Biotech Stock Roundup: Biogen Up for S&P100, Geron Plunges on Clinical Hold - Analyst Blog

Biogen BIIB to Be Added to S&P 100: Biogen's shares were up 3.9% on news that it will be added to the S&P 100 index after market close on Friday, Mar 21. With a market cap of more than $80 billion, Biogen is considered to be more representative of the mega-cap market space.

Geron GERN Plunges on FDA Clinical Hold: Geron saw its shares plunging 61.6% on news that the FDA has placed a full clinical hold on the company's sole pipeline candidate, imetelstat.

A clinical hold is an order issued by the FDA under which the sponsor of the study is asked to delay a proposed trial or suspend an ongoing trial. So, not only will the company not be able to initiate a study on imetelstat as it was planning to do, the notice will also affect currently ongoing studies on imetelstat which have been sponsored by Geron.

What is really a matter of concern is that the FDA is worried about the occurrence of persistent low-grade liver function test (LFT) abnormalities in a phase II study for essential thrombocythemia/polycythemia vera (ET/PV) as well as the potential risk of liver damage following long-term exposure to imetelstat.

Needless to say, the full clinical hold on imetelstat is a major setback for Geron. Geron has suffered imetelstat-related setbacks earlier too. Even if imetelstat studies continue, concerns about LFT abnormalities could limit the commercial potential of the candidate and restrict its long-term usage.

Alexion Ups Guidance: Alexion boosted its 2014 earnings and revenue guidance based on a reimbursement deal in France for Soliris. The company raised its revenue guidance by $150 million and earnings guidance by 67 cents. Investors expressed their approval and sent shares up 7.1%.

Regado Gains on Fast Track Status: Regado's shares popped 38.1% on news that the FDA has given fast track status to the company's anticoagulant treatment currently in a phase III program. Fast-track status means the development and review process could be speedier with more frequent and timely communication and meetings with the FDA. The candidate could also be granted priority review.

Other Developments:

KYTHERA Acquires Ex-U.S. Rights to ATX-101: KYTHERA regained ex-U.S. rights to its double chin reduction candidate, ATX-101, from Bayer. Shares were up 4.7% as worldwide rights to the candidate return to KYTHERA. The company intends to file for U.S. approval in the second quarter and approval in other countries over the next 12 months. KYTHERA can pursue new partnerships for ex-U.S. territories and can also be an attractive takeover candidate for companies interested in the facial aesthetics market.

Gilead's Patent Woes: Idenix IDIX is going on adding to its patent infringement lawsuits against Gilead regarding the latter's hepatitis C virus treatment, Sovaldi (sofosbuvir). This time round, the company has filed patent infringement lawsuits against Gilead in three countries -- France, Germany and the U.K. According to Idenix, Sovaldi infringes Idenix's European patent.

This is not the first patent infringement lawsuit to be filed by Idenix against Gilead. Late last year, Idenix had filed lawsuits in the U.S. as well.

Raptor Down on Guidance: Investors expressed their disappointment on Raptor Pharmaceuticals' guidance for Procysbi, which is approved for the management of nephropathic cystinosis. Shares were down 23.9%.

Celgene CELG Down on Revlimid News: Shareholders of Celgene got spooked by two Revlimid related news – the first news came from the U.K. where draft guidance rejecting the use of multiple myeloma drug, Revlimid, in certain situations was issued. The second news is related to a patent infringement lawsuit for Revlimid in the U.S. The trial is set to commence sooner than expected. Shares were down 4.2% on these updates. However, both developments should not be major sources of concern.

The Week So Far:

Amgen Scores with Evolucumab - Again: Amgen AMGN shares were up 4% this week with the company continuing to present positive data on its PCSK9 inhibitor, evolocumab.

What's Up with Intercept? Intercept Pharma ICPT, which saw its shares skyrocketing 281% earlier this year, seems to be on a rollercoaster ride with shares first declining 11.9% at the beginning of this week and then regaining 6.8%. Share price movement was driven by negative and positive updates on the company's lead pipeline candidate - obeticholic acid (OCA).

Five Prime Cuts $350 million Deal: Five Prime Therapeutics, Inc. FPRX saw it shares soar 22.6% on its collaboration agreement with Bristol-Myers for the discovery, development and commercialization of immuno-oncology treatments, a hot therapeutic area.

Prosensa Up on Data: Dutch company, Prosensa, said that a further analysis of data on its experimental drug, drisapersen (Duchenne muscular dystrophy DMD) showed that treating earlier in DMD and treating longer shows a delay in disease progression. The company also provided positive 48-week data from a mid-stage study. Shares were up 3.9%.

Biogen Faces Delay in Plegridy Approval Date: Biogen, well known for its strong presence in the multiple sclerosis MS market, is facing a delay in the approval process for its experimental MS drug, Plegridy. The FDA has extended the review period by three months.

Medivation Files for Chemo-Naïve Population: Medivation and partner Astellas are looking to get the label for their prostate cancer treatment, Xtandi, expanded into the chemo-naïve patient population.

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