The Daily Biotech Pulse: Acceleron's Positive Data Readout, Surface Oncology Gets Nod For Pushing 2 Antibodies Into Clinics

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 TXG
• Achillion Pharmaceuticals, Inc. ACHN(announced early termination of waiting period for its proposed acquisition by Alexion Pharmaceuticals, Inc. ALXN)
• Cidara Therapeutics Inc CDTX
• Cleveland BioLabs, Inc. CBLI(saw a coronavirus-induced rally )
• Denali Therapeutics Inc DNLI
• Dr.Reddy's Laboratories Ltd RDY(reacted to its Q3 results)
• Inovio Pharmaceuticals Inc INO(announced
• Nevro Corp NVRO
• Oyster Point Pharma Inc OYST
• Quest Diagnostics Inc DGX
• Rapt Therapeutics Inc RAPT
• SI-Bone Inc SIBN
• Vaccinex Inc VCNX
• Vir Biotechnology Inc VIR

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Jan. 27)

• Alkermes Plc ALKS
• Allogene Therapeutics Inc ALLO
• Autolus Therapeutics Ltd – ADR AUTL
• Axovant Gene Therapies Ltd AXGT
• Avanos Medical Inc AVNS
• Blueprint Medicines Corp BPMC
• Correvio Pharma Corp CORV
• Enanta Pharmaceuticals Inc ENTA
• Heat Biologics Inc HTBX
• HTG Molecular Diagnostics Inc HTGM
• Kura Oncology Inc KURA
• Madrigal Pharmaceuticals Inc MDGL
• MediciNova, Inc. MNOV
• Nemaura Medical Inc NMRD
• Neuronetics Inc STIM
• Portola Pharmaceuticals Inc PTLA
• Rhythm Pharmaceuticals Inc RYTM
• Sellas Life Sciences Group Inc SLS
• Stealth BioTherapeutics Corp MITO
• Spectrum Pharmaceuticals, Inc. SPPI
• Therapix Biosciences Ltd – ADR TRPX
• X4 Pharmaceuticals Inc XFOR
• VIVUS, Inc. VVUS

See Also: The Week Ahead In Biotech: Amgen, Eli Lilly, Pfizer In Earnings Mix, IPO Flow Resumes

Stocks In Focus

Acceleron's Pulmonary Arterial Hypertension Drug Aces Mid-Stage Study

Acceleron Pharma Inc 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 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 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 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 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 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.

Offerings

Alector Inc 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.