Iterum Therapeutics Provides Business Update
Iterum Therapeutics provided a business update. Market Access Update: Medicare Part D Milestone: The company announces another signed rebate agreement with one of the top three Medicare Part D Pharmacy Benefit Managers. This agreement positions Orlynvah for inclusion on their Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies. Patent Portfolio: Iterum has been granted a patent in the United States as patent number 12,544,337, entitled "Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof", that covers a bilayer tablet comprising sulopenem etzadroxil and probenecid, a method of making the bilayer tablet, and methods of treating diseases, including uncomplicated urinary tract infection. This US patent is projected to expire in December 2039, absent any patent term extensions, and assuming timely payments of all maintenance fees during the lifetime of the patent. FDA: The US Food and Drug Administration has responded to Iterum's request to discuss the use of Orlynvah as step-down therapy and the collection of real world data to support the proposed claim. The FDA has determined that Iterum would need to provide substantial evidence of effectiveness from an adequate and well-designed clinical trial in a supplemental new drug application to support the proposed indication for Orlynvah as step-down treatment of complicated urinary tract infections. The FDA recommends that Iterum request a Type C meeting to discuss the design and endpoints of any proposed clinical investigation to support the proposed indication.
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ITERUM THERAPEUTICS PLC: FDA Suggests Type C Meeting for Proposed Clinical Study of ORLYNVAH
- FDA Recommendation: The FDA has recommended a type C meeting for a proposed clinical investigation related to Orlyn NVH.
- Purpose of Meeting: The meeting aims to discuss the clinical development plan and address any questions regarding the proposed investigation.
IO Biotech (IOBT) Explores Strategic Alternatives, Stock Surges 19.36%
- Strategic Alternatives: IO Biotech announced it will explore various strategic alternatives to maximize shareholder value, resulting in a 19.36% stock surge to $0.25, indicating strong investor interest in potential mergers or asset sales.
- Cost-Cutting Measures: The company is evaluating further reductions in force and other measures to significantly cut operating expenses, aiming to enhance financial flexibility and pave the way for future strategic options.
- Speculative Trading: Cue Biopharma's stock rose 10.67% to $0.42 despite no new company news, suggesting speculative trading activity may reflect investor optimism in the biotech sector.
- Continued Growth Trend: InfuSystem and Cabaletta Bio saw stock increases of 7.19% and 7.68%, respectively, demonstrating ongoing investor interest in the medical services and biotech sectors, despite the absence of new corporate updates.
Iterum Expands ORLYNVAH™ Coverage to 25 Million Lives in the U.S.
- Expanded Coverage: ORLYNVAH™ now reaches nearly 25% of insured lives in the U.S., with increasing integration into employer groups and payer formularies, which is expected to enhance market penetration significantly.
- Pharmacy Benefit Agreement: Iterum has signed a rebate agreement with a top Medicare Part D Pharmacy Benefit Manager, positioning ORLYNVAH™ for inclusion in their formularies starting Q1 2026, which will greatly improve product accessibility in the market.
- Increased Distribution Channels: ORLYNVAH™ is now stocked at additional distributors like Cencora, allowing physicians to procure the product through various channels, thereby enhancing market availability and procurement flexibility for doctors.
- Patent Expansion: The European Patent Office has indicated its intention to grant a patent covering a bilayer tablet of sulopenem etzadroxil and probenecid, projected to expire in December 2039, which strengthens Iterum's intellectual property protection in the anti-infective space.
Butterfly Network and Citius Pharma Boost Biotech Activity in After-Hours Trading
Butterfly Network Update: Butterfly Network's shares rose 6.04% after announcing CEO Joseph DeVivo and Interim CFO Megan Carlson will participate in investor meetings at the Evercore Healthcare Conference on December 2, 2025, highlighting their handheld ultrasound technology.
Citius Pharmaceuticals Collaboration: Citius Pharmaceuticals saw a 7.90% increase in shares after announcing a collaboration with Verix to utilize its AI-powered Tovana platform for the U.S. commercialization of LYMPHIR, an FDA-approved immunotherapy for cutaneous T-cell lymphoma.
General Market Activity: ProQR Therapeutics, Perrigo Company, and Tempest Therapeutics also experienced share price increases, with Tempest announcing plans to acquire CAR-T programs to enhance its pipeline.
Other Stocks Performance: Iterum Therapeutics and Processa Pharmaceuticals had minor share price movements without any new updates, reflecting varied investor sentiment in the biotech sector.
Applied Therapeutics, Omeros, and Others Experience Significant Price Changes After Market Close
Milestone Scientific Inc. Earnings: Milestone Scientific's shares rose 36.10% after reporting a third-quarter net loss of $1.2 million, with revenue slightly down to $2.4 million due to weaker domestic dental sales but stronger international demand.
Applied Therapeutics Inc. Update: Applied Therapeutics saw a 14.78% increase in shares after narrowing its Q3 net loss to $19 million and announcing a meeting with the FDA to discuss the regulatory path for govorestat in Classic Galactosemia.
Omeros Corp. Financial Results: Omeros Corp. shares gained 20.54% following a Q3 net loss of $30.9 million, with an update on its Biologics License Application for narsoplimab and an extended FDA action date to December 2025.
The Oncology Institute Inc. Performance: The Oncology Institute's shares rose 19.48% after reporting a 36.7% increase in Q3 revenue to $136.6 million, while also raising its full-year revenue guidance to between $495 million and $505 million.
Earnings Report Ahead of Market Opening for November 14, 2025: SR, SRRK, TWST, BTBT, SGML, FRGE, SBC, GAUZ, INKT, MRSN, ITRM, LMFA
Earnings Reports Overview: Several companies, including Spire Inc., Scholar Rock Holding Corporation, and Twist Bioscience Corporation, are set to report their earnings for the quarter ending September 30, 2025, with varying forecasts for earnings per share (EPS) and growth compared to the previous year.
Spire Inc. Performance: Spire Inc. is expected to report an EPS of $-0.46, reflecting a 14.81% increase year-over-year, with a Price to Earnings (P/E) ratio of 20.08, indicating stronger growth potential than its industry peers.
Scholar Rock Holding Corporation and Twist Bioscience: Scholar Rock is forecasted to have an EPS of $-0.88, a 33.33% decrease from last year, while Twist Bioscience anticipates an EPS of $-0.40, a 32.20% increase, despite missing previous earnings expectations.
Other Notable Companies: Companies like Bit Digital, Sigma Lithium, and SBC Medical Group are also reporting, with SBC Medical expected to show significant growth with a 333.33% increase in EPS, while others like MiNK Therapeutics and Mersana Therapeutics are facing declines in their EPS forecasts.
ITERUM THERAPEUTICS PLC: FDA Suggests Type C Meeting for Proposed Clinical Study of ORLYNVAH
- FDA Recommendation: The FDA has recommended a type C meeting for a proposed clinical investigation related to Orlyn NVH.
- Purpose of Meeting: The meeting aims to discuss the clinical development plan and address any questions regarding the proposed investigation.
IO Biotech (IOBT) Explores Strategic Alternatives, Stock Surges 19.36%
- Strategic Alternatives: IO Biotech announced it will explore various strategic alternatives to maximize shareholder value, resulting in a 19.36% stock surge to $0.25, indicating strong investor interest in potential mergers or asset sales.
- Cost-Cutting Measures: The company is evaluating further reductions in force and other measures to significantly cut operating expenses, aiming to enhance financial flexibility and pave the way for future strategic options.
- Speculative Trading: Cue Biopharma's stock rose 10.67% to $0.42 despite no new company news, suggesting speculative trading activity may reflect investor optimism in the biotech sector.
- Continued Growth Trend: InfuSystem and Cabaletta Bio saw stock increases of 7.19% and 7.68%, respectively, demonstrating ongoing investor interest in the medical services and biotech sectors, despite the absence of new corporate updates.
Iterum Expands ORLYNVAH™ Coverage to 25 Million Lives in the U.S.
- Expanded Coverage: ORLYNVAH™ now reaches nearly 25% of insured lives in the U.S., with increasing integration into employer groups and payer formularies, which is expected to enhance market penetration significantly.
- Pharmacy Benefit Agreement: Iterum has signed a rebate agreement with a top Medicare Part D Pharmacy Benefit Manager, positioning ORLYNVAH™ for inclusion in their formularies starting Q1 2026, which will greatly improve product accessibility in the market.
- Increased Distribution Channels: ORLYNVAH™ is now stocked at additional distributors like Cencora, allowing physicians to procure the product through various channels, thereby enhancing market availability and procurement flexibility for doctors.
- Patent Expansion: The European Patent Office has indicated its intention to grant a patent covering a bilayer tablet of sulopenem etzadroxil and probenecid, projected to expire in December 2039, which strengthens Iterum's intellectual property protection in the anti-infective space.
Butterfly Network and Citius Pharma Boost Biotech Activity in After-Hours Trading
Butterfly Network Update: Butterfly Network's shares rose 6.04% after announcing CEO Joseph DeVivo and Interim CFO Megan Carlson will participate in investor meetings at the Evercore Healthcare Conference on December 2, 2025, highlighting their handheld ultrasound technology.
Citius Pharmaceuticals Collaboration: Citius Pharmaceuticals saw a 7.90% increase in shares after announcing a collaboration with Verix to utilize its AI-powered Tovana platform for the U.S. commercialization of LYMPHIR, an FDA-approved immunotherapy for cutaneous T-cell lymphoma.
General Market Activity: ProQR Therapeutics, Perrigo Company, and Tempest Therapeutics also experienced share price increases, with Tempest announcing plans to acquire CAR-T programs to enhance its pipeline.
Other Stocks Performance: Iterum Therapeutics and Processa Pharmaceuticals had minor share price movements without any new updates, reflecting varied investor sentiment in the biotech sector.
Applied Therapeutics, Omeros, and Others Experience Significant Price Changes After Market Close
Milestone Scientific Inc. Earnings: Milestone Scientific's shares rose 36.10% after reporting a third-quarter net loss of $1.2 million, with revenue slightly down to $2.4 million due to weaker domestic dental sales but stronger international demand.
Applied Therapeutics Inc. Update: Applied Therapeutics saw a 14.78% increase in shares after narrowing its Q3 net loss to $19 million and announcing a meeting with the FDA to discuss the regulatory path for govorestat in Classic Galactosemia.
Omeros Corp. Financial Results: Omeros Corp. shares gained 20.54% following a Q3 net loss of $30.9 million, with an update on its Biologics License Application for narsoplimab and an extended FDA action date to December 2025.
The Oncology Institute Inc. Performance: The Oncology Institute's shares rose 19.48% after reporting a 36.7% increase in Q3 revenue to $136.6 million, while also raising its full-year revenue guidance to between $495 million and $505 million.
Earnings Report Ahead of Market Opening for November 14, 2025: SR, SRRK, TWST, BTBT, SGML, FRGE, SBC, GAUZ, INKT, MRSN, ITRM, LMFA
Earnings Reports Overview: Several companies, including Spire Inc., Scholar Rock Holding Corporation, and Twist Bioscience Corporation, are set to report their earnings for the quarter ending September 30, 2025, with varying forecasts for earnings per share (EPS) and growth compared to the previous year.
Spire Inc. Performance: Spire Inc. is expected to report an EPS of $-0.46, reflecting a 14.81% increase year-over-year, with a Price to Earnings (P/E) ratio of 20.08, indicating stronger growth potential than its industry peers.
Scholar Rock Holding Corporation and Twist Bioscience: Scholar Rock is forecasted to have an EPS of $-0.88, a 33.33% decrease from last year, while Twist Bioscience anticipates an EPS of $-0.40, a 32.20% increase, despite missing previous earnings expectations.
Other Notable Companies: Companies like Bit Digital, Sigma Lithium, and SBC Medical Group are also reporting, with SBC Medical expected to show significant growth with a 333.33% increase in EPS, while others like MiNK Therapeutics and Mersana Therapeutics are facing declines in their EPS forecasts.
