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

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 [...]

By |March 29th, 2017|Digest|0 Comments

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

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 [...]

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

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

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 [...]

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

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

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 [...]

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

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

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 [...]

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

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

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 [...]

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

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

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 [...]

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

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

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); [...]

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

Premarket Biotech Digest – $GKOS receives code renewal, $EDIT prices stock offering, $SNOA reports +ve results

Glaukos Corporation ($GKOS) stocks showed an upward spike as the company that the CPT codes used by physicians for reimbursement for implanting the iStent device have been extended five years. The extension has been granted by the AMA CPT Editorial Panel. CPT codes are used by [...]

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

Premarket Biotech Digest – $TROV inks new deal, $PFE gets Chinese approval, $NVLN reports Q4 results

Shire PLC ($SHPG) announced that the European Medicines Agency has approved expanded indications for its hereditary angioedema treatment CINRYZE (C1 inhibitor [human]). The product may now be used for routine prevention of angioedema attacks in children as young as six years with severe and [...]

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

Premarket Biotech Digest – $MRK receives FDA approval, $AZN reports +ve results, $BIOC inks new deal

Merck ($MRK) announced receiving the FDA approval for its  PD-1 inhibitor KEYTRUDA (pembrolizumab) to treat adult and pediatric patients with refractory classical Hodgkin lymphoma or who have relapsed after three or more prior lines of therapy. The FDA granted the approval based on the [...]

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

Premarket Biotech Digest – $EDIT inks new deal, $AEMD reports +ve trial results, $PFE launches Zavicefta

Editas Medicine ($EDIT) announced inking a new exclusive R&D deal with Allergan ($AGN). The deal provides Allergan with an option to license up to five of EDIT's genome-editing ocular programs, including its lead program for Leber Congenital Amaurosis (LCA10), which is currently in preclinical [...]

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

Premarket Biotech Digest – $AMGN reports +ve trial results, $MYL inks settlement, $ZYNE completes enrollment

Amgen Inc. ($AMGN) announced the results of a late-stage study which showed that its injection Repatha significantly reduced the need for patients to undergo a procedure to reduce bad cholesterol. The news is expected to have positive impact on the stock price which is [...]

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

Premarket Biotech Digest –$ACOR receives +ve patent ruling, $CUR reports positive data, $KTOV inks new deal

Acorda Therapeutics Inc. ($ACOR) stock jumped up as the company announced that  the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upheld all four patents challenged via the inter partes review (IPR) process.  These patents were Nos. 8,663,685 (the ‘685 patent), [...]

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

Premarket Biotech Digest – $VRX restructures, $APRI sells selective assets, $BIOL reports quarterly loss

Pfizer Inc. ($PFE) announced that the FDA has accepted its new drug applications (NDA) for its diabetes candidate, ertugliflozin as a monotherapy as well as two fixed-dose combination tablets. The company is developing the drug in collaboration with Merck & Co. Inc. The companies [...]

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

Premarket Biotech Digest – $ETRM reports loss, $RVNC completes patient enrollment, $BLCm gets Outperformer rating

TiGenix ($TIG) stock touched its 52 weeks high of $16.10 in its Tuesday trading session as the company announced receiving positive feedback from the U.S. Food and Drug Administration (FDA) on an improved protocol for its global Phase III trial for the treatment of [...]

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

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
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