BIOINVEST BREAKING NEWS – Precigen held a virtual R&D presentation yesterday, updating data on five clinical trials from the novel Ultra-CAR-T and AdenoVerse platforms. The company has delivered objective responses in late-stage, refractory cancer patients (AML, ovarian, HPV-positive tumors) utilizing their Ultra-CAR-T system plus which offer the fastest (overnight vs. 4-6 weeks) low-cost CAR-T therapies around. (…more)
Author: conniebioinvest
MTSL Issue 962
MTSL Issue 962 (dated 10/14/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #MYOV #myovant $PCRX #pacira #PLXP #plxpharma #PGEN #precigen #VXRT #vaxart
MTSL Issue 959
MTSL Issue 959 (dated 9/02/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #PLXP #plxpharma #VXRT #vaxart
MTSL Issue 956
MTSL Issue 956 (dated 7/15/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #CLDX #celldex #PLXP #plxpharma #VXRT #vaxart
MTSL Issue 954
MTSL Issue 954 (dated 6/17/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #CLDX #celldex #INCY #incyte #PGEN #precigen
MTSL Issue 951
MTSL Issue 951 (dated 4/29/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #ESPR #esperion #SGMO #sangamo #VXRT #vaxart
MTSL Issue 948
MTSL Issue 948 (dated 3/18/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #CLDX #celldex #ESPR #esperion #ZIOP #ziopharm
Five Prime (FPRX) — AMGN To Acquire Five Prime for $38, TARGET PRICE of $33 More Than Achieved – Move To Sell
Special Update: Five Prime (FPRX) – This morning, FPRX announced that it is being bought by Amgen for $38 per share (~80% premium to yesterday’s closing price), representing an equity value of approximately $1.9 billion. Read more…
MTSL Issue 945
MTSL Issue 945 (dated 2/04/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #PCRX #Pacira #SGMO #sangamo #VXRT #vaxart
MTSL Issue 942
MTSL Issue 942 (dated 12/17/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes *INCY #incyte #IONS #ionis #NKTR #nektar #PGEN #precigen #SGMO #sangamo #ZYNE #zynerba
Five Prime (FPRX) — FPA144 Delivers Outstanding Top-Line Phase II Bema Data in Gastric Cancer Patients at SITC
Special Update: Five Prime (FPRX) – FPRX announced excellent topline results from the global, randomized, double-blind placebo-controlled Phase II FIGHT trial. Read more…
Esperion (ESPR) — NEXLETOL Launch Stifled Under COVID
(ESPR) BioInvest News — Esperion reported financials ($3 million in net sales) after the close yesterday and the stock is under pressure today as the Company continues to struggle with the new drug launch during the COVID-19 crisis.
MTSL Issue 937
MTSL Issue 937 (dated 10/08/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #ESPR #esperion #INCY #incyte #MDGL #madrigal #MYOV #myovant #PCRX #pacira #SGMO #sangamo #VXRT #vaxart
Myovant (MYOV) — Regugolix HERO Data Equivalent But Not Superior to Leuprolide in Castration Resistance-Free Survival, Remains on Track For Approval With Dec. 20 PDUFA
BIOINVEST BREAKING NEWS – MYOV announced results of an additional secondary endpoint from the Phase III HERO study evaluating relugolix in men with advanced prostate cancer. Relugolix did not achieve statistical superiority for castration resistance-free survival compared to leuprolide acetate in men with metastatic disease through 48 weeks. (…more)
MTSL Issue 934
MTSL Issue 934 (dated 08/27/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ALKS #alkermes #CLDX #celldex #MYOV #myovant #PGEN #precigen
MTSL Issue 933
MTSL Issue 933 (dated 08/13/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #BMRN #biomarin #CLDX #celldex #ESPR #esperion #IONS #ionis #INCY #incyte #IONS #ionis #MDGL #madrigal #MYOV #myovant #NKTR #nektar #PCRX #pacira #PGEN #precigen #SGMO #sangamo #VXRT #vaxart #ZIOP #ziopharm #ZYNE #zynerba
Vaxart (VXRT) — Negating The Egregious NY Times Article
Special Update: Vaxart (VXRT) – Negating The Egregious NY Times Article – While we rarely rebut a short report or bear raid on one of our recommendations, the The NY Times published one of the more egregious “investigative” reports we have ever seen. Read more…
MTSL Issue 930
MTSL Issue 930 (dated 07/02/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis and updates: ##ESPR #esperion #MDGL #madrigal #MYOV #myovant #PCRX #pacira #PGEN #precigen #ZIOP #ziopharm #ZYNE #zynerba
MTSL Issue 928
MTSL Issue 928 (dated 05/28/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #MYOV #myovant #ZYNE #zynerba
MTSL Issue 925
MTSL Issue 925 (dated 04/16/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates:#ESPR #esperion #FPRX #fiveprime #MDGL #madrigal #NKTR #nektar #SGMO #sangamo
MTSL Issue 922
MTSL Issue 922 (dated 03/05/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #BMRN #biomarin #ESPR #esperion #IONS #ionis #NKTR #nektar #SGMO #sangamo
Esperion (ESPR) — FDA Approves of NEXLETOL (bempedoic acid)
(ESPR) BioInvest News — FDA approves of NEXLETOL (bempedoic acid)— the first new non-statin once daily LDL-cholesterol lowering medicine in 20 year. With a very seasoned management team that is extremely well-prepared for the imminent launch, on the positive news we reiterate our BUY rating.
MTSL Issue 920
MTSL Issue 920 (dated 02/06/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #ESPR #esperion #IONS #ionis #NKTR #nektar #ZIOP #ziopharm
MTSL Issue 919
MTSL Issue 919 (dated 01/23/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ESPR #esperion #FPRX #fiveprime #IONS #ionis #INCY #incyte #MDGL #madrigal #MYOV #myovant #NKTR #nektar #PCRX #pacira #ZIOP #ziopharm
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
Sangamo (SGMO) — SGMO’s PhaseI/II Fabry Disease Data Looks Great
BioInvest News – SGMO’s PhaseI/II Fabry Disease Data Looks Great – In it’s quarterly update, SGMO delivered news across multiple clinical programs today with the stock reacting positively to the excellent Fabry disease data. (…more)
MTSL Issue 961
MTSL Issue 961 (dated 9/30/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #INCY #incyte #NKTR #nektar #VXRT #vaxart
MTSL Issue 958
MTSL Issue 958 (dated 8/19/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #PGEN #precigen #SGMO #sangamo #VXRT #vaxart #ZIOP #ziopharm #ZYNE #zynerba
Celldex (CLDX) — Delivers Outstanding Phase 1b Data
BIOINVEST BREAKING NEWS – Celldex (CLDX) Delivers Outstanding Phase 1b Data, 19 of 20 Urticarial Patients Demonstrate Complete Response After Single Dose of CDX-0159, Raising BUY to 47 (from 30) and TARGET to 70 (from 40), Best in Class and a Pipeline in a Pill? (…more)
MTSL Issue 953
MTSL Issue 953 (dated 5/27/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #esperion #MYOV #myovant #NKTR #nektar #PCRX #pacira
MTSL Issue 950
MTSL Issue 950 (dated 4/15/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #CLDX #celldex #INCY #incyte #IONS #ionis #MYOV #myovant #PCRX #pacira #ZIOP #ziopharm
Acadia (ACAD) — FDA Bombs ACAD With Undisclosed sNDA Deficiencies, Lowering BUY to 28 and TARGET to 45
Special Update: Acadia (ACAD) – In another FDA surprise, after the close, the Agency notified ACAD that it has identified deficiencies in the dementia related psychosis (DRP) sNDA for pimavanserin that preclude discussion of labeling and post-marketing requirements. Read more…
MTSL Issue 946
MTSL Issue 946 (dated 2/18/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #INCY #incyte #MYOV #myovant #NKTR #nektar
MTSL Issue 944
MTSL Issue 944 (dated 1/21/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #BMRN #biomarin #ESPR #esperion #FPRX #fiveprime #MYOV #myovant #NKTR #nektar #PGEN #precigen#ZIOP #ziopharm
MTSL Issue 941
MTSL Issue 941 (dated 12/03/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #IONS #ionis
Vaxart (VXRT) — Pfizer/BNTX COVID-19 Vaccine Shows Better-Than-Expected Efficacy – The Vaccine Era Begins
Special Update: Vaxart (VXRT) – Following up on key features and still questions on the exceptional >90% efficacy in the first Phase II/III trial of their mRNA COVID vaccine from Pfizer/BNTX. BUY VXRT here as Rick Bright is back (see below). Read more…
MTSL Issue 938
MTSL Issue 938 (dated 10/22/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #PCRX #pacira #PGEN #precigen #VXRT #vaxart
Alkermes (ALKS) — FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder
BIOINVEST BREAKING NEWS – In late Breaking News, ALKS announced overwhelming and surprising positive votes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The FDA committees met to discuss ALKS 3831 (olanzapine/samidorphan), a novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with both schizophrenia and with bipolar I disorder.
MTSL Issue 936
MTSL Issue 936 (dated 09/24/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #CLDX #celldex #INCY #incyte #VXRT #vaxart #ZYNE #zynerba
BioMarin (BMRN) — (BMRN/SGMO) Surprise Roctavian CRL – Bad For BioMarin, Good For SGMO
BioInvest News – BMRN/SGMO – Surprise Roctavian CRL – Bad For BioMarin, Good For SGMO – This morning, the FDA issued a surprise Complete Response Letter for BioMarin’s Roctavian, its lead hemophilia A gene therapy program. (…more)
MTSL Issue 932
MTSL Issue 932 (dated 07/30/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ALKS #alkermes #CLDX #celldex #INCY #incyte #IONS #ionis #SGMO #sangamo #VXRT #vaxart
MTSL Issue 931
MTSL Issue 931 (dated 07/16/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #IONS #ionis #MYOV #myovant #PCRX #pacira #VXRT #vaxart #ZIOP #ziopharm
Zynerba (ZYNE) — Zygel Topline Results Fall Short of Statistical Significance, 80% of Patients With FMR1 Gene Had Positive Affect
BIOINVEST BREAKING NEWS – Special Update – #ZYNERBA – ZYNE’s stock is down significantly this morning after reporting disappointing top line results from the 14-week pivotal CONNECT-FX (Clinical study of Cannabidiol (CBD) in Children and Adolescents with Fragile X) trial. more…
MTSL Issue 927
MTSL Issue 927 (dated 05/14/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ESPR #esperion #FPRX #fiveprime #INCY #incyte #MDGL #madrigal #NKTR #nektar #PCRX #pacira #SGMO #sangamo #ZIOP #ziopharm #ZYNE #zynerba
MTSL Issue 924
MTSL Issue 924 (dated 04/02/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #esperion #INCY #incyte #MYOV #myovant
MTSL Companies Deliver The Goods In Mid-Issue Update
BIOINVEST BREAKING NEWS – In light of the historic, market selloff due to the coronavirus, we thought it was important to update subscribers with a brief summary of the highlights of our recommended stocks during this period of stock corrections unrelated to Company fundamentals. In sum, many of our companies have delivered the positive value creating news that we predicted (…more)
MTSL Issue 921
MTSL Issue 921 (dated 02/20/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #BMRN #biomarin #FPX #fiveprime #INCY #incyte #MYOV #myovant #PCRX #pacira #PGEN #precigen
Biotech Conference Highlights Pipeline at BioMarin
At the recent JPMorgan Conference, biotech BioMarin Pharmaceutical (BMRN) offered a presentation that included important and new information regarding its R&D pipeline for 2019, observes biotech specialist John McCamant, editor of Medical Technology Stock Letter.
Top Picks 2020: Myovant Sciences Ltd. (MYOV)
Myovant Sciences Ltd. (MYOV) offers a new drug “pipeline in a pill”, asserts biotech expert Jay Silverman, contributing editor to Medical Technology Stock Letter.
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 963
MTSL Issue 963 (dated 10/28/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #BMRN #biomarin #ESPR #esperion #IONS #ionis #MYOV #myovant #PGEN #precigen #VXRT #vaxart
MTSL Issue 960
MTSL Issue 960 (dated 9/16/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BMRN #biomarin #CLDX #celldex #ESPR #esperion #PCRX #pacira
MTSL Issue 957
MTSL Issue 957 (dated 8/05/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ALKS #alkermes #MDGL #madrigal #PLXP #plxpharma #VXRT #vaxart
MTSL Issue 955
MTSL Issue 955 (dated 7/1/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #esperion #INCY #incyte #MDGL #madrigal
MTSL Issue 952
MTSL Issue 952 (dated 5/13/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #CLDX #celldex #ESPR #esperion #MYOV #myovant #NKTR #nektar #PGEN #precigen #VXRT #vaxart #ZIOP #ziopharm #ZYNE #zynerba
MTSL Issue 949
MTSL Issue 949 (dated 4/01/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #CLDX #celldex #IONS #ionis #SGMO #sangamo
MTSL Issue 947
MTSL Issue 947 (dated 3/04/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #FPRX #fiveprime #IONS #ionis #MDGL #madrigal #NKTR #nektar #PCRX #pacira #PGEN #precigen #ZIOP #ziophparm
Nektar (NKTR) — NKTR Inks Two Partners, Merck & SFJ Pharmaceuticals (Abingworth & Blackstone Life Sciences) for BEMPEG Combo Registration Trials
BIOINVEST BREAKING NEWS – This morning NKTR announced that it has signed two deals to advance BEMPEG combos – one with Merck and the other with SFJ. The first is a Phase II/III trial of BEMPEG in combination with Merck’s KEYTRUDA for first-line treatment of patients with metastatic or un-resectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). (…more)
MTSL Issue 943
MTSL Issue 943 (dated 1/07/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #ESPR #esperion #MYOV #myovant #NKTR #nektar #PCRX #pacira #PGEN #precigen
MTSL Issue 940
MTSL Issue 940 (dated 11/19/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #ESPR #esperion #MDGL #madrigal #MYOV #myovant #PCRX #pacira #PGEN #precigen #VXRT #vaxart #ZIOP #ziopharm
MTSL Issue 939
MTSL Issue 939 (dated 11/05/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ESPR #esperion #INCY #incyte #IONS #ionis #MDGL #madrigal #NKTR #nektar #ZIOP #ziopharm
Vaxart (VXRT) — Starts Phase I Dosing & Delivers Positive Hamster Challenge Data, Stock Remains Under Short Selling Pressure
Special Update: Vaxart (VXRT) – VXRT has delivered two very good pieces of news – the Company has enrolled its first patient in the COVID vaccine study and also released uniformly positive hamster challenge data. Despite this good fundamental news, the stock has been under pressure from short sellers since then based on an SEC filing of a self offering filed on the same day as the clinical/pre-clinical updates. Read more…
[CONFERENCE] The MoneyShow Dallas (October 13-15)
Join John McCamant (editor of the Medical Technology Stock Letter) FREE at The MoneyShow live streaming event where he’ll be presenting along with dozens of the most respected economists, money managers, and professional traders in the country. His topic is: BIOTECH INVESTING SOLUTIONS FROM COVID-19.
MTSL Issue 935
MTSL Issue 935 (dated 09/10/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #CLDX #celldex #IONS #ionis #MDGL #madrigal #PCRX #pacria #SGMO #sangamo #VXRT #vaxart
Sangamo (SGMO) — (BMRN/SGMO) Surprise Roctavian CRL – Bad For BioMarin, Good For SGMO
BioInvest News – BMRN/SGMO – Surprise Roctavian CRL – Bad For BioMarin, Good For SGMO – This morning, the FDA issued a surprise Complete Response Letter for BioMarin’s Roctavian, its lead hemophilia A gene therapy program. (…more)
Celldex (CLDX) — CDX-0159 – The Mast Cell Warrior (New Recommendation)
BIOINVEST NEW RECOMMENDATION – Celldex (CLDX) We are initiating coverage of Celldex Therapeutics (CLDX, $12) with a BUY under $15 and a $30 TARGET PRICE. In our view, CDX-0159, the Company’s anti-C-KIT antibody has blockbuster potential in various mast cell diseases. With a market cap of ~$375 million with ~$200 million in cash, in our view, CLDX is extremely undervalued based on the potential of CDX—0159 alone. (…more)
Vaxart (VXRT) — VXRT’s Oral Vaccine for COVID-19 Poised to Enter Human Testing
BIOINVEST BREAKING NEWS – Special Update — NEW RECOMMENDATION: Vaxart (VXRT) – VXRT’s Oral Vaccine for COVID-19 Poised to Enter Human Testing. Read more…
MTSL Issue 929
MTSL Issue 929 (dated 06/18/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #BMRN #biomarin #ESPR #esperion #INCY #incyte #MYOV #myovant #SGMO #sangamo
MTSL Issue 926
MTSL Issue 926 (dated 04/30/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #BMRN #biomarin #ESPR #esperion #INCY #incyte #IONS #ionis #MYOV #myovant #PGEN #precigen #SGMO #sangamo
MTSL Issue 923
MTSL Issue 923 (dated 03/19/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #PGEN #precigen #ZIOP #ziopharm
Sangamo (SGMO) — BIIB Steps Up Big With Global Neuro Gene Editing Deal
BIOINVEST BREAKING NEWS – After the close, Sangamo announced a worldwide deal with Biogen for gene regulation therapies in neurology. BIIB is the global leader in developing neuro biologics with the top drugs in multiple sclerosis and an extremely deep Alzheimer’s/ALS R&D pipeline, in our view there is no better partner available than BIIB. (…more)
Myovant (MYOV) — Relugolix Uterine Fibroids Data Highly Competitive
BIOINVEST BREAKING NEWS – A very positive long-term follow-up (88% response rate) from the LIBERTY trial was released yesterday and we believe continues to further solidify relugolix in uterine fibroids (UF). Management will file for an NDA for the use of relugolix+ABT in UF in April (plus a separate filing for the treatment of relugoxi in prostate cancer in Q2:20). For relugolix in endometriosis, we expect MYOV to (…more)
ACADIA: From Depression to Schizophrenia
At the recent JPMorgan conference, ACADIA Pharmaceuticals (ACAD) presented a business update highlighting several catalysts anticipated in 2020, notes John McCamant, biotech sector expert and editor of Medical Technology Stock Letter.
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)
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.