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Concert (CNCE) Stock Up 17% Last Week on Sun Pharma Buyout Offer
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Shares of Concert Pharmaceuticals, Inc. were up 17.4% last week on its proposed acquisition by India-based Sun Pharmaceutical Industries Ltd. On Jan 19, Concert Pharmaceuticals announced a definitive agreement to be acquired by Sun Pharmaceutical Industries Ltd., the world's fourth-largest specialty generic pharmaceutical company, for $576 million.
The acquisition, if successfully closed, will add Concert Pharmaceutical’s lead product candidate, deuruxolitinib, to Sun Pharma’s global dermatology franchise. Deuruxolitinib is an oral inhibitor of janus kinases JAK1 and JAK2 and is currently under late-stage development for the treatment of alopecia areata. Concert completed its second phase III clinical study, THRIVE-AA, on deuruxolitinib and reported top-line results back in August 2022.
Per the terms of the definitive merger agreement, Sun Pharma is expected to initiate a tender offer to acquire all outstanding shares of Concert for $8.00 per share in cash, upon closing the deal. CNCE is also entitled to receive a non-tradeable contingent value right of up to an additional $3.50 per share in cash, payable when milestones in terms of deuruxolitinib’s net sales are met within specific periods. The transaction is expected to be completed in the first half of 2023.
The cash portion (exclusive of the contingent right) of $8.00 per share is a premium of around 16% over Concert’s closing price as of Jan 18, 2023.
The primary efficacy endpoint for THRIVE-AA was the percentage of patients achieving an absolute Severity of Alopecia Tool (SALT) score of 20 or less at Week 24 of treatment. This primary endpoint was met with statistical significance against patients treated with a placebo and the candidate was generally well tolerated. The key secondary endpoints of the percentage of responders on a Satisfaction of Hair Patient Reported Outcome scale at Week 24 and the percentage of patients achieving absolute SALT scores of 20 or less at each of Weeks 20, 16, and 12 were also met with statistical significance. The safety profiles of the candidate were also consistent with previous studies, with the most common adverse effects being, COVID-19 infection, nasopharyngitis, increased creatine kinase levels, acne and headache. Concert plans to submit a New Drug Application (NDA) for deuruxolitinib to the FDA in the first half of 2023.
Alopecia Areata is an autoimmune disease, affecting both men and women, in which the immune system attacks the hair follicles causing partial or complete hair loss on the scalp and body. Approximately 1.5 million Americans may be affected by this disease at any given time and is commonly associated with serious psychological consequences, including anxiety and depression. Treatment options for alopecia areata are extremely limited and represent a clear unmet medical need as a part of quality-of-life improvement.
In the past year, the stock of Concert Pharmaceuticals has shot up 172.4% against the industry’s decline of 14%.
Image Source: Zacks Investment Research
Sun Pharmaceutical’s vision of building a global Dermatology and Ophthalmology franchise will receive a significant boost from the addition of Concert’s late-stage, potential best-in-class treatment for alopecia areata in deuruxolitinib. Sun Pharma’s management claims to be well-positioned to successfully bring the product to market globally.
However, Concert, and upon acquisition, Sun Pharma will be facing stiff competition from prominent players in the medical market like Pfizer (PFE - Free Report) and Eli Lilly and Company (LLY - Free Report) . In September 2022, Pfizer announced that the FDA had accepted its NDA filing for its candidate, ritlecitinib, a selective JAK3/TEC kinase inhibitor, for adults and adolescents 12 years of age and older with alopecia areata.
This acceptance of the NDA by the FDA was based on Pfizer’s previously reported top-line results from the pivotal and dose-ranging phase IIb/III ALLEGRO study and an ongoing phase III ALLEGRO-LT open-label, long-term study. Pfizer expects the FDA to give its decision on the NDA in the second quarter of 2023, which will provide serious competition to Concert’s candidate upon approval.
In June 2022, Eli Lilly announced that the FDA had approved its marketed drug, JAK inhibitor, Olumiant (baricitinib) as a first-in-disease systemic treatment for adults with severe alopecia areata. This approval was based on topline results from Lilly’s BRAVE-AA1 and BRAVE-AA2 studies.
Zacks Rank and Stock to Consider
Concert Pharmaceutical currently has a Zacks Rank #3 (Hold).
Ardelyx’s 2022 loss per share estimate has narrowed from 70 cents to 52 cents in the past 90 days. During the same period, the loss estimate per share for 2023 has narrowed from 40 cents to 34 cents. In the past year, shares of Ardelyx have increased by 278.8%.
ARDX has witnessed a negative surprise of 2.84%, on average in the last four reported quarters.
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Concert (CNCE) Stock Up 17% Last Week on Sun Pharma Buyout Offer
Shares of Concert Pharmaceuticals, Inc. were up 17.4% last week on its proposed acquisition by India-based Sun Pharmaceutical Industries Ltd. On Jan 19, Concert Pharmaceuticals announced a definitive agreement to be acquired by Sun Pharmaceutical Industries Ltd., the world's fourth-largest specialty generic pharmaceutical company, for $576 million.
The acquisition, if successfully closed, will add Concert Pharmaceutical’s lead product candidate, deuruxolitinib, to Sun Pharma’s global dermatology franchise. Deuruxolitinib is an oral inhibitor of janus kinases JAK1 and JAK2 and is currently under late-stage development for the treatment of alopecia areata. Concert completed its second phase III clinical study, THRIVE-AA, on deuruxolitinib and reported top-line results back in August 2022.
Per the terms of the definitive merger agreement, Sun Pharma is expected to initiate a tender offer to acquire all outstanding shares of Concert for $8.00 per share in cash, upon closing the deal. CNCE is also entitled to receive a non-tradeable contingent value right of up to an additional $3.50 per share in cash, payable when milestones in terms of deuruxolitinib’s net sales are met within specific periods. The transaction is expected to be completed in the first half of 2023.
The cash portion (exclusive of the contingent right) of $8.00 per share is a premium of around 16% over Concert’s closing price as of Jan 18, 2023.
The primary efficacy endpoint for THRIVE-AA was the percentage of patients achieving an absolute Severity of Alopecia Tool (SALT) score of 20 or less at Week 24 of treatment. This primary endpoint was met with statistical significance against patients treated with a placebo and the candidate was generally well tolerated. The key secondary endpoints of the percentage of responders on a Satisfaction of Hair Patient Reported Outcome scale at Week 24 and the percentage of patients achieving absolute SALT scores of 20 or less at each of Weeks 20, 16, and 12 were also met with statistical significance. The safety profiles of the candidate were also consistent with previous studies, with the most common adverse effects being, COVID-19 infection, nasopharyngitis, increased creatine kinase levels, acne and headache. Concert plans to submit a New Drug Application (NDA) for deuruxolitinib to the FDA in the first half of 2023.
Alopecia Areata is an autoimmune disease, affecting both men and women, in which the immune system attacks the hair follicles causing partial or complete hair loss on the scalp and body. Approximately 1.5 million Americans may be affected by this disease at any given time and is commonly associated with serious psychological consequences, including anxiety and depression. Treatment options for alopecia areata are extremely limited and represent a clear unmet medical need as a part of quality-of-life improvement.
In the past year, the stock of Concert Pharmaceuticals has shot up 172.4% against the industry’s decline of 14%.
Image Source: Zacks Investment Research
Sun Pharmaceutical’s vision of building a global Dermatology and Ophthalmology franchise will receive a significant boost from the addition of Concert’s late-stage, potential best-in-class treatment for alopecia areata in deuruxolitinib. Sun Pharma’s management claims to be well-positioned to successfully bring the product to market globally.
However, Concert, and upon acquisition, Sun Pharma will be facing stiff competition from prominent players in the medical market like Pfizer (PFE - Free Report) and Eli Lilly and Company (LLY - Free Report) . In September 2022, Pfizer announced that the FDA had accepted its NDA filing for its candidate, ritlecitinib, a selective JAK3/TEC kinase inhibitor, for adults and adolescents 12 years of age and older with alopecia areata.
This acceptance of the NDA by the FDA was based on Pfizer’s previously reported top-line results from the pivotal and dose-ranging phase IIb/III ALLEGRO study and an ongoing phase III ALLEGRO-LT open-label, long-term study. Pfizer expects the FDA to give its decision on the NDA in the second quarter of 2023, which will provide serious competition to Concert’s candidate upon approval.
In June 2022, Eli Lilly announced that the FDA had approved its marketed drug, JAK inhibitor, Olumiant (baricitinib) as a first-in-disease systemic treatment for adults with severe alopecia areata. This approval was based on topline results from Lilly’s BRAVE-AA1 and BRAVE-AA2 studies.
Zacks Rank and Stock to Consider
Concert Pharmaceutical currently has a Zacks Rank #3 (Hold).
A better-ranked stock in the same industry is Ardelyx, Inc (ARDX - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Ardelyx’s 2022 loss per share estimate has narrowed from 70 cents to 52 cents in the past 90 days. During the same period, the loss estimate per share for 2023 has narrowed from 40 cents to 34 cents. In the past year, shares of Ardelyx have increased by 278.8%.
ARDX has witnessed a negative surprise of 2.84%, on average in the last four reported quarters.