The Daily Biotech Pulse: FDA Nod For Epizyme, Sonoma Explores Options For Dermatology Business, Roche's Cancer Drug Flunks Study

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 Jan. 23)

• Baudax Bio Inc BXRX
• Mesoblast limited MESO
• Nevro Corp NVRO
• Oyster Point Pharma Inc OYST
• Soligenix, Inc. SNGX
• Syneos Health Inc SYNH
• TELA Bio Inc TELA
• Trillium Therapeutics Inc TRIL
• Y-mAbs Therapeutics, Inc YMAB
• Zai Lab Ltd ZLAB

Down In The Dumps

(Biotech stocks hitting 52-week lows on Jan. 23)

• Avanos Medical Inc AVNS
• Blueprint Medicines Corp BPMC
• Enanta Pharmaceuticals Inc ENTA
• Evolus Inc EOLS
• Kura Oncology Inc KURA
• Madrigal Pharmaceuticals Inc MDGL
• Second Sight Medical Products Inc EYES
• Spectrum Pharmaceuticals, Inc. SPPI
• Therapix Biosciences Ltd – ADR TRPX

Related Link: 7 Blockbuster Drugs Expected To Be Launched In 2020

Stocks In Focus

Kura Oncology Announces Departure of Chief Medical Officer

Kura Oncology said Antonio Gualberto, serving as Head of Development and Chief Medical Officer, will leave to pursue other opportunities. The company named Bridget Martell, EVP, Clinical Development, as acting Chief Medical Officer.

The stock slipped 2.12% to $12.01 in after-hours trading.

Epizyme's Epithelioid Sarcoma Drug Approved

Epizyme Inc EPZM said the FDA has granted accelerated approved for its Tazverik, or tazemetostat, for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

Continued approval is contingent upon verification of clinical benefit in a confirmatory trial.

The stock slipped 1.76% to $26.25 in after-hours trading.

Roche Tecentriq Flunks Late-Stage Study In Urothelial Cancer

Roche Holdings AG Basel ADR RHHBY said a Phase 3 study that evaluated its Tecentriq as an adjuvant monotherapy after surgery for muscle-invasive urothelial cancer did not meet the primary endpoint of disease-free-survival.

Sonoma to Explore Strategic Options For US Dermatology Business

Sonoma Pharmaceuticals Inc SNOA has commenced a process to explore and evaluate strategic alternatives for its U.S. Dermatology Division. Maxim Group has been engaged to assist in this process, the company added.

"We look forward to working with Maxim to develop a strategy to maximize the value of this portfolio for our shareholders," said CEO Amy Trombly.

The shares rallied 27.27% to $6.31 in after-hours trading.

Intuitive Surgical Q4 Results Exceed Expectations

Intuitive Surgical, Inc.'s ISRG fourth-quarter revenues climbed 22% to $1.28 billion, thanks to strong procedures and systems placements. The non-GAAP net income rose from $2.96 per share to $3.48 per share. The results exceeded estimates.

The stock shed 2.60% to $599 in after-hours trading.

Offerings

Applied Therapeutics Inc APLT priced its upsized public offering of 2.74 million shares at $45.50 per share, with the offering expected to generate gross proceeds of $124.7 million. Previously, the company planned to offer 1.75 million shares.

The stock slipped 1.02% to $48.35 in after-hours trading.

PDUFA Dates

The FDA will announce its verdict on Merck & Co., Inc.'s MRK NDA and sNDA for DIFICID (fidaxomicin) to treat Clostridium difficile infections. The NDA pertains to an oral suspension formulation and the sNDA is for the expansion of the indication to treat children, ages six and older. Dificid, in tablet formulation, has already been approved to treat Clostridium difficile infections in adults 18 years and older.

Clinical Readouts

ASCO Gastrointestinal Cancers Symposium Presentations

Bellicum Pharmaceuticals Inc BLCM: Phase 1 Cohort 5B new translational data for its pancreatic cancer experimental drug BPX-601