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FDA Approves 3rd Humira Biosimilar, CLVS Tanks On Q3 Results, CRY On Watch


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(RTTNews.com) - Today's Daily Dose brings you news about ACADIA's CLARITY trial results; Clovis' lackluster third quarter financial results; CryoLife's revised earnings and revenue outlook for the year; FDA approval of the third Humira biosimilar, and Strongbridge's deal with Novo Nordisk.

Shares of ACADIA Pharmaceuticals Inc. (ACAD) dropped over 7% on Wednesday, following top-line results from CLARITY, a phase II study that evaluated Nuplazid (Pimavanserin) in major depressive disorder.

The study consisted of two stages. In Stage 1, 207 adult patients with a confirmed inadequate response to existing first-line SSRI or SNRI therapy for MDD received adjunctive treatment of either 34 mg Pimavanserin or placebo in addition to pre-existing first-line therapy for five weeks.

In Stage 2, those patients who did not show a response to placebo in Stage 1 were re-randomized to receive either Pimavanserin or placebo for a second five-week treatment period.

When the data from the two stages of the trial were pooled and analysed, Pimavanserin met the overall primary endpoint by significantly reducing 17-item Hamilton Depression Rating Scale (HAMD-17) total score compared to placebo.

In Stage 1 also, patients on Pimavanserin demonstrated a significant improvement in HAMD-17 versus placebo. However, the Stage 2 results did not demonstrate significant improvement over placebo non-responders.

ACADIA expects to initiate phase III program of Pimavanserin in adjunctive major depressive disorder in the first half of 2019.

Nuplazid (Pimavanserin) is already approved for the treatment of psychosis associated with Parkinson's disease.

ACAD closed Wednesday's trading at $19.48, down 7.63%.

Shares of Clovis Oncology Inc. (CLVS) took a hit on Wednesday, following lackluster financial results for the third quarter ended September 30, 2018.

The net loss for the third quarter of 2018 was $89.9 million or $1.71 per share on product revenue of $22.76 million. Analysts polled by Thomson Reuters expected a loss of $1.65 per share and revenue of $29.19 million.

The net loss was $60.7 million or $1.24 per share on product revenue of $16.8 million for the third quarter of 2017.

CLVS closed Wednesday's trading at $11.63, down 29.98%.

CRH Medical Corporation (CRH.TO) (CRHM) has reported 30% revenue growth for the third quarter ended September 30, 2018.

CRH Medical is a full-service gastroenterology anesthesia company that provides anesthesia services for patients undergoing endoscopic procedures in ambulatory surgical centers.

Total revenue for the third quarter of 2018 rose to $28.73 million from $22.16 million in the year-ago period. (The amounts are expressed in U.S. Dollars).

The Company, on Wednesday, entered into an exclusive agreement to develop and manage a monitored anesthesia care ("MAC") program with Digestive Health Specialists ("DHS"), in North Carolina. CRH Medical, which will develop and manage the MAC program, has an option to acquire up to 51% of the newly created anesthesia practice at a future date, no sooner than 12 months.

CRHM closed Wednesday's trading at $3.13, up 4.33%.

CryoLife Inc. (CRY) has reported better-than-expected earnings and revenue for the third quarter ended September 30, 2018, and boosted its revenue outlook for the year.

On a non-GAAP basis, net income for the recent third quarter was $3.08 million, or $0.08 per share, on total revenue of $64.6 million. Analysts polled by Thomson Reuters were expecting earnings of $0.07 per share on revenue of $61.84 million.

The Company's non-GAAP net income was $3.14 million or $0.09 per on revenue of $55 million in the third quarter of 2017.

Looking ahead to full year 2018, CryoLife now expects revenue to range between $261.5 million and $262.5 million, up from its prior forecast of $256.0 million to $260.0 million. The non GAAP EPS outlook for the year has been revised to a range of $0.30 to $0.33 from its earlier forecast range of $0.29 to $0.32. Wall Street analysts expect EPS of $0.32 and revenue of $260.68 million for the year.

CRY closed Wednesday's trading at $30.98, down 1.15%.

The FDA has approved Novartis' (NVS) Hyrimoz, a biosimilar version of mega blockbuster drug Humira.

Humira, developed by AbbVie (ABBV), had global sales of $18.4 billion in 2017.

Novartis' Hyrimoz is the third Humira biosimilar in the U.S. It is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

Amgen's Amgevita, which won FDA approval in September 2016, is the first Humira biosimilar to have been approved in the U.S. Boehringer Ingelheim's Cyltezo, approved by the FDA in August 2017, is another biosimilar for Humira in the country.

In the U.S., although the biosimilar versions of Humira have been approved, they are not going to be launched till 2023.

But that's not the case in Europe, with four of the five approved biosimiar versions of Humira having been launched - Amgen's Amgevita, Mylan and Fujifilm Kyowa Kirin Biologics' Hulio, Samsung Bioepis' Imraldi, and Novartis' Hyrimoz. Boehringer's Cyltezo, a biosimilar Humira, approved in Europe in November 2017, is yet to be launched.

NVS closed Wednesday's trading at $87.46, up 0.96%.

Strongbridge Biopharma plc (SBBP) has sold its U.S. and Canadian rights over MACRILEN to Novo Nordisk (NVO) for an upfront payment of $145 million plus tiered royalties on net sales.

In addition, Novo Nordisk will purchase approximately 5.24 million ordinary shares of Strongbridge Biopharma plc at a purchase price of $7.00 per share. This investment will result in gross proceeds of $36.7 million to Strongbridge.

MACRILEN is the first and only FDA-approved oral drug indicated for the diagnosis of adult growth hormone deficiency (AGHD). Strongbridge acquired the U.S. and Canadian rights to MACRILEN from Aeterna Zentaris Inc. (AEZS) (AEZS.TO) in January of this year.

In other news, Strongbridge reported third quarter 2018 financial results and provided a corporate update.

On a non-GAAP basis, net loss attributable to ordinary shareholders was $22.2 million or $0.47 per share in the third quarter of 2018 compared to a non-GAAP net loss attributable to ordinary shareholders of $13.1 million or $0.35 per share for the same period in 2017.

The total revenue in the recent third quarter was $5.3 million compared to net revenues of $2.5 million for the same period in 2017. The third quarter 2018 total revenue included product sales of KEVEYIS of $4.2 million and product sales of MACRILEN of $1.1 million.

Looking ahead, the Company now expects full-year 2018 KEVEYIS revenue to range from $18 million to $20 million, up from its prior outlook range of $16 million to $17 million.

SBBP closed Wednesday's trading at $6.40, up 58.02%. AEZS closed Wednesday's trading at $2.18, up 67.69%.


Read the original article on RTTNews (http://www.rttnews.com/2950043/fda-approves-3rd-humira-biosimilar-clvs-tanks-on-q3-results-cry-on-watch.aspx)


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