The Daily Biotech Pulse: EC Nod For Bristol-Myers Squibb, Kyowa Kirin's Parkinson's Add-On Therapy Approved

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks hitting 52-week highs on Aug. 27)

• Castle Biosciences Inc CSTL
• The Medicines Company MDCO

Down In The Dumps

(Biotech stocks hitting 52-week lows on Aug. 27)

• Abeona Therapeutics Inc ABEO
• Advaxis, Inc. ADXS
• Agios Pharmaceuticals Inc AGIO
• Alder Biopharmaceuticals Inc ALDR
• Aldeyra Therapeutics Inc ALDX
• Alimera Sciences Inc ALIM
• AnaptysBio Inc ANAB
• ASLAN PHARMACEU/ADR ASLN
• Assembly Biosciences Inc ASMB
• Cancer Genetics Inc CGIX
• Catalyst Biosciences Inc CBIO
• Clearside Biomedical Inc CLSD
• Crinetics Pharmaceuticals Inc CRNX
• DelMar Pharmaceuticals Inc DMPI(announced that its current cash position will be sufficient to complete enrollment in all three patient groups of its two ongoing Phase 2 trials for its lead compound VAL-083, which is likely to occur by the fourth quarter of 2020)
• ICU Medical, Incorporated ICUI
• Kala Pharmaceuticals Inc KALA
• Mallinckrodt PLC MNK(reacted to an unfavorable ruling on a patent infringement lawsuit regarding its inhaled nitric oxide product)
• Neuralstem, Inc. CUR
• Novus Therapeutics Inc NVUS
• Obalon Therapeutics Inc OBLN
• Regeneron Pharmaceuticals Inc REGN
• Regenxbio Inc RGNX
• Revance Therapeutics Inc RVNC(announced an amended agreement with Mylan NV MYL, extending the timeline for Mylan to decide whether to develop a Botox biosimilar)
• Rigel Pharmaceuticals, Inc. RIGL
• Strongbridge Biopharma plc SBBP
• Supernus Pharmaceuticals Inc SUPN
• Tocagen Inc TOCA
• Trinity Biotech plc TRIB
• Unity Biotechnology Inc UBX
• Viveve Medical Inc VIVE
• Zafgen Inc ZFGN

Stocks In Focus

EC Approves Bristol-Myers Squibb-AbbVie's Multiple Myeloma Drug

Bristol-Myers Squibb Co BMY announced the European Commission approved Empliciti plus pomalidomide and low-dose dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma, who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.

The triple combo regimen was approved in the U.S. in November 2018.

Empliciti is being developed by Bristol-Myers Squibb and AbbVie Inc ABBV, with the former solely responsible for commercial activities.

Bristol-Myers Squibb shares edged up 0.15% to $48 in after-hours trading.

Soligenix Says Data Monitoring Committee Recommends Increase In Sample Size

Soligenix, Inc. Common Stock SNGX said it has received a positive recommendation from the independent Data Monitoring Committee for continued enrollment into its Phase 3 "DOM–INNATE" study that is evaluating its SGX942 for the treatment of oral mucositis in patients with head and neck cancer.

The company noted that the IDMC recommended about 70 additional subjects to be randomized in the trial, increasing the study sample size from 190 to 260 evaluable subjects.

"The study remains on target to complete enrollment and provide topline results in the first half of 2020," the company said.

The stock was down 0.92% to $1.08 in pre-market trading.

Japan's Kyowa Kirin Gets FDA Nod For Add-on Drug For Parkinson's Disease

Kyowa Kirin Co Ltd KYKOF announced FDA approval for Nourianz tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing off episodes. An "off" episode is a time when a patient's medications are not working well, causing an increase in PD symptoms, such as tremor and difficulty walking.

Zealand Pharma Appoints Matthew Dallas as CFO

ZEALAND PHARMA/S ADR ZEAL announced the appointment of Matthew Dallas as VP and CFO, effective Oct. 7, 2019. Dallas most recently served as CFO of AVEO Pharmaceuticals, Inc. AVEO, and would be joining Zealand Pharma at a time when the company begins its commercialization efforts.

Medtronic Announces Planned Retirement Of CEO

Medtronic PLC MDT said its Chairman and CEO Omar Ishrak has announced his intention to retire as CEO on April 26, 2020. Following the relinquishment of office as CEO, Ishrak will transition to the role of Executive Chairman.

The company also said its board has appointed Geoff Martha, currently EVP of Restorative Therapies Group, as President of the company and also to the board, effective Nov. 1, 2019. Martha will succeed as Ishrak as CEO, effective April 27, 2020.

On The Radar

PDUFA Dates

IntelliPharmaCeutics International Inc. IPCIF awaits FDA nod for its NDA for its abuse-deterrent pain medication Rexista. An Adcom meeting scheduled by the FDA has been postponed, putting to doubt whether the approval would come through by the scheduled date.

Earnings

Edap Tms SA EDAP (before the market open)
Ascendis Pharma A/S ASND (after the market close)
MEI Pharma Inc MEIP (after the market close)