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 (NASDAQ: ALLK)
Allogene Therapeutics Inc (NASDAQ: ALLO)
Equillium Inc (NASDAQ: EQ)
Gritstone Oncology Inc (NASDAQ: GRTS)
Vericel Corp (NASDAQ: VCEL)(reported a beat-and-raise quarter)
Down In The Dumps
(Biotech stocks hitting 52-week lows on Nov. 6)
Adial Pharmaceuticals Inc (NASDAQ: ADIL)
Checkpoint Therapeutics Inc (NASDAQ: CKPT)
CytomX Therapeutics Inc (NASDAQ: CTMX)
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)(reported a Q3 revenue drop and a wider loss)
Kodiak Sciences Inc (NASDAQ: KOD)
Leap Therapeutics Inc (NASDAQ: LPTX)
Neos Therapeutics Inc (NASDAQ: NEOS)(priced a common stock offering of 17.39 million shares at $2.30)
Novelion Therapeutics Inc (NASDAQ: NVLN)
OncoSec Medical Inc (NASDAQ: 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 (NASDAQ: PTLA)
RA Medical Systems Inc (NYSE: RMED)
Stocks In Focus AbbVie Grants Momenta Non-exclusive License Agreement For its Rheumatoid Arthritis Drug
AbbVie Inc (NYSE: ABBV) and Momenta Pharmaceuticals, Inc. (NASDAQ: 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 (NYSE: 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 (NASDAQ: 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. (NASDAQ: 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. (NASDAQ: 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 (NASDAQ: 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. (NASDAQ: 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 (NASDAQ: ARPO) (before the market open)
• Affimed NV (NASDAQ: AFMD) (before the market open)
• Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) (before the market open)
• Amneal Pharmaceuticals Inc (NYSE: AMRX) (before the market open)
• Protalix Biotherapeutics Inc (NYSE: PLX) (before the market open)
• Intra-Cellular Therapies Inc (NASDAQ: ITCI) (before the market open)
• Evofem Biosciences Inc (NASDAQ: EVFM) (before the market open)
• Melinta Therapeutics Inc (NASDAQ: MLNT) (before the market open)
• Recro Pharma Inc (NASDAQ: REPH) (before the market open)
• Charles River Laboratories Intl. Inc (NYSE: CRL) (before the market open)
• Reata Pharmaceuticals Inc (NASDAQ: RETA) (before the market open)
• Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) (before the market open)=
• Horizon Pharma PLC (NASDAQ: HZNP) (before the market open)
• Miragen Therapeutics Inc (NASDAQ: MGEN) (before the market open)
• Pieris Pharmaceuticals Inc (NASDAQ: PIRS) (before the market open)
• Merrimack Pharmaceuticals Inc (NASDAQ: MACK) (before the market open)
• TRACON Pharmaceuticals Inc (NASDAQ: TCON) (after the market close)
• Zafgen Inc (NASDAQ: ZFGN) (after the market close)
• MacroGenics Inc (NASDAQ: MGNX) (after the market close)
• G1 Therapeutics Inc (NASDAQ: GTHX) (after the market close)
• Regenxbio Inc (NASDAQ: RGNX) (after the market close)
• Viking Therapeutics Inc (NASDAQ: VKTX) (after the market close)
• Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) (after the market close)
• Achieve Life Sciences Inc (NASDAQ: ACHV) (after the market close)
• Avalara Inc (NYSE: AVLR) (after the market close)
• Arbutus Biopharma Corp (NASDAQ: ABUS) (after the market close)
• Aileron Therapeutics Inc (NASDAQ: ALRN) (after the market close)
• Calithera Biosciences Inc (NASDAQ: CALA) (after the market close)
• Kindred Biosciences Inc (NASDAQ: KIN) (after the market close)
• Nektar Therapeutics (NASDAQ: NKTR) (after the market close)
• Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) (after the market close)
• Immunomedics, Inc. (NASDAQ: IMMU)
• Glaukos Corp (NYSE: GKOS) (after the market close)
• Editas Medicine Inc (NASDAQ: EDIT) (after the market close)
• Flexion Therapeutics Inc (NASDAQ: FLXN) (after the market close)
• Ocular Therapeutix Inc (NASDAQ: OCU) (after the market close)
• Hologic, Inc. (NASDAQ: HOLX) (after the market close)
• Pfenex Inc (NYSE: PFNX) (after the market close)
• Voyager Therapeutics Inc (NASDAQ: VYGR) (after the market close)
• Portola Pharmaceuticals Inc (NASDAQ: PTLA) (after the market close)
• TherapeuticsMD Inc (NASDAQ: TXMD) (after the market close)
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