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)
Category: Company Updates
Ziopharm Oncology (ZIOP) — We’ve Seen This Before
BIOINVEST BREAKING NEWS – We’ve Seen This Before – ZIOP Under Attack By Short Report – REITERATE BUY. ZIOP’s stock has been under pressure the past two days as an error-filled Seeking Alpha (a classic site for anonymous bears) short report was released on the internet. Read 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…
The Medicines Company (MDCO) — Inclisiran Indeed!
The Medicines Company (MDCO) – Inclisiran Indeed! Following up on the positive top-line results of the ORION 11 trial (released 8/26), the actual data presented at the ESC Congress 2019 were uniformly favorable for both efficacy and safety. In addition, despite the relatively smaller study and not powered for outcomes (n=1607), there was a strong reduction in Cardio Vascular Outcomes (CVO) in the Inclisiran treated arm versus placebo. (… more)
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)
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)
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
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.
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) — In Perfect HARMONY
BIOINVEST BREAKING NEWS â Special Update â ACAD — In Perfect HARMONY–This morning, ACAD released excellent data from the Phase III HARMONY study, a double-blind, placebo-controlled relapse prevention trial evaluating pimavanserin for the treatment of dementia-related psychosis. Â Read more…
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.