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The biotech sector witnessed a series of events over the past week. Quite a few companies reported quarterly results over the week alongside announcing pipeline updates. Over the past week while Amgen revised its annual guidance, Biogen reported quarterly numbers wherein sales missed estimates.
Recap of Important Stories:
Prothena Plunges on Discontinuation of Study: Shares of Prothena Corp. (PRTA - Free Report) plunged as the company decided to discontinue the development of its lead pipeline candidate, NEOD001. The candidate, an antibody, was being evaluated for the treatment of AL amyloidosis. A phase IIb study, PRONTO, did not meet its primary or secondary endpoints. Hence, the company asked the independent data monitoring committee (“DMC”) of the phase III VITAL study to review a futility analysis of the ongoing VITAL study. Thereafter, the DMC recommended discontinuation of the VITAL study for futility.
Hence, the company decided to discontinue all studies for the development of NEOD001, including the VITAL study as well as the open label extension studies. The decision came as a major blow to the investors as the company has a very limited number of candidates in its pipeline and NEOD001 was a lead candidate.
Incyte/Lilly’s Drug Gets FDA Advisory Committee Nod: Incyte Corp. (INCY - Free Report) and Eli Lilly and Company (LLY - Free Report) announced that the FDA’s Arthritis Advisory Committee has recommended an approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis for adult patients who have had an inadequate response or intolerance to methotrexate.
However, the advisory committee did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles.
While the FDA is generally not required to follow the Advisory Committee's recommendation, but it will consider the same during its review of the NDA for baricitinib. The FDA had earlier issued a Complete Response Letter for the same. The drug is approved as Olumiant in Europe.
Amgen Revises Annual Guidance: Amgen, Inc. (AMGN - Free Report) revised 2018 guidance concurrent with its first-quarter results. The company beat on sales and earnings in the first quarter driven by strong performance of newly and recently launched drugs.
The company now expects revenues in 2018 to be between $21.9 billion and $22.8 billion, compared to the earlier estimate of $21.8-$22.8 billion. Earnings per share is now projected to come between $12.80 and $13.70, compared to the earlier estimate of $12.60 and $13.70.
Biogen Misses on Sales: Biogen (BIIB - Free Report) missed revenue estimates in the first quarter as Spinraza sales were drab.
The company’s leading multiple sclerosis franchise also saw sales declining. This biotech has been struggling in 2018. Nevertheless, earnings beat estimates and shares recovered and ended on a positive note at the end of the session.
Earlier, the company also extended its collaboration with Ionis Pharmaceuticals (IONS - Free Report) through a new 10-year agreement to develop novel antisense drug candidates for a broad range of neurological diseases. Per the agreement, Biogen will pay Ionis $1 billion in cash, which will include $625 million to purchase 11.5 million shares of Ionis common stock at a price of $54.34 per share.
Calithera's Kidney Cancer Candidate Gets Fast Track Status: Shares of Calithera Biosciences, Inc. (CALA - Free Report) gained as the company announced that the FDA has granted Fast Track Designation to lead candidate, CB-839. The candidate is being developed in combination with Exelixis’ EXEL cabozantinib for the treatment of metastatic kidney cancer.
Calithera’s CB-839, a selective, potent inhibitor of glutaminase, is being evaluated in a phase II study – CANTATA – in combination with Cabometyx in clear cell renal cell carcinoma in patients previously treated with at least one vascular endothelial growth factor tyrosine kinase inhibitor or the combination of Opdivo and Yervoy. (Read more: Calithera's Kidney Cancer Candidate Gets Fast Track Status).
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index lost 3.84% over the last five trading sessions. Among major biotech stocks, Alexion lost 5.71%. Over the last six months, Regeneron lost 26.85% while Vertex gained 3.02% (See the last biotech stock roundup here: Biotech Stock Roundup: ALKS Up, CLDX Down, ALXN to Acquire Wilson Therapeutics).
What's Next in the Biotech World?
Stay tuned as quite are scheduled to report results later in the week and early next week.
Investor Alert: Breakthroughs Pending
A medical advance is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating substantial revenue, and even more wondrous products are in the pipeline.
Cures for a variety of deadly diseases are in sight, and so are big potential profits for early investors. Zacks names 5 stocks to buy now.
Image: Bigstock
Biotech Stock Roundup: PRTA Down, AMGN Revises View, BIIB Misses on Sales
The biotech sector witnessed a series of events over the past week. Quite a few companies reported quarterly results over the week alongside announcing pipeline updates. Over the past week while Amgen revised its annual guidance, Biogen reported quarterly numbers wherein sales missed estimates.
Recap of Important Stories:
Prothena Plunges on Discontinuation of Study: Shares of Prothena Corp. (PRTA - Free Report) plunged as the company decided to discontinue the development of its lead pipeline candidate, NEOD001. The candidate, an antibody, was being evaluated for the treatment of AL amyloidosis. A phase IIb study, PRONTO, did not meet its primary or secondary endpoints. Hence, the company asked the independent data monitoring committee (“DMC”) of the phase III VITAL study to review a futility analysis of the ongoing VITAL study. Thereafter, the DMC recommended discontinuation of the VITAL study for futility.
Hence, the company decided to discontinue all studies for the development of NEOD001, including the VITAL study as well as the open label extension studies. The decision came as a major blow to the investors as the company has a very limited number of candidates in its pipeline and NEOD001 was a lead candidate.
Prothena carries a Zacks Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Incyte/Lilly’s Drug Gets FDA Advisory Committee Nod: Incyte Corp. (INCY - Free Report) and Eli Lilly and Company (LLY - Free Report) announced that the FDA’s Arthritis Advisory Committee has recommended an approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis for adult patients who have had an inadequate response or intolerance to methotrexate.
However, the advisory committee did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles.
While the FDA is generally not required to follow the Advisory Committee's recommendation, but it will consider the same during its review of the NDA for baricitinib. The FDA had earlier issued a Complete Response Letter for the same. The drug is approved as Olumiant in Europe.
Amgen Revises Annual Guidance: Amgen, Inc. (AMGN - Free Report) revised 2018 guidance concurrent with its first-quarter results. The company beat on sales and earnings in the first quarter driven by strong performance of newly and recently launched drugs.
The company now expects revenues in 2018 to be between $21.9 billion and $22.8 billion, compared to the earlier estimate of $21.8-$22.8 billion. Earnings per share is now projected to come between $12.80 and $13.70, compared to the earlier estimate of $12.60 and $13.70.
Biogen Misses on Sales: Biogen (BIIB - Free Report) missed revenue estimates in the first quarter as Spinraza sales were drab.
The company’s leading multiple sclerosis franchise also saw sales declining. This biotech has been struggling in 2018. Nevertheless, earnings beat estimates and shares recovered and ended on a positive note at the end of the session.
Earlier, the company also extended its collaboration with Ionis Pharmaceuticals (IONS - Free Report) through a new 10-year agreement to develop novel antisense drug candidates for a broad range of neurological diseases. Per the agreement, Biogen will pay Ionis $1 billion in cash, which will include $625 million to purchase 11.5 million shares of Ionis common stock at a price of $54.34 per share.
(Read more: Biogen Q1 Earnings Beat, Sales Miss, Shares Down)
Calithera's Kidney Cancer Candidate Gets Fast Track Status: Shares of Calithera Biosciences, Inc. (CALA - Free Report) gained as the company announced that the FDA has granted Fast Track Designation to lead candidate, CB-839. The candidate is being developed in combination with Exelixis’ EXEL cabozantinib for the treatment of metastatic kidney cancer.
Calithera’s CB-839, a selective, potent inhibitor of glutaminase, is being evaluated in a phase II study – CANTATA – in combination with Cabometyx in clear cell renal cell carcinoma in patients previously treated with at least one vascular endothelial growth factor tyrosine kinase inhibitor or the combination of Opdivo and Yervoy. (Read more: Calithera's Kidney Cancer Candidate Gets Fast Track Status).
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index lost 3.84% over the last five trading sessions. Among major biotech stocks, Alexion lost 5.71%. Over the last six months, Regeneron lost 26.85% while Vertex gained 3.02% (See the last biotech stock roundup here: Biotech Stock Roundup: ALKS Up, CLDX Down, ALXN to Acquire Wilson Therapeutics).
What's Next in the Biotech World?
Stay tuned as quite are scheduled to report results later in the week and early next week.
Investor Alert: Breakthroughs Pending
A medical advance is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating substantial revenue, and even more wondrous products are in the pipeline.
Cures for a variety of deadly diseases are in sight, and so are big potential profits for early investors. Zacks names 5 stocks to buy now.
Click here to see them >>