The Daily Biotech Pulse: FDA Nod For Pfizer, Kiniksa Rises On Commercialization Pact With Regeneron, Bio-Techne To Buy Diagnostic Company - iShares Biotechnology ETF (NASDAQ:IBB)

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 March 3)

Aerie Pharmaceuticals, Inc. AERI
Bausch Health Companies Inc. BHC
ENDRA Life Sciences Inc. NDRA
iTeos Therapeutics, Inc. ITOS
Magenta Therapeutics, Inc. MGTA (reacted to fourth-quarter results)
MiMedx Group, Inc. MDXG
Renalytix AI plc RNLX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 3)

AbCellera Biologics Inc. ABCL
Athenex, Inc. ATNX
Brainstorm Cell Therapeutics Inc. BCLI
Epizyme, Inc. EPZM
Freeline Therapeutics Holdings plc FRLN
Galecto, Inc. GLTO
Inhibikase Therapeutics, Inc. IKT
Intercept Pharmaceuticals, Inc. ICPT
Karyopharm Therapeutics Inc KPTI
Lucira Health Inc LHDX
Protara Therapeutics, Inc. TARA
Sana Biotechnology, Inc. SANA
Sensei Biotherapeutics, Inc. SNSE
Talis Biomedical Corporation TLIS
Vallon Pharmaceuticals, Inc. VLON
Virios Therapeutics, LLC VIRI
Voyager Therapeutics, Inc. VYGR

Stocks In Focus

Kiniksa's UK Subsidiary Executes Rilonacept Commercialization Agreement With Regeneron

Kiniksa Pharmaceuticals, Ltd. KNSA said its U.K. subsidiary Kiniksa U.K. has entered into a commercial supply agreement with Regeneron Pharmaceuticals, Inc. REGN, under which Regeneron has the exclusive right to manufacture and supply rilonacept for Kiniksa U.K.'s requirements.

The agreement follows Kiniksa executing an asset transfer agreement to Kiniksa U.K. in January.

Kiniksa has a 2017 licensing agreement with Regeneron for the supply of rilonacept.

Kiniksa shares gained 10.34% to $24 in after-hours trading.

Pfizer Gets Label Expansion For Blood Cancer Drug

Pfizer Inc. PFE announced FDA approval for its supplemental biologics license application for Lorbrena, with the latest approval expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase non-small cell lung cancer.

Lorbrena has already been approved for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Regeneron-Sanofi Submit Regulatory Application For Dupixent Label Expansion

Sanofi SNY and Regeneron said the FDA has accepted the sBLA for Dupixent for review as an add-on treatment for children ages 6-11 with uncontrolled moderate-to-severe asthma.

Dupixent is approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma ages 12 and older with elevated eosinophils or oral corticosteroid-dependent asthma.

The target action date for the FDA decision is Oct. 21.

The companies said EU regulatory submission for children ages 6-11 years with asthma is planned for the first quarter of 2021.

Lilly's Type 2 Diabetes Drug Aces Late-Stage Study

Eli Lilly and Company LLY announced topline results from the Phase 3 SURPASS study showing that trizepatide led to superior A1C and body weight reductions from baseline across all three doses compared to injectable semaglutide 1 mg in adults with type 2 diabetes.

The stock was up 0.37% to $202.75 in premarket trading Thursday.

Kronos Bio To Proceed With Registrational Late-Stage Blood Cancer Study Following Positive End-Of-Phase 2 Meeting With FDA

Kronos Bio, Inc. KRON said following receipt of minutes from its end-of-Phase 2 meeting with the FDA, it will proceed with its plan to assess measurable residual disease negative complete response as the primary endpoint in a registrational Phase 3 trial to support potential accelerated approval of entospletinib in patients newly diagnosed with NPM1-mutated acute myeloid leukemia.

The company plans to initiate the Phase 3 trial in mid-2021, with MRD negative CR data expected in the second half of 2023.

Soligenix Announces Positive Preclinical Data For Heat-Stable COVID-19 Vaccine Program

Soligenix, Inc. SNGX announced publication of data from preclinical immunogenicity studies for CiVax, its heat stable COVID-19 vaccine program, demonstrating rapid-onset, broad-spectrum, neutralizing antibody and cell-mediated activity.

The company said it will continue the study under a $1.5-million Small Business Innovation Research grant awarded to it in December.

The stock was jumping 13.04% to $1.82 in premarket trading Thursday.

Luminex Gets Authorization For An Expanded Version of Respiratory Pathogen Panel

Luminex Corporation LMNX announced that it has received emergency use authorization from the FDA for a new expanded version of its NxTAG Respiratory Pathogen Panel that includes the SARS-CoV-2 virus for high-throughput respiratory testing.

The new test is a combination of the company's original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing and SARS-CoV-2.

Bio-Techne To Buy Texas-Based Cancer Diagnostics Company Asuragen For Up To $320M

Bio-Techne Corporation TECH announced it has reached an agreement to acquire Austin, Texas-based Asuragen for an initial consideration of $215 million in cash, plus contingent consideration of up to $105 million upon the achievement of certain future milestones. Asuragen develops and commercializes genetic carrier screening and oncology testing kits.

Bio-Techne anticipates the acquisition to close in the fourth quarter of its fiscal 2021.

Clearside Biomedical Gains On Insider Transactions

Clearside Biomedical, Inc.'s CLSD chief medical officer Thomas Ciulla purchased 40,000 shares through the vesting of employee stock options. Meanwhile, CEO George Lasezkay sold 6,000 shares at $3.37 per share. Subsequent to the sale, Lasezkay beneficially owned 433,609 shares in the company.

The stock rose 13.70% to $3.90 in after-hours trading.

Galapagos Reports Interim Safety Results From Studies In Male Patients With Rheumatoid Arthritis, Inflammatory Bowel Disease

Galapagos NV GLPG announced interim safety results from Phase 2 MANTA and MANTA-Ray studies investigating the effect of filgotinib on sperm parameters in males with inflammatory bowel disease or rheumatic conditions, showing 8.3% patients on placebo and 6.7% patients on filgotinib had a 50% or more decline in sperm concentration at week 13.

No new safety findings were identified, the companies added.

These studies are not powered for statistical comparison between groups and the data will now be submitted to relevant regulatory authorities, Galapagos said.

Earnings

Ampio Pharmaceuticals, Inc. AMPE said the FDA has requested to expand the company's intravenous and inhalation and COVID-19 studies, using Ampion, by conducting a Phase 2 trial for each. The agency indicated Ampion may be considered for emergency use authorization, and that the recommended trial design for both trials will help determine the safety and statistical significance and effectiveness of Ampion in comparison to standard-of-care.

The company also reported its financial results, showing a narrower loss of 9 cents per share for the fiscal year 2020 compared to a loss of 14 cents per share a year earlier. Cash and cash equivalents totaled $17.3 million at Dec. 31, 2020, compared to $6.5 million at Dec. 31, 2019.

The stock was up 9.79% to $1.57 in after-hours trading.

Earnings

Arbutus Biopharma Corp ABUS (before the market open)
Fulcrum Therapeutics, Inc. FULC (before the market open)
X4 Pharmaceuticals, Inc. XFOR (before the market open)
Eyepoint Pharmaceuticals Inc EYPT (before the market open)
X4 Pharmaceuticals Inc XFOR (before the market open)
Syros Pharmaceuticals Inc SYRS (before the market open)
Opiant Pharmaceuticals Inc OPNT (after the close)
Acorda Therapeutics Inc ACOR (after the close)
Anika Therapeutics Inc ANIK (after the close)
INmune Bio Inc INMB (after the close)
Synthetic Biologics Inc (NYSE SYN) (after the close)
T2 Biosystems Inc TTOO (after the close)
Evofem Biosciences Inc EVFM (after the close)
DermTech Inc DMTK (after the close)
Chiasma Inc CHMA (after the close)
Clearpoint Neuro Inc CLPT (after the close)
Fulgent Genetics, Inc. FLGT (after the close)

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