The Daily Biotech Pulse: Therapix Extends Merger Deadline, Five Prime Restructures, Gilead-Galapagos Rheumatism Drug Readout

The following is a roundup of top developments in the biotech space over the last 24 hours. 

Scaling The Peaks

(Biotech stocks that hit 52-week highs Oct. 10.)

• The Medicines Company MDCO
• Ra Pharmaceuticals Inc RARX (announced a deal to be bought by Belgium's UCB)

Down In The Dumps

(Biotech stocks that hit 52-week lows Oct. 10.)

• Adamas Pharmaceuticals Inc ADMS
• Adamis Pharmaceuticals Corp ADMP
• Aerie Pharmaceuticals Inc AERI
• Aerpio Pharmaceuticals Inc ARPO
• Aileron Therapeutics Inc ALRN
• Alkermes Plc ALKS
• Atreca Inc BCEL
• AzurRx BioPharma Inc AZRX (announced CEO departure)
• BioNano Genomics Inc BNGO
• BioTelemetry Inc BEAT
• Cellectis SA CLLS
• Cerus Corporation CERS
• Chimerix Inc CMRX
• Citius Pharmaceuticals Inc CTXR
• Clovis Oncology Inc CLVS
• Cocrystal Pharma Inc COCP
• CymaBay Therapeutics Inc CBAY
• DelMar Pharmaceuticals Inc DMPI
• Dermira Inc DERM
• Diffusion Pharmaceuticals Inc DFFN
• Enochian Biosciences Inc ENOB
• Galmed Pharmaceuticals Ltd GLMD
• Gemphire Therapeutics Inc GEMP
• Genprex Inc GNPX
• Gossamer Bio Inc GOSS
• Helius Medical Technologies Inc HSDT
• Homology Medicines Inc FIXX
• Hoth Therapeutics Inc HOTH
• Jaguar Health Inc JAGX (announced plans to explore options to license Mytesi in China)
• Meridian Bioscience, Inc. VIVO
• MOTIF BIO PLC/S ADR MTFB
• MOTIF BIO PLC/S ADR (: MTFB)
• Novus Therapeutics Inc NVUS
• Obalon Therapeutics Inc OBLN
• Onconova Therapeutics Inc ONTX
• Orgenesis Inc ORGS
• PAVmed Inc PAVM
• Precision BioSciences Inc DTIL
• Predictive Oncology Inc POAI
• Plus Therapeutics Inc PSTV
• Puma Biotechnology Inc PBYI
• Rexahn Pharmaceuticals, Inc. REXN
• Salarius Pharmaceuticals Inc SLRX
• Sophiris Bio Inc SPHS
• Sorrento Therapeutics Inc SRNE
• Strongbridge Biopharma plc SBBP
• Supernus Pharmaceuticals Inc SUPN
• TIZIANA LF SCIE/S ADR TLSA
• TRACON Pharmaceuticals Inc TCON
• Trevi Therapeutics Inc TRVI

See also: The Week Ahead In Biotech: Pfenex And Clinuvel On The Radar Ahead of FDA Decisions, 2 IPOs On Deck

Stocks In Focus

Therapix Extends Due Diligence Deadline For Proposed Merger With Destiny

Therapix Biosciences Ltd – ADR TRPX said it is moving to provide additional time for Destiny Biosciences to complete the due diligence process in a proposed merger between the two companies. According to a letter of intent signed in late July, a definitive agreement was to be signed by the third quarter, with provision for an extension until Oct. 31.

The stock rallied 18.18% to $2.16 in premarket trading.

Gilead, Galapagos Report Positive Data For Rheumatoid Arthritis Drug

Gilead Sciences, Inc. GILD and GALAPAGOS NV/S ADR GLPG released Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib for the treatment of moderately to severely active rheumatoid arthritis, which showed that the results were consistent with and supported efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier this year.

Eli Lily's Psoriasis Drug Taltz Found Superior to J&J's Tremfya

Eli Lilly And Co LLY presented at the 5th Annual Maui Derm NP+FA Fall meeting with detailed data from the Phase 4 IXORA-R study that compared its Taltz and Johnson & Johnson JNJ's Janssen unit's Tremfya using the Psoriasis Area Severity Index (PASI) 100 score as the primary endpoint.

In the study, Taltz met the primary endpoint of superiority versus Tremfya in the proportion of patients with moderate-to-severe plaque psoriasis achieving complete skin clearance as measured by PASI 100 at Week 12, as well as all key secondary endpoints.

Five Prime Announces Restructuring to Extend Cash Runway, 70 Job Cuts 

Five Prime Therapeutics Inc FPRX announced a corporate restructuring intended to extend its cash runway without impacting or delaying data timelines of its clinical programs.

The company has decided to retain a small research group focused on advancing their wholly owned, late-stage assets and rely on outsourcing and contracted capabilities,

Five Prime plans to eliminate 70 jobs across all functions, with 70% of cuts to be enacted by the end of 2019 and the remainder in 2020. The company is also initiating activities to reduce its corporate facilities footprint by either subletting a significant portion of its leased space or subletting the entirety of its building and relocating to smaller facilities.

The company expects annualized cost savings of about $20 million while incurring $3 million in pretax charges for severance and other costs related to the restructuring, primarily in 2019.

On The Radar

Clinical Trial Readouts

Adverum Biotechnologies Inc ADVM will present additional Phase 1 data for ADVM-022 in wet age-related macular degeneration at the American Academy of Ophthalmology, or AAO, 2019 in San Francisco, California.

Regenxbio Inc RGNX is due to present Phase 1/2a data for RGX-314 in wet AMD at the AAO 2019 meeting.

Kodiak Sciences Inc KOD is scheduled to present Phase 1b data for KSI-301 in diabetic macular edema at the Retina Subspecialty Day.

IPOs

Vir Biotechnology, a biotech developing immunologic therapies for infectious diseases, priced its IPO of 7.14 million shares at $20, the low end of the estimated price range of $20 to $22 per share. The shares are to be listed on the Nasdaq under the ticker symbol "VIR."

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