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Thu, Jun. 25, 5:35 PM
Wed, Jun. 24, 7:10 AM
- Bluebird bio (NASDAQ:BLUE) prices its public offering of 2,941,176 shares of common stock at $170 per share. Underwriters over-allotment is an additional 441,176 shares.
- Net proceeds will fund the advancement of its immuno-oncology programs, the buildup of its commercial infrastructure in Europe, the expansion of its manufacturing capabilities, the initiation of clinical studies of LentiGlobin for the treatment of beta-thalassemia major and general corporate purposes.
- Shares are down 2% premarket on light volume.
Tue, Jun. 23, 4:49 PM
Mon, Jun. 22, 9:01 AM
- Kite Pharma (NASDAQ:KITE) and bluebird bio (NASDAQ:BLUE) enter into a collaboration agreement to co-develop and co-commercialize second generation T cell receptor (TCR) product candidates directed against the human papillomavirus type 16 E6 (HPV-16 E6) oncoprotein incorporating gene editing and lentiviral technologies. Kite has a broad pipeline of TCR product candidates while bluebird has a gene delivery and editing platform with a focus on rare diseases and cancer immunotherapies.
- Kite will continue to develop its own TCR programs directed against high-risk HPV, including its Phase 1-stage HPV-16 E6 TCR and HPV-16 E7 TCR.
- Under the terms of the agreement, both firms will jointly develop and commercialize the product candidates. Kite will lead in the U.S. while bluebird has the option to lead in the European Union. Both will share overall costs and profits. Kite has the option of co-promoting in the EU while bluebird has the option of co-promoting in the U.S.
- HPV is the most common viral infection of the reproductive tract. HPV type 16 and type 18 are believed to cause 70% of cervical cancers.
- Kite will discuss the deal during its Investor Day on June 23.
- KITE is up 4% premarket on light volume. BLUE is up 2% premarket also on light volume.
Mon, Jun. 15, 4:12 PM
Wed, Jun. 3, 4:58 PM
- The collaboration between Celgene (NASDAQ:CELG) and bluebird bio (NASDAQ:BLUE) that began in March 2013 to develop and commercialize CAR-T therapies has a new focus. The companies will now direct their efforts on developing product candidates targeting B-cell maturation antigen (BCMA) for the next three years. BCMA is a cell surface protein that is expressed in normal plasma cells and in most myeloma cells, but is absent in other normal tissues.
- The companies will work together on the initial anti-BCMA candidate, known as bb2121, as well as next-generation anti-BCMA product candidates. A Phase 1 study of bb2121 will commence in early 2016.
- The rights to all other CAR-T programs developed by bluebird under the collaboration will remain with bluebird.
- Under the terms of the amended collaboration, bluebird will receive an upfront payment of $25M to fund the development of the lead anti-BCMA candidate through a Phase 1 study and the development of next-generation anti-BCMA candidates through Phase 1 trials. Celgene will have the option to develop and commercialize each product candidate worldwide and bluebird has the option to share equally in the development and commercialization of each candidate in the U.S. Celgene will pay bluebird development and regulatory milestone payments as well as royalties on net sales.
- BLUE is down 2% after hours on average volume. CELG is unchanged.
Tue, Jun. 2, 12:30 PM
- According to Bloomberg, AstraZeneca (AZN +0.1%) CEO Pascal Soriot said that his firm would consider buying a company like Juno Therapeutics (JUNO +12.9%).
- This isn't too surprising since oncology represents only 11% of AZN's business. CAR-Ts are all the rage in the cancer space. If their initial success can be validated in late-stage trials, they will command premium prices once approved, probably in the neighborhood of $500K per procedure. Acquiring one of the leaders would be a logical move for most members of Big Pharma or a number of larger biotechs. Juno's market cap is only $5.5B so it is not expensive if viewed on a long term basis.
- Related tickers: (KITE +5.4%)(BLUE -0.5%)(BLCM +8.2%)(ZIOP +4%)(CLLS +4.4%)
Tue, May 26, 4:21 PM
- Bluebird bio (NASDAQ:BLUE) and Five Prime Therapeutics (NASDAQ:FPRX) enter into a collaboration to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies based on Five Prime's proprietary human antibodies to a undisclosed cancer target for hematologic malignancies and solid tumors.
- Under the terms of the agreement, bluebird will have exclusive rights to Five Prime's novel human antibodies to the target and will develop CAR-T therapies against the target using its proprietary lentiviral gene therapy platform and CAR-T expertise. Five Prime will receive a $1.5M upfront payment, milestones up to ~$128.5M and tiered royalties on commercial sales. Bluebird will conduct and fund clinical trials as well as regulatory and commercial activities.
Thu, May 21, 10:30 AM
- On June 13, bluebird bio (BLUE +6%) will present clinical data on its ongoing Phase 1/2 trial, HGB-205, evaluating Lentiglobin BB305 in patients with beta-thalassemia and sickle cell disease (SCD), at the 20th Congress of the European Hematology Association in Vienna, Austria.
- Two patients with beta-thalassemia major remain transfusion independent at 14 months and 11 months post transplant, respectively.
- One SCD patient who was receiving chronic transfusions before transplantation was weaned off in 88 days and showed an anti-sickling hemoglobin level of 24% at 4.5 months follow up. According to the company, a level of at least 30 has the potential to reduce or eliminate the serious and life-threatening events associated with SCD.
- Lentiglobin BB305 is a gene therapy that inserts a functional human beta-globin gene into the patient's own hematopoietic stems cells in a process performed outside of the body. The modified cells are then infused into the patient.
Thu, May 21, 9:16 AM
Tue, May 19, 7:49 AM
- Based on meetings with regulatory authorities in the U.S. and Europe, bluebird bio (NASDAQ:BLUE) clarifies its regulatory strategy for the approval of LentiGlobin BB305 for the treatment of beta thalassemia major.
- In the U.S., the Biologics License Application (BLA) will be supported by the results from four clinical trials: Northstar and HGB-205, both of which are in process, and HGB-207 (adults and adolescents) and HGB-208 (pediatric), both of which are planned. The latter two trials will each enroll 15 patients with a follow-up period of 24 months. The primary endpoint will be 12 months of transfusion independence. The FDA designated LentiGlobin BB305 a Breakthrough Therapy in February. This provides for more intensive guidance from the agency on an approval path, the involvement of more senior personnel and a rolling review of the BLA.
- In Europe, approval will be pursued via the European Medicines Agency's Adaptive Pathways pilot program which will allow conditional approval based, in large part, on the results from the Northstar and HGB-205 studies. Full approval will be based on the results from HGB-207 and HGB-208, supportive long-term follow-up data and "real-life" post-approval monitoring data.
- The company will host a conference call this morning at 8:00 am ET for investors.
Wed, May 6, 5:49 PM
Tue, Apr. 28, 1:16 PM
- Retrophin (RTRX) initiated with a Buy rating and $50 (120% upside) price target by Deutsche Bank.
- Stemline Therapeutics (STML -0.8%) initiated with Buy rating and $38 (146% upside) price target by H.C. Wainwright.
- Trillium Therapeutics (TRIL -0.4%) initiated with Outperform rating and $29 (32% upside) price target by Leerink Swann.
- Juniper Pharmaceuticals (JNP -0.5%) initiated with Buy rating and $15 (102% upside) by Roth Capital.
- Radius Health (RDUS -2.8%) initiated with a Buy rating and $50 (35% upside) by Maxim Group.
- DARA Biosciences (DARA +1.1%) initiated with Buy rating and $2 (138% upside) price target by H.C. Wainwright.
- UniQure (QURE -2.5%) initiated with a Buy rating and $40 (60% upside) by Chardan Capital.
- NeuroDerm (NDRM -1.7%) initiated with Buy rating and $21 (70% upside) price target by Jefferies.
- Bluebird bio (BLUE +1.2%) initiated with Buy rating and $190 (42% upside) price target by Maxim Group.
- Cidara Therapeutics (CDTX -1.9%) initiated with Sell rating and $13 (12% upside) price target by WBB.
Sun, Apr. 26, 4:57 PM
- Celladon (NASDAQ:CLDN) says its Phase 2b CUPID2 trial did not meet its primary and secondary endpoints. All other exploratory efficacy endpoints were also inconsistent with a treatment effect.
- "We are surprised and very disappointed that MYDICAR failed to meet the endpoints in the CUPID2 trial, and we are rigorously analyzing the data in an attempt to better understand the observed outcome."
- The primary endpoint was time to recurrent heart failure related events. The secondary efficacy endpoint was time to first terminal event.
- Conference call Monday at 8:30 AM.
- Other stocks likely in play Monday morning: bluebird bio (NASDAQ:BLUE), Uniqure (NASDAQ:QURE), Avalanche (NASDAQ:AAVL)
- Source: Press Release
- Previously: Celladon trends lower on bearish article (Apr. 22)
- Related: Celladon: CUPID-2 Is Likely To Fail (Apr. 22)
- Related: Celladon: A Good Deal, And A Rare Buy-Write Opportunity (Apr. 20)
- Related: CEO Krisztina Zsebo on Q4 2014 Results (Mar. 31)
Mon, Mar. 30, 9:05 AM
- Intrexon (NYSE:XON) and Merck Serono establish a strategic collaboration to develop and commercialize Chimeric Antigen Receptor T-cell (CAR-T) cancer therapies. The partnership will leverage Merck Serono's expertise in immuno-oncology with Intrexon's cell engineering techniques and RheoSwitch platform. Merck Serono will have exclusive access to Intrexon's suite of technologies to engineer T cells with optimized and inducible gene expression.
- Under the terms of the agreement, Intrexon will receive an upfront payment of $115M. It will also receive research funding for the first two targets selected by Merck Serono plus milestones up to $826M and tiered royalties on commercial sales. Intrexon is eligible to receive further payments upon the achievement of certain technology development milestones.
- Merck Serono is the biopharmaceutical business of Merck KGaA.
- CAR-T-related tickers: (NASDAQ:JUNO) (NASDAQ:KITE) (NASDAQ:BLUE) (NASDAQ:BLCM)
Thu, Mar. 19, 1:29 PM
- Investors show some love for CAR-T-related stocks today. Drugs based on Chimeric Antigen Receptor technology are the "next big things" in cancer treatment. Early data show impressive results in certain blood cancers.
- Newcomer Cellectis (Pending:CLLS) should debut shortly.
- Related tickers: (JUNO +14.8%)(KITE +14.9%)(BLUE +5.2%)(BLCM +7.7%)(ZIOP +4.6%)(CNDO +40.1%)
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