Nu­mer­ous com­pa­nies have been ax­ing staff late­ly, such as Athenex Wednes­day cut­ting staff and Flex­ion buy­er Paci­ra lay­ing off 110 em­ploy­ees ear­li­er this month. And Thurs­day, the lay­off wave con­tin­ued, with a tiny Fre­mont, CA mi­graine-fo­cused phar­ma find­ing it­self the bud­get axe’s newest vic­tim.

Zosano Phar­ma an­nounced in its Q4 and FY2021 fi­nan­cial re­sults Thurs­day that it would lay off rough­ly a third of its staff. The com­pa­ny didn’t say much at all about the down­siz­ing, re­veal­ing on­ly a “re­duced work­force by ap­prox­i­mate­ly 31%” in a list of re­cent busi­ness up­dates.

Among the oth­er up­dates in­clude rais­ing just over $15 mil­lion in a pub­lic of­fer­ing last month, rene­go­ti­at­ing lease terms with de­vel­op­er Trin­i­ty Cap­i­tal and pub­lish­ing da­ta about im­muno­genic­i­ty us­ing an in­fluen­za vac­cine with its mi­cro nee­dle sys­tem.

Ac­cord­ing to Zosano’s 10-K filed with the SEC, the com­pa­ny was at 40 em­ploy­ees at the end of 2021, and is now cur­rent­ly at 31 em­ploy­ees.

Shares of the pen­ny stock play­er $ZSAN went down 8% this morn­ing when the mar­ket opened but re­bound­ed to about $0.19 per share, or down 3% in ear­ly Fri­day trad­ing. The price is a far cry from when the phar­ma orig­i­nal­ly went pub­lic in 2015 at $11 per share.

The news comes less than a month af­ter the FDA re­fused to re­view the com­pa­ny’s re­sub­mis­sion for its mi­graine treat­ment patch, say­ing the com­pa­ny didn’t ad­e­quate­ly re­spond to the de­fi­cien­cies iden­ti­fied in the ini­tial, 2020 CRL.

End­points News has reached out to Zosano for com­ment and will up­date ac­cord­ing­ly.

“We are in dis­cus­sions with the FDA to de­ter­mine if there is a vi­able op­tion to pur­sue ap­proval of M207 us­ing the cur­rent­ly avail­able clin­i­cal da­ta. In ad­di­tion, we are ac­tive­ly eval­u­at­ing fi­nan­cial and strate­gic al­ter­na­tives in col­lab­o­ra­tion with ex­ter­nal ad­vi­sors, with a goal of max­i­miz­ing val­ue,” Zosano pres­i­dent and CEO Steven Lo said in a pre­pared state­ment.

Those al­ter­na­tives may not be able to stave off con­cerns, how­ev­er. Zosano bled cash in 2021, los­ing $7 mil­lion in Q4 and just shy of $30 mil­lion over the course of the en­tire year. And while the to­tal came in mar­gin­al­ly low­er than the loss of $33.4 mil­lion the year be­fore, the com­pa­ny said in its 10-K that it will need “sub­stan­tial ad­di­tion­al fund­ing to fund our op­er­a­tions, and we will not be able to con­tin­ue as a go­ing con­cern if we are un­able to do so.”

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.