News of Note - March 1, 2023
BULL BEAR BRES|NAHAN
Wednesday, March 1, 2023
As of ➡ 09:21 EET
My typical tack has been to build out from a core large biopharma position with other bits directly complementary - a more intertwined core + satellite setup..
Spots of potential interest to the main positions, where success would draw them in, or where success might be an outright hedge to their business even if they never get involved!
yada yada yada
Now, that gets more complicated when in the core you've gone from Pfizer and Roche to Pfizer, Roche, Sanofi, and Novartis (which have some interplay amongst themselves as well)..
This has led to a dramatically culled biotech position in count (not size) as I better align my convictions and well coverage gaps.. Not sure the casting of a wider net would be productive or maybe that sentiment just comes from positions being pretty beaten up in short order.. X)
Individual readouts are being compensated once again and the FDA has been less of a hurdle.. 🤔
Maybe we are at that point where hands get thrown up in the air and an avalanche of deals come or things at least start to skew positive..
Apologies, lots of thinking out loud above!!
On everything else I remain NEUTRAL and see no reason to deviate beyond strategic allocations amongst asset classes and within, i.e., I wouldn't be taking any tactical bets.
Announces Completion of Phase I Subject Recruitment in Early Clinical Development Program for a First-of-its-Kind Macrocyclic Manganese-Based MRI Contrast Agent
Novel manganese-based macrocyclic Magnetic Resonance Imaging (MRI) agent could offer an alternative to gadolinium-based agents
Manganese is a trace element naturally occurring in, and efficiently eliminated from, the human body
The clinical trial program demonstrates GE HealthCare’s commitment to innovation in contrast media and to building a portfolio of MRI imaging agents to address radiologists’ needs for their patients
This is a big one and as has been mentioned in the press (and by myself before that) you could really read this two ways; this asset is seen as a tough commercial prospect – basically being forced to stop throwing more money at it and focus on aficamten, is generally seen as great..
Consider that Myokardia was bought for a hefty sum and their lead asset came from Cytokinetics with aficamten perhaps being a better molecule than mavacamten!!
Or so the bull spin goes.. X)
Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil
Receives Positive FDA Advisory Committee Votes Supporting Potential Approval for Vaccine Candidate to Help Combat RSV in Older Adults
FDA decision expected by PDUFA goal date in May 2023
The positive votes are based on compelling scientific evidence presented by the company, including Phase 3 efficacy and safety data
If authorized, vaccine candidate would help address the substantial burden of RSV in adults 60 years of age and older
EQNR NO | EQNR
Equinor strengthens its position in the northern North Sea
Equinor has signed an agreement to acquire equity interest in five discoveries in the Troll, Fram and Kvitebjørn area in the North Sea on the Norwegian continental shelf (NCS) from Wellesley Petroleum AS. Since 2019, Equinor has made seven discoveries in this area.
The transaction adds to Equinor’s equity share in the following discoveries: An additional 18.8% in Grosbeak, 45% in Toppand, 40% in Atlantis and 20% in Røver Nord and Røver Sør.
Reports Fourth Quarter and Full-Year 2022 Financial Results
Avidity Biosciences [bio]
Reports Fourth Quarter and Year-End 2022 Financial Results and Recent Highlights
Arcus Biosciences [bio]
Reports Fourth-Quarter and Full-Year 2022 Financial Results and Provides a Pipeline Update
Allogene Therapeutics [bio]
Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
Fate Therapeutics [bio]
Reports Fourth Quarter and Full Year 2022 Financial Results and Business Updates
Iovance Biotherapeutics [bio]
Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Updates
Mirati Therapeutics [bio]
Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Updates
Reports Strong Fourth Quarter and Full-Year 2022 Financial Results
Prometheus Biosciences [bio]
Reports Fourth Quarter and Full-Year 2022 Financial Results and Highlights Recent Corporate Progress
Molson Coors Beverage Company
Creates Commercial Business Function in the Americas
Michelle St. Jacques tapped to lead new function as company aims to accelerate growth through greater focus, prioritization
To close down its factory in Ehingen, Germany
Kiniksa Pharmaceuticals [bio]
Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Portfolio Execution
Edgewise Therapeutics [bio]
This some how stood out to me, need to dig in deeper, probably just the cardio angle.. Can you say RARE!!
Announces Upcoming Presentation at the American College of Cardiology's 72nd Annual Scientific Session Together with World Congress of Cardiology
To Present at ESMO Targeted Anticancer Therapies Congress
ADC Therapeutics [bio]
Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates
Bristol Myers Squibb
U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application and European Medicines Agency Validates Application for Opdivo (nivolumab) ….
The applications are based on results from the Phase 3 CheckMate -76K trial, in which Opdivo demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival
The U.S. Food and Drug Administration has assigned a target action date of October 13, 2023
U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application and European Medicines Agency Validates Application for Opdivo (nivolumab) as an Adjuvant Treatment for Patients with Completely Resected Stage IIB or IIC Melanoma
Provides Update on Phase 3 Trials KEYNOTE-641 and KEYNOTE-789
SpringWorks Therapeutics [bio]
Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Business Highlights
HMOs get Novel Food approval in EU
Final EU authorization of LNT, 3-FL and 3’-SL for safe use in infant formula at the highest dosage levels
Why Pfizer (and others) will be interested in Seagen
Go or no go? Vaccines and neurology up for discussion
New head of FDA’s neuroscience office takes over at crucial time
Pfizer was warned of Lyme study problems months ago, trial research startup's CEO tells employees
The link to ‘Care Access’ was broken by yours truly on Twitter; tooting my own horn aside, there have to be rather large ripples here and I suspect we see fallout – if anything you need to be very careful with any entities leaning on these folks..
In an environment where a quarter of the populace seems to have lost their minds any fuel for that fire does not help.. Perception is an issue and so is time, instead of quicker paths to market some therapies may now be delayed..
Celldex fleshes out case for Xolair challenger in chronic hives