Shares of Germany’s CureVac spiked 20% in US pre-market trading after the biopharma company announced that it has teamed up with Bayer to further develop and seek regulatory approval for its mRNA vaccine candidate, CVnCoV, against COVID-19.
As part of the collaboration agreement, Bayer will support the development, supply and key regulatory hurdles of CureVac´s (CVAC) COVID-19 vaccine candidate. Specifically, Bayer will lend its expertise and established infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information, supply chain performance as well as support in selected countries.
“We are very happy to join forces with Bayer, whose expertise and infrastructure will help us make our vaccine candidate CVnCoV even more rapidly available to as many people as possible,” said CureVac CEO Franz-Werner Haas. “Building on the positive data we have seen so far with CVnCoV, we now also have another strong partner on our side to get the vaccine to the people who need it following the receipt of the requisite regulatory approvals.”
Under the terms of the agreement, CureVac will remain the marketing authorization holder for the product, while Bayer (0P6S) will provide support with country operations within the European Union (EU) and selected additional markets. The companies said that they were gearing up their forces to put CureVac in a position to facilitate the supply of hundreds of millions of CVnCoV doses around the world, should regulatory approvals be granted.
The collaboration agreement comes after CureVac last month said it enrolled the first participant for its large-scale pivotal Phase 2b/3 study, which will test the safety and efficacy of CVnCoV in adults at a dose of 12 µg. The study is expected to include more than 35,000 participants at sites in Europe and Latin America. CureVac has previously announced plans to boost the manufacturing capacity of its COVID-19 vaccine candidate to up to 300 million doses in 2021 and up to 600 million doses in 2022.
CureVac shares have dropped 33% over the past month but have almost doubled since they started trading on the Nasdaq in August. Meanwhile, valuation prompted Credit Suisse analyst Martin Auster last month to cut the stock’s rating to Sell from Hold with a price target of $50, up from $47.
Auster views the stock’s risk/reward as “increasingly challenging” as the biopharma’s valuation rises, with “limited tail value” for COVID vaccines post-2023 amid a rising number of players and price competition over time.
The other analyst covering the stock recently, Berenberg Bank’s Zhiqiang Shu, reiterated a price target of $72 with a Buy rating. That provides CVAC with an average price target of $61, which implies downside potential of 30% over the coming 12 months.
Shu believes that CureVac is on track to present vaccine data from its Phase 2b/3 trial in the first quarter of 2021, with a regulatory decision set to come in early Q2. (See CVAC stock analysis on TipRanks)
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