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Research: Healthcare
Basilea presented a combination of eight presentations and abstracts on its antibiotic ceftobiprole (at the Infectious Diseases Week 2023 conference in Boston), which support its ongoing regulatory application with the FDA. The new data provide additional evidence on the drug’s utility and highlight ceftobiprole’s antimicrobial activity against clinically relevant pathogens, including MRSA, and support the dosing regimens utilised in the three Phase III studies for the three indications currently undergoing priority review by the FDA. As a reminder, the FDA has set a PDUFA date of 3 April 2024, which suggests that Basilea could potentially receive a regulatory decision for its lead antibiotic asset in the US in early-Q224. The FDA’s decision would be a significant catalyst for Basilea, considering the high prevalence of MRSA in US. The new data provide incremental support to the FDA application and instil confidence in a favourable outcome, in our view.
Written by
Basilea Pharmaceutica |
New data support FDA application for ceftobiprole |
Application update |
Pharma and biotech |
18 October 2023 |
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Basilea Pharmaceutica is a research client of Edison Investment Research Limited |
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Basilea presented a combination of eight presentations and abstracts on its antibiotic ceftobiprole (at the Infectious Diseases Week 2023 conference in Boston), which support its ongoing regulatory application with the FDA. The new data provide additional evidence on the drug’s utility and highlight ceftobiprole’s antimicrobial activity against clinically relevant pathogens, including MRSA, and support the dosing regimens utilised in the three Phase III studies for the three indications currently undergoing priority review by the FDA. As a reminder, the FDA has set a PDUFA date of 3 April 2024, which suggests that Basilea could potentially receive a regulatory decision for its lead antibiotic asset in the US in early-Q224. The FDA’s decision would be a significant catalyst for Basilea, considering the high prevalence of MRSA in US. The new data provide incremental support to the FDA application and instil confidence in a favourable outcome, in our view.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
148.1 |
(6.6) |
(56.9) |
0.0 |
N/A |
N/A |
12/22 |
147.8 |
12.3 |
104.1 |
0.0 |
37.6 |
N/A |
12/23e |
158.2 |
43.5 |
332.2 |
0.0 |
11.8 |
N/A |
12/24e |
180.7 |
63.2 |
482.3 |
0.0 |
8.1 |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
During the Infectious Diseases Week 2023 conference in Boston, Basilea presented new data on its antibiotic ceftobiprole (Zevtera) with a presentation and seven additional posters. These data collectively provided further evidence of ceftobiprole’s antimicrobial activity against clinically relevant pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and Gram-negative bacteria.
The four posters supported the dosing regimens used in the three separate Phase III studies, including for patients with Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
We note that these three indications are included in the New Drug Application, which is currently undergoing priority review by the FDA and has a Prescription Drug User Fee Act (PDUFA) date scheduled for 3 April 2024. Additionally, the presentation and three posters featured data from large in vitro susceptibility studies that tested bacterial isolates from US patients. These findings affirmed the in vitro activity of ceftobiprole against methicillin-susceptible Staphylococcus aureus (MSSA) and MRSA, as well as Streptococcus pneumoniae and Enterococcus faecalis. Importantly, the data demonstrated the sustained potency of ceftobiprole over several years against these clinically relevant pathogens.
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Research: Healthcare
Ultimovacs has announced that UV1 in combination with ipilimumab and nivolumab has shown clinically meaningful benefit in overall survival (reducing death risk by 27%), meeting a protocol-predefined threshold for statistical significance. Although overall survival (OS) is the secondary endpoint in the NIPU Phase II trial, OS is regarded as the gold standard in cancer treatment and is a critical consideration in malignant mesothelioma, an aggressive type of cancer with a high mortality rate and few therapeutic options in first-line treatment and no established standard of care in second-line treatment. This announcement follows the US FDA granting orphan drug designation (ODD) to UV1 for the treatment of mesothelioma and is a positive contrast from the June 2023 announcement (where a central independent review concluded the NIPU study did not meet the primary endpoint of progression-free survival). While we await the full study dataset to be presented by the lead investigator at ESMO 2023 (Saturday), these preliminary results are a positive indication of the vaccine’s efficacy. Shares reacted positively to the news and increased over 20% in early trading.