Geron Corporation (GERN – Analyst Report) was in the spotlight last week with the company striking a collaboration deal with Johnson & Johnson for its sole pipeline candidate, imetelstat. Meanwhile, companies like Gilead (GILD – Analyst Report) and Regeneron (REGN – Analyst Report) remained in the news thanks to regulatory updates.
Recap of the Week’s Most Important Stories
1. Geron, which had run into trouble earlier this year related to the development of its sole pipeline candidate, imetelstat, has struck a collaboration deal with Johnson & Johnson’s Janssen Biotech, Inc. Janssen gained exclusive global rights to develop and commercialize imetelstat for oncology, including hematologic malignancies, and other human therapeutics uses.
This agreement is a huge positive for Geron and comes shortly after the FDA lifted its full clinical hold on an investigational new drug (IND) application filed by the company for imetelstat. Under the Janssen collaboration, Geron could end up earning up to $935 million (including an upfront payment of $35 million) as well as royalties on sales.
Although Geron will be splitting development costs with Janssen and a major part of the payments from Janssen depends on the achievement of certain milestones, the agreement comes as a welcome respite for Geron shareholders – shares were up 19.5% immediately after the announcement and are up 37.2% so far (Read more: Geron Collaborates with J&J for Imetelstat).
2. Celldex Therapeutics, Inc.’s (CLDX – Snapshot Report) shares shot up on encouraging interim data from a mid-stage study evaluating rindopepimut in patients with recurrent glioblastoma (Read more: Celldex Therapeutics Surges on Positive Rindopepimut Data).
3. Regeneron’s blockbuster eye drug, Eylea, has gained approval for another indication, this time in Japan. Eylea, which was already approved in Japan for the treatment of patients with neovascular age-related macular degeneration, macular edema secondary to central retinal vein occlusion, and myopic choroidal neovascularization, can now be used for diabetic macular edema. Shares were up 3.4%.
4. Gilead is set to generate more sales from its hepatitis C virus (HCV) franchise with its latest offering, Harvoni, now gaining EU approval as well. Harvoni was approved in the U.S. in October. Harvoni, a cocktail treatment, is a once-daily single tablet regimen comprising ledipasvir and Sovaldi. High cure rates and a convenient dosing regimen should drive uptake. However, AbbVie (ABBV – Analyst Report) could shortly enter the HCV market with its cocktail treatment which is currently under regulatory review.
5. CytRx Corporation has received a notice from the FDA informing the company that a partial clinical hold has been placed on studies being conducted with its experimental cancer treatment, aldoxorubicin. A partial clinical hold means that although currently enrolled patients will continue being treated, no new patients will be enrolled.
The FDA placed the partial clinical hold due to the reported death of an advanced-stage cancer patient who had received the experimental treatment under the company’s compassionate use program. CytRx is working on getting the partial clinical hold lifted and does not expect study timelines to be materially impacted by this development.
Over the last five trading days, Regeneron was the only major biotech to record a gain with share price increasing 3.73%. Meanwhile, Biogen lost the most during this period (down 5.86%).
Vertex recorded the highest gain (70.75%) among major biotechs over the last six months.
Overall, the NASDAQ Biotechnology Index was down 0.30% over the last five trading days (See the last biotech stock roundup here: Gilead, AbbVie Score at Liver Meeting, Dendreon Files for Bankruptcy).
Last 6 Months
What’s Next in the Biotech World?
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