Shares of Krystal Biotech Inc. (KRYS) more than doubled during Monday’s trading session after the biotech company announced positive topline results from their GEM-3 Pivotal Trial of VYJUVEK(TM). This non-invasive, topical, and redosable gene therapy is the first of its kind for the treatment of dystrophic epidermolysis bullosa. According to Founder and CEO Suma Krishnan, dystrophic EB is referred to as “the worst disease you’ve never heard of.” The disease is a genetic structural deficiency in the skin that causes blistering wounds. The stock closed Monday up a whopping 121.35%.
- VYJUVEK(TM) is the first gene therapy that can be reapplied because it does not trigger an immune response.
- Krystal, the leader in redosable gene therapies for rare diseases, plans to file a Biologics License Application (BLA) with the FDA in the first half of 2022. This is the first step in getting VYJUVEK(TM) to patients in need.
- The company’s treatment is the only genetically corrective approach to dystrophic EB to successfully complete a double-blind Phase 3 trial.
KRYS traded between $68-$85 for much of February 2021 through May 2021. Today’s rally, which spiked as high as $103 before closing at $88.35, puts the stock right at the top end of that previous range. It will be interesting to see if there is some consolidation around the $85 area before making an extended move in one direction or the other. I plan to keep Krystal Biotech on my watchlist as any additional news on VYJUVEK(TM) is sure to cause volatility. My mantra is volatility breeds opportunities.
Hit the Road Jack
Twitter (TWTR) co-founder and CEO Jack Dorsey abruptly resigned on Monday, saying that the company was ready to move on from being founder-led. He will remain a member of the board until sometime in 2022. The move comes on the heels of another surprise resignation, with Lincoln Riley leaving Oklahoma to take the USC job, so it has become apparent that both men are scared of the SEC.
- Twitter named CTO Parag Agrawal as the new CEO, while Salesforce COO Bret Taylor will become chairman of the board.
- Dorsey is still CEO of payments technology company Square (SQ) (for the time being anyway).
- Shares were down 2.8% on Monday which has to be good for Jack’s ego, because how embarrassing would it be to announce your resignation and have the stock go up?
The new CEO is a 37-year-old software engineer who will be charged with leading the company into its next phase, which is widely expected to be a push to decentralize social media content to be viewed on a number of platforms. Fantastic, just what the world needs, broader access to the digital feces flinging fracas that is Twitter.
Moderna re: their announcement that they eventually plan to crush it.
Moderna continued its substantial rally on Monday after announcing plans to produce large quantities of vaccines that target the Omicron variant by early 2022. On top of that, the biotech company reported that it’s currently testing whether a higher dose of its extant booster shot is already sufficient to kick Omicron’s a*s. Shares spiked following the news and were up 11.80% when markets closed, extending Moderna’s multi-day gains to over 30%.
- The reason for Moderna’s confident timeline is that its vaccine-like Pfizer-BioNTech’s- is mRNA-based, and mRNA vaccines can be adapted to new virus variants really quickly. We’re talking 100 days kind of quick.
- Moderna needed this. Over the past three months, global recovery from the pandemic and Pfizer’s dominance in the pill-based vaccine market wiped out around 45% of Moderna’s share value, so for them Omicron’s arrival is… uh… good?
In the short term, Moderna’s in a good position to continue this rebound (read: they can pump out hundreds of millions of vaccine doses every month), but only time will tell whether they or Pfizer-BioNTech have a better vaccine for Omicron. In the long term, Moderna’s oddly situated to be a victim of their own success: if they manufacture a vaccine that successfully targets Omicron, they’ll make themselves obsolete and cause share value to eventually decline. Miss Cleo would probably say long-term growth is probably not in the cards for them.