Biotech Stock Mailbag: YM Bio, Infinity, Delcath and Galena

Investors will get the first detailed look at Infinity Pharmaceuticals' (INFI) PI13K inhibitor IPI-145 from a phase I study enrolling patients with various blood cancers, including CLL and MCL. A first peek at IPI-145 data from the abstract released in November caused Infinity's stock price to rise from $18 to $26 per share.

Ibrutinib and IPI-145 are considered competing drugs because they're being developed in many of the same blood-cancer indications. Their respective cancer-killing mechanisms -- BTK and PI13K inhibition -- are also closely related.

Investors are keen to compare ibrutinib and IPI-145 because the former has been the spark for an astonishing increase in Pharmacyclics' market value, which now stands at $3.7 billion. (And that's with Pharmacyclics sharing economic rights to ibrutinib with J&J.)

Infinity's market cap today is just under $1 billion, and the company owns 100% rights to IPI-145 (although there is some controversy over whether Takeda has opt-in rights.) IPI-145 is still in early-stage clinical trials but if the data at ASH live up to the hype, investors may see Infinity as the next big blood cancer drug stock, similar to what's happened already to Pharmacyclics.

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Tom P. writes, "Recent communications between the FDA and Delcath Systems (DCTH) have persuaded me that the FDA is likely to approve ChemoSat in June. The stock plunged when Delcath did not get priority review, but Delcath said in a largely ignored press release that the FDA had told them that in the long run, the standard review period would be better for them. ... Today, the FDA told Delcath that it would be best for them if they limited their New Drug Application to liver cancer stemming from ocular melanoma, as there is no other effective treatment available and it constitutes an unmet need. Unmet need equals 100% advisory panel vote which equals FDA approval."

Tom, I appreciate you trying to make lemonade from a lemon (Delcath), but your drink is still too sour.

I agree ChemoSat does stand a decent chance of receiving FDA approval next June, although it's not 100% guaranteed.

The more important issue you overlook is that the ChemoSat label, if granted, will be marginalized into near irrelevance from a commercial perspective. On Wednesday, Delcath disclosed an amendment to the ChemoSat NDA narrowing the proposed indication to treatment of patients with liver metastases stemming from ocular melanoma only. Dropped from consideration were patients with liver metastases from cutaneous melanoma.

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