The Daily Biotech Pulse: Immunomedics CEO Departs, Ultragenyx Offering, Karyopharm Awaits FDA Panel Vote

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 Feb. 25)

• Abbott Laboratories ABT
• Arena Pharmaceuticals, Inc. ARNA
• Argenx SE – ADR ARGX
• Biohaven Pharmaceutical Holding Co Ltd BHVN
• Clementia Pharmaceuticals Inc CMTAIPSEY
• Eton Pharmaceuticals Inc ETON
• Gossamer Bio Inc GOSS
• Homology Medicines Inc FIXX
• Ionis Pharmaceuticals Inc IONSNVS exercised its option to license TQJ230, an investigational agent from Akcea Therapeutics Inc AKCA, an affiliate of Ionis, being developed for targeted cardiovascular therapy)
• Merck & Co., Inc. MRK
• NeoGenomics, Inc. NEO
• Orthofix Medical Inc OFIX
• Orthopediatrics Corp KIDS
• PDL BioPharma Inc PDLI
• Spark Therapeutics Inc ONCERHHBY
• Uniqure NV QURE(moved on the Roche-Spark deal and analysts' view that it could be the next potential gene therapy takeout candidate)
• Varian Medical Systems, Inc. VAR

Down In The Dumps

(Biotech stocks hitting 52-week lows on Feb. 25)

• ANCHIANO THERAP/S ADR ANCN
• Unity Biotechnology Inc UBX

Stock In Focus

Immunomedics' CEO Steps Down, Loss Narrows

Immunomedics, Inc. IMMU announced the resignation of its CEO Michael Pehl due to personal reasons, as well as changes to its board, including the appointment of Charles Baum, CEO of Mirati Therapeutics Inc MRTX, to the board. The interim CFO Usama Malik has been appointed CFO, the company said.

Immunomedics, which is changing its fiscal-year end from June 30 to Dec. 31, also reported a net loss of 84 cents per share for the six-month period ended Dec. 31, called the transition period, compared to a loss of 88 cents per share for the same period last year.

The stock fell 8.43 percent to $13.90 in after-hours trading.

Regeneron, Sanofi to Contend Jury Verdict On Cholesterol Drug

Following a jury verdict, upholding three of the five asserted claims of two Amgen, Inc. AMGN's U.S. patents covering antibodies targeting PCSK9, Regeneron Pharmaceuticals Inc REGN and Sanofi SA SNY said they strongly disagree with certain aspects of the verdict.

The companies said the verdict does not impact U.S. physicians' and patients' access their cholesterol drug Praluent.

"Regeneron and Sanofi intend to file post-trial motions with the District Court over the next few months, seeking to overturn the jury verdict and also requesting a new trial," the companies said.

FDA Warns of Cardiovascular Risk, Death With Higher Dose of Pfizer's Rheumatoid Arthritis Drug

Assessing data from the required post-marketing trial of Pfizer Inc. PFE's Xeljanz, which was approved for rheumatoid arthritis in 2012, the FDA warned of a safety signal from the study that evaluated Xeljanz in 5mg twice daily or 10mg twice daily dose versus a control group to assess the risk of cardiovascular events, cancer and opportunistic infections.

The safety signal concerns pulmonary embolism and increased overall mortality in patients who were being administered the 10mg dose.

See Also: AstraZeneca's Brilinta Found To Alleviate Cardiovascular Risk In Late-Stage Study

Offerings

SAGE Therapeutics Inc SAGE said it has commenced an underwritten public offering of $5 million worth of its shares. All the shares are to be sold by the company.

The stock slipped 4.94 percent to $151.50 in after-hours trading.

Ultragenyx Pharmaceutical Inc RARE said it has commenced an underwritten public offering of $250 million shares of its common stock.

The stock moved down 4.84 percent to $60.30 in after-hours trading.

Vistagen Therapeutics Inc VTGN said it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. All shares are to be sold by the company. The company said it intends to use the net proceeds for developing its CNS pipeline programs and for general R&D, working capital and general corporate purposes.

The stock plummeted 19.12 percent to $1.10 in after-hours trading.

Earnings

Veracyte Inc VCYT reported a 31 percent increase in its fourth-quarter revenues to $25.8 million, and a loss per share of 8 cents, narrower than the year-ago loss of 24 cents. For 2019, the company guided to revenues of $113 million to $117 million and net cash used in operating activities in the range of $4 million to $6 million. The results exceeded expectations.

The stock rose 4.11 percent to $20.50 in after-hours trading.

Medpace Holdings Inc MEDP reported higher fourth-quarter revenues and adjusted earnings per share. The company guided full-year adjusted earnings per share below the consensus estimate, while the revenue guidance was in line.

The stock fell 10.74 percent to $63 in after-hours trading.

On The Radar

Adcom Meeting

FDA's Oncologic Drugs Advisory Committee is set to discuss Karyopharm Therapeutics Inc KPTI's NDA for Selinexor tablets. The pipeline asset is being evaluated in combination with dexamethasone, for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody. Briefing documents released Friday did not evince much enthusiasm concerning a positive outcome, as staffers expressed concerns about both safety and efficacy.