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. 4)
- Acceleron Pharma Inc (NASDAQ: XLRN)
- Alector Inc (NASDAQ: ALEC)
- Apellis Pharmaceuticals Inc (NASDAQ: APLS)
- Applied Therapeutics Inc (NASDAQ: APLT)
- Aptose Biosciences Inc (NASDAQ: APTO)
- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT)(IPOed Jan. 31)
- Black Diamond Therapeutics Inc (NASDAQ: BDTX)(IPOed Jan. 30)
- ChemoCentryx Inc (NASDAQ: CCXI)
- Eli Lilly And Co (NYSE: LLY)
- Fate Therapeutics Inc (NASDAQ: FATE)
- Frequency Therapeutics Inc (NASDAQ: FREQ)
- GALAPAGOS NV/S ADR (NASDAQ: GLPG)
- Hologic, Inc. (NASDAQ: HOLX)
- Insmed Incorporated (NASDAQ: INSM)(reacted to positive analyst actions following a positive data readout reported Monday)
- Insulet Corporation (NASDAQ: PODD)
- Johnson & Johnson (NYSE: JNJ)
- Masimo Corporation (NASDAQ: MASI)
- Medpace Holdings Inc (NASDAQ: MEDP)
- Molecular Templates Inc (NASDAQ: MTEM)
- Neoleukin Therapeutics Inc (NASDAQ: NLTX)
- PTC Therapeutics, Inc (NASDAQ: PTCT)
- Quest Diagnostics Inc (NYSE: DGX)
- Reata Pharmaceuticals Inc (NASDAQ: RETA)
- Repligen Corporation (NASDAQ: RGEN)
- ResMed Inc. (NYSE: RMD)
- Revance Therapeutics Inc (NASDAQ: RVNC)
- Tandem Diabetes Care Inc (NASDAQ: TNDM)
- Theravance Biopharma Inc (NASDAQ: TBPH)
- TG Therapeutics Inc common stock (NASDAQ: TGTX)
- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
- West Pharmaceutical Services Inc. (NYSE: WST)
- ZEALAND PHARMA/S ADR (NASDAQ: ZEAL)
- Zimmer Biomet Holdings Inc (NYSE: ZBH)(moved in reaction to its strong Q4 results)
Down In The Dumps
(Biotech Stocks Hitting 52-week lows on Feb. 5)
- CASI Pharmaceuticals Inc (NASDAQ: CASI)
- Correvio Pharma Corp (NASDAQ: CORV)
- Endologix, Inc. (NASDAQ: ELGX)
- I-Mab (NASDAQ: IMAB)(IPOed in mid-January)
- Neuronetics Inc (NASDAQ: STIM)
- Salarius Pharmaceuticals Inc (NASDAQ: SLRX)
- Spring Bank Pharmaceuticals Inc (NASDAQ: SBPH)
- Stealth BioTherapeutics Corp (NASDAQ: MITO)
- Wave Life Sciences Ltd (NASDAQ: WVE)
- X4 Pharmaceuticals Inc (NASDAQ: XFOR)
Stocks In Focus
United Therapeutics Gets Favorable Court Ruling In Antitrust Litigation
United Therapeutics Corporation (NASDAQ: UTHR) said a U.S. district court ruled in its favor, denying the request for preliminary injunction sought by Novartis AG's (NYSE: NVS) Sandoz unit and RareGen in a pending antitrust litigation. The court reasoned that the plaintiffs have not demonstrated a reasonable probability of eventual success in the litigation.
The lawsuit filed last April alleges United Therapeutics engaged in anti-competitive conduct with respect to efforts by Sandoz and RareGen to launch their generic version of Remodulin injection.
Merck To Spin-Off Women's Health, Legacy Brands And Biosimilars Business,
Merck & Co., Inc. (NYSE: MRK) announced plans to spin-off products from its Women's Health, trusted Legacy Brands and Biosimilars business into an independent, publicly traded company. The company said it would instead focus on its current key pillars of Oncology, Vaccines, Hospital and Animal Health, while also focusing on R&D. The transaction is expected to be completed in the first half of 2021.
Separately, the company reported sales growth of 8% to $11.9 billion, in line with the consensus estimate. The adjusted EPS came in a penny better than the consensus at $1.16. The company's full-year EPS guidance was above consensus, while the sales guidance was in line.
Morphosys Says Expanded Access Program Initiated For Cancer Drug
Morphosys Ag (NASDAQ: MOR) said an expanded access program has been initiated in the U.S. for tafasitamab, an investigational anti-CD19 antibody, which may provide access to tafasitamab for use in patients with relapsed or refractory diffuse large B cell lymphoma in combination with lenalidomide.
Expanded access programs, sometimes called compassionate use, allows patients to receive an investigational medicine for a serious disease or condition.
PhaseBio Presents Positive Midstage Long-term Data For Pulmonary Arterial Hypertension Drug
PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS) announced presentation at the 14th Pulmonary Vascular Research Institute Congress held in Lima, Peru, positive Phase 1b/2a data from a patient who received more than 18 months of treatment with its sustained-release vasoactive intestinal peptide analog PB1046 for the treatment of pulmonary arterial hypertension, or PAH.
PB1046 showed clinically-meaningful improvements in all of the hemodynamic parameters assessed, with the improvements sustained for up to three months after the last dose was administered.
"We believe these data validate the continued evaluation of PB1046 in the ongoing Phase 2b clinical trial and underscore its potential to be a once-weekly treatment for PAH, a progressive and life-threatening orphan disease with no known cure," said Raymond Benza, a cardiologists at the Allegheny Health Network in Pittsburgh, Pennsylvania.
The stock rose 3.64% to $5.70 in after-hours trading.
Qiagen NV's (NYSE: QGEN) fourth-quarter net sales rose 3% to $413.5 million and adjusted EPS came in at 48 cents, ahead of the 44 cents per share consensus. For 2020, the company expects 3-4% net sales growth in constant currency and adjusted EPS of $1.52-$1.54 in constant currency. Analysts, on average, estimate EPS of $1.49.
The stock rallied 6.57% to $35.35 in after-hours trading.
Gilead Sciences, Inc. (NASDAQ: GILD) reported fourth-quarter non-GAAP EPS of $1.30 on revenues of $5.9 billion, up 1.7% year-over-year. For the full year 2020, the company expects product sales of $21.8 billion to $22.2 billion and GAAP EPS of $5.15-$5.55.
The stock slipped 1.31% to $66.52 in after-hours trading.
Novo Nordisk A/S (NYSE: NVO) reported 9% sales growth for the fourth quarter, thanks to strong sales of GLP-1, Obesity care and Biopharm, Operating profit climbed 10%. The company expects 2020 sales to grow 3-6% in constant currency and operating profit to increase 1-5%.
Boston Scientific Corporation (NYSE: BSX)'s fourth quarter adjusted EPS of 46 cents exceeded the consensus estimate and sales rose 13.4% to $2.905 billion, slightly shy of the consensus estimate of $2.92 billion. The company issued lackluster first-quarter and full-year guidance.
ZIOPHARM Oncology Inc. (NASDAQ: ZIOP) said it intends to offer and sell shares of its common stock in an underwritten registered public offering. All the shares are being offered by the company.
The stock slipped 13.51% to $3.52 in after-hours trading.
On The Radar
Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR) (after the close)
Cardiovascular Systems Inc (NASDAQ: CSII) (after the close)
Misonix Inc (NASDAQ: MSON) (after the close)
SurModics, Inc. (NASDAQ: SRDX) (after the close)