Spero Ther­a­peu­tics has been strug­gling in the past few years, deal­ing with FDA holds and staff re­duc­tions amidst a rough biotech mar­ket, and the lat­est news from the Mass­a­chu­setts-based com­pa­ny con­firms what it an­tic­i­pat­ed in May: a CRL.

The com­pa­ny was slapped with the no-go for its NDA, the biotech dis­closed Mon­day. The com­pa­ny was seek­ing ap­proval for tebipen­em HBr oral tablets, in­tend­ed for the treat­ment of adult pa­tients with com­pli­cat­ed uri­nary tract in­fec­tion, or cU­TI, in­clud­ing pyelonephri­tis. The FDA had set a PDU­FA date of June 27.

Ac­cord­ing to Spero, the FDA had com­plet­ed its re­view of the NDA and de­ter­mined the ap­pli­ca­tion could not be ap­proved in its present form, an ac­tion that Spero ex­pect­ed. In May, the CRL was an­tic­i­pat­ed by the com­pa­ny based on feed­back re­ceived at the late-cy­cle meet­ing, in which the agency out­lined po­ten­tial de­fi­cien­cies in the ap­pli­ca­tion. In the CRL, the FDA ul­ti­mate­ly con­clud­ed that Spero’s Phase III study of tebipen­em HBr was in­suf­fi­cient to sup­port ap­proval and that ad­di­tion­al clin­i­cal study would be re­quired.

As a re­sult, Spero un­der­went “im­me­di­ate ces­sa­tion” of com­mer­cial­iza­tion work on the drug. The biotech al­so let its CMO and COO go in a sweep­ing lay­off that saw Spero cut 75% of its work­force, which com­prised 146 peo­ple at the end of 2021.

“We are dis­ap­point­ed with the FDA’s de­ci­sion, but we look for­ward to our con­tin­ued di­a­logue, ad­dress­ing the agency’s con­cerns and out­lin­ing a clear path for­ward for tebipen­em HBr,” said Ankit Ma­hade­via, Spero’s CEO.

This drug is im­por­tant for Spero: In 2021, it en­tered in­to a rev­enue in­ter­est fi­nanc­ing agree­ment with in­vest­ment firm Health­Care Roy­al­ty Part­ners for up to $125 mil­lion for the can­di­date. As part of the agree­ment, Spero re­ceived $50 mil­lion from Health­Care Roy­al­ty Part­ners, and if grant­ed FDA ap­proval, Spero would re­ceive an ad­di­tion­al $50 mil­lion, plus an ad­di­tion­al $25 mil­lion up­on an undis­closed com­mer­cial mile­stone.

But this is not the first time the com­pa­ny has had to halt its work due to FDA in­ter­ven­tion. In 2021, a clin­i­cal hold was placed on its Phase IIa tri­al for an oral ther­a­py can­di­date for the treat­ment of a rare, or­phan pul­monary dis­ease caused by non-tu­ber­cu­lous my­cobac­te­r­i­al in­fec­tions.

That hold came af­ter it no­ti­fied reg­u­la­tors of its de­ci­sion to pause dos­ing in the study af­ter sci­en­tists had un­cov­ered “mor­tal­i­ties with in­con­clu­sive causal­i­ty” in a tox­i­col­o­gy study in­volv­ing non-hu­man pri­mates, and the Safe­ty Re­view Board rec­om­mend­ed that they hit the brakes. The hold was even­tu­al­ly lift­ed in Jan­u­ary.

All this ac­tiv­i­ty has dropped the com­pa­ny’s stock $SPRO im­mense­ly. The com­pa­ny en­tered pen­ny stock sta­tus ear­li­er this month, with its price drop­ping 93% since last De­cem­ber.

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.