Depomed Inc. ($DEPO) appoints new CEO, two board members

By |March 31st, 2017|Opinions|

Depomed Inc. ($DEPO) is on its way to resolve its longstanding issues. The company recently announced that it has reached an agreement with its activist investor Starboard Value. The agreement results in Depomed appointing a new CEO. The company will also add two more seats to its Board of Directors. [...]

Premarket Biotech Digest – $IPXL gets favorable ruling, $AGEN to streamline operations, $ROSG announces net loss

By |March 31st, 2017|Digest|

Incyte Corporation ($INCY) announced that it has boosted its collaboration with Merck. Both the companies are working together to evaluate the combination of epacadostat, Incyte’s investigational oral selective IDO1 enzyme inhibitor, with KEYTRUDA®(pembrolizumab), Merck’s anti-PD-1 therapy, in patients across five tumor types. The collaboration [...]

MannKind Corporation reports annual net profit

By |March 30th, 2017|Opinions|

MannKind Corporation ($MNKD) recently reported its financial results for the fourth quarter and full year. The company’s total revenue for the quarter stood at $12.4 million. Its net income for the quarter was reported at $54 million. For the full financial year, MannKind earned $174.8 million in revenue while its [...]

Premarket Biotech Digest – $KPTI to resume trials, $AFMD announces Q4 results, $RHHBY gets FDA approval

By |March 30th, 2017|Digest|

Karyopharm Therapeutics Inc. ($KPTI) stock jumped as the company announced that the e U.S. Food and Drug Administration (FDA) Division of Hematology Products has lifted the partial clinical hold placed on the clinical trials for selinexor (KPT-330). This latest action will now allow Karyopharm [...]

Vertex Pharmaceuticals ($VRTX) reports positive results from two trials

By |March 29th, 2017|Opinions|

Vertex Pharmaceuticals ($VRTX) stock jumped over 22 percent in its current trading session as it also created a new 52 weeks high of $111.88. The stock responded to the company’s announcement that it has received positive results  from two Phase 3 clinical trials assessing the combination of tezacaftor and ivacaftor [...]

Premarket Biotech Digest – $ACOR announces +ve results, $CRSP gets new patent, $DCTH announces Q4 results

By |March 29th, 2017|Digest|

Acorda Therapeutics ($ACOR) reported positive results from  two studies of CVT-301, an inhaled formulation of levodopa for the treatment of OFF periods in Parkinson's disease patients. The results showed positive long term safety data. The two studies viz. CVT-301-004E and CVT-301-005 involved approximately 700 [...]

Verastem ($VSTM) creates new 52 weeks high

By |March 28th, 2017|Opinions|

Verastem Inc. ($VSTM) recently announced its fourth quarter and full year results. The company’s net loss for the year ended December 31, 2016 (2016 Period) was $36.4 million, or $0.99 per share, as compared to a net loss of $57.9 million, or $1.61 per share, for the year ended December 31, 2015. Verastem [...]

Premarket Biotech Digest – $CALA to get milestone payment, $RHHBY launches new test, $ARDM announces Q4 results

By |March 28th, 2017|Digest|

Calithera Biosciences Inc. ($CALA) announced that it is now eligible to claim a $12 million milestone payment from its collaboration partner Incyte. The milestone payment has been triggered by the achievement of pharmacokinetic and pharmacodynamic goals for oncology candidate CB-1158. Both the companies had [...]

Idera Pharmaceuticals ($IDRA) continues upward trajectory

By |March 27th, 2017|Opinions|

Idera Pharmaceuticals Inc. ($IDRA) recently reported that its fourth quarter net income stood at $822,000. The company had suffered a loss for the corresponding period of the previous year. Its net income per share basis was reported at $0.01. Idera earned $15.3 million in revenue during the said time period. [...]

Premarket Biotech Digest – $AGN reports +ve results, $ALGN inks new deal, $ONTX announces FY2016 results

By |March 27th, 2017|Digest|

Allergan ($AGN) reported positive results of two Phase 3 clinical trials assessing orally administered sarecycline in people with moderate-to-severe acne. The studies met their 12 week primary efficacy endpoints. Participants receiving 1.5 mg/kg/day of sarecycline experienced statistically significant reductions in inflammatory lesion counts compared [...]

Threshold Pharmaceuticals Inc. ($THLD) to merge with Molecular Templates

By |March 24th, 2017|Opinions|

Threshold Pharmaceuticals Inc. ($THLD) recently announced that it has agreed to merge with cancer-focused biopharmaceutical company Molecular Templates Inc. in an all-stock deal.  Under the terms of the deal, the current shareholders of Molecular Templates will own nearly 65.6% of the newly formed combined entity. The remaining 34.4% will be [...]

Premarket Biotech Digest – $HTGM gets CE marking, $INSY gets DEA approval, $APOP announces Q4 results

By |March 24th, 2017|Digest|

Roche Holding AG ($RHHBY) received breakthrough therapy designation from the U.S. Food And Drug Administration (FDA) for its Rituxan (rituximab) drug, which is being developed by its subsidiary Genentech. The drug is for treating Pemphigus Vulgaris (PV), a rare disease which has limited treatment [...]

Idera Pharmaceuticals reports Quarterly and full year results

By |March 23rd, 2017|Opinions|

Idera Pharmaceuticals Inc. ($IDRA) recently announced its fourth quarter financial results. The company’s quarterly net income stood at $822,000. On per share basis, it earned $0.01. Idera had suffered net loss in the corresponding quarter of the previous year. Its revenue for the quarter stood at $15.3 million. For the [...]

Premarket Biotech Digest – $MYL recalls Epipen, $HOLX completes acqusition, $IMMY announces Q4 results

By |March 23rd, 2017|Digest|

Egalet Corp ($EGLT) reported that it has received four new U.S. and international patents for Egalet's proprietary Guardian™ Technology. The US patent is number 9,549,899 covering ARYMO™ ER (morphine sulfate) extended-release tablets for oral use only. It is  the second U.S. patent covering ARYMO [...]

Pain Therapeutics Inc. ($PTIE) reports positive FDA feedback for REMOXY ER

By |March 22nd, 2017|Opinions|

Pain Therapeutics Inc. ($PTIE) stock jumped over 55 percent in the pre-market session for Tuesday as the company announced receiving the FDA feedback regarding  the additional studies needed to refile its New Drug Application seeking approval of abuse-deterrent REMOXY ER (extended-release oxycodone capsules CII). The update followed a meeting between [...]

Premarket Biotech Digest – $VREX inks new deal, $AST reports +ve results, $NEOG announces Q3 results

By |March 22nd, 2017|Digest|

Shire Plc. ($SHPG) announced that its drug candidate SHP655 has been designated for Fast Track Review by the FDA. The drug is under trial for treating acute episodes of hereditary thrombotic thrombocytopenic purpura in patients with a deficiency in an enzyme called ADAMTS13. Fast Track [...]

Array BioPharma ($ARRY) withdraws NDA for US approval

By |March 21st, 2017|Opinions|

Array BioPharma ($ARRY) announced that it has withdrawn its New Drug Application (NDA) in the U.S. seeking approval of binimetinib for the treatment of NRAS mutation-positive melanoma, a rare subtype of skin cancer. The company took the decision upon receiving feedback from the FDA that concluded that data from the [...]

Premarket Biotech Digest – $NKTR reports +ve results, $TENX announces Q4 results, $BPMC doses first patient

By |March 21st, 2017|Digest|

Pain Therapeutics Inc. ($PTIE) stock jumped over 55 percent in the pre-market session as the company announced receiving the FDA feedback regarding  the additional studies needed to refile its New Drug Application seeking approval of abuse-deterrent REMOXY ER (extended-release oxycodone capsules CII). The update [...]

Protalix BioTherapeutics ($PLX) Announces Financial Results

By |March 20th, 2017|Opinions|

Protalix BioTherapeutics Inc. ($PLX) reported update and financial results for 2016. During the year, the company announced positive six and twelve-month interim phase II data in March 2016 and final results of the trial in August 2016 for Pegunigalsidase alfa (PRX-102) for Fabry Disease. In october 2016, it enrolled the first [...]

Premarket Biotech Digest – $AZN reports +ve results, $ABUS inks new deal, $CRMD announces Q4 results

By |March 20th, 2017|Digest|

AstraZeneca ($AZN) reported results from its CVD-REAL studies for patients with type 2 diabetes (T2D) who were treated with SGLT-2 inhibitors.  The trial studied data  from more than 300K T2D patients across six countries and showed that treatment with SGLT-2 inhibitors [AstraZeneca's Farxiga (dapagliflozin); [...]

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