The Daily Biotech Pulse: Mixed Results For Merck's Keytruda In Stomach Cancer; Roche's Spark-Buy Delayed, Teva Recalls Hypertension Drug

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 April 25)

• Biohaven Pharmaceutical Holding Co Ltd BHVN
• Catalyst Pharmaceuticals Inc CPRX
• ZEALAND PHARMA/S ADR ZEAL

Down In The Dumps

(Biotech stocks hitting 52-week lows on April 25)

• Arbutus Biopharma Corp ABUS
• ContraVir Pharmaceuticals Inc CTRV (announced pricing of common stock offering)
• Nuvectra Corp NVTR
• OUTLOOK THERAPEUTICS, INC. OTLK
• Proteostasis Therapeutics Inc PTI
• Viveve Medical Inc VIVE

Stock In Focus

Merck's Keytruda Produces Mixed Results In Stomach Cancer Trial

Merck & Co., Inc. MRK announced topline findings from the final analysis of the pivotal Phase 3 KEYNOTE-062 trial evaluating Keytruda as a monotherapy and in combination with chemotherapy for the first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma. The results showed that in the monotherapy arm, Keytruda met a primary endpoint by demonstrating non-inferiority to chemotherapy, the current standard of care, for the overall survival.

However, the combination therapy was not found to be superior for overall survival or progression-free survival relative to chemotherapy alone.

Roche's Proposed Spark Buy Further Delayed Amid FTC Scrutiny

Roche Holdings AG Basel ADR RHHBY and Spark Therapeutics Inc ONCE announced Roche has withdrawn its premerger notification and report form under the Hart-Scott-Rodino Act in connection with the pending acquisition of Spark by Roche for $114.50 per Spark shares.

The companies said the withdrawal was due to the government with additional time to complete its review of the transaction. With the companies planning to refile their respective premerger notification by May 9, the waiting period will expire on or about May 24.

See Also: Gilead Reiterates Faith In NASH Combination Approach After Another Trial Disappointment

Teva Voluntarily Recalls 35 Lots Of Hypertension Tablets Due To Cancer Risk

Teva Pharmaceutical Industries Ltd TEVA initiated a voluntary recall in the U.S. at the patient level 35 lots of hypertension tablet Losartan Potassium due to the detection of an impurity, identified as N-Nitroso-N-methyl-4-aminobutyric acid. With the impurity exceeding the acceptable exposure limit of 9.82 ppm, there could be cancer risk in a few patients following long-term use, the company said.

Strongbridge Reports Positive Results For Cushing's Disease Drug

Strongbridge Biopharma plc SBBP announced new secondary endpoint results from the late-stage study dubbed Recorlev for the potential treatment of endogenous Cushing's syndrome, which showed that six-months of maintenance Recorlev therapy led to significant improvements in the clinical signs and symptoms of Cushing's syndrome including acne, hirsutism in women, and peripheral edema.

The company also noted that a reduction in mean free-testosterone in women and a modest increase in mean testosterone in men were observed.

The results were presented at the 2019 American Association of Clinical Endocrinologists Annual Scientific and Clinical Congress, held April 24 – 28, in Los Angeles, California

The stock climbed 6.12 percent to $5.03 in after-hours trading.

Tocagen Rises On Bullish Initiation

Cantor Fitzgerald analyst Elemer Piros initiated shares of Tocagen Inc TOCA with an Overweight rating.

Shares rose 4.27 percent to $9.52 in after-hours trading.

Earnings

Sanofi SA SNY reported better-than-expected first-quarter results, helped by strong vaccine sales and a solid offtake Dupixent. The company reiterated its profit forecast for the full year.

In pre-market trading Friday, the stock was seen up 0.70 percent to $41.50.

BioMarin Pharmaceutical Inc. BMRN reported 7 percent year-over-year revenue growth to $400.7 million for its first quarter. On a GAAP basis, net loss widened from 26 cents to 32 cents. Analysts expected a loss of 19 cents per share for the quarter.

The stock was seen trading down 2.92 percent to $82.82 in pre-market trading Friday.

BioTelemetry Inc BEAT's first-quarter revenues increased from $94.5 million a year ago to $104 million. On an adjusted basis, EPS rose from 39 cents to 42 cents. The results were in line

The stock fell 5.45 percent to $56 in after-hours trading.

Illumina, Inc. ILMN reported 8 percent revenue growth to $846 million. The non-GAAP net income per share climbed from $1.45 to $1.60. The results exceeded estimates. For 2019, the company continues to expect 13-14 percent revenue growth, in line with estimates, and non-GAAP EPS of $6.63-$6.73.

The stock moved down 4.06 percent to $306.25 in after-hours trading.

Seattle Genetics, Inc. SGEN reported better-than-expected first-quarter revenues and a narrower loss. The company maintained its 2019 revenue guidance but lifted its SG&A and R&D guidance.

The stock declined 4.35 percent to $68 in after-hours trading.

On The Radar

Clinical Trial Readouts

Horizon Pharma PLC HZNP is scheduled to present already-released Phase 3 data for its thyroid eye disease treatment Teprotumumab. The presentation by the company is to be made at the 28th Annual Scientific and Clinical Congress of the American Association of Clinical Endocrinologists.