Pricing won’t be known until later for Pfizer Inc.’s Zavzpret (zavegepant), which became the first and only calcitonin gene-related peptide receptor antagonist nasal spray approved by the U.S. FDA for acute treatment of migraine with or without aura in adults. The product is slated to launch this summer. Meanwhile, Wall Street has questions about New York-based Pfizer’s performance in the migraine space.
Bionomics Ltd. is gearing up for an end-of-phase-II meeting with the U.S. FDA later this year to discuss the full results from the phase II study called Prevail in social anxiety disorder (SAD) with BNC-210, which missed its primary endpoint but yielded encouraging signs. Top-line data were disclosed last December. An oral alpha-7 nicotinic acetylcholine receptor negative allosteric modulator, BNC-210 fell short in change from baseline to the average of the Subjective Unites of Distress Scale (SUDS) during a five-minute public speaking challenge.
Another step forward in the quest for an Epstein-Barr virus (EBV) vaccine took the form of Merck & Co. Inc.’s deal with Modex Therapeutics Inc., owned by Opko Health Inc., to advance MDX-2201 worldwide, an arrangement that brings $50 million up front for Opko plus as much as $872.5 million in milestone payments along with royalties.
Findings published in Nature showing that dual blockage of PD-L1 and CD47 can boost the therapeutic effects of oxaliplatin chemotherapy as well as the FOLFOX regimen – in a CT-26 mice tumor model, anyway – served to highlight CD47, a target that has spurred added efforts of late.
Esperion Therapeutics Inc.’s full results from the phase III outcomes trial called Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen, known by the rough acronym CLEAR, inspired excitement in the mainstream media worldwide but not on Wall Street, as numbers from the experiment fell short of what some wanted. Though the findings proved unmistakably positive, shares of Ann Arbor, Mich.-based Esperion (NASDAQ:ESPR) dropped almost 20% or $1.27 to close March 6 at $5.08.
Praxis Precision Medicines Inc. CEO Marcio Souza said it would be “disingenuous not to move forward” – U.S. FDA willing – into a phase III effort with an alternate design targeted for the second half of this year, given top-line results from the phase IIb Essential-1 study with ulixacaltamide (PRAX-944) for essential tremor.
Inovio Pharmaceuticals Inc. has “more work to do” in understanding mixed results with the DNA-based immunotherapy VGX-3100 as a treatment for cervical high-grade squamous intraepithelial lesions associated with human papillomavirus (HPV)-16 or HPV-18, said Michael Sumner, chief medical officer for the company. “We only got the data in our hands about a week ago.”
If clinical efforts pan out, gamma delta T-cell specialist TC Biopharm plc could plant the space’s first U.S. regulatory flag. Founded 10 years ago, the Glasgow, U.K.-based firm is marching ahead with phase IIb work testing main asset Omnimmune, an allogeneic unmodified cell therapy, in acute myeloid leukemia (AML).
Biocryst Pharmaceuticals Inc.’s unveiling of real-world data Feb. 24 with its approved Orladeyo (berotralstat) for prophylactic treatment of hereditary angioedema (HAE) brought more attention to the space, due to yield findings from would-be competitors in the near term.
Aiming to start afresh under a new name, troubled Mei Pharma Inc. wants to merge with Infinity Pharmaceuticals Inc. in an all-stock transaction that would provide the combined outfit enough cash to fund operations through mid-2025. Specifically, coffers of the newly made firm would contain about $100 million for the advancement of three oncology candidates in a pipeline led by Infinity’s phase II-stage eganelisib for head and neck squamous cell carcinoma.
