BIOINVEST BREAKING NEWS – TCRT’s stock is down on heavy volume as a blog post from the husband of treated Patient #2 reported that she has stopped therapy due to a mutation. While social media post are not company press releases, (…more)
MTSL Issue 983 (dated 08/25/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BMRN #biomarin #CLDX #celldex #ESPR #esperion #PLXP #plxpharma #PGEN #precigen
MTSL Issue 981 (dated 07/28/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #IONS #ionis #INCY #incyte #MYOV #myovant #VXRT #vaxart
MTSL Issue 979 (dated 06/30/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #acadia #ACAD #alaunos #TCRT #celldex #CLDX #ionis #IONS #MDGL #madrigal #ZYNE #zynerba
MTSL Issue 978 (dated 06/16/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #alaunos #TCRT #alkermes #ALKS #INCY #incyte
MTSL Issue 975 (dated 04/28/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #BMRN #biomarin #INCY #incyte
Bicycle (BCYC) —We Are Buyers On AACR Weakness. BCYC shares are weak today after presenting updated data on BT8009, a lead BTC clinical compound, at the AACR conference over the weekend. Our investment thesis remains intact. (…more)
MTSL Issue 971 (dated 03/03/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #CLDX #celldex #IONS #ionis #MDGL #madrigal #NKTR #nektar #PCRX #pacira #SGMO #sangamo #VXRT #vaxart #ZYNE #zynerba
Madrigal (MDGL) — One of the few broadly positive binary events in biotechnology of late, Madrigal’s best-in-class NASH compound is well on its way with de-risked, late-stage clinical results. With this wholly-owned compound heading to blockbuster status, MDGL remains a Top Pick for 2022. (…more)
MTSL Issue 966 (dated 12/23/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #CLDX #celldex #ESPR #esperion #NKTR #nektar #PCRX #pacira #PGEN #precigen #SGMO #sangamo #VXRT #vaxart
MTSL Issue 965 (dated 12/02/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BMRN #biomarin #NKTR #nektar #VXRT #vaxart
Alkermes (ALKS) — ALKS was blindsided by JNJ after the close yesterday received notices of partial early termination for two license agreements with Janssen Pharmaceutica N.V., a subsidiary of JNJ. These license agreements are for Alkermes’ nanoparticulate formulation technology, known as NanoCrystal® technology. (…more)
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 (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 (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 (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 (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 (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 (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
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 (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 (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 (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
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…
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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
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)
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)
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 (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 (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 (dated 03/19/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #PGEN #precigen #ZIOP #ziopharm
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)
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)
MTSL Issue 984 (dated 09/08/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #TCRT #alaunos #BCYC #bicycle #IONS #ionis #PCRX #pacira #SGMO #sangamo #VXRT #vaxart
MTSL Issue 982 (dated 08/11/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #BMRN #biomarin #BCYC #bicycle #CLDX #celldex #ESPR #esperion #IONS #ionis #INCY #incyte #MDGL #madrigal #MYOV #myovant #PGEN #precigen #SGMO #sangamo #VXRT #vaxart #ZYNE #zynerba
MTSL Issue 980 (dated 07/14/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #bicycle #BCYC #ionis #IONS #pacira #PCRX #precigen #PGEN
Madrigal (MDGL) — MDGL held a two hour conference call after all presentations at EASL to discuss the outstanding resmetirom data presented at yesterday. The Company focused on the 969-patient MAESTRO-NAFLD-1 safety study which showed the compound to have an excellent safety profile along with excellent efficacy. (…more)
MTSL Issue 977 (dated 06/02/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #TCRT #alaunos #BCYC #bicycle #BMRN #biomarin #MDGL #madrigal #PLXP #plxpharma #VXRT #vaxart
MTSL Issue 974 (dated 04/13/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BCYC #bicycle #CLDX #celldex #ESPR #esperion #IONS #ionis #MYOV #myovant
MTSL Issue 973 (dated 03/31/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BCYC #bicycle #INCY #incyte #IONS #ionis #SGMO #sangamo #TCRT #alaunos
MTSL Issue 970 (dated 02/17/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #CLDX #celldex #INCY #incyte #MDGL #madrigal #PCRX #pacira #VXRT #vaxart
MTSL Issue 968 (dated 01/20/22) – 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 #MDGL #madrigal #MYOV #myovant #NKTR #nektar #PGEN #precigen
Acadia (ACAD) – Yesterday after the close ACAD announced that it plans to resubmit its supplemental New Drug Application (sNDA) to the FDA for pimavanserin for the treatment of hallucinations and delusions associated with dementia. Read more…
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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)
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 (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 (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 (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 (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 (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
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 (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 (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
Special Update: Five Prime (FPRX) – FPRX announced excellent topline results from the global, randomized, double-blind placebo-controlled Phase II FIGHT trial. Read more…
(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 (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
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 (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 (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
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 (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 (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 (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 (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
(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.
Please join BioInvest FREE at The MoneyShow live streaming event on September 8 where John McCamant will be presenting along with dozens of the most respected economists, money managers, and professional traders in the country.
BIOINVEST SPECIAL UPDATE – Good Medicine for Biotechs: Great Data, Awesome Sales, Monster Deals Yesterday; 100+% Premium Acquisition Today. (…more)
BIOINVEST BREAKING NEWS – Precigen announced the sale of a wholly-owned non-healthcare subsidiary, Trans Ova Genetics, L.C. (“Trans Ova”) for $170 million. The proceeds will go towards retiring roughly $200 million in convertible debt due in 2023. (…more)
Acadia (ACAD) – ACAD received bad news when an FDA AdCom voted 9-3 against recommending pimavanserin for Alzheimer’s disease psychosis (ADP). This is disappointing and significantly lowers the probability of the FDA approving pimavanserin for this new indication on the 8/4/22 PDUFA. Read more…
MTSL Issue 976 (dated 05/19/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #TCRT #alaunos #CLDX #celldex #INCY #incyte #MDGL #madrigal #MYOV #myovant #PCRX #pacira #VXRT #vaxart
BIOINVEST BREAKING NEWS – FDA Delays MYOV/Pfizer Approval for Endometriosis on Labeling. MYOV and their partner Pfizer announced today a delay on the Supplemental New Drug Application (sNDA) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis. In our view, this is clearly a delay and not a rejection. (…more)
MTSL Issue 972 (dated 03/17/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #IONS #ionis #IONS #ionis #NKTR #nektar #PCRX #pacira #PLXP #plxpharma
MTSL Issue 969 (dated 02/03/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #IONS #ionis #INCY #incyte #MDGL #madrigal #TCRT #alaunos #ZIOP #ziopharm
MTSL Issue 967 (dated 01/06/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #MDGL #madrigal #MYOV #myovant #PCRX #pacira #PLXP #plxpharma #SGMO #sangamo
(ESPR) BioInvest News — ESPR Raises Cash To Get To CLEAR Outcomes Trial Data in Q12023, Lowering our BUY and our TARGET PRICE. ESPR shares were off 40% after they announced the closing of a $208.8 million of common stock and warrants. (More)
MTSL Issue 964 (dated 11/11/21) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ALKS #alkermes #IONS #ionis #MDGL #madrigal #NKTR #nektar #PCRX #pacira #PLXP #plxpharma #PGEN #precigen #SGMO #sangamo
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 (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 (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
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 (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 (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
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 (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 (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 (dated 12/03/20) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #IONS #ionis
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 (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
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 (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
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 (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 (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
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 (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 (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
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 (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
