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 (NASDAQ: XLRN)
- Alector Inc (NASDAQ: ALEC)
- Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)
- Anavex Life Sciences Corp (NASDAQ: AVXL)
- Arvinas Inc (NASDAQ: ARVN)
- Ascendis Pharma A/S (NASDAQ: ASND)
- Beam Therapeutics Inc (NASDAQ: BEAM) (IPOed Thursday)
- ChemoCentryx Inc (NASDAQ: CCXI)
- Eli Lilly And Co (NYSE: LLY)
- Fulgent Genetics Inc (NASDAQ: FLGT)
- Insmed Incorporated (NASDAQ: INSM)
- Insulet Corporation (NASDAQ: PODD)
- Johnson & Johnson (NYSE: JNJ)
- Novartis AG (NYSE: NVS)
- PPD Inc (NASDAQ: PPD) (IPOed Thursday)
- Principia Biopharma Inc (NASDAQ: PRNB)
- Profound Medical Corp (NASDAQ: PROF)
- PTC Therapeutics, Inc (NASDAQ: PTCT)
- ResMed Inc. (NYSE: RMD)
- Revance Therapeutics Inc (NASDAQ: RVNC) (announced FDA acceptance of BLA for DAXI to treat frown lines)
- TG Therapeutics Inc common stock (NASDAQ: TGTX)
- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
- Zimmer Biomet Holdings Inc (NYSE: ZBH)
Down In The Dumps
(Biotech Stocks Hitting 52-week lows on Feb. 6)
- Blueprint Medicines Corp (NASDAQ: 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. (NASDAQ: ELGX) (recovered from a 52-week low and ended 16.27% higher after the company made a positive pre-announcement)
- Intec Pharma Ltd (NASDAQ: NTEC)
- MediciNova, Inc. (NASDAQ: MNOV)
- Neuronetics Inc (NASDAQ: STIM)
- REDHILL BIOPHAR/S ADR (NASDAQ: RDHL)
- Salarius Pharmaceuticals Inc (NASDAQ: SLRX)(filed for common stock offering)
- Therapix Biosciences Ltd – ADR (NASDAQ: TRPX)
- Tonix Pharmaceuticals Holding Corp (NASDAQ: 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 (NASDAQ: ZSAN)
Stocks In Focus Myriad Genetics CEO Resigns Following Dismal Q2 Results and Weak Guidance
Molecular diagnostic company Myriad Genetics, Inc. (NASDAQ: 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 (NASDAQ: ASRT) said it has entered into a definitive agreement with Collegium Pharmaceutical Inc (NASDAQ: 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 (NASDAQ: ADRO) said it earned a $10 million development milestone payment under its worldwide licensing agreement with Merck & Co., Inc. (NYSE: 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. (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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.
Pacific Biosciences of California's (NASDAQ: 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 (NASDAQ: 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.
Corbus Pharmaceuticals Holdings Inc (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: QURE) is due to present Phase 2b one-year data for AMT-061 in hemophilia B at the EAHAD 2020 Congress.
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