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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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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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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