Brazil expects to sign a new deal next week with Pfizer Inc for 100 million more COVID-19 vaccine doses, a Health Ministry official said on Friday, which would double the U.S. drugmaker's delivery to the Latin American country this year.
Rodrigo Cruz, executive secretary at the ministry, told journalists the contract has been agreed and just needs to be signed. Earlier this week, Health Minister Marcelo Queiroga said 35 million of these shots are due to be delivered in October.
Here are six pieces of trading wisdom that I might touch upon in Sunday evening's happy hour session:
Biogen is under increasing pressure – as if it needs it – to deliver with its Ionis-partnered mRNA project tofersen in amyotrophic lateral sclerosis. The asset looks increasingly exposed among pivotal-stage ALS projects after the recent failure of Brainstorm’s NurOwn and that of Orphazyme’s arimoclomol, announced this morning. Investors will have to wait another week to find out the data from arimoclomol’s pivotal ALS trial, Orarials-01, when these are presented at the Encals meeting; for now, Orphazyme says in the 245-patient study arimoclomol failed to beat placebo on either its primary measure, 76-week CAFS score, or secondary endpoints, which included the ALSFRS-R score and slow vital capacity. This comes after US FDA said Brainstorm’s unequivocally negative pivotal study of the stem cell therapy NurOwn was insufficient for filing, Orion’s levosimendan failed in the Refals trial, and Amylyx was told that it had to run a full phase 3 study with AMX0035. Tofersen’s phase 3 Valor study, ending mid-2021, is the next big readout for ALS. In addition to failing in ALS arimoclomol has also flunked trials in inclusion body myositis and Niemann-Pick disease, though Orphazyme is pursuing a filing in the last indication.
| Late-stage ALS pipeline (selected projects, excluding riluzole formulations) | ||||
|---|---|---|---|---|
| Project | Mechanism | Company | Trial | Note |
| Phase III | ||||
| Simdax po (levosimendan) | PDE3 inhibitor | Orion | NCT03505021 (Refals) | Failed Jul 2020 |
| NurOwn Program One | Cell therapy | Brainstorm Cell Therapeutics | NCT03280056 | Failed Nov 2020; data insufficient for filing |
| Arimoclomol citrate | SOD1 chaperone | Orphazyme (ex Cytrx) | NCT03491462 (Orarials-01) | Failed May 2021 |
| Tofersen | SOD1 inhibitor mRNA | Biogen/Ionis | NCT02623699 (Valor) | 183 subjects; data due H2 2021 |
| Ultomiris | Anti-complement factor C5 Mab | Alexion | NCT04248465 | 382 subjects, ends Feb 2022 |
| Alsitek (masitinib) | CD117, FGFR3 & PDGFR antagonist | AB Science | NCT03127267 | 495 subjects, not yet recruiting, ends Dec 2022 |
| Phase II/III | ||||
| AMX0035 (sodium phenylbutyrate + Taurursodiol) | Histone deacetylase inhibitor + bax inhibitor | Amylyx | NCT03127514 (Centaur) | Centaur met primary endpoint, but FDA has demanded a full ph3 trial |
| CuATSM | Unknown | Collaborative Medicinal Development | NCT04082832 | 80 subjects; study ended, no data |
| Zilucoplan | Complement factor C5 inhibitor | UCB | NCT04436497 (HEALEY ALS Platform Trial – Regimen A) | 160 subjects, ends Oct (previously Mar) 2021 |
| Verdiperstat | Myeloperoxidase enzyme inhibitor | Biohaven | NCT04436510 (HEALEY ALS Platform Trial – Regimen B) | 161 subjects, ends Oct (previously Mar) 2021 |
| CNM-Au8 | Elemental gold nanocrystals | Clene Nanomedicine | NCT04414345 (HEALEY ALS Platform Trial – Regimen C) | 162 subjects, ends Oct (previously Mar) 2021 |
| Ketas (ibudilast/MN-166) | LTD4 receptor antagonist | Medicinova | NCT04057898 (Combat-ALS) | 230 subjects, ends Dec 2023 |
| Source: clinicaltrials & Evaluate Pharma. https://www.evaluate.com/vantage/articles/news/snippets/arimoclomol-failure-leaves-biogenionis-exposed | ||||
Becton Dickinson’s diabetes business, a major supplier of insulin pen injection devices, is by far the company’s slowest-growing unit, Evaluate Medtech data show. The consensus of sellside forecasts puts the division's annual growth at just 1% between 2020 and 2026, compared with 5-7% for all BD’s other divisions. This is clearly part of the rationale for the company’s decision, announced yesterday, to spin the unit off as a separate publicly traded company. BD’s chief executive, Tom Polen, said that, once independent, the diabetes business would be able to “unleash its growth potential” through more efficient allocation of its own capital. Leerink analysts said the division was a drag on the company’s topline growth rate, adding that the spin-off was likely necessitated by BD’s desire to pursue strategic investments in other areas. Lilly has also been cutting deals in this same segment: yesterday it agreed to make its Tempo Pen insulin injector and Tempo Smart Button, a small device that automatically records medication usage, compatible with diabetes management platforms from Dexcom, Glooko, Roche and the French group Mydiabby Healthcare.
Shares of Mednax (NYSE:MD) were soaring 16.3% higher at 11:56 a.m. EDT on Friday. The big gain came after the company announced its first-quarter results before the market opened.
Mednax reported net revenue in the first quarter of $446.8 million. This result was well above the consensus Wall Street estimate of $424.1 million. The company announced adjusted earnings per share (EPS) from continuing operations of $0.24. This trounced the average analysts' estimate of $0.13.
COVID-19 continued to weigh on the medical services provider's performance in Q1. However, patient volumes weren't affected as much as in the fourth quarter of 2020.
Perhaps the biggest reason the healthcare stock is rising today is that investors are more confident about Mednax's prospects. Increased availability of COVID-19 vaccines could further reduce the negative impact of the pandemic on Mednax's business. The company also acquired two physician groups in the first quarter that will help boost its revenue.
https://www.fool.com/investing/2021/05/07/why-mednax-stock-is-soaring-today/
