Stealth Bio may be re­think­ing its low-pro­file ap­proach to an IPO.

The com­pa­ny just launched its ini­tial of­fer­ing, pric­ing 6.5 mil­lion shares for $MI­TO at $12 — the low end of the range — and rais­ing $78 mil­lion for its work on a pipeline of drugs fo­cused on mi­to­chon­dr­i­al dis­eases af­ter ap­ply­ing for an IPO in Hong Kong that nev­er ma­te­ri­al­ized. 

Morn­ing­side vet­er­an Ree­nie Mc­Carthy — a lawyer by train­ing — is in charge of the en­ter­prise while Mark Bam­berg­er, a for­mer car­dio and meta­bol­ic re­search chief at Pfiz­er, is CSO.

Ree­nie Mc­Carthy

The team at Stealth may have re­mained un­der the radar, but they’ve burned through $400 mil­lion work­ing on new ther­a­pies re­lat­ed to mi­to­chon­dr­i­al dys­func­tion. Mi­to­chon­dria are the pow­er­hous­es of the cell, turn­ing fu­el in­to en­er­gy. And when that goes wrong, it can spur a host of dis­eases, run­ning from rare ge­net­ic con­di­tions to broad is­sues re­lat­ed to ag­ing.

Mark Bam­berg­er

The biotech has a Phase III pro­gram all lined up and ready to read out lat­er in the year, look­ing for promis­ing da­ta on elamipre­tide on pri­ma­ry mi­to­chon­dr­i­al my­opa­thy. The biotech has 4 clin­i­cal pro­grams un­der­way, with the ear­li­est tar­get­ing dry, age-re­lat­ed mac­u­lar de­gen­er­a­tion.

Morn­ing­side Ven­tures owned the li­on’s share of the eq­ui­ty go­ing in­to the IPO, with 95.3% of the stock.

Bayer committed $300 million to set up a joint venture on CRISPR/Cas9 tech with CRISPR Therapeutics $CRSP. But they’re handing off control now to the smaller biotech while retaining a couple of opt-ins for programs nearing an IND.

Bayer $BAY made much of the fact that they were going all-in on gene editing when they did their deal 3 years ago with CRISPR Therapeutics, which pitched $35 million in on their end. This was the cornerstone of their plan to set up new JVs that could make some serious leap forwards in hot new R&D spaces. Now CRISPR will have full management control of Casebia as they pursue programs in hemophilia, ophthalmology and autoimmune diseases.
Samarth Kulkarni, the CEO at CRISPR, made it sound like a natural progression.

J&J’s Stelara, which is set to be in the top ten list of blockbusters come 2025, is now cleared by the FDA for use in ulcerative colitis (UC), an inflammatory disease of the large intestine.

The biologic targets interleukin (IL)-12 and IL-23 cytokines, which are known to play a key role in inflammatory and immune responses. Stelara, which generated about $4.7 billion in the first nine months of 2019, is a key player in the crowded marketplace of drugs to treat autoimmune disorders such as psoriasis, rheumatoid arthritis and Crohn’s disease. AbbVie’s star therapy, Humira, continues to dominate, despite its looming patent cliff in the United States, while others including J&J’s $JNJ own anti-IL23 Tremfya, Lilly’s $LLY anti-IL-17 Taltz and AbbVie’s $ABBV recently approved anti-IL-23 antibody Skyrizi carve out a slice of market share.

→ Hours before the first federal opioid trial was set to begin, three drug distributors and an opioid manufacturer agreed to a $260 million agreement settlement, the Wall Street Journal was the first to report. The deal — which will see McKesson, Cardinal Health and AmerisourceBergen pay $215 million to Summit and Cuyahoga counties, and Teva deal out $35 million in cash and addiction treatments — does not resolve the pending, nationwide litigation that may result in a settlement worth upwards of $40 billion. Negotiators in that case, brought by 2,300 tribes, counties and cities nationwide and led by several states’ attorneys general, worked through much of Friday without success. Josh Stein, the attorney general for North Carolina, said they were trying to put together a $48 billion deal.

GlaxoSmithKline is leaving the deep dark woods and its viruses behind.

GSK has agreed to divest its vaccines for rabies, RabAvert, and tick-born encephalitis vaccine, Encepur, to Bavarian Nordic, part of the company’s broader efforts to narrow its pipeline and focus on oncology and immunology.

The deal is worth up to nearly $1.1 billion, with a $336 million upfront payment. GSK acquired the vaccines from Novartis as part of an exchange for their late-stage oncology programs in 2015 under former chief Sir Andrew Witty.

While the FDA recently spurned an application to allow AstraZeneca’s blockbuster drug Farxiga for type 1 diabetes that cannot be controlled by insulin, citing safety concerns — the US regulator has endorsed the use of the SGLT2 treatment to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes and established cardiovascular disease or multiple CV risk factors.