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. 27)
10X Genomics Inc (NASDAQ: TXG)
Cidara Therapeutics Inc (NASDAQ: CDTX)
Denali Therapeutics Inc (NASDAQ: DNLI)
Dr.Reddy's Laboratories Ltd (NYSE: RDY)(reacted to its Q3 results)
Inovio Pharmaceuticals Inc (NASDAQ: INO)(announced
Nevro Corp (NYSE: NVRO)
Oyster Point Pharma Inc (NASDAQ: OYST)
Quest Diagnostics Inc (NYSE: DGX)
Rapt Therapeutics Inc (NASDAQ: RAPT)
SI-Bone Inc (NASDAQ: SIBN)
Vaccinex Inc (NASDAQ: VCNX)
Vir Biotechnology Inc (NASDAQ: VIR)
Down In The Dumps
(Biotech Stocks Hitting 52-week lows on Jan. 27)
Alkermes Plc (NASDAQ: ALKS)
Allogene Therapeutics Inc (NASDAQ: ALLO)
Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL)
Axovant Gene Therapies Ltd (NASDAQ: AXGT)
Avanos Medical Inc (NYSE: AVNS)
Blueprint Medicines Corp (NASDAQ: BPMC)
Correvio Pharma Corp (NASDAQ: CORV)
Enanta Pharmaceuticals Inc (NASDAQ: ENTA)
Heat Biologics Inc (NASDAQ: HTBX)
HTG Molecular Diagnostics Inc (NASDAQ: HTGM)
Kura Oncology Inc (NASDAQ: KURA)
Madrigal Pharmaceuticals Inc (NASDAQ: MDGL)
MediciNova, Inc. (NASDAQ: MNOV)
Nemaura Medical Inc (NASDAQ: NMRD)
Neuronetics Inc (NASDAQ: STIM)
Portola Pharmaceuticals Inc (NASDAQ: PTLA)
Rhythm Pharmaceuticals Inc (NASDAQ: RYTM)
Sellas Life Sciences Group Inc (NASDAQ: SLS)
Stealth BioTherapeutics Corp (NASDAQ: MITO)
Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI)
Therapix Biosciences Ltd – ADR (NASDAQ: TRPX)
X4 Pharmaceuticals Inc (NASDAQ: XFOR)
VIVUS, Inc. (NASDAQ: VVUS)
Stocks In Focus Acceleron's Pulmonary Arterial Hypertension Drug Aces Mid-Stage Study
Acceleron Pharma Inc (NASDAQ: XLRN) said a Phase 2 study dubbed PULSAR that evaluated its sotatercept in patients with pulmonary arterial hypertension met its primary and key secondary endpoints. The experimental drug showed a statistically significant reduction in pulmonary vascular resistance – the primary endpoint - at week 24 versus placebo. It was also found to be generally well tolerated.
The stock jumped 64.55% to $87 in after-hours trading.
Surface Oncology's Cancer Antibody Candidates Cleared to Move Into Clinics
Surface Oncology Inc (NASDAQ: SURF) said the FDA cleared the investigational new drug applications, or INDs, for its antibody candidates SRF617, targeting CD39, and SRF388, targeting IL-27. The active INDs allow the company to initiate Phase 1 trial for both candidates.
The company said a Phase 1/1b trial will evaluate SRF617 in patients with advanced solid tumors, both as a monotherapy and in combination with other cancer therapies.
The stock added 16.90% to $3.39 in after-hours trading.
Concert Pharma Gets Favorable Court Rulings Relating to Hair Loss Drug
Concert Pharmaceuticals Inc (NASDAQ: CNCE) said the U.S. Court of Appeals for the Federal Circuit has granted its motion to vacate and remand the Patent Trial and Appeal Board's decision to invalidate a U.S. patent pertaining to CTP-543, its investigational candidate for alopecia areata. The petition challenge was filed by Incyte Corporation (NASDAQ: INCY). Concert Pharma said the case will now be remanded for reconsideration by a new panel of PTAB judges.
Separately, the company said it intends to sell shares of its common stock in an underwritten registered public offering. All shares are being sold by the company.
The stock gained 5.90% to $10.50 in after-hours trading.
MediciNova Gets Intention to Grant Notice From European Patent Office
MediciNova received a Notice of Intention to Grant from the European Patent Office for a pending patent application covering MN-001 for the treatment of idiopathic pulmonary fibrosis.
The stock gained 11.31% to $6.10 in after-hours trading.
FDA Approves Boehringer-Eli Lilly's Triple Combo Diabetes Drug
Boehringer Ingelheim and partner Eli Lilly And Co (NYSE: LLY) announced FDA nod for Trijardy XR to lower blood sugar in adults with Type 2 diabetes, along with diet and exercise.
"We are proud to offer Trijardy XR as a new once-daily option combining three well-established medicines, including an extended-release version of metformin, the most commonly prescribed initial treatment for type 2 diabetes, Jardiance, the most prescribed SGLT2 inhibitor, and Tradjenta, the only single-dose DPP-4 inhibitor," said Mohamed Eid, VP, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, at Boehringer.
In after-hours trading, Lilly shares rose 0.50% to $139.
Sanofi's Regulatory Application For Dupixent Label Expansion Accepted For Priority Review
Sanofi SA (NASDAQ: SNY) said the FDA has accepted for priority review its sBLA for Dupixent as an add-on maintenance therapy for children, aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies.
The company noted that the PDUFA date has been fixed for May 26.
Alector Inc (NASDAQ: ALEC) plans to sell, subject to market and other conditions, 5.095 million shares of its common stock in an underwritten public offering.
The stock slipped 2.84% to $25 in after-hours trading.
Denali, which received an upgrade from Goldman Sachs on Monday, intends to offer sell $150 million worth of its shares in an underwritten public offering.
The stock receded 2.68% to $27.23 in after-hours trading.
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