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.
BioInvest BREAKING News – This morning, Madrigal (MDGL) reported excellent top-line, 36-week results from a Phase II trial in patients with biopsy-proven non-alcoholic steatohepatitis (NASH). This is the best and most highly significant NASH data ever.
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 BREAKING News – Sangamo shares are weaker this morning due to what we believe should be causing the exact the opposite stock reaction after STAT News wrote a paper highlighting the potential side effects of CRSPR. The article(s) have nothing to do with SGMO’s ZFN gene editing technology. We suggest subscribers use the weakness in SGMO to…
BioInvest BREAKING News – This morning, Esperion (ESPR) delivered positive Phase III safety data for bempedoic acid (BA). Despite delivering a highly significant 20% LDL reduction for those on treatment – expectations were for 20-30% LDL reduction based on several previous BA studies. The low-end for efficacy combined with safety concerns unrelated to treatment with the drug development candidate have driven the stock down by more than a third, and excessively in our view.
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 BREAKING News – Nektar (NKTR) shares are down sharply as the ‘214/Opdivo combo data in the second cohort presented at ASCO is not as strong as the first cohort and the Company also failed to provide an update lung cancer.
BioInvest News – Nektar (NKTR) Continues Charge Forward With ‘181 & ‘214 Leading The Way. On the recent Q4 conference call, NKTR provided updates for both ‘181 and ‘214. The company has had two positive pre-NDA meetings with the FDA over the last two months regarding ‘181. One very important aspect discussed with the agency is a better abuse scheduling for ‘181 given its non-addictive properties than a Schedule 2 which is currently used for addictive opioids.
