This month's digest recaps the J.P. Morgan Healthcare Conference and previews the upcoming earnings season for Q4 2025.

This month I explore the recent surge in M&A activity, where 2025 ranks from a historical perspective, and evaluate the acquisition potential of the coverage ecosystem.

A look at what to expect when companies report third-quarter 2025 operating results beginning in late October and extending through November.

Despite solid cash flow from Vyjuvek, the gene therapy developer is neglecting R&D investments. The potential consequences are being ignored by investors and Wall Street.

A commercially uncompetitive competitive landscape and at-home dosing bodes very well for Vyjuvek, but its efficacy could stall growth from long-term patients – eventually.

The gene therapy developer received 284 patient start forms by the end of September 2023. Of those, 88% requested at-home dosing.

I have sold my position in Krystal Biotech. Former CCO Andy Orth is quickly vesting awarded options and liquidating his position, although that only represents the latest red flag for the company.

Krystal Biotech disclosed today in a regulatory filing that Andy Orth stepped down as Chief Commercial Officer (CCO). This is terrible news (with even worse optics) at a terrible time.

The company's first drug approval signals its transition to commercial operations. Vyjuvek is now a drug product and not a drug candidate.

The shifting timelines for clinical programs not named Vyjuvek / B-VEC is beginning to hamper the company's long-term ability to create value and live up to its true potential.

The gene therapy developer has an aesthetics subsidiary named Jeune Aesthetics. It recently dosed the first patient in the final cohort of an ongoing phase 1 clinical trial for KB301 in lateral canthal lines, or wrinkles on the upper cheek below the eyes, commonly called Crow's feet.

Quick updates for Coherus BioSciences, Exact Sciences, Krystal Biotech, and Selecta Biosciences.

Our model increases significantly if Vyjuvek earns FDA approval in mid-February 2023 – from the current midpoint of $67.55 per share to a prospective midpoint of $108.07 per share ($124.28 per share excluding dilution).

The soon-to-be commercial-scale gene therapy company has struggled to advance any asset aside from its lead drug candidate Vyjuvek. What's going on?

Krystal Biotech announced on August 18 the FDA accepted its biologics license application (BLA) for Vyjuvek in dystrophic epidermolysis bullosa (DEB). Investors now have three more pieces of information regarding the regulatory pathway.

Krystal Biotech will earn a priority review voucher (PRV) if Vyjuvek earns FDA approval, which seems very likely. The company can use it to accelerate regulatory review for a future asset, or sell it for over $100 million to another company to do the same.