The Daily Biotech Pulse: FDA Nod For Bristol-Myers Squibb, Momenta Strikes Patent License Deal With AbbVie

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 Nov. 6)

• Allakos Inc ALLK
• Allogene Therapeutics Inc ALLO
• Equillium Inc EQ
• Gritstone Oncology Inc GRTS
• Vericel Corp VCEL(reported a beat-and-raise quarter)

Down In The Dumps

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

• Adial Pharmaceuticals Inc ADIL
• Checkpoint Therapeutics Inc CKPT
• CytomX Therapeutics Inc CTMX
• Ironwood Pharmaceuticals, Inc. IRWD(reported a Q3 revenue drop and a wider loss)
• Kodiak Sciences Inc KOD
• Leap Therapeutics Inc LPTX
• Neos Therapeutics Inc NEOS(priced a common stock offering of 17.39 million shares at $2.30)
• Novelion Therapeutics Inc NVLN
• OncoSec Medical Inc ONCS(released preliminary results of the Phase 2b KEYNOTE-695 trial that evaluated its Tavo in combination with Keytruaa for treating patients with unresectable advanced melanoma who progressed after anti-PD-1 therapy alone)
• Portola Pharmaceuticals Inc PTLA
• RA Medical Systems Inc RMED

Stocks In Focus

AbbVie Grants Momenta Non-exclusive License Agreement For its Rheumatoid Arthritis Drug

AbbVie Inc ABBV and Momenta Pharmaceuticals, Inc. MNTA announced a patent license agreement over the latter's proposed biosimilar for the former's adalimumab product. Under the agreement, AbbVie will grant Momenta a non-exclusive license on specified dates to the former's intellectual property related to Humira.

Momenta's U.S. license is set to begin Nov. 20, 2023, while in the European Union, it can launch upon approval from the EMA.

Momenta shares advanced 4.57 percent to $15.09 in after-hours trading.

FDA Approves Bristol-Myers Squibb' Blood Cancer Treatment Combo

Bristol-Myers Squibb Co BMY said the FDA has approved its Empliciti injection for intravenous use in combination with pomalidomide and dexamethasone for treating adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

In a late-stage trial, the treatment combination demonstrated benefit, doubling both median progression-free survival and overall response rate, versus pomalidomide and dexamethasone.

See Also: The Week Ahead In Biotech: Earnings, Conferences, PDUFA Dates, Clinical Trial Results And IPOs

Earnings

PDL BioPharma Inc PDLI reported a 8 percent increase in Q3 revenues to $68 million, while its net loss widened from 14 cents per share to 18 cents per share.

The stock rallied 9.76 percent to $2.70 in after-hours trading.

Genomic Health, Inc. GHDX reported Q3 revenues of $101.3 million compared to a pre-606 adjusted revenues of $82.2 million. The company reversed to a profit of 32 cents per share from a loss of 6 cents per share last year. The company raised its revenue and earnings guidance for 2018.

The stock climbed 7.92 percent to $76.40 in after-hours trading.

Akorn, Inc. AKRX's net revenues declined 18.2 percent to $165.6 million, which however was in line with estimates. On an adjusted basis, the company reversed to a loss of 6 cents per share from a profit of 16 cents per share.

The stock fell 8.01 percent to $6.89 in after-hours trading.

Jazz Pharmaceuticals PLC JAZZ reported 14 percent growth in Q3 net revenues to $469.37 million. The company's adjusted earnings per share increased from $3.22 to $3.58. The company raised its full-year guidance.

The stock slipped 9.04 percent to $149.55 in after-hours trading.

Myriad Genetics, Inc. MYGN reported fiscal-year first-quarter revenues of $202.3 million, up 13 percent year-over-year and in line with the consensus. Adjusted earnings per share climbed 48 percent to 43 cents, exceeding the 30 cents per share consensus estimate. The company lowered its full-year 2019 revenue guidance, while it maintained its earnings per share guidance. Its Q2'19 guidance trailed estimates.

The stock fell 8.64 percent to $33.50 in after-hours trading.

On The Radar

Earnings

• Aerpio Pharmaceuticals Inc ARPO (before the market open)
• Affimed NV AFMD (before the market open)
• Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
• Amneal Pharmaceuticals Inc AMRX (before the market open)
• Protalix Biotherapeutics Inc PLX (before the market open)
• Intra-Cellular Therapies Inc ITCI (before the market open)
• Evofem Biosciences Inc EVFM (before the market open)
• Melinta Therapeutics Inc MLNT (before the market open)
• Recro Pharma Inc REPH (before the market open)
• Charles River Laboratories Intl. Inc CRL (before the market open)
• Reata Pharmaceuticals Inc RETA (before the market open)
• Momenta Pharmaceuticals, Inc. MNTA (before the market open)=
• Horizon Pharma PLC HZNP (before the market open)
• Miragen Therapeutics Inc MGEN (before the market open)
• Pieris Pharmaceuticals Inc PIRS (before the market open)
• Merrimack Pharmaceuticals Inc MACK (before the market open)
• TRACON Pharmaceuticals Inc TCON (after the market close)
• Zafgen Inc ZFGN (after the market close)
• MacroGenics Inc MGNX (after the market close)
• G1 Therapeutics Inc GTHX (after the market close)
• Regenxbio Inc RGNX (after the market close)
• Viking Therapeutics Inc VKTX (after the market close)
• Arena Pharmaceuticals, Inc. ARNA (after the market close)
• Achieve Life Sciences Inc ACHV (after the market close)
• Avalara Inc AVLR (after the market close)
• Arbutus Biopharma Corp ABUS (after the market close)
• Aileron Therapeutics Inc ALRN (after the market close)
• Calithera Biosciences Inc CALA (after the market close)
• Kindred Biosciences Inc KIN (after the market close)
• Nektar Therapeutics NKTR (after the market close)
• Vanda Pharmaceuticals Inc. VNDA (after the market close)
• Immunomedics, Inc. IMMU
• Glaukos Corp GKOS (after the market close)
• Editas Medicine Inc EDIT (after the market close)
• Flexion Therapeutics Inc FLXN (after the market close)
• Ocular Therapeutix Inc OCU (after the market close)
• Hologic, Inc. HOLX (after the market close)
• Pfenex Inc PFNX (after the market close)
• Voyager Therapeutics Inc VYGR (after the market close)
• Portola Pharmaceuticals Inc PTLA (after the market close)
• TherapeuticsMD Inc TXMD (after the market close)