Premarket Biotech Digest – $GALT reports +ve results, $IMUC receives FDA approval, $ETRM reports quarterly loss

Mesoblast Limited ($MESO) reported that the United States Food and Drug Administration (FDA) has granted a Fast Track designation for the use of its cell therapy, MSC-100-IV. The treatment is designed to achieve improved overall response rate in children with steroid refractory acute Graft [...]

By |March 7th, 2017|Digest|0 Comments

Premarket Biotech Digest – $MSTX announces new deal, $TGTX reports +ve results, $SCYX postpones new study

TG Therapeutics ($TGTX) announced that a combination of its experimental cancer drug ublituximab and AbbVie Inc's Imbruvica outperformed Imbruvica alone in high-risk leukemia patients. The late-stage study involved adult patients with high-risk chronic lymphocytic leukemia, who had undergone at least one prior therapy. TG [...]

By |March 6th, 2017|Digest|0 Comments

Premarket Biotech Digest – $VRML inks new deal, $JUNO ends cancer drug trials, $AUPH reports topline results

Coherus BioSciences Inc. ($CHRS) reported that CHS-1420, its proposed biosimilar of adalimumab (Humira®), met the primary endpoint in a clinical pharmacokinetic (PK) bioequivalence study that compared CHS-1420 to Humira in healthy subjects. These endpoints are maximum serum concentration (Cmax), area under the time-concentration curve [...]

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

Premarket Biotech Digest – $AERI resubmits NDA, $OPK reports quarterly results, $OMER announces Phase 2 Data

Roche Holding AG ($RHHBY) announced the positive results from the Phase III APHINITY study. The trial is being conducted by Roche Group firm Genentech, the Breast International Group (BIG) and Breast European Adjuvant Study Team. The study met its primary endpoint and showed that [...]

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

Premarket Biotech Digest – $SGYP reports trial results, $PRGO sells royalty stream, $ADXS inks new deal

Lexicon Pharmaceuticals Inc. ($LXRX) reported that it has received the FDA approval for its oral drug, Xarmelo, for treating carcinoid syndrome diarrhea, a condition that develops in patients with gastrointestinal tumors. The drug has been tested on patients unable to tolerate somatostatin analog therapy. [...]

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

Premarket Biotech Digest –$LJPC provides trial updates, $ANIP acquires two products, $INCY joins S&P500 Index

ANI Pharmaceuticals ($ANIP) announced the acquisition of Inderal® XL from Cranford Pharmaceuticals, LLC and InnoPran XL® from Holmdel Pharmaceuticals LP. As a part of the deals, the company acquired the NDA and trademark for InnoPran XL® including a license to an Orange Book listed [...]

By |February 28th, 2017|Digest|0 Comments

Premarket Biotech Digest – $ALIM files NDA, $MRK announces +ve results, $ABBV gets EMA nod

Merck & Co. ($MRK) announced the results for the pivotal Phase 3 clinical study of letermovir, an investigational antiviral medicine for the prevention of clinically-significant cytomegalovirus (CMV) infection in adult (18 years and older) CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. The [...]

By |February 27th, 2017|Digest|0 Comments

Premarket Biotech Digest – $PTX reports +ve results, $AOLS starts Phase I, $AGEN flunks study

OncoSec Medical Inc. ($ONCS) announced new positive clinical data from a Phase II Investigator Sponsored Trial assessing the combination of OncoSec's investigational intratumoral therapy, ImmunoPulse® IL-12, and the approved anti-PD- 1 therapy (pembrolizumab), in patients with unresectable metastatic melanoma. The results ndicated that ImmunoPulse® [...]

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

Premarket Biotech Digest – $PPHM stock shoots up, $AEMD reports +ve trial results, $HTGM receives delisting notice

Aethlon Medical Inc. ($AEMD) announced the results of its study seeking to validated the in vitro capture of Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and Herpes Simplex virus 1 (HSV1) by the Hemopurifier®. The results validated the ability of the Aethlon Hemopurifier® to capture latent [...]

By |February 23rd, 2017|Digest|2 Comments

Premarket Biotech Digest – $DCTH inks new deal, $HLS reports quarterly results, $ABT announces notes exchange

HealthSouth Corp ($HLS) stock gained over 2 percent in its Tuesday trading session as the company reported its quarterly numbers. Its earnings for the quarter stood at $0.72 per share, beating consensus estimates of $0.63 per share in earnings. The company’s revenue for the [...]

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

Cellect Biotechnology reports positive results for ApoGraft trial

Cellect Biotechnology ($APOP) shot up 14 percent in the current trading session as the company announced positive results from its clinical trial of ApoGraft™ in healthy donors. The primary objective for the study was to validate the Company's propriety method of stem cell selection by going through the process of [...]

By |February 21st, 2017|Digest|0 Comments

Premarket Biotech Digest – $VCEL receives FDA nod, $SRPT sells FDA voucher, $TRVN reports +ve results

Premarket Biotech Digest – $VCEL receives FDA nod, $SRPT sells FDA voucher, $TRVN reports +ve results $Digest, $VCEL, $SRPT, $TRVN Sarepta Therapeutics ($SRPT) announced selling an FDA review voucher to Gilead Sciences. The deal is expected to be worth $125 million. The company had [...]

By |February 21st, 2017|Digest|0 Comments

Premarket Biotech Digest – $BSX provides estimates, $PODD reports +ve outcome, $ARQL flunks trial

Momenta Pharmaceuticals ($MNTA) reported a potential hurdle in an application for its Glatopa products. The company said that Sandoz’s contracted fill/finish manufacturing partner, Pfizer, has received an FDA warning letter. The Pfizer facility is a key part of the supply chain for the Company’s [...]

By |February 20th, 2017|Digest|0 Comments

Premarket Biotech Digest – $VRX receives FDA approval, $GLD reports new deal, $XBIT meets endpoints

Gilead Sciences Inc. ($GILD) announced that it has received approval in Canada for its ODEFSEY for treating HIV-1 infection. ODEFSEY is indicated in Canada as a complete regimen for the treatment of adults infected with HIV-1 with no known mutations associated with resistance to [...]

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

Premarket Biotech Digest – $PLX provides updates, $MRK stops trial, $IART acquires new business

Our App Is Updated, Install it here Point your mobile browser to this link - https://gonative.io/share/wexpwj Download the APK for Android (Apple doesn't work yet), ignore the warning messages if any, and install it. Intellia Therapeutics ($NTLA) stock slumped over 9 percent in its [...]

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

Premarket Biotech Digest – $NVAX restarts clinical trial, $AET terminates merger, $IONS gets milestone payment

Our Android App Is Updated, Install it here Point your mobile browser to this link - app Download the APK for Android (Apple doesn't work yet), ignore the warning messages if any, and install it. Aetna Inc. ($AET) announced that its proposed merger with [...]

By |February 15th, 2017|Digest|0 Comments

Premarket Biotech Digest – $ZLTQ to be acquired, $CUTR reports results, $ANTM gets buy rating

Cutera Inc. ($CUTR) reported its fourth quarter and full financial year results. The company reported 26 percent increase in its revenue for the fourth quarter to a record $37.9 million, due primarily to a 45% growth in North American product revenue. This is the [...]

By |February 14th, 2017|Digest|0 Comments

Premarket Biotech Digest – $TEVA reports strong results, $DXCM gets buy rating, $ICPT changes protocol

Inovio Pharmaceuticals Inc. ($INO) announced its new collaboration with ApolloBio Corporation. The new pact deals with providing ApolloBio with with the exclusive right to develop and commercialize VGX-3100, Inovio’s DNA immunotherapy product designed to treat pre-cancers caused by human papillomavirus (HPV), within Greater China [...]

By |February 13th, 2017|Digest|0 Comments

Premarket Biotech Digest – $AMRN restructures. $NVGN receives grant, $ONVO reports Q3 results

TRACON Pharmaceuticals ($TCON) suffered a setback as the company announced the results from a Phase 2 clinical trial assessing lead product candidate TRC105 in recurrent glioblastoma. The study evaluated the effect on three-month progression-free survival (PFS) of TRC105 combined with Roche's Avastin (bevacizumab) compared [...]

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

Premarket Biotech Digest –$REGN gets court stay, $LFVN reports Q2 results, $LOXO gets buy rating

Diffusion Pharmaceuticals ($DFFN) stock saw a spike in its price as the company announced the data from a Phase 1/2 clinical trial assessing its trans sodium crocetinate (TSC) in newly diagnosed glioblastoma multiforme (GBM) showing a treatment benefit. The data collected from 59 patients [...]

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