Arcturus, CSL win approval for world’s first self-amplifying mRNA vaccine in Japan 

Not exactly "small cap" news but I hadn't seen it come up anywhere else ...

Arcturus Therapeutics (NASDAQ:ARCT) and its partner CSL announced Tuesday that Japan's Ministry of Health had approved their ARCT-154 COVID-19 vaccine, marking the world's first regulatory clearance of a self-amplifying mRNA (sa-mRNA) vaccine

Accordingly, in Japan, ARCT-154 will be indicated for initial and booster vaccinations in adults aged 18 years and older

Compared to conventional mRNA technology used by leading COVID-19 vaccine makers such as Pfizer (PFE)/ BioNTech (BNTX), and Moderna (MRNA), self-amplifying mRNA technology is associated with an enhanced immune response at lower vaccine doses

"Self-amplifying mRNA technology has the potential to be an enduring vaccine option," said Nobel laureate Dr. Drew Weissman, "I look forward to seeing this next generation mRNA technology protect many from COVID-19 and possibly other harmful infectious diseases." 

"Today's approval marks a historic and exciting milestone as the first sa-mRNA vaccine in the world to be registered," Jonathan Edelman, Senior Vice President of the Vaccines Innovation Unit at Australian biotech CSL (CSLLLY), said

The decision is based on data from multiple clinical studies for ARCT-154, including a large ongoing trial in Vietnam and a Phase 3 COVID-19 booster trial 

About sa-mRNA

Messenger RNA (mRNA) vaccine technology protects against infectious diseases by instructing cells in the body to make a specific protein, stimulating the immune response, and leaving a blueprint to recognize and fight future infection. However, sa-mRNA makes copies of the mRNA which generates the production of more protein compared to an equivalent amount of mRNA in a vaccine. The technology has the potential to create more potent cellular immune responses and increase duration of protection, while using considerably lower doses of mRNA

DISC: Held in RL

Not much to see here but FWIW Morgan Stanley has just released their first thoughts on CSL's First Capital Markets Day (CMD) today ...

Strategy to manage double-digit earnings growth looks robust; long-term Behring margins "beyond" pre pandemic levels, RIKA (automated plasma technology) could deliver 10% yield improvement:

We gleaned the following for CSL from its CMD presentation: i) It's positioned for double-digit earnings growth and is leading in a market with a large unmet need, yield/capacity is improving and R&D is yielding results; ii) current Ig yield is ~5% ahead of FY19, with ~8-13% likely within 3-5 years and ~16-27% likely by decade-end; iii) CSL expects to outgrow the market - Ig market growth 6-8% pa vs CSL at high-single digits, Hem B market growth 4-6% vs CSL at high-single digits, HAE market growth 4-6% vs CSL at high- single digits; iv) Rika is now in 15 centers with a final roll out timeline to be detailed by end CY23, with individual nomograms to deliver ~10% yield improvement; v) COVID-19 vaccine approvals expected across 2024-26; vi) realization of COGS efficiencies to drive Behring margins to pre-pandemic levels and beyond; vii) CIDP FcRn exposure appears lessened - it now accounts for 19% of IVIg revenue and 8% of SCIg revenue (vs. our estimate of 22-25% of total revenue previously); viii) Patient Blood Management is a key mid-term growth plank for V4; and ix) capex is down 30% from pcp with yield/process improvements delaying the need for expansion

DISC: Held in RL

Just adding to @mikebrisy's Broker Views for CSL

out of 16 analysts that Sentieo has in it's coverage database for CSL:

Strong Sell 0

Sell 0

Hold 3

Buy 10

Strong Buy 3

and out of 15 price targets the average is $315.77

and some of the analysts not in Mike's list from FNArena:

Morgan Stanley: Overweight ($327.00) (17/10/22)

RBC: Outperform ($329 (down from 339)) (17/10/22)

JP Morgan: Overweight ($330) (17/10/22)

There's also a new one from BofA but for some reason it's not loading right now