- Genmab and argenx have entereda multiyear collaborationbringing together capabilities to jointly discover, develop and commercialize antibody therapies
- Discovery programs against two differentiated targets are underway
Monday, April 17, 2023
Genmab, argenx Partner on Antibody Therapies in Immunology and Oncology
Amnel: Q1 prelims; affirms 2023 guidance
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) announced certain unaudited preliminary financial results for the first quarter ended March 31, 2023. The Company is also affirming financial guidance for the year ending December 31, 2023, which was previously issued on March 2, 2023. The Company plans to report actual first quarter 2023 financial results on May 5, 2023.
Unaudited Preliminary Financial Results for the First Quarter Ended March 31, 2023
Based on preliminary financial information, Amneal expects to report:
- Net revenue of $550 million to $560 million, an increase of approximately 12% compared to the first quarter of 2022
- Loss before income taxes of $10 million to $0, an improvement of approximately 50% compared to the first quarter of 2022
- Adjusted EBITDA(1) of $115 million to $120 million, an increase of approximately 18% compared to the first quarter of 2022
- Long-term debt(2) of $2.692 billion and cash and cash equivalents and restricted cash of $151 million as of March 31, 2023, resulting in net debt of $2.541 billion as of March 31, 2023, as compared to long-term debt(2) of $2.682 billion and cash and cash equivalents and restricted cash of $35 million as of December 31 2022, resulting in net debt of $2.647 billion as of December 31, 2022
“We are extremely pleased with the start of 2023 with strong double-digit top line and adjusted EBITDA growth and reduced net debt. We are tracking well across the key vectors of our strategy to drive sustainable growth, higher profitability, and reduce debt over time. In Generics, our large portfolio of complex products continues to perform well, and we are seeing good uptake of our biosimilars which are on-track with our full year plan. In Specialty, we are pleased with the growth of Rytary and Unithroid, and are working closely with the U.S. FDA ahead of our June 30th PDUFA date for IPX203 in Parkinson’s. Finally, AvKARE continues to deliver double-digit revenue growth. In summary, our business continues to flourish, and we believe Amneal is well positioned for continued success,” said Chirag and Chintu Patel, Co-Chief Executive Officers.
Cellectis: Preclinical Data on CAR T-cells to Enhance Efficacy Targeting Triple Negative Breast Cancer at AACR
Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today released preclinical data on TALEN®-edited MUC1 CAR T-cells at the American Association for Cancer Research (AACR) Annual Meeting 2023. The data showed the capability of armored allogeneic MUC1 CAR T-cells to excel in the immune suppressive tumor micro-environment suggesting that they could be an effective option in treating relapsed and refractory triple negative breast cancer (TNBC) patients with limited therapeutic options.
Tumor-associated MUC1 antigen is overexpressed in a large number of TNBC patients offering an effective discriminatory target for CAR T-cell therapy.
Cellectis’ MUC1 CAR T-cells are allogeneic and target Mucin 1 for TNBC and a variety of epithelial cancers. As other solid tumor targets can be plagued by safety concerns due to off-tumor expression, MUC1 is of high interest as its expression in normal epithelium is restricted to apical membranes. Additionally, MUC1 heavy glycosylation in normal tissue contrasts with Cellectis’ MUC1 CAR that is designed to recognize hypoglycosylated MUC1 present in cancer cells. Cellectis’ MUC1 CAR T-cells incorporate up to four TALEN®-mediated knockouts and two knock-ins.
Vaxcyte: Positive Data from Phase 2 Study of its 24-Valent Pneumococcal Conjugate Vax
- VAX-24 Showed Robust Immune Responses Across all 24 Serotypes (ST) at All Doses, Confirming Prior Phase 2 Results in Adults Aged 50-64
- VAX-24 2.2mcg Dose Met Opsonophagocytic Activity (OPA) Response Non-Inferiority Criteria for 18 of 20 STs Common with Prevnar 20® (PCV20) and Superiority Criteria for the Four Additional VAX-24 STs
- VAX-24 2.2mcg Dose Showed Further Improvement in Overall Immune Responses vs. PCV20 Relative to Results from Phase 2 Study in Adults Aged 50-64
- Full Six-Month Safety Data from Both Adult Studies Demonstrated VAX-24 Safety and Tolerability Results Similar to PCV20 at All Doses Studied
- Prespecified Pooled Immunogenicity Analyses of Data from Both Adult Phase 2 Studies Showed the VAX-24 2.2mcg Dose Met OPA Non-Inferiority Criteria for All 20 STs Common with PCV20 and Superiority Criteria for the Four Additional VAX-24 STs
- VAX-24 Well-Positioned for Adult Phase 3 Program with Topline Data Anticipated in 2025
- Company to Host Webcast/Conference Call Today at 7:30 a.m. ET / 4:30 a.m. PT
Vaxcyte will hold a webcast and conference call today, April 17, 2023, at 7:30 a.m. ET / 4:30 a.m. PT to discuss these results. To participate in the conference call, please dial (800) 267-6316 (domestic) or (203) 518-9783 (international) and refer to conference ID PCVX0417. A live webcast of the conference call will also be available on the investor relations page of the Vaxcyte corporate website at www.vaxcyte.com. After the live webcast, the event will remain archived on the Vaxcyte website for 30 days.
NanoViricides Ships Drug Products for Impending Clinical Trials of NV-CoV-2 COVID Drug
NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in nanomedicines against viruses, announced today that it has shipped the drug products for impending clinical trials of NV-CoV-2, its COVID drug candidate, to its collaborator, Karveer Meditech Pvt. Ltd., Kolhapur, India ("Karveer").
Karveer has already successfully obtained required regulatory permissions to conduct clinical evaluation of NV-CoV-2 as a COVID treatment in India. It has retained a well-regarded local Clinical Research Organization to conduct the NV-CoV-2 human clinical trials.
Even as U.S. President Joe Biden recently signed a resolution to end the COVID-19 emergency, SARS-CoV-2 continues to claim over 1,700 lives per week in the USA alone, in what is currently a "non-wave" period, claiming five times the number of lives taken by Influenza viruses. The SARS-CoV-2 virus with its continually evolving variants is now a continuously recurring phenomenon, like other seasonal viruses such as Influenzas.
The Company targets NV-CoV-2 to fulfill an important medical need that remains unmet even today. There is no antiviral COVID drug available yet that can be used for the treatment of all segments of patient population. Equally noteworthy, there is no antiviral COVID drug available yet that can be expected to continue to work even as new variants of the SARS-CoV-2 keep evolving and spreading in the field.
NV-CoV-2 is a broad-spectrum, pan-coronavirus drug that is unlikely to be overcome by SARS-CoV-2 variants, because of the very nature of how NV-CoV-2 is designed. It has been found to work against many unrelated coronaviruses in pre-clinical studies, supporting this expectation.
Additionally, the observed strong pre-clinical safety of NV-CoV-2 indicates that the drug would be applicable to treat disease in all populations from pediatrics to otherwise healthy adults to patients with co-morbidities. NV-CoV-2 has shown extremely strong safety in multiple pre-clinical animal models in both GLP and non-GLP studies. In particular, its extremely strong safety is seen in its NOAEL* value of 1,200 mg/Kg and MTD* value of 1,500 mg/Kg in rats. The drug was also found to be non-immunogenic and non-mutagenic. Further, there were no indications of possible allergy or injection-site reactions in any of the studies across multiple animal models.
NV-CoV-2 is expected to be available for the treatment of mild to moderate disease in two orally available forms, oral syrup and oral gummies to suit patients from pediatrics to healthy adults to patients with co-morbidities. It is expected to be available in an injectable form for the treatment of out-patients (i.e. non-hospitalized) with severe disease. It is also expected to be available in an infusion form as well as a direct lung inhalation form for the treatment of hospitalized patients with severe disease.
In contrast, currently approved antiviral drugs against SARS-CoV-2 have significant limitations on the segment of population in which they can be useful, severely restricting their applicability.
UCB: FINTEPLA® (fenfluramine) Oral Solution No Longer Listed as a Controlled Substance
UCB (Euronext: UCB), a global biopharmaceutical company, today announced the U.S. Drug Enforcement Administration (DEA) has published a final rule stating that FINTEPLA oral solution is no longer subject to the Controlled Substances Act (CSA). This change is immediate.
The DEA rule means all federally controlled substance restrictions have been removed for FINTEPLA. UCB will now begin the process of updating the compendia in states where they hold licensure. Once this process is completed, in most cases prescribers will be able to write a prescription for a full year's supply versus the current limitation of six months. Additionally, the descheduling will enable prescribers to send a prescription to pharmacies electronically.
FSD: Milestone in Completion of Dosing of Sentinel Subjects in First-in-Human MS Trial
FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) (“FSD Pharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative, inflammatory and metabolic disorders, today announced completion of the first-in-human (“FIH”) sentinel dosing of Lucid-21-302 (“Lucid-MS”) in the Company’s Phase I clinical trial evaluating its novel drug candidate as an orally-administered treatment for Multiple Sclerosis (“MS”). The sentinel dose was completed on Sunday, April 16, 2023.
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