Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

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.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

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.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

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.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Sanofi, GSK, Ha­le­on see stock prices dip and dive amid lit­i­ga­tion for re­called heart­burn drug

Zantac became one of the most well-known drugs on the market after being FDA-approved in 1983 — and now close to four decades later, lawsuits over safety concerns are rattling analysts and investors.

Sanofi, GSK and Haleon, GSK’s former consumer healthcare unit, have lost billions of dollars in market cap since Tuesday’s market close, according to Bloomberg. While Zantac is no longer on the market, the drop came after a suite of analysts, from Morgan Stanley and other firms, sounded the alarm on the potential impact of ongoing personal injury litigation.

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