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
Author: conniebioinvest
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
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.
10 Speculative Stock Plays in the Biotech Sector
For investors interested in biotech, there’s a lot to choose from, with options ranging from startups with potentially blockbuster new treatments to companies those that have been around the block a few times. John McCamant discusses Sangamo in this article.
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.
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).
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 & Thatâs Key, More Powerful 2nd Generation ZFNs in Clinic by Year-End, Stock Overreaction
Sangamo (SGMO) — JPM Update – WORLD, 5 Trials Underway, 4 More To Start
BioInvest News – Sangamo (SGMO) presented an overview of its clinical and technological gene therapy/editing leadership. With 5 trials underway and data from all five clinical results due this year, to us 2019 will be the year when SGMO gaps ahead of the gene editing crowd.
Madrigal (MDGL) Down Sharply After Positive Update at Liver Meeting
BioInvest BREAKING News (MDGL) – Down Sharply After Positive Update at Liver Meeting, Itâs The Unforgiving Market, To Come More In Line With Sentiment & Current Price, Lowering BUY and Target
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
Ionis (IONS) – IONS/AKCA Receive CRL From FDA for Waylivra Despite Positive AdCom
BioInvest BREAKING News – IONS/AKCA Receive CRL From FDA for Waylivra Despite Positive AdCom. In a somewhat surprising move, ONS/AKCA received a complete response letter (CRL) for Waylivra (volanesorsen) from the FDA. It is also unexpected given the 12-8 Advisory Committee vote in favor of approval on May 10th…
MTSL Issue 882
MTSL Issue 882 (dated 07/19/18) of Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #MDGL #MYOV #PCRX #SGMO #CRSP #EDIT #NTLA
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
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.
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
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
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)
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.
Ionis (IONS) — IONS Down on Competitive Threat From NVS’ Zolgensma For Sprinraza
Ionis (IONS) — An update from Spinraza competitor Zolgensma (NVS) and the shift out of health care stocks are driving today’s decline. Shares are down 14% after Novartis presented a positive update to its STRIVE study for Spinal Muscular Atrophy (SMA) yesterday at the MDA 2019 meeting.
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
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
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
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
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
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
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
Sangamo (SGMO) – Sangamo (SGMO), CRSPR (CRSP), Editas (EDIT), Intellia (NTLA)
BioInvest BREAKING News â FDA Releases Gene Therapy Guidelines & NATURE Publishes Damning CRSPR Research
BUY SGMO and SHORT CRSP, EDIT, NTLA.
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…
Madrigal (MDGL) 3196 Delivers Best-in-Class Phase II NASH Data
BioInvest BREAKING News â 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.
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.
BioMarin (BMRN) — Hem A Gene Therapy Update Is Good Enough
BioMarin (BMRN) – The widely anticipated BioMarin hemophilia A gene therapy delivered good news this morning, albeit with some caveats. BMRN announced both positive Phase I/II and Phase III data for ValRox (valoctocogene roxaparvovec) for adults with severe hemophilia A.
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
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
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
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
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.
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
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
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
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
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
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
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
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