Novel cellular immunotherapies for cancers and orphan inherited blood disorders (Seite 3)
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ISIN: US0794814048 · WKN: A2PZPL · Symbol: BLCM
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Gestern gab es ja nachbörslich noch die gute Nachricht das der Hold aufgehoben wurde.
Bellicum Announces Clinical Hold Lifted on U.S. Studies of BPX-501
HOUSTON, April 11, 2018 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, today announced that the U.S. Food and Drug Administration has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events. Bellicum will be working with U.S. clinical sites to resume patient recruitment based on the amended protocols. The FDA clinical hold did not affect the BP-004 registrational trial in Europe, which is fully enrolled.
http://ir.bellicum.com/node/8476
Hoffentlich ist die Nachbörse von Gestern heute zu halten mein Nachkauf hat sich zum Glück sehr gelohnt.
Bellicum Announces Clinical Hold Lifted on U.S. Studies of BPX-501
HOUSTON, April 11, 2018 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, today announced that the U.S. Food and Drug Administration has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events. Bellicum will be working with U.S. clinical sites to resume patient recruitment based on the amended protocols. The FDA clinical hold did not affect the BP-004 registrational trial in Europe, which is fully enrolled.
http://ir.bellicum.com/node/8476
Hoffentlich ist die Nachbörse von Gestern heute zu halten mein Nachkauf hat sich zum Glück sehr gelohnt.
Bellicum Announces Update on Clinical Hold of U.S. BPX-501 Studies
HOUSTON, Feb. 23, 2018 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, today announced it has received notification from the U.S. Food and Drug Administration (FDA) outlining the criteria required for lifting the clinical hold on U.S. studies of BPX-501. To address the FDA requirements, the Company plans to implement revisions to the U.S. study protocols, including the addition of more comprehensive monitoring and management of neurotoxicity. In addition, the Company will revise the Investigator Brochure and Informed Consent Documents to inform healthcare providers, patients and caregivers of the changes. The Company expects to provide a full response to the FDA within a few weeks.
The clinical hold does not affect the Company’s BP-004 registration trial in Europe.
http://ir.bellicum.com/news-releases/news-release-details/be…
HOUSTON, Feb. 23, 2018 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, today announced it has received notification from the U.S. Food and Drug Administration (FDA) outlining the criteria required for lifting the clinical hold on U.S. studies of BPX-501. To address the FDA requirements, the Company plans to implement revisions to the U.S. study protocols, including the addition of more comprehensive monitoring and management of neurotoxicity. In addition, the Company will revise the Investigator Brochure and Informed Consent Documents to inform healthcare providers, patients and caregivers of the changes. The Company expects to provide a full response to the FDA within a few weeks.
The clinical hold does not affect the Company’s BP-004 registration trial in Europe.
http://ir.bellicum.com/news-releases/news-release-details/be…
Citi raised its price target on Bellicum Pharmaceuticals (NASDAQ: BLCM) to $27.00 (from $24.00) while maintaining a Buy rating.
Analyst Robyn Karnauskas comments "We think CAR-T tech value is not currently in the stock, as potential partners according to the company want to see data showing that the activation switch works first. Potential partners could be cell therapy cos looking to add switch technology or I/O cos that haven’t entered cell therapy yet. BLCM stresses that it is an integrated cell therapy co and wants to develop products w/ partners rather than just provide tech."
Analyst Robyn Karnauskas comments "We think CAR-T tech value is not currently in the stock, as potential partners according to the company want to see data showing that the activation switch works first. Potential partners could be cell therapy cos looking to add switch technology or I/O cos that haven’t entered cell therapy yet. BLCM stresses that it is an integrated cell therapy co and wants to develop products w/ partners rather than just provide tech."
Meinungen zu Bellicum Pharmaceuticals (BLCM)?
Nach dem Clinical Hold von BPX-501 hat die Aktie rund 1/3 an Wert verloren.
BLCM scheint sich jedoch trotz Turbulenzen im Markt zu stabilisieren. (Gestern leicht im Plus)
RSI ist überverkauft.
Wenn das Clinical Hold wieder aufgehoben wird hat die Aktie leicht Spielraum auf Kurse zwischen USD 7.50 und USD 10.00. Spannend ist auch, dass der Clinical Hold nur für USA und nicht Europa gilt.
Nach dem Clinical Hold von BPX-501 hat die Aktie rund 1/3 an Wert verloren.
BLCM scheint sich jedoch trotz Turbulenzen im Markt zu stabilisieren. (Gestern leicht im Plus)
RSI ist überverkauft.
Wenn das Clinical Hold wieder aufgehoben wird hat die Aktie leicht Spielraum auf Kurse zwischen USD 7.50 und USD 10.00. Spannend ist auch, dass der Clinical Hold nur für USA und nicht Europa gilt.
Bellicum Pharmaceuticals Announces Clinical Hold on BPX-501 Clinical Trials in the United States
http://ir.bellicum.com/news-releases/news-release-details/be…
http://ir.bellicum.com/news-releases/news-release-details/be…
Und eben wieder raus ...
Hier dürfte nun dank Celgene / Juno was gehen! Aktie am Allzeittief...
Hier seit heute mal dabei !
Sickle cell disease is an autosomal recessive disorder caused by a simple mutation in the gene coding for hemoglobin, which affects hemoglobin's ability to carry oxygen and causes it to polymerize. These hemoglobin polymers distort red blood cells' shape and increase their rigidity, leading to anemia, occluded blood flow and pain crises during severe episodes.
Sickle cell disease is curable with stem cell transplantation, but most patients do not have a matched donor to serve as the graft source. Two groups, Gamida Cell and Bellicum (NASDAQ:BLCM), are working on expanded grafts that might be used by non-matched or partially matched patients.
Clearly, this is complex, but unlike stem cells few small-molecule or antibody approaches will treat the disease's underlying cause. The aim with rivipansel, for instance, is to reduce adhesion of red blood cells, thus making it harder for them to aggregate.
Also acting via anti-adhesive properties is Modus Therapeutics' Sevuparin, a phase II asset that has been licensed to Ergomed. Endari is similarly a symptom-targeting agent, aiming to reduce oxidative damage to cells, while Eliquis is being studied for its anticoagulant effects.
Sickle cell disease is curable with stem cell transplantation, but most patients do not have a matched donor to serve as the graft source. Two groups, Gamida Cell and Bellicum (NASDAQ:BLCM), are working on expanded grafts that might be used by non-matched or partially matched patients.
Clearly, this is complex, but unlike stem cells few small-molecule or antibody approaches will treat the disease's underlying cause. The aim with rivipansel, for instance, is to reduce adhesion of red blood cells, thus making it harder for them to aggregate.
Also acting via anti-adhesive properties is Modus Therapeutics' Sevuparin, a phase II asset that has been licensed to Ergomed. Endari is similarly a symptom-targeting agent, aiming to reduce oxidative damage to cells, while Eliquis is being studied for its anticoagulant effects.