Premarket Biotech Digest – $OPXA enters lease agreement, $CLLS receives IND, $CTLT reports Q2 results
$Digest, $OPXA, $CLLS, $CTLT

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Cellectis SA ($CLLS) announced receiving Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to conduct Phase 1 clinical trials with UCART123, which is the company’s wholly owned TALEN® gene-edited product candidate. The study will use the drug for treating patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
The company plans to start Phase 1 trials in the first half of 2017. This is the first allogeneic, “off-the-shelf” gene-edited CAR T-cell product candidate that the FDA has approved for clinical trials. Cellectis had recently inducted four new members to its Clinical Advisory Board. The company stock is up 18% on Year to Date basis.

Opexa Therapeutics Inc. ($OPXA) recently transferred its facility lease to KBI Biopharma Inc. which led to the establishment of a cellular therapy contract development and manufacturing organization (CDMO) in the Houston area. The facility was leased by the company a decade back for supporting GMP manufacturing for its proprietary cellular therapy platform. The annual lease obligations on the facility, including property tax and insurance, totaled approximately $1 million. KBI will assume the responsibility for the remaining leaser term. It will also pay Opexa a lump sum for its manufacturing and laboratory equipment.
The company stock has performed well this year as it gained 8.7% of its value, recouping some of the losses it had sustained in the previous year.


• LabCorp ($LH) is reported to be in talks with PPD for potential acquisition. The deal is expected to be worth over $8 billion including, according to the report by Reuters. PPD is owned by private equity firms Carlyle ($CG) and Hellman & Friedman. It was taken private for $3.9B in 2011. The firm focuses its research on a wide range of therapeutic areas, ranging from cardiovascular to urology.
• Johnson & Johnson’s ($JNJ) Mentor unit has been sued for allegedly selling defective breast implants and failing to conduct proper risk studies that were mandated by U.S. regulators. Johnson & Johnson's Mentor is one of the only three companies currently authorized by the FDA to sell silicone implants in the U.S. after the agency lifted a 14-year ban on the devices in 2006. The lawsuit is filed in California.

• Galena Biopharma ($GALE) announced that its two Phase 2 studies assessing NeuVax, in combination with Roche's Herceptin (trastuzumab), to prevent the recurrence of breast cancer will continue as planned. The independent Data Safety Monitoring Board (DSMB) reviewed the data and determined that there were no safety signals and neither study was found to be futile.
• ARIAD Pharmaceuticals ($ARIA) has submitted a Market Authorization Application (MAA) in Europe seeking approval of brigatinib for treating adult patients with ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with Pfizer's XALKORI (crizotinib). The company's U.S. marketing application is currently under FDA review with an action date of April 29.

• Mylan ($MYL) announced that it has agreed to pay $96.5M to settle litigation from direct purchasers of Cephalon's narcolepsy drug Provigil accusing the company of using pay-for-delay tactics to beat competition. The money will go to purchasers that bought brand-name Provigil from Cephalon directly, like wholesalers and distributors. However, the company stated that the settlement is not an admission of wrongdoing. A group of direct purchasers sued Mylan, Cephalon and two other companies in 2006.
• Northwest Biotherapeutics ($NWBO) announced that the FDA has lifted the partial clinical hold on its Phase 3 clinical trial assessing DCVax-L for the treatment of glioblastoma multiforme (GBM). The company says the study has accumulated a sufficient number of events of 248 for the progression-free survival (PFS) endpoint. The company will lock the data after the OS event threshold is achieved.

• Luminex Corporation ($LMNX) announced its results for the fourth quarter. The company earned $4.6 million in Non-GAAP income for the fourth quarter while for the full year its earnings stood at $40 million. Consolidated fourth quarter and full year 2016 revenue was reported at $72.3 million and $270.6 million, up 20% and 14% compared to the fourth quarter and full year 2015. Luminex suffered GAAP net loss for the fourth quarter at $3.4 million, or $0.08 per diluted share.

• Catalent Inc. ($CTLT) announced its second quarter 2017 revenue at $483.7 million. The company reported revenue of $925.9 million for the first six months of fiscal year 2017. Second quarter 2017 Adjusted EBITDA was $98.1 million. Its adjusted Net Income for the quarter was reported at $34.7 million, down from $38.9 million it had reported for the corresponding quarter of the previous year.

• Aviragen Therapeutics Inc. ($AVIR) receives Buy rating from H.C.Wainwright. The price target for the stock has been set at $5.
• Momenta Pharma ($MNTA) receives Hold rating from Aegis Capital. The price target for the stock has been set at $17.

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