WWith regulatory approval or rejection of the drugs at stake, perhaps no sector is more apt to generate massive overnight gains – or for that matter, losses – than the biotech industry.
With that in mind, it can be said that Wednesday brought a smile to AVEO Pharmaceuticals (AVEO) investors. Stocks soared after the FDA surprised the company positively.
The FDA gave the green light for Tivozanib, the company’s drug for the third and fourth line treatment of advanced renal cell carcinoma (RCC), earlier than the designated March 31 date for PDUFA.
Oral Vascular Endothelial Growth Factor (VEGF) Tyrosine Kinase Inhibitor (TKI) Approved Based on Positive Results from Pivotal Phase 3 Study, Regulator Giving Treatment Own Label . The FDA also did not request a post-market study of tivozanib.
A launch date has already been set for March 31, with the drug named Fotivda.
In preparation for the US launch, AVEO conducted market research and hired appropriate personnel for the business push, including the hiring of David W. Crist for the role of Vice President of Sales. Crist brings with him 20 years of oncology sales experience.
At the launch date, management said training for the 65 oncology sales teams should be completed.
“Given its commercial readiness, we expect AVEO to achieve a successful launch of Fotivda,” said HC Wainwright Swayampakula Ramakanth. “Along with the announcement of the approval of Fotivda, management also disclosed the price of the drug, set at a WAC price of $ 24,150 per cycle, which is above our assumption but within the cost range. approved TKIs. “
With the higher price, Ramakanth increased the projected price of Fotivda per US patient from $ 100,000 to $ 200,000. The analyst expects Fotivda to reign supreme, at least until the entry of generics in 2029.
Following FDA approval, Ramakanth more than doubled its AVEO price target from $ 12 to $ 27, which implies a 133% increase over the 12-month period. Unsurprisingly, the 5-star analyst rating remains a Buy.
Two other analysts recently reviewed AVEO’s outlook, and both came to the same conclusion as Ramakanth. AVEO’s strong buy consensus rating is supported by an average price target of $ 22.75, suggesting gains of around 96% over the coming year. (See the analysis of AVEO shares on TipRanks)
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