Biotech Stock Roundup: Sophiris & Cyclacel Plunge on Data – Zacks …
With the holiday season coming up, it’s been a relatively quiet week for the biotech sector with very few pipeline and regulatory updates. However, companies like Sophiris (SPHS – Snapshot Report) and Cyclacel saw their shares plunging on disappointing pipeline updates.
Recap of the Week’s Most Important Stories
1. Sophiris faced a major pipeline setback following an interim analysis of an ongoing late-stage study on its experimental prostate cancer treatment, PRX302. An early look at the data from the study evaluating PRX302 as a treatment for lower urinary tract symptoms of benign prostatic hyperplasia showed that a predefined efficacy threshold was not met. This is highly disappointing news for the company and shares plummeted 81.5% (Read more: Sophiris Plunges on Disappointing Data on its BPH Candidate).
2. Cyclacel’s shares plunged 75.9% on news that the company’s experimental leukemia treatment, sapacitabine, is not likely to meet the primary endpoint in a late-stage study. A planned interim analysis showed that the futility boundary had been crossed and the study will most likely fail to achieve a statistically significant improvement in survival. This is indeed disappointing news considering sapacitabine is the lead candidate in Cyclacel’s pipeline.
3. ChemoCentryx’s (CCXI – Snapshot Report) shares were up almost 25% on positive top-line data from a mid-stage study evaluating CCX140 for diabetic nephropathy, a type of kidney disease. Based on the encouraging data, ChemoCentryx should be in a position to move the candidate into phase III studies and also seek partnership opportunities (Read more: ChemoCentryx Up on Positive Diabetic Nephropathy Data).
4. Exelixis’ (EXEL – Snapshot Report) collaboration partner Roche (RHHBY – Analyst Report) is seeking FDA approval for their combination skin cancer treatment – cobimetinib plus Zelboraf. The companies are seeking EU approval as well. Phase III results showed that the cobimetinib – Zelboraf combination cut the risk of disease worsening or death by half. Median progression free survival was 9.9 months for the combination treatment compared to 6.2 months for Zelboraf alone (Read more: Roche Submitted NDA for Melanoma Combination Drug).
5. Alexion (ALXN – Analyst Report) got orphan drug status for Soliris for yet another indication in Japan. The product, which already has orphan drug designation in Japan for paroxysmal nocturnal hemoglobinuria (PNH), has now been granted orphan drug status for myasthenia gravis (MG), a rare, debilitating neurologic disorder.
Orphan drug status is granted in Japan to drugs and medical devices targeting serious diseases with high unmet medical need that affect less than 50,000 patients in the country. This designation provides benefits and incentives like priority review and 10 years of market exclusivity once approval is obtained (Read more: Alexion’s Soliris Receives Orphan Drug Status in Japan).
Alexion also announced its intention to buy back shares worth up to an additional $500 million. The company’s current $400 million share buyback program has approximately $22 million remaining (Read more: Alexion Announces New Share Repurchase Program of $500M).
Performance
Over the last five trading days, Alexion’s shares declined the most (11.04%) among major biotechs followed by Regeneron (8.45%).
Vertex recorded the highest gain (65.17%) among major biotechs over the last six months.
Overall, the NASDAQ Biotechnology Index was down 6.65% over the last five trading days (See the last biotech stock roundup here: Cubist to be Acquired by Merck, bluebird Shoots Up on ASH Data).
Company
Last Week
Last 6 Months
AMGN
-5.87%
38.45%
BIIB
-6.47%
5.57%
GILD
-5.15%
24.38%
CELG
-7.24%
36.69%
REGN
-8.45%
28.45%
ALXN
-11.04%
9.16%
VRTX
-7.85%
65.17%
What’s Next in the Biotech World?
A response from the FDA regarding the approval status of Cubist’s (CBST – Analyst Report) anti-infective, Zerbaxa, should be out shortly.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
View post:
Biotech Stock Roundup: Sophiris & Cyclacel Plunge on Data – Zacks …
