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Hot Stocks
Spero falls 15% to 80c after Complete Response Letter for tebipenem  16:13
06/27/22
06/27
16:13
06/27/22
16:13
SPRO

Spero Therapeutics

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SPRO Spero Therapeutics
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05/23/22 H.C. Wainwright
Spero Therapeutics price target lowered to $10 from $37 at H.C. Wainwright
05/20/22 Berenberg
Spero Therapeutics downgraded to Hold from Buy at Berenberg
05/17/22 Cantor Fitzgerald
Spero Therapeutics price target lowered to $5 from $27 at Cantor Fitzgerald
05/04/22 Cowen
Spero Therapeutics downgraded to Market Perform from Outperform at Cowen
SPRO Spero Therapeutics
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SPRO Spero Therapeutics
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Hot Stocks
Spero gets CRL from FDA for its NDA for tebipenem HBr oral tablets » 16:10
06/27/22
06/27
16:10
06/27/22
16:10
SPRO

Spero Therapeutics

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Spero Therapeutics…

Spero Therapeutics announced that it has received a Complete Response Letter, CRL. from the U.S. Food and Drug Administration, FDA, for its New Drug Application, NDA, seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection, including pyelonephritis. The FDA had set a Prescription Drug User Fee Act target action date of June 27.I n the CRL, the FDA communicated that it had completed its review of the NDA and determined that the NDA could not be approved in its present form. As previously disclosed in Spero's May 3, press release, the CRL was anticipated 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 3 cUTI study of tebipenem HBr was insufficient to support approval and that additional clinical study would be required. Spero intends to promptly request a Type A meeting with the FDA, to gain further insights as to the pathway forward towards a potential regulatory approval for tebipenem HBr. "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, M.D., Chief Executive Officer of Spero Therapeutics. "With this development, we continue to believe that tebipenem HBr offers patients and their providers an important new treatment option, that if approved, has the potential to address the critical unmet need for a new oral antibiotic for patients with cUTI." Dr. Mahadevia continued, "Our commitment to the development of effective new agents to address unmet medical needs remains strong, as we seek to identify the optimal path forward for tebipenem's regulatory approval, commercialization, and value creation, potentially through external partnerships. Tebipenem HBr remains an important part of the Spero pipeline and a complement to our SPR720 and SPR206 programs, which we continue to advance towards key clinical and regulatory milestones."

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SPRO Spero Therapeutics
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05/23/22 H.C. Wainwright
Spero Therapeutics price target lowered to $10 from $37 at H.C. Wainwright
05/20/22 Berenberg
Spero Therapeutics downgraded to Hold from Buy at Berenberg
05/17/22 Cantor Fitzgerald
Spero Therapeutics price target lowered to $5 from $27 at Cantor Fitzgerald
05/04/22 Cowen
Spero Therapeutics downgraded to Market Perform from Outperform at Cowen
SPRO Spero Therapeutics
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SPRO Spero Therapeutics
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Recommendations
Spero Therapeutics price target lowered to $10 from $37 at H.C. Wainwright » 06:20
05/23/22
05/23
06:20
05/23/22
06:20
SPRO

Spero Therapeutics

$1.37 /

-0.065 (-4.53%)

H.C. Wainwright analyst…

H.C. Wainwright analyst Raghuram Selvaraju lowered the firm's price target on Spero Therapeutics to $10 from $37 and keeps a Buy rating on the shares post the Q1 results. Tebipenem may be delayed considerably, but this does not totally negate Spero's value, Selvaraju tells investors in a research note.

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SPRO Spero Therapeutics
$1.37 /

-0.065 (-4.53%)

SPRO Spero Therapeutics
$1.37 /

-0.065 (-4.53%)

05/20/22 Berenberg
Spero Therapeutics downgraded to Hold from Buy at Berenberg
05/17/22 Cantor Fitzgerald
Spero Therapeutics price target lowered to $5 from $27 at Cantor Fitzgerald
05/04/22 Cowen
Spero Therapeutics downgraded to Market Perform from Outperform at Cowen
05/03/22 Evercore ISI
Evercore downgrades Spero with $2 target after 'shocking update'
SPRO Spero Therapeutics
$1.37 /

-0.065 (-4.53%)

SPRO Spero Therapeutics
$1.37 /

-0.065 (-4.53%)

Downgrade
Spero Therapeutics downgraded to Hold from Buy at Berenberg » 06:24
05/20/22
05/20
06:24
05/20/22
06:24
SPRO

Spero Therapeutics

$1.44 /

+0.005 (+0.35%)

Berenberg analyst Esther…

Berenberg analyst Esther Hong downgraded Spero Therapeutics to Hold from Buy with a $2 price target.

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SPRO Spero Therapeutics
$1.44 /

+0.005 (+0.35%)

SPRO Spero Therapeutics
$1.44 /

+0.005 (+0.35%)

05/17/22 Cantor Fitzgerald
Spero Therapeutics price target lowered to $5 from $27 at Cantor Fitzgerald
05/04/22 Cowen
Spero Therapeutics downgraded to Market Perform from Outperform at Cowen
05/03/22 Evercore ISI
Evercore downgrades Spero with $2 target after 'shocking update'
05/03/22 Evercore ISI
Spero Therapeutics downgraded to In Line from Outperform at Evercore ISI
SPRO Spero Therapeutics
$1.44 /

+0.005 (+0.35%)

SPRO Spero Therapeutics
$1.44 /

+0.005 (+0.35%)

Recommendations
Spero Therapeutics price target lowered to $5 from $27 at Cantor Fitzgerald » 07:56
05/17/22
05/17
07:56
05/17/22
07:56
SPRO

Spero Therapeutics

$1.70 /

-0.01 (-0.59%)

Cantor Fitzgerald analyst…

Cantor Fitzgerald analyst Louise Chen lowered the firm's price target on Spero Therapeutics to $5 from $27 and keeps an Overweight rating on the shares. Chen remains positive on the stock following a "solid" quarter of execution and despite a likely delay in the approval and launch of tebipenem HBr, the analyst tells investors in a research note. The decrease in the price target is driven by significantly lowering the firm's sales estimates for tebipenem HBr given a likely delay in its launch.

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SPRO Spero Therapeutics
$1.70 /

-0.01 (-0.59%)

SPRO Spero Therapeutics
$1.70 /

-0.01 (-0.59%)

05/04/22 Cowen
Spero Therapeutics downgraded to Market Perform from Outperform at Cowen
05/03/22 Evercore ISI
Evercore downgrades Spero with $2 target after 'shocking update'
05/03/22 Evercore ISI
Spero Therapeutics downgraded to In Line from Outperform at Evercore ISI
04/18/22 H.C. Wainwright
Spero Therapeutics price target lowered to $37 from $43 at H.C. Wainwright
SPRO Spero Therapeutics
$1.70 /

-0.01 (-0.59%)

SPRO Spero Therapeutics
$1.70 /

-0.01 (-0.59%)

Earnings
Spero Therapeutics reports Q1 EPS ($1.01), consensus (87c) » 16:11
05/16/22
05/16
16:11
05/16/22
16:11
SPRO

Spero Therapeutics

$1.70 /

-0.005 (-0.29%)

Reports Q1 revenue $2.1M,…

Reports Q1 revenue $2.1M, consensus $2.57M. As of March 31, Spero had cash, cash equivalents, and marketable securities of $122M. Based on the previously announced restructuring and the cessation of commercialization activities for the tebipenem HBr program and assuming the repayment of amounts under the company's Revenue Interest Financing Agreement with certain entities managed by HealthCare Royalty Management, Spero believes that its existing cash, cash equivalents and marketable securities, together with other non-dilutive funding commitments, will be sufficient to fund its planned operating expenses and capital expenditures pursuant to the priorities of its strategic refocusing through late 2023. During this period, the strategic refocusing prioritizes advancing SPR720 and SPR206 to key Phase 2 milestones.

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SPRO Spero Therapeutics
$1.70 /

-0.005 (-0.29%)

SPRO Spero Therapeutics
$1.70 /

-0.005 (-0.29%)

05/04/22 Cowen
Spero Therapeutics downgraded to Market Perform from Outperform at Cowen
05/03/22 Evercore ISI
Evercore downgrades Spero with $2 target after 'shocking update'
05/03/22 Evercore ISI
Spero Therapeutics downgraded to In Line from Outperform at Evercore ISI
04/18/22 H.C. Wainwright
Spero Therapeutics price target lowered to $37 from $43 at H.C. Wainwright
SPRO Spero Therapeutics
$1.70 /

-0.005 (-0.29%)

SPRO Spero Therapeutics
$1.70 /

-0.005 (-0.29%)

Over a quarter ago
Downgrade
Spero Therapeutics downgraded to Market Perform from Outperform at Cowen » 05:40
05/04/22
05/04
05:40
05/04/22
05:40
SPRO

Spero Therapeutics

$1.85 /

-3.245 (-63.75%)

Cowen analyst Ritu Baral…

Cowen analyst Ritu Baral downgraded Spero Therapeutics to Market Perform from Outperform without a price target after the company it will halt tebipenem launch spend based on feedback from the Food and Drug Administration. The analyst still believes in tebipenem's approvability and commercial viability, but says Spero may not be able to bring it forward themselves. In addition, the company has no pipeline catalysts until the second half of 2023, Baral tells investors in a research note.

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SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

05/03/22 Evercore ISI
Evercore downgrades Spero with $2 target after 'shocking update'
05/03/22 Evercore ISI
Spero Therapeutics downgraded to In Line from Outperform at Evercore ISI
04/18/22 H.C. Wainwright
Spero Therapeutics price target lowered to $37 from $43 at H.C. Wainwright
03/21/22 H.C. Wainwright
Spero Therapeutics price target raised to $43 from $40 at H.C. Wainwright
SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

Downgrade
Evercore downgrades Spero with $2 target after 'shocking update' » 16:26
05/03/22
05/03
16:26
05/03/22
16:26
SPRO

Spero Therapeutics

$1.85 /

-3.245 (-63.75%)

Evercore ISI analyst Josh…

Evercore ISI analyst Josh Schimmer downgraded Spero Therapeutics to In Line from Outperform with a price target of $2, down from $40. The company this morning "provided another shocking update" for tebipenem for complicated urinary tract infections, Schimmer tells investors in a research note. Spero said it will immediately defer current commercialization activities for tebipenem based on feedback from a recent late cycle meeting with the Food and Drug Administration regarding its New Drug Application. As a result, the analyst stripped tebipenem from his model, ascribed $50M in value to Spero's remaining antibiotic assets and added some of its net cash to arrive at the $2 price target. "With finite resources and early stage anti-infectives, it's no longer a name we can recommend owning," writes Schimmer. The stock closed Tuesday down 64%, or $3.24, to $1.85.

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SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

05/03/22 Evercore ISI
Spero Therapeutics downgraded to In Line from Outperform at Evercore ISI
04/18/22 H.C. Wainwright
Spero Therapeutics price target lowered to $37 from $43 at H.C. Wainwright
03/21/22 H.C. Wainwright
Spero Therapeutics price target raised to $43 from $40 at H.C. Wainwright
10/01/21
Fly Intel: Top five analyst downgrades
SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

Downgrade
Spero Therapeutics downgraded to In Line from Outperform at Evercore ISI » 16:19
05/03/22
05/03
16:19
05/03/22
16:19
SPRO

Spero Therapeutics

$1.85 /

-3.245 (-63.75%)

Evercore ISI analyst Josh…

Evercore ISI analyst Josh Schimmer downgraded Spero Therapeutics to In Line from Outperform with a price target of $2, down from $40.

ShowHide Related Items >><<
SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

04/18/22 H.C. Wainwright
Spero Therapeutics price target lowered to $37 from $43 at H.C. Wainwright
03/21/22 H.C. Wainwright
Spero Therapeutics price target raised to $43 from $40 at H.C. Wainwright
10/01/21
Fly Intel: Top five analyst downgrades
10/01/21 Oppenheimer
Spero Therapeutics downgraded to Perform from Outperform at Oppenheimer
SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

SPRO Spero Therapeutics
$1.85 /

-3.245 (-63.75%)

Hot Stocks
Spero will immediately defer current commercialization activities for tebipenem » 07:30
05/03/22
05/03
07:30
05/03/22
07:30
SPRO

Spero Therapeutics

$5.09 /

+0.23 (+4.73%)

Spero Therapeutics…

Spero Therapeutics announced that it will immediately defer current commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting, LCM, with the U.S. Food and Drug Administration, FDA, regarding Spero's New Drug Application, NDA, for tebipenem HBr. Although the review is still ongoing and the FDA has not yet made any final determination regarding approvability, the discussion suggested that the data package may be insufficient to support approval during this review cycle, as described below. In connection with this development, Spero announced that it is undertaking a reduction in its workforce by approximately 75% and a restructuring of its operations to reduce operating costs and reallocate resources towards the clinical development programs of SPR720 and SPR206, while continuing engagement with the FDA on the appropriate path forward for tebipenem HBr. Based on the anticipated cost-savings of this restructuring and other assumptions, Spero anticipates it will be able to fund its planned operating expenses and capital expenditure requirements pursuant to the priorities of its strategic refocusing through late 2023. "We are disappointed that the FDA has identified substantive review issues, and we strongly believe that tebipenem HBr would offer healthcare providers, payers and patients an important oral antibiotic alternative to IV treatment for cUTI for patients with limited oral treatment options," said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. "After careful consideration, and in light of the current FDA position, we have made the strategic decision to transition Spero's focus and resources to supporting the clinical development of our promising clinical-stage pipeline, including SPR720, aimed at treating non-tuberculous mycobacterial lung disease, and SPR206, aimed at treating MDR gram-negative bacterial infections. Further, we will continue to engage with the FDA on the appropriate path forward for tebipenem HBr. As a result, Spero will immediately refrain from investment in near-term commercialization activities for tebipenem HBr, and instead we will restructure our business to appropriately staff our new focus going forward. We believe these actions will help preserve the ongoing viability of tebipenem HBr's development program, enabling either eventual commercialization by Spero, or commercialization through potential partnership or other opportunities."

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SPRO Spero Therapeutics
$5.09 /

+0.23 (+4.73%)

SPRO Spero Therapeutics
$5.09 /

+0.23 (+4.73%)

04/18/22 H.C. Wainwright
Spero Therapeutics price target lowered to $37 from $43 at H.C. Wainwright
03/21/22 H.C. Wainwright
Spero Therapeutics price target raised to $43 from $40 at H.C. Wainwright
10/01/21
Fly Intel: Top five analyst downgrades
10/01/21 Oppenheimer
Spero Therapeutics downgraded to Perform from Outperform at Oppenheimer
SPRO Spero Therapeutics
$5.09 /

+0.23 (+4.73%)

SPRO Spero Therapeutics
$5.09 /

+0.23 (+4.73%)

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