The Daily Biotech Pulse: Alexion Pauses COVID-19 Study, NantKwest Readout, Organogenesis Jumps On Guidance, Trial Updates

Shanthi Rexaline
5 min read
0
In this article:

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. 13)

  • Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)

  • Atea Pharmaceuticals Inc (NASDAQ: AVIR)

  • Bioanalytical Systems, Inc. (NASDAQ: BASI)

  • Bioatla Inc (NASDAQ: BCAB)

  • Biodesix Inc (NASDAQ: BDSX) (announced a collaboration with HiberCell for the development of an enzyme-linked immunosorbent assay as a companion diagnostic in future registrational trials in breast cancer for Imprime PGG programs)

  • BIOLASE Inc (NASDAQ: BIOL)

  • C4 Therapeutics Inc (NASDAQ: CCCC)

  • Cassava Sciences Inc (NASDAQ: SAVA)

  • Celcuity Inc (NASDAQ: CELC)

  • CareDx Inc (NASDAQ: CDNA)

  • Celsius Holdings, Inc. (NASDAQ: CELH)

  • DermTech Inc (NASDAQ: DMTK) (announced inclusion of non-invasive genomic patch testing for melanoma in National Comprehensive Cancer Network program)

  • Dyne Therapeutics Inc (NASDAQ: DYN)

  • Edap Tms SA (NASDAQ: EDAP)

  • ESSA Pharma Inc (NASDAQ: EPIX) - announced a clinical collaboration with Johnson & Johnson (NYSE: JNJ) unit for prostate cancer study

  • Genetron Holdings Ltd – ADR (NASDAQ: GTH)

  • Genmab 10 Sponsored ADR Ord Shs (NASDAQ: GMAB) (announced achievement of $40 million milestone payment due from AbbVie for diffuse large B-cell lymphoma study)

  • Glaukos Corp (NYSE: GKOS) (announced positive Phase 2b data for iDose TR sustained-release travoprost implant)

  • Guardant Health Inc (NASDAQ: GH)

  • Halozyme Therapeutics, Inc. (NASDAQ: HALO)

  • Inari Medical Inc (NASDAQ: NARI) (reacted to preliminary fourth-quarter results)

  • Insulet Corporation (NASDAQ: PODD)

  • Kaleido Biosciences Inc (NASDAQ: KLDO)

  • Kodiak Sciences Inc (NASDAQ: KOD)

  • Laboratory Corp. of America Holdings (NYSE: LH)

  • Mediwound Ltd (NASDAQ: MDWD)

  • Natera Inc (NASDAQ: NTRA)

  • Neuronetics Inc (NASDAQ: STIM) (reacted to preliminary fourth-quarter results)

  • Novocure Ltd (NASDAQ: NVCR)

  • Pacira Biosciences Inc (NASDAQ: PCRX)

  • Renalytix AI PLC (NASDAQ: RNLX)

  • SAGE Therapeutics Inc (NASDAQ: SAGE) - Biogen Inc (NASDAQ: BIIB) disclosed a 10.7% stake in the company

  • Shockwave Medical Inc (NASDAQ: SWAV)

  • Supernus Pharmaceuticals Inc (NASDAQ: SUPN)

  • Syneos Health Inc (NASDAQ: SYNH)

  • TFF Pharmaceuticals Inc (NASDAQ: TFFP)

  • TG Therapeutics Inc common stock (NASDAQ: TGTX)

  • Vericel Corp (NASDAQ: VCEL)

  • X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)

  • Zai Lab Ltd – ADR (NASDAQ: ZLAB)

Down In The Dumps

None of the biotech/medical device/diagnostics shares hit 52-week lows in the session.

Stocks In Focus Alexion Halts Late-Stage COVID-19 Study In Patients Requiring Mechanical Ventilation

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) announced its decision to pause further enrollment in the global Phase 3 study of Ultomiris in adults with severe COVID-19 requiring mechanical ventilation.

This decision is based on the recommendation of an independent data monitoring committee following the review of data from a pre-specified interim analysis. The IDMC recommended that additional enrollment be paused pending further analysis of the data due to lack of efficacy when Ultomiris was added to best supportive care, compared to best supportive care alone.

NantKwest Reports Positive Results For Combo Therapy In Advanced Pancreatic Cancer

Nantkwest Inc (NASDAQ: NK) and Immunity Bio announced early interim results from the pivotal QUILT 88 Phase 2 study trial that is evaluating standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with PD-L1 t-haNK, Anktiva and aldoxorubicin, showing median survival rates more than doubled that of the historic rate in patients with advanced metastatic pancreatic cancer for whom no other FDA-approved treatment exists.

The company noted that primary endpoint of overall survival was achieved, with 15 out of 18 (83%) of patients enrolled with second-line or greater pancreatic cancer remaining alive to date.

Orchard's Gene Therapy Designated As Regenerative Medicine Advanced Therapy

Orchard Therapeutics PLC – ADR (NASDAQ: ORTX) said the FDA granted a regenerative medicine advanced therapy designation to OTL-200, an investigational ex-vivo autologous hematopoietic stem cell gene therapy for the treatment of early onset metachromatic leukodystrophy.

The stock was adding 6.74% premarket to $6.65.

Related Link: The Week Ahead In Biotech (Jan 10-16): Expect Stocks To Move As J.P. Morgan Healthcare Conference Kicks Off

Preannouncements

Apyx Medical Corp (NASDAQ: APYX) preannounced fourth-quarter revenue of $10.9 million to $11.3 million, representing a 30%-35% year-over-year increase. The company guided to full-year revenue of $27.1 million to $27.5 million. Analysts, on average, estimated revenues of $8.09 million for the fourth quarter and $24.35 million for the full year.

The stock rallied 24.30% to $9.72 in after-hours session.

Organogenesis Holdings Inc (NASDAQ: ORGO) said it expects fourth-quarter revenue of $104.6 million to $106 million, up 40%-42% year-over-year, and full-year net revenue of $336.1 million to $337.5 million, up about 29%.

This notably exceeded the consensus estimates that call for revenue of $80.84 million for the quarter and $312.34 million for the year.

Separately, the company announced the commencement of a pivotal Phase 3 clinical trial evaluating the safety and efficacy of ReNu, a cryopreserved amniotic suspension allograft, for the management of symptoms associated with knee osteoarthritis.

The stock was surging 32.15% premarket Thursday to $9.70.

Integra Lifesciences Holdings Corp (NASDAQ: IART) preannounced fourth-quarter revenue of $387 million to $389 million, a decline of 1.6%-2.1%. For the full year, the company expects revenue in a range of $1.37 billion to $1.372 billion, representing a decrease of 9.7% to 9.6%.

Analysts, on average, estimate revenues of $389.05 million for the quarter and $1.37 billion for the year.

The stock was slipping 0.96% to $65.02 in premarket trading Thursday.

Offerings

Evoke Pharma Inc (NASDAQ: EVOK) said it has priced an underwritten public offering of 5 million shares of its common stock at $2.50 per share to raise gross proceeds of $12.5 million.

The stock was up 1.83% premarket at $2.78.

Aldeyra Therapeutics Inc (NASDAQ: ALDX) priced an underwritten public offering of 6.842 million shares of its common stock at $9.50 per share. The gross proceeds from the offering are expected to be approximately $65 million.

The company anticipates using the net proceeds from the offering for the continued development of its lead compound reproxalap, and its other product candidates, as well as for working capital and other general corporate purposes.

The stock was up 5.01% premarket at $10.68.

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

See more from Benzinga

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Advertisement

Recommended Stories