The Daily Biotech Pulse: Sorrento, Immutep Surge On COVID-19 Study Data, T2 Biosystems Sinks On Preannouncement

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 Jan. 26)

Alexion Pharmaceuticals, Inc. ALXN
Alnylam Pharmaceuticals, Inc. ALNY
Aslan Pharmaceuticals Ltd ASLN (reacted to new preclinical data showing its investigational asset ASLAN003 have the lowest potential for hepatotoxicity)
BIOLASE Inc BIOL (reacted to its preliminary fourth-quarter results)
BioNano Genomics Inc BNGO
CASI Pharmaceuticals Inc CASI
Cassava Sciences Inc SAVA
Clearpoint Neuro Inc CLPT
Cleveland BioLabs, Inc. CBLI
DarioHealth Corp DRIO
DermTech Inc DMTK
Eli Lilly And Co LLY (reacted to positive data for its monoclonal antibody cocktail in treating COVID-19)
ENDRA Life Sciences Inc NDRA
ESSA Pharma Inc EPIX
Evelo Biosciences Inc EVLO
Evogene Ltd EVGN
GW Pharmaceuticals PLC- ADR GWPH
Illumina, Inc. ILMN
ImmuCell Corporation ICCC
Immunome Inc IMNM
Inari Medical Inc NARI
Insmed Incorporated INSM
Ionis Pharmaceuticals Inc IONS
Johnson & Johnson JNJ (reacted to better-than-expected fourth-quarter results and positive guidance)
Kintara Therapeutics Inc KTRA
Krystal Biotech IncKRYS
LeMaitre Vascular Inc LMAT
Merit Medical Systems, Inc. MMSI
Merus NV MRUS
NeoGenomics, Inc. NEO
Omnicell, Inc. OMCL
Oramed Pharmaceuticals, Inc. ORMP
Regulus Therapeutics Inc RGLS
Rhythm Pharmaceuticals IncRYTM (announced positive Phase 2 BASKET study data evaluating setmelanotide in additional MC4R pathway deficiency-related obesities)
Sesen Bio Inc SESN
SI-Bone Inc SIBN
Silence Therapeutics ADR Representing 3 Ord Shs SLN
Summit Therapeutics Inc SMMT
Supernus Pharmaceuticals Inc SUPN
Syneos Health Inc SYNH
T2 Biosystems Inc TTOO
Vericel Corp VCEL
Vir Biotechnology Inc VIR ( reacted to positive topline results from the Phase 1 study of VIR-3434 in hepatitis B viral infection)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Jan. 26)

Pharming Group PHAR

Stocks In Focus

Immutep's Lead Compound Found Safe In Mid-stage Study In Hospitalized COVID-19 Patients

Immutep IMMP said its lead investigational asset eftilagimod alpha has been given the clearance to advance into the randomized portion of a Phase 2 study that is evaluating it in hospitalized patients with COVID-19. This followed a safety run-in data review of the first six patients enrolled in the study by an independent Data and Safety Monitoring Board.

Immutep said up to 110 COVID-19 patients will participate in investigator-initiated study at the University Hospital Pilsen, Czech Republic.

The stock was up 8.89% to $3.43 in after-hours trading.

Agios Reports Positive Phase 3 Data For Mitapivat In Treating Genetic Blood Disorder

Agios Pharmaceuticals Inc AGIO said that the global, open-label Phase 3 ACTIVATE-T trial of mitapivat in regularly transfused adults with pyruvate kinase deficiency demonstrated a statistically significant and clinically meaningful reduction in transfusion burden.

Pyruvate kinase deficiency leads to break down of RBCs more easily, leading to anemia.

In the 24-week fixed dose period, 37% achieved a 33% or more reduction in transfusion burden compared to individual historical transfusion burden standardized to 24 weeks, and 22% were transfusion-free.

In after-hours trading, the stock added 10.41% to $53.04.

Sorrento Says Stem Cell Therapy Candidate Found Effective In Phase 1 Study In Severe COVID-19 Patients

Sorrento Therapeutics Inc SRNE announced positive preliminary results from its Phase 1b study of human allogeneic adipose-derived mesenchymal stem cells, dubbed COVI-MSC, for patients suffering from COVID-19-induced acute respiratory distress or acute respiratory distress syndrome.

This ongoing study is a single arm, non-randomized Phase 1b study of the safety and preliminary efficacy of COVI-MSCs administered every other day for three infusions for a total of 1 x 106 cells/kg.

Each of the first three patients was discharged from the hospital within a week of starting the patient's COVI-MSC infusions and two patients were discharged on the day of their last infusion, the company said.

The stock rallied 9.21% to $11.38 in after-hours trading.

Lilly, Vir, GSK to Study Antibody Combos For Mild-to-Moderate COVID-19

Eli Lilly And Co LLY, GlaxoSmithKline plc GSK and Vir Biotechnology Inc VIR announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19.

Lilly said it has expanded its ongoing BLAZE-4 trial to evaluate the administration of bamlanivimab, 700mg with VIR-7831, also known as GSK4182136, 500mg, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein.

Sanofi to Support COVID-19 Vaccine Manufacturing Efforts of Pfizer/BioNTech

Sanofi SA SNY announced an agreement with BioNTech SE – ADR BNTX under which Sanofi will support manufacturing and supply of BioNTech's COVID-19 vaccine which is being co-developed with Pfizer Inc. PFE.

Sanofi said it will provide BioNTech access to its established infrastructure and expertise to produce over 125 million doses of COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi's production facilities in Frankfurt from summer of 2021.

Regeneron Antibody Cocktail Found Effective Against New Coronavirus Mutations

Regeneron Pharmaceuticals Inc REGN said researchers in Dr. David Ho's Columbia University lab and Regeneron scientists have independently confirmed that REGEN-COV, its antibody cocktail, successfully neutralizes the circulating SARS-CoV-2 variants first identified in the UK (B.1.1.7) and South Africa (B.1.351).

T2 Biosystems Preannounces Q4, FY20 Revenue Shortfall

T2 Biosystems preannounced fourth-quarter revenues of $7.8 million, including product revenues of $5.8 million. This represented a 155% increase in total revenues and 274% increase in product revenues.

Revenues for the year are expected at $18.1 million.

Analysts, on average, estimate revenues of $8.74 million for the quarter and $19.04 million for the year.

The stock tumbled 15.30% to $2.38 in after-hours trading.

Offerings

Catalyst Pharmaceuticals Inc CPRX said it is offering shares of its common stock in an underwritten public offering. All of the shares in the offering are being offered by Catalyst.

Transenterix Inc TRXC said it has entered into an underwriting agreement with H.C. Wainwright & Co, under which the underwriter has agreed to purchase on a firm commitment basis 8.33 million shares of common stock of the company at a public offering price of $3 per share, for raising gross proceeds of $25 million. The offering is expected to close on or about Jan. 29, subject to customary closing conditions.

In after-hours trading, the stock lost 5.82% to $3.40.

Scopus Biopharma Inc SCPS announced the pricing of a $9 million follow-on public offering, consisting of one million shares of common stock at a public offering price of $9 per share.

Scopus said it intends to use the proceeds of the offering principally for further development of the company's lead drug candidate, including in combination with checkpoint inhibitors.

The stock ended down 1.04% to $10.50 in after-hours trading.

On The Radar

Clinical Readouts:

Zymeworks Inc ZYME is due to present a clinical progress update for ZW49, which is being evaluated in a Phase 1 clinical trial as a treatment for patients with locally advanced or metastatic HER2-expressing cancers. The presentation is scheduled at 4:30 pm.

Earnings

Abbott Laboratories ABT (before the market open)
Edwards Lifesciences Corp EW(after the close)
Hologic, Inc. HOLX (after the close)
Taro Pharmaceutical Industries Ltd. TARO (after the close)