The Daily Biotech Pulse: Teva Settles With FTC, Setback For Merck In Liver Cancer Trial, Sienna Biopharma Offering

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. 19)

• Alector Inc ALEC (IPOed early February)
• Avedro Inc AVDR(debuted Tuesday)
• BioDelivery Sciences International, Inc. BDSI
• Eton Pharmaceuticals Inc ETONBHC to sell U.S. rights to its investigational eye drops EM-100)
• NxStage Medical, Inc. NXTM
• Orthofix Medical Inc OFIX
• PDL BioPharma Inc PDLI
• Synthorx Inc THOR

Down In The Dumps

(Biotech stocks hitting 52-week lows on Feb. 19)

• Chimerix Inc CMRX
• MOTIF BIO PLC/S ADR MTFB(announced an amended agreement with its lender Hercules Capital, which provides for immediate early repayment of $7 million and a $0.5 million repayment on the earlier of 90 days, being May 18, or receipt of funds from an equity raise of $2 million or greater)

Stock In Focus

Merck's Keytruda Fails In Late-stage Trial For Liver Cancer

Merck & Co., Inc. MRK said a pivotal Phase 3 study dubbed KEYNOTE-240 that evaluated its anti-PD-1 therapy Keytruda plus best supportive care for advanced hepatocellular carcinoma in patients, who were previously treated with systemic therapy, did not meet its co-primary endpoints of overall survival and progression-free survival compared with placebo plus best supportive care.

The stock slipped 1.11 percent to $78.36 in after-hours trading.

Novartis' Sandoz Unit Announces U.S. Launch of Generic Drug to Treat Opioid Dependence

Novartis AG NVS said its generic unit Sandoz has launched the generic version of INDIVIOR PLC/S ADR INVVY's Suboxone (buprenorphine and naloxone) sublingual film in all four dosage strengths in the U.S. The sublingual film is used to treat opioid dependence.

See Also: Intercept Shares Soar To Multimonth High After NASH Drug Aces Late-Stage Trial

LeMaitre Q4 Exceeds Expectations

LeMaitre Vascular Inc LMAT reported a 9 percent year-over-year increase in fourth-quarter sales to $28.4 million, and EPS climbed from 21 cents to 30 cents per share. For the first quarter, the company expects EPS of 18-20 cents on sales of $27.7 million to $28.5 million. The company guided 2019 EPS to 82-86 cents and sales to $113 million to $114.4 million. The results were above consensus estimates.

The stock rallied 8.57 percent to $27.25 in after-hours trading.

Sienna Commences Common Stock Offering

Sienna Biopharmaceuticals Inc SNNA commenced a proposed underwritten public offering of its common stock. All shares earmarked for the offering are to be sold by the company.

The stock slumped 17.06 percent to $2.48 in after-hours trading.

Ovid To Offer Common Stock, Preferred Shares

Ovid Therapeutics Inc OVID intends to offer and sell shares of its common stock as well as Series A convertible preferred stock in two concurrent but separate underwritten public offerings. The company said it intends to use the net proceeds to advance clinical development of OV101 and OV935.

Teva Settles All Outstanding Litigation With FTC

Teva Pharmaceutical Industries Ltd TEVA said it reached a settlement agreement with the FTC to resolve all outstanding litigations between the parties. Under the agreement, FTC has agreed to dismiss its claims against Teva and its affiliates in three outstanding cases; The companies also agreed to modify certain terms in their 2015 consent decree.

Teva need not pay additional money to the FTC as part of the agreement, the company said.

Mirati Appoints New Chairman

Mirati Therapeutics Inc MRTX announced the appointment of Faheem Hasnain as its Chairman, effective Feb. 15 following the retirement of Dr. Rodney Lappe from the board and his role as Chairman. Hasnain was previously employed as the Executive Chairman of Gossamer Bio Inc GOSS.

Mirati shares rose 1.52 percent to $72.87 in after-hours trading.

Ultragenyx Reports Mixed Q4 Results

Ultragenyx Pharmaceutical Inc RARE reported a jump in fourth-quarter revenues from $2.414 million a year-ago to $12.797 million, with the bulk of the increase attributable to a surge in collaboration and license revenues. The net loss narrowed from $1.89 per share to $1.73 per share. The loss per share was narrower than expectations, while revenues trailed expectations.

Evotec Announces Antibiotics Drug Development Collaboration

Evotec AG EVTCY announced a three-year collaboration with the Helmholtz Centre for Infection Research, or HZI, for developing novel antibiotics for drug-resistant bacterial pathogens. The agreement provides for combining HZI's unique collection and know-how of natural products as well as access to in vitro and in vivo models of bacterial infection with Evotec's drug discovery platform, expertise in medicinal chemistry and pharmacology as well as its collection of bacterial pathogens.

On The Radar

Clinical Trial Results

Gamida Cell Ltd GMDA is due to present updated Phase 1 data on its non-Hodgkin lymphoma and multiple myeloma treatment candidate NAM-NK at the 2019 Transportation and Cellular Therapy Meetings.

TRACON Pharmaceuticals Inc TCON will present Phase 1 data for its TRC105 in combination with Bristol-Myers Squibb Co BMY's Opdivo at the International Association for the Study of Lung Cancer to be held between Feb. 20 and Feb. 23

Earnings

Genomic Health, Inc. GHDX (after the market close)