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 – 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)
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)
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.
(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.
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)
BIOINVEST BREAKING NEWS – Medicines Company (MDCO) — 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. Today’s 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)
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…
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)
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)
BIOINVEST BREAKING NEWS – Myovant (MYOV) Legendary blues rockers Little Feat song, ‘Time Loves a Hero,’ 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)
BIOINVEST BREAKING NEWS – 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 world’s 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)
