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

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 [...]

By |May 24th, 2017|Digest|0 Comments

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

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 [...]

By |May 23rd, 2017|Digest|0 Comments

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

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 [...]

By |May 22nd, 2017|Digest|0 Comments

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

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. [...]

By |May 19th, 2017|Digest|0 Comments

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

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 [...]

By |May 18th, 2017|Digest|0 Comments

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

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 [...]

By |May 17th, 2017|Digest|0 Comments

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

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 [...]

By |May 16th, 2017|Digest|0 Comments

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

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 15th, 2017|Digest|0 Comments

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 [...]

By |May 12th, 2017|Digest|0 Comments

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

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 [...]

By |May 11th, 2017|Digest|0 Comments

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

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 [...]

By |May 11th, 2017|Digest|0 Comments

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

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 [...]

By |May 10th, 2017|Digest|0 Comments

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

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 [...]

By |May 9th, 2017|Digest|0 Comments

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

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 [...]

By |May 8th, 2017|Digest|0 Comments

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

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 [...]

By |May 5th, 2017|Digest|0 Comments

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

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 [...]

By |May 4th, 2017|Digest|0 Comments

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

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 [...]

By |May 3rd, 2017|Digest|0 Comments

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

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 [...]

By |May 2nd, 2017|Digest|0 Comments

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

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 [...]

By |May 1st, 2017|Digest|0 Comments

Premarket Biotech Digest – $SNDX adds new patients, $BMRN receives FDA approval, $CLVS inks new deal

Medigus ($MDGS) reported that it has performed ten MUSE procedures in China for the initial phase of its clinical study. The trial is designed to have nearly 62 patients. The procedures will be performed through this year. The MUSE system is a single-use transoral [...]

By |April 28th, 2017|Digest|0 Comments
s2Member®