA Application
Thursday December 29, 11:02 am ET 
Genta Submits New Drug Application to FDA for Its Lead Anticancer Drug Candidate; Shares Rise


BERKELEY HEIGHTS, N.J. (AP) -- Genta Inc., a biopharmaceutical concern, said Thursday it finished filing a new drug application with Food and Drug Administration for its lead anticancer drug candidate, Genasense Injection.


The company's shares soared nearly 6 percent, or 7 cents, to $1.43 on the Nasdaq, where it has traded in a yearly range of 75 cents to $1.98.

Genta asks that Genasense, or oblimersen sodium, plus fludarabine and cyclophosphamide be used as treatment for patients with relapsed or refractory chronic lymphocytic leukemia. The potentially fatal disease, which affects more than 60,000 Americans, stems from a problem in the lymphocytes, a type of white blood cell that normally produces antibodies and serves important immune functions.

The application was submitted for "fast track" and "accelerated approval," programs, designed to expedite federal review for drugs that address an unmet medical need.

If selected for priority review, Genta may receive approval within six months of the filing date.



"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Press Release Source: Genta Incorporated


Genta Will Hold Conference Call to Update Investors on Regulatory Applications and Upcoming Milestones
Friday December 30, 8:00 am ET


BERKELEY HEIGHTS, N.J., Dec. 30 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA - News) announced that the Company will hold a conference call for investors to provide an update related to near-term regulatory activities for its lead anticancer compound Genasense® (oblimersen sodium) injection, and other upcoming Company milestones on Wednesday, January 4, 2006 at 9:00 AM ET. Raymond P. Warrell, Jr., M.D., Chairman and Chief Executive Officer will host the conference call.

    The conference call can be accessed live as follows:

     US/Canada Dial-in:       (877) 634-8606   Passcode: Genta Incorporated
     International Dial-In:   (706) 679-3140   Passcode: Genta Incorporated

    Live audio webcast:
http://www.genta.com/genta/InvestorRelation/events.html


Audio replay will be available approximately two hours after the completion of the call and will be archived for 30 days.

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company's research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense® (oblimersen sodium) Injection, the Company's lead compound from its oligonucleotide program, is currently undergoing late-stage, Phase 3 clinical testing. The Company has filed a new drug application (NDA) to the U.S. FDA for the use of Genasense in combination with chemotherapy for the treatment of relapsed or refractory CLL. In addition, the Company has also indicated its intention to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for the use of Genasense plus dacarbazine in patients with advanced melanoma before the end of 2005. The leading drug in Genta's small molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: http://www.genta.com.

This press release contains forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report/Form 10-K for 2004.

--------------------------------------------------------------------------------
Source: Genta Incorporated
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

#34
Moving UP!...Undervalued......bought in @ 1.40 on friday
With the FDA fast track approval in the works, continued good news, and no debt. This will start soon with a double digit stock price within the year, IMHO...
Look for the stock price to continue up, and going through the roof upon FDA approval. They have submitted an application with the FDA for fast track processing. Hope all continues well, and that they submit another approval for the melanoma cancer. Time will tell, but I feel good with this one!

Support @ $1.36...1.22...1.19
Resistance @ $1.54...1.60...1.65

Technicals
MACD is Bullish
Stochastic is Bullish
Close Above the 50-day EMA

Last Price Quote is:
3.81%above 13-day EMA
2.53%above 50-day EMA
RS Rating: 36 

Fundamentals
Key Data:
Market Cap (M): $167.05 
P/E Ratio: 5.44 
PEG Ratio: N/A 
Next Earnings: 02/16/2006
Last Analyst Rating: Hold
More...

Everyone on this thread got an Applaud from me ...Good Work.... ;D
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

wrangler

Hi setravis
See you're riding this one to. Should be a lot of movement on this one as time gets closer to FDA fast track approval. I have already set to targets on it and both looks promising with possible new highs being made.
Goodluck trading to all holding :)
wrangler

plocp

nice pick, i see a triangle at this point and gap in the near future, you guys see it? lol

equity

The FDA has not decided to give the drug priority review.  Even if they did, many drugs given "Fast track" status are never given approval.


wrangler

This is just my opinoin
The new drug they are trying to get approval for has already shown to improve patients with certain types of cancer. Also as setravis has noted they are debt free which means they are doing something right. Most companys in this sector are high in debt for research only when they begin to make marketable products with FDA approval are they able to go from red to green. When conferance meeting is done on 01-04-2006 I think there will be the beginning of an uptrend that may last untill either FDA will approve or not. As long as the drug keeps getting positive results from the patients in clinical trials this stock will keep moving up and if the FDA does approve their is no telling how high it might go. I trade for the short term though and have set to targets I'm hoping for as long as one of them gets hit I'll be happy with that. Below articles are from biospace.com .

12/30/2005 - Genta Incorporated (GNTA) Will Hold Conference Call To Update Investors On Regulatory Applications And Upcoming Milestones

BERKELEY HEIGHTS, N.J., Dec. 30 /PRNewswire-FirstCall/ -- Genta Incorporated announced that the Company will hold a conference call for investors to provide an update related to near-term regulatory activities for its lead anticancer compound Genasense(R) (oblimersen sodium) injection, and other upcoming Company milestones on Wednesday, January 4, 2006 at 9:00 AM ET. Raymond P. Warrell, Jr., M.D., Chairman and Chief Executive Officer will host the conference call.
(See Story from BioSpace.com) (12/30/2005)

12/29/2005 - Genta Incorporated (GNTA) Files New Drug Application For FDA Approval Of Genasense(R) Plus Chemotherapy For Patients With Advanced Or Refractory Chronic Lymphocytic Leukemia
First-in-Class Agent Targets Cancer Cell Death Pathway and Significantly Increases Durable Complete Remissions in Patients with Advanced Leukemia
(See Story from BioSpace.com) (12/29/2005)

12/12/2005 - Genta Incorporated (GNTA) Release: Pilot Clinical Study Of Genasense(R) Plus Rituxan(R) And Fludarabine Shows Activity In Chronic Lymphocytic Leukemia

ATLANTA, Ga., Dec. 12 /PRNewswire-FirstCall/ -- Genta Incorporated announced the presentation of preliminary clinical results regarding the use of its lead anticancer compound, Genasense(R) (oblimersen sodium) Injection, in combination with fludarabine plus rituximab (Rituxan(R); Genentech/IDEC) in patients with chronic lymphocytic leukemia (CLL). The data were presented this weekend at the 47th Annual American Society of Hematology meeting in Atlanta, GA.
(See Story from BioSpace.com) (12/12/2005)

12/6/2005 - Genta Incorporated (GNTA) Release: Annual Meeting Of The American Society of Hematology Highlights Clinical Data With Genasense(R) And The Importance Of Its Target In Cancer

BERKELEY HEIGHTS, N.J., Dec. 6 /PRNewswire-FirstCall/- Genta Incorporated announced that its lead anticancer drug Genasense(R) (oblimersen sodium) injection, and the central role of its Bcl-2 target in leukemia and lymphoma, will be featured in a number of presentations at the Annual Meeting of the American Society of Hematology (ASH). The meeting will take place in Atlanta, GA from December 9-13, 2005.
(See Story from BioSpace.com) (12/06/2005)

11/15/2005 - Genta Incorporated (GNTA) Release: Genasense(R) Enhances Preclinical Activity Of Tarceva Using An Intermittent Dosing Schedule

BERKELEY HEIGHTS, N.J., Nov. 15 /PRNewswire-FirstCall/ -- Genta Incorporated announced the presentation of scientific data that may greatly expand the use of the Company's lead anti-cancer drug, Genasense(R) (oblimersen sodium) injection. The new preclinical results showed that intermittent administration of Genasense by bolus injection significantly increased the anticancer activity of erlotinib (Tarceva(R); OSI Pharmaceuticals), including cancers that were not sensitive to erlotinib. Results of these studies were presented today at the annual AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia, PA.
(See Story from BioSpace.com) (11/15/2005)


wrangler

setravis

Moving up in the pre-market.... ;D

GENTA INC (NasdaqNM:GNTA) Delayed quote data 

Pre-Market (RT-ECN): 1.54  0.08 (+5.48%)

"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Press Release Source: Genta Incorporated


Genta Completes Marketing Authorization Application to EMEA for Approval of Genasense(R) plus Chemotherapy for Patients with Advanced Melanoma
Tuesday January 3, 8:03 am ET 
Application Includes Extensive Data from Long-Term Follow-up of Patients in Large Randomized Controlled Trial


BERKELEY HEIGHTS, N.J., Jan. 3 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA - News) announced that the Company has completed a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) that seeks approval of Genasense® (oblimersen concentrate for solution for injection) in combination with chemotherapy for the treatment of patients with advanced malignant melanoma.


Genta expects that the dossier will be formally reviewed for validation at a meeting of the Committee for Medicinal Products for Human Use (CHMP) that is scheduled for January 23-26, 2006. Assuming validation, the initial review of the MAA would commence thereafter, and Genta would anticipate receiving consolidated questions from the Agency approximately 120 days later. The centralized licensing procedure provides a single marketing authorization that is valid in all 25 member states of the European Community. Review of the application is coordinated by the EMEA, and Spain and France have been appointed as rapporteur and co-rapporteur countries, respectively.

Genasense, Genta's lead anticancer drug, is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of resistance to cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma.

"The European filing represents an important step toward our goal of advancing care for cancer patients who have significant unmet medical needs," commented Dr. Raymond P. Warrell, Jr., Chairman and Chief Executive Officer of Genta. "The near simultaneous submissions of regulatory filings for different indications in the U.S. and Europe are impressive accomplishments that confirm the expertise and dedication of the Genta team in advancing therapy for patients. We believe that Genasense represents a breakthrough treatment for patients, and we look forward to continued dialogue with regulatory authorities in Europe."

Conference Call to Discuss Worldwide Regulatory Filings

The Company's management will hold a conference call for investors to provide an update on regulatory and corporate activities on Wednesday, January 4, 2006, at 9:00 AM ET. The conference call can be accessed live as follows:


    US/Canada Dial-in:     (877) 634-8606   Passcode: Genta Incorporated
    International Dial-In: (706) 679-3140   Passcode: Genta Incorporated
    Live audio webcast:
     http://www.genta.com/genta/InvestorRelation/events.html.
Audio replay will be available approximately two hours after the completion of the call and will be archived for 30 days.

MAA Efficacy Data

The MAA is principally based on long-term data derived from the largest randomized controlled trial that has been conducted in patients with advanced melanoma. In this trial, which was conducted at 139 sites in 9 countries, 771 patients were randomly assigned to receive chemotherapy with dacarbazine (DTIC) alone or in combination with Genasense. The MAA is comprised of the updated final analysis of this trial, which includes data from 24-months of minimum follow-up on all patients and has demonstrated the following results based on an intent-to-treat analysis:



    Endpoint                 Genasense/DTIC            DTIC             P
    Overall response                  13.5%            7.5%          0.007
    Complete response                  2.8%            0.8%          0.03
    Durable response                   7.3%            3.6%          0.03
    Progression-free survival, median  2.6 mos.        1.6 mos.      0.0007
    Overall survival, median           9.0 mos.        7.8 mos.      0.077


Prior to randomization, patients were prospectively stratified according to certain risk factors, including elevated blood levels of an enzyme known as LDH - a factor that previous studies have shown is associated with poor outcome. The updated analysis has shown that LDH was the sole stratification factor significantly associated with a treatment interaction effect. When the treatment effect was tested by LDH level, the efficacy of Genasense was significantly superior for all major efficacy outcomes in patients who had normal LDH at baseline, a group that comprised approximately two-thirds of patients in the trial (N=508). In this group, the following efficacy results were observed:



    Endpoint                 Genasense/DTIC            DTIC             P
    Overall response                  17.2%            9.3%          0.009
    Complete response                  3.4%            0.8%          0.04
    Durable response                   9.6%            4.0%          0.014
    Progression-free survival, median  3.1 mos.        1.6 mos.      0.0007
    Overall survival, median          11.4 mos.        9.7 mos.      0.018


    MAA Safety Data
In the randomized trial, the most frequent serious adverse events that occurred in greater than or equal to 5% of patients were fever and disease progression (6.2% vs. 2.8%, and 5.1% vs. 4.7%, respectively, for Genasense/DTIC compared with DTIC alone). The most frequent Grade 3 or 4 adverse events that occurred in greater than or equal to 5% of patients were neutropenia (21.3% vs. 12.5%), thrombocytopenia (15.9% vs. 6.4%), leukopenia (7.5% vs. 3.9%), anemia (7.3% vs. 4.7%), and nausea (6.7% vs. 2.5%). Although there was an increase in discontinuations due to adverse events in the Genasense arm (19% vs. 11%), there was no difference in the number of fatal, treatment-emergent adverse events (i.e., events that lead to a death on study or within 30 days from last study treatment). In the MAA, these data have been supplemented by substantial additional safety data derived from patients who received Genasense in other clinical trials.

About Malignant Melanoma

Malignant melanoma is the most deadly form of skin cancer. Melanoma is responsible for more than 90% of all skin cancer deaths. The European Network of Cancer Registries estimates that more than 60,000 cases of melanoma are diagnosed each year. The incidence of this disease is increasing by approximately 4 percent annually in the U.S., where it is the number one cause of cancer deaths for women aged 25 to 29. For more information on melanoma, please visit: http://www.nci.nih.gov/cancer_information/cancer_type/melanoma

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company's research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense® (oblimersen sodium) Injection, the Company's lead compound from its oligonucleotide program, is currently undergoing late-stage, Phase 3 clinical testing. In addition to completing the MAA documentation, the Company has also submitted a new drug application (NDA) to the U.S. FDA for the use of Genasense plus chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia. The leading drug in Genta's small molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: www.genta.com.

This press release contains forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report/Form 10-K for 2004.
--------------------------------------------------------------------------------
Source: Genta Incorporated
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

wrangler

#41
Great post and research setravis. I see nothing but good results on GNTA and expect this to be a big player. Keep up the good work. Really liked the pre-market trading 1.54 :o
Applaud you for the above research. It should tell us what to expect from this company.
wrangler

wrangler

AP
Genta Files for Genasense OK in Europe
Tuesday January 3, 9:05 am ET 
Genta Expects European Regulators to Begin Reviewing Genasense Application Within Month

BERKELEY HEIGHTS, N.J. (AP) -- Biopharmaceutical company Genta Inc. said Tuesday it expects European regulators to begin reviewing a marketing application for its skin-cancer treatment later in the month.
The company said it completed the application for its Genasense cancer drug to treat advanced skin cancer, and expects the European Medicines Agency to begin validating the application at a meeting in late January.

Genta said it expects to begin receiving questions from the agency about 120 days later. Approval by the agency would apply to all 25 member states in the European Union.

Genasense acts by blocking a protein that helps cancer cells resist chemotherapy drugs.

The company filed an application with the Food and Drug Administration Dec. 29 for the drug to treat chronic lymphocytic leukemia, a cancer that attacks white blood cells.

Genta shares rose 7 cents, or 4.8 percent, to $1.53 in premarket activity.





wrangler

plocp

strong close, tomorrow big run

wrangler

Conference tomorrow,hope it's going to move this stock like I think it will.
Goodluck everybody holding :)
wrangler