Biotech Stock Roundup: Alkermes Drug Fares Well, Targacept …
Major updates in the biotech sector over the past four trading days were on the pipeline and regulatory front from companies like Alkermes (ALKS – Analyst Report) and Amgen (AMGN – Analyst Report) among others.
Recap of the Week’s Most Important Stories
1. Alkermes’ experimental schizophrenia treatment, ALKS 3831, fared well in a mid-stage study. Earlier this year, the company had said that the candidate had met the primary endpoint of the study. Latest data from the completed study supports the initial positive results. Alkermes is looking to move the candidate into pivotal development later this year (Read more: Alkermes Reports Encouraging Data on Schizophrenia Drug).
2. Regulus (RGLS) got some encouraging news with its partner AstraZeneca selecting a microRNA therapeutic candidate for clinical development. RG-125 (AZD4076) is the first clinical development candidate to be selected under the alliance, and will be evaluated for the treatment of nonalcoholic steatohepatitis (NASH) in type II diabetes/pre-diabetes patients. There is significant unmet medical need in this area. With AstraZeneca selecting a candidate, Regulus will receive a $2.5 million milestone payment. So far, Regulus has received $28 million under this alliance and is eligible to receive up to $495.5 million in future milestone payments.
3. Juno Therapeutics (JUNO), which has been in litigation with the Trustees of the University of Pennsylvania and Novartis announced a settlement agreement to resolve the dispute. The litigation, which started with a contract dispute, later included a dispute regarding U.S. Patent No. 8,399,645. However, with the litigation being resolved, Novartis has agreed to make an initial payment of $12.25 million to Juno along with milestone and royalty payments. Both Novartis and Juno are working on bringing CAR-T therapies to market. The CAR technology involves the activation of T cells in a patient so that cancer cells can be attacked. Apart from Juno and Novartis, several companies including Kite Pharma and Celgene are looking to bring CAR-T therapies to market.
4. Targacept (TRGT), which is set to merge with privately-held biopharma company Catalyst Biosciences, saw its shares falling on news that Pfizer has decided to walk out of a research and license agreement for the development and commercialization of Catalyst’s leading human Factor VIIa candidate for the treatment of hemophilia and surgical bleeding indications (Read more: Targacept Crumbles as Pfizer Pulls Out of Collaboration).
5. On the regulatory front, Gilead (GILD – Analyst Report) is looking to get its fixed-dose combination HIV treatment approved in the U.S. The company, which holds a strong position in the HIV market, believes that the high antiviral efficacy and favorable safety profile of the combination (emtricitabine/tenofovir alafenamide) could provide an improved backbone for a new generation of HIV regimens.
Meanwhile, biotech major, Amgen, said that its cancer treatment, Vectibix, has been approved in the EU for the first-line treatment (in combination with FOLFIRI) of adult patients with wild-type RAS metastatic colorectal cancer (mCRC).
Another company that received some encouraging news on the regulatory front is Repros. The company said that the FDA has accepted its regulatory filing for its experimental secondary hypogonadism treatment (Read more: Repros’ Secondary Hypogonadism Drug Under FDA Review). Moreover, the European Medicines Agency (EMA) told the company that the treatment is eligible for filing as a New Active Substance. This means that the company can apply for a supplementary protection certificate for the extension of exclusivity (Read more: Repros Gets EU Update on Secondary Hypogonadism Drug).
Performance
Over the last four trading days, Celgene’s (CELG – Analyst Report) shares were down 1.61% among major biotechs while Alexion was the highest gainer (3.83%). Biogen was the highest gainer (32.34%) over the last six months. Gilead lost 5.37% during this period.
The NASDAQ Biotechnology Index was up marginally (0.43%) over the last four trading days (See the last biotech stock roundup here: Horizon to Buy Hyperion, Conatus Up on Liver Disease Data).
Company
Last Week
Last 6 Months
AMGN
0.11%
16.68%
BIIB
1.03%
32.34%
GILD
0.99%
-5.37%
CELG
-1.61%
21.93%
REGN
0.11%
24.69%
ALXN
3.83%
4.79%
VRTX
3.47%
17.15%
What’s Next in the Biotech World?
With first quarter earnings season yet to start, watch out for the usual pipeline updates and data presentations from biotech companies. Meanwhile, The Medicines Co.’s Cangrelor is scheduled to be reviewed by an FDA advisory panel next week.
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Biotech Stock Roundup: Alkermes Drug Fares Well, Targacept …
