This week the FDA approved
J&J’s ( JNJ Quick Quote JNJ - Free Report) Rybrevant (amivantamab) for a rare lung cancer indication and also granted emergency approval to GlaxoSmithKline ( GSK Quick Quote GSK - Free Report) and Vir Biotechnology’s COVID-19 antibody drug, sotrovimab. While Sanofi ( SNY Quick Quote SNY - Free Report) and Glaxo began a global late-stage study on their COVID-19 vaccine candidate, Pfizer ( PFE Quick Quote PFE - Free Report) began a study to test use of its pneumococcal vaccine along with a booster shot of its COVID-19 vaccine. Recap of the Week’s Most Important Stories The FDA has granted accelerated approval to J&J’s Rybrevant (amivantamab) for the treatment of non-small cell lung cancer (NSCLC) that targets EGFR exon 20 insertion mutations, as detected by an FDA-approved test. With the FDA nod, Rybrevant becomes the first fully-human, bispecific antibody approved for this FDA Approves J&J’s New Lung Cancer Drug: serious and rare type of lung cancer.
The European Commission granted approval to J&J’s Ponvory (ponesimod),
an oral treatment for relapsing forms of multiple sclerosis (RMS). The approval was expected as the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had given a positive opinion in March recommending approval of the drug. Ponvory was approved by the FDA in March. The approval was based on data from the phase III OPTIMUM study.
J&J announced that the CHMP has given a positive opinion recommending expanded use of Darzalex subcutaneous (SC) formulation for two new indications in Europe
The FDA granted Emergency Use Authorization (EUA) to Glaxo and Vir Biotechnology’s dual-action monoclonal antibody FDA Approves Glaxo/Vir’s COVID-19 Antibody for Emergency Use: sotrovimab (previously VIR-7831) for treating mild-to-moderate COVID-19 in adult and pediatric patients (at least 12 years of age and weighing at least 40) who are at risk of progression to severe COVID-19, including hospitalization or death. The EUA submission was based on an interim analysis of efficacy and safety data from the phase III COMET-ICE study. A formal biologics license application (BLA) to the FDA is expected to be filed in the second half of 2021. Glaxo and Sanofi Sanofi/Glaxo COVID-19 Vaccine Enters Phase III: began a pivotal phase III study on their adjuvanted recombinant protein-based COVID-19 vaccine candidate. The study is expected to enrol more than 35,000 adult participants and will evaluate 10µg dose of Sanofi’s recombinant vaccine candidate in combination with Glaxo’s pandemic adjuvant. It will evaluate two formulations of the vaccine candidate targeting the original SARS-CoV-2 (the Wuhan virus) and B.1.351 (South African) variant. Meanwhile, a booster study programme is also planned to be initiated to complement the phase III study. The phase III study follows the encouraging interim data from a phase II study, announced earlier this month, which showed that the vaccine candidate demonstrated strong neutralizing antibody responses in all adult age groups, with 95 to100% seroconversion rates. Pfizer has begun a Pfizer Initiates Study to Test COVID-19 Booster & Pneumococcal Conjugate Vaccine: study to investigate co-administration of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of its COVID-19 vaccine in 600 adults 60 years and older. 20vPnC is under review in the United States with the FDA’s decision expected next month. The study’s main goal is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. The CHMP gave a positive opinion recommending approval of CHMP Nod for Merck’s Keytruda in Esophageal Cancer: Merck’s ( MRK Quick Quote MRK - Free Report) PD-L1 inhibitor, Keytruda in combination with chemotherapy as first-line treatment for certain patients with metastatic esophageal cancer or HER2-negative gastroesophageal junction (GEJ) adenocarcinoma. A final decision from the European Commission is expected in the second quarter of 2021. The positive CHMP opinion is based on results from the pivotal phase III KEYNOTE-590 study. Keytruda was approved for a similar indication by the FDA in March. EU Approval for Roche/AbbVie’s Venclyxto for First-Line AML: The European Commission granted approval to AbbVie ( ABBV Quick Quote ABBV - Free Report) and Roche’s cancer drug, Venclyxto in combination with hypomethylating agents, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed AML who are ineligible for intensive chemotherapy in Europe. The approval was based on data from the phase III VIALE-A study and phase Ib M14-358 study. Venclexta (Venclyxto’s brand name in United States) is already approved in the United States for a similar indication. Novartis Begins COVID-19 Study on Partnered Candidate: Novartis ( NVS Quick Quote NVS - Free Report) and Molecular Partners initiated a global multi-center phase II - III study, EMPATHY to evaluate safety and efficacy of their pipeline candidate, ensovibep for the treatment of COVID-19. The study is expected to enroll 2100 patients, with 400 patients in phase II, followed by 1700 patients in phase III. Molecular Partners announced positive data from a phase I study on ensovibeb in March. Novartis has collaborated with Molecular Partners to develop two DARPin therapies — ensovibep and MP0423 — designed for potential use against COVID-19, with an option to in-license global rights from the latter and development responsibilities to both therapies
The NYSE ARCA Pharmaceutical Index declined 1.9% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, all the stocks declined except Roche and Novartis. Roche rose the most (1.3%) while Merck declined the most (4.7%).
In the past six months, Lilly has recorded the maximum gain (30.2%) while Merck declined the most (5.9%)
(See the last pharma stock roundup here:
GSK/SNY COVID-19 Vaccine Data, PFE’s New EU Supply Deal) What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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