=Bellicum Pharma (BLCM) : FDA lifts the clinical hold on studies of BPX-501

• The University of Texas MD Anderson Cancer Center acquired Bellicum Pharmaceuticals in February 2024. The acquisition included Bellicum's cell therapy technologies, intellectual property, and clinical-grade stocks. MD Anderson also acquired Bellicum's Houston facility in 2020.

Bellicum Pharma: FDA 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.

-=Bellicum Pharma (BLCM) : U.S. studies of BPX-501 have been placed on clinical hold

Bellicum Pharma received FDA notice that U.S. studies of BPX-501 have been placed on clinical hold after three cases of encephalopathy deemed as possibly related 

Bellicum is awaiting formal communications from the FDA to determine the requirements for resuming studies, and will be working closely with the FDA to address their questions.

• The FDA clinical hold does not affect the ongoing BP-004 registration trial in Europe. Encephalopathy has been reported in the allogeneic stem cell transplant literature. Risk factors for encephalitis/encephalopathy after allogeneic stem cell transplants include prolonged immunodeficiency, selected medications, infections, and inflammatory processes such as graft versus host disease. Bellicum has treated more than 240 patients with BPX-501 cells on three allogeneic haploidentical stem cell transplantation protocols.These three cases are complex, with a number of potential confounding factors-including, in certain of the cases, prior failed transplants, prior history of immunodeficiency, concurrent infection, and administration of rimiducid in combination with other medications. Bellicum is working with FDA to evaluate the risk of encephalopathy in patients receiving BPX-501.

This week's biggest % winners & losers : Aug 28 - Sept 1, 17 (wk 35)

The following are this week's top 20 percentage gainers and top 20 percentage losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare:JUNO(41.92 +36.41%),BLUE(130.85 +33.73%), BLCM(10.72 +29.47%),KITE(178.05 +28%),CLLS(32.18 +27.75%),ADAP(6.58 +26.3%),CRIS(2.09 +25.15%),NTLA(21.51 +23.2%),ITCI(18.67 +22.27%),IMMU(12.59 +21.29%),MNKD(1.87 +20.65%),CORT(16.8 +19.74%)
• Industrials:AVAV(49.15 +26.58%),BW(2.72 +23.08%),HEES(24.70 +21.73%),HTZ(20.74 +20.44%)
• Consumer Discretionary:EROS(12.25 +33.88%)
• Information Technology:HIMX(10.46 +20.79%)
• Energy:CLMT(8.40 +28.24%)

This week's top 20 % losers

• Healthcare:OTIC(3.6 -82.04%),ACOR(21.70 -13.72%),CO(13.32 -9.2%)
• Materials:FRTA(3.34 -27.07%)
• Industrials:TITN(12.10 -22.54%)
• Consumer Discretionary:BNED(5.51 -21.06%),FINL(8.89 -16.68%),GCO(23.2 -16.4%),BBY(54.48 -11.94%),HRB(26.77 -9.9%),VRA(9.09 -9.46%),AOBC(16.52 -8.63%)
• Information Technology:AMBA(42.24 -20.27%),TECD(87.46 -17.82%),UBNT(58.97 -8.79%)
• Financials:GNBC(20.4 -8.93%)
• Energy:FRO(5.00 -11.03%)
• Consumer Staples:CPB(45.4 -11.67%),SFM(19.89 -8.93%)
• Utilities:EBR(5.61 -10.38%)

=Long trade : BLCM +19% (8/17)

• 8/24:  #7

This week's biggest % winners & losers : Aug 7 - 11, 17 (wk 32)

The following are this week's top 20 percentage gainers and top 20 percentage losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare: MYOK (36.7 +113.99%),EDIT(21.95 +28.66%),NTRA(10.62 +28.11%),NXTM(29.22 +26.27%),ACHN(4.7 +19.16%),FGEN(41.65 +19%),PRGO(78.49 +16.4%),EGRX(55.64 +16.4%),IPXL(18.3 +15.09%),CYH(7.45 +14.26%)
• Industrials:STS(20.95 +38.47%),HTZ(18.65 +30.24%)
• Consumer Discretionary:KORS(44.69 +21.44%),CROX(9.21 +15.99%),ERI(23.4 +15.27%)
• Information Technology:ATHM(61.52 +28.65%),EFII(31.81 +22.11%),SSNI(12.95 +15.94%),BITA(36.91 +14.52%)
• Consumer Staples:CHEF(17.6 +20.96%)

This week's top 20 % losers

• Healthcare:  SGRY(11.03 -43.75%),DEPO(6.32 -33.26%),CCXI(7.2 -30.7%), BLCM(7.96 -25.88%),EVH(18.4 -23.65%)
• Materials: FRTA(4.64 -46.48%)
• Industrials:BW(2.91 -70.99%),CBI(11.8 -30.47%),CECE(7.45 -23.27%)
• Consumer Discretionary: FOSL(8.2 -29.55%),ODP(4.27 -28.11%), JCP  3.93 -27.76%),FTD(13.85 -27.03%)
• Information Technology:LXFT(45.7 -25.57%),CALX(5.04 -24.78%)
• Financials:MHLD(7 -36.94%)
• Energy:OSG(2.2 -27.15%),TTI(1.99 -23.17%)
• Consumer Staples:BETR(7.63 -21.82%)

Bellicum Pharma (BLCM) reported earnings on Tue 8 Aug 17 (a/h)

** charts before earnings **

 

** charts after earnings **

Bellicum Pharma misses by $0.08, misses on revs

• Reports Q2 (Jun) loss of $0.74 per share, $0.08 worse than the Capital IQ Consensus of ($0.66); revenues were nil vs the $0.08 mln Capital IQ Consensus.
• Enrollment in the pivotal EU BP-004 trial remains on track for completion by the end of 2017. Bellicum expects to initiate an observational trial in pediatric patients receiving transplants from matched unrelated donors (MUD) without BPX-501 in the third quarter. Outcomes from these trials are expected to be the basis for filings of European Marketing Authorization Applications for BPX-501 and rimiducid. The Company expects to report top-line results of these studies in the second half of 2018, with MAA filings planned for 2019.
• Bellicum is finalizing plans for the design of registrational trials of BPX-501 in the U.S. The Company's current plans include conducting a controlled clinical trial in adult patients with acute myeloid leukemia (AML), which it expects to fund in part through its $16.9 million Product Development Award from the Cancer Prevention and Research Institute of Texas ("CPRIT"). In the pediatric non-malignant setting, Bellicum is designing a registrational trial to evaluate BPX-501 in a distinct subset of orphan inherited blood disorders.
• As of June 30, 2017, cash, restricted cash and investments totaled $139.0 million. Based on current operating plans, Bellicum continues to expect to end 2017 with approximately $85 to $95 million in cash and investments, and that current cash resources will be sufficient to meet operating requirements through 2018.