The Daily Biotech Pulse: Roche Presents Positive Hemlibra Data, Amgen's Tender Offer For Nuevolution Complete, Genmab 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 July 8)

• Adverum Biotechnologies Inc ADVM
• Inspire Medical Systems Inc INSP UNH coverage for Inspire therapy for the treatment of obstructive sleep apnea)
• Sol Gel Technologies Ltd SLGL(reported positive results for late-stage trials that evaluated its Epsolay microencapsulated benzoyl peroxide cream, 5%, in papulopustular rosacea.

Down In The Dumps

(Biotech stocks hitting 52-week lows on July 8)

• Advaxis, Inc. ADXS
• Aerie Pharmaceuticals Inc AERI
• Atara Biotherapeutics Inc ATRA
• Evolent Health Inc EVH
• Foamix Pharmaceuticals Ltd FOMX
• Gamida Cell Ltd GMDA
• GENFIT S A/ADR GNFT
• Harvard Bioscience, Inc. HBIO(announced departure of CEO Jeffrey Duchemin)
• Heat Biologics Inc HTBX
• Jaguar Health Inc JAGX
• Myovant Sciences Ltd MYOV
• Nuvectra Corp NVTR
• Puma Biotechnology Inc PBYI
• Tonix Pharmaceuticals Holding Corp TNXP
• TrovaGene Inc TROV

See Also: Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates

Stocks In Focus

Genmab Commences Offering To List ADSs On Nasdaq

Danish biotech GENMAB A/S/S ADR GMXAY has commenced a public offering of 27.80 million ADSs, representing 2.78 million of its ordinary shares, pursuant to a registration statement on Form F-1, as amended, filed with the SEC. The company has applied for listing the ADSs on the Nasdaq under the ticker symbol GMAB. It expects to price the offering in the week commencing July 15.

Neovasc Gets First Instalment of Grant Awarded For Allergic Asthma Vaccine

Neovasc Inc NVCN received a first payment within the grant awarded by the National Agency of Research, representing a total amount of up to 702,000 pounds toward its pre-clinical program AllergyVacs conducted in collaboration with Inserm and the Immunology and Allergy Department of the Pasteur Institute.

The award follows the company's proof of concept in allergies with its new IL-4/IL-13 Kinod therapeutic vaccine presented at two major scientific congresses.

The stock rose 3.14% to $4.92 in after-hours trading.

Roche Presents New Positive Data For Hemophilia Drug

Roche Holdings AG Basel ADR RHHBY presented new data from the four pivotal HAVEN clinical trials that evaluated its Hemlibra in people with hemophilia A with and without Factor VIII inhibitors at the International Society of Thrombosis and Haemostasis 2019 Congress, which demonstrated the long-term safety, efficacy and quality of life benefit of the drug.

The company also presented the first interim analysis from the Phase 3b STASEY study, which reinforced the safety profile of Hemlibra in adults and adolescents with hemophilia A with factor VIII inhibitors seen in the HAVEN 1 clinical trial.

New analysis of pivotal data also suggested that additional factor treatment may not be needed for people on Hemlibra undergoing certain minor surgery.

Sonoma Reports Higher Q4 Revenues, Narrower Loss

Sonoma Pharmaceuticals Inc SNOA announced fourth-quarter results, showing year-over-year revenue growth of 20% to $4.4 million, with the increase traced back to higher dermatology revenues and international revenues. The net loss per share narrowed from $8.45 to $2.45.

Amgen Tender Offer To Buy Nuevolution Now Complete

Amgen, Inc. AMGN announced that shareholders representing about 97.6% of the total number of outstanding shares and votes in Nuevolution have accepted its 32.50 Swedish Krona per share offer to buy the Scandinavian biotech.

Amgen, therefore, declared the offer unconditional and deemed that all conditions for completion of the offer have either been satisfied or waived.

The company also said it has decided to extend the acceptance period until July 24, to give the remaining shareholders the possibility to accept the offer.