Wall Street didn’t much like Uniqure NV’s decision to hold off reporting efficacy measures in the phase I/II trial with one-time gene therapy AMT-130 for the treatment of Huntington’s disease (HD), but safety findings proved encouraging and analysts held out hope.
Mythic Therapeutics Inc. officially launched with an oversubscribed series B round that garnered $103 million to design smarter, safer antibody-drug conjugates (ADCs) by way of a technology originated by the company and dubbed Fatecontrol. Co-founder and CEO Alex Nichols said that, after about 40 years’ worth of development – and despite fairly recent wins – ADCs have been hampered by “toxicity and poor therapeutic index [that] have stopped them from reaching what we would consider to be their full potential.”
Angion Biomedica Corp. CEO Jay Venkatesan said his firm is ransacking phase II data for “a clear and consistent trend” toward benefit with ANG-3777 before going to the next stage of development with the hepatocyte growth factor mimetic for patients undergoing cardiac surgery involving cardiopulmonary bypass who are at risk for developing acute kidney injury. A decision is due early next year.
In 2021, no drug approval garnered as much attention and debate as Biogen Inc.’s Aduhelm (aducanumab). The FDA’s surprise, accelerated approval of Aduhelm for Alzheimer’s disease flew in the face of the recommendation by an advisory committee, causing a stir that included the resignation of three adcom members, along with publicly made claims that the company’s relationship with regulators had become too cozy.
Daré Bioscience Inc.’s investors will have to wait a while for details regarding a commercialization partnership centered on Xaciato (2% clindamycin phosphate gel, formerly known as DARE-BV1) as a single-dose treatment of bacterial vaginosis (BV) in females 12 years of age and older. Approved Dec. 7, Xaciato is expected to launch next year.
Odyssey Therapeutics Inc. launched with a whopping $218 million series A round, the year’s second-largest, to fuel work by almost 100 employees recruited in the past few months, mostly from big pharma firms.
CEO Michael Raab said that would-be partners for Ardelyx Inc.’s Ibsrela (tenapanor), cleared in September 2019 to treat irritable bowel syndrome with constipation, “don't understand and don't approach the market in the manner that we will,” which is why the company has chosen to launch the sodium/hydrogen exchanger 3 inhibitor on its own in 2022.
Pricing of VBI Vaccines Inc.’s just-approved hepatitis B virus (HBV) vaccine, Prehevbrio, won’t be known before launch in the first quarter of next year, but CEO Jeff Baxter said the company will take into account that the sector is “one of the most price-intensive and price-competitive. A lot of the market-access research says that the wholesale acquisition cost is one of the key determinants” in avoiding sluggish adoption, he said, so that by staying moderate the firm can “supply [its] product on a much quicker basis than you might do, say, if you went with a 30% or 40% premium to standard of care.”
Ursula Matulonis, a co-principal investigator in the latest study with Immunogen Inc.’s antibody-drug conjugate mirvetuximab soravtansine in stubborn ovarian cancer, said the top-line data are “truly spectacular” and bring “the potential to be transformative for patients.”
What one analyst called “the single most important” nucleoside reverse transcriptase inhibitor in development – Merck & Co. Inc.’s islatravir – has met rocky terrain, with the firm and its partner, Gilead Sciences Inc., pausing combo trials.
