Amira Barkal’s grandmother’s long fight against chronic leukemia was the germ of the idea that’s become Pheast Therapeutics Inc., which just closed a series A financing. Her treatment in a clinical trial that gave the world Gleevec (imatinib, Novartis AG) changed both of their lives.
Protagonist Therapeutics Inc. continues having a tough time. The latest is a steep stock drop after a phase II trial in ulcerative colitis (UC) missed its primary endpoint, but the company insists the data are good enough to move into phase III. Top-line data showed a 450-mg BID dose of PN-943 in treating moderate to severe UC missed its primary endpoint, which was the number of participants achieving clinical remission at week 12 compared to placebo.
Privately held Orasis Pharmaceuticals Ltd. is a step closer to challenging Abbvie Inc.’s Vuity (pilocarpine hydrochloride) ophthalmic solution for treating presbyopia, a version of farsightedness. Orasis plans to submit an NDA to the U.S. FDA in the second half of the year based on phase III results from two studies showing CSF-1 hit its primary and secondary endpoints.
Abbvie Inc. is stepping away from a 2016 deal with Bioarctic AB to develop alpha-synuclein antibodies for treating Parkinson’s disease, originally valued at up to $775 million. Bioarctic said it plans to stay the course without its big-pocketed partner. Bioarctic’s stock (Stockholm:BIOA-B) fell 14.6% to SEK90 (US$9.40) on April 20.
Regeneron Pharmaceuticals Inc. proposes to buy Checkmate Pharmaceuticals Inc. though an all-cash price of $10.50 per share for about $250 million. That’s pretty much on target with Checkmate’s April 19 closing share price (NASDAQ:CMPI) of $10.35, as the stock gained a staggering 326% on the day.
A week before the U.S. FDA’s Oncologic Drugs Advisory Committee was to meet and review TG Therapeutics Inc.’s BLA and sNDA for the combo of ublituximab and Ukoniq (umbralisib) for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, the company voluntarily withdrew the submission and now is rethinking its oncology programs. The move was tied to an FDA-requested analysis of phase III data showing that, while study met its primary endpoint, there was an imbalance in updated overall survival (OS) results favoring the control arm. A June 25 PDUFA date had been set for the combination treatment.
It’s been one thing after another for rusfertide from Protagonist Therapeutics Inc. for the past year. Now the U.S. FDA has told the company it wants to rescind the breakthrough designation, a relatively rare occurrence, based on observed malignancies in a follow-up to September’s clinical hold.
Drug delivery opportunities are at the heart of Halozyme Therapeutics Inc.’s nearly $1 billion acquisition of Antares Pharma Inc. The deal brings Halozyme an autoinjector platform to complement its Enhanze drug delivery technology, which is designed to reduce hours-long treatments to minutes.
Actinium Pharmaceuticals Inc. is receiving an up-front $35 million with a possible $417 million in regulatory and commercial milestones in its new license and supply agreement with Immedica Pharma AB, of Stockholm. Immedica is getting the exclusive European, Middle Eastern and North African rights to Iomab-B, an antibody radiation conjugate comprising apamistamab, a CD45-targeting antibody, and the radioisotope iodine-131. Actinium is eligible for royalties in the mid-20% range on net sales.
The quixotic course of the cancer therapy Ontak continues with new top-line data from Citius Pharmaceuticals Inc. The company’s phase III study of I/Ontak (E-7777), a reformulation of previously FDA-approved oncology treatment Ontak (denileukin diftitox), was consistent with the prior formulation. No new safety signals were identified in treating persistent or recurrent cutaneous T-cell lymphoma.
