The Daily Biotech Pulse: Glaukos To Buy Avedro, Mixed Adcom Vote For Gilead, Dynavax 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 Aug. 7)

• Akero Therapeutics Inc AKRO
• Allakos Inc ALLK
• Cytokinetics, Inc. CYTK
• Guardant Health Inc GH (reacted to strong second-quarter results)
• Morphic Holding Inc MORF
• West Pharmaceutical Services Inc. WST

Down In The Dumps

(Biotech stocks hitting 52-week lows on Aug. 7)

• ABIOMED, Inc. ABMD
• Assertio Therapeutics Inc ASRT
• Bellicum Pharmaceuticals Inc BLCM
• Bicycle Therapeutics PLC BCYC
• BioCardia Inc BCDA
• BIOLINERX LTD/S ADR BLRX
• Biopharmx Corp NYSE: (BPMX)
• CAN-FITE BIOPHA/S ADR CANF
• CELLECT BIOTECH/S ADR APOP
• Cellular Biomedicine Group Inc CBMG(reacted to second-quarter results)
• Eloxx Pharmaceuticals Inc ELOX(reported second-quarter results)
• Guardion Health Sciences Inc GHSI(announced common stock offering of 9.5 million shares)
• Meridian Bioscience, Inc. VIVO
• Merit Medical Systems, Inc. MMSI
• Organovo Holdings Inc ONVO
• Prevail Therapeutics Inc PRVL
• Proteon Therapeutics Inc PRTO (reacted to second-quarter results)
• Psychemedics Corp. PMD
• Retrophin Inc RTRX(reacted to second-quarter results)
• Sienna Biopharmaceuticals Inc SNNA
• Supernus Pharmaceuticals Inc SUPN(reported below-consensus second-quarter results and lowered 2019 guidance)
• Titan Pharmaceuticals, Inc. common stock TTNP(announced $2.1 million registered direct offering of common stock and warrants)
• Tonix Pharmaceuticals Holding Corp TNXP
• Unum Therapeutics Inc UMRX
• Vaxart Inc VXRT

See Also: Biotech Stock On The Radar: Veru, A Catalyst-Rich Biopharma

Stocks In Focus

Glaukos To Buy Avedro In An-All Cash Deal

Glaukos Corp GKOS announced an agreement to acquire Avedro Inc AVDR, a hybrid ophthalmic pharma and medtech company focused on treating corneal disease and disorders, in an all-stock deal. For each Avedro shares, shareholders of the company will receive 0.365 of Glaukos shares.

The transaction is subject to approval by Avedro shareholders. It is expected to close in the fourth quarter of 2019.

Separately, Glaukos reported 36% net sales growth but a wider loss. The company raised its 2019 revenue guidance slightly. Avedro also released its second-quarter results, which showed 63% revenue growth.

Glaukos shares shed 6.98% to $68 in after-hours trading, while Avedro shares soared 28.96% to $22 in after-hours trading.

Gilead's AIDS Preventive Medication Gets Mixed FDA Panel Vote

Gilead Sciences, Inc. GILD said FDA's Antimicrobial Drugs Advisory Committee Meeting, which met to discuss its sNDA for Descovy and enofovir alafenamide 25 mg for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in men and transgender women, who have sex with men, recommended approval by a 16 to 2 vote margin. However, the committee voted 10-8 that there weren't adequate data regarding the efficacy of Descovy in cis-women.

Secondary/Debt Offerings

Clovis Oncology Inc CLVS said it intends to offer $225 million aggregate principal amount of convertible senior notes due 2024 in a private placement to qualified institutional buyers.

The stock slumped 10.81% to $8 in after-hours trading.

Stemline Therapeutics Inc STML said it intends to offer 5 million shares of its common stock in an underwritten public offering.

The stock fell 3.98% to $16.90 in after-hours trading.

MeiraGTx Holdings PLC MGTX said it has commenced an underwritten public offering of $75 million worth of shares. All the shares to be sold by the company. Separately, the company reported second-quarter revenues of $1.98 million and a wider-than-expected loss of 63 cents per share.

The stock slipped 8.13% to $23.50 in after-hours trading.

Dynavax Technologies Corporation DVAX said it plans to offer an aggregate of up to $60 million worth of shares, shares of newly designated non-voting Series A Convertible preferred stock and warrants to purchase common stock, in an underwritten public offering.

The company also reported second-quarter results, which showed sales rising year-over-year from $5.6 million to $8.3 million, with whole of the revenue coming from Heplisav-B sales. The net loss widened from a year ago.

The stock slumped 16.05% to $2.51 in after-hours trading.

Earnings

ICU Medical, Incorporated ICUI reported second-quarter revenues of $312.3 million, down from $360.5 million a year ago. The earnings per share trailed expectations. The company also lowered its 2019 guidance.

The stock fell 29.07% to $174.25 in after-hours trading.

Wright Medical Group NV WMGI's second-quarter revenues rose 11.8% to $229.7 million. The company lowered its 2019 bottom-line guidance.

The stock declined 20.14% to $22.41 in after-hours trading.

Neovasc Inc NVCN reported 8% second-quarter revenue growth and a narrower loss.

The stock slipped 10.66% to $2.85 in pre-market trading.

Transenterix TRXC reported lower revenues but a narrower loss for the second quarter.

The stock plunged 29.69% to 84 cents in pre-market trading.

On The Radar

Earnings

• Axsome Therapeutics Inc AXSM (before the market open)
• Pacira Biosciences Inc PCRX (before the market open)
• Protalix Biotherapeutics Inc PLX (before the market open)
• Esperion Therapeutics Inc ESPR (before the market open)
• ZIOPHARM Oncology Inc. ZIOP (before the market open)
• Eagle Pharmaceuticals Inc EGRX (before the market open)
• Catabasis Pharmaceuticals Inc CATB (before the market open)
• Akebia Therapeutics Inc AKBA (before the market open)
• Amicus Therapeutics, Inc. FOLD (before the market open)
• Adamas Pharmaceuticals Inc ADMS (after the close)
• Nektar Therapeutics NKTR (after the close)
• Puma Biotechnology Inc PBYI (after the close)
• Achieve Life Sciences Inc ACHV (after the close)
• Adverum Biotechnologies Inc ADVM (after the close)
• Adamis Pharmaceuticals Corp ADMP (after the close)
• BioDelivery Sciences International, Inc. BDSI (after the close)
• Innovate Biopharmaceuticals Inc INNT(after the close)
• Pulse Biosciences Inc PLSE (after the close)
• BioLife Solutions Inc BLFS (after the close)
• Cutera, Inc. CUTR (after the close)
• Endologix, Inc. ELGX (after the close)
• Inovio Pharmaceuticals Inc INO (after the close)
• Opiant Pharmaceuticals Inc OPNT (after the close)
• Rockwell Medical Inc RMTI (after the close)
• Vermillion, Inc. NASDAQ: (VRML) (after the close)
• Organovo Holdings Inc ONVO (after the close)
• Taro Pharmaceutical Industries Ltd. TARO (after the close)

IPO

Israeli medical device maker InMode has priced its IPO 5 million shares at $14, the lower end of the estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol INMD.