MTSL Issue 1037

MTSL Issue 1037 (dated 10/24/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BCYC #bicycletherapeutics #SGMO #sangamo #VKTX #viking

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Skye (SKYE) — Novo’s Mixed Monlunabant Data Good For SKYE, Despite Selloff

BIOINVEST BREAKING NEWS – Skye (SKYE) This morning Novo Nordisk announced mixed data for their CB1 receptor inverse agonist, monlunabant with solid weight loss but questionable neuropsychiatric side effects. The data showed that after 16 weeks of treatment, patients with a baseline bodyweight of 110.1 kg lost a mean of 7.1 kg after treatment with 10 mg doses of monlunabant. (…more)

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MTSL Issue 1033

MTSL Issue 1033 (dated 08/22/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #ESPR #esperion #INCY #incyte #SKYE

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MTSL Issue 1030

MTSL Issue 1030 (dated 07/11/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #PCRX #pacira #skye

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MTSL Issue 1028

MTSL Issue 1028 (dated 06/13/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #MDGL #madrigal #PGEN #preceign #SKYE #VXRT #vaxart #VKTX #viking

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MTSL Issue 1025

MTSL Issue 1025 (dated 04/25/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BCYC #bicycle #CLDX #celldex #INCY #incyte #MDGL #madrigal #PGEN #precigen #VKTX #viking

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Madrigal

Madrigal (MDGL) & Viking Therapeutics (VKTX) – LLY’s Phase II MASH Data Puts Pressure on MDGL (March 14 PDUFA) & VKTX (Q1 Phase I Oral Data)

BIOINVEST BREAKING NEWS – Viking (VKTX) Viking Therapeutics (VKTX) – LLY’s Phase II MASH Data Puts Pressure on MDGL (March 14 PDUFA) & VKTX (Q1 Phase I Oral Data), Both Still BUYS With Upcoming Catalysts (…more)

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MTSL Issue 1017

MTSL Issue 1017 (dated 01/04/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #BCYC #bicycle #ESPR #esperion

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MTSL Issue 1015

MTSL Issue 1015 (dated 11/30/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #BMRN #biomarin #CLDX #celldex #IONS #ionis

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MTSL Issue 1013

MTSL Issue 1013 (dated 11/02/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #BCYC #bicycle #CLDX #celldex #INCY #incyte #SGMO #sangamo #VXRT #vaxart

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MTSL Issue 1011

MTSL Issue 1011 (dated 09/28/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BCYC #bicycle #CLDX #celldex #IONS #ionis #VKTX #viking

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MTSL Issue 1008

MTSL Issue 1008 (dated 08/17/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #alaunos #TCRT esperion #ESPR #ionis #IONS #precigen #PGEN #thorne #THRN #sangamo #SGMO

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Thorne HealthTech (THRN) — New Recommendation

NEW RECOMMENDATION – We are initiating coverage on Thorne HealthTech (NASDAQ – THRN). For many reasons we believe Thorne is akin to the “Apple” of the nutritional supplement business. (…more)

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Madrigal

Madrigal (MDGL) — MDGL/VKTX Strong BUYs After Overreaction to Lilly Phase II Data

Madrigal (MDGL) / Viking (VKTX) are both strong BUYS after the overreaction to Lilly’s Phase II, 337 patients, data that showed a 24% weight loss at 48 weeks in the high dose from their new triple drug combo.Madrigal (MDGL) / Viking (VKTX) Strong BUYs After Overreaction to Lilly Phase II Data  (…more)

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MTSL Issue 1002

MTSL Issue 1002 (dated 5/25/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #SGMO #sangamo #VKTX #viking

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MTSL Issue 1000

MTSL Issue 1000 (dated 4/27/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #BMRN #biomarin #MDGL #madrigal #PGEN #precigen #SGMO #sangamo #VKTX #viking

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Celldex (CLDX) — Mix-Up At AAD Causes Undue Sell Off; EoE Trial Posted, Begins In May

BIOINVEST BREAKING NEWS – Celldex (CLDX) Celldex shares have been on a downward spiral since the exceptional durability data was presented at the AAAAI meeting in late February; the details are a bit lengthy but we remain steadfast that barzolvolimab (“barzo”) is the best-in-class and exceptionally unique mast cell inhibitor around. (…more)

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Esperion Theapeutics

Esperion (ESPR) — CLEAR Outcomes Reads Very Positive at ACC & Published in NEJM Editorial – Similar To PCSK9 Outcome Study, Doctors Will Prescribe It & Insurance Will Pay For It – BUY

(ESPR) BioInvest News — The full results from the Cholesterol Lowering via Bempedoic acid (BA), an ACL-Inhibiting Regimen (CLEAR) Outcomes trial – were presented at the American College of Cardiology (ACC) Annual meeting on Saturday by Dr. Steve Nissen (the king of CV drug trials) and simultaneously published in the New England Journal of Medicine. (More)

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MTSL Issue 994

MTSL Issue 994 (dated 2/02/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #IONS #ionis #PGEN #precigen #VXRT #vaxart

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MTSL Issue 989

MTSL Issue 988 (dated 11/17/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #TCRT #alaunos #BCYC #bicycle CLDX #celldex #ESPR #esperion #PGEN #precigen #VXRT #vaxart

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Myovant

Myovant (MYOV) — Myovant Accepts $27 From Sumitovant – Downgrade To Hold

BIOINVEST BREAKING NEWS – Last night, MTSL Recommendation MYOV announced that its board has accepted a $2.9 billion (fully-diluted) takeover offer from Sumitovant Biopharma for $27 per share. While we believed that the original $22.50 offer was way too low, the final price does represent (…more)

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MTSL Issue 986

MTSL Issue 986 (dated 10/06/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #IONS #ionis #MDGL #madrigal #MYOV #myovant

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Alaunos (TCRT) — Alaunos Therapeutics (TCRT) – Blog Update: Patient #2 on TCR-T Library Therapy Stops Treatment

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)

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MTSL Issue 983

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

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MTSL Issue 981

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

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MTSL Issue 979

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

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MTSL Issue 978

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

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MTSL Issue 975

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

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Bicycle Therapeutics (BCYC) — We Are Buyers On AACR Weakness

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)

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MTSL Issue 1036

MTSL Issue 1036 (dated 10/10/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #ESPR #esperion #IONS #ionis #VXRT #vaxart #VKTX #viking

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MTSL Issue 1035

MTSL Issue 1035 (dated 09/19/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BCYC #bicycletherapeutics #BMRN #biomarin #INCY #incyte #IONS #ionis #SKYE

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MTSL Issue 1032

MTSL Issue 1032 (dated 08/08/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #BCYC #bicycle #CLDX #celldex #INCY #incyte #MDGL #madrigal #PGEN #precigen #SGMO #sangamo #VXRT #vaxart

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Celldex (CLDX) — The Barzo Phase III Trial To Start Imminently; CindU Data Soon, Too, Then 52-Weeks – BUY

BIOINVEST BREAKING NEWS – Celldex (CLDX) Based upon the timing of the posting of the Phase III CSU trials, we expect Celldex will announce the first patient treated in the study will happen any day. In addition, the Phased II CindU data is also highly likely to be released this month, then the key 52-week Phase II CSU results will also happen sometime this summer/early fall. (…more)

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MTSL Issue 1027

MTSL Issue 1027 (dated 05/23/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BCYC #bicycle #ESPR #esperion #INCY #incyte #IONS #ionis #SGMO #sangamo #VXRT #vaxart

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MTSL Issue 1024

MTSL Issue 1024 (dated 04/11/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #ESPR #esperion #SKYE

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MTSL Issue 1022

MTSL Issue 1022 (dated 03/14/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #INCY #incyte #MDGL #madrigal #SGMO #sangamo #SKYE #VKTX #viking

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Celldex (CLDX) — FDA Approval Of Xolair For Food Allergies Bodes Well For Barzolvolimab

BIOINVEST BREAKING NEWS – On Friday, the FDA approved Roche/Genentech’s Xolair as the first treatment to help reduce severe allergic reactions brought on by accidental exposure to certain foods. (…more)

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MTSL Issue 1019

MTSL Issue 1019 (dated 02/01/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #esperion #IONS #ionis #VXRT #vaxart

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MTSL Issue 1016

MTSL Issue 1016 (dated 12/14/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ESPR #esperion #INCY #incyte #VKTX #viking

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MTSL Issue 1014

MTSL Issue 1014 (dated 11/16/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #ESPR #esperion #MDGL #madrigal #PGEN #precigen #VKTX #viking

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Celldex (CLDX) — Dupixent Receives CRL in CSU – BUY

BIOINVEST BREAKING NEWS – Celldex (CLDX) After the close on Friday, Regeneron and Sanofi announced that the FDA issued a Complete Response Letter (CRL) for Dupixent (“Dupi”) in chronic spontaneous urticaria (CSU). With an expected 2-year delay (or more), this is a major setback for Dupi. And hence, we believe it (…more)

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MTSL Issue 1010

MTSL Issue 1010 (dated 09/14/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BCYC #bicycle #BMRN #biomarin #MDGL #madrigal #VXRT #vaxart #VKTX #viking

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Precigen

Precigen (PGEN) — FDA Says PGEN’s 2012 Phase I/II Will Serve as Pivotal, Data in Q224, FDA Also Grants Breakthrough Therapy Designation

BIOINVEST BREAKING NEWS – PGEN received very good FDA news when the agency recently confirmed that the ongoing Phase I/II single arm trial of PRGN-2012 in RRP will serve as the pivotal study to support accelerated approval and no additional randomized, placebo-controlled trial will be required to support submission of a BLA. (…more)

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MTSL Issue 1006

MTSL Issue 1006 (dated 07/20/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #BCYC #bicycle #MDGL #madrigal #SGMO #sangamo

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MTSL Issue 1004

MTSL Issue 1004 (dated 6/22/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #ESPR #esperion #MDGL #madrigal #PGEN #precigen

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Viking (VKTX) — VKTX Delivers Excellent Phase IIb VOYAGER Data in NASH

BIOINVEST BREAKING NEWS – Viking (VKTX) delivered the goods this morning when they announced positive top-line results from its Phase IIb VOYAGER clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). (…more)

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MTSL Issue 999

MTSL Issue 999 (dated 4/13/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BCYC #bicycle #PCRX #pacira #PGEN #precigen

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MTSL Issue 997

MTSL Issue 997 (dated 3/16/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ESPR #esperion #INCY #incyte #PGEN #precigen #TCRT #alaunos #VXRT #vaxart

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MTSL Issue 996

MTSL Issue 996 (dated 3/02/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #BCYC #bicycle #CLDX #celldex #IONS #ionis #PCRX #pacira #SGMO #sangamo

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MTSL Issue 995

MTSL Issue 995 (dated 2/16/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: @ALKS #alkermes #BCYC #bicycle #INCY #incyte #VXRT #vaxart

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Precigen

Precigen (PGEN) — Precigen (PGEN-2012 Shows Strong/Complete Response in 50% of RRP Patients, Raises $75 Million at Large Discount

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)

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Madrigal

Madrigal (MDGL) — MAESTRO-NASH Takes a BOW!

Madrigal (MDGL) — Breaking News: MDGL has pitched a “perfect game” with their pristine MAESTRO-NASH Phase III trial hitting both primary, FDA agreed upon endpoints. The FDA had agreed that even hitting one primary endpoint would lead to approval. (…more)

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Esperion Theapeutics

Esperion (ESPR) — ESPR Delivers Positive CLEAR CVOT/Full Data at ACC March

(ESPR) BioInvest News — ESPR has delivered positive top-line data (at least 15% improvement in MACE-4) from their Phase IV Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial. The trial met its primary endpoint, demonstrating statistically significant risk reduction in MACE-4 in patients treated with 180 mg/day NEXLETOL compared to placebo. (More)

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MTSL Issue 987

MTSL Issue 987 (dated 10/20/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BMRN #biomarin #INCY #incyte #SGMO #sangamo

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MTSL Issue 984

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

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MTSL Issue 982

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

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MTSL Issue 980

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

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MTSL Issue 977

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

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MTSL Issue 974

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

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Celldex (CLDX) — Barzo 52-Week Data Delivers In A Big Way

BIOINVEST BREAKING NEWS – Celldex (CLDX) — Celldex reported the eagerly-awaited 52-week data for barzolvolimab (c-KIT antibody) in chronic spontaneous urticaria (CSU) as a late-breaker at EADV occurring in Amsterdam. We believe the data is overwhelming positive, continue to paint the best-in-class compound in urticaria and below address reasons for the stock weakness. (…more)

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MTSL Issue 1034

MTSL Issue 1034 (dated 09/05/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BMRN #biomarin #IONS #ionis #SKYE

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MTSL Issue 1031

MTSL Issue 1031 (dated 07/25/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #BCYC #bicycle #IONS #ionis #SGMO #sangamo #SKYE #VKTX #viking

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MTSL Issue 1029

MTSL Issue 1029 (dated 06/27/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #esperion #VKTX #viking

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MTSL Issue 1026

MTSL Issue 1026 (dated 05/09/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #ESPR #esperion #MDGL #madrigal #PCRX #pacira #VXRT #vaxart

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MTSL Issue 1023

MTSL Issue 1023 (dated 03/28/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #esperion #SGMO #sangamo #VXRT #vaxart #VKTX #viking

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MTSL Issue 1021

MTSL Issue 1021 (dated 02/29/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #BMRN #biomarin #CLDX #celldex #ESPR #esperion #SKYE #skye #VKTX #viking

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MTSL Issue 1020

MTSL Issue 1020 (dated 02/15/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #MDGL #madrigal #SGMO #sangamo #VKTX #viking

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MTSL Issue 1018

MTSL Issue 1018 (dated 01/18/24) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ALKS #alkermes #CLDX #celldex #ESPR #esperion #PGEN #precigen #VXRT #vaxart

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Viking Therapeutics (VKTX) – Significantly Undervalued After Roche Pays $2.7 Billion For Competitor

BIOINVEST BREAKING NEWS – Viking (VKTX) Viking Therapeutics (VKTX) – Significantly Undervalued After Roche Pays $2.7 Billion For Competitor, Phase I ‘2735 Oral Proof-of-Concept Data in Q1 2024. (…more)

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Celldex (CLDX) — CSU Events Further Solidify Barzo As Best-In-Class – BUY

BIOINVEST BREAKING NEWS – Celldex (CLDX) Underwhelming details of NVS remibrutinib (‘REMI’) Phase III trial in chronic spontaneous urticaria (‘CSU’) were released at a major medical meeting last week. Combining that negative event with two more disappointing regulatory/clinical events – the REGN/SNY’s receipt of a CRL of Dupixent and the failure of AMGN/AZN’s tezepelumab – potential competition for Celldex’s barzolvolimab (‘barzo’) is falling by the wayside. (…more)

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MTSL Issue 1012

MTSL Issue 1012 (dated 10/19/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #IONS #ionis #INCY #incyte #VKTX #viking

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MTSL Issue 1009

MTSL Issue 1009 (dated 08/31/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes #ESPR #esperion #THRN #thorne

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MTSL Issue 1007

MTSL Issue 1007 (dated 08/03/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermesg #ESPR #esperion #INCY #incyte #PCRX #pacira #THRN #thorne #VKTX #viking

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MTSL Issue 1005

MTSL Issue 1005 (dated 07/06/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ESPR #esperion #INCY #incyte #MDGL #madrigal #VKTX #viking #VXRT #vaxart

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MTSL Issue 1003

MTSL Issue 1003 (dated 6/08/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #TCRT #alaunos #ESPR #esperion #IONS #ionis #PGEN #precigen #VXRT #vaxart

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MTSL Issue 1001

MTSL Issue 1001 (dated 5/11/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #ALKS #alkermes #BCYC #bicycletherapeutics #BMRN #biomarin #CLDX #celldex #ESPR #esperion #MDGL #madrigal #PGEN #precigen #VXRT #vaxart

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MTSL Issue 998

MTSL Issue 998 (dated 3/30/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BCYC #bicycle #CLDX #celldex #INCY #incyte #IONS #ionis #MYOV #myovant #SGMO #sangamo #VKTX #viking #ZYNE #zynerba

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Sorting Through The Rubble

BIOINVEST SPECIAL UPDATE – Biotechs were under pressure this week as the sudden failure of SVB and drug pricing concerns delivered a double whammy in a continued rising rate environment. In our view, while all biotech stocks are being sold indiscriminately, we believe (…more)

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Bicycle Therapeutics (BCYC) — BCYC’s BT8009 Delivers Positive Phase I Data at ASCO GI

Bicycle (BCYC) — BCYC announced positive BT8009 Phase I data today in heavily pre-treated cancer patients at ASCO GI. In our view, the strong data point out the potential for BT8009 to become a best in class drug and a significant differentiated treatment option for cancer patients. (…more)

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MTSL Issue 993

MTSL Issue 993 (dated 1/19/23) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ACAD #acadia #TCRT #alaunos #ALKS #alkermes #BCYC #bicycle #CLDX #celldex #ESPR #esperion #IONS #ionis #PGEN #precigen #ZYNE #zynerba

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MTSL Issue 991

MTSL Issue 991 (dated 12/15/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #CLDX #celldex #ESPR #esperion #INCY #incyte #PCRX #pacira #PGEN #precigen #SGMO #sangamo

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MTSL Issue 990

MTSL Issue 990 (dated 12/01/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #BMRN #biomarin #TCRT #alaunos #VXRT #vaxart #ZYNE #zynerba

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MTSL Issue 988

MTSL Issue 988 (dated 11/03/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #ALKS #alkermes CLDX #celldex #ESPR #esperion #INCY #incyte #MDGL #madrigal #PCRX #pacira #SGMO #sangamo

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MTSL Issue 985

MTSL Issue 985 (dated 09/22/22) – This issue of the Medical Technology Stock Letter from BioInvest includes #Biotech Sector Analysis & updates: #TCRT #alaunos #BCYC #bicycletherapeutics #ESPR #esperion #PCRC #pacira #SGMO #sangamo

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Acadia

Acadia (ACAD) — FDA Advisory Committee Rejects ACAD’s Pimavanserin for Alzheimer’s Disease Psychosis (ADP) 9-3

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…

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MTSL Issue 976

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

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Myovant

Myovant (MYOV) — FDA Delays MYOV/Pfizer Approval for Endometriosis on Labeling/Post-marketing Requirements

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)

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