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Achillion's (ACHN) Danicopan Gets EMA's PRIME Tag for PNH

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Achillion Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has granted PRIority Medicines (PRIME) designation to its oral factor D inhibitor danicopan (previously ACH-4471) as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) in patients, who are not adequately responding to a C5 inhibitor.

The decision was based on safety and efficacy data from the phase II study, which evaluated danicopan in combination with Alexion’s (ALXN - Free Report) C5 inhibitor Soliris (eculizumab) for treating the above-mentioned patient population.

The EMA grants PRIME status to drugs with major therapeutic advantage over the existing treatments and target an unmet medical need or benefit patients without treatment options.

Shares of Achillion have skyrocketed 294.7% so far this year, significantly outperforming the industry’s rise of 2.5%.

 

We remind investors that in September 2019, danicopan was granted a Breakthrough Therapy designation by the FDA for PNH, a rare, acquired blood disease.

Achillion expects to advance danicopan’s development for PNH into a phase III study in early 2020.

Meanwhile, the company has completed enrollment in two phase II studies evaluating danicopan for another indication called C3 glomerulopathy, which is a rare kidney disorder.

The company is also developing its next-generation oral factor D inhibitor ACH-5228 and plans to initiate a phase II development of ACH-5228 in early 2020 for addressing PNH.

Importantly, there is a growing interest for developing treatments for PNH. Alexion’s Soliris and the recently-approved Ultomiris are already available for the given indication.

We would like to remind investors that in October 2019, Achillion received an acquisition offer from Alexion for an initial consideration of approximately $930 million. Alexion is offering $6.30 per share in cash for each share of Achillion. Moreover, the company’s stockholders are eligible to receive $1 per share upon the approval of danicopan and another $1 upon the initiation of phase III study on ACH-5228.

The deal is expected to close in the first half of 2020. With this buyout, Alexion is looking to strengthen its PNH franchise. A potential approval of danicopan will make the company a market leader in the PNH space.

Zacks Rank & Stocks to Consider

Achillion currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Anika Therapeutics Inc. (ANIK - Free Report) and NuCana PLC (NCNA - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings estimates have been revised 16% upward for 2019 and 19.1% for 2020 over the past 60 days. The stock has soared 78.9% so far this year.

NuCana’s loss per share estimates have narrowed 14.9% for 2019 and 13.6% for 2020 over the past 60 days.

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