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)
Author: conniebioinvest
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)
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)
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.
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
Ziopharm Oncology (ZIOP) — Sleeping Beauty TCR Solid Tumor Trial Posted By NIH Starts Next Week
BIOINVEST BREAKING NEWS â 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 worldâs 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)
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…
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
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
6 Healthcare Favorites Poised for Second-Half Gains
Last January, MoneyShow.com asked the leading newsletter advisors to select their favorite stocks for 2019. Healthcare was a popular sector in that survey, with several big first-half winners. Here’s a check-up on six healthcare favorites poised for the second half gains in 2019.
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.
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)
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
The Medicines Company (MDCO) — Novartis To Acquire The Medicines Company for $9.7 Billion or $85 Per Share
BIOINVEST BREAKING NEWS â Medicines Company (MDCO) â 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. Todayâs 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)
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
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
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
Acadia (ACAD) — HARMONY Data De-risks ACAD, DRP Market Much Larger Than PDP
BIOINVEST BREAKING NEWS â Special Update â ACADIA â ACAD’s Phase III HARMONY trial recently delivered robust statistically superior data (p=0.0033) compared to placebo in time to relapse of dementia-related psychosis (DRP). In our view, (…more) #acadia #ACAD
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
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
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
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
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
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
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, âTime Loves a Hero,â 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)
A Paradigm Change in Cardiovascular Treatment?
On their recent conference call for The Medicines Company (MDCO), management highlighted the power of Inclisiranâs profile and likelihood of its potential to change the paradigm of ASCVD (atherosclerotic cardiovascular disease) treatment, notes biotech expert John McCamant, editor of The Medical Technology Stock Letter.
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
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
[CONFERENCE] The MoneyShow Dallas (October 13-14)
I encourage you to join me, John McCamant, at The MoneyShow Dallas, October 13-14, where I’ll be presenting along with dozens of the most respected economists, money managers, and professional traders in the country.
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
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
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
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