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 [...]

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

By |April 28th, 2017|Digest|

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 [...]

Premarket Biotech Digest – $ANTM may increase premium, $IPXL receives FDA approval, $ZTS receives EC nod

By |April 27th, 2017|Digest|

MediciNova Inc. ($MNOV) announced that it has received positive preliminary results from a six-month open-label extension period evaluating MN-166 (ibudilast) in patients with amyotrophic lateral sclerosis. ALS patients who completed both the six-month treatment period in the Phase 2 clinical trial and the six-month open-label extension [...]

Premarket Biotech Digest – $AKBA boosts collaboration, $PRTK reports positive data, $ALR launches malaria product

By |April 26th, 2017|Digest|

The Medicines Company ($MDCO) reported that the  FDA has agreed to a Phase 3 program for cholesterol med inclisiran that will support a New Drug Application (NDA). The news sent the stock price over 5 percent up. The company said that the late-stage program [...]

Premarket Biotech Digest – $JAZZ reports positive results, $CTSO inks new contract, $AMGN forges collaboration

By |April 25th, 2017|Digest|

Capricor Therapeutics ($CAPR) announced encouraging six-month results in a Phase 1/2 clinical trial, HOPE, evaluating lead product candidate CAP-1002 in Duchenne muscular dystrophy (DMD) patients at least 12 years old with heart disease secondary to DMD. HOPE randomized 25 subjects to receive either a [...]

Premarket Biotech Digest – $BDX finalizes acquisition deal, $VNLPF receives CRL, $EYEG files S-1

By |April 24th, 2017|Digest|

Johnson & Johnson (JNJ) announced results from  a Phase 2 clinical trial assessing the triple combination of  Olysio (simeprevir), Achillion Pharmaceuticals' odalasvir (formerly ACH-3102) and Janssen's Alios BioPharma unit's AL-335 (JNJ-4178). The results showed a 100% cure rate for six- and eight-week treatment regimens [...]

Premarket Biotech Digest – $IMNP inks new deal, $TEVA launches new products, $IDXG introduces new financial plan

By |April 21st, 2017|Digest|

ContraVir Pharmaceuticals ($CTRV) reported positive results  from a Phase 2a clinical trial assessing tenofovir exalidex (TXL) in patients with chronic hepatitis B virus (HBV) infection. The preliminary results showed treatment with TXL for 21 days resulted in a mean HBV viral load of 3,630 [...]

Premarket Biotech Digest – $CTRV announces positive results, $TSRO launches PARP inhibitor, $ANIP introduces generic drug

By |April 20th, 2017|Digest|

Soligenix ($SNGX) stock buoyed as the company prepares to present the data for RiVax, its ricin toxin vaccine. The company will present the data at the 20th Annual Conference on Vaccine Research in Bethesda, MD. RiVax demonstrated 100% protection in ricin aerosol challenge models [...]

Premarket Biotech Digest – $AMED to amend financial statements, $VICL hits enrollment target, $IDXG receives insurance coverage

By |April 19th, 2017|Digest|

Roche ($RHHBY) announced receiving the FDA approval for its TECENTRIQ (atezolizumab). The approval was given under the agency’s Priority Review process. TECENTRIQ (atezolizumab) is designed for treating  patients with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin chemotherapy. The treatment [...]

Premarket Biotech Digest – $RPRX gets new patent, $CSII recalls pumps, $CAH acquires new business

By |April 18th, 2017|Digest|

Repros Therapeutics ($RPRX) reported that it has been granted a new patent by the USPTO. The patent No. 9,616,074 covers the use of selective progesterone receptor modulators (SPRMs) like telapristone acetate (Proellex) or ulipristal acetate with an off-drug interval (ODI) for the treatment of [...]

Premarket Biotech Digest – $LLY gets CRL, $LXRP inks JV, $ABT acquires Alere

By |April 17th, 2017|Digest|

Bristol Myers Squibb ($BMY) announced its new collaboration with Nordic Biosciences, which is a Danish company specializing in biomarker technologies. The collaboration will work towards developing biomarker technology for diagnosing and monitoring fibrotic diseases including non-alcoholic steatohepatitis (NASH). The agreement provides for the development of translational [...]

Premarket Biotech Digest – $CLSN reports positive data, $TEVA gets FDA warning, $DPLO renews agreement

By |April 14th, 2017|Digest|

Relmada Therapeutics Inc. ($RLMD) stock jumped up on the news of its lead product candidate, Phase 2a-stage REL-1017 (dextromethadone, d-Methadone), receiving Fast Track review for the adjunctive treatment of major depressive disorder (MDD) from the FDA. The new status will provide for more frequent [...]

Premarket Biotech Digest – $CLSN reports positive data, $TEVA gets FDA warning, $DPLO renews agreement

By |April 14th, 2017|Digest|

Top Pick Relmada Therapeutics Inc. ($RLMD) stock jumped up on the news of its lead product candidate, Phase 2a-stage REL-1017 (dextromethadone, d-Methadone), receiving Fast Track review for the adjunctive treatment of major depressive disorder (MDD) from the FDA. The new status will provide for more frequent interactions with the FDA [...]

Premarket Biotech Digest – $HOLX sued for patent infringement, $ENTL receives 510K clearance, $MCK signs acquisition deal

By |April 13th, 2017|Digest|

Female Health Company($FHCO) announced the results from the first phase of its bioequivalence (BE) study aimed at identifying the optimal formulation of its Tamsulosin Delayed Release Sachet (DRS) product for the treatment of men with benign prostatic hyperplasia (BPH) or enlarged prostate. The company [...]

Premarket Biotech Digest – $NOVN reports topline results, $INNV receives new patent, $AIQ signs merger agreement

By |April 12th, 2017|Digest|

Neurorine Biosciences Inc. ($NBIX) announced receiving FDA approval for its drug Ingrezza, which is designed for treating  tardive dyskinesia, a side effect of antipsychotic medications characterized by uncontrolled movements of the face and body. The drug is also the first treatment to be approved [...]

Premarket Biotech Digest – $CBMG inks new deal, $IPCI sued, $SYRS gets FDA nod

By |April 11th, 2017|Digest|

Geron Corporation ($GERN) stock picked up on the news that the company has agreed to a settlement related to a consolidated class-action securities lawsuit. The settlement will lead to the dismissal with prejudice of all claims against all defendants in the matter. It involves [...]

Premarket Biotech Digest – $GERN completes internal review, $BEAT files tender offer, $GILD receives FDA approval

By |April 10th, 2017|Digest|

Geron Corporation ($GERN) announced that the second internal data reviews of Imerge and Imbark have been completed by the Janssen Research & Development, LLC. These clinical trials are being done for the telomerase inhibitor imetelstat in lower risk myelodysplastic syndromes (MDS) and relapsed or [...]

Premarket Biotech Digest – $AVRX receives FDA approval, $MYGN inks new deal, $MRK receives CRL

By |April 7th, 2017|Digest|

This is a list of all the trades we did in our newly-launched swing trading group over the last two months. In 2 months, our profit was 66.5% as reported by members who made successful trades. If interested, go here to see the original intro - http://drkkd.com/swing-trading-room-the-details-are-here/ [...]

Premarket Biotech Digest – $NEOT receives new patent, $NBIO files IND, $TRPX inks sublicense deal

By |April 6th, 2017|Digest|

This is a list of all the trades we did in our newly-launched swing trading group over the last two months. In 2 months, our profit was 66.5% as reported by members who made successful trades. If interested, go here to see the original intro - http://drkkd.com/swing-trading-room-the-details-are-here/ [...]

Premarket Biotech Digest – $SYT gets conditional approval, $VBL reports new data, $RDHL inks new deal

By |April 5th, 2017|Digest|

This is a list of all the trades we did in our newly-launched swing trading group over the last two months. In 2 months, our profit was 66.5% as reported by members who made successful trades. If interested, go here to see the original intro - http://drkkd.com/swing-trading-room-the-details-are-here/ [...]

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