The Daily Biotech Pulse: Roche's Tecentriq Snags FDA Nod For Lung Cancer, Rapt Out-Licenses Cancer Drug

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. 3)

• Alnylam Pharmaceuticals, Inc. ALNY
• Antares Pharma Inc ATRS
• Ardelyx Inc ARDX(announced positive results for the Phase 3 study of tenapanor as monotherapy for treating hyperphosphatemia in patients with chronic kidney disease on dialysis)
• Audentes Therapeutics Inc BOLD( announced a deal to be bought by ASTELLAS PHARMA/ADR ALPMY)
• Axsome Therapeutics Inc AXSM(announced positive mid-stage readout for drug to treat narcolepsy)
• Cassava Sciences Inc SAVA
• Constellation Pharmaceuticals Inc CNST
• Dicerna Pharmaceuticals Inc DRNA
• DexCom, Inc. DXCM
• Eidos Therapeutics Inc EIDX
• ESSA Pharma Inc EPIX
• GALAPAGOS NV/S ADR GLPG
• Global Blood Therapeutics Inc GBT
• Inspire Medical Systems Inc INSP
• PTC Therapeutics, Inc. PTCT
• Recro Pharma Inc REPH
• Xenon Pharmaceuticals Inc XENE
• Zai Lab Ltd ZLAB

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 3)

• Checkpoint Therapeutics Inc CKPT
• Citius Pharmaceuticals Inc CTXR
• Evelo Biosciences Inc EVLO
• Midatech Pharma PLC-ADR MTP
• Neon Therapeutics Inc NTGN
• Orgenesis Inc ORGS
• Predictive Oncology Inc POAI
• Protagonist Therapeutics Inc PTGX(announced results from mid-stage study of PTG-300 in transfusion-dependent beta-thalassemia)
• Therapix Biosciences Ltd – ADR TRPX
• X4 Pharmaceuticals Inc XFOR

Stocks In Focus

Rapt Out-Licenses Cancer Drug In South Korea, Mainland China For Up To $118 Million

Rapt Therapeutics Inc RAPT announced a licensing and collaboration agreement with Hammi Pharma to out-license the Asian rights for FLX475, its oral, small molecule CCR4 antagonist being developed for multiple cancers.

The agreement provides for Rapt receiving a $10 million upfront payment and near-term milestone payment. Rapt is also eligible to receive up to $48 million in success-based development milestones and up to $60 million in potential sales milestones, as well as double-digit royalties on future sales in specified territories.

The stock rallied 11.74% to $27.88 in after-hours trading.

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

Roche's Tecentriq-Chemo Combo Now Approved For Lung Cancer Patients With No Genomic Abnormalities

Roche Holdings AG Basel RHHBY announced FDA approval for Tecentriq in combination with Bristol-Myers Squibb Co BMY's chemotherapy medications Arbaxane and carboplatin for the treatment pf non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

Veracyte In-licenses Dignostic Platform

Veracyte Inc VCYT said it has signed a definitive agreement with NanoString for the exclusive licensing of the latter's nCounter platform for diagnostic use. The deal, according to Veracyte, will help expand its genomic diagnostic business globally.

Offerings

Revance Therapeutics Inc RVNC announced a proposed underwritten public offering of its stock. The company said it intends to use the net proceeds to continue funding the commercialization of DAXI, and the remainder for working capital, R&D and general corporate purposes.

The stock slipped 9.78% to $18.18 in after-hours trading.

Adamas Pharmaceuticals Inc ADMS said in a filing it has entered into a sales agreement with Cowen to sell shares of its common stock, valued up to $50 million, with Cowen acting as its agent. The company said Cowen will be compensated by paying about 3% of the gross proceeds.

The stock moved down 7.68% to $6.01 in after-hours trading.

Immunomedics, Inc. IMMU said it has commenced an underwritten public offering of $250 million worth of its shares. The company said it expects to use the net proceeds primarily for accelerating commercial launch readiness, pending FDA approval of sacituzumab govitecan for the treatment of triple-negative breast cancer, continued development of sacituzumab govitecan, investing in platform development, continued scale-up of manufacturing as well as working capital and general corporate purposes.

The stock fell 7.37% to $17.60 in after-hours trading.

Relmada Therapeutics Inc RLMD priced its common-stock offering of 3.33 million shares at $30 per share. The company expects to raise gross proceeds of $100 million from the offering, which is expected to close Dec. 6.

The stock declined 8.59% to $31.50 in after-hours trading.

On The Radar

Clinical Trial Readouts

ACADIA Pharmaceuticals Inc. ACAD is scheduled to present at the 12th Clinical Trials On Alzheimer's Disease, or CTAD, annual meeting detailed Phase 3 data for pimavanserin in dementia-related psychosis.