Zosano Pharma has been unable to sufficiently reply excellent questions that led the FDA to show down the regulatory submission for its migraine remedy, so now, working low on money, the drug supply biotech is popping to cost-saving measures which have already shaved headcount by almost one third.
Fremont, California-based Zosano disclosed the company restructuring in its report of fourth quarter and full-year 2021 monetary outcomes, which posted after the market shut Thursday.
The lead product candidate of Zosano, M207, is a proprietary formulation of the migraine drug zolmitriptan that’s delivered through microneedles on a pores and skin patch. Zolmitriptan is an previous, generic drug out there in oral and nasal spray kinds. With its pores and skin patch system, Zosano goals to supply speedy absorption that permits the drug to work extra shortly and last more.
In 2020, the FDA turned down the Fremont, California-based biotech’s utility in search of approval of M207, citing inconsistent drug publicity ranges throughout medical research. The FDA additionally requested for extra product high quality validation knowledge. Zosano resubmitted its utility in January of this 12 months. A month later, the FDA despatched a letter informing the corporate that its responses had been insufficient. In line with the annual report, the regulator added that it couldn’t start to evaluation the M207 utility till Zosano’s responses to the excellent questions are full.
“There is no such thing as a assure that we will adequately handle the problems raised to the FDA’s satisfaction,” Zosano stated within the annual report. “If we don’t efficiently develop, obtain approval for, and commercialize our product candidates, our enterprise might be adversely affected.”
Zosano is already adversely affected. An expense discount begun this March has minimize about 31% of its employees. As of the submitting of the annual report Thursday, the corporate stated it employed 31 folks, 21 of which work in preclinical analysis and growth. The report additionally states that the corporate has employed SierraConstellation companions to discover choices that would embrace a sale of belongings or a three way partnership or partnership. As of the tip of 2021, Zosano reported a money place of about $11 million. The corporate raised $15.4 million in a February securities providing, however money woes stay. Within the annual report, Zosano stated the corporate doesn’t come up with the money for to final one 12 months.
“We’re in discussions with the FDA to find out if there’s a viable choice to pursue approval of M207 utilizing the presently out there medical knowledge.” Steven Lo, Zosano president and CEO stated in a ready assertion. “ As well as, we’re actively evaluating monetary and strategic alternate options in collaboration with exterior advisors, with a aim of maximizing worth. We consider our proprietary transdermal microneedle patch expertise provides potential therapeutic and sensible advantages to sufferers.”
Zosano just isn’t the one biotech that disclosed belt-tightening measures this week. Right here’s a take a look at a few of the others:
—Athenex introduced plans for a “important value discount plan” aiming to slash bills by greater than 50%. The associated fee-cutting plan comes just a little a couple of 12 months after the FDA rejected the corporate’s oral model of chemotherapy, asking the corporate to conduct one other Part 3 research. Buffalo, New York-based Athenex reported having $35.2 million in money and money equivalents as of the tip of 2021.
—Gene remedy developer Passage Bio introduced plans to minimize its employees by 13% in an effort to scale back bills and prolong its money runway into the second quarter of 2024. The Philadelphia-based firm stated it can deal with packages being developed beneath a partnership with the College of Pennsylvania’s Gene Remedy Program, in addition to its three lead clinical-stage packages for uncommon neurological problems. Passage Bio reported a money place of $128.9 million on the finish of final 12 months.
—Epilepsy and seizure medicines developer Ovid Therapeutics is trimming its workforce by about 20%. The New York-based biotech stated it expects the cuts will prolong the corporate’s money past 2024. Ovid’s former lead program, a potential remedy for Angelman syndrome, failed a key research in 2020. However the biotech landed $196 million final 12 months by promoting to Takeda Pharmaceutical rights to a partnered epilepsy program. Ovid put a few of that money to work in January, buying from AstraZeneca rights to preclinical small molecules in growth for treatment-resistant types of epilepsy. The corporate’s reported having $187.8 million in money on the finish of 2021.
Photograph by Flickr person Funding Zen through a Inventive Commons license
0 Comments