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)
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
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)
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
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
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
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
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
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
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
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)
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)