The Daily Biotech Pulse: NRx Rises On COVID-19 Drug Collaboration, Amgen's Lung Cancer Drug Conditionally Approved In Canada, Coherus Data Readout

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 Sept. 13)

  • Abbott Laboratories ABT
  • Adagio Therapeutics, Inc. ADGI
  • aTyr Pharma, Inc. LIFE (announced positive results from the Phase 1b/2a clinical trial of its lead therapeutic candidate, ATYR1923, in patients with pulmonary sarcoidosis)
  • Aurinia Pharmaceuticals Inc. AUPH
  • BELLUS Health Inc. BLU (announced positive findings from the Phase 2b study of BLU-5937 in patients with refractory chronic cough)
  • Bio-Techne Corporation TECH
  • C4 Therapeutics, Inc. CCCC
  • Itamar Medical Ltd. ITMR (reacted to an M&A deal to be acquired by the subsidiary of Japan's material sciences company Asahi Kasei)
  • Nuvalent, Inc. NUVL
  • Syneos Health, Inc. SYNH
  • Zentalis Pharmaceuticals, Inc. ZNTL (announced the commencement of Phase 1/2 trial of ZN-c3, in combination with chemotherapy medication gemcitabine, in relapsed or refractory osteosarcoma)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 13)

  • ACADIA Pharmaceuticals Inc. ACAD
  • Avanos Medical, Inc. AVNS
  • Alzamend Neuro, Inc. ALZN
  • Aytu Biopharma, Inc. AYTU
  • AzurRx BioPharma, Inc. AZRX (announced acquisition of First Wave Bio for $229 million in stock and cash)
  • Dermata Therapeutics, Inc. DRMA
  • Esperion Therapeutics, Inc. ESPR
  • HOOKIPA Pharma Inc. HOOK
  • Humanigen, Inc. HGEN
  • Indaptus Therapeutics, Inc. INDP
  • Inozyme Pharma, Inc. INZY
  • Molecular Templates, Inc. MTEM
  • MorphoSys AG MOR
  • Nanobiotix S.A. NBTX
  • Nautilus Biotechnology, Inc. NAUT
  • Passage Bio, Inc. PASG
  • Pharming Group N.V. PHAR
  • Seres Therapeutics, Inc. MCRB
  • Silverback Therapeutics, Inc. SBTX (reacted to cancer drug data)
  • TScan Therapeutics, Inc. TCRX

Click here to access Benzinga's FDA Calendar

Stocks In Focus

NRx to Collaborate With IQVIA For Pharmacovigilance Services In Preparation For Regulatory Actions

IQVIA IQV announced a transformative collaboration with NRx Pharmaceuticals NRXP for pharmacovigilance services and medical information in preparation for potential regulatory actions.

This collaboration will allow NRx to access IQVIA's domain experience with COVID-19, its unparalleled data assets, and analytics to support potential emergency use authorization of Zyesami. IQVIA will work closely with NRx to support key activities required for EUA activation, including the pharmacovigilance and medical information programs.

In premarket trading, NRx shares are trading up 6.10% to $11.65.

Pharming Announces Positive Results From Pilot Study of COVID-19 Treatment

Pharming announced positive topline results from two pilot clinical trials of patients hospitalized with COVID-19 treated with Ruconest for the prevention of severe SARS-CoV-2 infection. The primary endpoint in both studies was disease severity on the 7-point WHO ordinal scale on Day 7.

In the US study, conducted under a Pharming IND, which had included 32 patients at the time of the interim analysis, patients treated with Ruconest, plus standard of care had statistically significant lower WHO disease severity scores at Day 7 as compared with those patients who received standard of care alone. Data on secondary endpoints and biomarker evaluations were concordant with the primary endpoint findings.

Amgen's KRAS G12C Inhibitor Conditionally Approved In Canada For Lung Cancer

Amgen, Inc. AMGN announced Health Canada has approved Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received at least one prior systemic therapy.

Lumakras was granted a notice of compliance with conditions, based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Coherus Announces Positive Phase 3 Data For Toripalimab-chemo Combo In Lung Cancer Study

Coherus Biosciences, Inc. CHRS and Shanghai Junshi Biosciences presented positive interim results from the pivotal Phase 3 CHOICE-01 study evaluating toripalimab plus chemotherapy as the first-line treatment of advanced squamous or non-squamous non-small cell lung cancer without driver mutations.

The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival compared to chemotherapy alone.

The study also showed response rate and duration of response over chemotherapy alone, with a safety profile consistent with the PD-1 inhibitor class of drugs.

NanoViricides Completes Licensing Agreement For Coronavirus Field For Drug Development

NanoViricides, Inc. NNVC said it has completed the process of licensing the human Coronavirus field for drug development and commercialization from TheraCour Pharma, Inc. The license agreement for the field comprising anti-viral treatments for coronavirus derived human infections with TheraCour was executed on Sept. 8.

The stock was rallying 10.32% to $4.49 in premarket trading.

Related Link: The Week Ahead In Biotech (Sept. 12-18): Calliditas FDA Decision, Adcom Review For Pfizer/BioNTech COVID-19 Vaccine, Oncology Conference And IPOs

Novocure to Collaborate with Roche to Evaluate Tumor Treating Fields, In Combination With Tecentriq, For Pancreatic Cancer

Novocure NVCR announced it has entered into a clinical trial collaboration agreement with Roche Holding AG RHHBY to develop tumor treating fields together with Roche's anti-PD-L1 therapy Tecentriq in metastatic pancreatic ductal adenocarcinoma.

Axsome Files Regulatory Application For Approval of Migraine Treatment

Axsome Therapeutics, Inc. AXSM announced that the FDA has accepted for filing its new drug application for AXS-07 for the acute treatment of migraine, and has set a PDUFA target action date of April 30, 2022.

AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for migraine.

The stock was advancing 5.28% to $28.93 in premarket trading.

Mesa Labs to Buy Agena For $300M

Mesa Laboratories, Inc. MLAB, a company designing and manufacturing critical quality control solutions for the pharmaceutical, healthcare, and medical device industries, announced it has entered into a definitive agreement to acquire Agena Bioscience for a cash purchase price of $300 million, subject to customary purchase price adjustments.

Johnson & Johnson Announces Publication of Positive Data On Ebola Vaccine Regimen

Johnson & Johnson JNJ said data from two papers published in The Lancet Infectious Diseases demonstrated its Ebola vaccine regimen, Zabdeno and Mvabea, generated robust antibody immune responses in adults and children, ages 1-17.

Humoral immune responses persisted in adults for at least two years. The data also showed that booster vaccination with Ad26.ZEBOV, administered to adults two years after the initial vaccination, induced a strong anamnestic response within seven days. The vaccine has been granted marketing authorization by the European Commission in July 2020 and prequalification from the World Health Organization in April.

Medtronic Prevails In Patent Lawsuit Over InterStim Neuromodulation Device

Medtronic plc MDT announced it has won three additional important victories in a dispute over its intellectual property for its sacral neuromodulation device family, the InterStim systems.

The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office rejected Axonics, Inc. AXNX's attempt to invalidate three Medtronic patents in its IP infringement lawsuit.

Astellas Says Patient Developing Serious Adverse Event Following Gene Therapy Treatment Dies

Astellas Pharma Inc. ALPMY said the participant in the ASPIRO clinical trial  evaluating gene therapy treatment candidate AT132 in patients with X-linked myotubular myopathy who developed a serious adverse event as described on Sept. 1, passed away on Sept. 9. The cause of death is still pending.

X-linked myotubular myopathy is a rare neuromuscular disease.

This was the first and only participant dosed following the Dec. 23, 2020, release of the earlier FDA clinical hold.

In early September, Astellas announced it had paused screening and dosing of additional participants in its ASPIRO clinical trial. Thereafter, the FDA informed Astellas via email that the ASPIRO trial had been placed on clinical hold and a written letter is expected over the next several weeks.

Nyxoah's Obstructive Sleep Apnea Treatment Device Gets Breakthrough

Nyxoah S.A. NYXH said the FDA has granted the Genio bilateral hypoglossal nerve stimulation system "Breakthrough Device Designation" for the treatment of adult patients with moderate to severe obstructive sleep apnea and complete concentric collapse of the soft palate.

The stock was up 4.30% at $30.22 in premarket trading.

On The Radar

Clinical Readouts

Orchard Therapeutics ORTX said it will present its discovery and research efforts in hematopoietic stem cell gene therapy, including an update on the OTL-104 program in development for NOD2 Crohn's disease.

The company will also provide overviews of potential new applications in the areas of HSC-generated antigen-specific regulatory T cells and HSC-vectorization of monoclonal antibodies. A live webcast of the presentations will be available in the Investors & Media section of the company's website at 7 a.m. ET.

Related Link: Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates

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