Premarket Biotech Digest – $RDUS reports positive results, $RHHBY investigates case, $QDEL receives Japanese approval

By |May 25th, 2017|Digest|

Aerie Pharmaceuticals ($AERI) announced positive results from its Phase 3 clinical trial, Mercury 2. The trial compared the efficacy of Roclatan against each of its components, netarsudil and latanoprost, in lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The trial [...]

Premarket Biotech Digest – $MRK receives FDA approval, $TGTX announces trial results, $IMUN receives approval

By |May 24th, 2017|Digest|

TG Therapeutics ($TGTX) announced the results from an interim analysis of a Phase 3 clinical trial assessing the combination of TG-1101 (ublituximab) and TGR-1202 and each candidate alone in patients with chronic lymphocytic leukemia (CLL). The analysis showed the contribution of the combination has [...]

Premarket Biotech Digest – $OCX reports positive results, $REGN receives FDA nod, $ELTP acquires ANDA

By |May 23rd, 2017|Digest|

OncoCyte Corp ($OCX) stock surged as the company announced positive results in the development of a blood-based diagnostic test for lung cancer. the optimized final predictive algorithm showed sensitivity of 95%, specificity of 73% and area under the curve of 0.92. The test is [...]

Premarket Biotech Digest – $AMGN announces positive results, $FOLD completes analysis plan, $JNJ files lawsuit

By |May 22nd, 2017|Digest|

Amgen Inc. ($AMGN) announced that it has received positive results from a Phase 3 clinical trial, ARCH, assessing EVENITY (romosozumab) for preventing fractures in postmenopausal women at high risk of fracture. The company conducted the trial in collaboration with UCB. EVENITY is an investigational bone-forming [...]

Premarket Biotech Digest – $CUR completes dosage, $MRK receives FDA nod, $DFFN receives patent

By |May 19th, 2017|Digest|

Revance Therapeutic Inc. ($RVNC) announced the results from its US open-label, dose-escalating study assessing DaxibotulinumtoxinA Injectable (RT002) for the treatment of moderate-to-severe isolated cervical dystonia. The company reported that it showed a duration of effect of at least 24 weeks in all three cohorts. [...]

Premarket Biotech Digest – $RDY gets FDA approval, $ABSCF gets negative EU opinion, $ESRX completes acquisition

By |May 18th, 2017|Digest|

GlycoMimetics ($GLYC) reported receiving the FDA Breakthrough Therapy Designation for its GMI-1271 drug candidate. The drug is designed to be used for treating adult relapsed/refractory acute myeloid leukemia. It is currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial [...]

Premarket Biotech Digest – $BAYRY gets FDA nod, $UNH gets sued, $QDEL finalizes acquisition

By |May 17th, 2017|Digest|

Bayer ($BAYRY) has been intimated by the FDA regarding its copanlisib treatment. The FDA has agreed to accept its New Drug Application seeking the approval as the third-line treatment of relapsed/refractory follicular lymphoma under Priority Review. The treatment already has Orphan Drug and Fast [...]

Premarket Biotech Digest – $MDGS gets new patents, $GWPH appoints new CMO, $CRME updates loan agreement

By |May 16th, 2017|Digest|

Medigus ($MDGS) announced that it has been granted new patents with regard to its micro ScoutCam miniature camera technology. These patents have been granted by the Japanese Patent Office  and the European Patent Office. The ScoutCam portfolio consists of a range of video cameras [...]

Premarket Biotech Digest – $AZN reports positive results, $CLSN meets China administrators, $QHC divests two hospitals

By |May 15th, 2017|Digest|

Loxo Oncology Inc. ($LOXO) reported that it has received an Orphan Drug designation from the FDA for its larotrectinib (LOXO-101), for the treatment of solid tumors with rare genetic abnormalities called NTRK-fusion proteins. The drug inhibits a group of enzymes called tropomyosin receptor kinases (TRK), [...]

By |May 12th, 2017|Digest|

Teva Pharmaceutical Industries ($TEVA) announced its first quarter results. The company reported that its revenue for the quarter was up 17 percent at $5.63 billion, lagging behind the consensus estimate of $5.68 billion. Its earnings per share (EPS) slipped to $1.06 excluding exceptional items [...]

Premarket Biotech Digest – $ONCS collaborates with Merck, $MZOR reports Q1 results, $INCS announces merger

By |May 11th, 2017|Digest|

Fate Therapeutics ($FATE) reported receiving the FDA nod for its Investigational New Drug (IND) application for FATE-NK100 in advanced solid tumors. The company now plans to start and open-label, accelerated dose-escalation study called DIMENSION for assessing the candidate as monotherapy and in combination with [...]

Premarket Biotech Digest – $ONCS collaborates with Merck, $MZOR reports Q1 results, $INCS announces merger

By |May 11th, 2017|Digest|

Top Pick Fate Therapeutics ($FATE) reported receiving the FDA nod for its Investigational New Drug (IND) application for FATE-NK100 in advanced solid tumors. The company now plans to start and open-label, accelerated dose-escalation study called DIMENSION for assessing the candidate as monotherapy and in combination with monoclonal antibody therapy in [...]

Premarket Biotech Digest – $ARRY reports +ve results, $CRBP gets FDA rejection, $MYL posts Q1 results

By |May 10th, 2017|Digest|

NantKwest ($NK) reported that it has received the FDA approval for its NANT Cancer Vaccine IND application. The company plans to start its Phase ½ clinical trial with 80 subjects shortly. The co-primary endpoints are safety measures and objective response rate. According to the [...]

Premarket Biotech Digest – $BSX gets FDA nod, $AMRS inks equity deal, $XRAY reports Q1 results

By |May 9th, 2017|Digest|

Array Biopharma Inc. ($ARRY) announced its new collaboration with Merck for a clinical trial for investigating the safety and efficacy of its binimetinib MEK inhibitor with MRK's Keytruda anti-PD-1 therapy in metastatic colorectal cancer patients with microsatellite stable tumors. The trial will be sponsored by [...]

Premarket Biotech Digest – $BAX probed by DoJ, $CCP inks merger deal, $KITE reports quarterly loss

By |May 8th, 2017|Digest|

Axsome Therapeutics ($AXSM) reported that it has received fast track designation from the FDA for its Alzheimer’s disease treament AXS-05. The company said that currently there are no approved treatments for the condition of agitation in patients. Axsome had earlier received  Investigational New Drug [...]

Premarket Biotech Digest – $MRK gets EU approval, $GHDX receives LCD, $JNJ to pay $110 million

By |May 5th, 2017|Digest|

Merck ($MRK) scored a win as it received the European Union approval for its Keytruda drug. The approval allows the company to market the drug in all 28 EU member states plus Iceland, Lichtenstein, and Norway at the approved dose of 200 mg every [...]

Premarket Biotech Digest – $SGMO receives FDA nod, $KPTI inks new deal, $FOMX to start new trial

By |May 4th, 2017|Digest|

Sangamo Therapeutics Inc. ($SGMO) reported that the FDA has granted orphan drug status to its SB-525 cDNA gene therapy for Hemophilia A. The company also has  fast track designation for SB-FIX in vivo genome editing treatment for Hemophilia B while SB-913 has Rare Pediatric Disease [...]

Premarket Biotech Digest – $PIRS inks new deal, $MOH replaces CEO, $NVO reports Q1 results

By |May 3rd, 2017|Digest|

Abivax ($AAVXF) stock soared as the company announced Phase IIa results for its ABX464. The test results showed that the drug candidate has potential to become a “key functional cure element” for HIV.  Amongs evaluable patients (4 placebo and 14 ABX464-treated patients), a reduction [...]

Premarket Biotech Digest – $TNXP receives patent, $MRK raises guidance, $SHPG reports Q1 results

By |May 2nd, 2017|Digest|

Tenet Healthcare ($THC) announced inking a new deal with Humana. The deal allows for all of Tenet's hospitals and hospital-affiliated outpatient centers and employed physicians will be phased back into Humana's network between June and October. The agreement has multiyear tenure. Tenet also announced [...]

Premarket Biotech Digest – $BMY receives Chinese approval, $ALKS completes patient enrollment, $ABC inks new agreement

By |May 1st, 2017|Digest|

CEL-SCI ($CVM) reported receiving a new patent from the European Patent Office. The new patent pertains to its lead product candidate Multikine (Leukocyte Interleukin, Injection), an immunotherapy in development for certain head and neck cancers and peri-anal warts and cervical dysplasia in patients co-infected [...]

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