What's Happening Now is a quick, thoughtful, real-time briefing regarding material events in the stem cell industry...definitely not the usual stream of insignificant press releases. The most current Happenings are boxed on the left-hand side of most pages on this site. Feel free to use this page to explore the archive of all past Happening items, and subscribe to the RSS feed to stay on top of the events that move the market and the industry.
Fate Therapeutics Prices IPO
Oct 1, 2013
, developer of stem cell modulating drugs, priced
its IPO yesterday at $6-$8 per share for up to 7.7 million shares. At the midpoint of that range, the company's market cap would be $64 million. The proceeds will advance the company's current Phase 2 trial of ProHema (a hematopoietic stem cell modulator) as well as its preclinical Wnt7a program. At the offer's closing, Fate will become the SCSI's 17th component company.
BioTime Completes Acquisition of Geron's ESC Assets
Oct 1, 2013
(BTX) and Geron jointly announced
the completion of BioTime's acquisition of Geron's shuttered embryonic stem cell therapeutic development program in an all-stock deal. A BioTime subsidiary, Asterias Biotherapeutics, will control the assets. Geron shareholders will receive 21% of Asterias' outstanding shares. Fields of use include medical indications in neurology, oncology, orthopedics and cardiovascular.
Fate Therapeutics IPO Moving Forward
Sep 18, 2013
San Diego-based Fate Therapeutics
, developer of stem cell-modulating drugs, took another step toward its IPO yesterday by filing an SEC form 8-A
registration. The company intends to offer 4 million shares at $14-$16 per share. Upon completion of this initial public offering Fate will become the 17th SCSI component company, and its 3 current clinical trials will join our Clinical Trials Monitor
. Its shares will trade on the NASDAQ market under the symbol "FATE".
Cytomedix Restructures, Plans to Exit the Stem Cell Therapeutics Business
Sep 18, 2013
Perennial penny-stock Cytomedix
yesterday a reorganization and its intention to shutter its stem cell therapeutic development program, acquired in 2012 from Aldagen, by the end of the year.
FDA Lifts Hold On Pluristem Trial
Sep 16, 2013
The FDA has lifted
the clinical hold on Pluristem
's (PSTI) Phase 2 intermittent claudication trial
, imposed last June due to an adverse event.
Baxter Angina Trial Losing Sites At Accelerating Pace
Sep 13, 2013
With 3 years left to go in its Phase 3 trial of CD34+ stem cells for angina, Baxter Healthcare
(not a SCSI component company) reported in its latest ClinicalTrials update
that the trial has terminated the Univ. of Cincinnati Medical Ctr. and Birmingham, AL's Cardiology PC has withdrawn from the trial. This brings to 4 the number of sites withdrawn or terminated since Aug. 16, a trend that sometimes signals significant problems for a clinical trial.
Thermogenesis' Clinical Trial Reaches Primary Completion Without Company Comment
Sep 5, 2013
' (KOOL) uncontrolled, open-label clinical trial of its autologous bone marrow mononuclear cells for critical limb ischemia achieved primary completion this month (1+ years late), according to its ClinicalTrials.gov record
. In a move unusual in this industry, it did not mark the event with a press release discussing whether the trial's primary outcome objective was achieved. The company's SEC annual report, filed yesterday, was also silent on this point.
New Life For Athersys' Stroke Trial
Aug 27, 2013
After languishing for nearly two years with just a single recruiting site and no record updates, Athersys
' (ATHX) Phase 2 stroke trial showed new life in its most recent update
, introducing 32 new sites, 22 of which are actively recruiting, thereby prompting our Clinical Trials Monitor
to upgrade the trial from red- to yellow-flag status.
Baxter Terminating Trial Sites
Aug 27, 2013
In its most recent ClinicalTrials.gov record update
, Baxter Healthcare
(not a SCSI component company) reports terminating the Univ. of Miami School of Medicine from its Phase 3 trial of CD34+ autologous stem cells for refractory angina. This is the trial's second site termination this month. Site terminations are unusual among the stem cell clinical trials we monitor.
Aussie Stem Cell Company, Regeneus, Files IPO
Aug 20, 2013
Australian stem cell enterprise, Regeneus Ltd.
, has filed
for an IPO valued at USD $11 million. The company currently markets minimally manipulated autologous adipose-derived MSCs for orthopedic procedures and has recently completed an Australian Phase 2 clinical trial
in osteoarthritis. Funds will be used to develop an allogeneic stem cell therapy.
Fate Therapeutics Plans IPO
Aug 15, 2013
filed an S-1
with the SEC yesterday, signaling its intention to pursue a $69M IPO. If successful, the stem cell modulator company would become the third new component company added to our Stem Cell Stock Index this year. Its ProHema product (currently in a Phase 2 trial for marrow reconstitution) might compete with Cytomedix
's (CMXI) Aldagen products.
Athersys Acknowledges Recruiting Challenge, Sees Colitis Trial Results in Early 2014
Aug 15, 2013
Acknowledging a slow recruitment pace for Athersys
(ATHX) partner Pfizer's trial of MultiStem cells in ulcerative colitis due to competition for patients among numerous trials, CEO Van Bokkelen noted
a trend our Clinical Trials Monitor
first flagged in May of this year. Pfizer and Athersys expect results "early in 2014."
BrainStorm Prices New Dilutive Offering; Shares Drop
Aug 14, 2013
Israel-based and perennially under-capitalized BrainStorm Cell Therapeutics
(BCLI), in its 8th year of operation under a 'going concern' warning, priced
a highly dilutive new share offer yesterday, triggering a sell-off that drove BCLI shares down 18% to $0.17
Aastrom Offers New Shares; Price Plummets
Aug 14, 2013
In a move that will more than double its shares outstanding, Aastrom
a new share offering, triggering a massive sell-off that depressed the share price 43%. The new offer will raise roughly $8 million for the beleaguered company, leaving it $12 million in cash (about half a year of runway, with the completion of its only current clinical trial
still two years away).
Osiris Soars on Grafix trial success
Aug 13, 2013
Shares of Osiris Therapeutics
(OSIR) shot up 139% on extremely heavy volume on news
that the diabetic foot ulcer clinical trial for Grafix (a processed viable placental tissue wound dressing) will end early due to "overwhelming efficacy." While Grafix is not a stem cell treatment itself, its success provides Osiris with much-needed leeway to decide the fate of stem cell drug, Prochymal.
Athersys Confirms Plans to Launch Phase 2 Heart Attack Trial
Aug 13, 2013
On the heels of a promising Phase 1 trial and a new $2.8 million grant, Athersys
it will launch a Phase 2 heart attack clinical trial for MultiStem "early next year."
Cytori To Terminate European Heart Attack Trial
Aug 12, 2013
In its quarterly business update, Cytori
it will terminate its European heart attack trial, ADVANCE. The news validates the red-flag downgrade our Clinical Trials Monitor
assigned this trial as of late 2012.
SCSI Initiates Coverage of bluebird bio
Aug 11, 2013
Following the recent completion of its IPO, stem cell gene therapy company bluebird bio
joins the SCSI as the component
with the index's highest market cap, $648M versus #2 Osiris Therapeutics' $345M. bluebird's two clinical trials are now included in our Clinical Trials Monitor
NeoStem's Phase 2 Trial Downgraded
Aug 9, 2013
Continuing site withdrawals and an unfeasible completion date earned NeoStem
's (NBS) Phase 2 heart attack clinical trial a red flag downgrade from our automated Clinical Trials Monitor
for the trial record's most recent update.
Athersys Wins $2.8M Grant To Support Phase 2 Cardiac Trial
Aug 6, 2013
Athersys< Previous Page
receipt of a $2.8M SBIR grant from the U.S. National Heart, Lung, and Blood Institute to support a Phase 2 trial of MultiStem cells in heart attack.
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