The Daily Biotech Pulse: FDA Nod For Roche, Trial Results For Agios, Iovance And MacroGenics

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 May 15)

• Applied Therapeutics Inc APLT (debuted on Tuesday)
• Arena Pharmaceuticals, Inc. ARNA
• Avedro Inc AVDR
• Axsome Therapeutics Inc AXSM
• MeiraGTx Holdings PLC MGTX
• Shockwave Medical Inc SWAV
• Silk Road Medical Inc SILK
• Zynerba Pharmaceuticals Inc ZYNE

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 15)

• Amneal Pharmaceuticals Inc AMRX
• Auris Medical Holding Ltd EARS
• DelMar Pharmaceuticals Inc DMPI(reacted to its third-quarter results)
• ENDRA Life Sciences Inc NDRA(reacted to its first-quarter results)
• ImmunoGen, Inc. IMGN(FDA required a new Phase 3 study to be conducted for its ovarian cancer drug)
• Nuvectra Corp NVTR
• Outlook Therapeutics Inc OTLK(reacted to its second quarter results)
• Teva Pharmaceutical Industries Ltd TEVA
• United Therapeutics Corporation UTHR

Stock In Focus

Roche Gets FDA Nod For Leukemia Drug, Reports Positive Results For Solid Tumor Drug

Roche Holdings AG Basel ADR RHHBY said the FDA approved Venclexta in combination with Gazyva for treating people with previously untreated chronic lymphocytic leukemia, or CLL, or small lymphocytic lymphoma, or SLL.

The combo is the only chemo-free option of fixed duration providing durable responses, the company said. The approval was based on the results of a Phase 3 trial CLL14 study, which evaluated 12-month, fixed-duration treatment with Venclexta plus Gazyva compared to Gazyva plus chlorambucil.

Separately, Roche announced positive Phase 1/2 data for its STARTRK-NG study that evaluated its investigational drug entrectinib in children and adolescents with recurrent or refractory solid tumors with and without neurotrophic tyrosine receptor kinase, ROS1 or anaplastic lymphoma kinase (ALK) gene fusions.

Agios' Bile Duct Cancer Drug Found Effective In Patients With Certain Gene Mutation

Agios Pharmaceuticals Inc AGIO said a global Phase 3 study, dubbed ClarIDHy, of its Tibsovo in previously-treated cholangiocarcinoma patients with isocitrate dehydrogenase 1 met its primary endpoint of showing statistically significant improvement in progression-free survival compared with patients receiving placebo.

The company said it plans to submit a sNDA for Tibsovo in previously-treated IDH1 mutant cholangiocarcinoma by the end of 2019.

The stock rallied 19.81 percent to $56.73 in after-hours trading.

Iovance Reports Positive Results For Its TIL Therapy In Cervical Cancer and Melanoma

Iovance Biotherapeutics Inc IOVA announced new interim data from its clinical studies of tumor-infiltrating lymphocyte, or TIL, therapy LN-145 in patients with advanced cervical cancer, which showed an objective response rate, or ORR, of 44 percent, and a disease control rate of 89 percent. Merck & Co., Inc. MRK's Keytruda, which was used as a reference, had a 14 percent ORR.

Meanwhile, updated results from Cohort 2 in the ongoing innovaTIL-01 study of lifileucel in advanced melanoma showed an ORR of 38 percent and a disease control rate of 76 percent.

The stock advanced 19.77 percent to $13.45 in after-hours trading.

MacroGenics Says Breast Cancer Drug Aces Late-stage Trial

MacroGenics Inc MGNX announced additional details of the results from the Phase 3 SOPHIA study of margetuximab in patients with HER2-positive metastatic breast cancer who have been previously treated anti-HER2-targeted therapies, which showed that the study met the sequential primary endpoint of progression-free survival.

The company noted that the median progression-free survival of patients treated with margetuximab and chemotherapy was 5.8 months compared to 4.9 months in patients treated with Roche's Herceptin and chemotherapy. The ORR for the former was 22 percent compared to the 16 percent for the latter.

Margetuximab is an immune enhancing monoclonal antibody developed using the company's proprietary Fc Optimization technology platform.

The stock gained 13.03 percent to $18.39 in after-hours trading.

Aduro Shelves Study Of BION-1301 In Multiple Myeloma

Aduro BioTech Inc ADRO said it has decided not to continue the Phase 1/2 study of BION-1301, its humanized Immunoglobulin G4, or IgG4, monoclonal antibody, in multiple myeloma, citing a lack of ORR. However, the company has decided to pursue the development of the candidate in the IgA Nephropathy indication.

The stock fell 14.33 percent to $2.81 in after-hours trading.

Alphaeon To Sell 4M Evolus Shares

Alphaeon said it has agreed to sell about 4 million of Evolus Inc EOLS's common stock in an underwritten public offering. No shares earmarked for the offering will be sold by Evolus. Alphaeon said it will use the net proceeds to pay down its outstanding secured debt.

The stock moved down 7.95 percent to $20.50 in after-hours trading.

ADMA To Offer $45M Worth of Shares

ADMA Biologics Inc ADMA said it has commenced a $45 million underwritten common stock offering. The company said the proposed offering is subject to market and other conditions and that there can be no assurance that the offering will be completed or as to the actual size of the offering.

The stock slipped 9.66 percent to $4.02 in after-hours trading.

Earnings

Edap Tms SA EDAP reported a small year-over-year increase in first-quarter revenues from $11.3 million to $11.5 million, missing the $14.3 million consensus estimate. The company's net income increased from $0.1 million to $0.4 million.

The stock plunged 16.48 percent to $3.80 in after-hours trading.

Achieve Life Sciences Inc ACHV reported a wider-than-expected loss for its first quarter, as R&D expenses ballooned.

The stock declined 6.87 percent to $3.93 in after-hours trading.

On The Radar

Earnings

Bio-Path Holdings Inc BPTH (before the market open)
Egalet Corp ZCOR (after the market close)