Get all your news in one place.
100's of premium titles.
One app.
Start reading
Benzinga
Benzinga
Technology
Ragothaman Srinivasan

Spero Therapeutics' Shares Plunge As FDA Issued Refusal Letter For Urinary Tract Infection Candidate

FDA Spero rapeutics

The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to Spero Therapeutics ‘ (NASDAQ:SPRO) New Drug Application (NDA) seeking approval for tebipenem HBr oral tablets for the treatment of adult patients with complicated urinary tract infection (cUTI), including pyelonephritis.

The New Drug Application (NDA) was supported by the clinical data readout from the Phase 3 study investigating tebipenem HBr.

Sign up to read this article
Read news from 100's of titles, curated specifically for you.
Already a member? Sign in here
Related Stories
Top stories on inkl right now
One subscription that gives you access to news from hundreds of sites
Already a member? Sign in here
Our Picks
US Schools Record Nearly 12,000 Book Bans, the Highest Ever in a Single Year, as 'Jane Eyre' and 'Lessons in Chemistry' Join the List
PEN America reports nearly 12,000 book-ban instances in US schools, a record total, as Texas overtakes Florida and AI tools enter the removal process.
International Business Times UK
International Business Times UK
Alice Zaslavsky’s shortcut beetroot baked risotto – recipe
An unconventional technique makes this vibrant rice – finished with dill fronds – a lower-touch dinner for weeknights
The Guardian - AU
The Guardian - AU
Does your sleep tracker get it right? A Pittsburgh neuroscientist weighs in
On a typical night, I go to bed wearing a tracking watch on one wrist and another type of tracker on the other wrist. Then I compare their sleep findings while I drink my morning coffee.
The Conversation
The Conversation
There's A Reason Taxi Cabs Are Almost Always Yellow
Yellow taxis are easy to spot in traffic, but the color's history goes far beyond simple visibility.
Motor1
Motor1
How ‘technoference’ can disrupt parent-child connections
Have you ever been telling someone a story when their phone lights up, and their eyes flicker toward their device?
The Conversation
The Conversation
Holding Lightning by Emily Lordi review – an intimate portrait of Whitney Houston
An empathetic biography of the the singer recasts her tumultuous later career as a triumph of self-expression
The Guardian - UK
The Guardian - UK
Fourteen days free
Download the app
One app. One membership.
100+ trusted global sources.
Download on the AppStore Get it on Google Play