The Daily Biotech Pulse: FDA Nod For Roche, Bristol-Myers Hikes Dividend, 2 Biotechs To Debut

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

Scaling The Peak

(Biotech stocks hitting 52-week highs on Dec. 6)

• Gritstone Oncology Inc GRTS

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 6)

• Achaogen Inc AKAO
• Ardelyx Inc ARDX
• Assertio Therapeutics Inc ASRT
• Avadel Pharmaceuticals PLC AVDL
• AzurRx BioPharma Inc AZRX
• BIOLASE Inc BIOL
• Celldex Therapeutics, Inc. CLDX
• CELYAD SA/ADR CYAD
• Conatus Pharmaceuticals Inc CNAT(reacted to disappointing Phase 2b trial for its Emriscan that is being evaluated for liver disease)
• Curis, Inc. CRIS
• Cyclacel Pharmaceuticals Inc CYCC
• Edge Therapeutics Inc EDGE
• Endologix, Inc. ELGX
• Epizyme Inc EPZM
• Evogene Ltd EVGN
• Eyegate Pharmaceuticals Inc EYEG
• GlycoMimetics Inc GLYC
• Insys Therapeutics Inc INSY
• Intra-Cellular Therapies Inc ITCI
• Jaguar Health Inc JAGX
• Leap Therapeutics Inc LPTX
• Melinta Therapeutics Inc MLNT
• Mustang Bio Inc MBIO
• Nantkwest Inc NK
• Neuralstem, Inc. CUR
• Neurotrope Inc NTRP
• Novan Inc NOVN
• Novus Therapeutics Inc NVUS
• OHR Pharmaceutical Inc OHRP
• Oncomed Pharmaceuticals Inc OMED(announced a reverse merger with U.K.'s Mereo BioPharma)
• Ophthotech Corp OPHT
• Precision Therapeutics Inc AIPT
• Savara Inc SVRA
• Sienna Biopharmaceuticals Inc SNNA
• Sonoma Pharmaceuticals Inc SNOA
• Sunesis Pharmaceuticals, Inc. SNSS
• Tenax Therapeutics Inc TENX
• Tonix Pharmaceuticals Holding Corp TNXP
• Trillium Therapeutics Inc TRIL
• Verrica Pharmaceuticals Inc VRCA
• Voyager Therapeutics Inc VYGR

Related Link: Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates

Stocks In Focus

Roche Gets FDA Approval For Expanded Use of its Lung Cancer Drug

Roche Holdings AG Basel ADR RHHBY announced FDA approval for its Tecentriq in combination with Avastin, paclitaxel and carboplatin for treating people with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberations compared to Avastin plus chemotherapy.

The FDA has earlier extended the review period by three months before deciding on the sBLA.

Bristol-Myers Raises Dividend

Bristol-Myers Squibb Co BMY announced a 2.5 percent increase to its quarterly dividend, beginning in the first quarter of 2019.

Offerings

Global Blood Therapeutics Inc GBT announced an agreement to sell $150 million worth of shares in a registered underwritten public offering. The company said it would use the net proceeds for preparing for the commercial launch of voxelotor, if approved by the FDA, for future clinical trials and for working capital and general corporate purposes.

The stock fell 4.01 percent to $44.80 in after-hours trading.

Inspire Medical Systems Inc INSP said it has priced its previously announced public offering of 2.5 million shares at $40 per share, a discount to Thursday's closing price of $41.07. About 1.5 million shares earmarked for the offering will be sold by the company and the remaining 1 million by certain selling shareholders.

Momenta Pharmaceuticals, Inc. MNTA priced its underwritten public offering of 17.39 million shares of its common stock at $11.50 per share for total aggregate gross proceeds to Momenta of approximately $200 million.

Orthopediatrics Corp KIDS said it has commenced an underwritten public offering of 1.5 million shares of its common stock.

On The Radar

IPO

Moderna, which develops therapies based on its modified mRNA platform, priced its upsized initial public offering, or IPO, of 26.28 million at $23, the midpoint of the estimated price range of $22-$24. The shares will be listed on the Nasdaq under the ticker symbol MRNA.

Synthorx, which develops immunotherapies for solid tumors and autoimmune disorders, priced its IPO of 11.91 million shares, upsized from the initially revealed offer size of 9.1 million shares, at $11 per share, at the midpoint of the estimated range of $10 and $12. The shares will be listed on the Nasdaq under the ticker symbol THOR.