Biotech

Moderna and Merck's melanoma vaccine cut the risk of relapse by 42%

Phase 3 results for intismeran autogene with Keytruda were presented at ESMO and published in the NEJM.

Amber Watchlist: Binary-Event Playbook

Three events that could move a covered stock by half in a day, and what each outcome would do to our value per share.

Vertex: life after cystic fibrosis

Cystic fibrosis still brings in 96% of sales. A pain pill, a gene therapy, a kidney drug decision on November 30 and a $10 billion acquisition are meant to change that. An Amber first look.

Eli Lilly: how much of the obesity boom is left?

Revenue is up 48% and guidance has been raised twice this year, but prices are falling as fast as volumes are climbing. An Amber first look at what has to keep going right.

What a "PDUFA date" actually means

The date that moves biotech stocks more than any other, explained in plain English: where it comes from, what can happen on it, and why it moves.

Capricor and Praxis: what a three-month delay actually means

Two biotech decisions slipped by three months this year. Neither was a rejection. How FDA review extensions work, and what each company said about why.

Vertex's November 30 decision on povetacicept

Vertex is asking for accelerated approval in IgA nephropathy on the strength of a 52% drop in urine protein. What the data shows and what the FDA still needs to see.

Summit's November 14 decision: what the FDA is weighing

Ivonescimab cut the risk of lung cancer progression roughly in half, but the survival result missed statistical significance. Why that tension sits at the center of the review.

Watchlist: Biotech Dates to Know

Ten FDA decisions and readouts between now and early January, from Agios on November 1st to ImmunityBio on January 6th.

SELLAS: what happens when the REGAL trial finally reads out

The Phase 3 leukemia trial is still waiting on its 80th event. Here is the sequence from here, and what each outcome would mean for the stock.

ImmunityBio (IBRX): Haverhill Research Report

ANKTIVA is a real and growing product, but the stock already pays for it becoming a multi-billion-dollar franchise. Rated Hold, Haverhill price target $9.

SELLAS Life Sciences (SLS): Haverhill Research Report

A $2.5 billion bet on one leukemia trial, and the price already assumes it wins. Rated Sell, Haverhill price target $7.