Nektar

Nektar (NKTR) — FDA Rejects NKTR’s Oxycodegol 27-0

BIOINVEST BREAKING NEWS – The FDA rejected NKTR’s Oxycodegol (NKTR-181) by a vote of 27-0 at yesterday’s AdCom meeting. As a result of the negative vote the Company will withdraw the NDA for oxycodegol and make no further investment into the program. We listened to the majority of yesterday’s meeting which was mostly (…more)

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Nektar

Nektar (NKTR) — NKTR & BMY Announce Two New Phase III Trials

BIOINVEST BREAKING NEWS – Nektar (NKTR) and partner BMY announced today that the companies have agreed to a new joint development plan to further the advancement of bempegaldesleukin (bempeg/NKTR-214) plus Opdivo (nivolumab) into two new Phase III/registrational trials, bringing the total to five being tested.  In our view, BMS’ renewed (and public) commitment to the bempeg/Opdivo combo has further de-risked the largely out-of-favor NKTR stock. (…more)

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Sangamo Therapeutics

Sangamo (SGMO) — Data Updates Due For Hem A & Beta – Thal At ASH – BUY

BIOINVEST BREAKING NEWS – Sangamo (SGMO) will have a very busy December, with two clinical data updates coming at the American Society for Hematology (ASH, https://www.hematology.org/Annual-Meeting/). We remain steadfast that SGMO will emerge as the leader in gene therapy for hemophilia A with SB-525. (…more)

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Medicines Company

The Medicines Company (MDCO) — Inclisiran Shines At AHA

BIOINVEST BREAKING NEWS – Medicines Company (MDCO) — The oral presentations of the ORION-9 and -10 studies further confirm the revolutionary compound that is Inclisiran. On top of its durable LDL reductions and impeccable safety, the ease of use and high compliance rate, in our view, suggest blockbuster status is likely. With Phase III program successfully complete, we remain steadfast in expecting a much larger market for Inclisiran than the current stock price is forecasting. Raising BUY and TARGET PRICE.

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MTSL Issue 914

MTSL Issue 914 (dated 11/01/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ALKS #alkermes #INCY #incyte #MDGL #madrigal #MDCO #medicinescompany #MYOV #myovant

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Ziopharm Oncology

Ziopharm Oncology (ZIOP) — Sleeping Beauty TCR Solid Tumor Trial Posted By NIH Starts Next Week

BIOINVEST BREAKING NEWS – Ziopharm (ZIOP) – Sleeping Beauty TCR Solid Tumor Trial Posted By NIH Starts Next Week, Oct. 1, REITERATE BUY. The trial discussed below is the accumulation of decades of work by the world’s leading cancer gurus.  While CAR-Ts have shown remarkable successes in blood cancers, treating solid tumors with CAR-Ts has proven to be quite challenging.  (…more)

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Zynerba Pharmaceuticals

Zynerba (ZYNE) — ZYNE Sells Off Despite Positive Phase II Zygel Data in DEE

BIOINVEST BREAKING NEWS – Special Update – ZYNERBA – ZYNE’s stock has sold off since they announced positive top line results from the open label Phase II BELIEVE 1 (Open Label Study to Assess the Safety and Efficacy of Zygel (ZYN002) Administered as a Transdermal Gel to Children and Adolescents with Developmental and Epileptic Encephalopathy) clinical trial. Read more…

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MTSL Issue 910

MTSL Issue 910 (dated 9/05/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #esperion #MDCO #medicinescompany

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MTSL Issue 908

MTSL Issue 908 (dated 8/8/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ALKS #alkermes #BMRN #biomarin #ESPR #esperion #INCY #incyte #IONS #ionis #MDGL #madrigal #NKTR #nektar #PCRX #pacira #SGMO #sangamo #ZIOP #ziopharm #ZYNE #zynerba

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MTSL Issue 903

MTSL Issue 903 (dated 5/30/19) of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #biomarin #BMRN #incyte #INCY #nektar #NKTR #sangamo #SGMO #ziopharm #ZIOP

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Medicines Company

The Medicines Company (MDCO) — ORION-3 3-Year Data Displays Compelling, Persistent LDL Reduction & Pristine Safety

The Medicines Company (MDCO) – MDCO presented interim results from Group 1 of the ORION-3 Phase II study (n=290) at the NLA (Miami) on Saturday. The long-term 3-year data showed that patients given additional inclisiran doses had LDL cholesterol reduced by >50% over time, consistent with the shorter-term ORION-1 results. (…more)

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Alkermes

Alkermes (ALKS) — ALKS Misses on Aristada, Reports $30 Million After Guiding For $40 Million, Stock Selloff Overdone

This morning ALKS released their Q1:19 financial results that showed a big miss for Aristada coming in at $30 million after guiding for $40 million.  While a disappointment, the company did not change overall FY guidance and stated that an inventory work down was the primary cause.

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MTSL Issue 898

MTSL Issue 898 (dated 3/14/19) of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #XON #IONS #PCRX #ZIOP

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MTSL Issue 896

MTSL Issue 896 (dated 2/14/19) of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #INCY #incyte #MYOV #myovant #NKTR #nektar #PCRX #pacira #SGMO #sangamo #ZIOP #ziopharm

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MTSL Issue 895

MTSL Issue 895 (dated 1/31/18) of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #IONS #ionis #NVAX #novavax #SGMO #sangamo #MDCO #medicinescompany

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MTSL Issue 891

MTSL Issue 891 (dated 11/29/18) of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #ALKS #BMRN #SGMO #ZIOP

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MTSL Issue 889

MTSL Issue 889 (dated 11/01/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #BMRN #ESPR #INCY #IONS

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MTSL Issue 886

MTSL Issue 886 (dated 09/20/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #ALKS #FPRX #MDGL #MDCO

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MTSL Issue 884

MTSL Issue 884 (dated 08/23/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #FPRX #IONS #NKTR #NVAX #MDGL #SGMO #ZIOP

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Sangamo Therapeutics

Sangamo (SGMO) – CRSPR Cancer Risk Only Further Distiguishes SGMO’s Competitive Edge In Gene Editing

BioInvest BREAKING News – Sangamo shares are weaker this morning due to what we believe should be causing the exact the opposite stock reaction after STAT News wrote a paper highlighting the potential side effects of CRSPR. The article(s) have nothing to do with SGMO’s ZFN gene editing technology. We suggest subscribers use the weakness in SGMO to…

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Madrigal

Madrigal (MDGL) 3196 Delivers Best-in-Class Phase II NASH Data

BioInvest BREAKING News – This morning, Madrigal (MDGL) reported excellent top-line, 36-week results from a Phase II trial in patients with biopsy-proven non-alcoholic steatohepatitis (NASH). This is the best and most highly significant NASH data ever.

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Esperion

Esperion – BA First Phase III Successful, But Stock Down on Safety Confusion & Some Efficacy Concerns

BioInvest BREAKING News – This morning, Esperion (ESPR) delivered positive Phase III safety data for bempedoic acid (BA). Despite delivering a highly significant 20% LDL reduction for those on treatment – expectations were for 20-30% LDL reduction based on several previous BA studies. The low-end for efficacy combined with safety concerns unrelated to treatment with the drug development candidate have driven the stock down by more than a third, and excessively in our view.

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Nektar

Nektar (NKTR) — FDA Panel Will Vote on Oxycodegol (NKTR-181)

BIOINVEST BREAKING NEWS – On January 14-16, there is a Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. After a close review of the FDA briefing documents, the panel will vote on three options for the approval of NKTR-181 on Tuesday (1/14). The choices are for a narrow approval, a broad approval and a recommendation against approval.  In our view, the fact that NKTR (…more)

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MTSL Issue 917

MTSL Issue 917 (dated 12/20/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #IONS #ionis #MDGL #madrigal #NKTR #nektar #SGMO #sangamo #ZIOP #ziopharm

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Medicines Company

The Medicines Company (MDCO) — Novartis To Acquire The Medicines Company for $9.7 Billion or $85 Per Share

BIOINVEST BREAKING NEWS – Medicines Company (MDCO) — From the beginning of the ORION clinical trials program in 2016 until the recent successful three Phase III studies, we have been under the belief that Inclisiran would be much bigger than people think. Today’s announcement tells us that Novartis, too, believe as such – as the consensus suggests that Inclisiran will need to generate at least $2.2 billion annually for the deal to be NPV neutral. (…more)

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MTSL Issue 915

MTSL Issue 915 (dated 11/15/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ALKS #alkermes #ESPR #esperion #FPRX #fiveprime #MDGL #madrigal #MYOV #myovant #PCRX #pacira ##SGMO #sangamo #ZIOP #ziopharm #ZYNE #zynerba

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MTSL Issue 913

MTSL Issue 913 (dated 10/18/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #INCY #incyte #IONS #ionis #NKTR #nektar #ZIOP #ziopharm

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Medicines Company

The Medicines Company (MDCO) — ORION 9 & 10 Complete The Inclisiran Trifecta

BIOINVEST BREAKING NEWS – The Medicines Company (MDCO) – Efficacy & Safety “At Least As Favorable As ORION-11” – Positive topline results for the ORION-9 Phase 3 clinical study in patients with Heterozygous Familial Hypercholesterolemia (HeFH). ORION-9 met all primary and secondary endpoints, and … more

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Medicines Company

The Medicines Company (MDCO) — Inclisiran Excels As The ORION-11 Phase III Study

The Medicines Company (MDCO) – With efficacy consistent with the Phase I and II studies and a safety profile at least as favorable as in previous trials (e.g., ORION-1 Phase 2 and ORION-3 open-label extension studies), Inclisiran is well on its way to FDA approval and, in our view, blockbuster status… more

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MTSL Issue 907

MTSL Issue 907 (dated 7/25/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #IONS #ionis #MYOV #myovant #NKTR #nektar

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MTSL Issue 905

MTSL Issue 905 (dated 6/27/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #esperion #INCY #incyte #XON #intrexon #SGMO #sangamo #ZYNE #zynerba

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MTSL Issue 901

MTSL Issue 901 (dated 5/02/19) of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #ALKS #INCY #MDCO #PCRX

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MTSL Issue 900

MTSL Issue 900 (dated 4/18/19) of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #IONS #MDGL #SGMO

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MTSL Issue 899

MTSL Issue 899 (dated 4/04/19) of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #XON #NKTR #SGMO

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MTSL Issue 897

MTSL Issue 897 (dated 2/28/19) of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: ACAD, ALKS, FRPX, IONS, MDGL, NKTR, NVAX, PCRX, SGMO

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Nektar

Nektar (NKTR) — BMS/NKTR Release ‘214/Opdivo Urothelial Cancer Data in Front of ASCO GU

BioInvest News – NKTR’s stock is under pressure after the early update to NKTR’s Phase 2 PIVOT-02 trial of NKTR-214 in combination with Opdivo which includes 13 additional urothelial cancer (UC) patients vs. the 10 reported at ASCO 2018.   The data remains solid despite the small decrease in ORR which is now 48% vs. 60% prior.

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MTSL Issue 894

MTSL Issue 894 (dated 1/17/18) of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BMRN #ESPR #FPRX #INCY #IONS #MDCO #MYOV #NKTR #PCRX #SGMO

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MTSL Issue 890

MTSL Issue 890 (dated 11/15/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #IONS #MDGL #NKTR #SGMO #ZIOP

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MTSL Issue 888

MTSL Issue 888 (dated 10/18/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #FPRX #IONS #MYOV #ZIOP

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MTSL Issue 885

MTSL Issue 885 (dated 09/06/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #IONS #SGMO

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MTSL Issue 883

MTSL Issue 883 (dated 08/02/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #ESPR #INCY #IONS #MDCO #NKTR #PCRX #SGMO #ZIOP

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MTSL Issue 881

MTSL Issue 881 (dated 07/05/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #ALKS #IONS #MDCO #SGMO

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MTSL Issue 879

MTSL Issue 879 (dated 06/07/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #FPRX #IONS #INCY #MDGL #NKTR #SGMO #ZIOP

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MTSL Issue 878

MTSL Issue 878 (dated 05/24/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BMRN #ESPR #XON #SGMO #ZIOP

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MTSL Issue 918

MTSL Issue 918 (dated 01/09/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BMRN #biomarin #XON #intrexon #INCY #incyte #MYOV #myovant #NKTR #nektar #PCRX #pacira #SGMO #sangamo

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MTSL Issue 916

MTSL Issue 916 (dated 12/06/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #MDCO #medicinescompany #MYOV #myovant #SGMO #sangamo #ZIOP #ziopharm

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Myovant

Myovant (MYOV) — Time Loves a HERO as MYOV Delivers Excellent Phase III Data for Advanced Prostate Cancer

BIOINVEST BREAKING NEWS – Myovant (MYOV) Legendary blues rockers Little Feat song, ‘Time Loves a Hero,’ says it all for MYOV today as their Phase III prostate cancer data from HERO trial was excellent.  Patient MYOV investors were rewarded this morning as the Phase 3 HERO study of once-daily, oral relugolix (120 mg) met its primary efficacy endpoint and all six key secondary endpoints in men with advanced prostate cancer. (…more)

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MTSL Issue 912

MTSL Issue 912 (dated 10/4/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #FPRX #fiveprime #INCY #incyte #MDCO #medicinescompany #NKTR #nektar #SGMO #sangamo #ZIOP #ziopharm

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MTSL Issue 911

MTSL Issue 911 (dated 9/19/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #FPRX #fiveprime #IONS #ionis #PCRX #pacira #ZYNE #zynerba

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MTSL Issue 909

MTSL Issue 909 (dated 8/22/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #INCY #incyte #XON #intrexon #MYOV #myovant

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MTSL Issue 906

MTSL Issue 906 (dated 7/11/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #INCY #incyte #SGMO #sangamo #ZIOP #ziohparm

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MTSL Issue 904

MTSL Issue 904 (dated 6/13/19) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #FPRX #fiveprime #NKTR #nektar #ZIOP #ziopharm

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MTSL Issue 902

MTSL Issue 902 (dated 5/16/19) of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BMRN #ESPR FPRX #INCY #MYOV #NKTR #SGMO #ZIOP

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Pacira

Pacira (PCRX) — HTX-011 CRL Continues To Widen EXPAREL’s Lead

Pacira (PCRX) – On Tuesday (4/30), Heron (HRTX) received a surprise Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional CMC and non-clinical information.

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Sangamo Therapeutics

Sangamo (SGMO) — SGMO Firing On All Cylinders

BioInvest News – Sangamo (SGMO) has delivered excellent news across their proprietary ZFN drug development platform with promising human data from both the Hemophilia A program with Pfizer and Beta Thal with Sanofi. 

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Novavax

Novavax (NVAX) — ResVax Misses Primary Endpoint, Dropping Coverage

BioInvest News Novavax (NVAX) – This morning, NVAX reported disappointing top-line data from the ResVax Phase III PREPARE study for infant RSV prevention. Unfortunately, the trial failed on the primary endpoint of reducing medically significant RSV lower respiratory tract infection (LRTI).

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Sangamo Therapeutics

Sangamo (SGMO) — Updated MPS I & II Trials Disappoint But ERT Withdrawals Continue & That’s Key

BioInvest News – Sangamo (SGMO) Updated MPS I & II Trials Disappoint But ERT Withdrawals Continue & That’s Key, More Powerful 2nd Generation ZFNs in Clinic by Year-End, Stock Overreaction

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MTSL Issue 887

MTSL Issue 887 (dated 10/04/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #MDCO #XON #NKTR

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MTSL Issue 880

MTSL Issue 880 (dated 06/21/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #INCY #IONS #MDGL #NKTR #PCRX #SGMO #ZIOP

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Nektar

NKTR- Nektar Down on ASCO ‘214 Combo Data Concerns Despite Advancing Into 3 Pivotal Trials

BioInvest BREAKING News – Nektar (NKTR) shares are down sharply as the ‘214/Opdivo combo data in the second cohort presented at ASCO is not as strong as the first cohort and the Company also failed to provide an update lung cancer.

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MTSL Issue 877

MTSL Issue 877 (dated 05/10/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #CELG #ESPR #FPRX #IONS #MDGL #MDCO #NKTR #PCRX #SGMO

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