It was a relatively quieter week for the pharma sector, after a power-packed earnings season in the past two weeks. This week the FDA approved Roche’s RHHBY spinal muscular atrophy (SMA) drug risdiplam. Bayer BAYRY announced a new acquisition.
Recap of the Week’s Most Important Stories
FDA Approves Roche’s SMA Drug Risdiplam: The FDA granted approval to Roche’s risdiplam for the treatment of patients (adults and children two months of age and older) with SMA. With the approval, risdiplam, to be marketed by the trade name of Evrysdi, becomes the first at-home administered liquid medicine for people with SMA. The FDA approval was based on data from the pivotal FIREFISH and SUNFISH studies, which evaluated risdiplam across a broad patient population suffering from type 1, 2 or 3 SMA.
The FDA also accepted Roche’s supplemental biologics license application (sBLA) seeking approval of a self-administration prefilled syringe option for Xolair across all approved indications in the United States. Xolair is approved to treat moderate-to-severe persistent asthma and chronic idiopathic urticaria in the United States. The FDA’s decision is expected in the first quarter of 2021.
Bayer to Buy U.K. Based Biotech: Bayer announced that it will acquire U.K. based biotech KaNDy Therapeutics, which will add the latter’s pipeline candidate, NT-814 to its women’s healthcare pipeline. KaNDy Therapeutics recently completed a phase II study on the candidate, which evaluated NT-814 for the treatment of menopause symptoms, hot flashes and night sweats. A phase III study is expected to start in 2021. Bayer claims NT-814 has the potential to generate peak sales of euro 1 billion globally.
For the deal, Bayer will make an upfront payment of $425 million and will also be entitled to make potential milestone payments of up to $450 million
Pfizer to Help Manufacture Gilead’s Remdesivir: Pfizer PFE announced a multi-year deal to manufacture and supply Gilead’s investigational treatment for COVID-19, remdesivir. Per the deal, remdesivir will be manufactured at Pfizer’s McPherson, KS facility on a contract manufacturing basis.
Novo Nordisk Resumes Phase III Haemophilia Studies: Novo Nordisk NVO resumed phase III studies evaluating its subcutaneous prophylaxis treatment, concizumab in haemophilia A and B with or without inhibitors. A clinical hold was placed on the studies in March due to the occurrence of non-fatal thrombotic events in three patients enrolled in the studies. The clinical hold was lifted as the company agreed to new safety measures and guidelines with the FDA.
The NYSE ARCA Pharmaceutical Index rose 0.8% in the last five trading sessions.
Here is how the eight major stocks performed in the last five trading sessions.
Last week, Merck MRK recorded the highest increase (3.1%) while Lilly LLY declined the most (1.6%).
In the past six months, AstraZeneca AZN has risen the most (16.6%) while Novartis has declined the most (12.5%).
(See the last pharma stock roundup here: ABBV, MRK Q2 Earnings & Coronavirus Updates in Focus)
What’s Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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