The Daily Biotech Pulse: Seattle Genetics' Bladder Cancer Drug Gets FDA Nod, Paratek Wins Contract For Antibiotic

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 Dec. 18)

• 10X Genomics Inc TXG
• Acceleron Pharma Inc XLRN
• Allergan plc AGN
• Aptose Biosciences Inc APTO
• Axsome Therapeutics Inc AXSM
• Clearside Biomedical Inc CLSD
• Editas Medicine Inc EDIT
• Epizyme Inc EPZM( reacted to a positive verdict for its therapy to treat epithelioid sarcoma)
• Exagen Inc XGN
• Globus Medical Inc GMED
• Horizon Therapeutics PLC HZNP
• IGM Biosciences Inc IGMS
• Intuitive Surgical, Inc. ISRG
• Iovance Biotherapeutics Inc IOVA
• Ironwood Pharmaceuticals, Inc. IRWD
• Merck & Co., Inc. MRK(snagged positive verdict for Keytruda in bladder cancer)
• Mirati Therapeutics Inc MRTX
• Mirum Pharmaceuticals Inc MIRM
• Momenta Pharmaceuticals, Inc. MNTA
• NeoGenomics, Inc. NEO
• Neoleukin Therapeutics Inc NLTX(announced a common stock offering)
• NGM Biopharmaceuticals Inc NGM
• Repro-Med Systems, Inc. KRMD
• ResMed Inc. RMD
• SpringWorks Therapeutics Inc SWTX

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 18)

• Akorn, Inc. AKRX(announced that it is exploring a possible bankruptcy filing)
• Alterity Therapeutics Ltd ATHE
• Anixa Biosciences Inc ANIX
• Aridis Pharmaceuticals Inc ARDS
• Athersys, Inc. ATHX
• Biocept Inc BIOC
• Brickell Biotech Inc BBI
• Cocrystal Pharma Inc COCP
• Correvio Pharma Corp CORV
• Endologix, Inc. ELGX
• Evelo Biosciences Inc EVLO
• Milestone Pharmaceuticals Inc MIST
• Nemaura Medical Inc NMRD
• Phathom Pharmaceuticals Inc PHAT
• Regulus Therapeutics Inc RGLS
• Ritter Pharmaceuticals Inc RTTR
• Tetraphase Pharmaceuticals Inc TTPH
• Therapix Biosciences Ltd – ADR TRPX
• Tocagen Inc TOCA
• TRACON Pharmaceuticals Inc TCON
• Wave Life Sciences Ltd WVE
• Zafgen Inc ZFGN(announced merger with Chondrial Therapeutics)

Stocks In Focus

Paratek Wins BARDA Contract Valued Up To $285M For Developing Antibiotic For Pulmonary Anthrax

Paratek Pharmaceuticals Inc PRTK said the Department of Human Health, Office of the Assistant Secretary for Preparedness and Response, and Biomedical Advanced Research and Development Authority, has awarded it a five-year contract, with an option to extend it to 10 years, to support the development of its Nuzyra for the treatment of pulmonary anthrax.

The contract also includes support to post-marketing requirements related to the initial Nuzyra approval and the option to procure up to 10,000 treatment courses of Nuzyra for the the Strategic National Stockpile for use against potential biothreats.

The stock skyrocketed 69.49% to $5 in after-hours trading.

See Also: 8 Biotech Stocks Morgan Stanley Recommends For 2020

Seattle Genetics-Astellas' Antibody-Drug Conjugate Approved For Bladder Cancer

Seattle Genetics, Inc. SGEN and Astellas Pharma Inc. ALPMY said the FDA has granted accelerated approval for Padcev for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic setting.

Padcev is a antibody-drug conjugate, or ADC, that is directed against Nectin-4, a protein highly expressed in bladder cancer.

Seattle Genetics shares rose 8.21% to $122 in after-hours trading.

Roche Gets Regulatory Approval For Breast Cancer Drug In Europe

Roche Holdings AG Basel ADR RHHBY said the European Commission has approved its Kadcyla for the adjuvant treatment adult patients with HER2-positive early breast cancer. These patients had residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2- targeted therapy.

Minerva Depression Drug Flunks Mid-Stage Trial, To Shelve Study

Minerva Neurosciences Inc NERV said the Phase 2b study that evaluated MIN-117 in adult patients with moderate to severe major depressive disorder, or MDD, failed to meet its primary and key secondary endpoints.

The company said it has no plans for further clinical development of the molecule in MDD.

The stock plunged 27.43% to $5 in after-hours trading.

Novartis Opts Not To License Akcea's Cardiovascular Investigational Therapy

Akcea Therapeutics Inc AKCA, an affiliate of Ionis Pharmaceuticals Inc IONS, said Novartis AG NVS has decided not to exercise its option to license Akcea's antisense oligonucleotide AKCEA-APOCIII-LRx.

Akcea said it has retained rights to develop and commercialize the therapy for familial chylomicronemia syndrome, plus other indications. The company said it expects to release results from the Phase 2 study early in 2020.

89Bio Q3 Loss Widens

89bio Inc ETNB reported a wider-than-expected loss for its September quarter.

"With our strengthened capital position, we look forward to continuing to advance BIO89-100 through clinical development in NASH and initiating development of BIO89-100 in our planned Phase 2 study in severe hypertriglyceridemia (SHTG) in 2020," said Rohan Palekar, CEO of 89Bio.

The stock rose 6.68% to $30.50 in after-hours trading.

Offerings

Axsome, which recently reported positive late-stage results for its depression drug, said it intends to offer shares, subject to market and other conditions, in an underwritten public offering.

After closing at a 52-week high of $89.57 in the regular trading session, Axsome added 4.93% to $93.99 in after-hours trading.

Exicure Inc XCUR said it intends to offer shares of its common stock in an underwritten public offering. All the shares earmarked for the offering are being sold by the company. The company said it intends to use the net proceeds primarily for funding its clinical programs.

The stock fell 5.41% to $2.80 in after-hours trading.

On The Radar

IPO

Monopar Therapeutics priced its IPO of 1.11 million shares at $8 per share. The shares are expected to commence trading on the Nasdaq Wednesday under the ticker symbol "MNPR."