$CRBP Falls Sharply after Street’s Feuerstein Negative remarks

By |October 25th, 2016|News|

Corbus Pharmaceuticals Holdings Inc $CRBP nosedived after TheStreet�s Adam Feuerstein said that the stock is �headed for a big fall�, citing an unidentified healthcare fund manager who earlier shorted CytTx, Mast Therapeutics, Immunomedics and others. The analyst added that Resunab, the sold drug in the research pipeline, doesn�t work. The [...]

$DPRX Tumbles as Lead Product Candidate Locilex Fails Late-Stage Trials

By |October 25th, 2016|News|

Dipexium Pharmaceuticals $DPRX nosedived about 85% amid heavy volume trading in response to its announcement that both pivotal Phase 3 clinical studies, OneStep-1 and OneStep-2, evaluating lead product candidate Locilex (pexiganan cream 0.8%) for the treatment of mild infections of foot ulcers failed to show superiority over vehicle (placebo) plus [...]

$NVS posts mixed Q3 Results

By |October 25th, 2016|News|

Novartis posted revenue of $12.13 billion, a drop of 1.1% Y-o-Y, and missing the forecast by $110 million. EPS stood at $1.23, beating the forecast by $0.04. Performance of various units: Oncology: (-6.2%); Ophthalmology: (-0.2%); Est. Medicines: (-17.5%); Neuroscience: (+3.9%); Immunology & Dermatology: (+37.7%); Respiratory: (+18.9%); Cardio-Metabolic: (+22.2%).

$LLY Misses Q3 Forecast

By |October 25th, 2016|News|

Eli Lilly $LLY missed Q3 forecast. For the concluded quarter, revenue was $5.19 billion, a growth of 4.6%, Y-o-Y, but falling short of the forecast by $100 million. EPS for the quarter stood at $0.88, missing estimates by $0.07. The company expects fiscal 2016 EPS to come in the range [...]

$MRK Tops Revenue Forecast

By |October 25th, 2016|News|

Merck $MRK posted better-than-expected fiscal third quarter results. For the concluded quarter, EPS was $1.07, bettering forecast by $0.09. Revenue came at $10.54 billion, a 4.7% growth Y-o-Y, and beating estimates by $360 million. Worldwide sales for the quarter were $10.5 billion, a 5% growth, including a 1% negative impact [...]

Premarket Biotech Digest: $ADXS Results, $GSK Files BLA, $ADRO Setback

By |October 25th, 2016|Digest|

[/toggle] Results from a Phase 2 study, GOG-0265, evaluating Advaxis’ $ADXS lead product candidate axalimogene filolisbac in patients with persistent/recurrent metastatic carcinoma of the cervix showed a 37.5% overall survival (OS) rate at Month 12 based on 24-subject observations. The drug-maker said this is about [...]

Biotech Trade Alerts Archive -2016-10-24- $BNTC, $ADRO, $LIFE, $CTIC, $MRNS, $GSK

By |October 25th, 2016|Real Time Trade Alerts|

DRKKD.com Real Time Biotech Trade Alert Service October 24, 2016. Tickers covered: BNTC, ADRO, LIFE, CTIC, MRNS, GSK *** L3 or above subscription required to read further... Login or Subscribe/Upgrade here Posted: Mon, 24 Oct 2016 13:37:26 -0400 Ticker: BNTC InPortfolio: No ConvictionBuy: No Price: 1.73 RiskProfile: High [...]

$BNTC to Partner with NantVentures

By |October 24th, 2016|News|

Benitec Biopharma $BNTC entered in an oncology-focused R&D agreement with Nantworks under which the former will lead preclinical evaluation and clinical development of certain assets based on its ddRNAi technology. Specifically, it will lead clinical development of a Phase 2 gene-silencing asset for the treatment of a solid tumor indication [...]

$ADRO new patient enrollment for LADD clinical trial put on hold

By |October 24th, 2016|News|

Aduro Biotech $ADRO fell sharply amid heavy trading volume in response to its announcement that the FDA has put a partial clinical hold on its LADD (Listeria-based immunotherapy construct) clinical trials. The action, which halts new subjects enrollment , comes after a blood culture sample from an indwelling port of [...]

$LIFE’s Resolaris Fast Tracked

By |October 24th, 2016|News|

The FDA designated aTyr Pharma�s $LIFE Resolaris for Fast Track review for the treatment of facioscapulohumeral muscular dystrophy (FSHD), an unusual and severe genetic disorder characterized by muscle weakness and wasting. It affects roughly 19,000 Americans every year. There no approved drugs for the ailment. Fast Track designation provides more [...]

Baxalta $SHPG to return pacritinib to $CTIC

By |October 24th, 2016|News|

Baxalta $SHPG and CTI BioPharma $CTIC have inked an agreement under which Baxalta will be returning pacritinib to CTIC. As per the terms of the deal, Baxalta will pay CTI a one-time cash payment of $10.3 million as reimbursement for certain incurred or anticipated expenses. CTI will repay the $10.3 [...]

$MRNS to progress with Phase 2 studies with ganaxolone for treating epilepsy

By |October 24th, 2016|News|

Results from a 36-participant Phase 1 dose-escalation clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of Marinus Pharmaceuticals� $MRNS lead product candidate ganaxolone as an ascending bolus dose or continuous infusion achieved dose levels targeted for efficacy in patients with status epilepticus, an emergency-situation for of epilepsy characterized by [...]

$GSK Files BLA for shingles vaccine in U.S

By |October 24th, 2016|News|

GlaxoSmithKline $GSK filed a Biologics License Application (BLA) with the FDA, seeking approval of its shingles vaccine, branded as Shingrix, for the prevention of herpes zoster in people aged 50 and above. In the clinical trials, a two-dose regimen of shingrix demonstrated 90% efficacy in participants at least 70 years [...]

Is Alkermes Still A Buy?

By |October 24th, 2016|Opinions|

Alkermes $ALKS has seen a huge rally in the last three days after the company announced positive top-line results from its FORWARD-5, which is the third Phase 3 efficacy study to read out from the FORWARD pivotal program for ALKS 5461. The drug is being developed as a once-daily, oral [...]

$CTIC A Value Trap

By |October 24th, 2016|Opinions|

CTI Biopharma $CTIC announced that it has signed an agreement with Baxalta $SHPG returning pacritinib to CTIC. According to the terms of the agreement, Baxalta will pay CTI a one-time cash payment of $10.3M as reimbursement for certain incurred or expected-to-be incurred expenses. CTI will repay the $10.3M upon the [...]

Premarket Biotech Digest: $CERC Gets A Boost, $FDA to Review $BMY’s Opdivo, $ALKS Gets Bullish Analyst Comments

By |October 24th, 2016|Digest|

[/toggle] Nano-cap stock, Cerecor $CERC gained sharply on Friday amid heavy trading volume in response to Alkermes’ $ALKS successful late-stage clinical trial of ALKS 5461 in major depressive disorder (MDD). Cerecor’s lead product candidate is CERC-301, going through investigations under Phase 2 development for the [...]

The three ‘Gens and Gilead $GILD $CELG $BIIB $AMGN: Which has the most promise?

By |October 24th, 2016|Monthly Investment Ideas|

There are others, but these four companies - Celgene $CELG Biogen $BIIB Amgen $AMGN and Gilead $GILD - have often been discussed in these forums. These are a special subset of biotech companies, those that are large cap, have a long-tailed product line, but are still growth stocks. I have [...]

Premarket Biotech Digest: $ALKS Data, $AMGN Results, $OMER Mid-Stage Study Succeeds

By |October 21st, 2016|Digest|

[/toggle] Alkermes $ALKS reported encouraging top-line results from FORWARD-5, a third phase 3 efficacy trial to read out from the FORWARD pivotal program for ALKS 5461, a once-daily, oral investigational medicine with the novel mechanism of action of the adjunctive treatment of major depressive disorder [...]

Biotech Trade Alerts Archive -2016-10-21- $RIGL, $TEVA, $TBPH, $CELG, $PBYI, $RHHBY

By |October 21st, 2016|Real Time Trade Alerts|

DRKKD.com Real Time Biotech Trade Alert Service April 1, 2016. Tickers covered: RIGL, TEVA, TBPH, CELG, PBYI, RHHBY *** L3 or above subscription required to read further... Login or Subscribe/Upgrade here Posted: Thu, 20 Oct 2016 13:35:57 -0400 Ticker: RIGL InPortfolio: No ConvictionBuy: No Price: 2.56 RiskProfile: High InvestmentType: [...]

$RIGL’s fostamatinib fails late-stage trial in thrombocytopenia

By |October 20th, 2016|News|

Rigel Pharmaceuticals $RIGL nosedived more than 25% amid heavy trading volume in response to its announcement of failed results in the second of two Phase 3 study evaluating fostamatinib for the treatment of adult patients with chronic/persistent immune thrombocytopenia (low blood platelets). The trial, FIT 2 (Study 048), was unsuccessful [...]