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

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. ALNY
• Atea Pharmaceuticals Inc AVIR
• Bioanalytical Systems, Inc. BASI
• Bioatla Inc BCAB
• Biodesix Inc 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 BIOL
• C4 Therapeutics Inc CCCC
• Cassava Sciences Inc SAVA
• Celcuity Inc CELC
• CareDx Inc CDNA
• Celsius Holdings, Inc. CELH
• DermTech Inc DMTK (announced inclusion of non-invasive genomic patch testing for melanoma in National Comprehensive Cancer Network program)
• Dyne Therapeutics Inc DYN
• Edap Tms SA EDAP
• ESSA Pharma Inc EPIX - announced a clinical collaboration with Johnson & Johnson JNJ unit for prostate cancer study
• Genetron Holdings Ltd – ADR GTH
• Genmab 10 Sponsored ADR Ord Shs GMAB (announced achievement of $40 million milestone payment due from AbbVie for diffuse large B-cell lymphoma study)
• Glaukos Corp GKOS (announced positive Phase 2b data for iDose TR sustained-release travoprost implant)
• Guardant Health Inc GH
• Halozyme Therapeutics, Inc. HALO
• Inari Medical Inc NARI (reacted to preliminary fourth-quarter results)
• Insulet Corporation PODD
• Kaleido Biosciences Inc KLDO
• Kodiak Sciences Inc KOD
• Laboratory Corp. of America Holdings LH
• Mediwound Ltd MDWD
• Natera Inc NTRA
• Neuronetics Inc STIM (reacted to preliminary fourth-quarter results)
• Novocure Ltd NVCR
• Pacira Biosciences Inc PCRX
• Renalytix AI PLC RNLX
• SAGE Therapeutics Inc SAGE - Biogen Inc BIIB disclosed a 10.7% stake in the company
• Shockwave Medical Inc SWAV
• Supernus Pharmaceuticals Inc SUPN
• Syneos Health Inc SYNH
• TFF Pharmaceuticals Inc TFFP
• TG Therapeutics Inc common stock TGTX
• Vericel Corp VCEL
• X T L Biopharmaceuticals Ltd XTLB
• Zai Lab Ltd – ADR 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. 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 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 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 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 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 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 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 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