Pemetrexed

Junshi Biosciences Announces 2022 Full Year Financial Results and Provides Corporate Updates

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Vendredi, mars 31, 2023
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SHANGHAI, China, March 31, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced financial results for the 2022 full year and provided corporate updates.

Key Points: 
  • SHANGHAI, China, March 31, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced financial results for the 2022 full year and provided corporate updates.
  • Total research and development (“R&D”) expenses were approximately RMB 2,384 million in 2022, representing an increase of approximately 15% compared to 2021.
  • Loss attributable to the owners of the company was RMB 2,386 million in 2022, representing an increase of RMB 1,667 million compared to 2021.
  • In May 2022, the IND application for JS105, a PI3K-α inhibitor jointly developed by Risen (Suzhou) Biosciences Co., Ltd. (“Risen Biosciences”) and the company, was approved by the NMPA.

Lantern Pharma Announces First Patient Dosed in the Phase 2 Study, Harmonic™, for LP-300 in Never Smokers with Advanced Non-Small Cell Lung Cancer

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Mardi, mars 28, 2023
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“These patients show tremendous bravery and resolve in helping to establish signals of efficacy including potential increased survival in this Phase 2 trial that combines LP-300 with standard-of-care treatment.

Key Points: 
  • “These patients show tremendous bravery and resolve in helping to establish signals of efficacy including potential increased survival in this Phase 2 trial that combines LP-300 with standard-of-care treatment.
  • Lantern has activated 5 clinical trial sites, across 12 locations in the US including Gabrail Cancer Center , Northwest Oncology , New York Cancer and Blood Specialists , Texas Oncology , and Cancer and Blood Specialty Clinic.
  • Across the 5 Harmonic™ clinical trial sites, there is 1 dosed patient and 14 additional potential patients that have been pre-screened and are being monitored for possible enrollment.
  • Multiple additional trial sites across the US are expected to be activated in the 1st half of 2023 and will bolster patient recruitment and enrollment.

Eagle Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Results

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Lundi, mars 13, 2023
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During the fourth quarter of 2022, the Company reached the contractual limit for royalties paid to development partner on worldwide bendamustine profits.

Key Points: 
  • During the fourth quarter of 2022, the Company reached the contractual limit for royalties paid to development partner on worldwide bendamustine profits.
  • “2022 was an outstanding year for Eagle, as we tripled our adjusted non-GAAP net income per diluted share over 2021.
  • Q4 2022 RYANODEX® net product sales were $7.2 million, compared to $6.1 million in the fourth quarter of 2021.
  • Q4 2022 BELRAPZO net product sales were $11.0 million, compared to $5.5 million in the fourth quarter of 2021.

Merck Provides Update on Phase 3 Trials KEYNOTE-641 and KEYNOTE-789

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Mardi, février 28, 2023
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Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-641 and KEYNOTE-789.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-641 and KEYNOTE-789.
  • Merck is informing study investigators of the decision and advises patients in the study to speak to their physician regarding treatment.
  • In KEYNOTE-641, the combination was associated with a higher incidence of Grade 3-5 adverse events and serious adverse events compared to the control arm.
  • We are extremely grateful to all the investigators and patients for their participation in these studies.”

FDA Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC)

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Vendredi, janvier 27, 2023
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In patients who received adjuvant platinum-based chemotherapy following surgical resection, KEYTRUDA reduced the risk of disease recurrence or death by 27% (hazard ratio [HR]=0.73 [95% CI, 0.60-0.89]) versus placebo regardless of PD-L1 expression.

Key Points: 
  • In patients who received adjuvant platinum-based chemotherapy following surgical resection, KEYTRUDA reduced the risk of disease recurrence or death by 27% (hazard ratio [HR]=0.73 [95% CI, 0.60-0.89]) versus placebo regardless of PD-L1 expression.
  • In an exploratory subgroup analysis of the 167 patients (14%) who did not receive adjuvant chemotherapy, the DFS HR was 1.25 (95% CI, 0.76-2.05).
  • “While there have been many advances for patients with metastatic disease, surgery remains the typical treatment for people with stage IB, II and IIIA non-small cell lung cancer.
  • “Today’s approval for KEYTRUDA offers a new, important immunotherapy treatment option for stage IB (T2a ≥4 cm), II, or IIIA patients with non-small cell lung cancer following surgery and adjuvant chemotherapy.

Junshi Biosciences Announces Toripalimab as Perioperative Treatment for Operable NSCLC Patients Met Primary Endpoint in Phase 3 Clinical Study

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Mercredi, janvier 18, 2023
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The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint of event-free survival (“EFS”) has met the pre-defined efficacy boundary.

Key Points: 
  • The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint of event-free survival (“EFS”) has met the pre-defined efficacy boundary.
  • Junshi Biosciences will communicate with regulatory authorities regarding matters related to the supplemental New Drug Application in the near future.
  • Perioperative I-O therapy covering the whole process, including pre- and post-surgery, is expected to be a better treatment model for patients.
  • Based on the interim analysis, compared with chemotherapy alone, toripalimab in combination with chemotherapy as perioperative treatment for phase III operable NSCLC patients and toripalimab monotherapy for consolidation therapy thereafter may significantly extend EFS of patients.

Eagle Pharmaceuticals Provides Business Update and Guidance for 2023

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Mardi, janvier 10, 2023
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WOODCLIFF LAKE, N.J., Jan. 10, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today provided a business update and guidance for 2023.

Key Points: 
  • WOODCLIFF LAKE, N.J., Jan. 10, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today provided a business update and guidance for 2023.
  • Q4 2022 expiration of development partner royalty on the bendamustine franchise profits (BENDEKA®, BELRAPZO® & TREAKISYM®), representing approximately 10% of such profits.
  • In addition, we expect the 2023 decline in bendamustine to be manageable, and the 10% royalty on bendamustine products no longer applies.
  • These efforts, together with our intention to further expand the Company, including M&A, lead us to believe that Eagle is poised for another year of strong earnings growth and profitability in 2023,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Eagle Pharmaceuticals Receives FDA Approval for Additional Indication for PEMFEXY® in Combination with Pembrolizumab and Platinum Chemotherapy

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Lundi, décembre 19, 2022
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WOODCLIFF LAKE, N.J., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (“FDA”) has approved an additional indication for PEMFEXY® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (“NSCLC”) with no EGFR or ALK genomic tumor aberrations. Eagle’s approved PEMFEXY (pemetrexed injection) is a ready-to-dilute (“RTD”) novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug (“LD”), ALIMTA®.

Key Points: 
  • Eagle’s approved PEMFEXY (pemetrexed injection) is a ready-to-dilute (“RTD”) novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug (“LD”), ALIMTA®.
  • “With this fifth indication, PEMFEXY is now approved for all of the same indications as ALIMTA, and we believe it allows for key advantages such as eliminating the need for reconstitution.
  • At the same time, we also believe that Eagle is well positioned to capture the commercial opportunity that PEMFEXY represents,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
  • In February 2020, Eagle received approval from the FDA of its New Drug Application for PEMFEXY, following the settlement agreement of patent litigation with Eli Lilly and Company (NYSE: LLY) in December 2019.

NuCana Reports Third Quarter 2022 Financial Results and Provides Business Update

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Mercredi, novembre 16, 2022
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EDINBURGH, United Kingdom, Nov. 16, 2022 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the third quarter ended September 30, 2022 and provided an update on its broad clinical program with its transformative ProTide therapeutics.

Key Points: 
  • EDINBURGH, United Kingdom, Nov. 16, 2022 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the third quarter ended September 30, 2022 and provided an update on its broad clinical program with its transformative ProTide therapeutics.
  • As of September 30, 2022, NuCana had cash and cash equivalents of 50.8 million compared to 46.5 million as of June 30, 2022 and 60.3 million at December 31, 2021.
  • NuCana continues to advance its various clinical programs and reported a net loss of 4.5 million for the quarter ended September 30, 2022, as compared to a net loss of 8.0 million for the quarter ended September 30, 2021.
  • Basic and diluted loss per share was 0.09 for the quarter ended September 30, 2022, as compared to 0.15 per share for the quarter ended September 30, 2021.

Immutep Announces Promising Initial Clinical Data from INSIGHT-003 at SITC 2022

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Jeudi, novembre 10, 2022
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SYDNEY, AUSTRALIA, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces encouraging initial clinical data from the investigator-initiated INSIGHT-003 trial has been published in a poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022. INSIGHT-003 is the first trial evaluating Immutep’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”) as part of a triple combination therapy with standard-of-care anti-PD-1 therapy and chemotherapy.

Key Points: 
  • SYDNEY, AUSTRALIA, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep or the Company), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces encouraging initial clinical data from the investigator-initiated INSIGHT-003 trial has been published in a poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022.
  • The poster entitled Feasibility of eftilagimod alpha (soluble LAG-3 protein) combined with standard-of-care-therapy in advanced non-small-cell lung cancer (NSCLC).
  • Immuteps CEO Marc Voigt also added: We are encouraged to see these promising initial results from INSIGHT-003.
  • Table 1: ORR and DCR for INSIGHT-003 (data cut-off date: 14 October 2022)