Category: Company Updates

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Sangamo Therapeutics

Sangamo (SGMO) – CRSPR Cancer Risk Only Further Distiguishes SGMO’s Competitive Edge In Gene Editing

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…

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Esperion

Esperion – BA First Phase III Successful, But Stock Down on Safety Confusion & Some Efficacy Concerns

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.

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Nektar

Nektar (NKTR) Inks The Ultimate Monster Deal With BMS For NKTR-214

BioInvest News – Nektar (NKTR) NKTR has signed the largest single product deal in biotech history with BMS for their leading I/O development candidate NKTR-214. Clearly BMS paid handsomely for what may have been the most attractive asset in the space.

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Ionis

Ionis (IONS) Reports Positive TTR Data, Safety/Patient Death Causes Concern

BioInvest News – IONS – Reports Positive TTR Data, Safety/Patient Death Causes Concern – IONS reported positive Phase III data for inotersen (TTR-Rx) NEURO-TTR results in familial amyloid polyneuropathy (FAP) patients showing a statistically significant benefit in the two co-primary endpoints of modified Neuropathy Impairment Score (mNIS+7, p<0.0001) and the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN, P=0.0006) post 15 months of treatment.

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Nektar

NKTR- Nektar Down on ASCO ‘214 Combo Data Concerns Despite Advancing Into 3 Pivotal Trials

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.

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Nektar

Nektar (NKTR) Continues Charge Forward With ‘181 & ‘214 Leading The Way

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.

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Madrigal

Madrigal (MDGL) MGL-3196 Delivers Positive Phase II HeFH Data

BioInvest News – Madrigal (MDGL) – MGL-3196 Delivers Positive Phase II HeFH Data – MDGL has released positive top-line HeFH Phase II data. The trial enrolled 116 patients who were not at their LDL-C goal and were randomized in a 2:1 ratio to receive either MGL-3196 or placebo, in addition to their current cholesterol lowering regimen, which included approximately 75% taking high intensity statins (20/40 mg rosuvastatin or 80 mg atorvastatin), and about 2/3 of patients also taking ezetimibe.

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Sangamo Therapeutics

Sangamo (SGMO) PFE Global Deal for Hemophilia A Has Many Positive Implications

Breaking News – Sangamo Therapeutics (SGMO) – PFE Global Deal for Hemophilia A Has Many Positive Implications – In a very competitive bidding process SGMO has inked a significant global partnership with Pfizer, who brings a wealth of value to SGMO, and notably validates the latter company’s gene therapy platform.

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Madrigal

Madrigal (MDGL) 3196 Delivers Best-in-Class Phase II NASH Data

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.

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Sangamo Therapeutics

Sangamo (SGMO) Powerful Deal With GILD/KITE For ZFNs In Next Generation Off-The-Shelf CAR-Ts

BioInvest News – SGMO – Powerful Deal With GILD/KITE For ZFNs In Next Generation Off-The-Shelf CAR-Ts – Raising BUY to 30 & TARGET PRICE TO 40 – Despite being pre-clinical and early stage, GILD is paying $150 million upfront in cash and up to $3.1 billion in milestones plus tiered royalties on 10 SGMO-derived cancer drug candidates (or $300 million per product). Combining the KITE/GIlD expertise and infrastructure – with SGMO – will create a transformative leader in the field.

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Novavax

Novavax (NVAX) Delivers Some Positive Phase II Immunogenicity Data In COPD

BioInvest News – NVAX – Delivers Some Positive Phase II Immunogenicity Data In COPD…Investors Wanted an RSV Update – NVAX reported top line data from the Phase II older adult safety and immunogenicity trial (E205) demonstrated the benefit of adjuvant formulations and two-dose regimens in patients with RSV and chronic obstructive pulmonary disease (COPD).

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Medicines Company

The Medicines Company (MDCO) Inclisiran FDA Path Clear After End of Phase II Meeting – Lower Risk, Value Enhanced

BIOINVEST BREAKING NEWS – The Medicines Company (MDCO) – Inclisiran FDA Path Clear After End of Phase II Meeting – Lower Risk, Value Enhanced – The Medicines Company announced that the primary endpoint of the Phase III registrational trial will be LDL-C levels. This is a major positive for MDCO – significantly reduces the risk and increases the value of Inclisiran.

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