The Daily Biotech Pulse: Positive Data Readouts To Spur Aclaris, Moderna And Ultragenyx

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 Jan. 9)

Acceleron Pharma Inc XLRN
Allergan plc AGN
Applied Genetic Technologies Corp AGTC (announced positive midstage results for its gene therapy to treat inherited eye disorder)
Applied Therapeutics Inc APLT
Bio-Rad Laboratories, Inc. BIO
Bristol-Myers Squibb Co BMY
Collegium Pharmaceutical Inc COLL
COLLPLANT BIOTE/S ADR CLGN
DBV TECHNOLOGIE/S ADR DBVT (reported positive results for a late-stage study of its peanut allergy patch)
DexCom, Inc. DXCM
Global Blood Therapeutics Inc GBT
Grifols SA - ADR ADR Class B GRFS
Inspire Medical Systems Inc INSP
ITAMAR MED LTD/S ADR ITMR
Karyopharm Therapeutics Inc KPTI
LeMaitre Vascular Inc LMAT
Masimo Corporation MASI
Medtronic PLC MDT(announced the acquisition of Stimgenics)
Molecular Templates Inc MTEM
Morphosys Ag MOR
NuVasive, Inc. NUVA
PTC Therapeutics, Inc. PTCT
Regulus Therapeutics Inc RGLS
ResMed Inc. RMD
Sanofi SA SNY(reported pre-quarterly results and also announced a strategic collaboration agreement with Nurix Therapeutics for developing targeted protein degradation therapies)
TG Therapeutics Inc TGTX
Trillium Therapeutics Inc TRIL
Turning Point Therapeutics Inc TPTX
Varian Medical Systems, Inc. VAR
Vertex Pharmaceuticals Incorporated VRTX
Veru Inc VERU
Xenon Pharmaceuticals Inc XENE
Zoetis Inc ZTS
Zymeworks Inc ZYME

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Jan. 9)

Enzo Biochem, Inc. ENZ
Sellas Life Sciences Group Inc SLS(priced a $6.5 million registered direct offering of its common stock)
Therapix Biosciences Ltd – ADR TRPX
Theratechnologies Inc THTX

Stocks In Focus

Aclaris' Immuno-Inflammatory Drug Aces Early Stage Study

Aclaris Therapeutics Inc ACRS announced positive results from a single ascending dose and multiple ascending dose Phase 1 study of ATI-450, its investigational oral MK2 inhibitor.

The company noted that the experimental drug resulted in marked inhibition of L1β, IL8, and IL6 and had dose proportional pharmacokinetics with a terminal half-life of 9-12 hours. Additionally, it was found to be well tolerated at all doses tested in the trial and did not have meaningful food effect or drug-drug interaction with methotrexate.

The company said it intends to initiate the first Phase 2 trial with rheumatoid arthritis in the first half of 2020.

The stock rallied 27.96% to $2.38 in after-hours trading.

Moderna Reports Positive Phase 1 Results For Vaccine to Prevent Virus Causing Birth Defects

Moderna Inc MRNA announced positive seven-month interim safety and immunogenicity data after the third and fourth vaccination in the Phase 1 study of its investigational cytomegalovirus, or CMV, vaccine MRNA-1647. The company also said the first participant was dosed in the Phase 2 dose-confirmatory study.

CMV virus is the most common infectious cause of birth defects in the U.S. and has no currently approved vaccines to prevent it.

The stock jumped 18.04% to $21.72 in after-hours trading.

Ultragenyx' Urea Cycle Disorder Gene Therapy Found Effective and Safe

Ultragenyx Pharmaceutical Inc RARE announced topline positive safety and efficacy data from Cohort 3 and longer-term data from Cohort 2 of the Phase 1/2 study of DTX301, an investigational AAV gene therapy for the treatment of ornithine transcarbamylase, or OTC, deficiency.

OTC deficiency leads to build up of excessive levels of ammonia in blood, resulting in acute and chronic neurological deficits and other toxicities. It is a genetic disorder, caused by a genetic defect in a liver enzyme responsible for detoxification of ammonia.

The stock soared 14.57% to $50.10 in after-hours trading.

Portola Plunges On Weak Andexxa Sales Forecast For Q4

Portola Pharmaceuticals Inc PTLA announced preliminary Andexxa global net revenues of $28 million in the fourth quarter and $111 million for the full year. U.S. sales of Andexxa came in at $24 million in the fourth quarter, lower than the $33 million in the third quarter.

The stock slumped 39.45% to $14.98 in after-hours trading.

Aptinyx Plans To Offer Shares In Secondary Offering

Aptinyx Inc APTX intends to offer common shares in an underwritten public offering. All the shares are to be sold by the company. The company said it will use the net proceeds to advance preclinical and clinical development of its NMDA receptor modulators such as NYX-2925, NYX-783 and NYX-458 in development for chronic pain, post-traumatic stress disorder and cognitive impairment, respectively.

The stock shed 6.94% to $3.35 in after-hours trading.

Turning Point Announces Resignation of Chief Scientific Officer

Turning Point Therapeutics Inc TPTX said Jean Cui will step down as chief scientific officer Jan. 31, with family reasons cited for the departure. Cui, however, will serve as a consultant and support the company during a transition period until June 30.

The stock fell 2.45% to $63.75 in after-hours trading.

T2 Biosystems Names Diagnostic Industry Veteran John Sperzel as CEO; Q4 Sales Outlook Trails Estimate

T2 Biosystems Inc TTOO pre-announced fourth quarter revenues of $3 million, up 67% year-over-year. The consensus estimate calls for revenues of $3.67 million. As of Dec. 31, 2019, the company had cash and cash equivalents of $11 million.

Separately, the company announced that John Sperzel, a diagnostic industry veteran, has been appointed as President and CEO, effectively immediately.

The stock added 7.02% to $1.22 in after-hours trading.

Aduro BioTech to Eliminate 59% Jobs as Part of Plan to Extend Operating Capital

Aduro BioTech Inc ADRO announced a restructuring plan aimed at extending its operating capital and align personnel toward executing its clinical development strategy. The restructuring initiatives, include elimination of 59% of its workforce, minimizing of its corporate facilities footprint and shutting down of its Aduro Biotech Europe headquarters in the Netherlands by the end of the third quarter of 2020.

The stock slipped 2.26% to $1.30 in after-hours trading.

Intuitive Surgical Guides Q4, FY19 Revenues Above Consensus

Intuitive Surgical, Inc. ISRG pre-announced fourth quarter and full year results, expecting revenues of $1.278 billion and $4.479 billion, respectively. Analysts estimate revenues of $1.22 billion for the fourth quarter and $4.42 billion for the full year. The company said it shipped 336 da Vinci Surgical Systems in the fourth quarter.

The stock rose 2.77% to $602 in after-hours trading.

Aravive Appoints Rekha Hemrajani as CEO

Aravive Inc ARAV announced the appointment of Rekha Hemrajani as its CEO and director of the company, replacing Jay Shepard, who announced last year plans to step down from the CEO position. Shepard will transition to the role of the Chairman of the board, the company said.

The stock moved down 1.82% to $13.52 in after-hours trading.

Matinas Announces Common Stock Offering

Matinas BioPharma Holdings Inc MTNB said it has commenced an underwritten public offering of its common stock. All the shares are being sold by the company. Matinas said it expects to use the net proceeds for funding development of pipeline assets, primarily MAT9001 and for working capital and other corporate purposes.

The stock declined 11.52% to $1.69 in after-hours trading.

Flexion Pre-announces Revenue Shortfall

Flexion Therapeutics Inc FLXN announced preliminary fourth-quarter results, expecting full-year sales of $73 million, up more than 220% year-over-year. Analysts, on average, estimate revenues of $73.18 million. For the fourth quarter, the company expects revenues of $23.7 million, below the $24.09-million consensus estimate. The company also said it expects Zilretta revenues to be $120 million to $135 million in 2020.

The stock was down 0.62% to $21 in after-hours trading.

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