BioInvest News – Sangamo (SGMO) has delivered excellent news across their proprietary ZFN drug development platform with promising human data from both the Hemophilia A program with Pfizer and Beta Thal with Sanofi.
BioInvest News – Sangamo (SGMO) Updated MPS I & II Trials Disappoint But ERT Withdrawals Continue & That’s Key, More Powerful 2nd Generation ZFNs in Clinic by Year-End, Stock Overreaction
BioInvest News – Sangamo (SGMO) presented an overview of its clinical and technological gene therapy/editing leadership. With 5 trials underway and data from all five clinical results due this year, to us 2019 will be the year when SGMO gaps ahead of the gene editing crowd.
BioInvest BREAKING News – IONS/AKCA Receive CRL From FDA for Waylivra Despite Positive AdCom. In a somewhat surprising move, ONS/AKCA received a complete response letter (CRL) for Waylivra (volanesorsen) from the FDA. It is also unexpected given the 12-8 Advisory Committee vote in favor of approval on May 10th…
BioInvest News Novavax (NVAX) – This morning, NVAX reported disappointing top-line data from the ResVax Phase III PREPARE study for infant RSV prevention. Unfortunately, the trial failed on the primary endpoint of reducing medically significant RSV lower respiratory tract infection (LRTI).
(ESPR) — Nets $150 Million in Deal For Europe With Daiichi Sankyo Europe. ESPR entered into a substantial licensing agreement with Daiichi Sankyo Europe (DSE) providing DSE with exclusive rights to commercialize bempedoic acid (BA) and the bempedoic acid/ezetimibe combination pill in the European Economic Area and Switzerland.
Ionis (IONS) — Next generation LICA Technology In Focus At JPM. IONS focused on their next generation LICA technology during its recent JPM presentation. IONS’ partner Novartis plans to initiate an outcomes study for AKCEAAPO(a)-LRx following the recent positive end of Phase II meeting with the FDA.
BioInvest BREAKING News – SANGAMO – Q2 CALL BONANZA – Reiterate BUY (And Short CRSP, EDIT, NTLA) First Hemophilia A SB-525 Results Ideal In The ALTA Study-MPSII Patient 6 Treated with SB-913 in the CHAMPIONS Study
-First patient treated in the SB-318 Phase 1/2 EMPOWERS Study for MPS Enrolled the first patient in the Phase 1/2 Thales Study of ST-400 gene-edited cell therapy for beta-thalassemia
Presented further ZFN Safety via the Most Sensitive Assays ..
BioInvest News – NKTR’s stock is under pressure after the early update to NKTR’s Phase 2 PIVOT-02 trial of NKTR-214 in combination with Opdivo which includes 13 additional urothelial cancer (UC) patients vs. the 10 reported at ASCO 2018. The data remains solid despite the small decrease in ORR which is now 48% vs. 60% prior.
BioInvest News – NKTR made a strong presentation at the recent JPM conference with a detailed focus on the company’s I/O pipeline and the upcoming May 29 PDUFA for NKTR-181. NKTR-214 is poised to move into move pivotal studies over the course of 2019 including lung cancer, a major market opportunity.
BioInvest BREAKING News (MDGL) – Down Sharply After Positive Update at Liver Meeting, It’s The Unforgiving Market, To Come More In Line With Sentiment & Current Price, Lowering BUY and Target
BioInvest BREAKING News – FDA Releases Gene Therapy Guidelines & NATURE Publishes Damning CRSPR Research
BUY SGMO and SHORT CRSP, EDIT, NTLA.
