Spero Therapeutics Inc (SPRO)

Spero Shares Jump After FDA Clears First Oral Carbapenem Antibiotic for U.S. Market (SPRO)June 18, 2026 9:52 AM
IH Market News Spero Therapeutics (NASDAQ:SPRO) shares climbed 16% on Thursday after the U.S. Food and Drug Administration approved Utebzi, a novel oral carbapenem antibiotic developed through a collaboration between GSK (NYSE:GSK) and Spero, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in adults with limited or no suitable oral treatment alternatives. Landmark Approval Opens New Treatment Option Utebzi becomes the first oral carbapenem antibiotic to receive approval in the United States, marking a significant development in the treatment of serious urinary tract infections caused by drug-resistant bacteria. The product was developed under GSK’s exclusive global licensing agreement with Spero Therapeutics, excluding certain Asian markets. Addressing a Growing Medical Need Complicated urinary tract infections affect more than three million people annually in the United States, with treatment failures reported in up to one-third of cases. Many of these infections are linked to multidrug-resistant pathogens, creating a substantial burden on healthcare systems and generating more than $6 billion in annual medical costs. Until now, carbapenem antibiotics—often considered a key treatment option for severe resistant infections—have generally required intravenous administration, limiting their use outside hospital settings. Phase III Trial Supports Approval The FDA’s decision was supported by findings from the Phase III PIVOT-PO study, which evaluated tebipenem pivoxil against intravenous imipenem-cilastatin in hospitalized patients suffering from cUTIs, including kidney infections. Results showed tebipenem pivoxil achieved an overall success rate of 58.5% (261 of 446 patients), compared with 60.2% (291 of 483 patients) for imipenem-cilastatin. The adjusted treatment difference was -1.3% (95% CI: -7.5%, 4.8%), demonstrating non-inferiority to the intravenous standard of care. Safety Profile Remains Consistent The treatment’s safety profile was broadly comparable to that observed with imipenem-cilastatin and other carbapenem antibiotics. The most commonly reported side effects were diarrhoea and headache, with reported adverse events generally classified as mild to moderate and non-serious. Commercial Launch Expected by Year-End Utebzi is expected to become available to patients in the United States before the end of 2026. Development of tebipenem pivoxil received support from the U.S. Department of Health and Human Services through funding provided by the Biomedical Advanced Research and Development Authority (BARDA), helping advance the programme through late-stage clinical development. Spero Therapeutics stock priceThe post Spero Shares Jump After FDA Clears First Oral Carbapenem Antibiotic for U.S. Market (SPRO) appeared first on US Editors. Original: Spero Shares Jump After FDA Clears First Oral Carbapenem Antibiotic for U.S. Market (SPRO)

This board needs to wake up. 4 weeks to approval and possible buyout

SPRO.....Taking my 20% profit and moving on.

SPRO..................................................https://stockcharts.com/h-sc/ui?s=SPRO&p=W&b=5&g=0&id=p86431144783

SPRO.....picked up 2.16's last week.....

SPRO................................https://stockcharts.com/h-sc/ui?s=SPRO&p=W&b=5&g=0&id=p86431144783

SPRO........................................p/m

$SPRO: Firing off biggggggggg..... now $2.30

Nice of those to get in at $0.70 yesterday.


CONGRATS on that


GO $SPRO

SPRO news https://finance.yahoo.com/news/spero-therapeutics-gsk-announce-pivot-110000843.html

SPRO under $2

SPRO under $2

SPRO under $2

SPRO under $2

SPRO...................................https://stockcharts.com/h-sc/ui?s=SPRO&p=W&b=5&g=0&id=p86431144783

SPRO 10Q due March 13

SPRO under $2

SPRO new 52 week low

SPRO new 52 week low

SPRO new 52 week low

SPRO under $2

News?

$SPRO YuuuuGE FDA News

Spero Therapeutics shares were up 14% at $1.62 after the company received written agreement from the U.S. Food and
Drug Administration, under a Special Protocol Assessment, on the design and size of its pivotal Phase 3 clinical trial
of tebipenem HBr in patients with complicated urinary tract infection, including acute pyelonephritis.

Urinary tract infection drug,$66m reviewed up to 525m coming,royalties on sales is astronomical

Pfizer paid $5m of $40 and $80m total coming for license agreement,many more deals coming ,some phase 3 trials near done OMG THE BIG DEALS COMING

Look at the candle on this chart 6 month record high,now look back to see what happens with big vol

Look at the candle on this chart 6 month record high,now look back to see what happens with big vol

Relative vol up 28Xs ,buy vol up 1000s% I AM FOLLOWING THE $ ppl with big $ know something huge coming

Relative vol up 28Xs ,buy vol up 1000s% I AM FOLLOWING THE $ ppl with big $ know something huge coming

ive had some strange experiences with stocks but this one has me baffled but not beaten..

someone just unloaded a boat load and or shorted same. halfway around the cape and battered by high winds but not going anywhere. i cant

they will short this back down to .80 at this rate . eff me

folks keep walking away.. day after day after day.. ill be here im lashed to the mast of this bark as we get blistered around the cape

damn heavy unloading

big volume crashing again.. and i thought i was smart.. hahahahahastill bullish

must be some kind of inside news. this keeps falling and i dont get it.. but too late now .. this is the hill i die on or

a little retail short covering for the green. ill take it

another day of heavy downside volume in the cards..not good

shorts in control

GSK believed in SPRO enough to pay over 60 million at once, when investors get the same belief level it would in theory skyrocket, risk/reward and forward expectations are supposed to partially drive share price along with cash available to reduce risk of dilution, cash which GSK provided.

GSK believed in SPRO enough to pay over 60 million at once, when investors get the same belief level it would in theory skyrocket, risk/reward and forward expectations are supposed to partially drive share price along with cash available to reduce risk of dilution, cash which GSK provided.

a little run into earnings. ill hold through it and beyond

https://finance.yahoo.com/news/spero-therapeutics-announces-closing-exclusive-130500913.html

maybe we get some interest from this
https://finance.yahoo.com/news/spero-therapeutics-inc-spro-expected-140102871.html

ill be here when the mkt cap is over a billion

https://finance.yahoo.com/news/spero-therapeutics-present-data-idweek-120500461.html

almost no pre opening trading...the waters have stilled.. it wont stay calm for long ..lets see which way it breaks

bought more i wont be bought off with impatience

enter the flipper

just when you have given up hope a volume burst and a price pop