The Daily Biotech Pulse: Leadership Transition At Amarin, Vaccine Setback For J&J, FDA Nod For Label Expansion of Roche's Asthma Drug

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 April 12)

  • 180 Life Sciences Corp. ATNF (moved on insider buying)
  • Celcuity Inc. CELC
  • Fortress Biotech, Inc. FBIO
  • Gain Therapeutics, Inc. GANX
  • Medtronic plc MDT
  • Merit Medical Systems, Inc. MMSI
  • MiMedx Group, Inc. MDXG

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 12)

  • 4D Molecular Therapeutics, Inc. FDMT
  • ACADIA Pharmaceuticals Inc. ACAD
  • Achilles Therapeutics plc ACHL (reacted to presentation at the American Association of Cancer Research annual meeting)
  • Acutus Medical, Inc. AFIB
  • Adverum Biotechnologies, Inc. ADVM
  • Adagene Inc. ADAG
  • Aprea Therapeutics, Inc. APRE
  • Assembly Biosciences, Inc. ASMB
  • Axsome Therapeutics, Inc. AXSM
  • Bellerophon Therapeutics, Inc. BLPH
  • Biophytis SA BPTS
  • Bolt Biotherapeutics, Inc. BOLT
  • Calithera Biosciences, Inc. CALA
  • Checkmate Pharmaceuticals, Inc. CMPI (reacted to AACR presentation)
  • Coherus BioSciences, Inc. CHRS
  • Concert Pharmaceuticals, Inc. CNCE
  • ContraFect Corporation CFRX
  • Decibel Therapeutics, Inc. DBTX
  • Design Therapeutics, Inc. DSGN
  • Fusion Pharmaceuticals Inc. FUSN
  • Idera Pharmaceuticals, Inc. IDRA
  • Immunocore Holdings plc IMCR
  • Instil Bio, Inc. TIL (moved on AACR presentation)
  • Ionis Pharmaceuticals, Inc. IONS
  • Kronos Bio, Inc. KRON (reacted to preclinical data presented at AACR meeting)
  • Longboard Pharmaceuticals, Inc. LBPH
  • MediciNova, Inc. MNOV
  • Metacrine, Inc. MTCR
  • Millendo Therapeutics, Inc. MLND
  • NeuBase Therapeutics, Inc. NBSE
  • Qualigen Therapeutics, Inc. QLGN (withdrew emergency use authorization application for COVID-19 diagnostic test)
  • Reata Pharmaceuticals, Inc. RETA
  • Reneo Pharmaceuticals, Inc. RPHM (went public Friday)
  • Reviva Pharmaceuticals Holdings, Inc. RVPH
  • Sarepta Therapeutics, Inc. SRPT
  • Sigilon Therapeutics, Inc. SGTX
  • Soleno Therapeutics, Inc. SLNO
  • Syros Pharmaceuticals, Inc. SYRS
  • Titan Pharmaceuticals, Inc. TTNP
  • VectivBio Holding AG VECT (went public Friday)
  • Y-mAbs Therapeutics, Inc. YMAB (presented clinical data at AACR meeting)

Stocks In Focus

Amarin Names Insider Karim Mikhail As CEO

Amarin Corporation plc AMRN announced that CEO John Thero has informed the board of directors of his plan to retire from the position of CEO effective Aug. 1. He will also step down from the board at that time.

The board has appointed Karim Mikhail, Amarin's senior SVP and head of commercial for Europe, to succeed Thero as the company's next president and CEO and as a board member. Thero will continue to provide his guidance and expertise to the company in an advisory capacity through the end of 2021, the company said.

The stock was down 2.74% premarket at $5.68. 

Johnson & Johnson's Vaccine Use Paused By FDA

The Food and Drug Administration and the Centers for Disease Control and Prevention are recommending a pause in the use of Johnson & Johnson's JNJ COVID-19 vaccine due to reports of a rare type of blood clots.

The stock was down 2.68% at $157.30 in premarket trading Tuesday.

Roche Snags FDA Approval For Self-Injectable, Prefilled Syringe For Asthma Drug

Roche Holding AG RHHBY said the U.S. Food and Drug Administration has approved its supplemental Biologics License Application for Xolair, a prefilled syringe for self-injection across all approved U.S. indications.

Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria and nasal polyps.

Immunocore Presents Positive Phase 3 Data For Eye Cancer Drug

Immunocore presented at the AACR annual meeting with data from a Phase 3 trial comparing tebentafusp with investigator's choice, in first-line metastatic uveal melanoma, showing tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival as a first-line treatment for the condition. Treatment-related adverse events were manageable and consistent with the proposed mechanism.

The stock rose 3.57% to $33.37 in after-hours trading.

Burning Rock Biotech's Liquid Biopsy Assay Performs Strongly In Midstage Study

Burning Rock Biotech Limited BNR announced the publication in Nature Biotechnology of results from a FDA-led Sequencing Quality Control Phase 2 study.

The data shows the liquid biopsy assay has achieved strong performance. For samples at a 25ng input, Burning Rock's assay was the most accurate assay, with roughly equivalent sensitivity but superior precision compared to other assays, the company said. 

Related Link: The Week Ahead In Biotech (April 11-17): Avenue Therapeutics FDA Decision and Conference Presentations In The Spotlight

Lilly-Innovent Presents Positive Late-Stage Tyvyt Data In Second-Line Lung Cancer Setting

Eli Lilly and Company LLY and Hong Kong-based partner Innovent Biologics presented at the AACR annual meeting with results of the Phase 3 ORIENT-3 study evaluating Tyvyt versus the  chemotherapy medication docetaxel as a second-line treatment for advanced or metastatic squamous non-small cell lung cancer.

The presentation shows that Tyvyt demonstrated a statistically significant improvement in overall survival compared to docetaxel, meeting the pre-specified primary endpoint.

The median progression-free survival as assessed by investigators was 4.3 months versus 2.79 months, and the confirmed objective response rate was 25.5% versus 2.2%, respectively. Safety was consistent with previous studies of Tyvyt and no new safety signals were identified.

Tiziana to Seek Nasdaq Listing For Former Subsidiary Accustem

Tiziana Life Sciences PLC TLSA announced that its former subsidiary Accustem Sciences Limited intends to file a listing application with the Nasdaq after completion of the distribution of shares in Accustem to Tiziana shareholders.

The Nasdaq listing venue is more appropriate to the nature of Accustem's business in the view of Accustem's board. 

The stock was trading 0.69% higher at $706.80 premarket Tuesday.


Liquidia Corporation LQDA said it has entered into a common stock purchase agreement with certain institutional, accredited investors for the private placement of 8.626 million shares of common stock at a purchase price of $2.52 per share. The private placement is expected to close Tuesday and yield gross proceeds of approximately $21.7 million.

On The Radar

Clinical Readouts

Affimed N.V. AFMD will present at the AACR annual meeting initial clinical data from an investigator-sponsored Phase 1 study evaluating cord blood-derived natural killercells pre-complexed with Affimed's innate cell engager AFM13. The company's shares reacted positively Friday when the company released a statement elaborating on data from the study.

Auris Medical Holding Ltd. EARS is scheduled to provide a business update on its pre-clinical asset AM-301. AM-301 is being evaluated for protection against airborne viruses and allergens. 

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

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