The Daily Biotech Pulse: Assertio To Sell Opioid Pain Drug, Milestone Payment For Aduro, Myriad Genetics CEO Resigns

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 Feb. 6)

• Acceleron Pharma Inc XLRN
• Alector Inc ALEC
• Alnylam Pharmaceuticals, Inc. ALNY
• Anavex Life Sciences Corp AVXL
• Arvinas Inc ARVN
• Ascendis Pharma A/S ASND
• Beam Therapeutics Inc BEAM (IPOed Thursday)
• ChemoCentryx Inc CCXI
• Eli Lilly And Co LLY
• Fulgent Genetics Inc FLGT
• Insmed Incorporated INSM
• Insulet Corporation PODD
• Johnson & Johnson JNJ
• Novartis AG NVS
• PPD Inc PPD (IPOed Thursday)
• Principia Biopharma Inc PRNB
• Profound Medical Corp PROF
• PTC Therapeutics, Inc PTCT
• ResMed Inc. RMD
• Revance Therapeutics Inc RVNC (announced FDA acceptance of BLA for DAXI to treat frown lines)
• TG Therapeutics Inc common stock TGTX
• Vertex Pharmaceuticals Incorporated VRTX
• Zimmer Biomet Holdings Inc ZBH

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Feb. 6)

• Blueprint Medicines Corp BPMC(announced a 3-month extension to the PDUFA date for avapritinib for the treatment of adults with fourth-line gastrointestinal stromal tumor)
• Endologix, Inc. ELGX (recovered from a 52-week low and ended 16.27% higher after the company made a positive pre-announcement)
• Intec Pharma Ltd NTEC
• MediciNova, Inc. MNOV
• Neuronetics Inc STIM
• REDHILL BIOPHAR/S ADR RDHL
• Salarius Pharmaceuticals Inc SLRX(filed for common stock offering)
• Therapix Biosciences Ltd – ADR TRPX
• Tonix Pharmaceuticals Holding Corp TNXP( announced stalling of enrollment into a Phase 3 study of experimental drug to treat post-traumatic stress disorder following failed futility analysis)
• Zosano Pharma Corp ZSAN

Stocks In Focus

Myriad Genetics CEO Resigns Following Dismal Q2 Results and Weak Guidance

Molecular diagnostic company Myriad Genetics, Inc. MYGN announced abrupt resignation of its CEO Mark Capone, with immediate effect. The company named CFO Bryan Riggsbee as President and CEO, in addition to his CFO role.

The company reported fiscal-year 2020, second-quarter total revenues fell 10% year-over-year to $195.1 million, dragged by weak prenatal business. The company's adjusted EPS fell from 38 cents to 23 cents.

For 2020, the company expects adjusted EPS of 45 cents on revenues $735 million. The consensus estimates call for EPS of $1.06 on revenues of $807.31 million.

The stock slumped 29.84% to $20.55 in after-hours trading.

Assertio to Sell Opioid Pain Drug to Collegium For $375M

Assertio Therapeutics Inc ASRT said it has entered into a definitive agreement with Collegium Pharmaceutical Inc COLL to sell its Nucynta franchise products for $375 million in cash at closing, less royalties received by it in 2020. The agreement is expected to close Feb. 14.

Under a 2017 agreement, Assertio had licensed the opioid painkiller drug Nucynta to Collegium Pharma.

Assertio attributed the decision to its focus on aggressive de-leveraging. The company also said it is no longer pursuing the development of long-acting cosyntropin, given its belief that the development of this asset is no longer feasible in a timely manner.

Shares of Assertio jumped 52.88% to $1.59 in after-hours trading and Collegium was up 10.84% to $22.50.

Aduro Gets $10M Development Milestone Payment From Merck For Lung Cancer Drug

Aduro BioTech Inc ADRO said it earned a $10 million development milestone payment under its worldwide licensing agreement with Merck & Co., Inc. MRK following the initiation of Phase 2 clinical trial of MK-5890, an anti-CD27 agonist, in non-small cell lung cancer.

The stock added 8.91% to $2.75 in after-hours trading.

Zogenix' Pediatric Epileptic Drug Produces Mixed Results In Late-Stage Trial

Zogenix, Inc. ZGNX reported mixed topline results for a Phase 3 study, dubbed Study 1601, evaluating its lead investigational therapy Fintepla in Lennox-Gastaut Syndrome, or LGS, a severe treatment-resistant childhood-onset epilepsy.

The study met the primary objective of superiority of 0.7 mg/kg/day dose of Fintepla relative to placebo in reducing the frequency of drop seizures, based on the change between baseline and the titration and maintenance treatment period. The dose also met key secondary measures, including the proportion of patients with a clinically meaningful reduction in drop seizure frequency.

However, for a lower dose of Fintepla (0.2mg/kg/day) statistical significance was not achieved in the reduction of drop seizure frequency.

Zogenix shares slumped 32.92% to $35.30 in after-hours trading, while GW Pharmaceuticals PLC- ADR GWPH, which has an approved drug for LGS, added 9.1% to $129.

J&J Ordered To Pay $186.5M As Punitive Damages In Talc Litigation

A New Jersey state jury awarded J&J punitive damages of $750 million to four plaintiffs, who accused that the company's baby powder caused cancer due to the asbestos present in it. This is in addition to a $37.2 million awarded as compensation by a different jury. The state court later reduced the punitive damage to $186.5 million, as state laws limit the amount to five times the compensatory damages awarded to the plaintiffs last year.

Catalyst Presents Positive Mid-Phase Data For Hemophilia B Disorder Drug

Catalyst Biosciences Inc CBIO presented at the European Association for Hemophilia and Allied Disorders, or EAHAD, 2020 Congress positive efficacy and safety data from a Phase 2b study of dalcinonacog alfa, a subcutaneously administered Factor IX therapy, in hemophilia B.

Earnings

Pacific Biosciences of California's PACB fourth-quarter product service and other revenue rose 16% to $90.9 million. The company reported break-even results compared to a loss of 21 cents per share in the year-ago period. Analysts, on average, had forecast a loss of 16 cents per share for the quarter.

The stock gained 6.22% to $5.12 in after-hours trading.

LeMaitre Vascular Inc LMAT reported fourth-quarter sales of $30.2 million, up 6% year-over-year, and earnings, excluding special items, rose 3% to 23 cents per share, in line with the consensus estimate. The company guided first-quarter EPS to 14-17 cents on sales of $30.5 million. For 2020, the company expects EPS of 90-98 cents on sales of $127.4 million to $130.8 million. The first quarter guidance trailed estimates, while the 2020 guidance was in line.

The stock declined 14.81% to $31 in after-hours trading.

Offerings

Corbus Pharmaceuticals Holdings Inc CRBP said it plans to sell shares of its common stock in an underwritten registered public offering. All the shares are being offered by the company.

The stock slipped 6.41% to $6.42 in after-hours trading.

ADMA Biologics Inc ADMA said it has priced its previously announced underwritten public offering of 23.50 million shares at $3.50 per share for raising gross proceeds of about $82.3 million. The company expects the offering to close Feb. 11.

The stock slipped 5.25% to $3.79 in after-hours trading.

Miragen Therapeutics Inc MGEN said it intends to offer shares of its common stock and warrants to purchase its common stock in an underwritten public offering. All the shares and warrants are issued by the company.

The stock fell 17.97% to $1.05 in after-hours trading.

On The Radar

Clinical Readouts

Uniqure NV QURE is due to present Phase 2b one-year data for AMT-061 in hemophilia B at the EAHAD 2020 Congress.

Earnings

AbbVie Inc ABBV (before the market open)
Meridian Bioscience, Inc. VIVO (before the market open)